COMMISSION REGULATION (EU) No …/..of XXX laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council - Main contents
Contents
| Document date | 24-11-2011 |
|---|---|
| Publication date | 01-12-2011 |
| Reference | 17451/11 |
| From | European Commission, |
| To | General Secretariat of the Council |
| External link | original PDF |
| Original document in PDF |  |
COUNCIL OF Brussels, 24 November 2011
THE EUROPEAN UNION
17451/11
DENLEG 148 AGRI 807
COVER NOTE
from: European Commission, date of receipt: 22 November 2011
to: General Secretariat of the Council
No Cion doc.: D015454/02
Subject: COMMISSION REGULATION (EU) No …/..of XXX laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 i of the European Parliament and of the Council
Delegations will find attached Commission document D015454/02.
________________________
Encl.: D015454/02
EUROPEAN COMMISSION
Brussels, XXX SANCO/11368/2011 Rev. 5 (POOL/E3/2011/11368/11368R5- EN.doc) D015454/02 […] (2011) XXX draft
COMMISSION REGULATION (EU) No …/..
of XXX
laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council
(Text with EEA relevance)
EN EN
COMMISSION REGULATION (EU) No …/..
of XXX
laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1333/2008 i of the European Parliament and of the
Council of 16 December 2008 on food additives 1 , and in particular Articles 14 and 30(4)
thereof, and Regulation (EC) No 1331/2008 i of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food
enzymes and food flavourings 2 , and in particular Article 7(5) thereof,
Whereas:
(1) Specifications relating to origin, purity criteria and any other necessary information should be adopted for food additives listed in the Union lists in Annex II and III to Regulation (EC) No 1333/2008 i.
(2) To that end, specifications previously developed for food additives in Commission Directive 2008/128/EC of 22 December 2008 laying down specific purity criteria
concerning colours for use in foodstuffs 3 , Commission Directive 2008/84/EC of
27 August 2008 laying down specific purity criteria on food additives other than
colours and sweeteners 4 and Commission Directive 2008/60/EC of 17 June 2008 laying down specific purity criteria concerning sweeteners for use in foodstuffs 5
should be updated and taken over to this Regulation. As a consequence, those Directives should be repealed.
(3) It is necessary to take into account the specifications and analytical techniques as set out in the Codex Alimentarius drafted by the Joint FAO/WHO Expert Committee on Food Additives (hereafter JECFA).
1 OJ L 354, 31.12.2008, p. 16.
2 OJ L 354, 31.12.2008, p. 1.
3 OJ L 6, 10.1.2009, p. 20.
4 OJ L 253, 20.9.2008, p. 1.
5 OJ L 158, 18.6.2008, p. 17.
(4) The European Food Safety Authority (hereinafter "the Authority") expressed its
opinion on the safety of basic methacrylate copolymer 6 as a glazing agent. That food
additive has subsequently been authorised on the basis of specific uses and has been allocated the number E 1205. Therefore specifications should be adopted for that food
additive.
(5) Food colours ethyl ester of beta-apo-8'-carotenic acid (E 160 f), and brown FK (E 154), as well as the aluminium containing carrier bentonite (E 558) are not used any more according to information submitted by food manufacturers. Therefore, current specifications for those food additives should not be taken over to this Regulation.
(6) On 10 February 2010 the Authority expressed an opinion on the safety of sucrose
esters of fatty acids (E 473) prepared from vinyl esters of fatty acids 7 . Current
specifications should be adapted accordingly in particular by reducing maximum
limits for impurities of safety concern.
(7) Specific purity criteria currently applicable should be adapted by reducing maximum limits for individual heavy metals of interest where feasible and where the JECFA limits are lower than those currently in force. Pursuant to that approach maximum limits for the contaminant 4-methylimidazole in ammonia caramel (E 150 c), sulphated ash in beta-carotene (E 160 a (i)), and magnesium and alkali salts in calcium carbonate (E 170), should be lowered. That approach should be departed from only for additives trisodium citrate (E 331 (iii)) (lead content), carrageenan (E 407) and processed euchema seaweed (E407 a) (cadmium content), as manufacturers have declared that compliance with stricter Union provisions, reflecting JECFA limits, would not be technically feasible. The contribution to the total intake of those two contaminants (lead and cadmium) in those three individual food additives is not considered to be significant. On the contrary for phosphates (E 338 – E 341 and E 450- E 452) new significantly lower values, compared to the ones indicated by JECFA, should be established due to new developments of the manufacturing processes, by taking into account the recent recommendations of the Authority on a
reduction of the intake of arsenic, especially in the inorganic form 8 . In addition, a new
provision on arsenic for glutamic acid (E 620) should be introduced for safety reasons. The total balance of those adaptations benefits the consumers as maximum limits for heavy metals are becoming stricter in general and in most of the food additives. Detailed information on the production process and starting materials of a food additive should be included in the specifications to facilitate any future decision
pursuant to Article 12 of Regulation (EC) No 1333/2008 i.
6 EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); Scientific Opinion on the
use of Basic Methacrylate Copolymer as a food additive on request from the European Commission. EFSA Journal 2010; 8(2):1513.
7 EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); Scientific Opinion on the
safety of sucrose esters of fatty acids prepared from vinyl esters of fatty acids and on the extension of use of sucrose esters of fatty acids in flavourings on request from the European Commission. EFSA
Journal 2010; 8(3):1512.
8 EFSA Panel on Contaminants in the Food Chain (CONTAM); Scientific Opinion on Arsenic in Food.
EFSA Journal 2009; 7(10):1351.
(8) Specifications should not make reference to organoleptic tests related to the taste as it cannot be expected by the control authorities to take the risk to taste a chemical substance.
(9) Specifications should not make reference to classes as there is no added value in this reference.
(10) Specifications should not make reference to the general parameter "Heavy metals" as this parameter does not relate with toxicity, but rather with a generic analytical method. Parameters related to individual heavy metals are toxicity related and are included in the specifications.
(11) Some food additives are currently listed under various names (carboxy methyl cellulose (E 466), cross-linked sodium carboxymethylcellulose (E 468), enzymatically hydrolised carboxymethylcellulose (E 469) and beeswax, white and yellow (E 901)) in
various provisions of Directive 95/2/EC i 9 . Therefore the specifications established by
this Regulation should refer to those various names.
(12) Current provisions on Polycyclic Aromatic Hydrocarbons (PAHs) are too generic and not relevant to safety and should be replaced by maximum limits for individual PAHs of concern for food additives vegetable carbon (E 153) and microcrystalline wax (E 905). Similar maximum limits should be established for formaldehyde in carageenan (E 407) and processed euchema seaweed (E 407 a), for particular microbiological criteria in agar (E 406) and for salmonella spp. content in mannitol (E 421 (ii)) manufactured by fermentation.
(13) The use of propan-2-ol (isopropanol, isopropyl alcohol) should be allowed for manufacturing the additives curcumin (E 100) and paprika extract (E 160 c), in line with JECFA specifications, as this particular use has been considered safe by the
Authority 10 . The use of ethanol in replacement of propan-2-ol in the manufacturing of
gellan gum (E 418) should be permitted where the final product still complies with all other specifications and ethanol is considered to be of less safety concern.
(14) The percentage of the colouring principle in cochineal, carminic acid, carmines (E 120) should be specified, as maximum limits are to apply to quantities of that principle.
(15) The numbering system for subcategories of carotenes (E 160 a) should be updated in order to bring it in line with the Codex alimentarius numbering system.
(16) The solid form of lactic acid (E 270) should also be included in the specifications, as it can now be manufactured in the solid form and there is no safety concern.
(17) The current temperature value in loss on drying for monosodium citrate (E 331 (i)), anhydrous form should be adjusted as under the currently listed conditions the substance decomposes. Drying conditions for trisodium citrate (E 331 (iii)) should also be adjusted to improve the reproducibility of the method.
9 OJ L 61, 18.3.1995, p. 1.
10 EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); Scientific Opinion on the
re-evaluation of curcumin (E 100) as a food additive. EFSA Journal 2010; 8(9):1679.
(18) The current specific absorption value for alpha-tocopherol (E 307) should be corrected and the sublimation point for sorbic acid (E 200) should be replaced by a "solubility test" as the former is not relevant. The specification of bacterial sources for the manufacturing of nisin (E 234) and natamycin (E 235) should be updated according to the current taxonomic nomenclature.
(19) As new innovative manufacturing techniques resulting in less contaminated food additives are now available, the presence of aluminium in food additives should be restricted. In order to enhance legal certainty and non-discrimination it is appropriate to provide the manufacturers of food additives with a transitional period to adapt gradually to those restrictions.
(20) Maximum limits for aluminium should be established for food additives where relevant, and particularly for calcium phosphates (E 341 (i)-(iii)) intended to be used
in food for infants and young children 11 , according to the relevant opinion of Scientific Committee on Food expressed on 7 June 1996 12 . In this framework a maximum limit
for aluminum in calcium citrate (E 333) should also be established.
(21) The maximum limits for aluminium in calcium phosphates (E 341 (i)-(iii)), disodium diphosphate (E 450 (i)) and calcium dihydrogen diphosphate (E 450 (vii)) should be in
accordance with the opinion of the Authority of 22 May 2008 13 . Current limits should
be reduced, where this is technically feasible, and where the contribution to the total aluminium intake is significant. In this framework aluminium lakes of individual food
colours should be authorised only if technically needed.
(22) Provisions on maximum limits for aluminium in dicalcium phosphate (E 341 (ii)), tricalcium phosphate (E 341 (iii)) and calcium dihydrogen diphosphate (E 450 (vii)) should not cause any disruption of the market, due to a possible lack of supplies.
(23) According to Commission Regulation (EU) No 258/2010 of 25 March 2010 imposing special conditions on the imports of guar gum originating in or consigned from India
due to contamination risks by pentachlorophenol and dioxins 14 , maximum limits
should be set for the contaminant pentachlorophenol in guar gum (E 412).
(24) According to recital 48 of Commission Regulation (EC) No 1881/2006 of 19
December 2006 setting maximum levels for certain contaminants in foodstuffs 15
Member States are requested to examine other foodstuffs than the ones included in that Regulation for the occurrence of contaminant 3-MCPD in order to consider the need to set maximum levels for that substance. French authorities have submitted data on high concentrations of 3-MCPD in the food additive glycerol (E 422) and the average use level of this food additive in various food categories. Maximum limits for 3-MCPD in this particular food additive should be set in order to avoid contamination
11 As defined in Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based
foods and baby foods for infants and young children (Codified version), OJ L 339, 6.12.2006, p. 16.
12 Opinion on Additives in nutrient preparations for use in infant formulae, follow-on formulae and weaning foods. Reports of the Scientific Committee on food (40 th Series), p.13-30, (1997).
13 Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Food Contact
Materials on a request from European Commission on Safety of aluminium from dietary intake. The EFSA Journal (2008) 754, 1-34.
14 OJ L 80, 26.3.2010, p. 28.
15 OJ L 364, 20.12.2006, p. 5.
of the final food at a higher than permissible level, taking into account the dilution
factor.
(25) Due to the development of analytical methods certain current specifications should be updated. The current limit value "not detectable" is linked to the evolution of analytical methodologies and should be replaced by a specific number for additives acid esters of mono- and di-glycerides (E 472 a-f), polyglycerol esters of fatty acids (E 475) and propane-1,2-diol esters of fatty acids (E 477).
(26) Specifications relating to the manufacturing procedure should be updated for citric acid esters of mono- and diglycerides of fatty acids (E 472 c), as the use of alkaline bases is replaced today by the use of their milder acting salts.
(27) The current criterion "free fatty acids" for additives citric acid esters of mono- and diglycerides of fatty acids (E 472 c) and mono and diacetyltartaric acid esters of mono- and diglycerides of fatty acids (E 472 e) is not appropriate. It should be replaced by the criterion "acid value" as the latter expresses better the titrimetric
estimation of the free acidic groups. This is in accordance with the 71 st report on food additives from JECFA 16 where such change was adopted for mono and diacetyltartaric
acid esters of mono- and diglycerides of fatty acids (E 472 e).
(28) The current erroneous description of additive magnesium oxide (E 530) should be corrected according to information submitted by the manufacturers, in order to bring it
in line with the Pharmacopoeia Europea 17 . The current maximum value for the
reducing matter in additive gluconic acid (E 574) should also be updated as this limit is not technically feasible. For the estimation of the water content of xylitol (E 967) the current method based on "loss on drying", should be replaced by a more
appropriate method.
(29) Some current specifications for additive candelilla wax (E 902) should not be taken over to this Regulation since they are erratic. For calcium dihydrogen diphosphate (E 450 (vii)) the current entry concerning P 2 O 5 content should be corrected.
(30) In the current entry "assay" for thaumatin (E 957) a calculation factor should be corrected. That factor is to be used in the Kjeldahl method for the estimation of the total content of the substance based on the measurement of nitrogen. The calculation factor should be updated according to the relevant published literature for thaumatin (E 957).
(31) The Authority evaluated the safety of steviol glycosides, as a sweetener and expressed
its opinion of 10 March 2010 18 . The use of steviol glycosides, which have been
allocated number E 960, has subsequently been permitted on the basis of well defined
conditions of use. Therefore specifications should be adopted for this food additive.
(32) Due to a taxonomic change, current specifications for source materials (yeasts) used in the manufacturing of erythritol (E 968) should be updated.
16 WHO Technical Report Series, No 956, 2010.
17 EP 7.0 volume 2, p. 2415- 2416.
18 EFSA Panel on Food Additives and Nutrient Sources (ANS); Scientific Opinion on the safety of steviol
glycosides for the proposed uses as a food additive. The EFSA Journal (2010); 8(4):1537.
(33) For quillaia extract (E 999) the current specification relating to the pH range should be adjusted in order to bring it in line with JECFA.
(34) The combination of citric acid and phosphoric acid (which are currently both individually authorised for use in the manufacturing of additive polydextrose (E 1200)), should be allowed, where the final product still complies with the purity specifications, as it improves yields and results to more controllable reaction kinetics. There is no safety concern involved in such amendment.
(35) Unlike for small molecules, the molecular mass of a polymer is not one unique value. A given polymer may have a distribution of molecules with different masses. The distribution may depend on the way the polymer is produced. Polymer physical properties and behaviors are related to the mass and to the distribution of molecules with a certain mass in the mixture. A group of mathematical models describe the mixture in different ways in order to clarify the distribution of molecules in the mixture. Among the different models available, it is recommended in scientific literature to use the weight average molecular weight (Mw) to describe polymers. The specifications for polyvinylpyrrolidone (E 1201) should be adjusted accordingly.
(36) The criterion "Distillation range" referred to in current specifications for propane-1,2 diol (E 1520) leads to contradictory conclusions compared to results from the assay. That criterion should therefore be corrected and renamed into "Distillation test".
(37) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them,
HAS ADOPTED THIS REGULATION:
Article 1 Specifications for food additives
Specifications for food additives including colours and sweeteners listed in Annex II and III to Regulation (EC) No 1333/2008 i are laid down in the Annex to this Regulation.
Article 2
Repeals
Directives 2008/60/EC, 2008/84/EC and 2008/128/EC are repealed with effect from 1 December 2012.
Article 3 Transitional measures
Foodstuffs containing food additives that have been lawfully placed on the market before
stocks are exhausted.
EN 7 EN
Article 4 Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 1 December 2012.
However, the specifications laid down in the Annex for additives steviol glycosides (E 960) and basic methacrylate copolymer (E 1205) shall apply from the date of entry into force of this Regulation.
This Regulation shall be binding in its entirety and directly applicable in the Member States.
Done at Brussels,
For the Commission José Manuel BARROSO The President
ANNEX
ote: Ethylene oxide may not be used for sterilising purposes in food additives
Aluminium lakes for use in colours only where explicitly stated.
Definition: Aluminium lakes are prepared by reacting colours complying with the purity criteria set out in the appropriate specification monograph with alumina under aqueous conditions. The alumina is usually freshly prepared undried material made by reacting aluminium sulphate or chloride with sodium or calcium carbonate or bicarbonate or ammonia. Following lake formation, the product is filtered, washed with water and dried. Unreacted alumina may also be present in the finished product.
HCl insoluble Not more than 0,5 % matter Νot more than 0,5 %, for Ε 127 erythrosine only ΝaΟΗ insoluble matter
Ether Not more than 0,2 % (under neutral conditions) extractable
matter Specific purity criteria for the corresponding colours are
applicable.
E 100 CURCUMIN
Synonyms CI Natural Yellow 3; Turmeric Yellow; Diferoyl
Methane Definition Curcumin is obtained by solvent extraction of turmeric
i.e. the ground rhizomes of strains of Curcuma longa L.
In order to obtain a concentrated curcumin powder, the
extract is purified by crystallization. The product
consists essentially of curcumins; i.e. the colouring
principle (1,7-bis(4-hydroxy-3-methoxyphenyl)hepta
1,6-dien-3,5-dione) and its two desmethoxy derivatives
in varying proportions. Minor amounts of oils and
resins naturally occurring in turmeric may be present.
Curcumin is also used as the aluminium lake; the aluminium content is less than 30%.
Only the following solvents may be used in the extraction: ethylacetate, acetone, carbon dioxide, dichloromethane, n-butanol, methanol, ethanol, hexane, propan-2-ol.
Colour Index 75300 No
EINECS 207-280-5
Chemical name I 1,7-Bis(4-hydroxy-3-methoxyphenyl)hepta 1,6-diene-3,5-dione
II 1-(4-Hydroxyphenyl)-7-(4-hydroxy-3- methoxy-phenyl-)hepta-1,6-diene-3,5-dione
III 1,7-Bis(4-hydroxyphenyl)hepta-1,6-diene-3,5- dione
Chemical I C 21 H 20 O 6
formula
II C 20 H 18 O 5
III C 19 H 16 O 4
Molecular I. 368,39 II. 338,39 III. 308,39 weight
Assay Content not less than 90 % total colouring matters
E 1 % 1cm 1607 at ca 426 nm in ethanol
Description Orange-yellow crystalline powder
Identification
Spectrometry Maximum in ethanol at ca 426 nm
Melting Range 179 °C—182 °C Purity
Solvent Ethylacetate residues Acetone
n-butanol
Methanol Not more than 50 mg/kg, singly or in combination
Ethanol
Hexane
Propan-2-ol
Dichloromethane: not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Aluminium lakes of this colour may be used.
E 101 (i) RIBOFLAVIN
Synonyms Lactoflavin;
Definition
Colour Index No
EINECS 201-507-1
Chemical name 7,8-Dimethyl-10-(D-ribo-2,3,4,5- tetrahydroxypentyl)benzo(g)pteridine-2,4(3H,10H)- dione; 7,8-dimethyl-10-(1′-D-ribityl)isoalloxazine
Chemical C 17 H 20 N 4 O 6
formula
Molecular 376,37 weight
Assay Content not less than 98 % on the anhydrous basis
E 1 % 1 cm 328 at ca 444 nm in aqueous solution
Description Yellow to orange-yellow crystalline powder, with slight odour
Identification
Spectrometry The ratio A 375 /A 267 is
between 0,31 and 0,33 in aqueous solution
The ratio A 444 /A 267 is between 0,36 and 0,39
Maximum in water at ca 375 nm
Specific rotation [α] 20 D between -115° and -140° in a 0,05 N sodium
hydroxide solution
Purity
Loss on drying Not more than 1,5 % (105 °C, 4 hours)
Sulphated ash Not more than 0,1 %
Primary Not more than 100 mg/kg (calculated as aniline) aromatic amines
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 101 (ii) RIBOFLAVIN-5′-PHOSPHATE
Synonyms Riboflavin-5′-phosphate sodium
Definition These specifications apply to riboflavin 5′-phosphate together with minor amounts of free riboflavin and
riboflavin diphosphate.
Colour Index No
EINECS 204-988-6 Chemical name Monosodium(2R,3R,4S)-5-(3′)10′-dihydro-7′,8′- dimethyl-2′,4′-dioxo-10′-benzo[γ]pteridinyl)-2,3,4- trihydroxypentyl phosphate; monosodium salt of 5′- monophosphate ester of riboflavin
Chemical For the dihydrate form: C 17 H 20 N 4 NaO 9 P · 2H 2 O
formula For the anhydrous form: C 17 H 20 N 4 NaO 9 P
Molecular 514,36 weight
Assay Content not less than 95 % total colouring matters calculated as C 17 H 20 N 4 NaO 9 P.2H 2 O
E 1 % 1 cm 250 at ca 375 nm in aqueous solution
Description Yellow to orange crystalline hygroscopic powder, with slight odour
Identification
Spectrometry The ratio A 375 /A 267 is
between 0,30 and 0,34 in aqueous solution
The ratio A 444 /A 267 is between 0,35 and 0,40
Maximum in water at ca 375 nm
Specific rotation [α] 20 D between + 38° and + 42° in a 5 molar HCl
solution
Purity
Loss on drying Not more than 8 % (100 °C, 5 hours in vacuum over P 2 O 5 ) for the dihydrate form
Sulphated ash Not more than 25 %
Inorganic Not more than 1,0 % (calculated as PO 4 on the phosphate anhydrous basis)
Subsidiary Riboflavin (free): Not more than 6 % colouring
matters Riboflavine diphosphate: Not more than 6 %
Primary Not more than 70 mg/kg (calculated as aniline) aromatic amines
Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 102 TARTRAZINE
Synonyms CI Food Yellow 4
Definition Tartrazine is prepared from 4-amino-benzenesulphonic acid, which is diazotized using hydrochloric acid and
sodium nitrite. The diazo compound is then coupled with 4,5-dihydro-5-oxo-1-(4sulphophenyl)-1H- pyrazole-3-carboxylic acid or with the methyl ester, the ethyl ester, or a salt of this carboxylic acid. The resulting dye is purified and isolated as the sodium salt. Tartrazine consists essentially of trisodium 5-hydroxy 1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-H- pyrazole-3-carboxylate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components.
Tartrazine is described as the sodium salt. The calcium and the potassium salt are also permitted.
Colour Index 19140 No
EINECS 217-699-5
Chemical name Trisodium-5-hydroxy-1-(4-sulfonatophenyl)-4-(4- sulfonatophenylazo)-H-pyrazole-3-carboxylate
Chemical C 16 H 9 N 4 Na 3 O 9 S 2 formula
Molecular 534,37 weight
Assay Content not less than 85 % total colouring matters calculated as the sodium salt
E 1 % 1cm 530 at ca 426 nm in aqueous solution
Description Light orange powder or granules
Appearance of Yellow the aqueous solution
Identification
Spectrometry Maximum in water at ca 426 nm
Purity
Water Not more than 0,2 % insoluble matter
Subsidiary Not more than 1,0 % colouring matters
Organic compounds other than colouring matters:
4-hydrazinobenzene sulfonic acid
4-aminobenzene-1- sulfonic acid
5-oxo-1-(4- sulfophenyl)-2- pyrazoline-3- Total not more than 0,5 % carboxylic acid
4,4′- diazoaminodi(benzen e sulfonic acid)
Tetrahydroxysuccini c acid
Unsulfonated Not more than 0,01 % (calculated as aniline) primary aromatic amines
Ether Not more than 0,2 % under neutral conditions
extractable
matter
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Aluminium lakes of this colour may be used.
E 104 QUINOLINE YELLOW
Synonyms CI Food Yellow 13
Definition Quinoline Yellow is prepared by sulfonating 2-(2- quinolyl) indan-1,3-dione or a mixture containing about two-thirds 2-(2-quinolyl)indane-1,3-dione and one third 2-(2-(6-methylquinolyl))indane-1,3-dione. Quinoline Yellow consists essentially of sodium salts of a mixture of disulfonates (principally), monosulfonates and trisulfonates of the above compound and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured
components.
Quinoline Yellow is described as the sodium salt. The calcium and the potassium salt are also permitted.
Colour Index 47005 No
EINECS 305-897-5
Chemical name The disodium salts of the disulfonates of 2-(2-quinolyl) indan-1,3-dione (principal component)
Chemical C 18 H 9 N Na 2 O 8 S 2 (principal component) formula
Molecular 477,38 (principal component) weight
Assay Content not less than 70 % total colouring matters calculated as the sodium salt
Quinoline Yellow shall have the following composition:
Of the total colouring matters present:
not less than 80 % shall be disodium 2-(2-quinolyl) indan-1,3-dione-disulfonates
not more than 15 % shall be sodium 2-(2-quinolyl) indan-1,3-dione-monosulfonates
not more than 7,0 % shall be trisodium 2-(2-quinolyl) indan-1,3-dione-trisulfonate
E 1 % 1cm 865 (principal component) at ca 411 nm in
aqueous acetic acid solution
Description Yellow powder or granules
Appearance of Yellow the aqueous solution
Identification
Spectrometry Maximum in aqueous acetic acid solution of pH 5 at ca 411 nm
Purity
Water Not more than 0,2 % insoluble matter
Subsidiary Not more than 4,0 % colouring matters
Organic compounds other than colouring matters:
2-methylquinoline Total not more than 0,5 %
2-methylquinolinesulfonic acid
Phthalic acid
2,6-dimethyl quinoline 2,6-dimethyl quinoline sulfonic acid
2-(2- Not more than 4 mg/kg quinolyl)indan 1,3-dione
Unsulfonated Not more than 0,01 % (calculated as aniline) primary aromatic amines
Ether Not more than 0,2 % under neutral conditions extractable matter
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Aluminium lakes of this colour may be used.
E 110 SUNSET YELLOW FCF
Synonyms CI Food Yellow 3; Orange Yellow S
Definition Sunset Yellow FCF consists essentially of disodium 2- hydroxy-1-(4-sulfonatophenylazo) naphthalene-6- sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Sunset Yellow FCF is manufactured by diazotizing 4-aminobenzenesulphonic acid using hydrochloric acid and sodium nitrite or sulphuric acid and sodium nitrite. The diazo compound is coupled with 6-hydroxy-2-naphthalene-sulphonic acid. The dye is isolated as the sodium salt and dried.
Sunset Yellow FCF is described as the sodium salt. The calcium and the potassium salt are also permitted.
Colour Index 15985 No
EINECS 220-491-7 Chemical name Disodium 2-hydroxy-1-(4- sulfonatophenylazo)naphthalene-6-sulfonate
Chemical C 16 H 10 N 2 Na 2 O 7 S 2 formula
Molecular 452,37 weight
Assay Content not less than 85 % total colouring matters calculated as the sodium salt
E 1 % 1cm 555 at ca 485 nm in aqueous solution at pH 7
Description Orange-red powder or granules
Appearance of Orange the aqueous solution
Identification
Spectrometry Maximum in water at ca 485 nm at pH 7
Purity
Water Not more than 0,2 % insoluble matter
Subsidiary Not more than 5,0 % colouring matters
1-(Phenylazo)- Not more than 0,5 mg/kg 2-naphthalenol (Sudan I)
Organic compounds other than colouring matters:
4-aminobenzene-1-
sulfonic acid Total not more than 0,5 %
3- hydroxynaphthalene 2,7-disulfonic acid
6- hydroxynaphthalene 2-sulfonic acid
7- hydroxynaphthalene 1,3-disulfonic acid
4,4′- diazoaminodi(benzen e sulfonic acid)
6,6′- oxydi(naphthalene-2- sulfonic acid)
Unsulfonated Not more than 0,01 % (calculated as aniline) primary aromatic amines
Ether Not more than 0,2 % under neutral conditions
extractable
matter
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Aluminium lakes of this colour may be used.
E 120 COCHINEAL, CARMINIC ACID, CARMINES
Synonyms CI Natural Red 4
Definition Carmines and carminic acid are obtained from aqueous, aqueous alcoholic or alcoholic extracts from Cochineal, which consists of the dried bodies of the female insect
Dactylopius coccus Costa.
The colouring principle is carminic acid.
Aluminium lakes of carminic acid (carmines) can be formed in which aluminium and carminic acid are thought to be present in the molar ratio 1:2.
In commercial products the colouring principle is present in association with ammonium, calcium, potassium or sodium cations, singly or in combination, and these cations may also be present in excess.
Commercial products may also contain proteinaceous material derived from the source insect, and may also contain free carminate or a small residue of unbound aluminium cations.
Colour Index 75470 No
EINECS Cochineal: 215-680-6; carminic acid: 215-023-3; carmines: 215-724-4
Chemical name 7-β-D-glucopyranosyl-3,5,6,8-tetrahydroxy-1-methyl 9,10-dioxoanthracene-2-carboxylic acid (carminic
acid); carmine is the hydrated aluminium chelate of this acid
Chemical C 22 H 20 O 13 (carminic acid)
formula
Molecular 492,39 (carminic acid) weight
Assay Content not less than 2,0 % carminic acid in the extracts containing carminic acid; not less than 50 % carminic
acid in the chelates.
Description Red to dark red, friable, solid or powder. Cochineal extract is generally a dark red liquid but can also be dried as a powder.
Identification
Spectrometry Maximum in aqueous ammonia solution at ca 518 nm Maximum in dilute hydrochloric solution at ca 494 nm for carminic acid
E 1 % 1cm 139 at peak around 494 nm in dilute
hydrochloric acid for carminic acid
Purity
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Aluminium lakes of this colour may be used.
E 122 AZORUBINE, CARMOISINE
Synonyms CI Food Red 3
Definition Azorubine consists essentially of disodium 4-hydroxy 3-(4-sulfonato-1-naphthylazo) naphthalene-1-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal
uncoloured components.
Azorubine is described as the sodium salt. The calcium and the potassium salt are also permitted.
Colour Index 14720 No
EINECS 222-657-4
Chemical name Disodium 4-hydroxy-3-(4-sulfonato-1-naphthylazo) naphthalene-1-sulfonate
Chemical C 20 H 12 N 2 Na 2 O 7 S 2 formula
Molecular 502,44 weight
Assay Content not less than 85 % total colouring matters, calculated as the sodium salt
1 cm
EN 22 EN
Description Red to maroon powder or granules
Appearance of Red the aqueous solution
Identification
Spectrometry Maximum in water at ca 516 nm
Purity
Water Not more than 0,2 % insoluble matter
Subsidiary Not more than 1 % colouring matters
Organic compounds other than colouring matters:
4-aminonaphthalene 1-sulfonic acid
4- Total not more than 0,5 %
hydroxynaphthalene 1-sulfonic acid
Unsulfonated Not more than 0,01 % (calculated as aniline) primary aromatic amines
Ether Not more than 0,2 % under neutral conditions
extractable
matter
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Aluminium lakes of this colour may be used.
E 123 AMARANTH
Synonyms CI Food Red 9
Definition Amaranth consists essentially of trisodium 2-hydroxy 1-(4-sulfonato-1-naphthylazo) naphthalene-3,6-
disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Amaranth is manufactured by coupling 4-amino-1- naphthalenesulphonic acid with 3-hydroxy-2,7- naphthalenedisulphonic acid.
Amaranth is described as the sodium salt. The calcium
and the potassium salt are also permitted.
Colour Index 16185 No
EINECS 213-022-2
Chemical name Trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-3,6-disulfonate
Chemical C 20 H 11 N 2 Na 3 O 10 S 3 formula
Molecular 604,48 weight
Assay Content not less than 85 % total colouring matters, calculated as the sodium salt
E 1 % 1 cm 440 at ca 520 nm in aqueous solution
Description Reddish-brown powder or granules
Appearance of Red the aqueous solution
Identification
Spectrometry Maximum in water at ca 520 nm
Purity
Water Not more than 0,2 % insoluble matter
Subsidiary Not more than 3,0 % colouring matters
Organic compounds other than colouring matters:
4-aminonaphthalene 1-sulfonic acid
3- hydroxynaphthalene 2,7-disulfonic acid
6- hydroxynaphthalene
2-sulfonic acid Total not more than 0,5 %
7- hydroxynaphthalene 1,3-disulfonic acid
7- hydroxynaphthalene 1,3-6-trisulfonic acid
Unsulfonated Not more than 0,01 % (calculated as aniline) primary aromatic amines
Ether Not more than 0,2 % under neutral conditions
extractable
matter
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Aluminium lakes of this colour may be used.
E 124 PONCEAU 4R, COCHINEAL RED A
Synonyms CI Food Red 7; New Coccine
Definition Ponceau 4R consists essentially of trisodium 2- hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene 6,8-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Ponceau 4R is manufactured by coupling diazotized naphthionic acid to G acid (2-naphthol-6,8- disulphonic acid) and converting the coupling product to the trisodium salt.
Ponceau 4R is described as the sodium salt. The calcium and the potassium salt are also permitted.
Colour Index 16255 No
EINECS 220-036-2
Chemical name Trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-6,8-disulfonate
Chemical C 20 H 11 N 2 Na 3 O 10 S 3
formula
Molecular 604,48 weight
Assay Content not less than 80 % total colouring matters, calculated as the sodium salt.
E 1 % 1 cm 430 at ca 505 nm in aqueous solution
Description Reddish powder or granules
Appearance of Red the aqueous solution
Identification
Spectrometry Maximum in water at ca 505 nm
Purity
Water Not more than 0,2 % insoluble matter
Subsidiary Not more than 1,0 % colouring matters
Organic compounds other than colouring matters:
4-aminonaphthalene 1-sulfonic acid
7- hydroxynaphthalene 1,3-disulfonic acid
3- hydroxynaphthalene
2,7-disulfonic acid Total not more than 0,5 %
6- hydroxynaphthalene 2-sulfonic acid
7- hydroxynaphthalene 1,3-6-trisulfonic acid
Unsulfonated Not more than 0,01 % (calculated as aniline) primary aromatic amines
Ether Not more than 0,2 % under neutral conditions
extractable
matter
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Aluminium lakes of this colour may be used.
E 127 ERYTHROSINE
Synonyms CI Food Red 14
Definition Erythrosine consists essentially of disodium 2-(2,4,5,7- tetraiodo-3-oxido-6-oxoxanthen-9-yl) benzoate
monohydrate and subsidiary colouring matters together with water, sodium chloride and/or sodium sulphate as the principal uncoloured components. Erythrosine is manufactured by iodination of fluorescein, the condensation product of resorcinol and phthalic anhydride
Erythrosine is described as the sodium salt. The calcium
and the potassium salt are also permitted.
Colour Index 45430 No
EINECS 240-474-8
Chemical name Disodium 2-(2,4,5,7-tetraiodo-3-oxido-6-oxoxanthen-9- yl)benzoate monohydrate
Chemical C 20 H 6 I 4 Na 2 O 5 H 2 O formula
Molecular 897,88 weight
Assay Content not less than 87 % total colouring matters, calculated as the anhydrous sodium salt
E 1 % 1 cm 1 100 at ca 526 nm in aqueous solution at pH 7
Description Red powder or granules.
Appearance of Red the aqueous solution
Identification
Spectrometry Maximum in water at ca 526 nm at pH 7
Purity
Inorganic Not more than 0,1 % (calculated as sodium iodide) iodides
Water Not more than 0,2 % insoluble matter
Subsidiary Not more than 4,0 % colouring matters (except fluorescein)
Fluorescein Not more than 20 mg/kg
Organic compounds other than colouring matters:
Tri-iodoresorcinol Not more than 0,2 %
2-(2,4-dihydroxy Not more than 0,2 % 3,5-diiodobenzoyl) benzoic acid
Ether From a solution of pH from 7 through 8, not more than extractable 0,2 % matter
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Aluminium Lakes of this colour may be used.
E 129 ALLURA RED AC
Synonyms CI Food Red 17
Definition Allura Red AC consists essentially of disodium 2- hydroxy-1-(2-methoxy-5-methyl-4-sulfonatophenylazo)
naphthalene-6-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Allura Red AC is manufactured by coupling diazotized 5-amino-4-methoxy-2- toluenesulphonic acid with 6-hydroxy-2-naphthalene sulphonic acid
Allura Red AC is described as the sodium salt. The calcium and the potassium salt are also permitted.
Colour Index 16035 No EINECS 247-368-0
Chemical name Disodium 2-hydroxy-1-(2-methoxy-5-methyl-4- sulfonatophenylazo) naphthalene-6-sulfonate
Chemical C 18 H 14 N 2 Na 2 O 8 S 2 formula
Molecular 496,42 weight
Assay Content not less than 85 % total colouring matters, calculated as the sodium salt
E 1 % 1 cm 540 at ca 504 nm in aqueous solution at pH 7
Description Dark red powder or granules
Appearance of Red the aqueous solution
Identification
Spectrometry Maximum in water at ca 504 nm
Purity
Water Not more than 0,2 % insoluble matter
Subsidiary Not more than 3,0 % colouring matters
Organic compounds other than colouring matters:
6-hydroxy-2- Not more than 0,3 % naphthalene sulfonic acid, sodium salt
4-amino-5-methoxy Not more than 0,2 % 2-methylbenezene sulfonic acid
6,6-oxybis (2- Not more than 1,0 % naphthalene sulfonic acid) disodium salt
Unsulfonated Not more than 0,01 % (calculated as aniline) primary aromatic amines
Ether From a solution of pH 7, not more than 0,2 % extractable matter
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Aluminium lakes of this colour may be used.
E 131 PATENT BLUE V
Synonyms CI Food Blue 5
Definition Patent Blue V consists essentially of the calcium or sodium compound of [4-(α-(4-diethylaminophenyl)-5- hydroxy-2,4-disulfophenyl-methylidene)2,5-
cyclohexadien-1-ylidene] diethylammonium hydroxide inner salt and subsidiary colouring matters together with sodium chloride and/or sodium sulphate and/or calcium sulphate as the principal uncoloured components.
The potassium salt is also permitted.
Colour Index 42051 No
EINECS 222-573-8
Chemical name The calcium or sodium compound of [4-(α-(4- diethylaminophenyl)-5-hydroxy-2,4-disulfophenylmethylidene) 2,5-cyclohexadien-1-ylidene] diethylammonium hydroxide inner salt
Chemical Calcium compound: C 27 H 31 N 2 O 7 S 2 Ca 1/2
formula Sodium compound: C 27 H 31 N 2 O 7 S 2 Na
Molecular Calcium compound: 579,72
weight Sodium compound: 582,67
Assay Content not less than 85 % total colouring matters, calculated as the sodium salt
E 1 % 1 cm 2 000 at ca 638 nm in aqueous solution at pH 5
Description Dark-blue powder or granules
Appearance of Blue the aqueous solution
Identification
Spectrometry Maximum in water at 638 nm at pH 5
Purity
Water Not more than 0,2 % insoluble matter
Subsidiary Not more than 2,0 % colouring matters
Organic compounds other than colouring matters:
3-hydroxy benzaldehyde
3-hydroxy benzoic acid
3-hydroxy-4- Total not more than 0,5 %
sulfobenzoic acid
N,N-diethylamino benzene sulfonic acid
Leuco base Not more than 4,0 %
Unsulfonated Not more than 0,01 % (calculated as aniline) primary aromatic amines
Ether From a solution of pH 5 not more than 0,2 % extractable matter
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Aluminium lakes of this colour may be used.
E 132 INDIGOTINE, INDIGO CARMINE
Synonyms CI Food Blue 1
Definition Indigotine consists essentially of a mixture of disodium 3,3′dioxo-2,2′-bi-indolylidene-5,5′-disulfonate, and
disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′- disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components.
Indigotine is described as the sodium salt. The calcium and the potassium salt are also permitted.
Indigo carmine is obtained by sulphonation of indigo. This is accomplished by heating indigo (or indigo paste) in the presence of sulphuric acid. The dye is isolated and subjected to purification procedures.
Colour Index 73015 No
EINECS 212-728-8
Chemical name Disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,5′- disulfonate
Chemical C 16 H 8 N 2 Na 2 O 8 S 2 formula
Molecular 466,36 weight Assay Content not less than 85 % total colouring matters, calculated as the sodium salt;
disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′- disulfonate: not more than 18 %
E 1 % 1 cm 480 at ca 610 nm in aqueous solution
Description Dark-blue powder or granules
Appearance of Blue the aqueous solution
Identification
Spectrometry Maximum in water at ca 610 nm
Purity
Water Not more than 0,2 % insoluble matter
Subsidiary Excluding disodium 3,3′-dioxo-2,2′-bi-indolylidenecolouring
5,7′-disulfonate: not more than 1,0 %
matters
Organic compounds other than colouring matters:
Isatin-5-sulfonic acid
5-sulfoanthranilic
acid Total not more than 0,5 %
Anthranilic acid
Unsulfonated Not more than 0,01 % (calculated as aniline) primary aromatic amines
Ether Not more than 0,2 % under neutral conditions extractable matter
Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Aluminium lakes of this colour may be used.
E 133 BRILLIANT BLUE FCF
Synonyms CI Food Blue 2
Definition Brilliant Blue FCF consists essentially of disodium α- (4-(N-ethyl-3-sulfonatobenzylamino) phenyl)-α-(4-N- ethyl-3-sulfonatobenzylamino) cyclohexa-2,5-
dienylidene) toluene-2-sulfonate and its isomers and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components.
Brilliant Blue FCF is described as the sodium salt. The
calcium and the potassium salt are also permitted.
Colour Index 42090 No
EINECS 223-339-8
Chemical name Disodium α-(4-(N-ethyl-3-sulfonatobenzylamino) phenyl)-α-(4-N-ethyl-3-sulfonatobenzylamino)
cyclohexa-2,5-dienylidene) toluene-2-sulfonate
Chemical C 37 H 34 N 2 Na 2 O 9 S 3 formula
Molecular 792,84 weight
Assay Content not less than 85 % total colouring matters, calculated as the sodium salt
E 1 % 1 cm 1 630 at ca 630 nm in aqueous solution
Description Reddish-blue powder or granules
Appearance of Blue the aqueous solution
Identification
Spectrometry Maximum in water at ca 630 nm
Purity
Water Not more than 0,2 % insoluble matter
Subsidiary Not more than 6,0 % colouring matters
Organic compounds other than colouring matters:
Sum of 2-, 3- and 4- Not more than 1,5 % formyl benzene sulfonic acids
3-((ethyl)(4- Not more than 0,3 % sulfophenyl) amino) methyl benzene sulfonic acid
Leuco base Not more than 5,0 %
Unsulfonated Not more than 0,01 % (calculated as aniline)
primary
aromatic
amines
Ether Not more than 0,2 % at pH 7 extractable matter
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Aluminium lakes of this colour may be used.
E 140 (i) CHLOROPHYLLS
Synonyms CI Natural Green 3; Magnesium Chlorophyll;
Magnesium Phaeophytin
Definition Chlorophylls are obtained by solvent extraction of strains of edible plant material, grass, lucerne and nettle. During the subsequent removal of solvent, the naturally present co-ordinated magnesium may be wholly or partly removed from the chlorophylls to give the
corresponding phaeophytins. The principal colouring matters are the phaeophytins and magnesium chlorophylls. The extracted product, from which the solvent has been removed, contains other pigments such as carotenoids as well as oils, fats and waxes derived from the source material. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane.
Colour Index 75810 No
EINECS Chlorophylls: 215-800-7, chlorophyll a: 207-536-6, Chlorophyll b: 208-272-4
Chemical name The major colouring principles are:
Phytyl (13 2 R,17S,18S)-3-(8-ethyl-13 2 -
methoxycarbonyl-2,7,12,18-tetramethyl-13′-oxo-3-
vinyl-13 1 -13 2 -17,18-tetrahydrocyclopenta [at]-
porphyrin-17-yl)propionate, (Phaeophytin a), or as the magnesium complex (Chlorophyll a)
Phytyl (13 2 R,17S,18S)-3-(8-ethyl-7-formyl-13 2 -
methoxycarbonyl-2,12,18-trimethyl-13′-oxo-3-vinyl
13 1 -13 2 -17,18-tetrahydrocyclopenta[at]-porphyrin-17-
yl)propionate, (Pheophytin b), or as the magnesium complex (Chlorophyll b)
Chemical Chlorophyll a (magnesium complex): C 55 H 72 MgN 4 O 5
formula Chlorophyll a: C 55 H 74 N 4 O 5
Chlorophyll b (magnesium complex): C 55 H 70 MgN 4 O 6
Chlorophyll b: C 55 H 72 N 4 O 6
Molecular Chlorophyll a (magnesium complex): 893,51 weight Chlorophyll a: 871,22
Chlorophyll b (magnesium complex): 907,49 Chlorophyll b: 885,20
Assay Content of total combined Chlorophylls and their magnesium complexes is not less than 10 %
E 1 % 1 cm 700 at ca 409 nm in chloroform
Description Waxy solid ranging in colour from olive green to dark green depending on the content of co-ordinated
magnesium
Identification
Spectrometry Maximum in chloroform at ca 409 nm
Purity
Solvent Acetone residues Methyl Ethyl ketone
Methanol Not more than 50 mg/kg, Ethanol singly or in combination
Propan-2-ol
Hexane
Dichloromethane: Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 140 (ii) CHLOROPHYLLINS
Synonyms CI Natural Green 5; Sodium Chlorophyllin; Potassium Chlorophyllin
Definition The alkali salts of chlorophyllins are obtained by the saponification of a solvent extract of strains of edible plant material, grass, lucerne and nettle. The
saponification removes the methyl and phytol ester groups and may partially cleave the cyclopentenyl ring. The acid groups are neutralized to form the salts of potassium and/or sodium.
Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane.
Colour Index 75815 No
EINECS 287-483-3
Chemical name The major colouring principles in their acid forms are:
3-(10-carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2- vinylphorbin-7-yl)propionate (chlorophyllin a)
and
3-(10-carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9- oxo-2-vinylphorbin-7-yl)propionate
(chlorophyllin b)
Depending on the degree of hydrolysis the cyclopentenyl ring may be cleaved with the resultant production of a third carboxyl function.
Magnesium complexes may also be present.
Chemical Chlorophyllin a (acid form): C 34 H 34 N 4 O 5 formula Chlorophyllin b (acid form): C 34 H 32 N 4 O 6
Molecular Chlorophyllin a: 578,68 weight Chlorophyllin b: 592,66
Each may be increased by 18 daltons if the cyclopentenyl ring is cleaved.
Assay Content of total chlorophyllins is not less than 95 % of the sample dried at ca 100 °C for 1 hour.
E 1 % 1 cm 700 at ca 405 nm in aqueous solution at pH 9
1 cm
EN 39 EN
Description Dark green to blue/black powder
Identification
Spectrometry Maximum in aqueous phosphate buffer at pH 9 at ca 405 nm and at ca 653 nm
Purity
Solvent Acetone residues Methyl ethyl ketone
Methanol Not more than 50 mg/kg, singly Ethanol or in combination
Propan-2-ol
Hexane
Dichloromethane: not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 141 (i) COPPER COMPLEXES OF CHLOROPHYLLS
Synonyms CI Natural Green 3; Copper Chlorophyll; Copper
Phaeophytin
Definition Copper chlorophylls are obtained by addition of a salt of copper to the substance obtained by solvent
extraction of strains of edible plant material, grass, lucerne, and nettle. The product, from which the solvent has been removed, contains other pigments such as carotenoids as well as fats and waxes derived from the source material. The principal colouring matters are the copper phaeophytins. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane.
Colour Index 75810 No EINECS Copper chlorophyll a: 239-830-5; copper chlorophyll b: 246-020-5
Chemical name [Phytyl (13 2 R,17S,18S)-3-(8-ethyl-13 2 -
methoxycarbonyl-2,7,12,18-tetramethyl-13′-oxo-3-
vinyl-13 1 -13 2 -17,18-tetrahydrocyclopenta[at]-
porphyrin-17-yl)propionate] copper (II) (Copper Chlorophyll a)
[Phytyl (13 2 R,17S,18S)-3-(8-ethyl-7-formyl-13 2 -
methoxycarbonyl-2,12,18-trimethyl-13′-oxo-3-vinyl
13 1 -13 2 -17,18-tetrahydrocyclopenta[at]-porphyrin-17-
yl)propionate] copper (II) (Copper chlorophyll b)
Chemical Copper chlorophyll a: C 55 H 72 Cu N 4 O 5
formula Copper chlorophyll b: C 55 H 70 Cu N 4 O 6
Molecular Copper chlorophyll a: 932,75 weight Copper chlorophyll b: 946,73
Assay Content of total copper chlorophylls is not less than 10 %.
E 1 % 1 cm 540 at ca 422 nm in chloroform
E 1 % 1 cm 300 at ca 652 nm in chloroform
Description Waxy solid ranging in colour from blue green to dark green depending on the source material
Identification
Spectrometry Maximum in chloroform at ca 422 nm and at ca 652 nm
Purity
Solvent Acetone residues Methyl ethyl ketone
Methanol Not more than 50 mg/kg, singly Ethanol or in combination
Propan-2-ol
Hexane
Dichloromethane: not more than 10 mg/kg Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Copper ions Not more than 200 mg/kg
Total copper Not more than 8,0 % of the total copper phaeophytins
Aluminium lakes of this colour may be used.
E 141 (ii) COPPER COMPLEXES OF CHLOROPHYLLINS
Synonyms Sodium Copper Chlorophyllin; Potassium Copper Chlorophyllin; CI Natural Green 5
Definition The alkali salts of copper chlorophyllins are obtained by the addition of copper to the product obtained by the
saponification of a solvent extraction of strains of edible plant material, grass, lucerne, and nettle; the saponification removes the methyl and phytol ester groups and may partially cleave the cyclopentenyl ring. After addition of copper to the purified chlorophyllins, the acid groups are neutralized to form the salts of potassium and/or sodium.
Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide methanol, ethanol, propan-2-ol and hexane.
Colour Index 75815 No
EINECS
Chemical name The major colouring principles in their acid forms are 3- (10-Carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-
vinylphorbin-7-yl)propionate, copper complex (Copper chlorophyllin a) and 3-(10-Carboxylato-4-ethyl-3- formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin-7-yl) propionate, copper complex (Copper chlorophyllin b)
Chemical Copper chlorophyllin a (acid form): C 34 H 32 Cu N 4 O 5 formula
EN 42 EN
Molecular Copper chlorophyllin a: 640,20 weight Copper chlorophyllin b: 654,18
Each may be increased by 18 daltons if the cyclopentenyl ring is cleaved.
Assay Content of total copper chlorophyllins is not less than 95 % of the sample dried at 100 °C for 1 h.
E 1 % 1 cm 565 at ca 405 nm in aqueous phosphate buffer
at pH 7,5
E 1 % 1 cm 145 at ca 630 nm in aqueous phosphate buffer
at pH 7,5
Description Dark green to blue/black powder
Identification
Spectrometry Maximum in aqueous phosphate buffer at pH 7,5 at ca 405 nm and at 630 nm
Purity
Solvent Acetone residues Methyl ethyl ketone
Methanol Not more than 50 mg/kg, singly
Ethanol or in combination
Propan-2-ol
Hexane
Dichloromethane: not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Copper ions Not more than 200 mg/kg
Total copper Not more than 8,0 % of the total copper chlorophyllins
Aluminium lakes of this colour may be used.
E 142 GREEN S
Synonyms CI Food Green 4, Brilliant Green BS
Definition Green S consists essentially of sodium N-[4-[[4-
(dimethylamino)phenyl] 2-hydroxy-3,6-disulfo-1- naphthalenyl)methylene]-2,5-cyclohexadien-1-ylidene]- N-methylmethanaminium and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured compounds.
Green S is described as the sodium salt. The calcium and the potassium salt are also permitted.
Colour Index 44090 No
EINECS 221-409-2
Chemical name Sodium N-[4-[[4-(dimethylamino)phenyl](2-hydroxy 3,6-disulfo-1-naphthalenyl)-methylene]2,5-
cyclohexadien-1-ylidene]-N-methylmethanaminium; Sodium 5-[4-dimethylamino-α-(4- dimethyliminocyclohexa-2,5-dienylidene) benzyl]-6- hydroxy-7-sulfonato-naphthalene-2-sulfonate (alternative chemical name).
Chemical C 27 H 25 N 2 NaO 7 S 2 formula
Molecular 576,63 weight
Assay Content not less than 80 % total colouring matters calculated as the sodium salt
E 1 % 1 cm 1 720 at ca 632 nm in aqueous solution
Description Dark blue or dark green powder or granules
Appearance of Blue or green the aqueous solution
Identification
Spectrometry Maximum in water at ca 632 nm
Purity
Water Not more than 0,2 % insoluble matter
Subsidiary Not more than 1,0 % colouring matters
Organic compounds other than colouring matters:
4,4′- Not more than 0,1 % bis(dimethylamino)- benzhydryl alcohol
4,4′- Not more than 0,1 % bis(dimethylamino)- benzophenone
3- Not more than 0,2 % hydroxynaphthalene 2,7-disulfonic acid
Leuco base Not more than 5,0 %
Unsulfonated Not more than 0,01 % (calculated as aniline) primary aromatic amines
Ether Not more than 0,2 % under neutral conditions
extractable
matter
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Aluminium lakes of this colour may be used.
E 150a PLAIN CARAMEL
Synonyms Caustic caramel
Definition Plain caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the
monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose). To promote caramelisation, acids, alkalis and salts may be employed, with the exception of ammonium compounds and sulphites.
Colour Index No
EINECS 232-435-9
Chemical name
Chemical formula
Molecular weight
Assay
Description Dark brown to black liquids or solids
Identification
Purity
Colour bound Not more than 50 % by DEAE cellulose
Colour bound Not more than 50 % by phosphoryl cellulose
Colour 0,01—0,12
intensity 19
Total nitrogen Not more than 0,1 %
Total sulphur Not more than 0,2 %
Arsenic Not more than 1 mg/kg
19 Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water
in a 1 cm cell at 610 nm.
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 150b CAUSTIC SULPHITE CARAMEL
Synonyms
Definition Caustic sulphite caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the
monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis, in the presence of sulphite compounds (sulphurous acid, potassium sulphite, potassium bisulphite, sodium sulphite and sodium bisulphite); no ammonium compounds are used.
Colour Index No
EINECS 232-435-9
Chemical name
Chemical formula
Molecular weight
Assay
Description Dark brown to black liquids or solids
Identification
Purity
Colour bound More than 50 % by DEAE cellulose Colour 0,05—0,13
intensity 20
Total nitrogen Not more than 0,3 % 21
Sulphur Not more than 0,2 % 3
dioxide
Total sulphur 0,3—3,5 % 3
Sulphur bound More than 40 % by DEAE cellulose
Absorbance 19—34 ratio of colour bound by DEAE cellulose
Absorbance Greater than 50 ratio (A 280/560 )
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 150c AMMONIA CARAMEL
Synonyms
Definition Ammonia caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the
monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis, in the presence of ammonium compounds (ammonium hydroxide, ammonium carbonate, ammonium hydrogen carbonate and ammonium phosphate); no sulphite
20 Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water
in a 1 cm cell at 610 nm.
21 Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of
0,1 absorbance units.
compounds are used.
Colour Index No
EINECS 232-435-9
Chemical name
Chemical formula
Molecular weight
Assay
Description Dark brown to black liquids or solids
Identification
Purity
Colour bound Not more than 50 % by DEAE cellulose
Colour bound More than 50 % by phosphoryl cellulose
Colour 0,08—0,36
intensity 22
Ammoniacal Not more than 0,3 % 23
nitrogen
4- Not more than 200 mg/kg 5
methylimidazol e
2-acetyl-4- Not more than 10 mg/kg 5
tetrahydroxybutylimidazole
Total sulphur Not more than 0,2 % 5
22 Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water
in a 1 cm cell at 610 nm.
23 Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of
0,1 absorbance units.
Total nitrogen 0,7—3,3 % 5
Absorbance 13—35 ratio of colour bound by phosphoryl cellulose
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 150d SULPHITE AMMONIA CARAMEL
Synonyms
Definition Sulphite ammonia caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the
monomers glucose and fructose and/or polymers thereof (e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis in the presence of both sulphite and ammonium compounds (sulphurous acid, potassium sulphite, potassium bisulphite, sodium sulphite, sodium bisulphite, ammonium hydroxide, ammonium carbonate, ammonium hydrogen carbonate, ammonium phosphate, ammonium sulphate, ammonium sulphite and ammonium hydrogen sulphite).
Colour Index No
EINECS 232-435-9
Chemical name
Chemical formula
Molecular weight
Assay Description Dark brown to black liquids or solids
Identification
Purity
Colour bound More than 50 % by DEAE cellulose
Colour 0,10 - 0,60
intensity 24
Ammoniacal Not more than 0,6 % 25
nitrogen
Sulphur Not more than 0,2 % 7
dioxide
4- Not more than 250 mg/kg 7
methylimidazol e
Total nitrogen 0,3 - 1,7 % 7
Total sulphur 0,8 - 2,5 % 7
Nitrogen/sulph 0,7 - 2,7 ur ratio of alcohol precipitate
Absorbance 8 – 14 ratio of alcohol
precipitate 26
Absorbance Not more than 50 ratio (A 280/560 )
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
24 Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water
in a 1 cm cell at 610 nm.
25 Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of
0,1 absorbance units.
26 Absorbance ratio of alcohol precipitate is defined as the absorbance of the precipitate at 280 nm divided
by the absorbance at 560 nm (1 cm cell).
Cadmium Not more than 1 mg/kg
E 151 BRILLIANT BLACK BN, BLACK PN
Synonyms CI Food Black 1
Definition Brilliant Black BN consists essentially of tetrasodium 4-acetamido-5-hydroxy-6-[7-sulfonato-4-(4-
sulfonatophenylazo)-1-naphthylazo] naphthalene-1,7- disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components.
Brilliant Black BN is described as the sodium salt. The
calcium and the potassium salt are also permitted.
Colour Index 28440 No
EINECS 219-746-5
Chemical name Tetrasodium 4-acetamido-5-hydroxy-6-[7-sulfonato-4- (4-sulfonatophenylazo)-1-naphthylazo] naphthalene
1,7-disulfonate
Chemical C 28 H 17 N 5 Na 4 O 14 S 4
formula
Molecular 867,69 weight
Assay Content not less than 80 % total colouring matters calculated as the sodium salt
E 1 % 1 cm 530 at ca 570 nm in solution
Description Black powder or granules
Appearance of Black-bluish the aqueous solution
Identification
Spectrometry Maximum in water at ca 570 nm
Purity
Water Not more than 0,2 % insoluble matter
Subsidiary Not more than 4 % (expressed on the dye content)
colouring
matters
Organic compounds other than colouring matters:
4-acetamido-5- hydroxynaphthalene 1,7-disulfonic acid
4-amino-5- hydroxynaphthalene
1,7-disulfonic acid Total not more than 0,8 %
8-aminonaphthalene 2-sulfonic acid
4,4′-diazoaminodi(benzenesulfonic acid)
Unsulfonated Not more than 0,01 % (calculated as aniline) primary aromatic amines
Ether Not more than 0,2 % under neutral conditions extractable matter
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Aluminium lakes of this colour may be used.
E 153 VEGETABLE CARBON
Synonyms Vegetable black
Definition Vegetable activated carbon is produced by the carbonization of vegetable material such as wood, cellulose residues, peat and coconut and other shells. . The activated carbon thus produced is milled by a roller mill and the resulting highly activated powdered carbon is treated by a cyclone. The fine fraction from the cyclone is purified by hydrochloric acid washing, neutralised and then dried. The resulting product is what is known traditionally as Vegetable Black. Products with a higher colouring power are produced from the fine fraction by a further cyclone treatment or by extra milling, followed by acid washing,
neutralising and drying. It consists essentially of finely divided carbon. It may contain minor amounts of nitrogen, hydrogen and oxygen. Some moisture may be absorbed on the product after manufacture.
Colour Index 77266 No
EINECS 231-153-3
Chemical name Carbon
Chemical C formula
Atomic weight 12,01
Assay Content not less than 95 % of carbon calculated on an anhydrous and ash-free basis
Loss on drying Not more than 12% (120oC 4 h)
Description Black, odourless powder
Identification
Solubility Insoluble in water and organic solvents
Burning When heated to redness it burns slowly without a flame
Purity
Ash (Total) Not more than 4,0 % (ignition temperature: 625 °C)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Polycyclic Benzo(a)pyrene less than 50 µg/kg in the extract aromatic obtained by extraction of 1 g of the product with 10 g hydrocarbons pure cyclohexane in a continuous extraction.
Alkali soluble The filtrate obtained by boiling 2 g of the sample with matter 20 ml N sodium hydroxide and filtering shall be colourless
E 155 BROWN HT
Synonyms CI Food Brown 3
Definition Brown HT consists essentially of disodium 4,4′-(2,4- dihydroxy-5-hydroxymethyl-1,3-phenylene bisazo) di (naphthalene-1-sulfonate) and subsidiary colouring matters together with sodium chloride and/or sulphate as the principal uncoloured components.
Brown HT is described as the sodium salt. The calcium
and potassium salt are also permitted.
Colour Index 20285 No
EINECS 224-924-0
Chemical name Disodium 4,4′-(2,4-dihydroxy-5-hydroxymethyl-1,3- phenylene bisazo)di (naphthalene-1-sulfonate)
Chemical C 27 H 18 N 4 Na 2 O 9 S 2 formula
Molecular 652,57 weight
Assay Content not less than 70 % total colouring matters calculated as the sodium salt.
E 1 % 1 cm 403 at ca 460 nm in aqueous solution at pH 7
Description Reddish-brown powder or granules
Appearance of Brown the aqueous solution
Identification
Spectrometry Maximum in water of pH 7 at ca 460 nm
Purity
Water insoluble Not more than 0,2 % matter
Subsidiary Not more than 10 % (TLC method) colouring matters
Organic compounds other than colouring matters:
4- Not more than 0,7 % aminonaphthale ne 1-sulfonic acid
Unsulfonated Not more than 0,01 % (calculated as aniline) primary aromatic amines
Ether Not more than 0,2 % in a solution of pH 7 extractable matter
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Aluminium lakes of this colour may be used.
E 160 a (i) BETA-CAROTENE
Synonyms CI Food Orange 5
Definition These specifications apply predominantly to all trans isomer of beta-carotene together with minor amounts of other carotenoids. Diluted and stabilised preparations may have different trans-cis isomer ratios.
Colour index 40800 No
EINECS 230-636-6
Chemical name Beta-carotene; beta, beta-carotene
Chemical C 40 H 56
formula
Molecular 536,88 weight
Assay Not less than 96 % total colouring matters (expressed
as beta-carotene)
E 1 % 1 cm 2 500 at approximately by 440 nm to 457 nm
in cyclohexane
Description Red to brownish-red crystals or crystalline powder
Identification
Spectrometry Maximum in cyclohexane at 453 nm to 456 nm
Purity
Sulphated ash Not more than 0,1 %
Subsidiary Carotenoids other than beta-carotene: not more than
colouring 3,0 % of total colouring matters
matters
Lead Not more than 2 mg/kg
E 160 a (ii) PLANT CAROTENES
Synonyms CI Food Orange 5
Definition Plant carotenes are obtained by solvent extraction of strains of edible plants, carrots, vegetable oils, grass, alfalfa (lucerne) and nettle.
The main colouring principle consists of carotenoids of which beta-carotene accounts for the major part. Alpha, gamma-carotene and other pigments may be present. Besides the colour pigments, this substance may contain oils, fats and waxes naturally occurring in
the source material.
Only the following solvents may be used in the extraction: acetone, methyl ethyl ketone, methanol,
27
ethanol, propan-2-ol, hexane , dichloromethane and carbon dioxide.
Colour index 75130 No
EINECS 230-636-6
Chemical name
Chemical Beta-carotene: C 40 H 56
formula
Molecular Beta-carotene: 536,88 weight
Assay Content of carotenes (calculated as beta-carotene) is not less than 5 %. For products obtained by extraction of vegetables oils: not less than 0,2 % in edible fats
E 1 % 1 cm 2 500 at approximately 440 nm to 457 nm in
cyclohexane
Description
Identification
Spectrometry Maximum in cyclohexane at 440 nm to 457 nm and
470 nm to 486 nm
Purity
Solvent residues Acetone
Methyl ethyl ketone
Methanol Not more than 50 mg/kg, Propan-2-ol singly or in combination
Hexane
Ethanol
Dichloromethane Not more than 10 mg/kg
Lead Not more than 2 mg/kg
EN 58 EN
E 160 a (iii) BETA-CAROTENE FROM Blakeslea trispora
Synonyms CI Food Orange 5
Definition Obtained by a fermentation process using a mixed culture of the two sexual mating types (+) and (–) of strains of the fungus Blakeslea trispora. The betacarotene is extracted from the biomass with ethyl acetate or isobutyl acetate followed by propan-2-ol and crystallised. The crystallised product consists mainly of trans beta-carotene. Because of the natural process approximately 3 % of the product consists of mixed carotenoids, which is specific for the product.
Colour Index 40800 No
EINECS 230-636-6
Chemical name Beta-carotene; beta,beta-carotene
Chemical C 40 H 56 formula
Molecular 536,88 weight
Assay Not less than 96 % total colouring matters (expressed
as beta-carotene)
E 1 % 1cm 2 500 at approximately 440 nm to 457 nm in
cyclohexane
Description Red, brownish-red or purple-violet crystals or crystalline powder (colour varies according to extraction solvent used and conditions of crystallisation)
Identification
Spectrometry Maximum in cyclohexane at 453 nm to 456 nm
Purity
Solvent residues Ethyl acetate Not more than 0,8 %, singly or in
Ethanol combination
Isobutyl acetate: Not more than 1,0% Propan-2-ol: Not more than 0,1%
Sulphated ash Not more than 0,2 %
Subsidiary Carotenoids other than beta-carotene: not more than colouring 3,0 % of total colouring matters matters
Lead Not more than 2 mg/kg
Microbiological criteria
Moulds Not more than 100 colonies per gram
Yeasts Not more than 100 colonies per gram
Salmonella spp. Absent in 25 g
Escherichia coli Absent in 5 g
E 160 a (iv) ALGAL CAROTENES
Synonyms CI Food Orange 5
Definition Mixed carotenes may also be produced from strains of the algae Dunaliella salina, grown in large saline lakes located in Whyalla, South Australia. Beta-carotene is extracted using an essential oil. The preparation is a 20 to 30 % suspension in edible oil. The ratio of trans-cis isomers is in the range of 50/50 to 71/29.
The main colouring principle consists of carotenoids of which beta-carotene accounts for the major part.
Alpha-carotene, lutein, zeaxanthin and betacryptoxanthin may be present. Besides the colour pigments, this substance may contain oils, fats and waxes naturally occurring in the source material.
Colour Index 75130 No
EINECS
Chemical name
Chemical Beta-Carotene: C 40 H 56 formula
Molecular Beta-Carotene: 536,88 weight
Assay Content of carotenes (calculated as beta-carotene) is
not less than 20 %
E 1 % 1cm 2 500 at approximately by 440 nm to 457 nm
in cyclohexane
Description
Identification
Spectrometry Maximum in cyclohexane at 440 nm to 457 nm and
474 nm to 486 nm
Purity
Natural Not more than 0,3 % tocopherols in edible oil
Lead Not more than 2 mg/kg
E 160 b ANNATTO, BIXIN, NORBIXIN
(I) SOLVENT EXTRACTED BIXIN AND NORBIXIN
Synonyms CI Natural Orange 4
Definition Bixin is prepared by the extraction of the outer coating of the seeds of the annatto tree (Bixa orellana L.) with one or more of the following solvents: acetone,
methanol, hexane or dichloromethane, carbon dioxide followed by the removal of the solvent.
Norbixin is prepared by hydrolysis by aqueous alkali of the extracted bixin.
Bixin and norbixin may contain other materials extracted from the annatto seed.
The bixin powder contains several coloured components, the major single one being bixin, which may be present in both cis- and trans- forms. Thermal degradation products of bixin may also be present.
The norbixin powder contains the hydrolysis product of bixin, in the form of the sodium or potassium salts as the major colouring principle. Both cis- and transforms may be present.
Colour Index No 75120 EINECS Annatto: 215-735-4, annatto seed extract: 289-561-2; bixin: 230-248-7
Chemical name Bixin: 6′-Methylhydrogen-9′-cis-6,6′- diapocarotene-6,6′-dioate
6′-Methylhydrogen-9′-trans-6,6′- diapocarotene-6,6′-dioate
Norbixin: 9′cis-6,6′-Diapocarotene-6,6′-dioic acid
9′-trans-6,6′-Diapocarotene-6,6′- dioic acid
Chemical formula Bixin: C 25 H 30 O 4
Norbixin: C 24 H 28 O 4
Molecular weight Bixin: 394,51
Norbixin: 380,48
Assay Content of bixin powders not less than 75 % total carotenoids calculated as bixin.
Content of norbixin powders not less than 25 % total carotenoids calculated as norbixin
Bixin: E 1 % 1 cm 2 870 at ca 502 nm in chloroform
Norbixin: E 1 % 1 cm 2 870 at ca 482 nm in KOH
solution
Description Reddish-brown powder, suspension or solution
Identification
Spectrometry Bixin: maximum in chloroform at ca 502 nm
Norbixin: maximum in dilute KOH solution at ca 482 nm
Purity
Solvent residues Acetone not more than 50 mg/kg, singly or in combination
Methanol
Hexane
Dichloromethane: not more than 10 mg/kg
Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
(II) ALKALI EXTRACTED ANNATTO
Synonyms CI Natural Orange 4
Definition Water soluble annatto is prepared by extraction with aqueous alkali (sodium or potassium hydroxide) of the outer coating of the seeds of the annatto tree (Bixa
orellana L.)
Water soluble annatto contains norbixin, the hydrolysis product of bixin, in the form of the sodium or potassium salts, as the major colouring principle. Both cis- and trans- forms may be present.
Colour Index No 75120
EINECS Annatto: 215-735-4, annatto seed extract: 289-561-2;
bixin: 230-248-7
Chemical name Bixin: 6′-Methylhydrogen-9′-cis-6,6′- diapocarotene-6,6′-dioate
6′-Methylhydrogen-9′-trans-6,6′- diapocarotene-6,6′-dioate
Norbixin: 9′cis-6,6′-Diapocarotene-6,6′-dioic acid
9′-trans-6,6′-Diapocarotene-6,6′- dioic acid
Chemical formula Bixin: C 25 H 30 O 4
Norbixin: C 24 H 28 O 4
Molecular weight Bixin: 394,51
Norbixin: 380,48
Assay Contains not less than 0,1 % of total carotenoids expressed as norbixin
Norbixin: E 1 % 1 cm 2 870 at ca 482 nm in KOH
solution
Description Reddish-brown powder, suspension or solution
Identification
Spectrometry Bixin: maximum in chloroform at ca 502 nm
Norbixin: maximum in dilute KOH solution at ca 482 nm
Purity
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
(III) OIL EXTRACTED ANNATTO
Synonyms CI Natural Orange 4
Definition Annatto extracts in oil, as solution or suspension, are prepared by extraction of the outer coating of the seeds of the annatto tree (Bixa orellana L.) with edible
vegetable oil. Annatto extract in oil contains several coloured components, the major single one being bixin, which may be present in both cis- and trans- forms. Thermal degradation products of bixin may also be present.
Colour Index No 75120
EINECS Annatto: 215-735-4, annatto seed extract: 289-561-2;
bixin: 230-248-7
Chemical name Bixin: 6′-Methylhydrogen-9′-cis-6,6′- diapocarotene-6,6′-dioate
6′-Methylhydrogen-9′-trans-6,6′- diapocarotene-6,6′-dioate
Norbixin: 9′cis-6,6′-Diapocarotene-6,6′-dioic acid
9′-trans-6,6′-Diapocarotene-6,6′- dioic acid
Chemical formula Bixin: C 25 H 30 O 4
Norbixin: C 24 H 28 O 4
Molecular weight Bixin: 394,51
Norbixin: 380,48 Assay Contains not less than 0,1 % of total carotenoids
expressed as bixin
Bixin: E 1 % 1 cm 2 870 at ca 502 nm in chloroform
Description Reddish-brown powder, suspension or solution
Identification
Spectrometry Bixin: maximum in chloroform at ca 502 nm
Norbixin: maximum in dilute KOH solution at ca 482 nm
Purity
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 160 c PAPRIKA EXTRACT, CAPSANTHIN, CAPSORUBIN
Synonyms Paprika Oleoresin
Definition Paprika extract is obtained by solvent extraction of the strains of paprika, which consists of the ground fruits pods, with or without seeds, of Capsicum annuum L., and contains the major colouring principles of this
spice. The major colouring principles are capsanthin and capsorubin. A wide variety of other coloured compounds is known to be present.
Only the following solvents may be used in the extraction: methanol, ethanol, acetone, hexane, dichloromethane, ethyl acetate, propan-2-ol and carbon dioxide.
Colour Index No
EINECS Capsanthin: 207-364-1, capsorubin: 207-425-2
Chemical name Capsanthin: (3R, 3′S, 5′R)-3,3′-dihydroxy-β,κ-
carotene-6-one
Capsorubin: (3S, 3′S, 5R, 5R′)-3,3′-dihydroxy-κ,κ- carotene-6,6′-dione
Chemical formula Capsanthin: C 40 H 56 O 3
Capsorubin: C 40 H 56 O 4
Molecular weight Capsanthin: 584,85
Capsorubin: 600,85
Assay Paprika extract: content not less than 7,0 % carotenoids
Capsanthin/capsorubin: not less than 30 % of total
carotenoids
E 1 % 1 cm 2 100 at ca 462 nm in acetone
Description Dark-red viscous liquid
Identification
Spectrometry Maximum in acetone at ca 462 nm
Colour reaction A deep blue colour is produced by adding one drop of sulphuric acid to one drop of sample in 2—3 drops of chloroform
Purity
Solvent residues Ethyl acetate
Methanol
Ethanol Not more than 50 mg/kg, singly or Acetone in combination
Hexane
Propan-2-ol
Dichloromethane: not more than 10 mg/kg
Capsaicin Not more than 250 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg E 160 d LYCOPENE
i Synthetic Lycopene
Synonyms Lycopene from chemical synthesis
Definition Synthetic lycopene is a mixture of geometric isomeres of lycopenes and is produced by the Wittig
condensation of synthetic intermediates commonly used in the production of other carotenoids used in food. Synthetic lycopene consists predominantly of alltrans-lycopene together with 5-cis-lycopene and minor quantities of other isomers. Commercial lycopene preparations intended for use in food are formulated as suspensions in edible oils or water-dispersible or water- soluble powder.
Colour Index 75125 No
EINECS 207-949-1
Chemical name ψ,ψ-carotene, all-trans-lycopene, (all-E)-lycopene, (all-E)-2,6,10,14,19,23,27,31-octamethyl
2,6,8,10,12,14,16,18,20,22,24,26,30- dotriacontatridecaene
Chemical C 40 H 56 formula
Molecular 536,85 weight
Assay Not less than 96% total lycopenes (not less than 70% all-trans-lycopene)
E 1 % 1cm at 465 - 475 nm in hexane (for 100% pure alltrans-lycopene)
is 3450
Description Red crystalline powder
Identification
Spectrophotome A solution in hexane shows an absorption maximum at try approximately 470 nm
Test for The colour of the solution of the sample in acetone carotenoids disappears after successive additions of a 5% solution of sodium nitrite and 1N sulphuric acid
Solubility Insoluble in water, freely soluble in chloroform Properties of Is clear and has intensive red-orange colour 1% solution in chloroform
Purity
Loss on drying Not more than 0,5% (40 °C, 4 h at 20 mm Hg)
Apo-12’- Not more than 0,15% lycopenal
Triphenyl Not more than 0,01% phosphine oxide
Solvent residues Methanol not more than 200 mg/kg,
Hexane, Propan-2-ol: Not more than 10 mg/kg each.
Dichloromethane: Not more than 10 mg/kg (in commercial preparations only)
Lead Not more than 1 mg/kg
ii Lycopene from red tomatoes
Synonyms Natural Yellow 27
Definition Lycopene is obtained by solvent extraction of red tomatoes (Lycopersicon esculentum L.) with subsequent removal of the solvent. Only the following solvent may be used: carbon dioxide, ethyl acetate, acetone, propan-2-ol, methanol, ethanol and hexane. The major colouring principle of tomatoes is lycopene; minor amounts of other carotenoid pigments may be present. Besides the colour pigments the product may contain oil, fats, waxes and flavour components naturally occurring in tomatoes.
Colour Index 75125 No
EINECS 207-949-1
Chemical name Ψ,Ψ-carotene, all-trans-lycopene, (all-E)-lycopene, (all-E)-2,6,10,14,19,23,27,31-octamethyl
2,6,8,10,12,14,16,18,20,22,24,26,30- dotriacontatridecaene
EN 68 EN
formula
Molecular 536,85 weight
Assay E 1 % 1 cm at 465 - 475 nm in hexane (for 100% pure alltrans-lycopene)
is 3450.
Content not less than 5% total colouring matters
Description Dark red viscous liquid
Identification
Spectrophotome try Maximum in hexane at ca 472 nm
Purity
Solvent residues Propan−2−ol Not more than 50 mg/kg, singly or in combination
Hexane
Acetone
Ethanol
Methanol
Ethylacetate
Sulphated ash Not more than 1%
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
iii Lycopene from Blakeslea trispora
Synonyms Natural Yellow 27
Definition Lycopene from Blakeslea trispora is extracted from the fungal biomass and purified by crystallization and filtration. It consists predominantly of all-trans-lycopene. It also contains minor quantities of other carotenoids. Propan-2-ol and isobutyl acetate are the only solvents used in the manufacture. Commercial lycopene preparations intended for use in food are formulated as suspensions in edible oils or waterdispersible or water-soluble powder.
Colour 75125 Index No
EINECS 207-949-1
Chemical Ψ,Ψ-carotene, all-trans-lycopene, (all-E)-lycopene, ((all-E)- name 2,6,10,14,19,23,27,31-octamethyl 2,6,8,10,12,14,16,18,20,22,24,26,30-dotriacontatridecaene
Chemical C 40 H 56 formula
Molecular 536,85 weight
Assay Not less than 95% total lycopenes and not less than 90% alltrans-lycopene of all colouring matters
E 1 % 1 cm at 465 - 475 nm in hexane (for 100% pure all-trans-
lycopene) is 3450
Description Red crystalline powder
Identification
Spectroph A solution in hexane shows an absorption maximum at
otometry approximately 470 nm
Test of The colour of the solution of the sample in acetone disappears carotenoid after successive additions of a 5% solution of sodium nitrite
s and 1N sulphuric acid
Solubility Insoluble in water, freely soluble in chloroform
Properties Is clear and has intensive red-orange colour of 1% solution in chlorofor m
Purity
Loss on Not more than 0.5% (40 o C, 4 h at 20 mm Hg)
drying Other Not more than 5% carotenoid s
Solvent Propan-2-ol: Not more than 0.1% residues Isobutyl acetate: Not more than 1.0%
Dichloromethane: Not more than 10 mg/kg (in commercial
preparations only)
Sulphated Not more than 0.3 % ash
Lead Not more than 1 mg/kg
E 160 e BETA-APO-8′-CAROTENAL (C30)
Synonyms CI Food Orange 6
Definition These specifications apply predominantly to the alltrans isomer of β-apo-8′-carotenal together with minor amounts of other carotenoids. Diluted and stabilized forms are prepared from β-apo-8′-carotenal meeting these specifications and include solutions or
suspensions of ß-apo-8′carotenal in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios.
Colour Index 40820 No
EINECS 214-171-6
Chemical name β-Apo-8′-carotenal; trans-β-Apo-8′carotene-aldehyde
Chemical C 30 H 40 O formula
Molecular 416,65 weight
Assay Not less than 96 % of total colouring matters
E 1 % 1 cm 2 640 at 460—462 nm in cyclohexane
Description Dark violet crystals with metallic lustre or crystalline powder
Identification
Spectrometry Maximum in cyclohexane at 460—462 nm
Purity
Sulphated ash Not more than 0,1 %
Subsidiary Carotenoids other than β-apo-8′-carotenal: colouring
matters not more than 3,0 % of total colouring matters
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 161 b LUTEIN
Synonyms Mixed Carotenoids; Xanthophylls
Definition Lutein is obtained by solvent extraction of the strains of edible fruits and plants, grass, lucerne (alfalfa) and Tagetes erecta. The main colouring principle consists of carotenoids of which lutein and its fatty acid esters account for the major part. Variable amounts of
carotenes will also be present. Lutein may contain fats,
oils and waxes naturally occurring in the plant
material.
Only the following solvents may be used for the extraction: methanol, ethanol, propan-2-ol, hexane, acetone, methyl ethyl ketone and carbon dioxide
Colour Index No
EINECS 204-840-0
Chemical name 3,3′-dihydroxy-d-carotene
Chemical C 40 H 56 O 2
formula
Molecular 568,88 weight
Assay Content of total colouring matter not less than 4 % calculated as lutein
E 1 % 1 cm 2 550 at ca 445 nm in chloroform/ethanol
(10 + 90) or in hexane/ethanol/acetone (80 + 10 + 10)
Description Dark, yellowish brown liquid
Identification
Spectrometry Maximum in chloroform/ethanol (1:9) at ca 445 nm
Purity
Solvent residues Acetone
Methyl ethyl ketone
Methanol Not more than 50 mg/kg, singly Ethanol or in combination
Propan-2-ol
Hexane
Arsenic Not more than 3 mg/kg
Lead Not more than 3 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 161g CANTHAXANTHIN
Synonyms CI Food Orange 8
Definition These specifications apply to predominantly all-trans isomers of canthaxanthin together with minor amounts of other carotenoids. Diluted and stabilized forms are prepared from canthaxanthin meeting these
specifications and include solutions or suspensions of canthaxanthin in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios.
Colour Index 40850 No
EINECS 208-187-2
Chemical name β-Carotene-4,4′-dione; canthaxanthin; 4,4′-dioxo-β-
carotene
Chemical C 40 H 52 O 2
formula
Molecular 564,86 weight
Assay Not less than 96 % of total colouring matters (expressed as canthaxanthin)
E 1 % 1 cm 2 200 at ca 485 nm in chloroform
at 468—472 nm in cyclohexane
at 464—467 nm in petroleum ether
Description Deep violet crystals or crystalline powder
Identification
Spectrometry Maximum in chloroform at ca 485 nm
Maximum in cyclohexane at 468—472 nm
Maximum in petroleum ether at 464—467 nm
Purity
Sulphated ash Not more than 0,1 %
Subsidiary Carotenoids other than canthaxanthin: not more than
colouring 5,0 % of total colouring matters
matters
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 162 BEETROOT RED, BETANIN
Synonyms Beet Red
Definition Beet red is obtained from the roots of strains of red beets (Beta vulgaris L. var. rubra) by pressing crushed beet as press juice or by aqueous extraction of
shredded beet roots and subsequent enrichment in the active principle. The colour is composed of different pigments all belonging to the class betalaine. The main colouring principle consists of betacyanins (red) of which betanin accounts for 75—95 %. Minor amounts of betaxanthin (yellow) and degradation products of betalaines (light brown) may be present.
Besides the colour pigments the juice or extract consists of sugars, salts, and/or proteins naturally occurring in red beets. The solution may be concentrated and some products may be refined in order to remove most of the sugars, salts and proteins.
Colour Index No
EINECS 231-628-5
Chemical name (S-(R′,R′)-4-(2-(2-Carboxy-5(β-D- glucopyranosyloxy)-2,3-dihydro-6-hydroxy-1H-indol 1-yl)ethenyl)-2,3-dihydro-2,6-pyridine-dicarboxylic acid; 1-(2-(2,6-dicarboxy-1,2,3,4-tetrahydro-4- pyridylidene)ethylidene)-5-β-D-glucopyranosyloxy)-6- hydroxyindolium-2-carboxylate
Chemical Betanin: C 24 H 26 N 2 O 13
formula
Molecular 550,48 weight
Assay Content of red colour (expressed as betanine) is not
less than 0,4 %
E 1 % 1 cm 1 120 at ca 535 nm in aqueous solution at pH 5
Description Red or dark red liquid, paste, powder or solid
Identification
Spectrometry Maximum in water of pH 5 at ca 535 nm
Purity
Nitrate Not more than 2 g nitrate anion/g of red colour (as calculated from assay).
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 163 ANTHOCYANINS
Synonyms
Definition Anthocyanins are obtained by maceration or extraction with sulphited water, acidified water, carbon dioxide,
methanol or ethanol from the strains of vegetables and edible fruits, with subsequent concentration and /or purification if necessary. The resulting product can be transformed into powder by an industrial drying process. Anthocyanins contain common components of the source material, namely anthocyanine, organic acids, tannins, sugars, minerals etc., but not necessarily in the same proportions as found in the source material.Ethanol may naturally be present as a result of the maceration process. The colouring principle is anthocyanin. Products are marketed according to their colour strength as determined by the assay. Colour content is not expressed using quantitative units.
Colour Index No
EINECS 208-438-6 (cyanidin); 205-125-6 (peonidin); 208-437- 0 (delphinidin); 211-403-8 (malvidin); 205-127-7
(pelargonidin); 215-849-4 (petunidin)
Chemical name 3,3′,4′,5,7-Pentahydroxy-flavylium chloride (cyanidin)
3,4′,5,7-Tetrahydroxy-3′-methoxyflavylium chloride (peonidin)
3,4′,5,7-Tetrahydroxy-3′,5′-dimethoxyflavylium chloride (malvidin)
3,5,7-Trihydroxy-2-(3,4,5,trihydroxyphenyl)-1- benzopyrylium chloride (delphinidin)
3,3′4′,5,7-Pentahydroxy-5′-methoxyflavylium chloride (petunidin)
3,5,7-Trihydroxy-2-(4-hydroxyphenyl)-1-
benzopyrilium chloride (pelargonidin)
Chemical Cyanidin: C 15 H 11 O 6 Cl
formula Peonidin: C 16 H 13 O 6 Cl
Malvidin: C 17 H 15 O 7 Cl
Delphinidin: C 15 H 11 O 7 Cl
Petunidin: C 16 H 13 O 7 Cl
Pelargonidin: C 15 H 11 O 5 Cl
Molecular Cyanidin: 322,6 weight Peonidin: 336,7
Malvidin: 366,7
Delphinidin: 340,6
Petunidin: 352,7
Pelargonidin: 306,7
Assay E 1 % 1 cm 300 for the pure pigment at 515-535 nm at pH
3,0
Description Purplish-red liquid, powder or paste, having a slight characteristic odour
Identification
Spectrometry Maximum in methanol with 0,01 % conc. HCl
Cyanidin: 535 nm
Peonidin: 532 nm
Malvidin: 542 nm
Delphinidin: 546 nm
Petunidin: 543 nm
Pelargonidin: 530 nm
Purity
Solvent residues Methanol Not more than 50 mg/kg Not more than 200 mg/kg
Ethanol
Sulfur dioxide Not more than 1 000 mg/kg per percent pigment
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Aluminium lakes of this colour may be used.
E 170 CALCIUM CARBONATE
Synonyms CI Pigment White 18; Chalk
Definition Calcium carbonate is the product obtained from ground limestone or by the precipitation of calcium ions with
carbonate ions.
Colour Index 77220 No
EINECS Calcium carbonate: 207-439-9
Limestone: 215-279-6
Chemical name Calcium carbonate
Chemical CaCO 3 formula
Molecular 100,1 weight
Assay Content not less than 98 % on the anhydrous basis
Description White crystalline or amorphous, odourless and tasteless powder
Identification
Solubility Practically insoluble in water and in alcohol. Dissolves with effervescence in diluted acetic acid, in diluted
hydrochloric acid and in diluted nitric acid, and the resulting solutions, after boiling, give positive tests for calcium.
Purity
Loss on drying Not more than 2,0 % (200 °C, 4 hours)
Acid-insoluble Not more than 0,2 % substances
Magnesium and Not more than 1% alkali salts
Fluoride Not more than 50 mg/kg
Antimony (as Sb)
Copper (as Cu)
Chromium (as Not more than 100 mg/kg, singly or in combination Cr)
Zinc (as Zn)
Barium (as Ba)
Arsenic Not more than 3 mg/kg
Lead Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
E 171 TITANIUM DIOXIDE
Synonyms CI Pigment White 6
Definition Titanium dioxide consists essentially of pure anatase and/or rutile titanium dioxide which may be coated
with small amounts of alumina and/or silica to improve the technological properties of the product.
The anatase grades of pigmentary titanium dioxide can only be made by the sulphate process which creates a large amount of sulphuric acid as a by-product. The rutile grades of titanium dioxide are typically made by
the chloride process.
Certain rutile grades of titanium dioxide are produced using mica (also known as potassium aluminum silicate) as a template to form the basic platelet structure. The surface of the mica is coated with
titanium dioxide using a specialised patented process.
Rutile titanium dioxide, platelet form is manufactured by subjecting titanium dioxide (rutile) coated mica nacreous pigment to an extractive dissolution in acid followed by an extractive dissolution in alkali. All of the mica is removed during this process and the resulting product is a platelet form of rutile titanium dioxide.
Colour Index 77891 No
EINECS 236-675-5
Chemical name Titanium dioxide
Chemical TiO 2 formula
Molecular 79,88 weight
Assay Content not less than 99 % on an alumina and silicafree basis
Description White to slightly coloured powder
Identification
Solubility Insoluble in water and organic solvents. Dissolves slowly in hydrofluoric acid and in hot concentrated sulphuric acid.
Purity
Loss on drying Not more than 0,5 % (105 °C, 3 hours)
Loss on ignition Not more than 1,0 % on a volatile matter free basis (800 °C)
Aluminium Total not more than 2,0 % oxide and/or silicon dioxide
Matter soluble Not more than 0,5 % on an alumina and silica-free in 0,5 N HCl basis and, in addition, for products containing alumina and/or silica, not more than 1,5 % on the basis of the product as sold.
Water soluble Not more than 0,5 % matter Cadmium Not more than 1 mg/kg after an extraction with 0,5 N HCl.
Antimony Not more than 2 mg/kg after an extraction with 0,5 N HCl.
Arsenic Not more than 1 mg/kg after an extraction with 0,5 N HCl.
Lead Not more than 10 mg/kg after an extraction with 0,5 N HCl.
Mercury Not more than 1 mg/kg after an extraction with 0,5 N HCl.
E 172 IRON OXIDES AND IRON HYDROXIDES
Synonyms Iron Oxide Yellow: CI Pigment Yellow 42 and 43
Iron Oxide Red: CI Pigment Red 101 and 102
Iron Oxide Black: CI Pigment Black 11
Definition Iron oxides and iron hydroxides are produced synthetically and consist essentially of anhydrous and/or hydrated iron oxides. The range of hues includes yellows, reds, browns and blacks. Food quality iron oxides are primarily distinguished from technical grades by the comparatively low levels of contamination by other metals. This is achieved by the selection and control of the source of the iron and/or by the extent of chemical purification during the manufacturing process.
Colour Index Iron Oxide Yellow: 77492 No Iron Oxide Red: 77491
Iron Oxide Black: 77499
EINECS Iron Oxide Yellow: 257-098-5
Iron Oxide Red: 215-168-2
Iron Oxide Black: 235-442-5
Chemical name Iron Oxide Yellow: hydrated ferric oxide, hydrated
iron (III) oxide
Iron Oxide Red: anhydrous ferric oxide, anhydrous iron (III) oxide
Iron Oxide Black: ferroso ferric oxide, iron (II, III) oxide
Chemical Iron Oxide Yellow: FeO(OH) · H2O formula
Iron Oxide Red: Fe 2 O 3
Iron Oxide Black: FeO.Fe 2 O 3
Molecular 88,85: FeO(OH) weight
159,70: Fe 2 O 3
231,55: FeO.Fe 2 O 3
Assay Yellow not less than 60 %, red and black not less than 68 % total iron, expressed as iron
Description Powder; yellow, red, brown or black in hue
Identification
Solubility Insoluble in water and in organic solvents Soluble in concentrated mineral acids
Purity
Water soluble Not more than 1,0 % matter
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Chromium Not more than 100 mg/kg
Copper Not more than 50 mg/kg By total dissolution
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Nickel Not more than 200 mg/kg
Zinc Not more than 100 mg/kg
E 173 ALUMINIUM
Synonyms CI Pigment Metal
Definition Aluminium powder is composed of finely divided particles of aluminium. The grinding may or may not be carried out in the presence of edible vegetable oils and/or food additive quality fatty acids. It is free from admixture with substances other than edible vegetable oils and/or food additive quality fatty acids.
Colour Index 77000 No
EINECS 231-072-3
Chemical name Aluminium
Chemical Al formula
Atomic weight 26,98
Assay Not less than 99 % calculated as Al on an oil-free basis
Description A silvery-grey powder or tiny sheets
Identification
Solubility Insoluble in water and in organic solvents. Soluble in dilute hydrochloric acid.
Test for A sample dissolved in dilute hydrochloric acid passes aluminium test
Purity
Loss on drying Not more than 0,5 % (105 °C, to constant weight)
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 174 SILVER
Synonyms Argentum
Definition
Colour Index No 77820 EINECS 231-131-3
Chemical name Silver
Chemical Ag formula
Atomic weight 107,87
Assay Content not less than 99,5 % Ag
Description Silver-coloured powder or tiny sheets
Identification
Purity
E 175 GOLD
Synonyms Pigment Metal 3; Aurum
Definition
Colour Index No 77480
EINECS 231-165-9
Chemical name Gold
Chemical Au formula
Atomic weight 197,0
Assay Content not less than 90 % Au
Description Gold-coloured powder or tiny sheets
Identification
Purity
Silver Not more than 7 % After complete Copper Not more than 4 % dissolution
E 180 LITHOLRUBINE BK
Synonyms CI Pigment Red 57; Rubinpigment; Carmine 6B Definition Lithol Rubine BK consists essentially of calcium 3-
hydroxy-4-(4-methyl-2-sulfonatophenylazo)-2- naphthalenecarboxylate and subsidiary colouring matters together with water, calcium chloride and/or calcium sulphate as the principal uncoloured components.
Colour Index 15850:1 No
EINECS 226-109-5
Chemical name Calcium 3-hydroxy-4-(4-methyl-2- sulfonatophenylazo)-2-naphthalene-carboxylate
Chemical C 18 H 12 CaN 2 O 6 S
formula
Molecular 424,45 weight
Assay Content not less than 90 % total colouring matters
E 1 % 1 cm 200 at ca 442 nm in dimethylformamide
Description Red powder
Identification
Spectrometry Maximum in dimethylformamide at ca 442 nm
Purity
Subsidiary Not more than 0,5 % colouring matters
Organic compounds other than colouring matters:
2-Amino-5- Not more than 0,2 % methylbenzenesulfoni c acid, calcium salt
3-hydroxy-2- Not more than 0,4 % naphthalenecarboxyli c acid, calcium salt Unsulfonated Not more than 0,01 % (expressed as aniline) primary aromatic amines
Ether From a solution of pH 7, not more than 0,2 % extractable matter
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Aluminium lakes of this colour may be used.
E 200 SORBIC ACID
Synonyms
Definition
EINECS 203-768-7
Chemical name Sorbic acid; trans, trans-2,4-Hexadienoic acid
Chemical C 6 H 8 O 2 formula
Molecular 112,12 weight
Assay Content not less than 99 % on the anhydrous basis
Description Colourless needles or white free flowing powder, having a slight characteristic odour and showing no change in colour after heating for 90 minutes at
105 °C
Identification
Melting range Between 133 °C and 135 °C, after vacuum drying for four hours in a sulphuric acid desiccator
Spectrometry A propan-2-ol solution (1 in 4 000 000) shows absorbance maximum at 254 ± 2 nm
Test for double Passes test bonds
Solubility Slightly soluble in water, soluble in ethanol.
Purity
Water content Not more than 0,5 % (Karl Fischer method)
Sulphated ash Not more than 0,2 %
Aldehydes Not more than 0,1 % (as formaldehyde)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 202 POTASSIUM SORBATE
Synonyms
Definition
EINECS 246-376-1
Chemical name Potassium sorbate; Potassium (E,E)-2,4-hexadienoate; Potassium salt of trans, trans 2,4-hexadienoic acid
Chemical C 6 H 7 O 2 K
formula
Molecular 150,22 weight
Assay Content not less than 99 % on the dried basis
Description White crystalline powder showing no change in colour after heating for 90 minutes at 105 °C
Identification
Melting range Melting range of sorbic acid isolated by acidification for sorbic acid and not recrystallized 133 °C to 135 °C after vacuum drying in a sulphuric acid desiccator Test for Passes test potassium
Test for double Passes test bonds
Purity
Loss on drying Not more than 1,0 % (105 °C, 3 hours)
Acidity or Not more than about 1,0 % (as sorbic acid or K 2 CO 3 )
alkalinity
Aldehydes Not more than 0,1 %, calculated as formaldehyde
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 203 CALCIUM SORBATE
Synonyms
Definition
EINECS 231-321-6
Chemical name Calcium sorbate; Calcium salts of trans, trans-2,4- hexadienoic acid
Chemical C 12 H 14 O 4 Ca
formula
Molecular 262,32 weight
Assay Content not less than 98 % on the dried basis
Description Fine white crystalline powder not showing any change in colour after heating at 105 °C for 90 minutes
Identification
Melting range Melting range of sorbic acid isolated by acidification for sorbic acid and not recrystallized 133 °C to 135 °C after vacuum
drying in a sulphuric acid desiccator
Test for calcium Passes test
Test for double Passes test bonds
Purity
Loss on drying Not more than 2,0 %, determined by vacuum drying for four hours in a sulphuric acid desiccator
Aldehydes Not more than 0,1 % (as formaldehyde)
Fluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 210 BENZOIC ACID
Synonyms
Definition
EINECS 200-618-2
Chemical name Benzoic acid; Benzenecarboxylic acid; Phenylcarboxylic acid
Chemical C 7 H 6 O 2 formula
Molecular 122,12 weight
Assay Content not less than 99,5 % on the anhydrous basis
Description White crystalline powder
Identification
Melting range 121,5 °C -123,5 °C Sublimation test Passes test
Test for Passes test benzoate
pH About 4 (solution in water)
Purity
Loss on drying Not more than 0,5 % (3 hours, over sulphuric acid)
Sulphated ash Not more than 0,05 %
Chlorinated Not more than 0,07 % expressed as chloride organic corresponding to 0,3 % expressed as compounds monochlorobenzoic acid
Readily Add 1,5 ml of sulphuric acid to 100 ml of water, heat
oxidisable to boiling point and add 0,1 N KMnO 4 in drops, until
substances the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the
heated solution, and titrate with 0,1 N KMnO 4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required
Readily A cold solution of 0,5 g of benzoic acid in 5 ml of carbonisable 94,5 to 95,5 % sulphuric acid must not show a substances stronger colouring than that of a reference liquid
containing 0,2 ml of cobalt chloride TSC 28 , 0,3 ml of ferric chloride TSC 29 , 0,1 ml of copper sulphate TSC 30 and 4,4 ml of water
28 Cobalt chloride TSC: dissolve approximately 65 g of cobalt chloride CoCl
2 ·6H 2 O in a sufficient quantity of a mixture of 25 ml hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place exactly 5 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 5 ml of 3 % hydrogen peroxide, then 15 ml of a 20 % solution of sodium hydroxide. Boil for 10 minutes, allow to cool, add 2 g of potassium iodide and 20 ml of 25 % sulphuric acid. After the precipitate is completely dissolved, titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS(*). 1 ml of sodium thiosulphate (0,1 N) corresponds to 23,80 mg of CoCl 2 ·6H 2 O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water mixture to give a solution containing 59,5 mg of CoCl 2 ·6H 2 O per ml.
29 Ferric chloride TSC: dissolve approximately 55 g of ferric chloride in a sufficient quantity of a mixture
of 25 ml of hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 15 ml of water and 3 g of potassium iodide; leave the mixture to stand for 15 minutes. Dilute with 100 ml of water then titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS(*). 1 ml of sodium thiosulphate (0,1 N) corresponds to 27,03 mg of FeCl 3 ·6H 2 O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water to give a solution containing 45,0 mg of
FeCl 3 ·6H 2 O per ml.
30 Copper sulphate TSC: dissolve approximate by 65 g of copper sulphate CuSO
4 ·5H 2 O in a sufficient quantity of a mixture of 25 ml of hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 40 ml
Polycyclic acids On fractional acidification of a neutralized solution of benzoic acid, the first precipitate must not have a
different melting point from that of the benzoic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 211 SODIUM BENZOATE
Synonyms
Definition
EINECS 208-534-8
Chemical name Sodium benzoate; Sodium salt of benzenecarboxylic acid; Sodium salt of phenylcarboxylic acid
Chemical C 7 H 5 O 2 Na
formula
Molecular 144,11 weight
Assay Not less than 99 % of C 7 H 5 O 2 Na, after drying at
105 °C for four hours
Description A white, almost odourless, crystalline powder or granules
Identification
Solubility Freely soluble in water, sparingly soluble in ethanol
Melting range Melting range of benzoic acid isolated by for benzoic acid acidification and not recrystallized 121,5 °C to 123,5 °C, after drying in a sulphuric acid desiccator
of water, 4 ml of acetic acid and 3 g of potassium iodide. Titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS(*). 1 ml of sodium thiosulphate (0,1 N) corresponds to 24,97 mg of CuSO 4 ·5H 2 O. Adjust final volume of solution by the addition of a sufficient quantity of the
hydrochloric acid/water mixture to give a solution containing 62,4 mg of CuSO 4 ·5H 2 O per ml. (*) Starch TS: triturate 0,5 g starch (potato starch, maize starch or soluable starch) with 5 ml of water; to
the resulting paste add a sufficient quantity of water to give a total volume of 100 ml, stirring all the time. Boil for a few minutes, allow to cool, filter. The starch must be freshly prepared.
Test for Passes test benzoate
Test for sodium Passes test
Purity
Loss on drying Not more than 1,5 % (105 °C, 4 hours)
Readily Add 1,5 ml of sulphuric acid to 100 ml of water, heat
oxidisable to boiling point and add 0,1 N KMnO 4 in drops, until
substances the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the
heated solution, and titrate with 0,1 N KMnO 4 to a
pink colour that persists for 15 seconds. Not more than 0,5 ml should be required
Polycyclic acids On fractional acidification of a (neutralized) solution of sodium benzoate, the first precipitate must not have a different melting range from that of benzoic acid
Chlorinated Not more than 0,06 % expressed as chloride, organic corresponding to 0,25 % expressed as compounds monochlorobenzoic acid
Acidity or Neutralization of 1 g of sodium benzoate, in the alkalinity presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 212 POTASSIUM BENZOATE
Synonyms
Definition
EINECS 209-481-3
Chemical name Potassium benzoate; Potassium salt of benzenecarboxylic acid; Potassium salt of phenylcarboxylic acid
EN 92 EN
formula
Molecular 214,27 weight
Assay Content not less than 99 % C 7 H 5 KO 2 after drying at 105 °C to constant weight
Description White crystalline powder
Identification
Melting range Melting range of benzoic acid isolated by for benzoic acid acidification and not recrystallized 121,5 °C to 123,5 °C, after vacuum drying in a sulphuric acid desiccator
Test for Passes test benzoate
Test for Passes test potassium
Purity
Loss on drying Not more than 26,5 %(105 °C, 4 hours)
Chlorinated Not more than 0,06 % expressed as chloride, organic corresponding to 0,25 % expressed as compounds monochlorobenzoic acid
Readily Add 1,5 ml of sulphuric acid to 100 ml of water, heat
oxidisable to boiling point and add 0,1 N KMnO 4 in drops, until
substances the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the
heated solution, and titrate with 0,1 N KMnO 4 to a
pink colour that persists for 15 seconds. Not more than 0,5 ml should be required
Readily A cold solution of 0,5 g of benzoic acid in 5 ml 94,5 carbonisable to 95,5 % sulphuric acid must not show a stronger substances colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water
Polycyclic acids On fractional acidification of a (neutralized) solution of potassium benzoate, the first precipitate must not have a different melting range from that of benzoic
acid Acidity or Neutralization of 1 g of potassium benzoate, in the alkalinity presence of phenolphthalein, must not require more
than 0,25 ml of 0,1 N NaOH or 0,1 N HCl
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 213 CALCIUM BENZOATE
Synonyms Monocalcium benzoate
Definition
EINECS 218-235-4
Chemical name Calcium benzoate; Calcium dibenzoate
Chemical Anhydrous: C 14 H 10 O 4 Ca formula
Monohydrate: C 14 H 10 O 4 Ca·H 2 O
Trihydrate: C 14 H 10 O 4 Ca·3H 2 O
Molecular Anhydrous: 282,31 weight Monohydrate: 300,32
Trihydrate: 336,36
Assay Content not less than 99 % after drying at 105 °C
Description White or colourless crystals, or white powder
Identification
Melting range Melting range of benzoic acid isolated by for benzoic acid acidification and not recrystallized 121,5 °C to 123,5 °C, after vacuum drying in a sulphuric acid desiccator
Test for Passes test benzoate
Test for calcium Passes test Purity
Loss on drying Not more than 17,5 % (105 °C, to constant weight)
Water insoluble Not more than 0,3 % matter
Chlorinated Not more than 0,06 % expressed as chloride, organic corresponding to 0,25 % expressed as compounds monochlorobenzoic acid
Readily Add 1,5 ml of sulphuric acid to 100 ml of water, heat oxidisable to boiling point and add 0,1 N KMnO 4 in drops, until substances the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO 4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required
Readily Cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 carbonisable to 95,5 % sulphuric acid must not show a stronger substances colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water
Polycyclic acids On fractional acidification of a (neutralized) solution of calcium benzoate, the first precipitate must not be a different melting range from that of benzoic acid
Acidity or Neutralization of 1 g of calcium benzoate, in the alkalinity presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl
Fluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 214 ETHYL p-HYDROXYBENZOATE
Synonyms Ethylparaben; Ethyl p-oxybenzoate
Definition
EINECS 204-399-4
Chemical name Ethyl-p-hydroxybenzoate; Ethyl ester of p- hydroxybenzoic acid
Chemical C 9 H 10 O 3 formula
Molecular 166,8 weight
Assay Content not less than 99,5 % after drying for two
hours at 80 °C
Description Almost odourless, small, colourless crystals or a white, crystalline powder
Identification
Melting range 115 °C - 118 °C
Test for p Melting range of p-hydroxybenzoic acid isolated by hydroxybenzoat acidification and not recrystallized: 213 °C to 217 °C, e after vacuum drying in a sulphuric acid desiccator
Test for alcohol Passes test
Purity
Loss on drying Not more than 0,5 % (80 °C, 2 hours)
Sulphated ash Not more than 0,05 %
p- Not more than 0,35 % expressed as p-hydroxybenzoic
Hydroxybenzoic acid
acid and
salicylic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 215 SODIUM ETHYL p-HYDROXYBENZOATE
Synonyms
Definition
EINECS 252-487-6
Chemical name Sodium ethyl p-hydroxybenzoate; Sodium compound of the ethyl ester of p-hydroxybenzoic acid
Chemical C 9 H 9 O 3 Na
formula
Molecular 188,8 weight
Assay Content of ethylester of p-hydroxybenzoic acid not less than 83 % on the anhydrous basis
Description White, crystalline hygroscopic powder
Identification
Melting range 115 °C to 118 °C, after vacuum drying in a sulphuric
acid desiccator
Test for p Melting range of p-hydroxybenzoic acid derived from
hydroxybenzoat the sample is 213 °C to 217 °C
e
Test for sodium Passes test
pH 9,9 - 10,3 (0,1 % aqueous solution)
Purity
Loss on drying Not more than 5 %, (by vacuum drying in a sulphuric
acid desiccator)
Sulphated ash 37 to 39 %
p- Not more than 0,35 % expressed as p-hydroxybenzoic
Hydroxybenzoic acid
acid and
salicylic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg E 218 METHYL p-HYDROXYBENZOATE
Synonyms Methylparaben; Methyl-p-oxybenzoate
Definition
EINECS 243-171-5
Chemical name Methyl p-hydroxybenzoate; Methyl ester of p- hydroxybenzoic acid
Chemical C 8 H 8 O 3 formula
Molecular 152,15 weight
Assay Content not less than 99 % after drying for two hours at 80 °C
Description Almost odourless, small colourless crystals or white crystalline powder
Identification
Melting range 125 °C - 128 °C
Test for p Melting range of p-hydroxybenzoic acid derived from
hydroxybenzoat the sample is 213 °C to 217 °C after drying for two
e hours at 80 °C
Purity
Loss on drying Not more than 0,5 % (80 °C, 2 hours)
Sulphated ash Not more than 0,05 %
p- Not more than 0,35 % expressed as p-hydroxybenzoic
Hydroxybenzoic acid
acid and
salicylic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg E 219 SODIUM METHYL p-HYDROXYBENZOATE
Synonyms
Definition
EINECS
Chemical name Sodium methyl p-hydroxybenzoate; Sodium compound of the methylester of p-hydroxybenzoic acid
Chemical C 8 H 7 O 3 Na formula
Molecular 174,15 weight
Assay Content not less than 99,5 % on the anhydrous basis
Description White, hygroscopic powder
Identification
Melting range The white precipitate formed by acidifying with hydrochloric acid a 10 % (w/v) aqueous solution of the sodium derivative of methyl p-hydroxybenzoate (using litmus paper as indicator) shall, when washed with water and dried at 80 °C for two hours, have a melting range of 125 °C to 128 °C
Test for sodium Passes test
pH 9,7 – 10,3 (0,1 % solution in carbon dioxide free water)
Purity
Water content Not more than 5 % (Karl Fischer method)
Sulphated ash 40 % to 44,5 % on the anhydrous basis
p- Not more than 0,35 % expressed as p-hydroxybenzoic
Hydroxybenzoic acid
acid and
salicylic acid
Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 220 SULPHUR DIOXIDE
Synonyms
Definition
EINECS 231-195-2
Chemical name Sulphur dioxide; Sulphurous acid anhydride
Chemical SO 2 formula
Molecular 64,07 weight
Assay Content not less than 99 %
Description Colourless, non-flammable gas with strong pungent suffocating odour
Identification
Test for Passes test sulphurous substances
Purity
Water content Not more than 0,05 % (Karl Fischer method)
Non-volatile Not more than 0,01 % residue
Sulphur trioxide Not more than 0,1 %
Selenium Not more than 10 mg/kg
Other gases not No trace normally present in the air
Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 221 SODIUM SULPHITE
Synonyms
Definition
EINECS 231-821-4
Chemical name Sodium sulphite (anhydrous or heptahydrate)
Chemical Anhydrous: Na 2 SO 3 formula
Heptahydrate: Na 2 SO 3 7H 2 O
Molecular Anhydrous: 126,04 weight Heptahydrate: 252,16
Assay Anhydrous: Not less than 95 % of Na 2 SO 3 and not less than 48 % of SO 2
Heptahydrate: Not less than 48 % of Na 2 SO 3 and not less than 24 % of SO 2
Description White crystalline powder or colourless crystals
Identification
Test for sulphite Passes test
Test for sodium Passes test
pH 8,5 - 11,5, (anhydrous: 10% solution; heptahydrate:
20% solution )
Purity
Thiosulphate Not more than 0,1 % based on the SO 2 content
Iron Not more than 10 mg/kg based on the SO 2 content
EN 101 EN
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 222 SODIUM BISULPHITE
Synonyms
Definition
EINECS 231-921-4
Chemical name Sodium bisulphite; Sodium hydrogen sulphite
Chemical NaHSO 3 in aqueous solution
formula
Molecular 104,06 weight
Assay Content not less than 32 % w/w NaHSO 3
Description A clear, colourless to yellow solution
Identification
Test for sulphite Passes test
Test for sodium Passes test
pH 2,5 - 5,5 (10 % aqueous solution)
Purity
Iron Not more than 10 mg/kg of Na 2 SO 3 based on the SO 2 content
Selenium Not more than 5 mg/kg based on the SO 2 content
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg E 223 SODIUM METABISULPHITE
Synonyms Pyrosulphite; Sodium pyrosulphite
Definition
EINECS 231-673-0
Chemical name Sodium disulphite; Disodium pentaoxodisulphate
Chemical Na 2 S 2 O 5 formula
Molecular 190,11 weight
Assay Content not less than 95 % Na 2 S 2 O 5 and not less than
64 % of SO 2
Description White crystals or crystalline powder
Identification
Test for sulphite Passes test
Test for sodium Passes test
pH 4,0 - 5,5 (10 % aqueous solution)
Purity
Thiosulphate Not more than 0,1 % based on the SO 2 content
Iron Not more than 10 mg/kg based on the SO 2 content
Selenium Not more than 5 mg/kg based on the SO 2 content
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 224 POTASSIUM METABISULPHITE
Synonyms Potassium pyrosulphite
Definition
EINECS 240-795-3
Chemical name Potassium disulphite; Potassium pentaoxo disulphate
Chemical K 2 S 2 O 5 formula
Molecular 222,33 weight
Assay Content not less than 90 % K 2 S 2 O 5 and not less than 51,8 % of SO 2 , the remainder being composed almost
entirely of potassium sulphate
Description Colourless crystals or white crystalline powder
Identification
Test for sulphite Passes test
Test for Passes test potassium
Purity
Thiosulphate Not more than 0,1 % based on the SO 2 content
Iron Not more than 10 mg/kg based on the SO 2 content
Selenium Not more than 5 mg/kg based on the SO 2 content
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 226 CALCIUM SULPHITE
Synonyms
Definition
EINECS 218-235-4
Chemical name Calcium sulphite
Chemical CaSO 3 ·2H 2 O formula
Molecular 156,17 weight
Assay Content not less than 95 % of CaSO 3 ·2H 2 O and not less than 39 % of SO 2
Description White crystals or white crystalline powder
Identification
Test for sulphite Passes test
Test for calcium Passes test
Purity
Iron Not more than 10 mg/kg based on the SO 2 content
Selenium Not more than 5 mg/kg based on the SO 2 content
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 227 CALCIUM BISULPHITE
Synonyms
Definition
EINECS 237-423-7
Chemical name Calcium bisulphite; Calcium hydrogen sulphite
formula
Molecular 202,22
EN 105 EN
weight
Assay 6 to 8 % (w/v) of sulphur dioxide and 2,5 to 3,5 % (w/v) of calcium dioxide corresponding to 10 to 14 % (w/v) of calcium bisulphite [Ca(HSO 3 ) 2 ]
Description Clear greenish-yellow aqueous solution having a distinct odour of sulphur dioxide
Identification
Test for sulphite Passes test
Test for calcium Passes test
Purity
Iron Not more than 10 mg/kg based on the SO 2 content
Selenium Not more than 5 mg/kg based on the SO 2 content
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 228 POTASSIUM BISULPHITE
Synonyms
Definition
EINECS 231-870-1
Chemical name Potassium bisulphite; Potassium hydrogen sulphite
Chemical KHSO 3 in aqueous solution formula
Molecular 120,17 weight
Assay Content not less than 280 g KHSO 3 per litre (or 150 g
SO 2 per litre)
Description Clear colourless aqueous solution
Identification
Test for sulphite Passes test
Test for Passes test potassium
Purity
Iron Not more than 10 mg/kg based on the SO 2 content
Selenium Not more than 5 mg/kg based on the SO 2 content
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 234 NISIN
Synonyms
Definition Nisin consists of several closely related polypeptides produced by strains of Lactococcus lactis subsp. lactis
EINECS 215-807-5
Chemical name
Chemical C 143 H 230 N 42 O 37 S 7
formula
Molecular 3 354 ,12 weight
Assay Nisin concentrate contains not less than 900 units per mg in a mixture of non-fat milk solids and a minimum sodium chloride content of 50 %
Description White powder
Identification
Purity
Loss on drying Not more than 3 % (102 °C to 103 °C, to constant weight)
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 235 NATAMYCIN
Synonyms Pimaricin
Definition Natamycin is a fungicide of the polyene macrolide group, and is produced by strains of Streptomyces natalensis and other relevant species
EINECS 231-683-5
Chemical name A stereoisomer of 22-(3-Amino-3,6-dideoxy-β-D- mannopyranosyloxy)-1,3,26-trihydroxy-12-methyl
10-oxo-6,11,28-trioxatricyclo[22.3.1.0 5,7 ]octacosa
8,14,16,18,20-pentaene-25-carboxylic acid.
Chemical C 33 H 47 O 13 N formula
Molecular 665,74 weight
Assay Content not less than 95 % on the dried basis
Description White to creamy-white crystalline powder
Identification
Colour reactions On adding a few crystals of natamycin on a spot plate,
to a drop of:
concentrated hydrochloric acid, a
blue colour develops,
concentrated phosphoric acid, a green colour develops,which changes into pale red after a few
minutes
Spectrometry A 0,0005 % w/v solution in 1 % methanolic acetic acid solution has absorption maxima at about 290 nm, 303 nm and 318 nm, a shoulder at about 280 nm and exhibits minima at about 250 nm, 295,5 nm and 311 nm
pH 5,5 - 7,5 (1 % w/v solution in previously neutralized mixture of 20 parts dimethylformamide and 80 parts of water)
Specific rotation [α] 20 D + 250° to + 295° (a 1 % w/v solution in glacial
acetic acid, at 20 °C and calculated with reference to the dried material)
Purity
Loss on drying Not more than 8 % (over P 2 O 5 , in vacuum at 60 °C to
constant weight)
Sulphated ash Not more than 0,5 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Microbiological criteria
Total plate count Not more than 100 colonies per gram
E 239 HEXAMETHYLENE TETRAMINE
Synonyms Hexamine; Methenamine
Definition
EINECS 202-905-8
Chemical name 1,3,5,7-Tetraazatricyclo [3.3.1.1 3,7 ]-decane,
hexamethylenetetramine
Chemical C 6 H 12 N 4
formula
Molecular 140,19 weight
Assay Content not less than 99 % on the anhydrous basis Description Colourless or white crystalline powder
Identification
Test for Passes test formaldehyde
Test for Passes test ammonia
Sublimation Approximately 260 °C point :
Purity
Loss on drying Not more than 0,5 % (at 105 °C in vacuum over P 2 O 5
for 2 hours)
Sulphated ash Not more than 0,05 %
Sulphates Not more than 0,005 % expressed as SO 4
Chlorides Not more than 0,005 % expressed as Cl
Ammonium Not detectable salts
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 242 DIMETHYL DICARBONATE
Synonyms DMDC; Dimethyl pyrocarbonate
Definition
EINECS 224-859-8
Chemical name Dimethyl dicarbonate; Pyrocarbonic acid dimethyl ester
formula
EN 110 EN
Molecular 134,09 weight
Assay Content not less than 99,8 %
Description Colourless liquid, decomposes in aqueous solution. It is corrosive to skin and eyes and toxic by inhalation
and ingestion
Identification
Decomposition After dilution positive tests for CO 2 and methanol
Melting point 17 °C
Boiling point 172 °C with decomposition
Density 20 °C Approximately 1,25 g/cm 3
Infrared Maxima at 1 156 and 1 832 cm − 1
absorption spectrum
Purity
Dimethyl Not more than 0,2 % carbonate
Chlorine, total Not more than 3 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 249 POTASSIUM NITRITE
Synonyms
Definition
EINECS 231-832-4
Chemical name Potassium nitrite
EN 111 EN
formula
Molecular 85,11 weight
Assay Content not less than 95 % on the anhydrous basis 31
Description White or slightly yellow, deliquescent granules
Identification
Test for nitrite Passes test
Test for Passes test potassium
pH 6,0 - 9,0 (5 % solution)
Purity
Loss on drying Not more than 3 % (4 hours, over silica gel)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 250 SODIUM NITRITE
Synonyms
Definition
EINECS 231-555-9
Chemical name Sodium nitrite
Chemical NaNO 2
formula
Molecular 69,00 weight
EN 112 EN
Assay Content not less than 97 % on the anhydrous basis 32
Description White crystalline powder or yellowish lumps
Identification
Test for nitrite Passes test
Test for sodium Passes test
Purity
Loss on drying Not more than 0,25 % (4 hours, over silica gel)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 251 SODIUM NITRATE
I. SOLID SODIUM NITRATE
Synonyms Chile saltpetre; Cubic or soda nitre
Definition
EINECS 231-554-3
Chemical name Sodium nitrate
Chemical NaNO 3 formula
Molecular 85,00 weight
Assay Content not less than 99 % on the anhydrous basis
Description White crystalline, slightly hygroscopic powder
Identification
EN 113 EN
Test for nitrate Passes test
Test for sodium Passes test
pH 5,5 - 8,3 (5 % solution)
Purity
Loss on drying Not more than 2 % (105 °C, 4 hours)
Nitrites Not more than 30 mg/kg expressed as NaNO 2
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
II. LIQUID SODIUM NITRATE
Synonyms
Definition Liquid sodium nitrate is an aqueous solution of sodium nitrate as the direct result of the chemical reaction between sodium hydroxide and nitric acid in stoechiometric amounts, without subsequent crystallisation. Standardised forms prepared from liquid sodium nitrate meeting these specifications may contain nitric acid in excessive amounts, if clearly stated or labelled.
EINECS 231-554-3
Chemical name Sodium nitrate
Chemical NaNO 3 formula
Molecular 85,00 weight
Assay Content between 33,5 % and 40,0 % of NaNO 3
Description Clear colourless liquid
Identification
Test for nitrate Passes test
Test for sodium Passes test
pH 1,5 - 3,5
Purity
Free nitric acid Not more than 0,01 %
Nitrites Not more than 10 mg/kg expressed as NaNO 2
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 0,3 mg/kg
This specification refers to a 35 % aqueous solution
E 252 POTASSIUM NITRATE
Synonyms Chile saltpetre; Cubic or soda nitre
Definition
EINECS 231-818-8
Chemical name Potassium nitrate
Chemical KNO 3
formula
Molecular 101,11 weight
Assay Content not less than 99 % on the anhydrous basis
Description White crystalline powder or transparent prisms having a cooling, saline, pungent taste
Identification
Test for nitrate Passes test
Test for Passes test potassium pH 4,5 - 8,5 (5 % solution)
Purity
Loss on drying Not more than 1 % (105 °C, 4 hours)
Nitrites Not more than 20 mg/kg expressed as KNO 2
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 260 ACETIC ACID
Synonyms
Definition
EINECS 200-580-7
Chemical name Acetic acid; Ethanoic acid
Chemical C 2 H 4 O 2 formula
Molecular 60,05 weight
Assay Content not less than 99,8 %
Description Clear, colourless liquid having a pungent, characteristic odour
Identification
Boiling point 118 °C at 760 mm pressure (of mercury)
Specific gravity About 1,049
Test for acetate A one in three solution gives positive tests for acetate
Solidification Not lower than 14,5 °C point
Purity
Non-volatile Not more than 100 mg/kg residue
Formic acid, Not more than 1 000 mg/kg expressed as formic acid formates and other oxidizable substances
Readily Dilute 2 ml of the sample in a glass-stoppered oxidisable container with 10 ml of water and add 0,1 ml of 0,1 N substances potassium permanganate. The pink colour does not change to brown within 30 minutes
Arsenic Not more than 1 mg/kg
Lead Not more than 0,5 mg/kg
Mercury Not more than 1 mg/kg
E 261 POTASSIUM ACETATE
Synonyms
Definition
EINECS 204-822-2
Chemical name Potassium acetate
Chemical C 2 H 3 O 2 K
formula
Molecular 98,14 weight
Assay Content not less than 99 % on the anhydrous basis
Description Colourless, deliquescent crystals or a white crystalline powder, odourless or with a faint acetic odour
Identification
pH 7,5 – 9,0 (5 % aqueous solution)
Test for acetate Passes test
Test for Passes test potassium
Purity
Loss on drying Not more than 8 % (150 °C, 2 hours)
Formic acid, Not more than 1 000 mg/kg expressed as formic acid formates and other oxidizable substances
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 262 (i) SODIUM ACETATE
Synonyms
Definition
EINECS 204-823-8
Chemical name Sodium acetate
Chemical C 2 H 3 NaO 2 ·nH 2 O (n = 0 or 3)
formula
Molecular weight Anhydrous: 82,03
Trihydrate: 136,08
Assay Content (for both of anhydrous and trihydrate form) not less than 98,5 % on the anhydrous basis
Description Anhydrous: White, odourless, granular, hygroscopic powder
Trihydrate: Colourless, transparent crystals or a granular crystalline powder, odourless or with a faint, acetic odour. Effloresces in warm, dry air
Identification
pH 8,0 – 9,5 (1 % aqueous solution) Test for acetate Passes test
Test for sodium Passes test
Purity
Loss on drying Anhydrous: Not more than 2 % (120 °C, 4 hours)
Trihydrate: Between 36 and 42 % (120 °C, 4 hours)
Formic acid, Not more than 1 000 mg/kg expressed as formic acid formates and other oxidizable substances
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 262 (ii) SODIUM DIACETATE
Synonyms
Definition Sodium diacetate is a molecular compound of sodium acetate and acetic acid
EINECS 204-814-9
Chemical name Sodium hydrogen diacetate
Chemical C 4 H 7 NaO 4 ·nH 2 O (n = 0 or 3) formula
Molecular 142,09 (anhydrous) weight
Assay Content 39 to 41 % of free acetic acid and 58 to 60 % of sodium acetate
Description White, hygroscopic crystalline solid with an acetic odour
Identification pH 4,5 – 5,0 (10 % aqueous solution)
Test for acetate Passes test
Test for sodium Passes test
Purity
Water content Not more than 2 % (Karl Fischer method)
Formic acid, Not more than 1 000 mg/kg expressed as formic acid
formates and
other oxidizable
substances
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 263 CALCIUM ACETATE
Synonyms
Definition
EINECS 200-540-9
Chemical name Calcium acetate
Chemical Anhydrous: C 4 H 6 O 4 Ca formula
Monohydrate: C 4 H 6 O 4 Ca·H 2 O
Molecular Anhydrous: 158,17 weight Monohydrate: 176,18
Assay Content not less than 98 % on the anhydrous basis
Description Anhydrous calcium acetate is a white, hygroscopic, bulky, crystalline solid with a slightly bitter taste. A slight odour of acetic acid may be present. The
monohydrate may be needles, granules or powder
Identification pH 6,0 – 9,0 (10 % aqueous solution)
Test for acetate Passes test
Test for calcium Passes test
Purity
Loss on drying Not more than 11 % (155 °C to constant weight, for the monohydrate)
Water insoluble Not more than 0,3 % matter
Formic acid, Not more than 1 000 mg/kg expressed as formic acid formates and other oxidizable substances
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 270 LACTIC ACID
Synonyms
Definition Consists of a mixture of lactic acid (C 3 H 6 O 3 ) and lactic acid lactate (C 6 H 10 O 5 ). It is obtained by the
lactic fermentation of sugars or is prepared synthetically.
Lactic acid is hygroscopic and when concentrated by boiling, it condenses to form lactic acid lactate, which on dilution and heating hydrolyzes to lactic acid.
EINECS 200-018-0
Chemical name Lactic acid; 2-Hydroxypropionic acid; 1- Hydroxyethane-1-carboxylic acid
Chemical C 3 H 6 O 3
formula
Molecular 90,08 weight Assay Content not less than 76 %
Description Colourless or yellowish, nearly odourless, syrupy liquid to solid
Identification
Test for lactate Passes test
Purity
Sulphated ash Not more than 0,1 %
Chloride Not more than 0,2 %
Sulphate Not more than 0,25 %
Iron Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
ote: This specification refers to a 80 % aqueous solution; for weaker aqueous solutions, calculate values corresponding to their lactic acid content
E 280 PROPIONIC ACID
Synonyms
Definition
EINECS 201-176-3
Chemical name Propionic acid; Propanoic acid
Chemical C 3 H 6 O 2
formula
Molecular 74,08 weight
Assay Content not less than 99,5 %
Description Colourless or slightly yellowish, oily liquid with a slightly pungent odour
Identification
Melting point − 22 °C
Distillation 138,5 °C to 142,5 °C range
Purity
Non-volatile Not more than 0,01 % when dried at 140 °C to residue constant weight
Aldehydes Not more than 0,1 % expressed as formaldehyde
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 281 SODIUM PROPIONATE
Synonyms
Definition
EINECS 205-290-4
Chemical name Sodium propionate; Sodium propanoate
Chemical C 3 H 5 O 2 Na formula
Molecular 96,06 weight
Assay Content not less than 99 % after drying for two hours at 105 °C
Description White crystalline hygroscopic powder, or a fine white powder
Identification
Test for Passes test propionate
Test for sodium Passes test
pH 7,5 – 10,5 (10 % aqueous solution)
Purity
Loss on drying Not more than 4 % (105 °C, 2 hours)
Water insoluble Not more than 0,1 % matter
Iron Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 282 CALCIUM PROPIONATE
Synonyms
Definition
EINECS 223-795-8
Chemical name Calcium propionate
Chemical C 6 H 10 O 4 Ca
formula
Molecular 186,22 weight
Assay Content not less than 99 %, after drying for two hours at 105 °C
Description White crystalline powder
Identification
Test for Passes test propionate Test for calcium Passes test
pH 6,0 – 9,0 (10 % aqueous solution)
Purity
Loss on drying Not more than 4 % (105 °C, 2 hours)
Water insoluble Not more than 0,3 % matter
Iron Not more than 50 mg/kg
Fluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 283 POTASSIUM PROPIONATE
Synonyms
Definition
EINECS 206-323-5
Chemical name Potassium propionate; Potassium propanoate
Chemical C 3 H 5 KO 2
formula
Molecular 112,17 weight
Assay Content not less than 99 % after drying for two hours at 105 °C
Description White crystalline powder
Identification
Test for Passes test propionate Test for Passes test potassium
Purity
Loss on drying Not more than 4 % (105 °C, 2 hours)
Water insoluble Not more than 0,1 % matter
Iron Not more than 30 mg/kg
Fluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 284 BORIC ACID
Synonyms Boracic acid; Orthoboric acid; Borofax
Definition
EINECS 233-139-2
Chemical name
Chemical H 3 BO 3
formula
Molecular 61,84 weight
Assay Content not less than 99,5 %
Description Colourless, odourless, transparent crystals or white granules or powder; slightly unctuous to the touch; occurs in nature as the mineral sassolite
Identification
Melting point At approximately 171 °C
Burning test Burns with a nice green flame pH 3,8 – 4,8 (3,3 % aqueous solution)
Purity
Peroxides No colour develops with added KI-solution
Arsenic Not more than 1 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 285 SODIUM TETRABORATE (BORAX)
Synonyms Sodium borate
Definition
EINECS 215-540-4
Chemical name Sodium tetraborate; Sodium biborate; Sodium pyroborate; Anhydrous tetraborate
Chemical Na 2 B 4 O 7 formula Na 2 B 4 O 7 ·10H 2 O
Molecular 201,27 weight
Assay
Description Powder or glass-like plates becoming opaque on exposure to air; slowly soluble in water
Identification
Melting range Between 171 °C and 175 °C with decomposition
Purity
Peroxides No colour develops with added KI-solution
Arsenic Not more than 1 mg/kg
Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg
E 290 CARBON DIOXIDE
Synonyms Carbonic acid gas; Dry ice (solid form); Carbonic anhydride
Definition
EINECS 204-696-9
Chemical name Carbon dioxide
Chemical CO 2
formula
Molecular 44,01 weight
Assay Content not less than 99 % v/v on the gaseous basis
Description A colourless gas under normal environmental conditions with a slight pungent odour. Commercial carbon dioxide is shipped and handled as a liquid in pressurized cylinders or bulk storage systems, or in compressed solid blocks of «dry ice». Solid (dry ice) forms usually contain added substances, such as propylene glycol or mineral oil, as binders
Identification
Precipitate When a stream of the sample is passed through a formation solution of barium hydroxide, a white precipitate is produced which dissolves with effervescence in dilute acetic acid
Purity
Acidity 915 ml of gas bubbled through 50 ml of freshly boiled water must not render the latter more acid to
methylorange than is 50 ml freshly boiled water to which has been added 1 ml of hydrochloric acid (0,01 N)
Reducing 915 ml of gas bubbled through 25 ml of ammoniacal substances, silver nitrate reagent to which has been added 3 ml of hydrogen ammonia must not cause clouding or blackening of phosphide and this solution sulphide
Carbon Not more than 10 µl/l monoxide
Oil content Not more than 5 mg/kg
E 296 MALIC ACID
Synonyms Pomalous acid
Definition
EINECS 230-022-8, 210-514-9, 202-601-5
Chemical name hydroxybutanedioic acid; hydroxysuccinic acid
Chemical C 4 H 6 O 5
formula
Molecular 134,09 weight
Assay Content not less than 99,0 %
Description White or nearly white crystalline powder or granules
Identification
Melting range 127 °C - 132 °C
Test for malate Passes test
Purity
Sulphated ash Not more than 0,1 %
Fumaric acid Not more than 1,0 %
Maleic acid Not more than 0,05 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg E 297 FUMARIC ACID
Synonyms
Definition
EINECS 203-743-0
Chemical name trans-Butenedioic acid; trans-1,2-Ethylenedicarboxylic acid
Chemical C 4 H 4 O 4 formula
Molecular 116,07 weight
Assay Content not less than 99,0 % on the anhydrous basis
Description White crystalline powder or granules
Identification
Melting range 286 °C - 302 °C (closed capillary, rapid heating)
Test for double Passes test bonds
Test for 1,2- Passes test dicarboxylic acid
pH 3,0 - 3,2 (0,05 % solution at 25 °C)
Purity
Loss on drying Not more than 0,5 % (120 °C, 4 hours)
Sulphated ash Not more than 0,1 %
Maleic acid Not more than 0,1 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg E 300 ASCORBIC ACID, L-ASCORBIC ACID
Synonyms L-xylo-Ascorbic acid; L(+)- Ascorbic acid
Definition
EINECS 200-066-2
Chemical name L-ascorbic acid; Ascorbic acid; 2,3-Didehydro-L- threo-hexono-1,4-lactone; 3-Keto-L-
gulofuranolactone
Chemical C 6 H 8 O 6
formula
Molecular 176,13 weight
Assay contains not less than 99 % of C 6 H 8 O 6 after drying in
a vacuum desiccator over sulphuric acid for 24 hours,
Description White to pale yellow, odourless crystalline powder
Melting range Between 189 °C and 193 °C with decomposition
Identification
Test for ascorbic Passes test acid
pH Between 2,4 and 2,8 (2 % aqueous solution)
Specific rotation [α] 20 D between + 20,5° and + 21,5° (10 % w/v
aqueous solution)
Purity
Loss on drying Not more than 0,4 % (in vacuum over sulphuric acid, 24 hours)
Sulphated ash Not more than 0,1 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg E 301 SODIUM ASCORBATE
Synonyms Sodium L-ascorbate; L-Ascorbic acid monosodium salt
Definition
EINECS 205-126-1
Chemical name Sodium ascorbate; Sodium L-ascorbate; 2,3- Didehydro-L-threo-hexono-1,4-lactone sodium enolate; 3-Keto-L-gulofurano-lactone sodium enolate
Chemical C 6 H 7 O 6 Na formula
Molecular 198,11 weight
Assay Sodium ascorbate, after drying in a vacuum desiccator over sulphuric acid for 24 hours, contains not less
than 99 % of C 6 H 7 O 6 Na
Description White or almost white, odourless crystalline powder which darkens on exposure to light
Identification
Test for Passes test ascorbate
Test for sodium Passes test
pH Between 6,5 and 8,0 (10 % aqueous solution)
Specific rotation [α] 20 D between + 103° and + 106° (10 % w/v aqueous
solution)
Purity
Loss on drying Not more than 0,25 % (in vacuum over sulphuric acid, 24 hours)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg E 302 CALCIUM ASCORBATE
Synonyms Calcium ascorbate dihydrate
Definition
EINECS 227-261-5
Chemical name Calcium ascorbate dihydrate; Calcium salt of 2,3- didehydro-L-threo-hexono-1,4-lactone dihydrate
Chemical C 12 H 14 O 12 Ca·2H 2 O formula
Molecular 426,35 weight
Assay Content not less than 98 % on a volatile matter-free basis
Description White to slightly pale greyish-yellow odourless crystalline powder
Identification
Test for Passes test ascorbate
Test for calcium Passes test
pH Between 6,0 and 7,5 (10 % aqueous solution)
Specific rotation [α] 20 D between + 95° and + 97° (5 % w/v aqueous
solution)
Purity
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Volatile matter Not more than 0,3 % determined by drying at room temperature for 24 hours in a desiccator containing sulphuric acid or phosphorus pentoxide
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg E 304 (i) ASCORBYL PALMITATE
Synonyms L-ascorbyl palmitate
Definition
EINECS 205-305-4
Chemical name Ascorbyl palmitate; L-ascorbyl palmitate; 2,3- didehydro-L-threo-hexono-1,4-lactone-6-palmitate; 6- palmitoyl-3-keto-L-gulofuranolactone
Chemical C 22 H 38 O 7 formula
Molecular 414,55 weight
Assay Content not less than 98 % on the dried basis
Description White or yellowish-white powder with a citrus-like odour
Identification
Melting range Between 107 °C and 117 °C
Specific rotation [α] 20 D between + 21° and + 24° (5 % w/v in methanol
solution)
Purity
Loss on drying Not more than 2,0 % (vacuum oven, 56 °C - 60 °C, 1 hour)
Sulphated ash Not more than 0,1 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 304 (ii) ASCORBYL STEARATE
Synonyms
Definition
EINECS 246-944-9
Chemical name Ascorbyl stearate; L-ascorbyl stearate; 2,3-didehydro L-threo-hexono-1,4-lactone-6-stearate; 6-stearoyl-3- keto-L-gulofuranolactone
Chemical C 24 H 42 O 7 formula
Molecular 442,6 weight
Assay Content not less than 98 %
Description White or yellowish, white powder with a citrus-like odour
Identification
Melting point About 116 °C
Purity
Loss on drying Not more than 2,0 % (vacuum oven, 56 °C - 60 °C, 1 hour)
Sulphated ash Not more than 0,1 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 306 TOCOPHEROL-RICH EXTRACT
Synonyms
Definition Product obtained by the vacuum steam distillation of edible vegetable oil products, comprising
concentrated tocopherols and tocotrienols
Contains tocopherols such as d-α-, d-β-, d-γ- and d-δ- tocopherols
EINECS Chemical name
Chemical formula
Molecular 430,71 (d-α-tocopherol) weight
Assay Content not less than 34 % of total tocopherols
Description Brownish red to red, clear, viscous oil having a mild, characteristic odour and taste. May show a slight
separation of wax-like constituents in microcrystalline
form
Identification
By suitable gas liquid chromatographic method
Specific rotation [α] 20 D not less than + 20°
Solubility Insoluble in water. Soluble in ethanol. Miscible in ether
Purity
Sulphated ash Not more than 0,1 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 307 ALPHA-TOCOPHEROL
Synonyms dl-α-Tocopherol; (all rac)-α-Tocopherol
Definition
EINECS 233-466-0
Chemical name DL-5,7,8-Trimethyltocol; DL-2,5,7,8-tetramethyl-2- (4′,8′,12′-trimethyltridecyl)-6-chromanol
Chemical C 29 H 50 O 2 formula
Molecular 430,71 weight
Assay Content not less than 96 %
Description Slightly yellow to amber, nearly odourless, clear, viscous oil which oxidizes and darkens on exposure to air or light
Identification
Solubility Insoluble in water, freely soluble in ethanol, miscible in ether
Spectrophotome In absolute ethanol the maximum absorption is about try 292 nm
Specific rotation [α] 25 D 0° ± 0,05° (1 in 10 solution in chloroform)
Purity
Refractive index [n] 20 D 1,503 — 1,507
Specific E 1%
absorption in 1cm (292 nm) 71—76
ethanol (0,01 g in 200 ml of absolute ethanol)
Sulphated ash Not more than 0,1 %
Lead Not more than 2 mg/kg
E 308 GAMMA-TOCOPHEROL
Synonyms dl-γ-Tocopherol
Definition
EINECS 231-523-4
Chemical name 2,7,8-trimethyl-2-(4′,8′,12′-trimethyltridecyl)-6- chromanol
formula
EN 137 EN
Molecular 416,69 weight
Assay Content not less than 97 %
Description Clear, viscous, pale yellow oil which oxidizes and darkens on exposure to air or light
Identification
Spectrometry Maximum absorptions in absolute ethanol at about 298 nm and 257 nm
Purity
Specific E 1%
absorption in 1cm (298 nm) between 91 and 97 ethanol E 1%
1cm (257 nm) between 5,0 and 8,0
Refractive index [n] 20 D 1,503—1,507
Sulphated ash Not more than 0,1 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 309 DELTA-TOCOPHEROL
Synonyms
Definition
EINECS 204-299-0
Chemical name 2,8-dimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-
chromanol
Chemical C 27 H 46 O 2
formula
Molecular 402,7 weight Assay Content not less than 97 %
Description Clear, viscous, pale yellowish or orange oil which oxidizes and darkens on exposure to air or light
Identification
Spectrometry Maximum absorptions in absolute ethanol at about 298 nm and 257 nm
Purity
Specific E 1%
absorption 1cm (298 nm) between 89 and 95 E 1% 1cm in E 1% (257 nm) between 3,0 and 6,0
ethanol 1cm
Refractive index [n] 20 D 1,500—1,504
Sulphated ash Not more than 0,1 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 310 PROPYL GALLATE
Synonyms
Definition
EINECS 204-498-2
Chemical name Propyl gallate; Propyl ester of gallic acid; n-propyl ester of 3,4,5-trihydroxybenzoic acid
Chemical C 10 H 12 O 5 formula
Molecular 212,20 weight
Assay Content not less than 98 % on the anhydrous basis
Description White to creamy-white, crystalline, odourless solid Identification
Solubility Slightly soluble in water, freely soluble in ethanol, ether and propane-1,2-diol
Melting range Between 146 °C and 150 °C after drying at 110 °C for four hours
Purity
Loss on drying Not more than 0,5% (110 °C, 4 hours)
Sulphated ash Not more than 0,1 %
Free acid Not more than 0,5 % (as gallic acid)
Chlorinated Not more than 100 mg/kg (as C1) organic compound
Specific E 1%
absorption in 1cm (275 nm) not less than 485 and not more than
ethanol 520
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 311 OCTYL GALLATE
Synonyms
Definition
EINECS 213-853-0
Chemical name Octyl gallate; Octyl ester of gallic acid; n-octyl ester of 3,4,5-trihydroxybenzoic acid
Chemical C 15 H 22 O 5 formula
Molecular 282,34 weight
Assay Content not less than 98 % after drying at 90 °C for six hours
Description White to creamy-white odourless solid
Identification
Solubility Insoluble in water, freely soluble in ethanol, ether and
propane-1,2-diol
Melting range Between 99 °C and 102 °C after drying at 90 °C for six hours
Purity
Loss on drying Not more than 0,5 % (90 °C, 6 hours)
Sulphated ash Not more than 0,05 %
Free acid Not more than 0,5 % (as gallic acid)
Chlorinated Not more than 100 mg/kg (as C1) organic compound
Specific E 1%
absorption in 1cm (275 nm) not less than 375 and not more than
ethanol 390
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 312 DODECYL GALLATE
Synonyms Lauryl gallate
Definition
EINECS 214-620-6
Chemical name Dodecyl gallate; n-dodecyl (or lauryl) ester of 3,4,5- trihydroxybenzoic acid; Dodecyl ester of gallic acid
formula
EN 141 EN
Molecular 338,45 weight
Assay Content not less than 98 % after drying at 90 °C for six hours
Description White or creamy-white odourless solid
Identification
Solubility Insoluble in water, freely soluble in ethanol and ether
Melting range Between 95 °C and 98 °C after drying at 90 °C for six hours
Purity
Loss on drying Not more than 0,5 % (90 °C, 6 hours)
Sulphated ash Not more than 0,05 %
Free acid Not more than 0,5 % (as gallic acid)
Chlorinated Not more than 100 mg/kg (as Cl) organic compound
Specific E 1%
absorption in 1cm (275 nm) not less than 300 and not more than
ethanol 325
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 315 ERYTHORBIC ACID
Synonyms Isoascorbic acid; D-Araboascorbic acid
Definition
EINECS 201-928-0
Chemical name D-Erythro-hex-2-enoic acid γ-lactone; Isoascorbic acid; D-Isoascorbic acid
Chemical C 6 H 8 O 6 formula
Molecular 176,13 weight
Assay Content not less than 98 % on the anhydrous basis
Description White to slightly yellow crystalline solid which darkens gradually on exposure to light
Identification
Melting range About 164 °C to 172 °C with decomposition
Test for ascorbic Passes test acid/colour reaction
Specific rotation [α] 25 D 10 % (w/v) aqueous solution between − 16,5°
to − 18,0°
Purity
Loss on drying Not more than 0,4 % after drying under (reduced pressure on silica gel, 3 hours)
Sulphated ash Not more than 0,3 %
Oxalate To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid and 5 ml of 10 % calcium acetate solution. The solution should remain clear
Lead Not more than 2 mg/kg
E 316 SODIUM ERYTHORBATE
Synonyms Sodium isoascorbate
Definition
EINECS 228-973-9
Chemical name Sodium isoascorbate; Sodium D-isoascorbic acid; Sodium salt of 2,3-didehydro-D-erythro-hexono-1,4- lactone; 3-keto-D-gulofurano-lactone sodium enolate monohydrate
Chemical C 6 H 7 O 6 Na·H 2 O formula
Molecular 216,13 weight
Assay Content not less than 98 % after drying in a vacuum desiccator over sulphuric acid for 24 hours expressed on the monohydrate basis
Description White crystalline solid
Identification
Solubility Freely soluble in water, very slightly soluble in ethanol
Test for ascorbic Passes test acid/colour reaction
Test for sodium Passes test
pH 5,5 to 8,0 (10 % aqueous solution)
Specific rotation [α] 25 D 25 D 10 % (w/v) aqueous solution between + 95°
and + 98°
Purity
Loss on drying Not more than 0,25 % after drying (in vacuum over sulphuric acid,24 hours)
Oxalate To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid and 5 ml of 10 % calcium acetate solution. The solution should remain clear.
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 319 TERTIARY-BUTYLHYDROQUINONE (TBHQ)
Synonyms TBHQ
Definition
EINECS 217-752-2
Chemical name Tert-butyl-1,4-benzenediol; 2-(1,1-Dimethylethyl)-
1,4-benzenediol
Chemical
formula C 10 H 14 O 2
Molecular
weight 166,22
Assay Content not less than 99 % of C 10 H 14 O 2
Description White crystalline solid having a characteristic odour
Identification
Solubility Practically insoluble in water; soluble in ethanol
Melting point Not less than 126,5 °C
Phenolics Dissolve about 5 mg of the sample in 10 ml of methanol and add 10,5 ml of dimethylamine solution (1 in 4). A red to pink colour is produced
Purity
Tertiary-Butyl Not more than 0,2 % p-benzoquinone
2,5-Di-tertiary Not more than 0,2 % butyl hydroquinone
Hydroxyquinone Not more than 0,1 %
Toluene Not more than 25 mg/kg
Lead Not more than 2 mg/kg
E 320 BUTYLATED HYDROXYANISOLE (BHA)
Synonyms BHA
Definition
EINECS 246-563-8
Chemical name 3-Tertiary-butyl-4-hydroxyanisole; A mixture of 2- tertiary-butyl-4-hydroxyanisole and 3-tertiary-butyl-4- hydroxyanisole
Chemical C 11 H 16 O 2
formula
Molecular 180,25 weight
Assay Content not less than 98,5 % of C 11 H 16 O 2 and not less than 85 % of 3-tertiary-butyl-4-hydroxyanisole isomer
Description White or slightly yellow flakes or waxy solid with a slight aromatic smell
Identification
Solubility Insoluble in water, freely soluble in ethanol
Melting range Between 48 o C and 63 o C
Colour reaction Passes test for phenol groups
Purity
Sulphated ash Not more than 0,05 % after calcination at 800 ± 25 o C
Phenolic Not more than 0,5 % impurities
Specific E 1%
absorption 1cm (290 nm) not less than 190 and not more than 210
E 1% 1cm (228 nm) not less than 326 and not more than
345
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 321 BUTYLATED HYDROXYTOLUENE (BHT)
Synonyms BHT
Definition
EINECS 204-881-4
Chemical name 2,6-Ditertiary-butyl-p-cresol; 4-Methyl-2,6- ditertiarybutylphenol
Chemical C 15 H 24 O formula
Molecular 220,36 weight
Assay Content not less than 99 %
Description White, crystalline or flaked solid, odourless or having a characteristic faint aromatic odour
Identification
Solubility Insoluble in water and propane- 1,2-diol
Freely soluble in ethanol
Melting point At 70 °C
Spectrometry The absorption in the range 230 to 320 nm of a 2 cm layer of a 1 in 100 000 solution in dehydrated ethanol exhibits a maximum only at 278 nm
Purity
Sulphated ash Not more than 0,005 %
Phenolic Not more than 0,5 % impurities
Specific E 1%
absorption in 1cm (278 nm) not less than 81 and not more than 88
ethanol
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 322 LECITHINS
Synonyms Phosphatides; Phospholipids
Definition Lecithins are mixtures or fractions of phosphatides obtained by physical procedures from animal or
vegetable foodstuffs; they also include hydrolysed products obtained through the use of harmless and appropriate enzymes. The final product must not show any signs of residual enzyme activity
The lecithins may be slightly bleached in aqueous medium by means of hydrogen peroxide. This oxidation must not chemically modify the lecithin phosphatides
EINECS 232-307-2
Chemical name
Chemical formula
Molecular weight
Assay Lecithins: not less than 60,0 % of substances insoluble in acetone
Hydrolysed lecithins: not less than 56,0 % of substances insoluble in acetone
Description Lecithins: brown liquid or viscous semi-liquid or powder
Hydrolysed lecithins: light brown to brown viscous liquid or paste
Identification
Test for choline Passes test
Test for Passes test phosphorus
Test for fatty Passes test acids
Test for To a 800 ml beaker add 500 ml of water (30 °C— hydrolysed 35 °C). Then slowly add 50 ml of the sample with lecithin constant stirring. Hydrolysed lecithin will form a homogeneous emulsion. Non-hydrolysed lecithin will form a distinct mass of about 50 g
Purity
Loss on drying Not more than 2,0 % (105 °C, 1 hour)
Toluene Not more than 0,3 % insoluble matter
Acid value Lecithins: not more than 35 mg of potassium hydroxide per gram
Hydrolysed lecithins: not more than 45 mg of potassium hydroxide per gram
Peroxide value Equal to or less than 10
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 325 SODIUM LACTATE
Synonyms
Definition
EINECS 200-772-0
Chemical name Sodium lactate; Sodium 2-hydroxypropanoate
Chemical C 3 H 5 NaO 3
formula
Molecular 112,06 (anhydrous) weight
Assay Content not less than 57 % and not more than 66 %
Description Colourless, transparent, liquid. Odourless, or with a slight, characteristic odour
Identification
Test for lactate Passes test
Test for Passes test potassium
pH 6,5 to 7,5 (20 % aqueous solution)
Purity
Acidity Not more than 0,5 % after drying expressed as lactic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Reducing No reduction of Fehling's solution substances
ote: This specification refers to a 60 % aqueous solution
E 326 POTASSIUM LACTATE
Synonyms
Definition
EINECS 213-631-3
Cheminal name Potassium lactate; Potassium 2-hydroxypropanoate
Chemical C 3 H 5 O 3 K
formula
Molecular 128,17 (anhydrous) weight
Assay Content not less than 57 % and not more than 66 %
Description Slightly viscous, almost odourless clear liquid.
Odourless, or with a slight, characteristic odour
Identification
Ignition Ignite potassium lactate solution to an ash. The ash is alkaline, and an effervescence occurs when acid is
added Colour reaction Overlay 2 ml of potassium lactate solution on 5 ml of
a 1 in 100 solution of catechol in sulphuric acid. A deep red colour is produced at the zone of contact
Test for Passes test potassium
Test for lactate Passes test
Purity
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Acidity Dissolve 1 g of potassium lactate solution in 20 ml of water, add 3 drops of phenolphthalein TS and titrate with 0,1 N sodium hydroxide. Not more than 0,2 ml should be required
Reducing No reduction of Fehling's solution substances
ote: This specification refers to a 60 % aqueous solution
E 327 CALCIUM LACTATE
Synonyms
Definition
EINECS 212-406-7
Chemical name Calcium dilactate; Calcium dilactate hydrate; 2- Hydroxypropanoic acid calcium salt
Chemical (C 3 H 5 O 2 ) 2 Ca·nH 2 O (n = 0 - 5) formula
Molecular 218,22 (anhydrous) weight
Assay Content not less than 98 % on the anhydrous basis
Description Almost odourless, white crystalline powder or granules
Identification
Test for lactate Passes test
Test for calcium Passes test
Solubility Soluble in water and practically insoluble in ethanol
pH Between 6,0 and 8,0 (5 % solution)
Purity
Loss on drying anhydrous: not more than 3,0 % (120 °C, 4 hours)
with 1 molecule of water: not more than 8,0 % (120 °C, 4 hours)
with 3 molecules of water: not more than 20,0 % (120 °C, 4 hours)
with 4,5 molecules of water: not more than 27,0 % (120 °C, 4 hours)
Acidity Not more than 0,5 % of the dry matter expressed as lactic acid
Fluoride Not more than 30 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Reducing No reduction of Fehling's solution substances
E 330 CITRIC ACID
Synonyms
Citric acid is produced from lemon or pineapple juice,
Definition by fermentation of carbohydrate solutions or other suitable media using Candida spp. or non-toxicogenic
strains of Aspergillus niger
EINECS 201-069-1 Chemical name Citric acid; 2-Hydroxy-1,2,3-propanetricarboxylic acid; β-Hydroxytricarballylic acid
Chemical (a) C 6 H 8 O 7 (anhydrous) formula (b) C 6 H 8 O 7 ·H2O (monohydrate)
Molecular (a) 192,13 (anhydrous) weight (b) 210,15 (monohydrate)
Assay Citric acid may be anhydrous or it may contain 1 molecule of water. Citric acid contains not less than
99,5 % of C 6 H 8 O 7 , calculated on the anhydrous basis
Description Citric acid is a white or colourless, odourless, crystalline solid, having a strongly acid taste. The monohydrate effloresces in dry air
Identification
Solubility Very soluble in water; freely soluble in ethanol;
soluble in ether
Purity
Water content Anhydrous citric acid contains not more than 0,5 % water; citric acid monohydrate contains not more than 8,8 % water (Karl Fischer method)
Sulphated ash Not more than 0,05 % after calcination at 800 ± 25 °C
Arsenic Not more than 1 mg/kg
Lead Not more than 0,5 mg/kg
Mercury Not more than 1 mg/kg
Oxalates Not more than 100 mg/kg, expressed as oxalic acid,
after drying
Readily Heat 1 g of powdered sample with 10 ml of 98 % carbonisable minimum sulphuric acid in a water bath at 90 °C in substances the dark for one hour. Not more than a pale brown colour should be produced (Matching Fluid K)
E 331 (i) MONOSODIUM CITRATE
Synonyms Monobasic sodium citrate
Definition
EINECS 242-734-6
Chemical name Monosodium citrate; Monosodium salt of 2-hydroxy 1,2,3-propanetricarboxylic acid
Chemical (a) C 6 H 7 O 7 Na (anhydrous) formula
-
b)C 6 H 7 O 7 Na·H 2 O (monohydrate)
Molecular (a) 214,11 (anhydrous) weight (b) 232,23 (monohydrate)
Assay Content not less than 99 % on the anhydrous basis
Description Crystalline white powder or colourless crystals
Identification
Test for citrate Passes test
Test for sodium Passes test
pH Between 3,5 and 3,8 (1 % aqueous solution)
Purity
Loss on drying anhydrous: not more than 1,0 % (140 °C, 0,5 hours)
monohydrate: not more than 8,8 % (180 °C, 4 hours)
Oxalates Not more than 100 mg/kg expressed as oxalic acid,
after drying
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 331 (ii) DISODIUM CITRATE
Synonyms Dibasic sodium citrate
Definition
EINECS 205-623-3
Chemical name Disodium citrate; Disodium salt of 2-hydroxy-1,2,3- propanetricarboxylic acid; Disodium salt of citric acid with 1,5 molecules of water
Chemical C 6 H 6 O 7 Na 2 ·1,5H 2 O formula
Molecular 263,11 weight
Assay Content not less than 99 % on the anhydrous basis
Description Crystalline white powder or colourless crystals
Identification
Test for citrate Passes test
Test for sodium Passes test
pH Between 4,9 and 5,2 (1 % aqueous solution)
Purity
Loss on drying Not more than 13,0 % (180 °C, 4 hours)
Oxalates Not more than 100 mg/kg expressed as oxalic acid,
after drying
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 331 (iii) TRISODIUM CITRATE
Synonyms Tribasic sodium citrate
Definition
EINECS 200-675-3 Chemical name Trisodium citrate; Trisodium salt of 2-hydroxy-1,2,3- propanetricarboxylic acid; Trisodium salt of citric acid, in anhydrous, dihydrate or pentahydrate form
Chemical Anhydrous: C 6 H 5 O 7 Na 3 formula
Hydrated: C 6 H 5 O 7 Na 3 ·nH 2 O (n = 2 or 5)
Molecular 258,07 (anhydrous) weight 294,10 (hydrated n = 2)
348,16 (hydrated n = 5)
Assay Not less than 99 % on the anhydrous basis
Description Crystalline white powder or colourless crystals
Identification
Test for citrate Passes test
Test for sodium Passes test
pH Between 7,5 and 9,0 (5 % aqueous solution)
Purity
Loss of drying Anhydrous: not more than 1,0 % (180 °C, 18 hours)
Dihydrate: 10,0 to 13,0 % (180 °C, 18 hours)
Pentahydrate: not more than 30,3 % (180 °C, 4 hours)
Oxalates Not more than 100 mg/kg expressed as oxalic acid,
after drying
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 332 (i) MONOPOTASSIUM CITRATE
Synonyms Monobasic potassium citrate
Definition
EINECS 212-753-4
Chemical name Monopotassium citrate; Monopotassium salt of 2- hydroxy-1,2,3-propanetricarboxylic acid; Anhydrous monopotassium salt of citric acid
Chemical C 6 H 7 O 7 K formula
Molecular 230,21 weight
Assay Content not less than 99 % on the anhydrous basis
Description White, hygroscopic, granular powder or transparent crystals
Identification
Test for citrate Passes test
Test for Passes test potassium
pH Between 3,5 and 3,8 (1 % aqueous solution)
Purity
Loss on drying Not more than 1,0 % (180 °C, 4 hours)
Oxalates Not more than 100 mg/kg expressed as oxalic acid,
after drying
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 332 (ii) TRIPOTASSIUM CITRATE
Synonyms Tribasic potassium citrate
Definition
EINECS 212-755-5
Chemical name Tripotassium citrate; Tripotassium salt of 2-hydroxy 1,2,3-propanetricarboxylic acid; Monohydrated
tripotassium salt of citric acid
Chemical C 6 H 5 O 7 K 3 ·H 2 O
formula
Molecular 324,42 weight
Assay Content not less than 99 % on the anhydrous basis
Description White, hygroscopic, granular powder or transparent crystals
Identification
Test for citrate Passes test
Test for Passes test potassium
pH Between 7,5 and 9,0 (5 % aqueous solution)
Purity
Loss on drying Not more than 6,0 % (180 °C, 4 hours)
Oxalates Not more than 100 mg/kg (expressed as oxalic acid,
after drying)
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 333 (i) MONOCALCIUM CITRATE
Synonyms Monobasic calcium citrate
Definition
EINECS Chemical name Monocalcium citrate; Monocalcium salt of 2- hydroxy-1,2,3-propanetricarboxylic acid; Monohydrate monocalcium salt of citric acid
Chemical (C 6 H 7 O 7 ) 2 Ca·H 2 O formula
Molecular 440,32 weight
Assay Content not less than 97,5 % on the anhydrous basis
Description Fine white powder
Identification
Test for citrate Passes test
Test for calcium Passes test
pH Between 3,2 and 3,5 (1 % aqueous solution)
Purity
Loss on drying Not more than 7,0 % (180 °C, 4 hours)
Oxalates Not more than 100 mg/kg (expressed as oxalic acid,
after drying)
Fluoride Not more than 30 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Aluminium Not more than 30 mg/kg (only if added to food for infants and young children)
Not more than 200 mg/kg (for all uses except food for
infants and young children)
Carbonates Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles
E 333 (ii) DICALCIUM CITRATE
Synonyms Dibasic calcium citrate
Definition
EINECS
Chemical name Dicalcium citrate; Dicalcium salt of 2-hydroxy-1,2,3- propanetricarboxylic acid; Trihydrated dicalcium salt of citric acid
Chemical (C 6 H 7 O 7 ) 2 Ca 2 ·3H 2 O
formula
Molecular 530,42 weight
Assay Not less than 97,5 % on the anhydrous basis
Description Fine white powder
Identification
Test for citrate Passes test
Test for calcium Passes test
Purity
Loss on drying Not more than 20,0 % (180°C, 4 hours)
Oxalates Not more than 100 mg/kg (expressed as oxalic acid,
after drying)
Fluoride Not more than 30 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Aluminium Not more than 30 mg/kg (only if added to food for infants and young children)
Not more than 200 mg/kg (for all uses except food for
infants and young children)
Carbonates Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles
E 333 (iii) TRICALCIUM CITRATE
Synonyms Tribasic calcium citrate
Definition
EINECS 212-391-7
Chemical name Tricalcium citrate; Tricalcium salt of 2-hydroxy 1,2,3-propanetricarboxylic acid; Tetrahydrated tricalcium salt of citric acid
Chemical (C 6 H 6 O 7 ) 2 Ca 3 ·4H 2 O
formula
Molecular 570,51 weight
Assay Not less than 97,5 % on the anhydrous basis
Description Fine white powder
Identification
Test for citrate Passes test
Test for calcium Passes test
Purity
Loss on drying Not more than 14,0 % (180 °C, 4 hours)
Oxalates Not more than 100 mg/kg (expressed as oxalic acid,
after drying)
Fluoride Not more than 30 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Aluminium Not more than 30 mg/kg (only if added to food for infants and young children)
Not more than 200 mg/kg (for all uses except food for
infants and young children)
Carbonates Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles
E 334 L(+)-TARTARIC ACID, TARTARIC ACID
Synonyms
Definition
EINECS 201-766-0
Chemical name L-tartaric acid; L-2,3-dihydroxybutanedioic acid; dα,β-dihydroxysuccinic acid
Chemical C 4 H 6 O 6
formula
Molecular 150,09 weight
Assay Content not less than 99,5 % on the anhydrous basis
Description Colourless or translucent crystalline solid or white crystalline powder
Identification
Melting range Between 168 °C and 170 °C
Test for tartrate Passes test
Specific rotation [α] 20 D between + 11,5° and + 13,5° (20 % w/v
aqueous solution)
Purity
Loss on drying Not more than 0,5 % (over P 2 O 5 , 3 hours)
Sulphated ash Not more than 1 000 mg/kg (after calcination at 800 ± 25 °C)
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
E 335 (i) MONOSODIUM TARTRATE
Synonyms Monosodium salt of L-(+)-tartaric acid
Definition
EINECS
Chemical name Monosodium salt of L-2,3-dihydroxybutanedioic acid; Monohydrated monosodium salt of L-(+)-tartaric acid
Chemical C 4 H 5 O 6 Na·H 2 O
formula
Molecular 194,05 weight
Assay Content not less than 99 % on the anhydrous basis
Description Transparent colourless crystals
Identification
Test for tartrate Passes test
Test for sodium Passes test
Purity
Loss on drying Not more than 10,0 % (105 °C, 4 hours)
Oxalates Not more than 100 mg/kg (expressed as oxalic acid,
after drying)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 335 (ii) DISODIUM TARTRATE
Synonyms
Definition
EINECS 212-773-3
Chemical name Disodium L-tartrate; Disodium (+)-tartrate; Disodium salt of (+)-2,3-dihydroxybutanedioic acid; Dihydrated disodium salt of L-(+)-tartaric acid
Chemical C 4 H 4 O 6 Na 2 ·2H 2 O
formula
Molecular 230,8 weight
Assay Content not less than 99 % on the anhydrous basis
Description Transparent, colourless crystals
Identification
Test for tartrate Passes test
Test for sodium Passes test
Solubility 1 gram is insoluble in 3 ml of water. Insoluble in ethanol
pH Between 7,0 and 7,5 (1 % aqueous solution)
Purity
Loss on drying Not more than 17,0 % (150 °C, 4 hours)
Oxalates Not more than 100 mg/kg (expressed as oxalic acid,
after drying)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 336 (i) MONOPOTASSIUM TARTRATE
Synonyms Monobasic potassium tartrate
Definition
EINECS
Chemical name Anhydrous monopotassium salt of L-(+)-tartaric acid; Monopotassium salt of L-2,3-dihydroxybutanedioic
acid
Chemical C 4 H 5 O 6 K formula
Molecular 188,16 weight
Assay Content not less than 98 % on the anhydrous basis
Description White crystalline or granulated powder
Identification
Test for tartrate Passes test
Test for Passes test potassium
Melting point 230 °C
pH 3,4 (1 % aqueous solution)
Purity
Loss on drying Not more than 1,0 % (105 °C, 4 hours)
Oxalates Not more than 100 mg/kg (expressed as oxalic acid,
after drying)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 336 (ii) DIPOTASSIUM TARTRATE
Synonyms Dibasic potassium tartrate
Definition
EINECS 213-067-8
Chemical name Dipotassium salt of L-2,3-dihydroxybutanedioic acid; Dipotassium salt with half a molecule of water of L-
(+)-tartaric acid
Chemical C 4 H 4 O 6 K 2 ·½H 2 O
formula
Molecular 235,2 weight
Assay Content not less than 99 % on the anhydrous basis
Description White crystalline or granulated powder
Identification
Test for tartrate Passes test
Test for Passes test potassium
pH Between 7,0 and 9,0 (1 % aqueous solution)
Purity
Loss on drying Not more than 4,0 % (150 °C, 4 hours)
Oxalates Not more than 100 mg/kg (expressed as oxalic acid,
after drying)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 337 POTASSIUM SODIUM TARTRATE
Synonyms Potassium sodium L-(+)-tartrate; Rochelle salt;
Seignette salt
Definition
EINECS 206-156-8 Chemical name Potassium sodium salt of L-2,3-dihydroxybutanedioic acid; Potassium sodium L-(+)-tartrate
Chemical C 4 H 4 O 6 KNa·4H 2 O formula
Molecular 282,23 weight
Assay Content not less than 99 % on the anhydrous basis
Description Colourless crystals or white crystalline powder
Identification
Test for tartrate Passes test
Test for Passes test potassium
Test for sodium Passes test
Solubility 1 gram is soluble in 1 ml of water, insoluble in ethanol
Melting range 70 - 80 °C
pH Between 6,5 and 8,5 (1 % aqueous solution)
Purity
Loss on drying Not more than 26,0 % and not less than 21,0 % (150
°C, 3 hours)
Oxalates Not more than 100 mg/kg (expressed as oxalic acid,
after drying)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 338 PHOSPHORIC ACID
Synonyms Orthophosphoric acid; Monophosphoric acid
Definition
EINECS 231-633-2
Chemical name Phosphoric acid
Chemical H 3 PO 4 formula
Molecular 98,00 weight
Assay Content not less than 67,0 % and not more than 85,7 %. Phosphoric acid is commercially available as an aqueous solution at variable concentrations.
Description Clear, colourless, viscous liquid
Identification
Test for acid Passes test
Test for Passes test phosphate
Purity
Volatile acids Not more than 10 mg/kg (as acetic acid)
Chlorides Not more than 200 mg/kg (expressed as chlorine)
Nitrates Not more than 5 mg/kg (as NaNO 3 )
Sulphates Not more than 1 500 mg/kg (as CaSO 4 )
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
ote: This specification refers to a 75 % aqueous solution
E 339 (i) MONOSODIUM PHOSPHATE
Synonyms Monosodium monophosphate; Acid monosodium monophosphate; Monosodium orthophosphate;
Monobasic sodium phosphate; Sodium dihydrogen monophosphate
Definition
EINECS 231-449-2
Chemical name Sodium dihydrogen monophosphate
Chemical Anhydrous: NaH 2 PO 4
formula Monohydrate: NaH 2 PO 4 · H 2 O
Dihydrate: NaH 2 PO 4 · 2H 2 O
Molecular Anhydrous: 119,98 weight Monohydrate: 138,00
Dihydrate: 156,01
Assay After drying at 60 °C for one hour and then at 105 °C for four hours, contains not less than 97 % of
NaH 2 PO 4
P 2 O 5 content between 58,0 % and 60,0 % on the anhydrous basis
Description A white odourless, slightly deliquescent powder, crystals or granules
Identification
Test for sodium Passes test
Test for Passes test phosphate
Solubility Freely soluble in water. Insoluble in ethanol or ether
pH Between 4,1 and 5,0 (1 % solution)
Purity
Loss on drying The anhydrous salt loses not more than 2,0 %, the monohydrate not more than 15,0 %, the dihydrate not more than 25 % (60 °C, 1 hour then 105 °C, 4 hours)
Water insoluble Not more than 0,2 % on the anhydrous basis matter
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 339 (ii) DISODIUM PHOSPHATE
Synonyms Disodium monophosphate; Secondary sodium phosphate; Disodium orthophosphate;
Definition
EINECS 231-448-7
Chemical name Disodium hydrogen monophosphate; Disodium hydrogen orthophosphate
Chemical Anhydrous:Na 2 HPO 4
formula Hydrate: Na 2 HPO 4 · nH 2 O (n = 2, 7 or 12)
Molecular 141,98 (anhydrous) weight
Assay After drying at 40 °C for three hours and subsequently at 105 °C for five hours, contains not less than 98 %
of Na 2 HPO 4
P 2 O 5 content between 49 % and 51 % on the anhydrous basis
Description Anhydrous disodium hydrogen phosphate is a white, hygroscopic, odourless powder. Hydrated forms
available include the dihydrate: a white crystalline, odourless solid; the heptahydrate: white, odourless, efflorescent crystals or granular powder; and the dodecahydrate: white, efflorescent, odourless powder or crystals
Identification
Test for sodium Passes test
Test for Passes test phosphate
Solubility Freely soluble in water. Insoluble in ethanol
pH Between 8,4 and 9,6 (1 % solution) Purity
Loss on drying The anhydrous salt loses not more than 5,0 %, the dihydrate not more than 22,0 %, the heptahydrate not more than 50,0 %, the dodecahydrate not more than 61,0 % (40 °C, 3 hours then 105 °C, 5 hours)
Water insoluble Not more than 0,2 % on the anhydrous basis matter
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 339 (iii) TRISODIUM PHOSPHATE
Synonyms Sodium phosphate; Tribasic sodium phosphate;
Trisodium orthophosphate
Definition Trisodium phosphate is obtained from aqueous solutions and crystallises in the anhydrous form and
with 1/2, 1, 6, 8 or 12 H 2 O. The dodecahydrate always
crystallises from aqueous solutions with an excess of sodium hydroxide. It contains ¼ molecule of NaOH
EINECS 231-509-8
Chemical name Trisodium monophosphate; Trisodium phosphate; Trisodium orthophosphate
Chemical Anhydrous: Na 3 PO 4
formula Hydrated: Na 3 PO 4 nH 2 O (n = 1/2, 1, 6, 8, or 12)
Molecular 163,94 (anhydrous) weight
Assay Sodium phosphate anhydrous and the hydrated forms, with the exception of the dodecahydrate, contain not
less than 97,0 % of Na 3 PO 4 calculated on the dried basis. Sodium phosphate dodecahydrate contains not less than 92,0 % of Na 3 PO 4 calculated on the ignited basis P 2 O 5 content between 40,5 % and 43,5 % on the anhydrous basis
Description White odourless crystals, granules or crystalline powder
Identification
Test for sodium Passes test
Test for Passes test phosphate
Solubility Freely soluble in water. Insoluble in ethanol
pH Between 11,5 and 12,5 (1 % solution)
Purity
Loss on ignition When dried at 120 °C for two hours and then ignited at about 800 °C for 30 minutes, the losses in weight are as follows: anhydrous not more than 2,0 %,
monohydrate not more than 11,0 %, dodecahydrate: between 45,0 % and 58,0 %
Water insoluble Not more than 0,2 % on the anhydrous basis matter
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 340 (i) MONOPOTASSIUM PHOSPHATE
Synonyms Monobasic potassium phosphate; Monopotassium monophosphate; Mono potassium orthophosphate
Definition
EINECS 231-913-4
Chemical name Potassium dihydrogen phosphate; Monopotassium dihydrogen orthophosphate; Monopotassium
dihydrogen monophosphate Chemical KH 2 PO 4 formula
Molecular 136,09 weight
Assay Content not less than 98,0 % after drying at 105 °C
for four hours
P 2 O 5 content between 51,0 % and 53,0 % on the anhydrous basis
Description Odourless, colourless crystals or white granular or crystalline powder
Identification
Test for Passes test potassium
Test for Passes test phosphate
Solubility Freely soluble in water. Insoluble in ethanol
pH Between 4,2 and 4,8 (1 % solution)
Purity
Loss on drying Not more than 2,0 % (105 °C, 4 hours)
Water insoluble Not more than 0,2 % on the anhydrous basis matter
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 340 (ii) DIPOTASSIUM PHOSPHATE
Synonyms Dipotassium monophosphate; Secondary potassium phosphate; Dipotassium orthophosphate; Dibasic
potassium phosphate Definition
EINECS 231-834-5
Chemical name Dipotassium hydrogen monophosphate; Dipotassium hydrogen phosphate; Dipotassium hydrogen
orthophosphate
Chemical K 2 HPO 4 formula
Molecular 174,18 weight
Assay Content not less than 98 % after drying at 105°C for four hours
P 2 O 5 content between 40,3 % and 41,5 % on the
anhydrous basis
Description Colourless or white granular powder, crystals or masses; deliquescent substance, hygroscopic
Identification
Test for Passes test potassium
Test for Passes test phosphate
Solubility Freely soluble in water. Insoluble in ethanol
pH Between 8,7 and 9,4 (1 % solution)
Purity
Loss on drying Not more than 2,0 % (105 °C, 4 hours)
Water insoluble Not more than 0,2 % (on the anhydrous basis) matter
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg E 340 (iii) TRIPOTASSIUM PHOSPHATE
Synonyms Tribasic potassium phosphate; Tripotassium orthophosphate
Definition
EINECS 231-907-1
Chemical name Tripotassium monophosphate; Tripotassium phosphate; Tripotassium orthophosphate
Chemical Anhydrous: K 3 PO 4
formula
Hydrated: K 3 PO 4 · nH 2 O (n = 1 or 3)
Molecular 212,27 (anhydrous) weight
Assay Content not less than 97 % calculated on the ignited basis
P 2 O 5 content between 30,5 % and 34,0 % on the ignited basis
Description Colourless or white, odourless hygroscopic crystals or granules. Hydrated forms available include the
monohydrate and trihydrate
Identification
Test for Passes test potassium
Test for Passes test phosphate
Solubility Freely soluble in water. Insoluble in ethanol
pH Between 11,5 and 12,3 (1 % solution)
Purity
Loss on ignition Anhydrous: not more than 3,0 %; hydrated: not more than 23,0 % (determined by drying at 105 °C for one hour and then ignite at about 800 °C ± 25 °C for 30
minutes)
Water insoluble Not more than 0,2 % (on the anhydrous basis) matter
Fluoride Not more than 10 mg/kg (expressed as fluorine) Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 341 (i) MONOCALCIUM PHOSPHATE
Synonyms Monobasic calcium phosphate; Monocalcium orthophosphate
Definition
EINECS 231-837-1
Chemical name Calcium dihydrogen phosphate
Chemical Anhydrous: Ca(H 2 PO 4 ) 2
formula Monohydrate: Ca(H 2 PO 4 ) 2 · H 2 O
Molecular 234,05 (anhydrous) weight 252,08 (monohydrate)
Assay Content not less than 95 % on the dried basis
P 2 O 5 content between 55,5 % and 61,1 % on the anhydrous basis
Description Granular powder or white, deliquescent crystals or granules
Identification
Test for calcium Passes test
Test for Passes test phosphate
CaO content Between 23,0 % and 27,5 % (anhydrous)
Between 19,0 % and 24,8 % (monohydrate)
Purity
Loss on drying Anhydrous: not more than 14 % (105 °C, 4 hours) Monohydrate: not more than 17,5 % (105 °C, 4 hours)
Loss on ignition Anhydrous: not more than 17,5 % (after ignition at 800 °C ± 25 °C for 30 minutes)
Monohydrate: not more than 25,0 % (determined by drying at 105 °C for one hour, then ignite at 800 °C ± 25 °C for 30 minutes)
Fluoride Not more than 30 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Aluminium Not more than 70 mg/kg (only if added to food for infants and young children)
Not more than 200 mg/kg (for all uses except food for infants and young children)
E 341 (ii) DICALCIUM PHOSPHATE
Synonyms Dibasic calcium phosphate; Dicalcium
orthophosphate
Definition
EINECS 231-826-1
Chemical name Calcium monohydrogen phosphate; Calcium hydrogen orthophosphate; Secondary calcium phosphate
Chemical Anhydrous: CaHPO 4
formula Dihydrate: CaHPO 4 · 2H 2 O
Molecular 136,06 (anhydrous) weight 172,09 (dihydrate)
Assay Dicalcium phosphate, after drying at 200 °C for three hours, contains not less than 98 % and not more than the equivalent of 102 % of CaHPO 4
EN 177 EN
anhydrous basis
Description White crystals or granules, granular powder or powder
Identification
Test for calcium Passes test
Test for Passes test phosphate
Solubility Sparingly soluble in water. Insoluble in ethanol
Purity
Loss on ignition Not more than 8,5 % (anhydrous), or 26,5 % (dihydrate) after ignition at 800 °C ± 25 °C for 30 minutes
Fluoride Not more than 50 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Aluminium Not more than 100 mg/kg for the anhydrous form and not more than 80 mg/kg for the dihydrated form (only if added to food for infants and young children)
Not more than 600 mg/kg for the anhydrous form and not more than 500 mg/kg for the dihydrated form (for all uses except food for infants and young children)
This applies until 31 March 2015.
Not more than 200 mg/kg for the anhydrous form and the dihydrated form (for all uses except food for infants and young children) This applies from 1 April 2015.
E 341 (iii) TRICALCIUM PHOSPHATE
Synonyms Calcium phosphate, tribasic; Calcium orthophosphate; Pentacalcium hydroxy monophosphate; Calcium
hydroxyapatite
Definition Tricalcium phosphate consists of a variable mixture of calcium phosphates obtained from neutralisation of
phosphoric acid with calcium hydroxide and having the approximate composition of 10CaO· ·3P 2 O 5 ·H 2 O
EINECS 235-330-6 (Pentacalcium hydroxy monophosphate)
231-840-8 (Calcium orthophosphate)
Chemical name Pentacalcium hydroxy monophosphate; Tricalcium
monophosphate
Chemical Ca 5 (PO 4 ) 3 ·OH or Ca 3 (PO 4 ) 2
formula
Molecular 502 or 310 weight
Assay Content not less than 90 % calculated on the ignited basis
P 2 O 5 content between 38,5 % and 48,0 % on the
anhydrous basis
Description A white, odourless powder which is stable in air
Identification
Test for calcium Passes test
Test for Passes test phosphate
Solubility Practically insoluble in water; insoluble in ethanol, soluble in dilute hydrochloric and nitric acid
Purity
Loss on ignition Not more than 8 % after ignition at 800 °C ± 25 °C for 0,5 hours
Fluoride Not more than 50 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Aluminium Not more than 150 mg/kg (only if added to food for infants and young children)
Not more than 500 mg/kg (for all uses except food for infants and young children). This applies until 31
March 2015
Not more than 200 mg/kg (for all uses except food for infants and young children). This applies from 1 April 2015.
E 343(i) MONOMAGNESIUM PHOSPHATE
Synonyms Magnesiumdihydrogenphosphate;
Magnesiumphosphate, monobasic; Monomagnesium orthophosphate
Definition
EINECS 236-004-6
Chemical name Monomagnesiumdihydrogenmonophosphate
Chemical Mg(H 2 PO 4 ) 2 nH 2 O (where n = 0 to 4)
formula
Molecular 218,30 (anhydrous) weight
Assay Not less than 51,0 % after ignition calculated as P2O5 at the ignited basis (800 °C ± 25 °C for 30 minutes)
Description White, odourless, crystalline powder, slightly soluble in water
Identification
Test for Passes test magnesium
Test for Passes test phosphate
MgO content Not less than 21,5 % after ignition or at an anhydrous basis (105°C, 4 hours)
Purity
Fluoride Not more than 10 mg/kg (as fluorine) Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 343(ii) DIMAGNESIUM PHOSPHATE
Synonyms Magnesiumhydrogenphosphate;
Magnesiumphosphate, dibasic; Dimagnesium orthophosphate; Secondary magnesiumphosphate
Definition
EINECS 231-823-5
Chemical name Dimagnesiummonohydrogenmonophosphate
Chemical MgHPO 4 · nH 2 O (where n = 0 - 3) formula
Molecular 120,30 (anhydrous) weight
Assay Not less than 96 % after ignition (800 °C ± 25 °C for
30 minutes)
Description White, odourless, crystalline powder, slightly soluble in water
Identification
Test for Passes test magnesium
Test for Passes test phosphate
MgO content Not less than 33,0 % calculated on the anhydrous basis (105°C, 4 hours)
Purity
Fluoride Not more than 10 mg/kg (as fluorine) Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 350 (i) SODIUM MALATE
Synonyms Sodium salt of malic acid
Definition
EINECS
Chemical name Disodium DL-malate; disodium salt of hydroxybutanedioic acid
Chemical Hemihydrate: C 4 H 4 Na 2 O 5 ½ H 2 O formula Trihydrate: C 4 H 4 Na 2 O 5 3H 2 O
Molecular Hemihydrate: 187,05 weight Trihydrate: 232,10
Assay Content not less than 98,0 % on the anhydrous basis
Description White crystalline powder or lumps
Identification
Test for 1,2- Passes test dicarboxylic acid
Test for sodium Passes test
Azo dye Positive formation
Solubility Freely soluble in water
Purity
Loss on drying Hemihydrate: Not more than 7,0 % (130 °C, 4 hours) Trihydrate: 20,5 % - 23,5 % (130 °C, 4 hours)
Alkalinity Not more than 0,2 % as Na 2 CO 3
Fumaric acid Not more than 1,0 %
Maleic acid Not more than 0,05 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 350 (ii) SODIUM HYDROGEN MALATE
Synonyms Monosodium salt of DL-malic acid
Definition
EINECS
Chemical name Monosodium DL-malate; monosodium 2-DL-hydroxy succinate
Chemical C 4 H 5 NaO 5
formula
Molecular 156,07 weight
Assay Content not less than 99,0 % on the anhydrous basis
Description White powder
Identification
Test for 1,2- Passes test dicarboxylic acid
Test for sodium Passes test
Azo dye Positive formation
Purity
Loss on drying Not more than 2,0 % (110 °C, 3h)
Maleic acid Not more than 0,05 %
Fumaric acid Not more than 1,0 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 351 POTASSIUM MALATE
Synonyms Potassium salt of malic acid
Definition
EINECS
Chemical name Dipotassium DL-malate; dipotassium salt of hydroxybutanedioic acid
Chemical C 4 H 4 K 2 O 5 formula
Molecular 210,27 weight
Assay Content not less than 59,5 %
Description Colourless or almost colourless aqueous solution
Identification
Test for 1,2- Passes test dicarboxylic acid
Test for Passes test potassium
Azo dye Positive formation
Purity
Alkalinity Not more than 0,2 % as K 2 CO 3
Fumaric acid Not more than 1,0 %
Maleic acid Not more than 0,05 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 352 (i) CALCIUM MALATE
Synonyms Calcium salt of malic acid
Definition
EINECS
Chemical name Calcium DL-malate; calcium-α-hydroxysuccinate; calcium salt of hydroxybutanedioic acid
Chemical C 4 H 5 CaO 5 formula
Molecular 172,14 weight
Assay Content not less than 97,5 % on the anhydrous basis
Description White powder
Identification
Test for malate Passes test
Test 1,2- Passes test dicarboxylic acid
Test for calcium Passes test
Azo dye Positive formation
Solubility Slightly soluble in water Purity
Loss on drying Not more than 2 % (100 °C, 3 hours)
Alkalinity Not more than 0,2 % as CaCO 3
Maleic acid Not more than 0,05 %
Fumaric acid Not more than 1,0 %
Fluoride Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 352 (ii) CALCIUM HYDROGEN MALATE
Synonyms Monocalcium salt of DL-malic acid
Definition
EINECS
Chemical name Monocalcium DL-malate; monocalcium 2-DL- hydroxysuccinate
Chemical (C 4 H 5 O 5 ) 2 Ca formula
Molecular weight
Assay Content not less than 97,5 % on the anhydrous basis
Description White powder
Identification
Test for 1,2- Passes test dicarboxylic acid
Test for calcium Passes test Azo dye Positive formation
Purity
Loss on drying Not more than 2,0 % (110 °C, 3 hours)
Maleic acid Not more than 0,05 %
Fumaric acid Not more than 1,0 %
Fluoride Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 353 METATARTARIC ACID
Synonyms Ditartaric acid
Definition
EINECS
Chemical name Metatartaric acid
Chemical C 4 H 6 O 6 formula
Molecular weight
Assay Not less than 99,5 %
Description Crystalline or powder form with a white or yellowish colour. Very deliquescent with a faint odour of
caramel
Identification
Solubility Very soluble in water and ethanol
Identification Place a sample of 1 to 10 mg of this substance in a test test tube with 2 ml of concentrated sulphuric acid and
EN 187 EN
150 °C, an intense violet coloration appears
Purity
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 354 CALCIUM TARTRATE
Synonyms L-Calcium tartrate
Definition
EINECS
Chemical name Calcium L(+)-2,3-dihydroxybutanedioate di-hydrate
Chemical C 4 H 4 CaO 6 · 2H 2 O formula
Molecular 224,18 weight
Assay Not less than 98,0 %
Description Fine crystalline powder with a white or off-white colour
Identification
Solubility Slightly soluble in water. Solubility approximately 0,01 g/100 ml water (20 °C). Sparingly soluble in ethanol. Slightly soluble in diethyl ether. Soluble in acids
Specific rotation [α] 20 D + 7,0° to + 7,4° (0,1 % in a 1N HCl solution)
pH Between 6,0 and 9,0 (5 % slurry)
Purity
Sulphates Not more than 1 g/kg (as H 2 SO 4 )
Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 355 ADIPIC ACID
Synonyms
Definition
EINECS 204-673-3
Chemical name Hexanedioic acid; 1,4-butanedicarboxylic acid
Chemical C 6 H 10 O 4 formula
Molecular 146,14 weight
Assay Content not less than 99,6 %
Description White odourless crystals or crystalline powder
Identification
Melting range 151,5 - 154,0 °C
Solubility Slightly soluble in water. Freely soluble in ethanol
Purity
Water Not more than 0,2 % (Karl Fischer method)
Sulphated ash Not more than 20 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 356 SODIUM ADIPATE
Synonyms
Definition
EINECS 231-293-5
Chemical name Sodium adipate
Chemical C 6 H 8 Na 2 O 4
formula
Molecular 190,11 weight
Assay Content not less than 99,0 % (on anhydrous basis)
Description White odourless crystals or crystalline powder
Identification
Melting range 151 °C - 152 °C (for adipic acid)
Solubility Approximately 50 g/100 ml water (20 °C)
Test for sodium Passes test
Purity
Water content Not more than 3 % (Karl Fischer)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 357 POTASSIUM ADIPATE
Synonyms
Definition
EINECS 242-838-1
Chemical name Potassium adipate
formula
EN 190 EN
Molecular 222,32 weight
Assay Content not less than 99,0 % (on anhydrous basis)
Description White odourless crystals or crystalline powder
Identification
Melting range 151 °C - 152 °C (for adipic acid)
Solubility Approximately 60 g/100 ml water (20 °C)
Test for Passes test potassium
Purity
Water Not more than 3 % (Karl Fischer)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 363 SUCCINIC ACID
Synonyms
Definition
EINECS 203-740-4
Chemical name Butanedioic acid
Chemical C 4 H 6 O 4 formula
Molecular 118,09 weight
Assay Content no less than 99,0 %
Description Colourless or white, odourless crystals
Identification Melting range 185,0 °C - 190,0 °C
Purity
Residue on Not more than 0,025 % (800 °C, 15 min) ignition
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 380 TRIAMMONIUM CITRATE
Synonyms Tribasic ammonium citrate
Definition
EINECS 222-394-5
Chemical name Triammonium salt of 2-hydroxypropan-1,2,3- tricarboxylic acid
Chemical C 6 H 17 N 3 O 7 formula
Molecular 243,22 weight
Assay Content not less than 97,0 %
Description White to off-white crystals or powder
Identification
Test for Passes test ammonium
Test for citrate Passes test
Solubility Freely soluble in water
Purity
Oxalate Not more than 0,04 % (as oxalic acid) Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 385 CALCIUM DISODIUM ETHYLENEDIAMINETETRAACETATE
Synonyms Calcium disodium EDTA; Calcium disodium edetate
Definition
EINECS 200-529-9
Chemical name N,N′-1,2-Ethanediylbis [N-(carboxymethyl)-
glycinate] [(4-)-O,O′,O N ,O N ]calciate(2)-disodium;
Calcium disodium ethylenediaminetetra acetate; Calcium disodium (ethylenedinitrilo)tetra acetate
Chemical C 10 H 12 O 8 CaN 2 Na 2 ·2H 2 O formula
Molecular 410,31 weight
Assay Content not less than 97 % on the anhydrous basis
Description White, odourless crystalline granules or white to nearly white powder, slightly hygroscopic
Identification
Test for sodium Passes test
Test for calcium Passes test
Chelating Positive activity to metal ions
pH Between 6,5 and 7,5 (1 % solution)
Purity
Arsenic Not more than 3 mg/kg
EN 193 EN
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 392 EXTRACTS OF ROSEMARY
Synonyms Extract of rosemary leaf (antioxidant)
Definition Extracts of rosemary contain several components, which have been proven to exert antioxidative functions. These components belong mainly to the classes of phenolic acids, flavonoids, diterpenoids. Besides the antioxidant compounds, the extracts can also contain triterpenes and organic solvent extractable material specifically defined in the following specification.
EINECS 283-291-9
Chemical name Rosemary extract (Rosmarinus officinalis)
Description Rosemary leaf extract antioxidant is prepared by extraction of the leaves of Rosmarinus officinalis using a food approved solvent system. Extracts may then be deodorised and decolourised. Extracts may be standardised.
Identification
Reference Carnosic acid (C 20 H 28 O 4 ) and Carnosol (C 20 H 26 O 4 ) antioxidative (which comprise not less than 90% of the total compounds: phenolic diterpenes) phenolic diterpenes
Reference key Borneol, Bornyl Acetate, Camphor, 1,8-Cineol, volatiles Verbenone
Density > 0,25 g/ml
Solubility Insoluble in water
Purity
Loss of drying < 5%
Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg
1 – Extracts of rosemary produced from dried rosemary leaves by acetone extraction.
Description Extracts of rosemary are produced from dried rosemary leaves by acetone extraction, filtration, purification and solvent evaporation, followed by drying and sieving to obtain a fine powder or a liquid.
Identification
Content of ≥ 10 % w/w, expressed as the total of carnosic acid reference and carnosol antioxidative compounds
Antioxidant / (Total % w/w of carnosic acid and carnosol) ≥ 15 Volatiles – Ratio (% w/w of reference key volatiles)* (* as a percentage of total volatiles in the extract, measured by Gas Chromatography - Mass Spectrometry Detection, "GC-MSD" ))
Purity
Residual Acetone: Not more than 500 mg/kg Solvents
2 – Extracts of rosemary prepared by extraction of dried rosemary leaves by means of supercritical carbon dioxide..
Description Extracts of rosemary produced from dried rosemary leaves extracted by means of supercritical carbon
dioxide with a small amount of ethanol as entrainer.
Identification
Content of ≥13 % w/w, expressed as the total of carnosic acid reference and carnosol antioxidative compounds
Antioxidant / (Total % w/w of carnosic acid and carnosol) ≥ 15 Volatiles – Ratio (% w/w of reference key volatiles)* (* as a percentage of total volatiles in the extract, measured by Gas Chromatography - Mass Spectrometry Detection, "GC-MSD" ))
Purity
Residual Ethanol: not more than 2% Solvents
3 – Extracts of rosemary prepared from a deodorised ethanolic extract of rosemary.
Description Extracts of rosemary which are prepared from a deodorised ethanolic extract of rosemary. The
extracts may be further purified, for example by treatment with active carbon and/or molecular distillation. The extracts may be suspended in suitable and approved carriers or spray dried.
Identification
Content of ≥5 % w/w, expressed as the total of carnosic acid and reference carnosol antioxidative compounds
Antioxidant / (Total % w/w of carnosic acid and carnosol) ≥ 15 Volatiles – Ratio (% w/w of reference key volatiles)* (* as a percentage of total volatiles in the extract, measured by Gas Chromatography - Mass Spectrometry Detection, "GC-MSD" ))
Purity
Residual Ethanol: not more than 500 mg/kg Solvents
4 -Extracts of rosemary decolourised and deodorised, obtained by a two-step extraction using hexane and ethanol. .
Description Extracts of rosemary which are prepared from a deodorised ethanolic extract of rosemary, undergone a hexane extraction. The extract may be further purified, for example by treatment with active carbon and/or molecular distillation. They may be suspended in suitable and approved carriers or spray dried.
Identification
Content of ≥5 % w/w, expressed as the total of carnosic acid and reference carnosol antioxidative compounds
Antioxidant / (Total % w/w of carnosic acid and carnosol) ≥ 15 Volatiles – Ratio (% w/w of reference key volatiles)* (* as a percentage of total volatiles in the extract, measured by Gas Chromatography - Mass Spectrometry Detection, "GC-MSD" ))
Purity
Residual Hexane: not more than 25 mg/kg Solvents Ethanol: not more than 500 mg/kg
E 400 ALGINIC ACID
Synonyms
Definition Linear glycuronoglycan consisting mainly of β-(1-4) linked D-mannuronic and α-(1-4) linked L-guluronic acid units in pyranose ring form. Hydrophilic
colloidal carbohydrate extracted by the use of dilute alkali from strains of various species of brown seaweeds (Phaeophyceae)
EINECS 232-680-1
Chemical name
Chemical (C 6 H 8 O 6 ) n
formula
Molecular 10 000 - 600 000 (typical average) weight
Assay Alginic acid yields, on the anhydrous basis, not less than 20 % and not more than 23 % of carbon dioxide
(CO 2 ), equivalent to not less than 91 % and not more than 104,5 % of alginic acid (C 6 H 8 O 6 ) n (calculted on equivalent weight basis of 200)
Description Alginic acid occurs in filamentous, grainy, granular and powdered forms. It is a white to yellowish brown and nearly odourless
Identification
Solubility Insoluble in water and organic solvents, slowly soluble in solutions of sodium carbonate, sodium hydroxide and trisodium phosphate
Calcium To a 0,5 % solution of the sample in 1 M sodium chloride hydroxide solution add one fifth of its volume of a 2,5 precipitation test % solution of calcium chloride. A voluminous, gelatinous precipitate is formed. This test distinguishes alginic acid from acacia gum, sodium carboxymethyl cellulose, carboxymethyl starch, carrageenan, gelatin, gum ghatti, karaya gum, locust bean gum, methyl cellulose and tragacanth gum.
Ammonium To a 0,5 % solution of the sample in 1 M sodium sulphate hydroxide solution add one half of its volume of a precipitation test saturated solution of ammonium sulphate. No precipitate is formed. This test distinguishes alginic acid from agar, sodium carboxymethyl cellulose, carrageenan, de-esterified pectin, gelatin, locust bean gum, methyl cellulose and starch.
Colour reaction Dissolve as completely as possible 0,01 g of the sample by shaking with 0,15 ml of 0,1 N sodium hydroxide and add 1 ml of acid ferric sulphate
solution. Within 5 minutes a cherry-red colour develops that finally becomes deep purple.
pH Between 2,0 and 3,5 (3 % suspension)
Purity
Loss on drying Not more than 15 % (105 °C, 4 hours)
Sulphated ash Not more than 8 % on the anhydrous basis
Sodium Not more than 2 % on the anhydrous basis hydroxide (1 M solution) insoluble matter
Formaldehyde Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Microbiological criteria
Total plate count Not more than 5 000 colonies per gram
Yeast and Not more than 500 colonies per gram moulds Escherichia coli Absent in 5 g
Salmonella spp. Absent in 10 g
E 401 SODIUM ALGINATE
Synonyms
Definition
EINECS
Chemical name Sodium salt of alginic acid
Chemical (C 6 H 7 NaO 6 ) n formula
Molecular 10 000 - 600 000 (typical average) weight
Assay Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding
to not less than 90,8 % and not more than 106,0 % of sodium alginate (calculated on equivalent weight basis of 222)
Description Nearly odourless, white to yellowish fibrous or granular powder
Identification
Test for sodium Passes test
Test for alginic Passes test acid
Purity
Loss on drying Not more than 15 % (105 °C, 4 hours)
Water insoluble Not more than 2 % on the anhydrous basis matter
Formaldehyde Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Microbiological criteria
Total plate count Not more than 5 000 colonies per gram
Yeast and Not more than 500 colonies per gram moulds
Escherichia coli Absent in 5 g
Salmonella spp. Absent in 10 g
E 402 POTASSIUM ALGINATE
Synonyms
Definition
EINECS
Chemical name Potassium salt of alginic acid
Chemical (C 6 H 7 KO 6 ) n formula
Molecular 10 000 - 600 000 (typical average) weight
Assay Yields, on the anhydrous basis, not less than 16,5 % and not more than 19,5 % of carbon dioxide
corresponding to not less than 89,2 % and not more than 105,5 % of potassium alginate (calculated on an equivalent weight basis of 238)
Description Nearly odourless, white to yellowish fibrous or granular powder
Identification
Test for Passes test potassium Test for alginic Passes test acid
Purity
Loss on drying Not more than 15 % (105 °C, 4 hours)
Water insoluble Not more than 2 % on the anhydrous basis matter
Formaldehyde Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Microbiological criteria
Total plate count Not more than 5 000 colonies per gram
Yeast and Not more than 500 colonies per gram moulds
Escherichia coli Absent in 5 g
Salmonella spp. Absent in 10 g
E 403 AMMONIUM ALGINATE
Synonyms
Definition
EINECS
Chemical name Ammonium salt of alginic acid
Chemical (C 6 H 11 NO 6 ) n formula
weight
EN 201 EN
Assay Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding
to not less than 88,7 % and not more than 103,6 % ammonium alginate (calculated on an equivalent weight basis of 217)
Description White to yellowish fibrous or granular powder
Identification
Test for Passes test ammonium
Test for alginic Passes test acid
Purity
Loss on drying Not more than 15 % (105 °C, 4 hours)
Sulphated ash Not more than 7 % on the dried basis
Water insoluble Not more than 2 % on the anhydrous basis matter
Formaldehyde Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Microbiological criteria
Total plate count Not more than 5 000 colonies per gram
Yeast and Not more than 500 colonies per gram moulds
Escherichia coli Absent in 5 g
Salmonella spp. Absent in 10 g
E 404 CALCIUM ALGINATE
Synonyms Calcium salt of alginate
Definition
EINECS
Chemical name Calcium salt of alginic acid
Chemical (C 6 H 7 Ca 1/2 O 6 ) n formula
Molecular 10 000 - 600 000 (typical average) weight
Assay Yields, on the anhydrous basis, not less than 18 % and not more than 21 % carbon dioxide corresponding to
not less than 89,6 % and not more than 104,5 % of calcium alginate (calculated on an equivalent weight basis of 219)
Description Nearly odourless, white to yellowish fibrous or granular powder
Identification
Test for calcium Passes test
Test for alginic Passes test acid
Purity
Loss on drying Not more than 15,0 % (105 °C, 4 hours)
Formaldehyde Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Microbiological criteria
Total plate count Not more than 5 000 colonies per gram
Yeast and Not more than 500 colonies per gram moulds
Escherichia coli Absent in 5 g
Salmonella spp. Absent in 10 g
E 405 PROPANE-1,2-DIOL ALGINATE
Synonyms Hydroxypropyl alginate; 1,2-Propanediol ester of alginic acid; Propylene glycol alginate
Definition
EINECS
Chemical name 1,2-Propanediol ester of alginic acid; varies in composition according to its degree of esterification and the percentage of free and neutralised carboxyl groups in the molecule
Chemical (C 9 H 14 O 7 ) n (esterified) formula
Molecular 10 000 – 600 000 (typical average) weight
Assay Yields, on the anhydrous basis, not less than 16 % and
not more than 20 % of carbon dioxide (CO 2)
Description Nearly odourless, white to yellowish brown fibrous or granular powder
Identification
Test for 1,2- Passes test (after hydrolysis) propanediol
Test for alginic Passes test (after hydrolysis) acid
Purity
Loss on drying Not more than 20 % (105 °C, 4 hours)
Total propane Not less than 15 % and not more than 45 % 1,2-diol content
Free propane- Not more than 15 % 1,2-diol content
Water insoluble Not more than 2 % on the anhydrous basis matter
Formaldehyde Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Microbiological criteria
Total plate count Not more than 5 000 colonies per gram
Yeast and Not more than 500 colonies per gram moulds
Escherichia coli Absent in 5 g
Salmonella spp. Absent in 10 g
E 406 AGAR
Synonyms Gelose; Kanten, Bengal, Ceylon, Chinese or Japanese isinglass; Layor Carang
Agar is a hydrophilic colloidal polysaccharide consisting mainly of galactose units with a regular alternation of L and D isomeric forms. These hexoses are alternately linked with alpha-1,3 and beta-1,4
bonds in the copolymer. On about every tenth D- Definition galactopyranose unit one of the hydroxyl groups is
esterified with sulphuric acid which is neutralised by calcium, magnesium, potassium or sodium. It is extracted from certain strains of marine algae of the families Gelidiaceae and Gracilriaceae and relevant
red algae of the class Rhodophyceae
EINECS 232-658-1
Chemical name Chemical formula
Molecular weight
Assay The threshold gel concentration should not be higher
than 0,25 %
Description Agar is odourless or has a slight characteristic odour. Unground agar usually occurs in bundles consisting of thin, membranous, agglutinated strips, or in cut,
flaked or granulated forms. It may be light yellowishorange, yellowish-grey to pale yellow, or colourless. It is tough when damp, brittle when dry. Powdered agar is white to yellowish-white or pale yellow. When examined in water under a microscope, agar powder appears more transparent. In chloral hydrate solution, the powdered agar appears more transparent than in water, more or less granular, striated, angular and occasionally contains frustules of diatoms. Gel strength may be standardised by the addition of dextrose and maltodextrines or sucrose
Identification
Solubility Insoluble in cold water; soluble in boiling water
Purity
Loss on drying Not more than 22 % (105 °C, 5 hours)
Ash Not more than 6,5 % on the anhydrous basis determined at 550 °C
Acid-insoluble Not more than 0,5 % determined at 550 °C on the ash (insoluble in anhydrous basis approximately 3N Hydrochloric acid)
Insoluble matter Not more than 1,0 % (after stirring for 10 minutes in hot water)
Starch Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine
solution. No blue colour is produced Gelatin and Dissolve about 1 g of agar in 100 ml of boiling water other proteins and allow to cool of about 50 °C. To 5 ml of the
solution add 5 ml of trinitrophenol solution (1 g of anhydrous trinitrophenol/100 ml of hot water). No turbidity appears within 10 minutes
Water Place 5 g to agar in a 100 ml graduated cylinder, fill absorption to the mark with water, mix and allow to stand at about 25 °C for 24 hours. Pour the contents of the cylinder through moistened glass wool, allowing the water to drain into a second 100 ml graduated cylinder. Not more than 75 ml of water is obtained
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Microbiological criteria
Total plate count Not more than 5 000 colonies per gram
Yeast and Not more than 300 colonies per gram moulds
Escherichia coli Absent in 5g
Salmonella spp. Absent in 5g
E 407 CARRAGEENAN
Synonyms Products of commerce are sold under different names such as:
Irish moss gelose; Eucheuman (from Eucheuma spp.); Iridophycan (from Iridaea spp.); Hypnean (from Hypnea spp.); Furcellaran or Danish agar (from Furcellaria fastigiata); Carrageenan (from Chondrus
and Gigartina spp.)
Definition Carrageenan is obtained by extraction with water or dilute aqueous alkali of strains of seaweeds of Gigartinaceae, Solieriaceae, Hypneaceae and Furcellariaceae, families of the class Rhodophyceae (red seaweeds).
Carrageenan consists chiefly of the potassium, sodium, magnesium and calcium sulphate esters of galactose and 3,6-anhydrogalactose polysacharide. These hexoses are alternately linked α-1,3 and β-1,4 in the copolymer.
The prevalent polysaccharides in carrageenan are designated as kappa, iota, lambda depending on the number of sulphate by repeating unit (i.e. 1,2,3 sulphate). Between kappa and iota there is a continuum of intermediate compositions differing in number of sulphates per repeat units between 1 and 2.
During the process, no organic precipitant shall be
used other than methanol, ethanol and propan-2-ol.
The wording carrageenan is reserved for the non hydrolysed or otherwise chemically degraded
polymer.
Formaldehyde may be present as an adventitious
impurity up to a maximum of 5 mg/kg.
EINECS 232-524-2
Chemical name Sulphate esters of polygalactose
Chemical formula
Molecular weight
Assay
Description Yellowish to colourless, coarse to fine powder which is practically odourless
Identification
Test for Passes test galactose
Test for Passes test anhydrogalactos e
Test for sulphate Passes test
Solubility Soluble in hot water; insoluble in alcohol for a 1,5 % dilution
Purity
Solvent residues Not more than 0,1 % of methanol, ethanol, propan-2- ol, singly or in combination
Viscosity Not less than 5 mPa.s (1,5 % solution at 75 °C)
Loss on drying Not more than 12 % (105 °C, 4 hours)
Sulphates Not less than 15 % and not more than 40 % on the dried basis (as SO 4 )
Ash Not less than 15 % and not more than 40 % determined on the dried basis at 550 °C
Acid-insoluble Not more than 1 % on the dried basis (insoluble in 10
ash % hydrochloric acid)
Acid-insoluble Not more than 2 % on the dried basis (insoluble in 1 matter % v/v sulphuric acid)
Low molecular Not more than 5 % weight carrageenan (Molecular weight fraction below 50 kDa)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 2 mg/kg
Microbiological criteria
Total plate count Not more than 5 000 colonies per gram
Yeast and Not more than 300 colonies per gram moulds
Escherichia coli Absent in 5 g
Salmonella spp. Absent in 10 g E 407a PROCESSED EUCHEUMA SEAWEED
Synonyms PES (acronym for processed eucheuma seaweed). The PES obtained from Euchema cottonii is generally
called kappa PES and the PES from Euchema spinosum iota PES.
Definition Processed eucheuma seaweed is obtained by aqueous alkaline (KOH) treatment at high temperature of the strains of seaweeds Eucheuma cottonii and Eucheuma spinosum, of the class Rhodophyceae (red seaweeds) followed by fresh water washing to remove impurities and drying to obtain the product. Further purification may be achieved by washing with an alcohol. The
alcohols authorised are restricted to methanol, ethanol or propan-2-ol. The product consists chiefly of the potassium, sodium, magnesium and calcium sulphate esters of galactose and 3,6-anhydrogalactose polysaccharide. Up to 15 % algal cellulose is also present in the product. The wording processed eucheuma seaweed is reserved to the non hydrolysed or otherwise chemically degraded polymer. Formaldehyde may be present up to a maximum of 5 mg/kg.
Description Tan to yellowish, coarse to fine powder which is practically odourless
Identification
Test for Passes test galactose
Test for Passes test anhydrogalactos e
Test for sulphate Passes test
Solubility Forms cloudy viscous suspensions in water. Insoluble in ethanol for a 1,5 % solution.
Purity
Solvent residues Not more than 0,1 % of methanol, ethanol, propan-2- ol, singly or in combination
Viscosity Not less than 5 mPa.s (1,5 % solution at 75 °C)
Loss on drying Not more than 12 % (105 °C, 4 hours) Sulphate Not less than 15 % and not more than 40 % on the
dried basis (as SO 4 )
Ash Not less than 15 % and not more than 40 % determined on the dried basis at 550 °C
Acid-insoluble Not more than 1 % on the dried basis (insoluble in 10
ash % hydrochloric acid)
Acid-insoluble Not less than 8 % and not more than 15 % on the matter dried basis (insoluble in 1 % v/v sulphuric acid)
Low molecular Not more than 5 % weight carrageenan (Molecular weight fraction below 50 kDa)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 2 mg/kg
Microbiological criteria
Total plate count Not more than 5 000 colonies per gram
Yeast and Not more than 300 colonies per gram moulds
Escherichia coli Absent in 5 g
Salmonella spp. Absent in 10 g
E 410 LOCUST BEAN GUM
Synonyms Carob bean gum; Algaroba gum
Definition Locust bean gum is the ground endosperm of the seeds of the strains of carob tree, Cerationia siliqua (L.) Taub. (family Leguminosae). Consists mainly of a high molecular weight hydrocolloidal
polysaccharide, composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as galactomannan
EINECS 232-541-5
Chemical name
Chemical formula
Molecular 50 000 - 3 000 000 weight
Assay Galactomannan content not less than 75 %
Description White to yellowish-white, nearly odourless powder
Identification
Test for Passes test galactose
Test for Passes test mannose
Microscopic Place some ground sample in an aqueous solution examination containing 0,5 % iodine and 1 % potassium iodide on a glass slide and examine under microscope. Locust bean gum contains long stretched tubiform cells, separated or slightly interspaced. Their brown contents are much less regularly formed than in guar gum. Guar gum shows close groups of round to pear shaped cells. Their contents are yellow to brown
Solubility Soluble in hot water, insoluble in ethanol
Purity
Loss on drying Not more than 15 % (105 °C, 5 hours)
Ash Not more than 1,2 % determined at 800 °C
Protein Not more than 7 % (N × 6,25)
Acid-insoluble Not more than 4 % matter
Starch Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine
solution. No blue colour is produced
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Ethanol and Not more than 1 %, single or in combination propan-2-ol
E 412 GUAR GUM
Synonyms Gum cyamopsis; Guar flour
Definition Guar gum is the ground endosperm of the seeds of strains of the guar plant, Cyamopsis tetragonolobus (L.) Taub. (family Leguminosae). Consists mainly of a high molecular weight hydrocolloidal
polysaccharide composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as galactomannan. The gum may be partially hydrolysed by either heat treatment, mild acid or alcaline oxidative treatment for viscosity adjustment.
EINECS 232-536-0
Chemical name
Chemical formula
Molecular 50 000 - 8 000 000 weight
Assay Galactomannan content not less than 75 %
Description A white to yellowish-white, nearly odourless powder
Identification
Test for Passes test galactose Test for Passes test mannose
Solubility Soluble in cold water
Purity
Loss on drying Not more than 15 % (105 °C, 5 hours)
Ash Not more than 5,5 % determined at 800 °C
Acid-insoluble Not more than 7 % matter
Protein Not more than 10 % (factor N x 6,25)
Starch Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine
solution. (No blue colour is produced)
Organic Not more than 0,7 meq active oxygen /kg sample peroxides
Furfural Not more than 1 mg/kg
Pentachlorophen Not more than 0,01 mg/kg ol
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 413 TRAGACANTH
Synonyms Tragacanth gum; Tragant
Definition Tragacanth is a dried exudation obtained from the stems and branches of strains of Astragalus gummifer Labillardiere and other Asiatic species of Astragalus (family Leguminosae). It consists mainly of high molecular weight polysaccharides (galactoarabans and acidic polysaccharides) which, on hydrolysis, yield galacturonic acid, galactose, arabinose, xylose and fucose. Small amounts of rhamnose and of glucose (derived from traces of starch and/or cellulose) may also be present
EINECS 232-252-5
Chemical name
Chemical formula
Molecular Approximately 800 000 weight
Assay
Description Unground Tragacanth gum occurs as flattened, lamellated, straight or curved fragments or as spirally twisted pieces 0,5-2,5 mm thick and up to 3 cm in length. It is white to pale yellow in colour but some pieces may have a red tinge. The pieces are horny in texture, with a short fracture. It is odourless and solutions have an insipid mucilaginous taste.
Powdered tragacanth is white to pale yellow or pinkish brown (pale tan) in colour
Identification
Solubility 1 g of the sample in 50 ml of water swells to form a smooth, stiff, opalescent mucilage; insoluble in
ethanol and does not swell in 60 % (w/v) aqueous ethanol
Purity
Test for Karaya Negative. Boil 1 g with 20 ml of water until a gum mucilage is formed. Add 5 ml of hydrochloric acid and again boil the mixture for five minutes. No permanent pink or red colour develops
Loss on drying Not more than 16 % (105 °C, 5 hours)
Total ash Not more than 4 %
Acid insoluble Not more than 0,5 % ash
Acid insoluble Not more than 2 % matter
Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Microbiological criteria
Salmonella spp. Absent in 10 g
Escherichia coli Absent in 5 g
E 414 ACACIA GUM
Synonyms Gum arabic
Definition Acacia gum is a dried exudation obtained from the stems and branches of strains of Acacia senegal (L) Willdenow or closely related species of Acacia
(family Leguminosae). It consists mainly of high molecular weight polysaccharides and their calcium, magnesium and potassium salts, which on hydrolysis yield arabinose, galactose, rhamnose and glucuronic acid
EINECS 232-519-5
Chemical name
Chemical formula
Molecular Approximately 350 000 weight
Assay
Description Unground acacia gum occurs as white or yellowishwhite spheroidal tears of varying sizes or as angular fragments and is sometimes mixed with darker
fragments. It is also available in the form of white to yellowish-white flakes, granules, powder or spraydried material.
Identification
which flows readily and is acid to litmus, insoluble in
EN 216 EN
ethanol
Purity
Loss on drying Not more than 17 % (105 °C, 5 hours) for granular and not more than 10 % (105 °C, 4 hours) for spraydried material
Total ash Not more than 4 %
Acid insoluble Not more than 0,5 % ash
Acid insoluble Not more than 1 % matter
Starch or dextrin Boil a 1 in 50 solution of the gum and cool. To 5 ml add 1 drop of iodine solution. No bluish or reddish colours are produced
Tannin To 10 ml of a 1 in 50 solution add about 0,1 ml of ferric chloride solution (9 g FeCl 3 .6H 2 O made up to 100 ml with water). No blackish colouration or
blackish precipitate is formed
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Hydrolysis Mannose, xylose and galacturonic acid are absent products (determined by chromatography)
Microbiological criteria
Salmonella spp. Absent in 10 g
Escherichia coli Absent in 5 g
E 415 XANTHAN GUM
Synonyms
Definition Xanthan gum is a high molecular weight polysaccharide gum produced by a pure-culture fermentation of a carbohydrate with strains of Xanthomonas campestris, purified by recovery with ethanol or propan-2-ol, dried and milled. It contains D-glucose and D-mannose as the dominant hexose units, along with D-glucuronic acid and pyruvic acid, and is prepared as the sodium, potassium or calcium salt. Its solutions are neutral
EINECS 234-394-2
Chemical name
Chemical formula
Molecular
weight Approximately 1 000 000
Assay Yields, on dried basis, not less than 4,2 % and not
more than 5 % of CO 2 corresponding to between 91 %
and 108 % of xanthan gum
Description Cream-coloured powder
Identification
Solubility Soluble in water. Insoluble in ethanol
Purity
Loss on drying Not more than 15 % (105 °C, 2,5 hours)
Not more than 16 % on the anhydrous basis Total ash determined at 650 °C after drying at 105 °C for four
hours
Pyruvic acid Not less than 1,5 %
Nitrogen Not more than 1,5 %
Ethanol and
propan-2-ol Not more than 500 mg/kg singly or in combination
Lead Not more than 2 mg/kg
Microbiological criteria
Total plate count Not more than 5 000 colonies per gram
Yeast and Not more than 300 colonies per gram moulds
Escherichia coli Absent in 5 g
Salmonella spp. Absent in 10 g
Xanthomonas
campestris Viable cells absent in 1 g
E 416 KARAYA-GUM
Synonyms Katilo; Kadaya; Gum sterculia; Sterculia; Karaya, gum karaya; Kullo; Kuterra
Definition Karaya gum is a dried exudation from the stems and branches of strains of: Sterculia urens Roxburgh and other species of Sterculia (family Sterculiaceae) or from Cochlospermum gossypium A.P. De Candolle or other species of Cochlospermum (family Bixaceae). It consists mainly of high molecular weight acetylated polysaccharides, which on hydrolysis yield galactose, rhamnose, and galacturonic acid, together with minor amounts of glucuronic acid
EINECS 232-539-4
Chemical name
Chemical formula
Molecular weight
Assay
Description Karaya gum occurs in tears of variable size and in broken irregular pieces having a characteristic semicrystalline appearance. It is pale yellow to pinkish brown in colour, translucent and horny. Powdered karaya gum is a pale grey to pinkish brown. The gum has a distinctive odour of acetic acid
Identification
Solubility Insoluble in ethanol
Swelling in Karaya gum swells in 60 % ethanol distinguishing it ethanol solution from other gums
Purity
Loss on drying Not more than 20 % (105 °C, 5 hours)
Total ash Not more than 8 %
Acid insoluble
ash Not more than 1 %
Acid insoluble
matter Not more than 3 %
Volatile acid Not less than 10 % (as acetic acid)
Starch Not detectable
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Microbiological criteria
Salmonella spp. Absent in 10 g
Escherichia coli Absent in 5 g
E 417 TARA GUM
Definition Tara gum is obtained by grinding the endosperm of the seeds of strains of Caesalpinia spinosa (family Leguminosae). It consists chiefly of polysaccharides of high molecular weight composed mainly of
galactomannans. The principal component consists of a linear chain of (1-4)-β-D-mannopyranose units with α-D-galactopyranose units attached by (1-6) linkages.
The ratio of mannose to galactose in tara gum is 3:1. (In locust bean gum this ratio is 4:1 and in guar gum 2:1)
EINECS 254-409-6 Chemical name
Chemical formula
Molecular weight
Assay
Description A white to white-yellow odourless powder
Identification
Solubility Soluble in water, insoluble in ethanol
Gel formation To an aqueous solution of the sample add small amounts of sodium borate. A gel is formed
Purity
Loss on drying Not more than 15 %
Ash Not more than 1,5 %
Acid insoluble
matter Not more than 2 %
Protein Not more than 3,5 % (factor N x 5,7)
Starch Not detectable
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 418 GELLAN GUM
Synonyms
Definition Gellan gum is a high molecular weight polysaccharide gum produced by a pure culture fermentation of a
carbohydrate by strains of Pseudomonas elodea, purified by recovery with propan-2-ol or ethanol, dried, and milled. The high molecular weight polysaccharide is principally composed of a tetrasaccharide repeating unit of one rhamnose, one glucuronic acid, and two glucoses, and substituted with acyl (glyceryl and acetyl) groups as the O- glycosidically linked esters. The glucuronic acid is neutralised to a mixed potassium, sodium, calcium, and magnesium salt
EINECS 275-117-5
Chemical name
Chemical formula
Molecular
weight Approximately 500 000
Assay Yields, on the dried basis, not less than 3,3 % and not more than 6,8 % of CO 2
Description An off-white powder
Identification
Soluble in water, forming a viscous solution. Solubility
Insoluble in ethanol
Purity
Loss on drying Not more than 15 % after drying (105 °C, 2,5 hours)
Nitrogen Not more than 3 %
Propan-2-ol Not more than 750 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Microbiological criteria
Total plate count Not more than 10 000 colonies per gram Yeast and
moulds Not more than 400 colonies per gram
Escherichia coli Negative in 5 g
Salmonella spp. Negative in 10 g
E 420 (i) — SORBITOL
Synonyms D-glucitol; D-sorbitol
Definition Sorbitol is obtained by hydrogenation of D-glucose. It is mainly composed of D- sorbitol. According to the level of D-glucose, the part of the products which is not D- sorbitol is composed of related substances such as mannitol, iditol, maltitol.
EINECS 200-061-5
Chemical name D-glucitol
Chemical C 6 H 14 O 6
formula
Molecular 182,2 weight
Assay Content not less than 97 % of total glycitols and not less than 91 % of D-sorbitol on dry weight basis
(glycitols are compounds with the structural formula
CH 2 OH-(CHOH) n -CH 2 OH, where “n” is an
integer).
Description White hygroscopic powder, crystalline powder, flakes or granules.
Appearance of The solution is clear . the aqueous solution:
Identification
Solubility Very soluble in water, slightly soluble in ethanol Melting range 88 to 102°C
Sorbitol To 5 g of the sample add 7 ml of methanol, 1 ml of monobenzylide benzaldehyde and 1 ml of hydrochloric acid. Mix ne derivative and shake in a mechanical shaker until crystals appear. Filter with the aid of suction, dissolve the crystals in 20 ml of boiling water containing 1 g of sodium bicarbonate, filter while hot, cool the filtrate, filter with suction, wash with 5 ml of methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between 173 and 179°C
Purity
Water content Not more than 1,5 % (Karl Fischer method)
Sulphated ash Not more than 0,1 % (expressed on dry weight basis)
Reducing Not more than 0,3 % (expressed as glucose on dry sugars weight basis)
Total sugars Not more than 1 % (expressed as glucose on dry
weight basis)
Chlorides Not more than 50 mg/kg (expressed on dry weight basis)
Sulphates Not more than 100 mg/kg (expressed on dry weight basis)
Nickel Not more than 2 mg/kg (expressed on dry weight basis)
Arsenic Not more than 3 mg/kg (expressed on dry weight basis)
Lead Not more than 1 mg/kg (expressed on dry weight basis)
E 420 (ii) — SORBITOL SYRUP
Synonyms D-glucitol syrup
Sorbitol syrup formed by hydrogenation of glucose
Definition syrup is composed of D-sorbitol, D-mannitol and hydrogenated saccharides.
The part of the product which is not D-sorbitol is composed mainly of hydrogenated oligosaccharides formed by the hydrogenation of glucose syrup used
as raw material (in which case the syrup is noncrystallising) or mannitol. Minor quantities of glycitols where n ≤ 4 may be present (glycitols are compounds with the structural formula CH 2 OH- (CHOH) n -CH 2 OH, where “n” is an integer)
EINECS 270-337-8
Chemical name
Chemical formula
Molecular weight
Assay Content not less than 69 % total solids and not less than 50 % of D-sorbitol on the anhydrous basis
Description Clear and colourless aqueous solution
Identification
Solubility Miscible with water, with glycerol, and with
propane-1,2-diol
Sorbitol To 5 g of the sample add 7 ml of methanol, 1 ml of monobenzylide benzaldehyde and 1 ml of hydrochloric acid. Mix ne derivative and shake in a mechanical shaker until crystals appear. Filter with the aid of suction, dissolve the crystals in 20 ml of boiling water containing 1 g of sodium bicarbonate, filter while hot. Cool the filtrate filter with suction, wash with 5 ml of methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between 173 and 179°C
Purity
Water content Not more than 31 % (Karl Fischer method)
Sulphated ash Not more than 0,1 % (on dry weight basis)
Reducing Not more than 0,3 % (expressed as glucose on dry sugars weight basis)
Chlorides Not more than 50 mg/kg (on dry weight basis) Sulphates Not more than 100 mg/kg (on dry weight basis)
Nickel Not more than 2 mg/kg (on dry weight basis)
Arsenic Not more than 3 mg/kg (on dry weight basis)
Lead Not more than 1 mg/kg (on dry weight basis)
E 421 — MANNITOL
(I)MANNITOL
Synonyms D-mannitol
Definition The product contains min. 96 % mannitol. The part of the product which is not mannitol is mainly composed of sorbitol (2 % max), maltitol (2 % max) and isomalt (1,1 GPM (1-O-alpha-D- Glucopyranosyl-D-mannitol dehydrate): 2 % max and 1,6 GPS (6-O-alpha-D-Glucopyranosyl-D- Sorbitol): 2 % max). Unspecified impurities shall not represent more than 0.1 % of each.
Manufactured by catalytic hydrogenation of carbohydrate solutions containing glucose and/or fructose
EINECS 200-711-8
Chemical name D-mannitol
Chemical C 6 H 14 O 6 formula
Molecular 182,2 weight
Assay Content not less than 96,0 % D-mannitol and not more than 102 % on the dried basis
Description White, odourless, crystalline powder
Identification
Solubility Soluble in water, very slightly soluble in ethanol, practically insoluble in ether
Melting range Between 164 and 169 °C Infrared Comparison with a reference standard e.g. EP or Absorption USP Spectrometry
Specific [α] 20 D + 23° to + 25° (borate solution)
rotation
pH Between 5 and 8. Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v
solution of the sample, then measure the pH
Purity
Water content Not more than 0,5 % (Karl Fischer method)
Reducing Not more than 0,3 % (as glucose) sugars
Total sugars Not more than 1 % (expressed as glucose)
Sulphated ash Not more than 0,1 %
Chlorides Not more than 70 mg/kg
Sulphate Not more than 100 mg/kg
Nickel Not more than 2 mg/kg
Lead Not more than 1 mg/kg
(II)MANNITOL MANUFACTURED BY FERMENTATION
Synonyms D-mannitol
Definition Manufactured by discontinuous fermentation under aerobic conditions using a conventional strain of the yeast Zygosaccharomyces rouxii. The part of the
product which is not mannitol is mainly composed of sorbitol, maltitol and isomalt.
EINECS 200-711-8
Chemical name D-mannitol
Chemical C 6 H 14 O 6
formula
Molecular 182,2 weight Assay Not less than 99 % on the dried basis
Description White, odourless crystalline powder
Identification
Solubility Soluble in water, very slightly soluble in ethanol, practically insoluble in ether
Melting range Between 164 and 169 °C
Infrared Comparison with a reference standard e.g. EP or Absorption USP Spectrometry
Specific [α] 20 D + 23° to + 25° (borate solution)
rotation
pH Between 5 and 8
Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH
Purity
Arabitol Not more than 0,3 %
Water content Not more than 0,5 % (Karl Fischer method)
Reducing Not more than 0,3 % (expressed as glucose) sugars
Total sugars Not more than 1 % (as glucose)
Sulphated ash Not more than 0,1 %
Chlorides Not more than 70 mg/kg
Sulphate Not more than 100 mg/kg
Lead Not more than 1 mg/kg
Microbiological criteria
Aerobic Not more than 1 000 colonies per gram mesophilic bacteria Coliforms Absent in 10 g
Salmonella Absent in 25 g spp.
Escherichia Absent in 10 g coli
Staphylococcus Absent in 10 g aureus
Pseudomonas Absent in 10 g aeruginosa
Moulds Not more than 100 colonies per gram
Yeasts Not more than 100 colonies per gram
E 422 GLYCEROL
Synonyms Glycerin; Glycerine
Definition
EINECS 200-289-5
Chemical name 1,2,3-propanetriol; Glycerol; Trihydroxypropane
Chemical C 3 H 8 O 3 formula
Molecular 92,10 weight
Assay Content not less than 98 % of glycerol on the anhydrous basis
Description Clear, colourless hygroscopic syrupy liquid with not more than a slight characteristic odour, which is
neither harsh nor disagreeable
Identification
Acrolein Heat a few drops of the sample in a test tube with formation on about 0,5 g of potassium bisulphate. The heating characteristic pungent vapours of acrolein are evolved Specific gravity Not less than 1,257 (25 °C/25 °C)
Refractive index [n] 20 D between 1,471 and 1,474
Purity
Water content Not more than 5 % (Karl Fischer method)
Sulphated ash Not more than 0,01 % determined at 800 ± 25 °C
Butanetriols Not more than 0,2 %
Acrolein, Heat a mixture of 5 ml of glycerol and 5 ml of glucose and potassium hydroxide solution (1 in 10) at 60 °C for ammonium five minutes. It neither becomes yellow nor emits an compounds odour of ammonia
Fatty acids and Not more than 0,1 % calculated as butyric acid esters
Chlorinated Not more than 30 mg/kg (as chlorine) compounds
3- Not more than 0,1 mg/kg Monochloroprop ane-1,2-diol (3- MCPD)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 425(i) KONJAC GUM
Synonyms
Definition Konjac gum is a water-soluble hydrocolloid obtained from the Konjac flour by aqueous extraction. Konjac flour is the unpurified raw product from the root of the perennial plant Amorphophallus konjac. The main component of Konjac gum is the water-soluble high-molecularweight polysaccharide glucomannan, which consists of D-mannose and D-glucose units at a molar ratio of 1,6:1,0, connected by β(1-4)-glycosidic bonds. Shorter side chains are attached through β(1-3)- glycosidic bonds, and acetyl groups occur at random at a ratio of about 1 group per 9 to 19 sugar units
EINECS
Chemical name
Chemical formula
Molecular The main component, glucomannan, has an average weight molecular weight of 200 000 to 2 000 000
Assay Not less than 75 % carbohydrate
Description A white to cream to light tan powder
Identification
Solubility Dispersible in hot or cold water forming a highly viscous solution with a pH between 4,0 and 7,0
Gel formation Add 5 ml of a 4 % sodium borate solution to a 1 % solution of the sample in a test tube, and shake
vigorously. A gel forms
Formation of Prepare a 2 % solution of the sample by heating it in heat-stable gel a boiling water bath for 30 min, with continuous agitation and then cooling the solution to room temperature. For each g of the sample used to prepare 30 g of the 2 % solution, add 1 ml of 10 % potassium carbonate solution to the fully hydrated sample at ambient temperature. Heat the mixture in a water bath to 85 °C, and maintain for 2 h without agitation. Under these conditions a thermally stable gel is formed
Purity
Loss on drying Not more than 12 % (105 °C, 5 hours)
Starch Not more than 3 %
Protein Not more than 3 % (factor N × 5,7)
Viscosity (1 % Not less than 3 kgm -1 s -1 at 25 °C
solution) Ether-soluble Not more than 0,1 % material
Total ash Not more than 5,0 % (800 °C, 3 to 4 hours)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Microbiological criteria
Salmonella spp. Absent in 12,5 g
Escherichia coli Absent in 5 g
E 425(ii) KONJAC GLUCOMANNAN
Synonyms
Definition Konjac glucomannan is a water-soluble hydrocolloid obtained from Konjac flour by washing with water-containing ethanol. Konjac flour is the unpurified raw product from the tuber of the perennial plant Amorphophallus konjac. The main component is the water-soluble highmolecular-weight polysaccharide glucomannan, which consists of D-mannose and D-glucose units at a molar ratio of 1,6:1,0, connected by β(1-4)- glycosidic bonds with a branch at about each 50th or 60th unit. About each 19th sugar residue is acetylated
EINECS
Chemical name
Chemical formula
Molecular 500 000 to 2 000 000 weight
Assay Total dietary fibre: not less than 95 % on a dry
weight basis
Description White to slightly brownish fine particle size, free flowing and odourless powder
Identification
Solubility Dispersible in hot or cold water forming a highly viscous solution with a pH between 5,0 and 7,0. Solubility is increased by heat and mechanical
agitation
Formation of Prepare a 2 % solution of the sample by heating it in
heat-stable gel a boiling water bath for 30 min, with continuous
agitation and then cooling the solution to room
temperature. For each g of the sample used to
prepare 30 g of the 2 % solution, add 1 ml of 10 %
potassium carbonate solution to the fully hydrated
sample at ambient temperature. Heat the mixture in
a water bath to 85 °C, and maintain for 2 h without
agitation. Under these conditions a thermally stable
gel is formed
Purity
Loss on drying Not more than 8 % (105 °C, 3 hours)
Starch Not more than 1 %
Viscosity (1 % Not less than 20 kgm -1 s -1 at 25 °C
solution)
Protein Not more than 1,5 % (N × 5,7)
Determine nitrogen by Kjeldahl method. The percentage of nitrogen in the sample multiplied by 5,7 gives the percent of protein in the sample
Ether-soluble Not more than 0,5 % material
Sulphite (as Not more than 4 mg/kg SO 2 )
Chloride Not more than 0,02 %
50 % Alcohol Not more than 2,0 % soluble
material
Total ash Not more than 2,0 % (800 °C, 3 to 4 hours)
Lead Not more than 1 mg/kg Microbiological criteria
Salmonella spp. Absent in 12,5 g
Escherichia coli Absent in 5 g
E 426 SOYBEAN HEMICELLULOSE
Synonyms
Definition Soybean Hemicellulose is a refined water-soluble polysaccharide obtained from strain soybean fibre by hot water extraction. No organic precipitant shall be used other than ethanol
EINECS
Chemical name Water soluble soybean polysaccharides; Water soluble soybean fibre
Chemical formula
Molecular weight
Assay Not less than 74 % carbohydrate
Description Free flowing white or yellowish white powder
Identification
Solubility Soluble in hot and cold water without gel formation
pH 5,5 ± 1,5 (1% solution)
Purity
Loss on drying Not more than 7 % (105 °C, 4 hours)
Protein Not more than 14 %
Viscosity Not more than 200 mPa.s (10 % solution)
Total ash Not more than 9,5 % (600 °C, 4 hours)
Arsenic Not more than 2 mg/kg Ethanol Not more than 2%
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Microbiological criteria
Total plate count Not more than 3000 colonies per gram
Yeast and Not more than 100 colonies per gram moulds
Escherichia coli Absent in 10 g
E 427 CASSIA GUM
Synonyms
Definition Cassia gum is the ground purified endosperm of the seeds of Cassia tora and Cassia obtusifoli (Leguminosae) containing less than 0.05 % of Cassia occidentalis. It consists mainly of high molecular weight polysaccharides composed primarily of a linear chain of 1,4-β-D- mannopyranose units linked with 1,6-α-D- galactopyranose units. The ratio of mannose to galactose is about 5:1.
In the manufacture the seeds are dehusked and degermed by thermal mechanical treatment followed by milling and screening of the endosperm. The ground endosperm is further purified by extraction with propan-2-ol.
Assay Not less than 75% of Galactomannan
Description Pale yellow to off-white, odourless powder
Identification
Solubility Insoluble in ethanol. Disperses well in cold water forming a colloidal solution.
Gel formation To an aqueous dispersion of the sample add sufficient sodium borate test solution (TS) to raise
with borate the pH to above 9; a gel is formed.
Gel formation Weigh 1.5 g of the sample and 1.5 g of xanthan with xanthan gum and blend them. Add this blend (with rapid gum stirring) into 300 ml water at 80° in a 400 ml beaker. Stir until the mixture is dissolved and continue stirring for an extra 30 min after dissolution (maintain the temperature above 60° C during the stirring process). Discontinue stirring and allow the mixture to cool at room temperature for at least 2 h.
A firm, viscoelastic gel forms after the temperature drops below 40°, but no such gel forms in a 1% control solution of cassia gum or xanthan gum alone prepared in a similar manner.
Viscosity Less than 500 mPa.s (25 °C, 2h, 1% solution) corresponding to an average molecular weight of 200 000-300 000 Da
Purity
Acid insoluble Not more than 2.0% matter
pH 5.5-8 (1% aqueous solution)
Crude fat Not more than 1%
Protein Not more than 7 %
Total ash Not more than 1,2 %
Loss on drying Not more than 12% (5h, 105 °C)
Total Not more than 0.5 mg/kg(detection limit) Anthraquinones
Solvent residues Not more than 750 mg/kg Propan-2-ol
Lead Not more than 1 mg/kg
Microbiological criteria
Total plate count Not more than 5 000 colony forming units per gram
Yeast and Not more than 100 colony forming units per gram moulds Salmonella spp Absent in 25g
Escherichia coli Absent in 1 g
E 431 POLYOXYETHYLENE (40) STEARATE
Synonyms Polyoxyl (40) stearate; Polyoxyethylene (40) monostearate
Definition A mixture of the mono- and diesters of edible commercial stearic acid and mixed polyoxyethylene diols (having an average polymer length of about 40 oxyethylene units) together with free polyol
EINECS
Chemical name
Chemical formula
Molecular weight
Assay Content not less than 97,5 % on the anhydrous basis
Description Cream-coloured flakes or waxy solid at 25 °C with a faint odour
Identification
Solubility Soluble in water, ethanol, methanol and ethyl acetate. Insoluble in mineral oil
Congealing 39 °C - 44 °C range
Infrared Characteristic of a partial fatty acid ester of a absorption polyoxyethylated polyol spectrum
Purity
Water content Not more than 3 % (Karl Fischer method)
Acid value Not more than 1
Saponification Not less than 25 and not more than 35 value
Hydroxyl value Not less than 27 and not more than 40
1,4-Dioxane Not more than 5 mg/kg
Ethylene oxide Not more than 0,2 mg/kg
Ethylene glycols Not more than 0,25 % (mono- and di-)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 432 POLYOXYETHYLENE SORBITAN MONOLAURATE (POLYSORBATE 20)
Synonyms Polysorbate 20; Polyoxyethylene (20) sorbitan monolaurate
Definition A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial lauric acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
EINECS
Chemical name
Chemical formula
Molecular weight
Assay Content not less than 70 % of oxyethylene groups, equivalent to not less than 97,3 % of
polyoxyethylene (20) sorbitan monolaurate on the anhydrous basis
Description A lemon to amber-coloured oily liquid at 25 °C with a faint characteristic odour
Identification
Solubility Soluble in water, ethanol, methanol, ethyl acetate and dioxane. Insoluble in mineral oil and petroleum ether
Infrared Characteristic of a partial fatty acid ester of a absorption polyoxyethylated polyol spectrum
Purity
Water content Not more than 3 % (Karl Fischer method)
Acid value Not more than 2
Saponification Not less than 40 and not more than 50 value
Hydroxyl value Not less than 96 and not more than 108
1,4-dioxane Not more than 5 mg/kg
Ethylene oxide Not more than 0,2 mg/kg
Ethylene glycols Not more than 0,25 % (mono- and di-)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 433 POLYOXYETHYLENE SORBITAN MONOOLEATE (POLYSORBATE 80)
Synonyms Polysorbate 80; Polyoxyethylene (20) sorbitan monooleate
Definition A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial oleic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
EINECS
Chemical name
Chemical formula
Molecular weight
Assay Content not less than 65 % of oxyethylene groups, equivalent to not less than 96,5 % of
polyoxyethylene (20) sorbitan monooleate on the anhydrous basis
Description A lemon to amber-coloured oily liquid at 25 °C with a faint characteristic odour
Identification
Solubility Soluble in water, ethanol, methanol, ethyl acetate and toluene. Insoluble in mineral oil and petroleum ether
Infrared Characteristic of a partial fatty acid ester of a absorption polyoxyethylated polyol spectrum
Purity
Water content Not more than 3 % (Karl Fischer method)
Acid value Not more than 2
Saponification Not less than 45 and not more than 55 value
Hydroxyl value Not less than 65 and not more than 80
1,4-dioxane Not more than 5 mg/kg
Ethylene oxide Not more than 0,2 mg/kg
Ethylene glycols Not more than 0,25 % (mono- and di-)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 434 POLYOXYETHYLENE SORBITAN MONOPALMITATE (POLYSORBATE 40)
Synonyms Polysorbate 40; Polyoxyethylene (20) sorbitan monopalmitate
Definition A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial palmitic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
EINECS
Chemical name
Chemical formula
Molecular weight
Assay Content not less than 66 % of oxyethylene groups, equivalent to not less than 97 % of polyoxyethylene (20) sorbitan monopalmitate on the anhydrous basis
Description A lemon to orange-coloured oily liquid or semi-gel at 25 °C with a faint characteristic odour
Identification
Solubility Soluble in water, ethanol, methanol, ethyl acetate and acetone. Insoluble in mineral oil
Infrared Characteristic of a partial fatty acid ester of a absorption polyoxyethylated polyol spectrum
Purity
Water content Not more than 3 % (Karl Fischer method)
Acid value Not more than 2 Saponification Not less than 41 and not more than 52 value
Hydroxyl value Not less than 90 and not more than 107
1,4-dioxane Not more than 5 mg/kg
Ethylene oxide Not more than 0,2 mg/kg
Ethylene glycols Not more than 0,25 % (mono- and di-)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 435 POLYOXYETHYLENE SORBITAN MONOSTEARATE (POLYSORBATE 60)
Synonyms Polysorbate 60; Polyoxyethylene (20) sorbitan monostearate
Definition A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial stearic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
EINECS
Chemical name
Chemical formula
Molecular weight
Assay Content not less than 65 % of oxyethylene groups, equivalent to not less than 97 % of polyoxyethylene (20) sorbitan monostearate on the anhydrous basis
Description A lemon to orange-coloured oily liquid or semi-gel at 25 °C with a faint characteristic odour
Identification
Solubility Soluble in water, ethyl acetate and toluene. Insoluble in mineral oil and vegetable oils
Infrared Characteristic of a partial fatty acid ester of a absorption polyoxyethylated polyol spectrum
Purity
Water content Not more than 3 % (Karl Fischer method)
Acid value Not more than 2
Saponification Not less than 45 and not more than 55 value
Hydroxyl value Not less than 81 and not more than 96
1,4-dioxane Not more than 5 mg/kg
Ethylene oxide Not more than 0,2 mg/kg
Ethylene glycols Not more than 0,25 % (mono- and di-)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 436 POLYOXYETHYLENE SORBITAN TRISTEARATE (POLYSORBATE 65)
Synonyms Polysorbate 65; Polyoxyethylene (20) sorbitan tristearate
Definition A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial stearic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
EINECS Chemical name
Chemical formula
Molecular weight
Assay Content not less than 46 % of oxyethylene groups, equivalent to not less than 96 % of polyoxyethylene (20) sorbitan tristearate on the anhydrous basis
Description A tan-coloured, waxy solid at 25 °C with a faint characteristic odour
Identification
Solubility Dispersible in water. Soluble in mineral oil, vegetal oils, petroleum ether, acetone, ether, dioxane,
ethanol and methanol
Congealing 29-33 °C range
Infrared Characteristic of a partial fatty acid ester of a absorption polyoxyethylated polyol spectrum
Purity
Water content Not more than 3 % (Karl Fischer method)
Acid value Not more than 2
Saponification Not less than 88 and not more than 98 value
Hydroxyl value Not less than 40 and not more than 60
1,4-dioxane Not more than 5 mg/kg
Ethylene oxide Not more than 0,2 mg/kg
Ethylene glycols Not more than 0,25 % (mono- and di-)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 440 (i) PECTIN
Synonyms
Definition Pectin consists mainly of the partial methyl esters of polygalacturonic acid and their ammonium, sodium, potassium and calcium salts. It is obtained by
extraction in an aqueous medium of strains of appropriate edible plant material, usually citrus fruits or apples. No organic precipitant shall be used other than methanol, ethanol and propan-2-ol
EINECS 232-553-0
Chemical name
Chemical formula
Molecular weight
Assay Content not less than 65 % of galacturonic acid on the ash-free and anhydrous basis after washing with acid and alcohol
Description White, light yellow, light grey or light brown powder
Identification
Solubility Soluble in water forming a colloidal, opalescent solution. Insoluble in ethanol
Purity
Loss on drying Not more than 12 % (105 °C, 2 hours)
Acid insoluble Not more than 1 % (insoluble in approximately 3N ash hydrochloric acid)
Sulphur dioxide Not more than 50 mg/kg on the anhydrous basis Nitrogen content Not more than 1,0 % after washing with acid and ethanol
Total insolubles Not more than 3 %
Solvent residues Not more than 1 % of free methanol, ethanol and propan-2-ol, singly or in combination, on the
volatile matter-free basis
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 440 (ii) AMIDATED PECTIN
Synonyms
Definition Amidated pectin consists mainly of the partial methyl esters and amides of polygalacturonic acid and their ammonium, sodium, potassium and calcium salts. It is obtained by extraction in an aqueous medium of appropriate strains of edible plant material, usually citrus fruits or apples and treatment with ammonia under alkaline conditions. No organic precipitant shall be used other than methanol, ethanol and propan-2-ol
EINECS
Chemical name
Chemical formula
Molecular weight
Assay Content not less than 65 % of galacturonic acid on the ash-free and anhydrous basis after washing with acid and alcohol
Description White, light yellow, light greyish or light brownish powder
Identification
Solubility Soluble in water forming a colloidal, opalescent solution. Insoluble in ethanol
Purity
Loss on drying Not more than 12 % (105 °C, 2 hours)
Acid-insoluble Not more than 1 % (insoluble in approximately 3N ash hydrochloric acid)
Degree of Not more than 25 % of total carboxyl groups amidation
Sulphur dioxide Not more than 50 mg/kg on the anhydrous basis residue
Nitrogen content Not more than 2,5 % after washing with acid and ethanol
Total insolubles: Not more than 3 %
Solvent residues Not more than 1 % of methanol, ethanol and propan-2-ol, singly or in combination, on a volatile matter-free basis
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 442 AMMONIUM PHOSPHATIDES
Synonyms Ammonium salts of phosphatidic acid; Mixed ammonium salts of phoshorylated glycerides
Definition A mixture of the ammonium compounds of phosphatidic acids derived from edible fat and oil . One or two or three glyceride moieties may be attached to phosphorus. Moreover, two phosphorus esters may be linked together as phosphatidyl phosphatides
EINECS
Chemical name
Chemical formula
Molecular weight
Assay The phosphorus content is not less than 3 % and not more than 3,4 % by weight; the ammonium content is not less than 1,2 % and not more than 1,5 %
(calculated as N)
Description Unctuous semi-solid to oily solid
Identification
Solubility Soluble in fats. Insoluble in water. Partially soluble in ethanol and in acetone
Test for glycerol Passes test
Test fatty acids Passes test
Test for Passes test phosphate
Purity
Petroleum ether Not more than 2,5 % insoluble matter
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 444 SUCROSE ACETATE ISOBUTYRATE
Synonyms SAIB
Definition Sucrose acetate isobutyrate is a mixture of the reaction products formed by the esterification of food grade sucrose with acetic acid anhydride and isobutyric anhydride, followed by distillation. The mixture contains all possible combinations of esters in which the molar ratio of acetate to butyrate is about 2:6
EINECS 204-771-6
Chemical name Sucrose diacetate hexaisobutyrate
Chemical C 40 H 62 O 19 formula
Molecular 832-856 (approximate), C 40 H 62 O 19 : 846,9 weight
Assay Content not less than 98,8 % and not more than
101,9 % of C 40 H 62 O 19
Description A pale straw-coloured liquid, clear and free of sediment and having a bland odour
Identification
Solubility Insoluble in water. Soluble in most organic solvents
Refractive index [n] 40 D : 1,4492 - 1,4504
Specific gravity [d] 25 D : 1,141 - 1,151
Purity
Triacetin Not more than 0,1 %
Acid value Not more than 0,2
Saponification Not less than 524 and not more than 540 value
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg E 445 GLYCEROL ESTERS OF WOOD ROSIN
Synonyms Ester gum
Definition A complex mixture of tri- and diglycerol esters of resin acids from wood rosin. The rosin is obtained by the solvent extraction of aged pine stumps
followed by a liquid-liquid solvent refining process. Excluded from these specifications are substances derived from gum rosin, and exudate of living pine trees, and substances derived from tall oil rosin, a by-product of kraft (paper) pulp processing. The final product is composed of approximately 90 % resin acids and 10 % neutrals (non-acidic compounds). The resin acid fraction is a complex mixture of isomeric diterpenoid monocarboxylic acids having the empirical molecular formula of C 20 H 30 O 2 , chiefly abietic acid. The substance is purified by steam stripping or by countercurrent steam distillation
EINECS
Chemical name
Chemical formula
Molecular weight
Assay
Description Hard, yellow to pale amber-coloured solid
Identification
Solubility Insoluble in water, soluble in acetone
Infrared Characteristic of the compound absorption spectrum
Purity
Specific gravity [d] 20 25 not less than 0,935 when determined in a 50
of solution % solution in d-limonene (97 %, boiling point
20
EN 250 EN
Ring and ball Between 82 °C and 90 °C softening range
Acid value Not less than 3 and not more than 9
Hydroxyl value Not less than 15 and not more than 45
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Test for absence When sulphur-containing organic compounds are of tall oil rosin heated in the presence of sodium formate, the (sulphur test) sulphur is converted to hydrogen sulphide which can readily be detected by the use of lead acetate paper. A positive test indicates the use of tall oil rosin instead of wood rosin
E 450 (i) DISODIUM DIPHOSPHATE
Synonyms Disodium dihydrogen diphosphate; Disodium dihydrogen pyrophosphate; Sodium acid
pyrophosphate; Disodium pyrophosphate
Definition
EINECS 231-835-0
Chemical name Disodium dihydrogen diphosphate
Chemical Na 2 H 2 P 2 O 7 formula
Molecular 221,94 weight
Assay Content not less than 95 % of disodium diphosphate
P 2 O 5 content not less than 63,0 % and not more than
64,5 %
Description White powder or grains
Identification
Test for sodium Passes test
Test for Passes test phosphate
Solubility Soluble in water
pH Between 3,7 and 5,0 (1 % solution)
Purity
Loss on drying Not more than 0,5 % (105 °C, 4 hours)
Water insoluble Not more than 1 % matter
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Aluminium Not more than 200 mg/kg
E 450 (ii) TRISODIUM DIPHOSPHATE
Synonyms Trisodium pyrophosphate; Trisodium monohydrogen diphosphate; Trisodium monohydrogen pyrophosphate; Trisodium diphosphate
Definition
EINECS 238-735-6
Chemical name
Chemical Monohydrate: Na 3 HP 2 O 7 · H 2 O
formula Anhydrous: Na 3 HP 2 O 7
Molecular Monohydrate: 261,95 weight Anhydrous: 243,93
Assay Content not less than 95 % on the dried basis P 2 O 5 content not less than 57 % and not more than 59 %
Description White powder or grains, occurs anhydrous or as a monohydrate
Identification
Test for sodium Passes test
Test for Passes test phosphate
Solubility Soluble in water
pH Between 6,7 and 7,5 (1 % solution)
Purity
Loss on ignition Not more than 4,5 % on the anhydrous compound (450 – 550 oC).
Not more than 11,5 % on the monohydrate basis
Loss on drying Not more than 0,5 % (105 °C, 4 hours) for
anhydrous
Not more than 1,0 % (105 °C, 4 hours) for monohdyrate
Water insoluble Not more than 0,2 % matter
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 450 (iii) TETRASODIUM DIPHOSPHATE
Synonyms Tetrasodium pyrophosphate; Tetrasodium disphosphate; Tetrasodium phosphate
Definition
EINECS 231-767-1
Chemical name Tetrasodium diphosphate
Chemical Anhydrous: Na 4 P 2 O 7 formula Decahydrate: Na 4 P 2 O 7 · 10H 2 O
Molecular Anhydrous: 265,94 weight Decahydrate: 446,09
Assay Content not less than 95 % of Na 4 P 2 O 7 on the
ignited basis
P 2 O 5 content not less than 52,5 % and not more than
54,0 %
Description Colourless or white crystals, or a white crystalline or granular powder. The decahydrate effloresces
slightly in dry air
Identification
Test for sodium Passes test
Test for Passes test phosphate
Solubility Soluble in water. Insoluble in ethanol
pH Between 9,8 and 10,8 (1 % solution)
Purity
Loss on ignition Not more than 0,5 % for the anhydrous salt, not less than 38 % and not more than 42 % for the
decahydrate (105 °C, 4 hours then 550°C, 30 minutes)
Water insoluble Not more than 0,2 % matter
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1mg/kg
Mercury Not more than 1 mg/kg E 450 (v) TETRAPOTASSIUM DIPHOSPHATE
Synonyms Tetrapotassium pyrophosphate
Definition
EINECS 230-785-7
Chemical name Tetrapotassium diphosphate
Chemical K 4 P 2 O 7 formula
Molecular 330,34 (anhydrous) weight
Assay Content not less than 95 % (800°C for 0,5 hours)
P 2 O 5 content not less than 42,0 % and not more than
43,7 % on the anhydrous basis
Description Colourless crystals or white, very hygroscopic powder
Identification
Test for Passes test potassium
Test for Passes test phosphate
Solubility Soluble in water, insoluble in ethanol
pH Between 10,0 and 10,8 (1 % solution)
Purity
Loss on ignition Not more than 2 % (105 °C, 4 hours then 550°C, 30 minutes)
Water insoluble Not more than 0,2 % matter
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg Mercury Not more than 1 mg/kg
E 450 (vi) DICALCIUM DIPHOSPHATE
Synonyms Calcium pyrophosphate
Definition
EINECS 232-221-5
Chemical name Dicalcium diphosphate
Dicalcium pyrophosphate
Chemical Ca 2 P 2 O 7
formula
Molecular 254,12 weight
Assay Content not less than 96 %
P 2 O 5 content not less than 55 % and not more than
56 %
Description A fine, white, odourless powder
Identification
Test for calcium Passes test
Test for Passes test phosphate
Solubility Insoluble in water. Soluble in dilute hydrochloric and nitric acids
pH Between 5,5 and 7,0 (10 % suspension in water)
Purity
Loss on ignition Not more than 1,5 % (800 °C ± 25 °C, 30 minutes
Fluoride Not more than 50 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg Mercury Not more than 1 mg/kg
E 450 (vii) CALCIUM DIHYDROGEN DIPHOSPHATE
Synonyms Acid calcium pyrophosphate; Monocalcium dihydrogen pyrophosphate
Definition
EINECS 238-933-2
Chemical name Calcium dihydrogen diphosphate
Chemical CaH 2 P 2 O 7
formula
Molecular 215,97 weight
Assay Content not less than 90 % on the anhydrous basis
P 2 O 5 content not less than 61 % and not more than 66 %
Description White crystals or powder
Identification
Test for calcium Passes test
Test for Passes test phosphate
Purity
Acid-insoluble Not more than 0,4 % matter
Fluoride Not more than 30 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Aluminium Not more than 800 mg/kg. This applies until 31
March 2015.
Not more than 200 mg/kg. This applies from 1 April
2015.
E 451 (i) PENTASODIUM TRIPHOSPHATE
Synonyms Pentasodium tripolyphosphate; Sodium tripolyphosphate
Definition
EINECS 231-838-7
Chemical name Pentasodium triphosphate
Chemical Na 5 O 10 P 3 · nH 2 O (n = 0 or 6) formula
Molecular 367,86 weight
Assay Content not less than 85,0 % (anhydrous) or 65,0 %
(hexahydrate)
P 2 O 5 content not less than 56 % and not more than 59 % (anhydrous) or not less than 43 % and not more than 45 % (hexahydrate)
Description White, slightly hygroscopic granules or powder
Identification
Solubility Freely soluble in water. Insoluble in ethanol
Test for sodium Passes test
Test for Passes test phosphate
pH Between 9,1 and 10,2 (1 % solution)
Purity
Loss on drying Anhydrous: Not more than 0,7 % (105 °C, 1 hour)
Hexahydrate: Not more than 23,5 % (60 °C, 1 hour, then 105 °C, 4 hours)
Water insoluble Not more than 0,1 % matter Higher Not more than 1 % polyphosphates
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 451 (ii) PENTAPOTASSIUM TRIPHOSPHATE
Synonyms Pentapotassium tripolyphosphate; Potassium triphosphate; Potassium tripolyphosphate
Definition
EINECS 237-574-9
Chemical name Pentapotassium triphosphate; Pentapotassium tripolyphosphate
Chemical K 5 O 10 P 3 formula
Molecular 448,42 weight
Assay Content not less than 85 % on the anhydrous basis
P 2 O 5 content not less than 46,5 % and not more than
48 %
Description White, very hygroscopic powder or granules
Identification
Solubility Very soluble in water
Test for Passes test potassium
Test for Passes test phosphate
pH Between 9,2 and 10,5 (1 % solution) Purity
Loss on ignition Not more than 0,4 % (105 °C, 4 hours, then 550 °C,
30 minutes)
Water insoluble Not more than 2 % matter
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 452 (i) SODIUM POLYPHOSPHATE
I. SOLUBLE POLYPHOSPHATE
Synonyms Sodium hexametaphosphate; Sodium tetrapolyphosphate; Graham's salt; Sodium polyphosphates, glassy; Sodium
polymetaphosphate; Sodium metaphosphate
Definition Soluble sodium polyphosphates are obtained by fusion and subsequent chilling of sodium
orthophosphates. These compounds are a class consisting of several amorphous, water-soluble polyphosphates composed of linear chains of metaphosphate units, (NaPO 3 ) x where x ≥ 2, terminated by Na 2 PO 4 groups. These substances are usually identified by their Na 2 O/P 2 O 5 ratio or their P 2 O 5 content. The Na 2 O/P 2 O 5 ratios vary from about 1,3 for sodium tetrapolyphosphate, where x = approximately 4; to about 1,1 for Graham's salt, commonly called sodium hexametaphosphate, where x = 13 to 18; and to about 1,0 for the higher molecular weight sodium polyphosphates, where x = 20 to 100 or more. The pH of their solutions varies from 3,0 to 9,0
EINECS 272-808-3
Chemical name Sodium polyphosphate
Chemical Heterogenous mixtures of sodium salts of linear condensed polyphosphoric acids of general formula
formula H (n + 2) P n O (3n + 1) where “n” is not less than 2
Molecular (102) n
weight
Assay P 2 O 5 content not less than 60 % and not more than 71 % on the ignited basis
Description Colourless or white, transparent platelets, granules, or powders
Identification
Solubility Very soluble in water
Test for sodium Passes test
Test for Passes test phosphate
pH Between 3,0 and 9,0 (1 % solution)
Purity
Loss on ignition Not more than 1 %
Water insoluble Not more than 0,1 % matter
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
II. INSOLUBLE POLYPHOSPHATE
Synonyms Insoluble sodium metaphosphate; Maddrell's salt;
Insoluble sodium polyphosphate; IMP
Definition Insoluble sodium metaphosphate is a high molecular weight sodium polyphosphate composed of two
long metaphosphate chains (NaPO 3 ) x that spiral in
opposite directions about a common axis. The Na 2 O/P 2 O 5 ratio is about 1,0. The pH of 1 in 3 suspension in water is about 6,5
EINECS 272-808-3 Chemical name Sodium polyphosphate
Chemical Heterogenous mixtures of sodium salts of linear formula condensed polyphosphoric acids of general formula H (n + 2) P n O (3n + 1) where «n» is not less than 2
Molecular (102) n
weight
Assay P 2 O 5 content not less than 68,7 % and not more than 70,0 %
Description White crystalline powder
Identification
Solubility Insoluble in water, soluble in mineral acids and in solutions of potassium and ammonium (but not
sodium) chlorides
Test for sodium Passes test
Test for Passes test phosphate
pH About 6,5 (1 in 3 suspension in water)
Purity
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 452 (ii) POTASSIUM POLYPHOSPHATE
Synonyms Potassium metaphosphate; Potassium polymetaphosphate; Kurrol salt
Definition
EINECS 232-212-6
Chemical name Potassium polyphosphate Chemical (KPO 3 )n formula Heterogenous mixtures of potassium salts of linear condensed polyphosphoric acids of general formula H (n + 2) P n O (3n + 1) where «n» is not less than 2
Molecular (118) n
weight
Assay P 2 O 5 content not less than 53,5 % and not more than 61,5 % on the ignited basis
Description Fine white powder or crystals or colourless glassy platelets
Identification
Solubility 1 g dissolves in 100 ml of a 1 in 25 solution of
sodium acetate
Test for Passes test potassium
Test for Passes test phosphate
pH Not more than 7,8 (1 % suspension)
Purity
Loss on ignition Not more than 2 % (105 °C, 4 hours then 550 °C, 30 minutes)
Cyclic Not more than 8 % on P 2 O 5 content
phosphate
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 452(iii) SODIUM CALCIUM POLYPHOSPHATE
Synonyms Sodium calcium polyphosphate, glassy
Definition
EINECS 233-782-9
Chemical name Sodium calcium polyphosphate
Chemical (NaPO 3 ) n CaO where n is typically 5
formula
Molecular weight
Assay P 2 O 5 content not less than 61 % and not more than 69 % on the ignited basis
Description White glassy crystals, spheres
Identification
pH Approximately 5 to 7 (1 % m/m slurry)
CaO content 7 % - 15 % m/m
Purity
Fluoride Not more than 10 mg/kg
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 452 (iv) CALCIUM POLYPHOSPHATE
Synonyms Calcium metaphosphate; Calcium polymetaphosphate
Definition
EINECS 236-769-6
Chemical name Calcium polyphosphate
formula
EN 264 EN
Heterogenous mixtures of calcium salts of condensed polyphosphoric acids of general formula H (n + 2) P n O (n + 1) where «n» is not less than 2
Molecular (198) n weight
Assay P 2 O 5 content not less than 71 % and not more than 73 % on the ignited basis
Description Odourless, colourless crystals or white powder
Identification
Solubility Usually sparingly soluble in water. Soluble in acid medium
Test for calcium Passes test
Test for Passes test phosphate
CaO content 27 to 29,5 %
Purity
Loss on ignition Not more than 2 % (105 °C, 4 hours then 550 °C, 30 minutes)
Cyclic Not more than 8 % (on P 2 O 5 content)
phosphate
Fluoride Not more than 30 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 459 BETA-CYCLODEXTRIN
Synonyms
Definition Beta-cyclodextrin is a non-reducing cyclic saccharide consisting of seven α-1,4-linked D- glucopyranosyl units. The product is manufactured by the action of the enzyme
cycloglycosyltransferase (CGTase) obtained from Bacillus circulans, Paenibacillus macerans or recombinant Bacillus licheniformis strain SJ1608 on partially hydrolysed starch
EINECS 231-493-2
Chemical name Cycloheptaamylose
Chemical (C 6 H 10 O 5 ) 7
formula
Molecular 1 135 weight
Assay Content not less than 98,0 % of (C 6 H 10 O 5 ) 7 on an
anhydrous basis
Description Virtually odourless white or almost white crystalline solid
Appearance of the aqueous solution
Clear and colourless
Identification
Solubility Sparingly soluble in water; freely soluble in hot water; slightly soluble in ethanol
Specific rotation [α] 25 D + 160 o o to + 164 (1 % solution)
pH value: 5,0-8,0 (1 % solution)
Purity
Water content Not more than 14 % (Karl Fischer method)
Other Not more than 2 % on an anhydrous basis cyclodextrins
Solvent residues Not more than 1 mg/kg of each of toluene and
trichloroethylene
Sulphated ash Not more than 0,1 %
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
E 460 (i) MICROCRYSTALLINE CELLULOSE
Synonyms Cellulose gel
Definition Microcrystalline cellulose is purified, partally depolymerised cellulose prepared by treating alphacellulose, obtained as a pulp from strains of fibrous plant material, with mineral acids. The degree of polymerisation is typically less than 400
EINECS 232-674-9
Chemical name Cellulose
Chemical (C 6 H 10 O 5 ) n formula
Molecular About 36 000 weight
Assay Not less than 97 % calculated as cellulose on the anhydrous basis
Particle size Not less than 5 µm (not more than 10 % of particles of less than 5 µm)
Description A fine white or almost white odourless powder
Identification
Solubility Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution
Colour reaction To 1 mg of the sample, add 1 ml of phosphoric acid and heat on a water bath for 30 minutes. Add 4 ml
of a 1 in 4 solution of pyrocatechol in phosphoric acid and heat for 30 minutes. A red colour is produced
Infrared To be identified absorption spectroscopy
Suspension test Mix 30 g of the sample with 270 ml of water in a high-speed (12 000 rpm) power blender for 5
minutes. The resultant mixture will be either a freefollowing suspension or a heavy, lumpy suspension which flows poorly, if at all, settles only slightly and contains many trapped air bubbles. If a free-flowing suspension is obtained, transfer 100 ml into a 100- ml graduated cylinder and allow to stand for 1 hour. The solids settles and a supernatant liquid appears
pH The pH of the supernatant liquid is between 5,0 and 7,5 (10 % suspension in water)
Purity
Loss on drying Not more than 7 % (105 °C, 3 hours)
Water soluble Not more than 0,24% matter
Sulphated ash Not more than 0,5 % (800 ± 25 °C)
Starch Not detectable
To 20 ml of the dispersion obtained in Identification, suspension test, add a few drops of iodine solution and mix. No purplish to blue or blue
colour should be produced
Carboxyl groups Not more than 1 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 460 (ii) POWDERED CELLULOSE
Definition Purified, mechanically disintegrated cellulose prepared by processing alpha-cellulose obtained as a pulp from strains of fibrous plant materials
EINECS 232-674-9
Chemical name Cellulose; Linear polymer of 1:4 linked glucose residues
Chemical (C 6 H 10 O 5 ) n
formula
Molecular (162) n (n is predominantly 1 000 and greater) weight
Assay Content not less than 92 % Particle size Not less than 5 µm (not more than 10 % of particles of less than 5 µm)
Description A white, odourless powder
Identification
Solubility Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution
Suspension test Mix 30 g of the sample with 270 ml of water in a high-speed (12 000 rpm) power blender for 5
minutes. The resultant mixture will be either a freeflowing suspension or a heavy, lumpy suspension which flows poorly, if at all, settles only slightly and contains many trapped air bubbles. If a free-flowing suspension is obtained, transfer 100 ml into a 100- ml graduated cylinder and allow to stand for 1 hour. The solids settles and a supernatant liquid appears
pH The pH of the supernatant liquid is between 5,0 and 7,5 (10 % suspension in water)
Purity
Loss on drying Not more than 7 % (105 °C, 3 hours)
Water soluble Not more than 1,0 % matter
Sulphated ash Not more than 0,3 % (800 ± 25 °C)
Starch Not detectable
To 20 ml of the dispersion obtained in Identification, suspension test, add a few drops of iodine solution and mix. No purplish to blue or blue
colour should be produced
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 461 METHYL CELLULOSE
Synonyms Cellulose methyl ether
Definition Methyl cellulose is cellulose obtained directly from strains of fibrous plant material and partially
etherified with methyl groups
EINECS
Chemical name Methyl ether of cellulose
Chemical The polymers contain substituted anhydroglucose formula units with the following general formula:
C 6 H 7 O 2 (OR 1 )(OR 2 )(OR 3 ) where R 1 , R 2 , R 3 each may be
one of the following:
– H
– CH 3 or
– CH 2 CH 3
Molecular From about 20 000 to 380 000 weight
Assay Content not less than 25 % and not more than 33 % of methoxyl groups (-OCH 3 ) and not more than 5 % of hydroxyethoxyl groups (-OCH 2 CH 2 OH)
Description Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
Identification
Solubility Swelling in water, producing a clear to opalescent, viscous, colloidal solution.
Insoluble in ethanol, ether and chloroform.
Soluble in glacial acetic acid
pH Not less than 5,0 and not more than 8,0 (1 % colloidal solution)
Purity
Loss on drying Not more than 10 % (105 °C, 3 hours)
Sulphated ash Not more than 1,5 % (800 ± 25 °C) Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 462 ETHYL CELLULOSE
Synonyms Cellulose ethyl ether
Definition Ethyl cellulose is cellulose obtained directly from fibrous plant material and partially etherified with ethyl groups
EINECS
Chemical name Ethyl ether of cellulose
Chemical The polymers contain substituted anhydroglucose formula units with the following general formula:
C 6 H 7 O 2 (OR 1 )(OR 2 ) where R 1 and R 2 may be any of the
following:
– H
– CH 2 CH 3
Molecular weight
Assay Content not less than 44 % and not more than 50 % of ethoxyl groups (-OC 2 H 5 ) on the dried basis
(equivalent to not more than 2,6 ethoxyl groups per anhydroglucose unit)
Description Slightly hygroscopic white to off-white, odourless and tasteless powder
Identification
Solubility Practically insoluble in water, in glycerol and in propane-1,2-diol but soluble in varying proportions in certain organic solvents depending upon the ethoxyl content. Ethyl cellulose containing less than 46 to 48 % of ethoxyl groups is freely soluble in tetrahydrofuran, in methyl acetate, in chloroform and in aromatic hydrocarbon ethanol mixtures. Ethyl cellulose containing 46 to 48 % or more of ethoxyl groups is freely soluble in ethanol, in
methanol, in toluene, in chloroform and in ethyl acetate
Film forming Dissolve 5 g of the sample in 95 g of an 80:20 test (w/w) mixture of toluene ethanol. A clear, stable, slightly yellow solution is formed. Pour a few ml of the solution onto a glass plate and allow the solvent to evaporate. A thick, tough, continuous, clear film remains. The film is flammable
pH Neutral to litmus (1 % colloidal solution)
Purity
Loss on drying Not more than 3 % (105 °C, 2 hours)
Sulphated ash Not more than 0,4 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 463 HYDROXYPROPYL CELLULOSE
Synonyms Cellulose hydroxypropyl ether
Definition Hydroxypropylcellulose is cellulose obtained directly from strains of fibrous plant material and partially etherified with hydroxypropyl groups
EINECS
Chemical name Hydroxypropyl ether of cellulose
Chemical The polymers contain substituted anhydroglucose formula units with the following general formula:
C 6 H 7 O 2 (OR 1 )(OR 2 )(OR 3 ),
EN 272 EN
one of the following:
-
-H
-
-CH 2 CHOHCH 3
-
CH 2 CHO(CH 2 CHOHCH 3 )CH 3
-
-CH 2 CHO[CH 2 CHO(CH 2 CHO HCH 3 )CH 3 ]CH 3
Molecular From about 30 000 to 1 000 000 weight
Assay Content not more than 80,5 % of hydroxypropoxyl
groups (-OCH 2 CHOHCH 3 ) equivalent to not more
than 4,6 hydroxypropyl groups per anhydroglucose unit on the anhydrous basis
Description Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
Identification
Solubility Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Soluble in ethanol.
Insoluble in ether
Gas Determine the substituents by gas chromotography
chromatography
pH Not less than 5,0 and not more than 8,0 (1 % colloidal solution)
Purity
Loss on drying Not more than 10 % (105 °C, 3 hours)
Sulphated ash Not more than 0,5 % determined at 800 ± 25 °C
Propylene Not more than 0,1 mg/kg chlorohydrins
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg
E 464 HYDROXYPROPYL METHYL CELLULOSE
Synonyms
Definition Hydroxypropyl methyl cellulose is cellulose obtained directly from strains of fibrous plant material and
partially etherified with methyl groups and containing a small degree of hydroxypropyl substitution
EINECS
Chemical name 2-Hydroxypropyl ether of methylcellulose
Chemical The polymers contain substituted anhydroglucose formula units with the following general formula:
C 6 H 7 O 2 (OR 1 )(OR 2 )(OR 3 ), where R 1 , R 2 R 3 each may be one of the
following:
– - H
– - CH 3
– - CH 2 CHOHCH 3
– - CH 2 CHO (CH 2 CHOHCH 3 ) CH 3
– - CH 2 CHO[CH 2 CHO (CH 2 CHOHCH 3 )
CH 3 ]CH 3
Molecular From about 13 000 to 200 000 weight
Assay Content not less than 19 % and not more than 30 %
methoxyl groups (-OCH 3 ) and not less than 3 % and
not more than 12 % hydroxypropoxyl groups (- OCH 2 CHOHCH 3 ), on the anhydrous basis
Description Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
Identification
Solubility Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Insoluble in ethanol
Gas Determine the substituents by gas chromatography chromatograph y
pH Not less than 5,0 and not more than 8,0 (1 % colloidal solution)
Purity
Loss on drying Not more than 10 % (105 °C, 3 hours)
Sulphated ash Not more than 1,5 % for products with viscosities of 50 mPa.s or above
Not more than 3 % for products with viscosities below 50 mPa.s
Propylene Not more than 0,1 mg/kg chlorohydrins
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 465 ETHYL METHYL CELLULOSE
Synonyms Methylethylcellulose
Definition Ethyl methyl cellulose is cellulose obtained directly from strains of fibrous plant material and partially
etherified with methyl and ethyl groups
EINECS
Chemical name Ethyl methyl ether of cellulose
Chemical The polymers contain substituted anhydroglucose formula units with the following general formula:
C 6 H 7 O 2 (OR 1 )(OR 2 )(OR 3 ), where R 1 , R 2 R 3 each may
be one of the following:
– H
– CH 3
– CH 2 CH 3
Molecular From about 30 000 to 40 000 weight
Assay Content on the anhydrous basis not less than 3,5 % and not more than 6,5 % of methoxyl groups (-
OCH 3 ) and not less than 14,5 % and not more than 19 % of ethoxyl groups (-OCH 2 CH 3 ), and not less than 13,2 % and not more than 19,6 % of total alkoxyl groups, calculated as methoxyl
Description Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
Identification
Solubility Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Soluble in ethanol.
Insoluble in ether
pH Not less than 5,0 and not more than 8,0 (1 % colloidal solution)
Purity
Loss on drying Not more than 15 % for the fibrous form, and not more than 10 % for the powdered form (105 °C to constant weight)
Sulphated ash Not more than 0,6 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg E 466 SODIUM CARBOXY METHYL CELLULOSE, CARBOXY METHYL CELLULOSE, CELLULOSE GUM
Synonyms CMC; NaCMC; Sodium CMC;
Definition Carboxy methyl cellulose is the partial sodium salt of a carboxymethyl ether of cellulose, the cellulose
being obtained directly from strains of fibrous plant material
EINECS
Chemical name Sodium salt of the carboxymethyl ether of cellulose
Chemical The polymers contain substituted anhydroglucose formula units with the following general formula:
C 6 H 7 O 2 (OR 1 )(OR 2 )(OR 3 ), where R 1 , R 2 R 3 each may
be one of the following:
– H
– CH 2 COONa
– CH 2 COOH
Molecular Higher than approximately 17 000 (degree of weight polymerisation approximately 100)
Assay Content on the anhydrous basis not less than 99,5 %
Description Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
Identification
Solubility Yields a viscous colloidal solution with water. Insoluble in ethanol
Foam test A 0,1 % solution of the sample is shaken vigorously. No layer of foam appears. (This test permits the
distinction of sodium carboxymethyl cellulose from other cellulose ethers)
Precipitate To 5 ml of a 0,5 % solution of the sample, add 5 ml formation of 5 % solution of copper sulphate or of aluminium sulphate. A precipitate appears. (This test permits the distinction of sodium carboxymethyl cellulose from other cellulose ethers and from gelatine, locust bean gum and tragacanth)
Colour reaction Add 0,5 g powdered carboxy methyl cellulose sodium to 50 ml of water, while stirring to produce an uniform dispersion. Continue the stirring until a clear solution is produced, and use the solution for the following test:
To 1 mg of the sample, diluted with an equal volume
of water, in a small test tube, add 5 drops of 1-
naphthol solution. Incline the test tube, and carefully
introduce down the side of the tube 2 ml of sulphuric
acid so that it forms a lower layer. A red-purple
colour develops at the interface
pH Not less than 5,0 and not more than 8,5 (1 % colloidal solution)
Purity
Degree of Not less than 0,2 and not more than 1,5
substitution carboxymethyl groups (-CH 2 COOH) per
anhydroglucose unit
Loss on drying Not more than 12 % (105 °C to constant weight)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Total glycolate Not more than 0,4 %, calculated as sodium glycolate on the anhydrous basis
Sodium Not more than 12,4 % on the anhydrous basis
E 468 CROSS-LINKED SODIUM CARBOXYMETHYLCELLULOSE, CROSS-
LINKED CELLULOSE GUM
Synonyms Cross-linked carboxymethyl cellulose; Cross-linked CMC; Cross-linked sodium CMC;
Definition Cross-linked sodium carboxymethyl cellulose is the sodium salt of thermally cross-linked partly O-
carboxymethylated cellulose EINECS
Chemical name Sodium salt of the cross-linked carboxymethyl ether cellulose
Chemical The polymers containing substituted anhydroglucose formula units with the general formula:
C 6 H 7 O 2 (OR 1 )(OR 2 )(OR 3 )
where R 1 , R 2 and R 3 may be any of the following:
– H
– CH 2 COONa
– CH 2 COOH
Molecular weight
Assay
Description Slightly hygroscopic, white to off white, odourless powder
Identification
Precipitate Shake 1 g with 100 ml of a solution containing formation 4 mg/kg methylene blue and allow to settle. The substance to be examined absorbs the methylene blue and settles as a blue, fibrous mass
Colour reaction Shake 1 g with 50 ml of water. Transfer 1 ml of the mixture to a test tube, add 1 ml water and 0,05 ml of freshly prepared 40 g/l solution of alpha-naphthol in methanol. Incline the test tube and add carefully 2 ml of sulphuric acid down the side so that it forms a lower layer. A reddish-violet colour develops at the interface
Test for Passes test sodium
pH Not less than 5,0 and not more than 7,0 (1% solution)
Purity
Loss on drying Not more than 6 % (105 o C, 3 hours)
Water soluble Not more than 10 % matter Degree of Not less than 0,2 and not more than 1,5 carboxymethyl substitution groups per anhydroglucose unit
Sodium Not more than 12,4 % on anhydrous basis content
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Cadmium Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 469 ENZYMATICALLY HYDROLYSED CARBOXYMETHYLCELLULOSE,
ENZYMATICALLY HYDROLISED CELLULOSE GUM
Synonyms Sodium carboxymethyl cellulose, enzymatically hydrolysed
Definition Enzymatically hydrolysed carboxymethylcellulose is obtained from carboxymethylcellulose by enzymatic digestion with a cellulase produced by Trichoderma longibrachiatum (formerly T. reesei)
EINECS
Chemical name Carboxymethyl cellulose, sodium, partially enzymatically hydrolysed
Chemical Sodium salts of polymers containing substituted formula anhydroglucose units with the general formula:
[C 6 H 7 O 2 (OH) x (OCH 2 COONa) y ] n
where n is the degree of polymerisation
x = 1,50 to 2,80
y = 0,2 to 1,50
x + y = 3,0
(y = degree of substitution)
Molecular 178,14 where y = 0,20 weight 282,18 where y = 1,50 Macromolecules: Not less than 800 (n about 4)
Assay Not less than 99,5 %, including mono- and disaccharides, on the dried basis
Description White or slightly yellowish or greyish, odourless, slightly hygroscopic granular or fibrous powder
Identification
Solubility Soluble in water, insoluble in ethanol
Foam test Vigorously shake a 0,1 % solution of the sample. No layer of foam appears. This test distinguishes sodium carboxymethyl cellulose, whether hydrolysed or not, from other cellulose ethers and from alginates and
natural gums
Precipitate To 5 ml of a 0,5 % solution of the sample add 5 ml of formation a 5 % solution of copper or aluminium sulphate. A precipitate appears. This test distinguishes sodium carboxymethyl cellulose, whether hydrolysed or not, from other cellulose ethers and from gelatine, carob bean gum and tragacanth gum
Colour reaction Add 0,5 g of the powdered sample to 50 ml of water, while stirring to produce a uniform dispersion.
Continue the stirring until a clear solution is produced. Dilute 1 ml of the solution with 1 ml of water in a small test tube. Add 5 drops of 1-naphthol TS. Incline the tube, and carefully introduce down the side of the tube 2 ml of sulphuric acid so that it forms a lower layer. A red-purple colour develops at the interface
Viscosity Not less than 2.500 kgm -1 s -1 at 25 °C corresponding to
(60 % solids) an average molecule weight of 5 000 Da
pH Not less than 6,0 and not more than 8,5 (1 % colloidal solution)
Purity
Loss on drying Not more than 12 % (105 °C to constant weight)
Degree of Not less than 0,2 and not more than 1,5 carboxymethyl
substitution groups per anhydroglucose unit on the dried basis
Sodium Not more than 0,5 % singly or in combination chloride and sodium glycolate
Residual Passes test. No change in viscosity of test solution enzyme occurs, which indicates hydrolysis of the sodium activity carboxymethyl cellulose
Lead Not more than 3 mg/kg
E 470a SODIUM, POTASSIUM AND CALCIUM SALTS OF FATTY ACIDS
Synonyms
Definition Sodium, potassium and calcium salts of fatty acids occurring in food oils and fats, these salts being
obtained either from edible fats and oils or from distilled food fatty acids.
EINECS
Chemical name
Chemical formula
Molecular weight
Assay Content on the anhydrous basis not less than 95 %(105 °C till a constant weight)
Description White or creamy white light powders, flakes or semisolids
Identification
Solubility Sodium and potassium salts: soluble in water and ethanol. Calcium salts: insoluble in water, ethanol and ether
Test for cations Passes test
Test for fatty Passes test acids
Purity
Sodium Not less than 9 % and not more than 14 % expressed as
EN 282 EN
Potassium Not less than 13 % and not more than 21,5 % expressed
as K 2 O
Calcium Not less than 8,5 % and not more than 13 % expressed as CaO
Unsaponifiable Not more than 2 % matter
Free fatty acids Not more than 3 % estimated as oleic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Free alkali Not more than 0,1 % expressed as NaOH
Matter Not more than 0,2 % (sodium and potassium salts only)
insoluble in
alcohol
E 470b MAGNESIUM SALTS OF FATTY ACIDS
Synonyms
Definition Magnesium salts of fatty acids occurring in foods oils and fats, these salts being obtained either from edible fats and oils or from distilled food fatty acids
EINECS
Chemical name
Chemical formula
Molecular weight
Assay Content on the anhydrous basis not less than 95 % (105 °C till a constant weight)
Description White or creamy-white light powders, flakes or semisolids
Identification
Solubility Insoluble in water, partially soluble in ethanol and ether
Test for Passes test magnesium
Test for fatty Passes test acids
Purity
Magnesium Not less than 6,5 % and not more than 11 % expressed as MgO
Free alkali Not more than 0,1 % expressed as MgO
Unsaponifiable Not more than 2 % matter
Free fatty acids Not more than 3 % estimated as oleic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 471 MONO- AND DIGLYCERIDES OF FATTY ACIDS
Synonyms Glyceryl monostearate; Glyceryl monopalmitate;
Glyceryl monooleate, etc.; Monostearin; Monopalmitin; Monoolein, etc.; GMS (for glyceryl monostearate)
Definition Mono- and diglycerides of fatty acids consist of mixtures of glycerol mono-, di- and triesters of fatty acids occurring in food oils and fats. They may contain small amounts of free fatty acids and glycerol
EINECS
Chemical name
Chemical formula
Molecular weight
Assay Content of mono- and diesters: not less than 70 %
Description The product varies from a pale yellow to pale brown oily liquid to a white or slightly off-white hard waxy solid. The solids may be in the form of flakes, powders or small beads
Identification
Infrared Characteristic of a partial fatty acid ester of a polyol absorption spectrum
Test for Passes test glycerol
Test for fatty Passes test acids
Solubility Insoluble in water, soluble in ethanol and toluene at 50 °C
Purity
Water content Not more than 2 % (Karl Fischer method)
Acid value Not more than 6
Free glycerol Not more than 7 %
Polyglycerols Not more than 4 % diglycerol and not more than 1 % higher polyglycerols both based on total glycerol
content
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Total glycerol Not less than 16 % and not more than 33 % Sulphated ash Not more than 0,5 % determined at 800 ± 25 °C
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
E 472 a ACETIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY
ACIDS
Synonyms Acetic acid esters of mono- and diglycerides;
Acetoglycerides; Acetylated mono- and diglycerides; Acetic and fatty acid esters of glycerol
Definition Esters of glycerol with acetic and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free acetic acid and
free glycerides
EINECS
Chemical name
Chemical formula
Molecular weight
Assay
Description Clear, mobile liquids to solids, from white to pale yellow in colour
Identification
Test for Passes test glycerol
Test for fatty Passes test acids
Test for acetic Passes test acid
Solubility Insoluble in water. Soluble in ethanol
Purity
Acids other Less than 1% than acetic and fatty acids
Free glycerol Not more than 2 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Total acetic Not less than 9 % and not more than 32 % acid
Free fatty acids Not more than 3 % estimated as oleic acid (and acetic acid)
Total glycerol Not less than 14 % and not more than 31 %
Sulphated ash Not more than 0,5 % determined at 800 ± 25 °C
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
E 472 b LACTIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY
ACIDS
Synonyms Lactic acid esters of mono- and diglycerides;
Lactoglycerides; Mono- and diglycerides of fatty acids esterified with lactic acid
Definition Esters of glycerol with lactic acid and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free lactic acid and free glycerides
Description Clear, mobile liquids to waxy solids of variable consistency, from white to pale yellow in colour
Identification
Test for Passes test glycerol, Test for fatty Passes test acids
Test for lactic Passes test acid
Solubility Insoluble in cold water but dispersible in hot water
Purity
Acids other Less than 1% than lactic and fatty acids
Free glycerol Not more than 2 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Total lactic Not less than 13 % and not more than 45 % acid
Free fatty acids Not more than 3 % estimated as oleic acid (and lactic acid)
Total glycerol Not less than 13 % and not more than 30 %
Sulphated ash Not more than 0,5 % (800 ± 25 °C)
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
E 472 c CITRIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY
ACIDS
Synonyms Citrem; Citric acid esters of mono- and diglycerides; Citroglycerides; Mono- and diglycerides of fatty acids esterified with citric acid
Definition Esters of glycerol with citric acid and fatty acids occurring in food oils and fats. They may contain small amounts of free glycerol, free fatty acids, free citric acid and free glycerides. They may be partially or wholly neutralised with sodium, potassium or calcium salts suitable for the purpose and authorised as food additives according to this Regulation.
EINECS
Chemical name
Chemical formula
Molecular weight
Assay
Description Yellowish or light brown liquids to waxy solids or semi-solids
Identification
Test for Passes test glycerol
Test for fatty Passes test acids
Test for citric Passes test acid
Solubility Insoluble in cold water, dispersible in hot water, soluble in oils and fats, insoluble in cold ethanol
Purity
Acids other Less than 1% than citric and fatty acids
Free glycerol Not more than 2 %
Total glycerol Not less than 8 % and not more than 33 %
Total citric Not less than 13 % and not more than 50 % acid
Sulphated ash Non-neutralised products: not more than 0,5 % (800 ±
Partially or wholly neutralised products: not more than
EN 289 EN
10 % (800 ± 25 °C)
Lead Not more than 2 mg/kg
Acid value Not more than 130
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however, these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
E 472 d TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS
Synonyms Tartaric acid esters of mono- and diglycerides; Monoand diglycerides of fatty acids esterified with tartaric acid
Definition Esters of glycerol with tartaric acid and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric acid and free glycerides
EINECS
Chemical name
Chemical formula
Molecular weight
Assay
Description Sticky viscous yellowish liquids to hard yellow waxes
Identification
Test for Passes test glycerol
Test for fatty Passes test acids
Test for tartaric Passes test acid
Purity
Acids other Less than 1,0% than tartaric and fatty acids
Free glycerol Not more than 2 %
Total glycerol Not less than 12 % and not more than 29 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Total tartaric Not less than 15 % and not more than 50 % acid
Free fatty acids Not more than 3 % estimated as oleic acid
Sulphated ash Not more than 0,5 % (800 ± 25 °C)
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
E 472 e MONO- AND DIACETYLTARTARIC ACID ESTERS OF MONO- AND
DIGLYCERIDES OF FATTY ACIDS
Synonyms Diacetyltartaric acid esters of mono- and diglycerides; Mono-and diglycerides of fatty acids esterified with
mono- and diacetyltartaric acid; Diacetyltartaric and fatty acid esters of glycerol
Definition Mixted esters of glycerol with mono- and diacetyltartaric acids (obtained from tartaric acid) and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and acetic acids and their combinations, and free glycerides. Contains also tartaric and acetic esters of fatty acids
EINECS
Chemical name
Chemical formula
Molecular weight
Assay
Description Sticky viscous liquids through a fat-like consistency to yellow waxes which hydrolyse in moist air to liberate acetic acid
Identification
Test for Passes test glycerol
Test for fatty Passes test acids
Test for tartaric Passes test acid
Test for acetic Passes test acid
Purity
Acids other Less than 1% than acetic, tartaric and fatty acids
Free glycerol Not more than 2 %
Total glycerol Not less than 11 % and not more than 28 %
Sulphated ash Not more than 0,5 % determined at 800 ± 25 °C
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Total tartaric Not less than 10 % and not more than 40 % acid
Total acetic Not less than 8 % and not more than 32 % acid
Acid value Not less than 40 and not more than 130
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
E 472 f MIXED ACETIC AND TARTARIC ACID ESTERS OF MONO- AND
DIGLYCERIDES OF FATTY ACIDS
Synonyms Mono- and diglycerides of fatty acids esterified with acetic acid and tartaric acid
Definition Esters of glycerol with acetic and tartaric acids and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and acetic acids, and free glycerides. May contain mono- and diacetyltartaric esters of mono- and diglycerides of fatty acids
EINECS
Chemical name
Chemical formula
Molecular weight
Assay
Description Sticky liquids to solids, from white to pale-yellow in colour
Identification
Test for Passes test glycerol
Test for fatty Passes test acids
Test for tartaric Passes test acid
Test for acetic Passes test acid
Purity
Acids other than acetic, Less than 1,0% tartaric and fatty acids
Free glycerol Not more than 2 %
Total glycerol Not less than 12 % and not more than 27 %
Sulphated ash Not more than 0,5 % (800 ± 25 °C)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Total acetic Not less than 10 % and not more than 20 % acid
Total tartaric Not less than 20 % and not more than 40 % acid
Free fatty acids Not more than 3 % estimated as oleic acid
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
E 473 SUCROSE ESTERS OF FATTY ACIDS
Synonyms Sucroesters; Sugar esters
Definition Essentially the mono-, di- and triesters of sucrose with fatty acids occurring in food fats and oils. They may be prepared from sucrose and the methyl, ethyl and vinyl esters of food fatty acids (including lauric acid) or by extraction from sucroglycerides. No organic solvent
other than dimethylsulphoxide, dimethylformamide, ethyl acetate, propan-2-ol, 2-methyl-1-propanol, propylene glycol, methyl ethyl ketone and supercritical carbondioxide may be used for their preparation. p- methoxy phenol can be used as a stabiliser during the manufacturing procedure.
EINECS
Chemical name
Chemical formula
Molecular weight
Assay Content not less than 80 %
Description Stiff gels, soft solids or white to slightly greyish-white powders
Identification
Test for sugar Passes test
Test for fatty Passes test acids
Solubility Sparingly soluble in water, soluble in ethanol
Purity
Sulphated ash Not more than 2 % (800 ± 25 °C)
Free sugar Not more than 5 %
Free fatty acids Not more than 3 % estimated as oleic acid
p-methoxy Not more than 100 µg/kg phenol
Acetaldehyde Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Methanol Not more than 10 mg/kg Dimethylsulph Not more than 2 mg/kg oxide
Dimethylforma Not more than 1 mg/kg mide
2-methyl-1- Not more than 10 mg/kg propanol
Ethyl acetate
Propan-2-ol Not more than 350 mg/kg, singly or in combination
Propylene glycol
Methyl ethyl Not more than 10 mg/kg ketone
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
E 474 SUCROGLYCERIDES
Synonyms Sugar glycerides
Definition Sucroglycerides are produced by reacting sucrose with an edible fat or oil to produce a mixture of essentially mono-, di- and triesters of sucrose and fatty acids
(including lauric acid) together with residual mono-, diand
triglycerides from fat or oil. No organic solvents
shall be used in their preparation other than
cyclohexane, dimethylformamide, ethyl acetate, 2-
methyl-1-propanol and propan-2-ol
EINECS
Chemical name
Chemical formula
Molecular weight Assay Content not less than 40 % and not more than 60 % of sucrose fatty acid esters
Description Soft solid masses, stiff gels or white to off-white powders
Identification
Test for sugar Passes test
Test for fatty Passes test acids
Solubility Insoluble in cold water, soluble in ethanol
Purity
Sulphated ash Not more than 2 % (800 ± 25 °C)
Free sugar Not more than 5 %
Free fatty acids Not more than 3 % (estimated as oleic acid)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Methanol Not more than 10 mg/kg
Dimethylforma Not more than 1 mg/kg mide
Not more than 10 mg/kg, single or in combination
2-Methyl-1- propanol
Cyclohexane
Not more than 350 mg/kg, single or in combination
Ethyl acetate
Propan-2-ol
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
E 475 POLYGLYCEROL ESTERS OF FATTY ACIDS
Synonyms Polyglycerol fatty acid esters; Polyglycerin esters of fatty acid esters
Definition Polyglycerol esters of fatty acids are produced by the esterification of polyglycerol with food fats and oils or with fatty acids occurring in foods fats and oils. The polyglycerol moiety is predominantly di-, tri- and
tetraglycerol and contains not more than 10 % of polyglycerols equal to or higher than heptaglycerol
EINECS
Chemical name
Chemical formula
Molecular weight
Assay Content of total fatty acid ester not less than 90 %
Description Light yellow to amber, oily to very viscous liquids; light tan to medium brown, plastic or soft solids; and light tan to brown, hard, waxy solids
Identification
Test for Passes test glycerol,
Test for Passes test polyglycerols
Test for fatty Passes test acids
Solubility The esters range from very hydrophilic to very lipophilic, but as a class tend to be dispersible in water and soluble in organic solvents and oils
Purity
Sulphated ash Not more than 0,5 % (800 ± 25 °C) Acids other Less than 1% than fatty acids
Free fatty acids Not more than 6 % estimated as oleic acid
Total glycerol Not less than 18 % and not more than 60 % and polyglycerol
Free glycerol Not more than 7 % and polyglycerol
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
E 476 POLYGLYCEROL POLYRICINOLEATE
Synonyms Glycerol esters of condensed castor oil fatty acids;
Polyglycerol esters of polycondensed fatty acids from castor oil; Polyglycerol esters of interesterified ricinoleic acid; PGPR
Definition Polyglycerol polyricinoleate is prepared by the esterification of polyglycerol with condensed castor oil fatty acids
EINECS
Chemical name
Chemical formula
Molecular weight
Assay Description Clear, highly viscous liquid
Identification
Solubility Insoluble in water and in ethanol; soluble in ether, hydrocarbons and halogenated hydrocarbons
Test for Passes test glycerol
Test for Passes test polyglycerol
Test for Passes test ricinoleic acid
Refractive [n] 65 D between 1,4630 and 1,4665
index
Purity
Polyglycerols The polyglycerol moiety shall be composed of not less than 75 % of di-, tri- and tetraglycerols and shall
contain not more than 10 % of polyglycerols equal to or higher than heptaglycerol
Hydroxyl value Not less than 80 and not more than 100
Acid value Not more than 6
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 477 PROPANE-1,2-DIOL ESTERS OF FATTY ACIDS
Synonyms Propylene glycol esters of fatty acids
Definition Consists of mixtures of propane-1,2-diol mono- and diesters of fatty acids occurring in food fats and oils. The alcohol moiety is exclusively propane-1,2-diol together with dimer and traces of trimer. Organic acids other than food fatty acids are absent
EINECS
Chemical name
Chemical formula
Molecular weight
Assay Content of total fatty acid ester not less than 85 %
Description Clear liquids or waxy white flakes, beads or solids having a bland odour
Identification
Test for Passes test propylene glycol
Test for fatty Passes test acids
Purity
Sulphated ash Not more than 0,5 % (800 ± 25 °C)
Acids other Less than 1% than fatty acids
Free fatty acids Not more than 6 % estimated as oleic acid
Total propane Not less than 11 % and not more than 31 % 1,2-diol
Free propane Not more than 5 % 1,2-diol
Dimer and Not more than 0,5 % trimer of propylene glycol
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
E 479 b THERMALLY OXIDISED SOYA BEAN OIL INTERACTED WITH MONO- AND DIGLYCERIDES OF FATTY ACIDS
Synonyms TOSOM
Definition Thermally oxidised soya bean oil interacted with mono- and diglycerides of fatty acids is a complex mixture of esters of glycerol and fatty acids found in edible fat and fatty acids from thermally oxidised soya bean oil. It is produced by interaction and
desodorisation under vacuum at 130 °C of 10 % of thermally oxidised soya bean oil and 90 % mono- and diglycerides of food fatty acids. Soya bean oil is exclusively made from strains of soya beans
EINECS
Chemical name
Chemical formula
Molecular weight
Assay
Description Pale yellow to light brown a waxy or solid consistency
Identification
Solubility Insoluble in water. Soluble in hot oil or fat
Purity
Melting range 55 — 65 °C
Free fatty acids Not more than 1,5 % estimated as oleic acid
Free glycerol Not more than 2 % Total fatty 83 — 90 % acids
Total glycerol 16 — 22 %
Fatty acid Not more than 9 % of total fatty acid methyl esters methyl esters, not forming adduct with urea
Fatty acids, Not more than 2 % of total fatty acids insoluble in petroleum ether
Peroxide value Not more than 3
Epoxides Not more than 0,03 % oxirane oxygen
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 481 SODIUM STEAROYL-2-LACTYLATE
Synonyms Sodium stearoyl lactylate; Sodium stearoyl lactate
Definition A mixture of the sodium salts of stearoyl lactylic acids and its polymers and minor amounts of sodium salts of other related acids, manufactured by the reaction of
stearic acid and lactic acid. Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid used
EINECS 246-929-7
Chemical name Sodium di-2-stearoyl lactate
Sodium di(2-stearoyloxy)propionate
formula
EN 303 EN
Molecular weight
Assay
Description White or slightly yellowish powder or brittle solid with a characteristic odour
Identification
Test for Passes test sodium
Test for fatty Passes test acids
Test for lactic Passes test acid
Solubility Insoluble in water. Soluble in ethanol
Purity
Sodium Not less than 2,5 % and not more than 5 %
Ester value Not less than 90 and not more than 190
Acid value Not less than 60 and not more than 130
Total lactic Not less than 15 % and not more than 40 % acid
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 482 CALCIUM STEAROYL-2-LACTYLATE
Synonyms Calcium stearoyl lactate
Definition A mixture of the calcium salts of stearoyl lactylic acids and its polymers and minor amounts of calcium salts of other related acids, manufactured by the reaction of
stearic acid and lactic acid. Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid used
EINECS 227-335-7
Chemical name Calcium di-2-stearoyl lactate
Calcium di(2-stearoyloxy)propionate
Chemical C 42 H 78 O 8 Ca ; C 38 H 70 O 8 Ca, C 40 H 74 O 8 Ca (major formula components)
Molecular weight
Assay
Description White or slightly yellowish powder or brittle solid with a characteristic odour
Identification
Test for Passes test calcium
Test for fatty Passes test acids
Test for lactid Passes test acid
Solubility Slightly soluble in hot water
Purity
Calcium Not less than 1 % and not more than 5,2 %
Ester value Not less than 125 and not more than 190
Total lactic Not less than 15 % and not more than 40 % acid
Acid value Not less than 50 and not more than 130
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg
E 483 STEARYL TARTRATE
Synonyms Stearyl palmityl tartrate
Definition Product of the esterification of tartaric acid with commercial stearyl alcohol, which consists essentially of stearyl and palmityl alcohols. It consists mainly of diester, with minor amounts of monoester and of unchanged starting materials
EINECS
Chemical name Distearyl tartrate
Dipalmityl tartrate
Stearylpalmityl tartrate
Chemical C 40 H 78 O 6 (Distearyl tartrate) formula C 36 H 70 O 6 (Dipalmityl tartrate)
C 38 H 74 O 6 (Stearylpalmityl tartrate)
Molecular 655 (Distearyl tartrate) weight 599 (Dipalmityl tartrate)
627 (Stearylpalmityl tartrate)
Assay Content of total ester not less than 90 % corresponding to an ester value of not less than 163 and not more than 180
Description Cream-coloured unctuous solid (at 25 °C)
Identification
Test for tartrate Passes test
Melting range Between 67 °C and 77 °C. After saponification the saturated long chain fatty alcohols have a melting range of 49 °C to 55 °C
Purity
Hydroxyl value Not less than 200 and not more than 220
Acid value Not more than 5,6
Total tartaric Not less than 18 % and not more than 35 % acid
Sulphated ash Not more than 0,5 % (800 ± 25 °C)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Unsaponifiable Not less than 77 % and not more than 83 % matter
Iodine value Not more than 4 (Wijs method)
E 491 SORBITAN MONOSTEARATE
Synonyms
Definition A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial stearic acid
EINECS 215-664-9
Chemical name
Chemical formula
Molecular weight
Assay Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters
Description Light, cream- to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour
Identification
Solubility Soluble at temperatures above its melting point in toluene, dioxane, carbon tetrachloride, ether, methanol, ethanol and aniline; insoluble in petroleum ether and acetone; insoluble in cold water but dispersible in warm water; soluble with haze at temperatures above 50 °C in mineral oil and ethyl acetate
Congealing 50 — 52 °C range
Infrared Characteristic of a partial fatty acid ester of a polyol absorption spectrum
Purity
Water content Not more than 2 % (Karl Fischer method)
Sulphated ash Not more than 0,5 %
Acid value Not more than 10
Saponification Not less than 147 and not more than 157 value
Hydroxyl value Not less than 235 and not more than 260
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 492 SORBITAN TRISTEARATE
Synonyms
Definition A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial stearic acid
EINECS 247-891-4
Chemical name
Chemical formula
Molecular weight
Assay Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters
Description Light, cream- to tan-coloured beads or flakes or hard, waxy solid with a slight odour
Identification
Solubility Slightly soluble in toluene, ether, carbon tetrachloride and ethyl acetate; dispersible in petroleum ether,
mineral oil, vegetable oils, acetone and dioxane; insoluble in water, methanol and ethanol
Congealing 47 — 50 °C range
Infrared Characteristic of a partial fatty acid ester of a polyol absorption spectrum
Purity
Water content Not more than 2 % (Karl Fischer method)
Sulphated ash Not more than 0,5 %
Acid value Not more than 15
Saponification Not less than 176 and not more than 188 value
Hydroxyl value Not less than 66 and not more than 80
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 493 SORBITAN MONOLAURATE
Synonyms
Definition A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial lauric acid
EINECS 215-663-3
Chemical name
Chemical formula
Molecular weight
Assay Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters
Description Amber-coloured oily viscous liquid, light cream to tancoloured beads or flakes or a hard, waxy solid with a
slight odour
Identification
Solubility Dispersible in hot and cold water
Infrared Characteristic of a partial fatty acid ester of a polyol absorption spectrum
Purity
Water content Not more than 2 % (Karl Fischer method)
Sulphated ash Not more than 0,5 %
Acid value Not more than 7
Saponification Not less than 155 and not more than 170 value
Hydroxyl value Not less than 330 and not more than 358
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg Cadmium Not more than 1 mg/kg
E 494 SORBITAN MONOOLEATE
Synonyms
Definition A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial oleic acid. Major constituent is 1,4-sorbitan monooleate. Other
constituents include isosorbide monooleate, sorbitan dioleate and sorbitan trioleate
EINECS 215-665-4
Chemical name
Chemical formula
Molecular weight
Assay Content not less than 95 % of a mixture of sorbitol, sorbitan and isosorbide esters
Description Amber-coloured viscous liquid, light cream to tancoloured beads or flakes or a hard, waxy solid with a slight characteristic odour
Identification
Solubility Soluble at temperatures above its melting point in ethanol, ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and carbon tetrachloride. Insoluble in cold water, dispersible in warm water
Iodine value The residue of oleic acid, obtained from the saponification of the sorbitan monooleate in assay, has a iodine value between 80 and 100
Purity
Water content Not more than 2 % (Karl Fischer method)
Sulphated ash Not more than 0,5 %
Acid value Not more than 8 Saponification Not less than 145 and not more than 160 value
Hydroxyl value Not less than 193 and not more than 210
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 495 SORBITAN MONOPALMITATE
Synonyms Sorbitan palmitate
Definition A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial palmitic acid
EINECS 247-568-8
Chemical name
Chemical formula
Molecular weight
Assay Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters
Description Light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour
Identification
Solubility Soluble at temperatures above its melting point in ethanol, methanol, ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and carbon tetrachloride. Insoluble in cold water but dispersible in warm water
Congealing 45 — 47 °C range
Infrared Characteristic of a partial fatty acid ester of polyol absorption spectrum
Purity
Water content Not more than 2 % (Karl Fischer method)
Sulphate ash Not more than 0,5 %
Acid value Not more than 7,5
Saponification Not less than 140 and not more than 150 value
Hydroxyl value Not less than 270 and not more than 305
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 500(i) SODIUM CARBONATE
Synonyms Soda ash
Definition
EINECS 207-838-8
Chemical name Sodium carbonate
Chemical Na 2 CO 3 · nH 2 O (n = 0, 1 or 10) formula
Molecular 106,00 (anhydrous) weight
Assay Content not less than 99 % of Na 2 CO 3 on the
anhydrous basis
Description Colourless crystals or white, granular or crystalline powder
The anhydrous form is hygroscopic, the decahydrate
efflorescent
Identification
Test for Passes test sodium
Test for Passes test carbonate
Solubility Freely soluble in water. Insoluble in ethanol
Purity
Loss on drying Not more than 2 % (anhydrous), 15 % (monohydrate) or 55 %-65 % (decahydrate) (70 °C raising gradually to 300 °C, to constant weight)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 500(ii) SODIUM HYDROGEN CARBONATE
Synonyms Sodium bicarbonate; sodium acid carbonate;
Bicarbonate of soda; Baking soda
Definition
EINECS 205-633-8
Chemical name Sodium hydrogen carbonate
Chemical NaHCO 3 formula
Molecular 84,01 weight
Assay Content not less than 99 % on the anhydrous basis
Description Colourless or white crystalline masses or crystalline powder
Identification
Test for Passes test sodium Test for Passes test carbonate
pH Between 8,0 and 8,6 (1 % solution)
Solubility Soluble in water. Insoluble in ethanol
Purity
Loss on drying Not more than 0,25 % (over silica gel, 4 hours)
Ammonium No odour of ammonia detectable after heating salts
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 500(iii) SODIUM SESQUICARBONATE
Synonyms
Definition
EINECS 208-580-9
Chemical name Sodium monohydrogen dicarbonate
Chemical Na 2 CO 3 · NaHCO 3 · 2H 2 O
formula
Molecular 226,03 weight
Assay Content between 35,0 % and 38,6 % of NaHCO 3 and between 46,4 % and 50,0 % of Na 2 CO 3
Description White flakes, crystals or crystalline powder
Identification
Test for Passes test sodium
Test for Passes test carbonate
Solubility Freely soluble in water
Purity
Sodium Not more than 0,5 % chloride
Iron Not more than 20 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 501(i) POTASSIUM CARBONATE
Synonyms
Definition
EINECS 209-529-3
Chemical name Potassium carbonate
Chemical K 2 CO 3 · nH 2 O (n = 0 or 1,5) formula
Molecular 138,21 (anhydrous) weight
Assay Content not less than 99,0 % on the anhydrous basis
Description White, very deliquescent powder.
The hydrate occurs as small, white, translucent crystals
or granules
Identification
Test for Passes test potassium
Test for Passes test carbonate Solubility Very soluble in water. Insoluble in ethanol
Purity
Loss on drying Not more than 5 % (anhydrous) or 18 % (hydrate) (180 °C, 4 hours)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 501(ii) POTASSIUM HYDROGEN CARBONATE
Synonyms Potassium bicarbonate; Acid potassium carbonate
Definition
EINECS 206-059-0
Chemical name Potassium hydrogen carbonate
Chemical KHCO 3 formula
Molecular 100,11 weight
Assay Content not less than 99,0 % and not more than
101,0 % KHCO 3 on the anhydrous basis
Description Colourless crystals or white powder or granules
Identification
Test for Passes test potassium
Test for Passes test carbonate
Solubility Freely soluble in water. Insoluble in ethanol
Purity
Loss on drying Not more than 0,25 % (over silica gel, 4 hours) Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 503(i) AMMONIUM CARBONATE
Synonyms
Definition Ammonium carbonate consists of ammonium carbamate, ammonium carbonate and ammonium hydrogen carbonate in varying proportions
EINECS 233-786-0
Chemical name Ammonium carbonate
Chemical CH 6 N 2 O 2 , CH 8 N 2 O 3 and CH 5 NO 3 formula
Molecular Ammonium carbamate 78,06; ammonium carbonate weight 98,73; ammonium hydrogen carbonate 79,06
Assay Content not less than 30,0 % and not more than 34,0 % of NH 3
Description White powder or hard, white or translucent masses or crystals. Becomes opaque on exposure to air and is
finally converted into white porous lumps or powder (of ammonium bicarbonate) due to loss of ammonia and carbon dioxide
Identification
Test for Passes test ammonium
Test for Passes test carbonate
pH About 8,6 (5 % solution)
Solubility Soluble in water
Purity
Non-volatile Not more than 500 mg/kg matter
Chlorides Not more than 30 mg/kg
Sulphate Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 503(ii) AMMONIUM HYDROGEN CARBONATE
Synonyms Ammonium bicarbonate
Definition
EINECS 213-911-5
Chemical name Ammonium hydrogen carbonate
Chemical CH 5 NO 3 formula
Molecular 79,06 weight
Assay Content not less than 99,0 %
Description White crystals or crystalline powder
Identification
Test for Passes test ammonium
Test for Passes test carbonate
pH About 8,0 (5 % solution)
Solubility Freely soluble in water. Insoluble in ethanol Purity
Non-volatile Not more than 500 mg/kg matter
Chlorides Not more than 30 mg/kg
Sulphate Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 504(i) MAGNESIUM CARBONATE
Synonyms Hydromagnesite
Definition Magnesium carbonate is a basic hydrated or a monohydrated magnesium carbonate or a mixture of the two.
EINECS 208-915-9
Chemical name Magnesium carbonate
Chemical MgCO 3 · nH 2 O
formula
Assay Not less than 24 % and not more than 26,4 % of Mg
Description Odourless, light, white friable masses or as a bulky white powder
Identification
Test for Passes test magnesium
Test for Passes test carbonate
Solubility Practically insoluble both in water or ethanol
Purity
Acid insoluble Not more than 0,05 % matter
Water soluble Not more than 1,0 % matter
Calcium Not more than 0,4 %
Arsenic Not more than 4 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 504(ii) MAGNESIUM HYDROXIDE CARBONATE
Synonyms Magnesium hydrogen carbonate; Magnesium subcarbonate (light or heavy); Hydrated basic magnesium carbonate; Magnesium carbonate hydroxide
Definition
EINECS 235-192-7
Chemical name Magnesium carbonate hydroxide hydrated
Chemical 4MgCO 3 Mg(OH) 2 · 5H 2 O formula
Molecular 485 weight
Assay Mg content not less than 40,0 % and not more than 45,0 % calculated as MgO
Description Light, white friable mass or bulky white powder
Identification
Test for Passes test magnesium
Test for Passes test carbonate
Solubility Practically insoluble in water. Insoluble in ethanol Purity
Acid insoluble Not more than 0,05 % matter
Water soluble Not more than 1,0 % matter
Calcium Not more than 1,0 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 507 HYDROCHLORIC ACID
Synonyms Hydrogen chloride; Muriatic acid
Definition
EINECS 231-595-7
Chemical name Hydrochloric acid
Chemical HCl formula
Molecular 36,46 weight
Assay Hydrochloric acid is commercially available in varying concentrations. Concentrated hydrochloric acid
contains not less than 35,0 % HCl
Description Clear, colourless or slightly yellowish, corrosive liquid having a pungent odour
Identification
Test for acid Passes test
Test for Passes test chloride
Solubility Soluble in water and in ethanol Purity
Total organic Total organic compounds (non-fluorine containing): compounds not more than 5 mg/kg
Benzene: not more than 0,05 mg/kg
Fluorinated compounds (total): not more than 25 mg/kg
Non-volatile Not more than 0,5 % matter
Reducing Not more than 70 mg/kg (as SO 2 )
substances
Oxidising Not more than 30 mg/kg (as Cl 2 ) substances
Sulphate Not more than 0,5 %
Iron Not more than 5 mg/kg
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 508 POTASSIUM CHLORIDE
Synonyms Sylvine; Sylvite
Definition
EINECS 231-211-8
Chemical name Potassium chloride
Chemical KCl formula
Molecular 74,56 weight
Assay Content not less than 99 % on the dried basis
Description Colourless, elongated, prismatic or cubital crystals or white granular powder. Odourless
Identification
Solubility Freely soluble in water. Insoluble in ethanol
Test for Passes test potassium
Test for Passes test chloride
Purity
Loss on drying Not more than 1 % (105 °C, 2 hours)
Test for Negative sodium
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 509 CALCIUM CHLORIDE
Synonyms
Definition
EINECS 233-140-8
Chemical name Calcium chloride
Chemical CaCl 2 · nH 2 O (n = 0,2 or 6)
formula
Molecular 110,99 (anhydrous), 147,02 (dihydrate), 219,08 weight (hexahydrate)
Assay Content not less than 93,0 % on the anhydrous basis
Description White, odourless, hygroscopic powder or deliquescent crystals
Identification
Test for Passes test calcium
Test for Passes test chloride
Solubility Soluble in water and in ethanol
Purity
Magnesium Not more than 5 % on the dried basis (calculated as
and alkali salts sulphates)
Fluoride Not more than 40 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 511 MAGNESIUM CHLORIDE
Synonyms
Definition
EINECS 232-094-6
Chemical name Magnesium chloride
Chemical MgCl 2 · 6H 2 O
formula
Molecular 203,30 weight
Assay Content not less than 99,0 %
Description Colourless, odourless, very deliquescent flakes or crystals
Identification
Test for Passes test magnesium Test for Passes test chloride
Solubility Very soluble in water, freely soluble in ethanol
Purity
Ammonium Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 512 STANNOUS CHLORIDE
Synonyms Tin chloride; Tin dichloride
Definition
EINECS 231-868-0
Chemical name Stannous chloride dihydrate
Chemical SnCl 2 · 2H 2 O
formula
Molecular 225,63 weight
Assay Content not less than 98,0 %
Description Colourless or white crystals
May have a slight odour of hydrochloric acid
Identification
Test for tin (II) Passes test
Test for Passes test chloride
Solubility Water: soluble in less than its own weight of water, but it forms an insoluble basic salt with excess water
Ethanol: soluble
Purity
Sulphate Not more than 30 mg/kg
Arsenic Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Lead Not more than 2 mg/kg
E 513 SULPHURIC ACID
Synonyms Oil of vitriol; Dihydrogen sulphate
Definition
EINECS 231-639-5
Chemical name Sulphuric acid
Chemical H 2 SO 4 formula
Molecular 98,07 weight
Assay Sulphuric acid is commercially available in varying concentrations. The concentrated form contains not less than 96,0 %
Description Clear, colourless or slightly brown, very corrosive oily liquid
Identification
Test for acid Passes test
Test for Passes test sulphate
Solubility Miscible with water, with generation of much heat, also with ethanol
Purity
Ash Not more than 0,02 % Reducing Not more than 40 mg/kg (as SO 2 ) matter
Nitrate Not more than 10 mg/kg (on H 2 SO 4 basis)
Chloride Not more than 50 mg/kg
Iron Not more than 20 mg/kg
Selenium Not more than 20 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 514(i) SODIUM SULPHATE
Synonyms
Definition
EINECS
Chemical name Sodium sulphate
Chemical Na 2 SO 4 · nH 2 O (n = 0 or 10) formula
Molecular 142,04 (anhydrous) weight 322,04 (decahydrate)
Assay Content not less than 99,0 % on the anhydrous basis
Description Colourless crystals or a fine, white, crystalline powder
The decahydrate is efflorescent
Identification
Test for Passes test sodium
Test for Passes test sulphate pH Neutral or slightly alkaline to litmus paper (5 % solution)
Purity
Loss on drying Not more than 1,0 % (anhydrous) or not more than
57 % (decahydrate) at 130 o C
Selenium Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 514(ii) SODIUM HYDROGEN SULPHATE
Synonyms Acid sodium sulphate; Sodium bisulphate; Nitre cake
Definition
Chemical name Sodium hydrogen sulphate
Chemical NaHSO 4 formula
Molecular 120,06 weight
Assay Content not less than 95,2 %
Description White, odourless crystals or granules
Identification
Test for Passes test sodium
Test for Passes test sulphate
pH Solutions are strongly acidic
Purity
Loss on drying Not more than 0,8 % Water Not more than 0,05 % insoluble matter
Selenium Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 515(i) POTASSIUM SULPHATE
Synonyms
Definition
EINECS
Chemical name Potassium sulphate
Chemical K 2 SO 4
formula
Molecular 174,25 weight
Assay Content not less than 99,0 %
Description Colourless or white crystals or crystalline powder
Identification
Test for Passes test potassium
Test for Passes test sulphate
pH Between 5,5 and 8,5 (5 % solution)
Solubility Freely soluble in water, insoluble in ethanol
Purity
Selenium Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 515(ii) POTASSIUM HYDROGEN SULPHATE
Synonyms Potassium bisulphate; Potassium acid sulphate
Definition
EINECS
Chemical name Potassium hydrogen sulphate
Chemical KHSO 4
formula
Molecular 136,17 weight
Assay Content not less than 99 %
Description White deliquescent crystals, pieces or granules
Identification
Melting point 197 °C
Test for Passes test potassium
Solubility Freely soluble in water, insoluble in ethanol
Purity
Selenium Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg E 516 CALCIUM SULPHATE
Synonyms Gypsum; Selenite; Anhydrite
Definition
EINECS 231-900-3
Chemical name Calcium sulphate
Chemical CaSO 4 · nH 2 O (n = 0 or 2)
formula
Molecular 136,14 (anhydrous), 172,18 (dihydrate) weight
Assay Content not less than 99,0 % on the anhydrous basis
Description Fine, white to slightly yellowish-white odourless powder
Identification
Test for Passes test calcium
Test for Passes test sulphate
Solubility Slightly soluble in water, insoluble in ethanol
Purity
Loss on drying Anhydrous: not more than 1,5 % (250 °C, constant weight)
Dihydrate: not more than 23 % (250 °C, constant weight)
Fluoride Not more than 30 mg/kg
Selenium Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg E 517 AMMONIUM SULPHATE
Synonyms
Definition
EINECS 231-984-1
Chemical name Ammonium sulphate
Chemical (NH 4 ) 2 SO 4
formula
Molecular 132,14 weight
Assay Content not less than 99,0 % and not more than 100,5 %
Description White powder, shining plates or crystalline fragments
Identification
Test for Passes test ammonium
Test for Passes test sulphate
Solubility Freely soluble in water, insoluble in ethanol
Purity
Loss on Not more than 0,25 % ignition
Selenium Not more than 30 mg/kg
Lead Not more than 3 mg/kg
E 520 ALUMINIUM SULPHATE
Synonyms Alum
Definition
EINECS Chemical name Aluminium sulphate
Chemical Al 2 (SO 4 ) 3
formula
Molecular 342,13 weight
Assay Content not less than 99,5 % on the ignited basis
Description White powder, shining plates or crystalline fragments
Identification
Test for Passes test aluminium
Test for Passes test sulphate
pH 2,9 or above (5 % solution)
Solubility Freely soluble in water, insoluble in ethanol
Purity
Loss on Not more than 5 % (500 °C, 3 hours) ignition
Alkalies and Not more than 0,4 % alkaline earths
Selenium Not more than 30 mg/kg
Fluoride Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 521 ALUMINIUM SODIUM SULPHATE
Synonyms Soda alum; Sodium alum
Definition
EINECS 233-277-3
Chemical name Aluminium sodium sulphate
Chemical AlNa(SO 4 ) 2 · nH 2 O (n = 0 or 12)
formula
Molecular 242,09 (anhydrous) weight
Assay Content on the anhydrous basis not less than 96,5 % (anhydrous) and 99,5 % (dodecahydrate)
Description Transparent crystals or white crystalline powder
Identification
Test for Passes test aluminium
Test for Passes test sodium
Test for Passes test sulphate
Solubility Dodecahydrate is freely soluble in water. The anhydrous form is slowly soluble in water. Both forms are insoluble in ethanol
Purity
Loss on drying Anhydrous form: not more than 10,0 % (220 °C, 16 hours)
Dodecahydrate: not more than 47,2 % (50 °C - 55 °C, 1
hour then 200 °C, 16 hours)
Ammonium No odour of ammonia detectable after heating salts
Selenium Not more than 30 mg/kg
Fluoride Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg
E 522 ALUMINIUM POTASSIUM SULPHATE
Synonyms Potassium alum; Potash alum
Definition
EINECS 233-141-3
Chemical name Aluminium potassium sulphate dodecahydrate
Chemical AlK(SO 4 ) 2 · 12 H 2 O
formula
Molecular 474,38 weight
Assay Content not less than 99,5 %
Description Large, transparent crystals or white crystalline powder
Identification
Test for Passes test aluminium
Test for Passes test potassium
Test for Passes test sulphate
pH Between 3,0 and 4,0 (10 % solution)
Solubility Freely soluble in water, insoluble in ethanol
Purity
Ammonium No odour of ammonia detectable after heating salts
Selenium Not more than 30 mg/kg
Fluoride Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 523 ALUMINIUM AMMONIUM SULPHATE
Synonyms Ammonium alum
Definition
EINECS 232-055-3
Chemical name Aluminium ammonium sulphate
Chemical AlNH 4 (SO 4 ) 2 · 12 H 2 O formula
Molecular 453,32 weight
Assay Content not less than 99,5 %
Description Large, colourless crystals or white powder
Identification
Test for Passes test aluminium
Test for Passes test ammonium
Test for Passes test sulphate
Solubility Freely soluble in water, soluble in ethanol
Purity
Alkali metals Not more than 0,5 % and alkaline earths
Selenium Not more than 30 mg/kg
Fluoride Not more than 30 mg/kg Arsenic Not more than 3 mg/kg
Lead Not more than 3 mg/kg
Mercury Not more than 1 mg/kg
E 524 SODIUM HYDROXIDE
Synonyms Caustic soda; Lye
Definition
EINECS 215-185-5
Chemical name Sodium hydroxide
Chemical NaOH formula
Molecular 40,0 weight
Assay Content of solid forms not less than 98,0 % of total alkali (as NaOH). Content of solutions accordingly, based on the stated or labelled percentage of NaOH
Description White or nearly white pellets, flakes, sticks, fused masses or other forms. Solutions are clear or slightly turbid, colourless or slightly coloured, strongly caustic and hygroscopic and when exposed to the air they absorb carbon dioxide, forming sodium carbonate
Identification
Test for Passes test sodium
pH Strongly alkaline (1 % solution)
Solubility Very soluble in water. Freely soluble in ethanol
Purity
Water A 5 % solution is completely clear and colourless to insoluble and slightly coloured organic matter Carbonate Not more than 0,5 % (as Na 2 CO 3 )
Arsenic Not more than 3 mg/kg
Lead Not more than 0,5 mg/kg
Mercury Not more than 1 mg/kg
E 525 POTASSIUM HYDROXIDE
Synonyms Caustic potash
Definition
EINECS 215-181-3
Chemical name Potassium hydroxide
Chemical KOH formula
Molecular 56,11 weight
Assay Content not less than 85,0 % of alkali calculated as KOH
Description White or nearly white pellets, flakes, sticks, fused masses or other forms
Identification
Test for Passes test potassium
pH Strongly alkaline (1 % solution)
Solubility Very soluble in water. Freely soluble in ethanol
Purity
Water A 5 % solution is completely clear and colourless insoluble matter
EN 339 EN
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 526 CALCIUM HYDROXIDE
Synonyms Slaked lime; Hydrated lime
Definition
EINECS 215-137-3
Chemical name Calcium hydroxide
Chemical Ca(OH) 2
formula
Molecular 74,09 weight
Assay Content not less than 92,0 %
Description White powder
Identification
Test for alkali Passes test
Test for Passes test calcium
Solubility Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol
Purity
Acid insoluble Not more than 1,0 % ash
Magnesium Not more than 2,7 % and alkali salts
Barium Not more than 300 mg/kg
Fluoride Not more than 50 mg/kg Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
E 527 AMMONIUM HYDROXIDE
Synonyms Aqua ammonia; Strong ammonia solution
Definition
EINECS
Chemical name Ammonium hydroxide
Chemical NH 4 OH formula
Molecular 35,05 weight
Assay Content not less than 27 % of NH 3
Description Clear, colourless solution, having an exceedingly pungent, characteristic odour
Identification
Test for Passes test ammonia
Purity
Non-volatile Not more than 0,02 % matter
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
E 528 MAGNESIUM HYDROXIDE
Synonyms
Definition
EINECS
Chemical name Magnesium hydroxide
Chemical Mg(OH) 2 formula
Molecular 58,32 weight
Assay Content not less than 95,0 % on the anhydrous basis
Description Odourless, white bulky powder
Identification
Test for Passes test magnesium
Test for alkali Passes test
Solubility Practically insoluble in water and in ethanol
Purity
Loss on drying Not more than 2,0 % (105 °C, 2 hours)
Loss on Not more than 33 % (800 °C to constant weight) ignition
Calcium oxide Not more than 1,5 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
E 529 CALCIUM OXIDE
Synonyms Burnt lime
Definition
EINECS 215-138-9
Chemical name Calcium oxide
Chemical CaO formula
Molecular 56,08 weight
Assay Content not less than 95,0 % on the ignited basis
Description Odourless, hard, white or greyish white masses of granules, or white to greyish powder
Identification
Test for alkali Passes test
Test for Passes test calcium
Reaction with Heat is generated on moistening the sample with water
water
Solubility Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol
Purity
Loss on Not more than 10,0 % (ca 800 °C to constant weight) ignition
Acid insoluble Not more than 1,0 % matter
Barium Not more than 300 mg/kg
Magnesium Not more than 3,6 % and alkali salts
Fluoride Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
E 530 MAGNESIUM OXIDE
Synonyms
Definition
EINECS 215-171-9
Chemical name Magnesium oxide
Chemical MgO formula
Molecular 40,31 weight
Assay Content not less than 98,0 % on the ignited basis
Description A very bulky, white powder known as light magnesium oxide or a relative dense, white powder known as
heavy magnesium oxide. 5 g of light magnesium oxide occupy a volume of at least 33 ml, while 5 g of heavy magnesium oxide occupy a volume of not more than 20 ml
Identification
Test for alkali Passes test
Test for Passes test magnesium
Solubility Practically insoluble in water. Insoluble in ethanol
Purity
Loss on Not more than 5,0 % (ca 800 °C to constant weight) ignition
Calcium oxide Not more than 1,5 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
E 535 SODIUM FERROCYANIDE
Synonyms Yellow prussiate of soda; Sodium hexacyanoferrate
Definition
EINECS 237-081-9
Chemical name Sodium ferrocyanide
Chemical Na 4 Fe(CN) 6 · 10 H 2 O formula
Molecular 484,1 weight
Assay Content not less than 99,0 %
Description Yellow crystals or crystalline powder
Identification
Test for Passes test sodium
Test for Passes test ferrocyanide
Purity
Free moisture Not more than 1,0 %
Water Not more than 0,03 % insoluble matter
Chloride Not more than 0,2 %
Sulphate Not more than 0,1 %
Free cyanide Not detectable
Ferricyanide Not detectable
Lead Not more than 5 mg/kg
E 536 POTASSIUM FERROCYANIDE
Synonyms Yellow prussiate of potash; Potassium hexacyanoferrate
Definition
EINECS 237-722-2
Chemical name Potassium ferrocyanide
Chemical K 4 Fe(CN) 6 · 3 H 2 O formula
Molecular 422,4 weight
Assay Content not less than 99,0 %
Description Lemon yellow crystals
Identification
Test for Passes test potassium
Test for Passes test ferrocyanide
Purity
Free moisture Not more than 1,0 %
Water Not more than 0,03 % insoluble matter
Chloride Not more than 0,2 %
Sulphate Not more than 0,1 %
Free cyanide Not detectable
Ferricyanide Not detectable
Lead Not more than 5 mg/kg
E 538 CALCIUM FERROCYANIDE
Synonyms Yellow prussiate of lime; Calcium hexacyanoferrate
Definition
EINECS 215-476-7 Chemical name Calcium ferrocyanide
Chemical Ca 2 Fe(CN) 6 · 12H 2 O
formula
Molecular 508,3 weight
Assay Content not less than 99,0 %
Description Yellow crystals or crystalline powder
Identification
Test for Passes test calcium
Test for Passes test ferrocyanide
Purity
Free moisture Not more than 1,0 %
Water Not more than 0,03 % insoluble matter
Chloride Not more than 0,2 %
Sulphate Not more than 0,1 %
Free cyanide Not detectable
Ferricyanide Not detectable
Lead Not more than 5 mg/kg
E 541 SODIUM ALUMINIUM PHOSPHATE, ACIDIC
Synonyms SALP
Definition
EINECS 232-090-4
Chemical name Sodium trialuminium tetradecahydrogen octaphosphate tetrahydrate (A); Trisodium dialuminium
pentadecahydrogen octaphosphate (B)
Chemical NaAl 3 H 14 (PO 4 ) 8 · 4H 2 O (A)
formula Na 3 Al 2 H 15 (PO 4 ) 8 (B)
Molecular 949,88 (A) weight 897,82 (B)
Assay Content not less than 95,0 % (both forms)
Description White odourless powder
Identification
Test for Passes test sodium
Test for Passes test aluminium
Test for Passes test phosphate
pH Acid to litmus
Solubility Insoluble in water. Soluble in hydrochloric acid
Purity
Loss on 19,5 % - 21,0 % (A) (750 °C - 800 °C, 2 hours) ignition 15 % - 16 % (B) (750 °C - 800 °C, 2 hours)
Fluoride Not more than 25 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 4 mg/kg
Cadmium Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 551 SILICON DIOXIDE
Synonyms Silica; Silicium dioxide
Definition Silicon dioxide is an amorphous substance, which is produced synthetically by either a vapour-phase
hydrolysis process, yielding fumed silica, or by a wet process, yielding precipitated silica, silica gel, or hydrous silica. Fumed silica is produced in essentially an anhydrous state, whereas the wet-process products are obtained as hydrates or contain surface absorbed water
EINECS 231-545-4
Chemical name Silicon dioxide
Chemical (SiO 2 ) n
formula
Molecular 60,08 (SiO 2 ) weight
Assay Content after ignition not less than 99,0 % (fumed silica) or 94,0 % (hydrated forms)
Description White, fluffy powder or granules. Hygroscopic
Identification
Test for silica Positive
Purity
Loss on drying Not more than 2,5 % (fumed silica, 105 °C, 2 hours)
Not more than 8,0 % (precipitated silica and silica gel,
105 °C, 2 hours)
Not more than 70 % (hydrous silica, 105 °C, 2 hours)
Loss on Not more than 2,5 % after drying (1 000 °C, fumed ignition silica)
Not more than 8,5 % after drying (1 000 °C, hydrated forms)
Soluble Not more than 5,0 % (as Na 2 SO 4 )
ionisable salts
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg
E 552 CALCIUM SILICATE
Synonyms
Definition Calcium silicate is a hydrous or anhydrous silicate with varying proportions of CaO and SiO 2 . The product
should be free of asbestos.
EINECS 215-710-8
Chemical name Calcium silicate
Chemical formula
Molecular weight
Assay Content on the anhydrous basis:
– - as SiO 2 not less than 50 % and not more than 95 %
– - as CaO not less than 3 % and not more than 35 %
Description White to off-white free-flowing powder that remains so after absorbing relatively large amounts of water or
other liquids
Identification
Test for silicate Passes test
Test for Passes test calcium
Gel formation Forms a gel with mineral acids
Purity
Loss on drying Not more than 10 % (105 °C, 2 hours)
Loss on Not less than 5 % and not more than 14 % (1 000 °C, ignition constant weight) Sodium Not more than 3 %
Fluoride Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 553a(i) MAGNESIUM SILICATE
Synonyms
Definition Magnesium silicate is a synthetic compound of which the molar ratio of magnesium oxide to silicon dioxide is approximately 2:5
EINECS
Chemical name
Chemical formula
Molecular weight
Assay Content not less than 15 % of MgO and not less than 67 % of SiO 2 on the ignited basis
Description Very fine, white, odourless powder, free from grittiness
Identification
Test for Passes test magnesium
Test for silicate Passes test
pH Between 7,0 and 10,8 (10 % slurry)
Purity
Loss on drying Not more than 15 % (105 °C, 2 hours)
Loss on Not more than 15 % after drying (1 000 °C, 20 min) ignition
Water soluble Not more than 3 % salts
Free alkali Not more than 1 % (as NaOH)
Fluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 553a(ii) MAGNESIUM TRISILICATE
Synonyms
Definition
EINECS 239-076-7
Chemical name Magnesium trisilicate
Chemical Mg 2 Si 3 O 8 · nH 2 O (approximate composition)
formula
Molecular weight
Assay Content not less than 29,0 % of MgO and not less than 65,0 % of SiO 2 both on the ignited basis
Description Fine, white powder, free from grittiness
Identification
Test for Passes test magnesium
Test for silicate Passes test
pH Between 6,3 and 9,5 (5 % slurry)
Purity
Loss on Not less than 17 % and not more than 34 % (1 000 °C)
ignition
Water soluble Not more than 2 % salts
Free alkali Not more than 1 % (as NaOH)
Fluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 553b TALC
Synonyms Talcum
Definition Naturally occurring form of hydrous magnesium silicate containing varying proportions of such
associated minerals as alpha-quartz, calcite, chlorite, dolomite, magnesite, and phlogopite. The product should be free of asbestos.
EINECS 238-877-9
Chemical name Magnesium hydrogen metasilicate
Chemical Mg 3 (Si 4 O 10 )(OH) 2
formula
Molecular 379,22 weight
Assay
Description Light, homogeneous, white or almost white powder, greasy to the touch
Identification
Infrared Characteristic peaks at 3 677, 1 018 and 669 cm -1
absorption spectrum
X-ray Peaks at 9,34/4,66/3,12 Å diffraction
Solubility Insoluble in water and ethanol
Purity
Loss on drying Not more than 0,5 % (105 °C, 1 hour)
Acid soluble Not more than 6 % matter
Water soluble Not more than 0,2 % matter
Acid-soluble Not detectable iron
Arsenic Not more than 10 mg/kg
Lead Not more than 2 mg/kg
E 554 SODIUM ALUMINIUM SILICATE
Synonyms Sodium silicoaluminate; Sodium aluminosilicate;
Aluminium sodium silicate
Definition
EINECS
Chemical name Sodium aluminium silicate
Chemical formula
Molecular weight
Assay Content on the anhydrous basis:
– as SiO 2 not less than 66,0 % and not more than 88,0 %
– as Al 2 O 3 not less than 5,0 %
and not more than 15,0 %
Description Fine white amorphous powder or beads
Identification
Test for Passes test sodium
Test for Passes test aluminium
Test for silicate Passes test
pH Between 6,5 and 11,5 (5 % slurry)
Purity
Loss on drying Not more than 8,0 % (105 °C, 2 hours)
Loss on Not less than 5,0 % and not more than 11,0 % on the ignition anhydrous basis (1 000 °C to constant weight)
Sodium Not less than 5 % and not more than 8,5 % (as Na 2 O)
on the anhydrous basis
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 555 POTASSIUM ALUMINIUM SILICATE
Synonyms Mica
Definition Natural mica consists of mainly potassium aluminium silicate (muscovite)
EINECS 310-127-6
Chemical name Potassium aluminium silicate
Chemical KAl 2 [AlSi 3 O 10 ](OH) 2 formula
Molecular 398 weight
Assay Content not less than 98 % Description Light grey to white crystalline platelets or powder
Identification
Solubility Insoluble in water, diluted acids and alkali and organic solvents
Purity
Loss on drying Not more than 0,5 % (105 °C, 2 hours)
Antimony Not more than 20 mg/kg
Zinc Not more than 25 mg/kg
Barium Not more than 25 mg/kg
Chromium Not more than 100 mg/kg
Copper Not more than 25 mg/kg
Nickel Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 2 mg/kg
Lead Not more than 5 mg/kg
E 556 CALCIUM ALUMINIUM SILICATE
Synonyms Calcium aluminosilicate; Calcium silicoaluminate;
Aluminium calcium silicate
Definition
EINECS
Chemical name Calcium aluminium silicate
Chemical formula
Molecular weight Assay Content on the anhydrous basis:
– as SiO 2 not less than 44,0 %
and not more than 50,0 %
– as Al 2 O 3 not less than 3,0 % and not more than 5,0 %
– as CaO not less than 32,0 % and not more than 38,0 %
Description Fine white, free-flowing powder
Identification
Test for Passes test calcium
Test for Passes test aluminium
Test for silicate Passes test
Purity
Loss on drying Not more than 10,0 % (105 °C, 2 hours)
Loss on Not less than 14,0 % and not more than 18,0 on the ignition anhydrous basis (1 000 °C, constant weight)
Fluoride Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 559 ALUMINIUM SILICATE (KAOLIN)
Synonyms Kaolin, light or heavy
Definition Aluminium silicate hydrous (kaolin) is a purified white plastic clay composed of kaolinite, potassium
aluminium silicate, feldspar and quartz. Processing should not include calcination. The raw kaolinitic clay used in the production of aluminium silicate shall have a level of dioxin which does not make it injurious to health or unfit for human consumption. The product should be free of asbestos
EINECS 215-286-4 (kaolinite)
Chemical name
Chemical Al 2 Si 2 O 5 (OH) 4 (kaolinite) formula
Molecular 264 weight
Assay Content not less than 90 % (sum of silica and alumina, after ignition)
Silica Betwe (SiO 2 ) en 45 % and 55 %
Alumi Betwe na en (Al 2 O 30 % 3 ) and 39 %
Description Fine, white or greyish white, unctuous powder. Kaolin is made up of loose aggregations of randomly oriented
stacks of kaolinite flakes or of individual hexagonal flakes
Identification
Test for Passes test alumina
Test for Passes test silicate
X-ray Characteristic peaks at 7,18/3,58/2,38/1,78 Å diffraction:
Infrared Peaks at 3 700 and 3 620 cm -1
absorption spectrum
Purity
Loss on Between 10 and 14 % (1 000 °C, constant weight) ignition
Water soluble Not more than 0,3 % matter
Acid soluble Not more than 2 % matter
Iron Not more than 5 %
Potassium Not more than 5 %
oxide (K 2 O)
Carbon Not more than 0,5 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 570 FATTY ACIDS
Synonyms
Definition Linear fatty acids, caprylic acid (C 8 ), capric acid (C 10 ), lauric acid (C 12 ), myristic acid (C 14 ), palmitic acid (C 16 ), stearic acid (C 18 ), oleic acid (C 18:1 )
EINECS
Chemical octanoic acid (C 8 ); decanoic acid (C 10 ); dodecanoic acid name (C 12 ); tetradecanoic acid (C 14 ); hexadecanoic acid (C 16 );
octadecanoic acid (C 18 ); 9-octadecenoic acid (C 18:1 )
Chemical formula
Molecular weight
Assay Not less than 98 % by chromatography
Description A colourless liquid or white solid obtained from oils and fats
Identification
Identification Individual fatty acids can be identified by acid value, test iodine value, gas chromatog-raphy
Purity
Residue on Not more than 0,1 % ignition
Unsaponifiabl Not more than 1,5 % e matter
Water content Not more than 0,2 % (Karl Fischer method)
Arsenic Not more than 3 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 574 GLUCONIC ACID
Synonyms D-gluconic acid; Dextronic acid
Definition Gluconic acid is an aqueous solution of gluconic acid and glucono-delta-lactone
EINECS
Chemical Gluconic acid name
Chemical C 6 H 12 O 7 (gluconic acid)
formula
Molecular 196,2 weight
Assay Content not less than 49,0 % (as gluconic acid)
Description Colourless to light yellow, clear syrupy liquid
Identification
Formation of Positive. Compound formed melts between 196 °C and
ne derivative
Purity
EN 360 EN
Residue on Not more than 1,0 % 550 °C +/- 20 °C till ignition disappearance of organic residues (black spots).
Reducing Not more than 2,0 % (as D-glucose) matter
Chloride Not more than 350 mg/kg
Sulphate Not more than 240 mg/kg
Sulphite Not more than 20 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 575 GLUCONO-DELTA-LACTONE
Synonyms Gluconolactone; GDL; D-Gluconic acid delta-lactone;
Delta-gluconolactone
Definition Glucono-delta-lactone is the cyclic 1,5-intramolecular ester of D-gluconic acid. In aqueous media it is
hydrolysed to an equilibrium mixture of D-gluconic acid (55 % - 66 %) and the delta- and gamma-lactones
EINECS 202-016-5
Chemical D-Glucono-1,5-lactone name
Chemical C 6 H 10 O 6 formula
Molecular 178,14 weight
Assay Content not less than 99,0 % on the anhydrous basis
Description Fine, white, nearly odourless, crystalline powder
Identification
Formation of Positive. Compound formed melts between 196 °C and
ne derivative
EN 361 EN
of gluconic acid
Solubility Freely soluble in water. Sparingly soluble in ethanol
Purity
Water content Not more than 0,2 % (Karl Fischer method)
Reducing Not more than 0,5 % (as D-glucose) substances
Lead Not more than 1 mg/kg
E 576 SODIUM GLUCONATE
Synonyms Sodium salt of D-gluconic acid
Definition Manufactured by fermentation or chemical catalytic oxidation
EINECS 208-407-7
Chemical Sodium D-gluconate name
Chemical C 6 H 11 NaO 7 (anhydrous) formula
Molecular 218,14 weight
Assay Content not less than 99,0 %
Description White to tan, granular to fine, crystalline powder
Identification
Test for Passes test sodium
Test for Passes test gluconate
Solubility Very soluble in water. Sparingly soluble in ethanol
pH Between 6,5 and 7,5 (10 % solution) Purity
Reducing Not more than 1,0 % (as D-glucose) matter
Lead Not more than 1 mg/kg
E 577 POTASSIUM GLUCONATE
Synonyms Potassium salt of D-gluconic acid
Definition
EINECS 206-074-2
Chemical Potassium D-gluconate name
Chemical C 6 H 11 KO 7 (anhydrous)
formula C 6 H 11 KO 7 · H 2 O (monohydrate)
Molecular 234,25 (anhydrous) weight 252,26 (monohydrate)
Assay Content not less than 97,0 % and not more than 103,0 % on dried basis
Description Odourless, free flowing white to yellowish white, crystalline powder or granules
Identification
Test for Passes test potassium
Test for Passes test gluconate
pH Between 7,0 and 8,3 (10 % solution)
Purity
Loss on Anhydrous: not more than 3,0 % (105 °C, 4 hours, drying vacuum)
Monohydrate: not less than 6 % and not more than 7,5 % (105 °C, 4 hours, vacuum)
Reducing Not more than 1,0 % (as D-glucose) substances
Lead Not more than 2 mg/kg
E 578 CALCIUM GLUCONATE
Synonyms Calcium salt of D-gluconic acid
Definition
EINECS 206-075-8
Chemical Calcium di-D-gluconate name
Chemical C 12 H 22 CaO 14 (anhydrous)
formula C 12 H 22 CaO 14 · H 2 O (monohydrate)
Molecular 430,38 (anhydrous form) weight 448,39 (monohydrate)
Assay anhydrous : Content not less than 98 % and not more than 102 % on the dried basis
monohydrate : not less than 98 % and not more than 102 % on the ”as is” basis.
Description Odourless, white crystalline granules or powder, stable in air
Identification
Test for Passes test calcium
Test for Passes test gluconate
Solubility Soluble in water, insoluble in ethanol
pH Between 6,0 and 8,0 (5 % solution)
Purity
Loss on Not more than 3,0 % (105 °C, 16 hours) (anhydrous) drying Not more than 2,0 % (105 °C, 16 hours) (monohydrate)
Reducing Not more than 1,0 % (as D-glucose) substances
Lead Not more than 2 mg/kg
E 579 FERROUS GLUCONATE
Synonyms
Definition
EINECS 206-076-3
Chemical Ferrous di-D-gluconate dihydrate; Iron(II) di-gluconate name dihydrate
Chemical C 12 H 22 FeO 14 ·2H 2 O
formula
Molecular 482,17 weight
Assay Content not less than 95 % on the dried basis
Description Pale greenish-yellow to yellowish-grey powder or granules, which may have a faint odour of burnt sugar
Identification
Solubility Soluble with slight heating in water. Practically
insoluble in ethanol
Test for Passes test ferrous ion
Formation of Positive phenylhydrazine derivative of gluconic acid
pH Between 4 and 5,5 (10 % solution)
Purity
Loss on Not more than 10 % (105 °C, 16 hours) drying
Oxalic acid Not detectable
Iron (Fe III) Not more than 2 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Reducing Not more than 0,5 % expressed as glucose substances
E 585 FERROUS LACTATE
Synonyms Iron(II) lactate; Iron(II) 2-hydroxy propanoate;
Propanoic acid, 2-hydroxy-iron(2 +) salt (2:1)
Definition
EINECS 227-608-0
Chemical Ferrous 2-hydroxy propanoate name
Chemical C 6 H 10 FeO 6 · nH 2 O (n = 2 or 3) formula
Molecular 270,02 (dihydrate) weight 288,03 (trihydrate)
Assay Content not less than 96 % on the dried basis
Description Greenish-white crystals or light green powder having a characteristic smell
Identification
Solubility Soluble in water. Practically insoluble in ethanol
Test for Passes test ferrous ion Test for Passes test lactate
pH Between 4 and 6 (2 % solution)
Purity
Loss on Not more than 18 % (100 °C, under vacuum, drying approximately 700 mm Hg)
Iron (Fe III) Not more than 0,6 %
Arsenic Not more than 3 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 586 4-HEXYLRESORCINOL
Synonyms 4-Hexyl-1,3-benzenediol; Hexylresorcinol
Definition
EINECS 205-257-4
Chemical 4-Hexylresorcinol name
Chemical C 12 H 18 O 2
formula
Molecular 197,24 weight
Assay Not less than 98 % on the dried basis (4 hours at room temperature)
Description White powder
Identification
Solubility Freely soluble in ether and acetone; very slightly
soluble in water
Nitric acid To 1 ml of a saturated solution of the sample, add 1 ml
test of nitric acid. A light red colour appears
Bromine test To 1 ml of saturated solution of the sample, add 1 ml of bromine TS. A yellow, flocculent precipitate dissolves producing a yellow solution
Purity
Melting range 62 to 67 °C
Acidity Not more than 0,05 %
Sulphated ash Not more than 0,1 %
Resorcinol Shake about 1 g of the sample with 50 ml of water for a and other few minutes, filter, and to the filtrate add 3 drops of phenols ferric chloride TS. No red or blue colour is produced
Nickel Not more than 2 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 3 mg/kg
E 620 GLUTAMIC ACID
Synonyms L-Glutamic acid; L-α-Aminoglutaric acid
Definition
EINECS 200-293-7
Chemical L-Glutamic acid; L-2-amino-pentanedioic acid name
Chemical C 5 H 9 NO 4
formula
Molecular 147,13 weight
Assay Content not less than 99,0 % and not more than 101,0 % on the anhydrous basis
Solubility Sparingly soluble in water; practically insoluble in ethanol or ether
Description White crystals or crystalline powder
Identification
Test for Passes test glutamic acid (by thin layer chromatograp hy)
Specific [α] 20 D between + 31,5° and + 32,2°
rotation (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
pH Between 3,0 and 3,5 (saturated solution)
Purity
Loss on Not more than 0,2 % (80 °C, 3 hours) drying
Sulphated ash Not more than 0,2 %
Chloride Not more than 0,2 %
Pyrrolidone Not more than 0,2 % carboxylic acid
Arsenic Not more than 2,5 mg/kg
Lead Not more than 1 mg/kg
E 621 MONOSODIUM GLUTAMATE
Synonyms Sodium glutamate; MSG
Definition
EINECS 205-538-1
Chemical Monosodium L-glutamate monohydrate name
formula
EN 369 EN
Molecular 187,13 weight
Assay Content not less than 99,0 % and not more than 101,0 % on the anhydrous basis
Solubility Freely soluble in water; practically insoluble in ethanol or ether
Description White, practically odourless crystals or crystalline powder
Identification
Test for Passes test sodium
Test for Passes test glutamic acid (by thin-layer chromatograp hy)
Specific [α] 20 D between + 24,8° and + 25,3°
rotation (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
pH Between 6,7 and 7,2 (5 % solution)
Purity
Loss on Not more than 0,5 % (98 °C, 5 hours) drying
Chloride Not more than 0,2 %
Pyrrolidone Not more than 0,2 % carboxylic acid
Lead Not more than 1 mg/kg
E 622 MONOPOTASSIUM GLUTAMATE
Synonyms Potassium glutamate; MPG
Definition
EINECS 243-094-0
Chemical Monopotassium L-glutamate monohydrate name
Chemical C 5 H 8 KNO 4 · H 2 O
formula
Molecular 203,24 weight
Assay Content not less than 99,0 % and not more than 101,0 % on the anhydrous basis
Solubility Freely soluble in water; practically insoluble in ethanol or ether
Description White, practically odourless crystals or crystalline powder
Identification
Test for Passes test potassium
Test for Passes test glutamic acid (by thin-layer chromatograp hy)
Specific [α] 20 D between + 22,5° and + 24,0°
rotation (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
pH Between 6,7 and 7,3 (2 % solution)
Purity
Loss on Not more than 0,2 % (80 °C, 5 hours) drying
Chloride Not more than 0,2 %
Pyrrolidone Not more than 0,2 % carboxylic acid
Lead Not more than 1 mg/kg
E 623 CALCIUM DIGLUTAMATE
Synonyms Calcium glutamate
Definition
EINECS 242-905-5
Chemical Monocalcium di-L-glutamate name
Chemical C 10 H 16 CaN 2 O 8 · nH 2 O (n = 0, 1, 2 or 4) formula
Molecular 332,32 (anhydrous) weight
Assay Content not less than 98,0 % and not more than 102,0 % on the anhydrous basis
Solubility Freely soluble in water; practically insoluble in ethanol or ether
Description White, practically odourless crystals or crystalline powder
Identification
Test for Passes test calcium
Test for Passes test glutamic acid (by thin-layer chromatograp hy)
Specific [α] 20 D between + 27,4° and + 29,2° (for calcium
rotation diglutamate with n = 4) (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
Purity Water content Not more than 19,0 % (for calcium diglutamate with n = 4) (Karl Fischer)
Chloride Not more than 0,2 %
Pyrrolidone Not more than 0,2 % carboxylic acid
Lead Not more than 1 mg/kg
E 624 MONOAMMONIUM GLUTAMATE
Synonyms Ammonium glutamate
Definition
EINECS 231-447-1
Chemical Monoammonium L-glutamate monohydrate name
Chemical C 5 H 12 N 2 O 4 · H 2 O
formula
Molecular 182,18 weight
Assay Content not less than 99,0 % and not more 101,0 % on
the anhydrous basis
Solubility Freely soluble in water; practically insoluble in ethanol or ether
Description White, practically odourless crystals or crystalline powder
Identification
Test for Passes test ammonium
Test for Passes test glutamic acid (by thin-layer chromatograp hy)
Specific [α] 20 D between + 25,4° and + 26,4°
rotation (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
pH Between 6,0 and 7,0 (5 % solution)
Purity
Loss on Not more than 0,5 % (50 °C, 4 hours) drying
Sulphated ash Not more than 0,1 %
Pyrrolidone Not more than 0,2 % carboxylic acid
Lead Not more than 1 mg/kg
E 625 MAGNESIUM DIGLUTAMATE
Synonyms Magnesium glutamate
Definition
EINECS 242-413-0
Chemical Monomagnesium di-L-glutamate tetrahydrate name
Chemical C 10 H 16 MgN 2 O 8 · 4H 2 O
formula
Molecular 388,62 weight
Assay Content not less than 95,0 % and not more than 105,0 % on the anhydrous basis
Solubility Very soluble in water; practically insoluble in ethanol or ether
Description Odourless, white or off-white crystals or powder
Identification Test for Passes test magnesium
Test for Passes test glutamic acid (by thin-layer chromatograp hy)
Specific [α] 20 D between + 23,8° and + 24,4°
rotation (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
pH Between 6,4 and 7,5 (10 % solution)
Purity
Water content Not more than 24 % (Karl Fischer)
Chloride Not more than 0,2 %
Pyrrolidone Not more than 0,2 % carboxylic acid
Lead Not more than 1 mg/kg
E 626 GUANYLIC ACID
Synonyms 5'-Guanylic acid
Definition
EINECS 201-598-8
Chemical Guanosine-5'-monophosphoric acid name
Chemical C 10 H 14 N 5 O 8 P formula
Molecular 363,22 weight
Assay Content not less than 97,0 % on the anhydrous basis
Solubility Slightly soluble in water, practically insoluble in ethanol Description Odourless, colourless or white crystals or white
crystalline powder
Identification
Test for Passes test ribose
Test for Passes test organic phosphate
pH Between 1,5 and 2,5 (0,25 % solution)
Spectrometry Maximum absorption of a 20 mg/l solution in 0,01N
HCl at 256 nm
Purity
Loss on Not more than 1,5 % (120 °C, 4 hours) drying
Other Not detectable by thin-layer chromatography nucleotides
Lead Not more than 1 mg/kg
E 627 DISODIUM GUANYLATE
Synonyms Sodium guanylate; Sodium 5'-guanylate
Definition
EINECS 221-849-5
Chemical Disodium guanosine-5'-monophosphate name
Chemical C 10 H 12 N 5 Na 2 O 8 P · nH 2 O (n = ca. 7) formula
Molecular 407,19 (anhydrous) weight
Assay Content not less than 97,0 % on the anhydrous basis
Solubility Soluble in water, sparingly soluble in ethanol, practically insoluble in ether
Description Odourless, colourless or white crystals or white crystalline powder
Identification
Test for Passes test ribose
Test for Passes test organic phosphate
Test for Passes test sodium
pH Between 7,0 and 8,5 (5 % solution)
Spectrometry maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm
Purity
Loss on Not more than 25 % (120 °C, 4 hours) drying
Other Not detectable by thin-layer chromatography nucleotides
Lead Not more than 1 mg/kg
E 628 DIPOTASSIUM GUANYLATE
Synonyms Potassium guanylate; Potassium 5'-guanylate
Definition
EINECS 226-914-1
Chemical Dipotassium guanosine-5'-monophosphate name
Chemical C 10 H 12 K 2 N 5 O 8 P
formula
Molecular 439,40 weight
Assay Content not less than 97,0 % on the anhydrous basis Solubility Freely soluble in water, practicaly insoluble in ethanol
Description Odourless, colourless or white crystals or white crystalline powder
Identification
Test for Passes test ribose
Test for Passes test organic phosphate
Test for Passes test potassium
pH Between 7,0 and 8,5 (5 % solution)
Spectrometry Maximum absorption of a 20 mg/l solution in 0,01N
HCl at 256 nm
Purity
Loss on Not more than 5 % (120 °C, 4 hours) drying
Other Not detectable by thin-layer chromatography nucleotides
Lead Not more than 1 mg/kg
E 629 CALCIUM GUANYLATE
Synonyms Calcium 5'-guanylate
Definition
EINECS
Chemical Calcium guanosine-5'-monophosphate name
Chemical C 10 H 12 CaN 5 O 8 P · nH 2 O formula
Molecular 401,20 (anhydrous) weight Assay Content not less than 97,0 % on the anhydrous basis
Solubility Sparingly soluble in water
Description Odourless, white or off-white crystals or powder
Identification
Test for Passes test ribose
Test for Passes test organic phosphate
Test for Passes test calcium
pH Between 7,0 and 8,0 (0,05 % solution)
Spectrometry Maximum absorption of a 20 mg/l solution in 0,01N
HCl at 256 nm
Purity
Loss on Not more than 23,0 % (120 °C, 4 hours) drying
Other Not detectable by thin-layer chromatography nucleotides
Lead Not more than 1 mg/kg
E 630 INOSINIC ACID
Synonyms 5'-Inosinic acid
Definition
EINECS 205-045-1
Chemical Inosine-5'-monophosphoric acid name
Chemical C 10 H 13 N 4 O 8 P formula
Molecular 348,21 weight
Assay Content not less than 97,0 % on the anhydrous basis
Solubility Freely soluble in water, slightly soluble in ethanol
Description Odourless, colourless or white crystals or powder
Identification
Test for Passes test ribose
Test for Passes test organic phosphate
pH Between 1,0 and 2,0 (5 % solution)
Spectrometry Maximum absorption of a 20 mg/l solution in 0,01N
HCl at 250 nm
Purity
Loss on Not more than 3,0 % (120 °C, 4 hours) drying
Other Not detectable by thin-layer chromatography nucleotides
Lead Not more than 1 mg/kg
E 631 DISODIUM INOSINATE
Synonyms Sodium inosinate; Sodium 5'-inosinate
Definition
EINECS 225-146-4
Chemical Disodium inosine-5'-monophosphate name
Chemical C 10 H 11 N 4 Na 2 O 8 P · H 2 O formula
Molecular 392,17 (anhydrous) weight Assay Content not less than 97,0 % on the anhydrous basis
Solubility Soluble in water, sparingly soluble in ethanol, practically insoluble in ether
Description Odourless, colourless or white crystals or powder
Identification
Test for Passes test ribose
Test for Passes test organic phosphate
Test for Passes test sodium
pH Between 7,0 and 8,5
Spectrometry Maximum absorption of a 20 mg/l solution in 0,01N
HCl at 250 nm
Purity
Water content Not more than 28,5 % (Karl Fischer)
Other Not detectable by thin-layer chromatography nucleotides
Lead Not more than 1 mg/kg
E 632 DIPOTASSIUM INOSINATE
Synonyms Potassium inosinate; Potassium 5'-inosinate
Definition
EINECS 243-652-3
Chemical Dipotassium inosine-5'-monophosphate name
Chemical C 10 H 11 K 2 N 4 O 8 P formula
Molecular 424,39 weight
Assay Content not less than 97,0 % on the anhydrous basis
Solubility Freely soluble in water; practically insoluble in ethanol
Description Odourless, colourless or white crystals or powder
Identification
Test for Passes test ribose
Test for Passes test organic phosphate
Test for Passes test potassium
pH Between 7,0 and 8,5 (5 % solution)
Spectrometry Maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm
Purity
Water content Not more than 10,0 % (Karl Fischer)
Other Not detectable by thin-layer chromatography nucleotides
Lead Not more than 1 mg/kg
E 633 CALCIUM INOSINATE
Synonyms Calcium 5'-inosinate
Definition
EINECS
Chemical Calcium inosine-5'-monophosphate name
formula
EN 382 EN
Molecular 386,19 (anhydrous) weight
Assay Content not less than 97,0 % on the anhydrous basis
Solubility Sparingy soluble in water
Description Odourless, colourless or white crystals or powder
Identification
Test for Passes test ribose
Test for Passes test organic phosphate
Test for Passes test calcium
pH Between 7,0 and 8,0 (0,05 % solution)
Spectrometry Maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm
Purity
Water content Not more than 23,0 % (Karl Fischer)
Other Not detectable by thin-layer chromatography nucleotides
Lead Not more than 1 mg/kg
E 634 CALCIUM 5'-RIBONUCLEOTIDE
Synonyms
Definition
EINECS
Chemical Calcium 5'-ribonucleotide is essentially a mixture of name calcium inosine-5'-monophosphate and calcium guanosine-5'-monophosphate
EN 383 EN
formula C 10 H 12 N 5 CaO 8 P · nH 2 O
Molecular weight
Assay Content of both major components not less than 97,0 %, and of each component not less than 47,0 % and not
more than 53 %, in every case on the anhydrous basis
Solubility Sparingly soluble in water
Description Odourless, white or nearly white crystals or powder
Identification
Test for Passes test ribose
Test for Passes test organic phosphate
Test for Passes test calcium
pH Between 7,0 and 8,0 (0,05 % solution)
Purity
Water content Not more than 23,0 % (Karl Fischer)
Other Not detectable by thin-layer chromatography nucleotides
Lead Not more than 1 mg/kg
E 635 DISODIUM 5'-RIBONUCLEOTIDE
Synonyms Sodium 5'-ribonucleotide
Definition
EINECS
Chemical Disodium 5'-ribonucleotide is essentially a mixture of name disodium inosine-5'-monophosphate and disodium guanosine-5'-monophosphate Chemical C 10 H 11 N 4 O 8 P · nH 2 O formula
C 10 H 12 N 5 Na 2 O 8 P · nH 2 O
Molecular weight
Assay Content of both major components not less than 97,0 %, and of each component not less than 47,0 % and not
more than 53 %, in every case on the anhydrous basis
Solubility Soluble in water, sparingy solyble in ethanol practically
insoluble in ether
Description Odourless, white or nearly white crystals or powder
Identification
Test for Passes test ribose
Test for Passes test organic phosphate
Test for Passes test sodium
pH Between 7,0 and 8,5 (5 % solution)
Purity
Water content Not more than 26,0 % (Karl Fischer)
Other Not detectable by thin-layer chromatography nucleotides
Lead Not more than 1 mg/kg
E 640 GLYCINE AND ITS SODIUM SALT
(I) GLYCINE
Synonyms Aminoacetic acid; Glycocoll
Definition
EINECS 200-272-2
Chemical Aminoacetic acid name
Chemical C 2 H 5 NO 2 formula
Molecular 75,07 weight
Assay Content not less than 98,5 % on the anhydrous basis
Description White crystals or crystalline powder
Identification
Test for Passes test amino acid
Purity
Loss on Not more than 0,2 % (105 °C, 3 hours) drying
Residue on Not more than 0,1 % ignition
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
(II) SODIUM GLYCINATE
Synonyms
Definition
EINECS 227-842-3
Chemical Sodium glycinate name
Chemical C 2 H 5 NO 2 Na formula
weight
EN 386 EN
Assay Content not less than 98,5 % on the anhydrous basis
Description White crystals or crystalline powder
Identification
Test for Passes test amino acid
Test for Passes test sodium
Purity
Loss on Not more than 0,2 % (105 °C, 3 hours) drying
Residue on Not more than 0,1 % ignition
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 650 ZINC ACETATE
Synonyms Acetic acid, zinc salt, dihydrate
Definition
EINECS
Chemical Zinc acetate dihydrate name
Chemical C 4 H 6 O 4 Zn · 2H 2 O formula
Molecular 219,51 weight
Assay Content not less than 98 % and not more than 102 % of
C 4 H 6 O 4 Zn · 2H 2 O
Description Colourless crystals or fine, off-white powder
Identification
Test for Passes test acetate
Test for zinc Passes test
pH Between 6,0 and 8,0 (5 % solution)
Purity
Water Not more than 0,005 % insoluble matter
Chlorides Not more than 50 mg/kg
Sulphates Not more than 100 mg/kg
Alkalines and Not more than 0,2 % alkaline earths
Organic Passes test volatile impurities
Iron Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 20 mg/kg
Cadmium Not more than 5 mg/kg
E 900 DIMETHYL POLYSILOXANE
Synonyms Polydimethyl siloxane; Silicone fluid; Silicone oil;
Dimethyl silicone
Definition Dimethylpolysiloxane is a mixture of fully methylated linear siloxane polymers containing repeating units of
the formula (CH 3 ) 2 SiO and stabilised with trimethylsiloxy end-blocking units of the formula (CH 3 ) 3
SiO
EINECS
Chemical Siloxanes and silicones, di-methyl name Chemical (CH 3 ) 3 -Si-[O-Si(CH 3 ) 2 ] n -O-Si(CH 3 ) 3 formula
Molecular weight
Assay Content of total silicon not less than 37,3 % and not
more than 38,5 %
Description Clear, colourless, viscous liquid
Identification
Specific Between 0,964 and 0,977 gravity (25° C/25 °C)
Refractive [n] 25 D between 1,400 and 1,405
index
Infrared The infrared absorption spectrum of a liquid film of the absorption sample between two sodium chloride plates exhibits spectrum relative maxima at the same wavelengths as those of a similar preparation of Dimethylpolysiloxane Reference Standard
Purity
Loss on Not more than 0,5 % (150 °C, 4h) drying
Viscosity Not less than 1,00 · 10 -4 m 2 s -1 at 25 °C
Arsenic Not more than 3 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 901 BEESWAX, WHITE AND YELLOW
Synonyms White wax; Yellow wax
Definition Yellow bees wax is the wax obtained by melting the walls of the honeycomb made by the honey bee, Apis mellifera L., with hot water and removing foreign matter
White beeswax is obtained by bleaching yellow beeswax EINECS 232-383-7
Chemical name
Chemical formula
Molecular weight
Assay
Description Yellowish white (white form) or yellowish to greyish brown (yellow form) pieces or plates with a fine-grained and non-crystalline fracture, having an agreeable, honeylike odour
Identification
Melting range Between 62 °C and 65 °C
Specific About 0,96 gravity
Solubility Insoluble in water, sparingly soluble in alcohol, very soluble in chloroform and ether
Purity
Acid value Not less than 17 and not more than 24
Saponificatio 87-104 n value
Peroxide Not more than 5 value
Glycerol and Not more than 0,5 % (as glycerol) other polyols
Ceresin, Transfer 3.0 g of the sample to a 100 ml round-bottomed paraffins and flask, add 30 ml of a 4% w/v solution of potassium certain other hydroxide in aldehyde-free ethanol and boil gently under waxes a reflux condenser for 2 h. Remove the condenser and immediately insert a thermometer. Place the flask in
water at 80 o C and allow to cool, swirling the solution
continuously. No precipitate is formed before the
temperature reaches 65 o C, although the solution may be
opalescent.
Fats, Japan Boil 1 g of the sample for 30 min with 35 ml of a 1 in 7 wax, rosin solution of sodium hydroxide, maintaining the volume and soaps by the occasional addition of water, and cool the mixture. The wax separates and the liquid remains clear. Filter the cold mixture and acidify the filtrate with hydrochloric acid. No precipitate is formed.
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 902 CANDELILLA WAX
Synonyms
Definition Candelilla wax is a purified wax obtained from the leaves of the candelilla plant, Euphorbia antisyphilitica
EINECS 232-347-0
Chemical name
Chemical formula
Molecular weight
Assay
Description Hard, yellowish brown, opaque to translucent wax
Identification
Specific About 0,98 gravity
Melting range Between 68,5 °C and 72,5 °C
Solubility Insoluble in water, soluble in chloroform and toluene
Purity
Acid value Not less than 12 and not more than 22 Saponificatio Not less than 43 and not more than 65 n value
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 903 CARNAUBA WAX
Synonyms
Definition Carnauba wax is a purified wax obtained from the leaf buds and leaves of the Brazilian Mart wax palm,
Copernicia cerifera
EINECS 232-399-4
Chemical name
Chemical formula
Molecular weight
Assay
Description Light brown to pale yellow powder or flakes or hard and brittle solid with a resinous fracture
Identification
Specific About 0,997 gravity
Melting range Between 82 °C and 86 °C
Solubility Insoluble in water, partly soluble in boiling ethanol, soluble in chloroform and diethyl ether
Purity
Sulphated ash Not more than 0,25 %
Acid value Not less than 2 and not more than 7 Ester value Not less than 71 and not more than 88
Unsaponifiabl Not less than 50 % and not more than 55 % e matter
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 904 SHELLAC
Synonyms Bleached shellac; White shellac
Definition Shellac is the purified and bleached lac, the resinous secretion of the insect Laccifer (Tachardia) lacca Kerr (Fam. Coccidae)
EINECS 232-549-9
Chemical name
Chemical formula
Molecular weight
Assay
Description Bleached shellac — off-white, amorphous, granular resin
Wax-free bleached shellac — light yellow, amorphous,
granular resin
Identification
Solubility Insoluble in water; freely (though very slowly) soluble in alcohol; slightly soluble in acetone
Acid value Between 60 and 89
Purity
Loss on Not more than 6,0 % (40 °C, over silica gel, 15 hours) drying
Rosin Absent
Wax Bleached shellac: not more than 5,5 %
Wax-free bleached shellac: not more than 0,2 %
Lead Not more than 2 mg/kg
E 905 MICROCRYSTALLINE WAX
Synonyms Petroleum wax; Hydrocarbon wax; Fischer-Tropsch wax; Synthetic wax; Synthetic paraffin
Definition Refined mixtures of solid, saturated hydrocarbons, obtained from petroleum or synthetic feedstocks
Description White to amber, odourless wax
Identification
Solubility Insoluble in water, very slightly soluble in ethanol
Refractive [n] 100 D 1,434-1,448
Index
Alternative [n] 120 D 1,426-1,440
Purity
Molecular Average not less than 500 weight
Viscosity Not less than 1,1 x 10 -5 2 m s -1 at 100 °C
Alternative: Not less than 0,8 x 10 -5 2 m s -1 at 120 °C, if
solid at 100 °C
Residue on Not more than 0,1 % ignition
Carbon Not more than 5 % of molecules with carbon number number at less than 25 5 % distillation point
Colour Passes test Sulphur Not more than 0,4 wt %
Arsenic Not more than 3 mg/kg
Lead Not more than 3 mg/kg
Polycyclic Benzo(a)pyrene no more than 50 µg/kg aromatic compounds
E 907 HYDROGENATED POLY-1-DECENE
Synonyms Hydrogenated polydec-1-ene; Hydrogenated poly-alphaolefin
Definition
EINECS
Chemical name
Chemical C 10n H 20n+2 where n = 3 - 6
formula
Molecular 560 (average) weight
Assay Not less than 98,5% of hydrogenated poly-1-decene, having the following oligomer distribution:
C 30 : 13 – 37 %
C 40 : 35 – 70 %
C 50 : 9 – 25 %
C 60 : 1 – 7 %
Description
Identification
Solubility Insoluble in water; slightly soluble in ethanol; soluble in toluene
Burning Burns with a bright flame and a paraffin-like
characteristic smell
Viscosity Between 5,7 x 10 -6 and 6,1 x 10 -6 m 2 s -1 at 100 °C
Purity
Compounds Not more than 1,5 % with carbon number less than 30
Readily After 10 minutes shaking in a boiling water bath, a tube
carbonisable of sulphuric acid with a 5 g sample of hydrogenated
substances poly-1-decene is not darker than a very slight straw
colour
Nickel Not more than 1 mg/kg
Lead Not more than 1 mg/kg
E 912 MONTAN ACID ESTERS
Synonyms
Definition Montan acids and/or esters with ethylene glycol and/or 1,3-butanediol and/or glycerol
EINECS
Chemical Montan acid esters name
Chemical formula
Molecular weight
Assay
Description Almost white to yellowish flakes, powder, granules or pellets
Identification
Density Between 0,98 and 1,05 (20 °C)
Drop point Greater than 77 °C
Purity
Acid value Not more than 40
Glycerol Not more than 1 % (by gas chromatography)
Other polyols Not more than 1 % (by gas chromatography)
Other wax Not detectable (by differential scanning calorimetry
types and/or infrared spectroscopy)
Arsenic Not more than 2 mg/kg
Chromium Not more than 3 mg/kg
Lead Not more than 2 mg/kg
E 914 OXIDISED POLYETHYLENE WAX
Synonyms
Definition Polar reaction products from mild oxidation of polyethylene
EINECS
Chemical Oxidised polyethylene name
Chemical formula
Molecular weight
Assay
Description Almost white flakes, powder, granules or pellets
Identification
Density Between 0,92 and 1,05 (20 °C)
Drop point Greater than 95 °C
Purity
Acid value Not more than 70
Viscosity Not less than 8,1 · 10 -5 m 2 s -1 at 120 °C
Other wax Not detectable (by differential scanning calorimetry types and/or infrared spectroscopy)
Oxygen Not more than 9,5 %
Chromium Not more than 5 mg/kg
Lead Not more than 2 mg/kg
E 920 L-CYSTEINE
Synonyms
Definition L-cysteine hydrochloride or hydrochloride monohydrate. Human hair may not be used as a source for this
substance
EINECS 200-157-7 (anhydrous)
Chemical name
Chemical C 3 H 7 NO 2 S · HCl · nH 2 O (where n = 0 or 1) formula
Molecular 157,62 (anhydrous) weight
Assay Content not less than 98,0 % and not more than 101,5 % on the anhydrous basis
Description White powder or colourless crystals
Identification
Solubility Freely soluble in water and in ethanol
Melting range Anhydrous form melts at about 175 °C
Specific [α] 20 D : between + 5,0° and + 8,0° or
rotation
[α] 25 D : between + 4,9° and 7,9°
Purity
Loss on Between 8,0 % and 12,0 %
drying Not more than 2,0 % (anhydrous form)
Residue on Not more than 0,1 % ignition
Ammonium Not more than 200 mg/kg ion
Arsenic Not more than 1,5 mg/kg
Lead Not more than 5 mg/kg
E 927b CARBAMIDE
Synonyms Urea
Definition
EINECS 200-315-5
Chemical name
Chemical CH 4 N 2 O
formula
Molecular 60,06 weight
Assay Content not less than 99,0 % on the anhydrous basis
Description Colourless to white, prismatic, crystalline powder or small, white pellets
Identification
Solubility Very soluble in water
Soluble in ethanol
Precipitation To pass the test a white, crystalline precipitate is formed
with nitric
acid
Colour To pass the test a reddish-violet colour is produced reaction
Melting range 132 °C to 135 °C Purity
Loss on Not more than 1,0 % (105 °C, 1 hour) drying
Sulphated ash Not more than 0,1 %
Ethanol Not more than 0,04 % insoluble matter
Alkalinity Passes test
Ammonium Not more than 500 mg/kg ion
Biuret Not more than 0,1 %
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
E 938 ARGON
Synonyms
Definition
EINECS 231-147-0
Chemical Argon name
Chemical Ar formula
Atomic 40 weight
Assay Not less than 99 %
Description Colourless, odourless, non-flammable gas
Identification
Purity
Water content Not more than 0,05 %
Methane and Not more than 100 µl/l (calculated as methane)
other
hydrocarbons
E 939 HELIUM
Synonyms
Definition
EINECS 231-168-5
Chemical Helium name
Chemical He formula
Atomic 4 weight
Assay Not less than 99 %
Description Colourless, odourless, non-flammable gas
Identification
Purity
Water content Not more than 0,05 %
Methane and Not more than 100 µl/l (calculated as methane)
other
hydrocarbons
E 941 NITROGEN
Synonyms
Definition
EINECS 231-783-9 Chemical Nitrogen name
Chemical N 2 formula
Molecular 28 weight
Assay Not less than 99 %
Description Colourless, odourless, non-flammable gas
Identification
Purity
Water content Not more than 0,05 %
Carbon Not more than 10 µl/l monoxide
Methane and Not more than 100 µl/l (calculated as methane) other hydrocarbons
Nitrogen Not more than 10 µl/l dioxide and nitrogen oxide
Oxygen Not more than 1 %
E 942 NITROUS OXIDE
Synonyms
Definition
EINECS 233-032-0
Chemical Nitrous oxide name
Chemical N 2 O
formula
EN 402 EN
weight
Assay Not less than 99 %
Description Colourless, non-flammable gas, sweetish odour
Identification
Purity
Water content Not more than 0,05 %
Carbon Not more than 30 µl/l monoxide
Nitrogen Not more than 10 µl/l dioxide and nitrogen oxide
E 943a BUTANE
Synonyms n-Butane
Definition
EINECS
Chemical Butane name
Chemical CH 3 CH 2 CH 2 CH 3 formula
Molecular 58,12 weight
Assay Content not less than 96 %
Description Colourless gas or liquid with mild, characteristic odour
Identification
Vapour 108,935 kPa at 20 °C pressure
Purity
Methane Not more than 0,15 % v/v Ethane Not more than 0,5 % v/v
Propane Not more than 1,5 % v/v
Isobutane Not more than 3,0 % v/v
1,3-butadiene Not more than 0,1 % v/v
Moisture Not more than 0,005 %
E 943b ISOBUTANE
Synonyms 2-Methyl propane
Definition
EINECS
Chemical 2-methyl propane name
Chemical (CH 3 ) 2 CH CH 3 formula
Molecular 58,12 weight
Assay Content not less than 94 %
Description Colourless gas or liquid with mild, characteristic odour
Identification
Vapour 205,465 kPa at 20 °C pressure
Purity
Methane Not more than 0,15 % v/v
Ethane Not more than 0,5 % v/v
Propane Not more than 2,0 % v/v
n-Butane Not more than 4,0 % v/v
1,3-butadiene Not more than 0,1 % v/v
Moisture Not more than 0,005 % E 944 PROPANE
Synonyms
Definition
EINECS
Chemical Propane name
Chemical CH 3 CH 2 CH 3 formula
Molecular 44,09 weight
Assay Content not less than 95 %
Description Colourless gas or liquid with mild, characteristic odour
Identification
Vapour 732,910 kPa at 20 °C pressure
Purity
Methane Not more than 0,15 % v/v
Ethane Not more than 1,5 % v/v
Isobutane Not more than 2,0 % v/v
n-Butane Not more than 1,0 % v/v
1,3-butadiene Not more than 0,1 % v/v
Moisture Not more than 0,005 %
E 948 OXYGEN
Synonyms
Definition
EINECS 231-956-9
Chemical Oxygen name Chemical O 2 formula
Molecular 32 weight
Assay Not less than 99 %
Description Colourless, odourless, non-flammable gas
Identification
Purity
Water content Not more than 0,05 %
Methane and Not more than 100 µl/l (calculated as methane)
other
hydrocarbons
E 949 HYDROGEN
Synonyms
Definition
EINECS 215-605-7
Chemical Hydrogen name
Chemical H 2
formula
Molecular 2 weight
Assay Content not less than 99,9 %
Description Colourless, odourless, highly flammable gas
Identification
Purity
Water content Not more than 0,005 % v/v
Oxygen Not more than 0,001 % v/v Nitrogen Not more than 0,07 % v/v
E 950 ACESULFAME K
Synonyms Acesulfame potassium; Potassium salt of 3,4-dihydro-6- methyl-1,2,3-oxathiazin-4-one-2,2-dioxide
Definition
EINECS 259-715-3
Chemical 6-methyl-1,2,3-oxathiazin-4(3H)-one-2,2-dioxide name potassium salt
Chemical C 4 H 4 KNO 4 S
formula
Molecular 201,24 weight
Assay Content not less than 99 % of C 4 H 4 KNO 4 S on the
anhydrous basis
Description Odourless, white, crystalline powder. Approximately 200 times as sweet as sucrose
Identification
Solubility Very soluble in water, very slightly soluble in ethanol
Ultraviolet Maximum 227 ± 2 nm for a solution of 10 mg in absorption 1 000 ml of water
Test for Passes test (test the residue obtained by igniting 2 g of potassium the sample)
Precipitatio Add a few drops of a 10 % solution of sodium n test cobaltnitrite to a solution of 0,2 g of the sample in 2 ml of acetic acid and 2 ml of water. A yellow precipitate is produced
Purity
Loss on Not more than 1 % (105 °C, 2 hours) drying
Organic Passes test for 20 mg/kg of UV active components impurities Fluoride Not more than 3 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 951 ASPARTAME
Synonyms Aspartyl phenylalanine methyl ester
Definition
EINECS 245-261-3
Chemical N-L-α-Aspartyl-L-phenylalanine-1-methyl ester, 3- name amino-N-(α-carbomethoxy-phenethyl)-succinamic acid N-methyl ester
Chemical C 14 H 18 N 2 O 5
formula
Molecular 294,31 weight
Assay Not less than 98 % and not more than 102 % of C 14 H 18 N 2 O 5 on the anhydrous basis
Description White, odourless, crystalline powder having a sweet taste. Approximately 200 times as sweet as sucrose
Identification
Solubility Slightly soluble in water and in ethanol
pH Between 4,5 and 6,0 (1 in 125 solution)
Specific [α] 20 D : + 14,5° to + 16,5°
rotation Determine in a 4 in 100/15 N formic acid solution within 30 minutes after preparation of the sample solution
Purity
Loss on Not more than 4,5 % (105 °C, 4 hours) drying
Sulphated Not more than 0,2 % (expressed on dry weight basis) ash
Transmittan The transmittance of a 1 % solution in 2N hydrochloric ce acid, determined in a 1-cm cell at 430 nm with a suitable spectrophotometer, using 2N hydrochloric acid as a reference, is not less than 0,95, equivalent to an absorbance of not more than approximately 0,022
Arsenic Not more than 3 mg/kg (expressed on dry weight basis)
Lead Not more than 1 mg/kg (expressed on dry weight basis)
5-Benzyl Not more than 1,5 % (expressed on dry weight basis) 3,6-dioxo 2- piperazinea cetic acid
E 952 CYCLAMIC ACID AND ITS Na AND Ca SALTS
(I) CYCLAMIC ACID
Synonyms Cyclohexylsulphamic acid; Cyclamate
Definition
EINECS 202-898-1
Chemical Cyclohexanesulphamic acid; cyclohexylaminosulphonic
name acid
Chemical C 6 H 13 NO 3 S formula
Molecular 179,24 weight
Assay Cyclohexylsulphamic acid contains not less than 98 % and not more than the equivalent of 102 % of
C 6 H 13 NO 3 S, calculated on the anhydrous basis
Description A practically colourless, white crystalline powder.
Approximately 40 times as sweet as sucrose
Identification
Solubility Soluble in water and in ethanol Precipitatio Acidify a 2 % solution with hydrochloric acid, add 1 ml n test of an approximately molar solution of barium chloride in water and filter if any haze or precipitate forms. To the clear solution add 1 ml of a 10 % solution of sodium nitrite. A white precipitate forms.
Purity
Loss on Not more than 1 % (105 °C, 1 hour) drying
Selenium Not more than 30 mg/kg (expressed as selenium on dry weight basis)
Lead Not more than 1 mg/kg (expressed on dry weight basis)
Arsenic Not more than 3 mg/kg (expressed on dry weight basis)
Cyclohexyl Not more than 10 mg/kg (expressed on dry weight amine basis)
Dicyclohex Not more than 1 mg/kg (expressed on dry weight basis) ylamine
Aniline Not more than 1 mg/kg (expressed on dry weight basis)
(II) SODIUM
CYCLAMATE
Synonyms Cyclamate; Sodium salt of cyclamic acid
Definition
EINECS 205-348-9
Chemical Sodium cyclohexanesulphamate, sodium name cyclohexylsulphamate
Chemical C 6 H 12 NNaO 3 S and the dihydrate form formula C 6 H 12 NNaO 3 S·2H 2 O
Molecular 201,22 calculated on the anhydrous form weight 237,22 calculated on the hydrated form
Assay Not less than 98 % and not more than 102 % on the dried basis
Dihydrate form: not less than 84 % on the dried basis Description White, odourless crystals or crystalline powder.
Approximately 30 times as sweet as sucrose
Identification
Solubility Soluble in water, practically insoluble in ethanol
Purity
Loss on Not more than 1 % (105 °C, 1 hour) drying Not more than 15,2 % (105 °C, 2 hours) for the dihydrate form
Selenium Not more than 30 mg/kg (expressed as selenium on dry weight basis)
Arsenic Not more than 3 mg/kg (expressed on dry weight basis)
Lead Not more than 1 mg/kg (expressed on dry weight basis)
Cyclohexyl Not more than 10 mg/kg (expressed on dry weight amine basis)
Dicyclohex Not more than 1 mg/kg (expressed on dry weight basis)
ylamine
Aniline Not more than 1 mg/kg (expressed on dry weight basis)
(III) CALCIUM
CYCLAMATE
Synonyms Cyclamate; Calcium salt of cyclamic acid
Definition
EINECS 205-349-4
Chemical Calcium cyclohexanesulphamate, calcium name cyclohexylsulphamate
Chemical C 12 H 24 CaN 2 O 6 S 2 · 2H 2 O formula
Molecular 432,57 weight
Assay Not less than 98 % and not more than 101 % on the dried basis
Description White, colourless crystals or crystalline powder.
Approximately 30 times as sweet as sucrose
Identification
Solubility Soluble in water, sparingly soluble in ethanol
Purity
Loss on Not more than 1 % (105 °C, 1 hour) drying Not more than 8,5 % (140 °C, 4 hours) for the dihydrate form
Selenium Not more than 30 mg/kg (expressed as selenium on dry weight basis)
Arsenic Not more than 3 mg/kg (expressed on dry weight basis)
Lead Not more than 1 mg/kg (expressed on dry weight basis)
Cyclohexyl Not more than 10 mg/kg (expressed on dry weight amine basis)
Dicyclohex Not more than 1 mg/kg (expressed on dry weight basis) ylamine
Aniline Not more than 1 mg/kg (expressed on dry weight basis)
E 953 ISOMALT
Synonyms Hydrogenated isomaltulose.
Manufactured by enzymatic conversion of sucrose Definition with nonviable cells of Protaminobacter rubrum
followed by catalytic hydrogenation
EINECS
Chemical Isomalt is a mixture of hydrogenated mono- and name disaccharides whose principal components are the disaccharides:
6-O-α-D-Glucopyranosyl-D-sorbitol (1,6-GPS) and
1-O-α-D-Glucopyranosyl-D-mannitol dihydrate (1,1- GPM)
Chemical 6-O-α-D-Glucopyranosyl-D-sorbitol: C 12 H 24 O 11 formula 1-O-α-D-Glucopyranosyl-D-mannitol dihydrate: C 12 H 24 O 11 .2H 2 O
Molecular 6-O-α-D-Glucopyranosyl-D-sorbitol: 344,3 weight 1-O-α-D-Glucopyranosyl-D-mannitol dihydrate: 380,3
Assay Content not less than 98 % of hydrogenated mono- and disaccharides and not less than 86 % of the mixture of 6-O-α-D-Glucopyranosyl-D-sorbitol and 1-O-α-D-
Glucopyranosyl-D-mannitol dihydrate determined on the anhydrous basis.
Description Odourless, white, slightly hygroscopic, crystalline mass.
Identification
Solubility Soluble in water, very slightly soluble in ethanol.
HPLC test Comparison with an appropriate reference standard of Isomalt shows that the 2 principal peaks in the
chromatogram of the test solution are similar in retention time to the 2 principal peaks in the chromatogram obtained with the reference solution.
Purity
Water Not more than 7 % (Karl Fischer Method) content
Sulphated ash Not more than 0,05 % (expressed on dry weight basis)
D-Mannitol Not more than 3 %
D-Sorbitol Not more than 6 %
Reducing sugars Not more than 0,3 % (expressed as glucose on dry weight basis)
Nickel Not more than 2 mg/kg (expressed on dry weight basis)
Arsenic Not more than 3 mg/kg (expressed on dry weight basis)
Lead Not more than 1 mg/kg (expressed on dry weight basis)
E 954 SACCHARIN AND ITS Na. K AND Ca SALTS
(I) SACCHARIN
Synonyms
Definition
EINECS 201-321-0
Chemical 3-Oxo-2,3dihydrobenzo(d)isothiazol-1,1-dioxide name
Chemical C 7 H 5 NO 3 S formula
Molecular 183,18 weight
Assay Not less than 99 % and not more than 101 % of C 7 H 5 NO 3 S on the anhydrous basis
Description White crystals or a white crystalline powder, odourless or with a faint, aromatic odour. Approximately between 300 and 500 times as sweet as sucrose
Identification
Solubility Slightly soluble in water, soluble in basic solutions, sparingly soluble in ethanol
Purity
Loss on Not more than 1 % (105°C, 2 hours) drying
Melting 226 to 230°C range
Sulphated Not more than 0,2 % (expressed on dry weight basis) ash
Benzoic To 10 ml of a 1 in 20 solution, previously acidified with
and five drops of acetic acid, add three drops of an
salicylic approximately molar solution of ferric chloride in
acid water. No precipitate or violet colour appears
o- Not more than 10 mg/kg (expressed on dry weight Toluenesul basis) phonamide
p- Not more than 10 mg/kg (expressed on dry weight Toluenesul phonamide basis)
Benzoic Not more than 25 mg/kg (expressed on dry weight acid p- basis) sulphonami de
Readily Absent carbonisabl e substances
Arsenic Not more than 3 mg/kg (expressed on dry weight basis)
Selenium Not more than 30 mg/kg (expressed on dry weight basis)
Lead Not more than 1 mg/kg (expressed on dry weight basis)
(II) SODIUM
SACCHARIN
Synonyms Saccharin; Sodium salt of saccharin
Definition
EINECS 204-886-1
Chemical Sodium o-benzosulphimide; sodium salt of 2,3-dihydroname 3-oxobenzisosulphonazole; oxobenzisosulphonazole; 1,2-benzisothiazolin-3-one-1, 1-dioxide sodium salt dihydrate
Chemical C 7 H 4 NNaO 3 S·2H 2 O formula
Molecular 241,19 weight
Assay Not less than 99 % and not more than 101 % of
C 7 H 4 NNaO 3 S on the anhydrous basis
Description White crystals or a white crystalline efflorescent powder, odourless or with a faint odour. Approximately between 300 and 500 times as sweet as sucrose in dilute solutions
Identification
Solubility Freely soluble in water, sparingly soluble in ethanol Purity
Loss on Not more than 15 % (120°C, 4 hours) drying
Benzoic To 10 ml of a 1 in 20 solution, previously acidified with and five drops of acetic acid, add three drops of an salicylic approximately molar solution of ferric chloride in acid water. No precipitate or violet colour appears
o- Not more than 10 mg/kg (expressed on dry weight Toluenesul basis) phonamide
p- Not more than 10 mg/kg (expressed on dry weight Toluenesul basis) phonamide
Benzoic Not more than 25 mg/kg (expressed on dry weight acid pbasis) sulphonami de
Readily Absent carbonisabl e substances
Arsenic Not more than 3 mg/kg (expressed on dry weight basis)
Selenium Not more than 30 mg/kg (expressed on dry weight basis)
Lead Not more than 1 mg/kg (expressed on dry weight basis)
(III) CALCIUM SACCHARIN
Synonyms Saccharin; Calcium salt of saccharin
Definition
Chemical Calcium o-benzosulphimide; calcium salt of 2,3- name dihydro-3-oxobenzisosulphonazole; 1,2- benzisothiazolin-3-one-1,1-dioxide calcium salt hydrate (2:7)
EINECS 229-349-9
EN 416 EN
formula
Molecular 467,48 weight
Assay Not less than 95 % of C 14 H 8 CaN 2 O 6 S 2 on the anhydrous basis
Description White crystals or a white crystalline powder, odourless or with a faint odour. Approximately between 300 and 500 times as sweet as sucrose in dilute solutions
Identification
Solubility Freely soluble in water, soluble in ethanol
Purity
Loss on Not more than 13,5 % (120°C, 4 hours) drying
Benzoic To 10 ml of a 1 in 20 solution, previously acidified with and five drops of acetic acid, add three drops of an salicylic approximately molar solution of ferric chloride in acid water. No precipitate or violet colour appears
o- Not more than 10 mg/kg expressed (on dry weight Toluenesul basis) phonamide
p- Not more than 10 mg/kg expressed (on dry weight Toluenesul basis) phonamide
Benzoic Not more than 25 mg/kg expressed (on dry weight acid pbasis) sulphonami de
Readily Absent carbonisabl e substances
Arsenic Not more than 3 mg/kg (expressed on dry weight basis)
Selenium Not more than 30 mg/kg (expressed on dry weight basis)
Lead Not more than 1 mg/kg (expressed on dry weight basis) (IV) POTASSIUM
SACCHARIN
Synonyms Saccharin; Potassium salt of saccharin
Definition
EINECS
Chemical Potassium o-benzosulphimide; potassium salt of 2,3- name dihydro-3-oxobenzisosulphonazole; potassium salt of 1,2-benzisothiazolin-3-one-1,1-dioxide monohydrate
Chemical C 7 H 4 KNO 3 S·H 2 O formula
Molecular 239,77 weight
Assay Not less than 99 % and not more than 101 % of
C 7 H 4 KNO 3 S on the anhydrous basis
Description White crystals or a white crystalline powder, odourless or with a faint odour, having an intensely sweet taste,
even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose
Identification
Solubility Freely soluble in water, sparingly soluble in ethanol
Purity
Loss on Not more than 8 % (120°C, 4 hours) drying
Benzoic To 10 ml of a 1 in 20 solution, previously acidified with
and five drops of acetic acid, add three drops of an
salicylic approximately molar solution of ferric chloride in
acid water. No precipitate or violet colour appears
o- Not more than 10 mg/kg (expressed on dry weight Toluenesul basis) phonamide
p- Not more than 10 mg/kg (expressed on dry weight Toluenesul basis) phonamide
Benzoic Not more than 25 mg/kg (expressed on dry weight acid psulphonami basis) de
Readily Absent carbonisabl e substances
Arsenic Not more than 3 mg/kg (expressed on dry weight basis)
Selenium Not more than 30 mg/kg (expressed on dry weight basis)
Lead Not more than 1 mg/kg (expressed on dry weight basis)
E 955 SUCRALOSE
Synonyms 4,1’,6’-Trichlorogalactosucrose
Definition
EINECS 259-952-2
Chemical 1,6-Dichloro-1,6-dideoxy-β-D-fructofuranosyl-4- name chloro-4-deoxy-α-D-galactopyranoside
Chemical C 12 H 19 Cl 3 O 8
formula
Molecular 397,64 weight
Assay Content not less than 98 % and not more than 102 % C 12 H 19 Cl 3 O 8 calculated on an anhydrous basis.
Description White to off-white, practically odourless, crystalline powder.
Identification
Solubility Freely soluble in water, methanol and ethanol
Slightly soluble in ethyl acetate
Infrared The infrared spectrum of a potassium bromide absorption dispersion of the sample exhibits relative maxima at spectrum similar wave numbers as those shown in the reference spectrum obtained using a sucralose reference standard.
Thin layer The main spot in the test solution has the same Rf value
chromatogr as that of the main spot of standard solution A referred
aphy to in the test for other chlorinated disaccharides. This
standard solution is obtained by dissolving 1,0g of
sucralose reference standard in 10 ml of methanol.
Specific [α] 20 D + 84,0° to + 87,5° calculated on the anhydrous
rotation basis (10 % w/v solution)
Purity
Water Not more than 2,0 % (Karl Fischer method) content
Sulphated Not more than 0,7 % ash
Other Not more than 0,5 % chlorinated disaccharid es
Chlorinated Not more than 0,1 % monosacch arides
Triphenylp Not more than 150 mg/kg hosphine oxide
Methanol Not more than 0,1 %
Lead Not more than 1 mg/kg
E 957 THAUMATIN
Synonyms
Definition
EINECS 258-822-2
Chemical Thaumatin is obtained by aqueous extraction (pH 2,5 to name 4) of the arils of the fruit of strains of Thaumatococcus daniellii (Benth) and consists essentially of the proteins thaumatin I and thaumatin II together with minor amounts of plant constituents derived from the source material Chemical Polypeptide of 207 aminoacids formula
Molecular Thaumatin I 22209 weight Thaumatin II 22293
Assay Not less than 15,1 % nitrogen on the dried basis equivalent to not less than 93 % proteins (N × 6,2)
Description Odourless, cream-coloured powder. Approximately
2 000 to 3 000 times as sweet as sucrose
Identification
Solubility Very soluble in water, insoluble in acetone
Purity
Loss on Not more than 9 % (105 °C to constant weight) drying
Carbohydra Not more than 3 % (expressed on dry weight basis) tes
Sulphated Not more than 2 % (expressed on dry weight basis) ash
Aluminium Not more than 100 mg/kg (expressed on dry weight basis)
Arsenic Not more than 3 mg/kg (expressed on dry weight basis)
Lead Not more than 3 mg/kg (expressed on dry weight basis)
Microbiological criteria
Total Not more than 1 000 colonies per gram aerobic microbial count
Escherichia Absent in 1 g coli
E 959 NEOHESPERIDINE DIHYDROCHALCONE
Synonyms Neohesperidin dihydrochalcone; NHDC; Hesperetin dihydrochalcone-4′-β-neohesperidoside; Neohesperidin DC
Definition It is obtained by catalytic hydrogenation of neohesperidin
EINECS 243-978-6
Chemical 2-O-α-L-rhamnopyranosyl-4′-β-D-glucopyranosyl name hesperetin dihydrochalcone.
Chemical C 28 H 36 O 15
formula
Molecular 612,6 weight
Assay Content not less than 96 % on the dried basis
Description Off-white, odourless, crystalline powder.
Approximately between 1 000 and 1 800 times as sweet as sucrose
Identification
Solubility Freely soluble in hot water, very slightly soluble in cold water, practically insoluble in ether and benzene
Ultraviolet 282 to 283 nm for a solution of 2 mg in 100 ml absorption methanol maximum
Neu's test Dissolve about 10 mg of neohesperidine DC in 1 ml methanol, add 1 ml of a 1 % 2-aminoethyl diphenyl borate methanolic solution. A bright yellow colour is produced
Purity
Loss on Not more than 11 % (105°C, 3 hours) drying
Sulphated Not more than 0,2 % (expressed on dry weight basis) ash
Arsenic Not more than 3 mg/kg expressed on dry weight basis
Lead Not more than 2 mg/kg (expressed on dry weight basis) E 960 STEVIOL GLYCOSIDES
Synonyms
Definition The manufacturing process comprises two main phases: the first involving water extraction of the leaves of the
Stevia rebaudiana Bertoni plant and preliminary purification of the extract by employing ion exchange chromatography to yield a steviol glycoside primary extract, and the second involving recrystallisation of the steviol glycosides from methanol or aqueous ethanol resulting in a final product consisting mainly (at least 75%) of stevioside and/or rebaudioside A.
The additive may contain residues of ion-exchange resins used in the manufacturing process. Several other related steviol glycosides that may be generated as a result of the production process, but do not occur naturally in the Stevia rebaudiana plant have been identified in small amounts (0.10 to 0.37% w/w).
Chemical Stevioside: 13-[(2-O-β-D-glucopyranosyl-β-D- name glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D- glucopyranosyl ester
Rebaudioside A: 13-[(2-O-β-D-glucopyranosyl-3-O-β- D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en 18-oic acid, β-D-glucopyranosyl ester
Chemical Trivial name Formula Conversion formula factor
Steviol C 20 H 30 O 3 1,00
Stevioside C 38 H 60 O 18 0,40
Rebaudioside A C 44 H 70 O 23 0,33
Rebaudioside C C 44 H 70 O 22 0,34
Dulcoside A C 38 H 60 O 17 0,40
Rubusoside C 32 H 50 O 13 0,50
Steviolbioside C 32 H 50 O 13 0,50
Rebaudioside B C 38 H 60 O 18 0,40
Rebaudioside D C 50 H 80 O 28 0,29
EN 423 EN
Rebaudioside F C 43 H 68 O 22 0,34
Molecular Trivial name CAS Number Molecular weight
weight and
CAS Nr. Stevioside 57817-89-7 804,87
Rebaudioside A 58543-16-1 967,01
Assay: Not less than 95% stevioside, rebaudiosides A, B, C, D, E and F, steviolbioside, rubusoside and dulcoside on the dried basis.
Description White to light yellow powder, approximately between 200 and 300 times sweeter than sucrose
Identification
Solubility Freely soluble to slightly soluble in water
Stevioside The main peak in the chromatogram obtained following and the procedure in Method of Assay corresponds to either rebaudiosid stevioside or rebaudioside A e A
pH Between 4,5 and 7,0 (1 in 100 solution)
Purity
Total ash Not more than 1%
Loss on Not more than 6% (105° C, 2h) drying
Residual Not more than 200 mg/kg methanol solvents Not more than 5000 mg/kg ethanol
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg E 961 NEOTAME
Synonyms N-[N-(3,3-dimethylbutyl)-L-α-aspartyl]-L-phenylalanine 1-methyl ester;
N(3,3-dimethylbutyl)-L-aspartyl-L-phenylalanine methyl ester.
Definition Neotame is manufactured by reaction under hydrogen pressure of aspartame with 3,3,- dimethylbutyraldehyde in methanol in presence of a palladium/carbon catalyst. It is isolated and purified by filtration, where diatomaceous earth may be used. After solvent removal via distillation, neotame is washed with water, isolated by centrifugation and finally vacuum dried .
CAS Nr.: 165450-17-9
Chemical N-[N-(3,3-dimethylbutyl)-L-α-aspartyl]-L- name phenylalanine 1-methyl ester
Chemical C 20 H 30 N 2 O 5 formula
Molecular 378,47 weight
Description white to off-white powder
Assay Not less than 97,0% on the dried basis
Identification
Solubility 4,75% (w/w) at 60°C in water, soluble in ethanol and ethyl acetate
Purity
Water content Not more than 5% (Karl Fischer, sample size 25±5mg)
pH 5,0 – 7,0 (0,5 % aqueous solution)
Melting range 81°C to 84°C
N-[(3,3- Not more than 1,5% dimethylbutyl )-L-α- aspartyl]-L- phenylalanine Lead Not more than 1 mg/kg
E 962 SALT OF ASPARTAME-ACESULFAME
Synonyms Aspartame-acesulfame; Aspartame-acesulfame salt
Definition The salt is prepared by heating an approximately 2:1 ratio (w/w) of aspartame and acesulfame K in solution at acidic pH and allowing crystallisation to occur. The potassium and moisture are eliminated. The product is more stable than aspartame alone.
EINECS
Chemical 6-Methyl-1,2,3-oxathiazine-4(3H)-one-2,2-dioxide salt name of L-phenylalanyl-2-methyl-L-α-aspartic acid
Chemical C 18 H 23 O 9 N 3 S formula
Molecular 457,46 weight
Assay 63,0 % to 66,0 % aspartame (dry basis) and 34,0 % to 37,0 % acesulfame (acid form on a dry basis)
Description A white, odourless, crystalline powder
Identification
Solubility Sparingly soluble water; slightly soluble in ethanol
Transmittan The transmittance of a 1 % solution in water determined ce in a 1 cm cell at 430 nm with a suitable spectrophotometer using water as a reference, is not less than 0,95, equivalent to an absorbance of not more than approximately 0,022.
Specific [α] 20 D + 14,5° to + 16,5°
rotation Determine at a concentration of 6,2 g in 100ml formic acid (15N) within 30 min of preparation of the solution. Divide the calculated specific rotation by 0,646 to correct for the aspartame content of the salt of aspartame-acesulfame
Purity
Loss on Not more than 0,5 % (105°C, 4 hours) drying
5-Benzyl Not more than 0,5 % 3,6-dioxo 2- piperazinea cetic acid
Lead Not more than 1 mg/kg
E 965 (i) MALTITOL
Synonyms D-Maltitol; Hydrogenated maltose
Maltitol is obtained by hydrogenation of D-maltose. It Definition is mainly composed of D-maltitol. It may contain small
amounts of sorbitol and related polyhydric alcohols.
EINECS 209-567-0
Chemical (α)-D-Glucopyranosyl-1,4-D-glucitol name
Chemical C 12 H 24 O 11
formula
Molecular 344,3 weight
Assay Content not less than 98 % D-maltitol C 12 H 24 O 11 on the anhydrous basis
Description White crystalline powder
Identification
Solubility Very soluble in water, slightly soluble in ethanol
Melting 148 to 151°C range
Specific [α] 20 D + 105,5° to + 108,5° (5 % w/v solution)
rotation
Purity
Appearance The solution is clear and colourless of the aqueous solution
Water Not more than 1 % (Karl Fischer method) content
Sulphated Not more than 0,1 % (expressed on an anhydrous basis)
ash
Reducing Not more than 0,1 % (expressed as glucose on an sugars anhydrous basis)
Chlorides Not more than 50 mg/kg (expressed on anhydrous basis)
Sulphates Not more than 100 mg/kg (expressed on anhydrous basis)
Nickel Not more than 2 mg/kg (expressed on anhydrous basis)
Arsenic Not more than 3 mg/kg (expressed on anhydrous basis)
Lead Not more than 1 mg/kg (expressed on anhydrous basis)
E 965 (ii) MALTITOL SYRUP
Synonyms Hydrogenated high-maltose-glucose syrup;
Hydrogenated glucose syrup; Maltitol liquid
Definition A mixture consisting of mainly maltitol with sorbitol and hydrogenated oligo- and polysaccharides. It is
manufactured by the catalytic hydrogenation of high maltose-content glucose syrup or by the hydrogenation of its individual components followed by blending. The article of commerce is supplied both as a syrup and as a solid product.
EINECS
Chemical name
Chemical formula
Molecular weight
Assay Content not less than 99 % of total hydrogenated saccharides on the anhydrous basis and not less than 50 % of maltitol on the anhydrous basis
Description Colourless and odourless, clear viscous liquids or white crystalline masses
Identification
Solubility Very soluble in water, slightly soluble in ethanol
HPLC test Comparison with an appropriate reference standard of Maltitol shows that the principle peak in the
chromatogram of the test solution is similar in retention time to the principal peak in the chromatogram obtained
with the reference solution (ISO 10504:1998).
Purity
Appearance The solution is clear and colourless of the aqueous solution
Water Not more than 31 % (Karl Fischer method) content
Reducing Not more than 0,3 % (expressed as glucose on an sugars anhydrous basis)
Sulphated Not more than 0,1 % ash
Chlorides Not more than 50 mg/kg
Sulphate Not more than 100 mg/kg
Nickel Not more than 2 mg/kg
Lead Not more than 1 mg/kg
E 966 LACTITOL
Synonyms Lactit; Lactositol; Lactobiosit
Definition Lactitol is manufactured via catalytic hydrogenation of lactose
EINECS 209-566-5
Chemical 4-O-β-D-Galactopyranosyl-D-glucitol name
Chemical C 12 H 24 O 11 formula
Molecular 344,3 weight
Assay Not less than 95 % on the dry weight basis
Description Crystalline powderor colourless solution. Crystalline products occur in anhydrous, monohydrate and
dihydrate forms. Nickel is used as a catalyst.
Identification
Solubility Very soluble in water
Specific [α] 20 D = + 13° to + 16° calculated on the anhydrous
rotation basis (10 % w/v aqueous solution)
Purity
Water Crystalline products; not more than 10,5 % (Karl content Fischer method)
Other Not more than 2,5 % (on the anhydrous basis) polyols
Reducing Not more than 0,2 % (expressed as glucose on dry sugars weight basis)
Chlorides Not more than 100 mg/kg (expressed on dry weight basis)
Sulphates Not more than 200 mg/kg (expressed on dry weight basis)
Sulphated Not more than 0,1 % (expressed on dry weight basis) ash
Nickel Not more than 2 mg/kg (expressed on dry weight basis)
Arsenic Not more than 3 mg/kg (expressed on dry weight basis Lead Not more than 1 mg/kg (expressed on dry weight basis)
E 967 XYLITOL
Synonyms Xylitol
Xylitol is mainly composed of D-xylitol. The part
Definition which is not D-xylitol is composed of related substances such as L-arabinitol, galactitol, mannitol,
sorbitol
EINECS 201-788-0
Chemical D-xylitol name
Chemical C 5 H 12 O 5 formula
Molecular 152,2 weight
Assay Not less than 98,5 % as xylitol on the anhydrous basis
Description White, crystalline powder, practically odourless.
Identification
Solubility Very soluble in water, sparingly soluble in ethanol
Melting 92 to 96°C range
pH 5 to 7 (10 % w/v aqueous solution)
Infrared Comparison with a reference standard e.g. EP or USP. absorption spectroscop y
Purity
Water Not more than 1% (Karl-Fischer method) content
Sulphated ash Not more than 0,1 % (expressed on dry weight basis) Reducing sugars Not more than 0,2 % (expressed as glucose on dry weight basis)
Other polyhydric Not more than 1 % (expressed on dry weight basis) alcohols
Nickel Not more than 2 mg/kg (expressed on dry weight basis)
Arsenic Not more than 3 mg/kg (expressed on dry weight basis)
Lead Not more than 1 mg/kg (expressed on dry weight basis)
Chlorides Not more than 100 mg/kg (expressed on dry weight basis)
Sulphates Not more than 200 mg/kg (expressed on dry weight basis)
E 968 ERYTHRITOL
Synonyms Meso-erythritol; Tetrahydroxybutane; Erythrite
Definition Obtained by fermentation of carbohydrate source by safe and suitable food grade osmophilic yeasts such as Moniliella pollinis or Moniliella megachilensis,
followed by purification and drying
EINECS 205-737-3
Chemical 1,2,3,4-Butanetetrol name
Chemical C 4 H 10 O 4 formula
Molecular 122,12 weight
Assay Not less than 99% after drying
Description White, odourless, non-hygroscopic, heat-stable crystals with a sweetness of approximately 60-80% that of
sucrose.
Identification
Solubility Freely soluble in water, slightly soluble in ethanol, insoluble in diethyl ether.
Melting 119-123 °C range
Purity
Loss on Not more than 0,2 % (70 °C, 6 hours, in a vacuum drying desiccator)
Sulphated Not more than 0,1 % ash
Reducing Not more than 0,3 % expressed as D-glucose substances
Ribitol and Not more than 0,1 % glycerol
Lead Not more than 0,5 mg/kg
E 999 QUILLAIA EXTRACT
Synonyms Soapbark extract; Quillay bark extract; Panama bark extract; Quillai extract; Murillo bark extract; China bark extract
Definition Quillaia extract is obtained by aqueous extraction of
Quillaia saponaria Molina, or other Quillaia species, trees of the family Rosaceae. It contains a number of triterpenoid saponins consisting of glycosides of quillaic acid. Some sugars including glucose, galactose, arabinose, xylose, and rhamnose are also present, along with tannin, calcium oxalate and other minor components
EINECS
Chemical name
Chemical formula
Molecular weight
Assay
Description Quillaia extract in the powder form is light brown with a pink tinge. It is also available as an aqueous solution
Identification
pH Between 3,7 and 5,5 (4 % solution)
Purity
Water Not more than 6,0 % (Karl Fischer method) (powder form
content only)
Arsenic Not more than 2 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
E 1103 INVERTASE
Synonyms
Definition Invertase is produced from Saccharomyces cerevisiae
EINECS 232-615-7
Enzyme EC 3.2.1.26 Commission No
Systematic β-D-Fructofuranoside fructohydrolase name
Chemical name
Chemical formula
Molecular weight
Assay
Description
Identification
Purity
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Cadmium Not more than 0,5 mg/kg
Microbiological criteria
Total Not more than 50 000 colonies per gram bacterial count
Salmonella Absent in 25 g spp.
Coliforms Not more than 30 colonies per gram
Escherichia Absent in 25 g coli
E 1105 LYSOZYME
Synonyms Lysozyme hydrochloride; Muramidase
Definition Lysozyme is a linear polypeptide obtained from hens' egg whites consisting of 129 amino acids. It possesses
enzymatic activity in its ability to hydrolyse the β(1-4) linkages between N-acetylmuramic acid and N- acetylglucosamine in the outer membranes of bacterial species, in particular gram-positive organisms. Is usually obtained as the hydrochloride
EINECS 232-620-4
Enzyme EC 3.2.1.17 Commission No
Chemical name
Chemical formula
Molecular About 14 000 weight
Assay Content not less than 950 mg/g on the anhydrous basis Description White, odourless powder having a slightly sweet taste
Identification
Isoelectric 10,7 point
pH Between 3,0 and 3,6 (2 % aqueous solution)
Spectrophot Absorption maximum of an aqueous solution ometry (25 mg/100 ml) at 281 nm, a minimum at 252 nm
Purity
Water Not more than 6,0 % (Karl Fischer method) (powder form
content only)
Residue on Not more than 1,5 % ignition
Nitrogen Not less than 16,8 % and not more than 17,8 %
Arsenic Not more than 1 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Microbiological criteria
Total Not more than 5 × 10 4 colonies per gram
bacterial count
Salmonella Absent in 25 g spp.
Staphylococ Absent in 1 g cus aureus
Escherichia Absent in 1 g coli
E 1200 POLYDEXTROSE
Synonyms Modified polydextroses
Definition Randomly bonded glucose polymers with some sorbitol end-groups, and with citric acid or phosphoric acid
residues attached to the polymers by mono or diester bonds. They are obtained by melting and condensation of the ingredients and consist of approximately 90 parts D- glucose, 10 parts sorbitol and 1 part citric acid and/or 0,1 part phosphoric acid. The 1,6-glucosidic linkage predominates in the polymers but other linkages are present. The products contain small quantities of free glucose, sorbitol, levoglucosan (1,6-anhydro-D-glucose) and citric acid and may be neutralised with any food grade base and/or decolorised and deionised for further purification. The products may also be partially hydrogenated with Raney nickel catalyst to reduce residual glucose. Polydextrose-N is neutralised polydextrose
EINECS
Chemical name
Chemical formula
Molecular weight
Assay Content not less than 90 % of polymer on the ash free and anhydrous basis
Description White to light tan-coloured solid. Polydextroses dissolve in water to give a clear, colourless to straw coloured
solution
Identification
Test for Passes test sugar
Test for Passes test reducing sugar
pH Between 2,5 and 7,0 for polydextrose (10 % solution)
Between 5,0 and 6,0 for polydextrose-N (10 % solution)
Purity
Water Not more than 4,0 % (Karl Fischer method) content Sulphated Not more than 0,3 % (polydextrose) ash Not more than 2,0 % (polydextrose N)
Nickel Not more than 2 mg/kg for hydrogenated polydextroses
1,6- Not more than 4,0 % on the ash-free and the dried basis Anhydro-D- glucose
Glucose and Not more than 6,0 % combined on the ash-free and the sorbitol dried basis; glucose and sorbitol are determined separately
Molecular Negative test for polymers of molecular weight greater weight limit than 22,000
5-Hydroxy Not more than 0,1 % (polydextrose) methylfurfur
al Not more than 0,05 % (polydextrose-N)
Lead Not more than 0,5 mg/kg
E 1201 POLYVINYLPYRROLIDONE
Synonyms Povidone; PVP; Soluble polyvinylpyrrolidone
Definition
EINECS
Chemical Polyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)- name ethylene]
Chemical (C 6 H 9 NO) n formula
Weight Not less than 25 000 Average Molecular Weight
Assay Content not less than 11,5 % and not more than 12,8 % of nitrogen (N) on the anhydrous basis
Description White or nearly white powder
Identification
Solubility Soluble in water and in ethanol. Insoluble in ether
pH Between 3,0 and 7,0 (5 % solution)
Purity
Water Not more than 5 % (Karl Fischer) content
Total ash Not more than 0,1 %
Aldehyde Not more than 500 mg/kg (as acetaldehyde)
Free-N- Not more than 10 mg/kg vinylpyrrolid one
Hydrazine Not more than 1 mg/kg
Lead Not more than 2 mg/kg
E 1202 POLYVINYLPOLYPYRROLIDONE
Synonyms Crospovidone; Cross linked polyvidone; Insoluble polyvinylpyrrolidone
Definition Polyvinylpolypyrrolidone is a poly-[1-(2-oxo-1- pyrrolidinyl)-ethylene], cross linked in a random fashion. It is produced by the polymerisation of N-vinyl-2- pyrrolidone in the presence of either caustic catalyst or N, N'-divinyl-imidazolidone. Due to its insolubility in all common solvents the molecular weight range is not amenable to analytical determination
EINECS
Chemical Polyvinylpyrrolidone; poly-[1-(2-oxo-1-pyrrolidinyl)- name ethylene]
Chemical (C 6 H 9 NO) n formula
Molecular weight
Assay Content not less than 11 % and not more than 12,8 % nitrogen (N) on the anhydrous basis
Description A white hygroscopic powder with a faint, nonobjectionable odour
Identification
Solubility Insoluble in water, ethanol and ether
pH Between 5,0 and 8,0 (1 % suspension in water)
Purity
Water Not more than 6 % (Karl Fischer) content
Sulphated Not more than 0,4 % ash
Water Not more than 1 % soluble matter
Free-N- Not more than 10 mg/kg vinylpyrrolid one
Free-N,N'- Not more than 2 mg/kg divinylimidazolidon e
Lead Not more than 2 mg/kg
E 1203 POLYVINYL ALCOHOL
Synonyms Vinyl alcohol polymer, PVOH
Definition Polyvinyl alcohol is a synthetic resin prepared by the polymerisation of vinyl acetate, followed by partial hydrolysis of the ester in the presence of an alkaline catalyst. The physical characteristics of the product depend on the degree of polymerisation and the degree of hydrolysis.
Chemical Ethenol homopolymer name
Chemical (C 2 H 3 OR) n where R = H or COCH 3 formula
Description Odourless, tasteless, translucent, white or cream-coloured granular powder
Identification
Solubility Soluble in water ; sparingly soluble in ethanol
Precipitation Dissolve 0,25g of the sample in 5 ml of water with reaction warming and let the solution cool to room temperature. The addition of 10 ml of ethanol to this solution leads to a
white, turbid or flocculent precipitate.
Colour Dissolve 0,01g of the sample in 100 ml of water with reaction warming and let the solution cool to room temperature. A blue colour is produced when adding (to 5 ml solution) one drop of iodine test solution (TS) and a few drops of boric
acid solution
Dissolve 0,5g of the sample in 10 ml of water with warming and let the solution cool to room temperature. A dark red to blue colour is produced after adding one drop
of iodine TS to 5 ml of solution.
Viscosity 4,8 to 5,8 mPa.s (4% solution at 20°C) corresponding to an average molecular weight of 26000-30000 Da
Purity
Water Not more than 0.1% insoluble matter
Ester Value Between 125 and 153 mg KOH/g
Degree of 86.5 to 89.0% hydrolysis
Acid value Not more than 3,0
Solvent Not more than 1,0 % Methanol, 1,0 % Methyl acetate residues
pH 5,0 to 6,5 (4% solution)
Loss on drying Not more than 5,0 % (105°C, 3 hours)
Residue in Not more than 1.0% ignition
Lead Not more than 2 mg/kg
E 1204 PULLULAN
Synonyms Definition Linear, neutral glucan consisting mainly of maltotriose
units connected by -1,6 glycosidic bonds. It is produced by fermentation from a food-grade hydrolysed starch using a non-toxin-producing strain of Aureobasidium pullulans. After completion of the fermentation, the fungal cells are removed by microfiltration, the filtrate is heat-sterilised and pigments and other impurities are removed by adsorption and ion exchange chromatography
EINECS 232-945-1
Chemical name
Chemical (C 6 H 10 O 5 ) n
formula
Molecular weight
Assay Not less than 90 % of glucan on the dried basis
Description White to off-white odourless powder
Identification
Solubility Soluble in water, practically insoluble in ethanol
pH 5,0 to 7,0 (10 % solution)
Precipitation Add 2 ml of polyethylene glycol 600 to 10 ml of a 2 % with aqueous solution of pullulan. A white precipitate is polyethylene formed glycol 600
Depolymeris Prepare two test tubes each with 10 ml of a 10 % pullulan ation with solution. Add 0,1 ml pullulanase solution having activity pullulanase 10 units/g to one test tube, and 0,1 ml water to the other. After incubation at about 25 °C for 20 minutes, the viscosity of the pullulanase-treated solution is visibly lower than that of the untreated solution
Viscosity 100 to 180 mm 2 /s (10 % w/w aqueous solution at 30 °C)
Purity
Loss on Not more than 6 % (90 °C, pressure not more than 50 mm drying Hg, 6 hours)
Mono-, di Not more than 10 % expressed as glucose and oligosacchar ides
Lead Not more than 1 mg/kg
Microbiological criteria
Yeast and Not more than 100 colonies per gram moulds
Coliforms Absent in 25 g
Salmonella Absent in 25 g spp.
E 1205 BASIC METHACRYLATE COPOLYMER
Synonyms Basic butylated methacrylate copolymer; amino methacrylate copolymer; aminoalkyl methacrylate copolymer E; butyl methacrylate, dimethylaminoethyl methacrylate, methyl methacrylate polymer; butyl methacrylate, methyl methacrylate, dimethylaminoethyl methacrylate polymer
Definition Basic methacrylate copolymer is manufactured by thermic controlled polymerisation of the monomers methyl methacrylate, butyl methacrylate and
dimethylaminoethyl methacrylate, dissolved in propan-2- ol) by using a free radical donor initiator system. An alkyl mercaptane is used as chain modifying agent. The solid polymer is milled (first milling step) and extruded and granulated under vacuum to remove residual volatile components. The granules resulting are commercialised as such or undergo a second milling step (micronisation).
Chemical Poly(butyl methacrylate-co-(2- name dimethylaminoethyl)methacrylate-co-methyl methacrylate) 1:2:1
Chemical Poly[(CH 2 :C(CH 3 )CO 2 (CH 2 ) 2 N(CH 3 ) 2 )-coformula (CH 2 :C(CH 3 )CO 2 CH 3 )-co-(CH 2 :C(CH 3 )CO 2 (CH 2 ) 3 CH 3 )]
Weight Approximately 47000g/mol Average Molecular Weight estimated by Gel Permeation Chromatogra phy Particle size < 50 µm more than 50% of powder
(when used < 0,1 µm 5,1 – 5,5 %
forms a film)
Assay: 20,8 - 25,5% dimethylaminoethyl (DMAE) groups on dry substance
(according to Ph.
Eur. 2.2.20 "Potentiometric titration")
Description Granules are colourless to yellow tinged, the powder is white
Identification
Infrared To be identified absorption spectroscopy
Viscosity of 3 – 6 mPa.s a 12,5% solution in 60:40 (w/w/) propan-2-ol to acetone
Refractive [n] 20 D 1,380 – 1,385
index
Solubility 1 g dissolves in 7 g Methanol, Ethanol, propan-2-ol, dichloromethane, aqueous Hydrochloric acid 1N.
Not soluble in petroleum ether.
Purity
Loss of Not more than 2,0 % (105°C, 3H) drying
Alkali value 162 – 198 mg KOH/ g of dried substance
Sulphated Not more than 0,1 % ash
Residual Butylmethacrylate < 1000 mg/kg monomers Methyl methacrylate < 1000 mg/kg
Dimethylaminoethyl methacrylate < 1000 mg/kg Solvent propan-2-ol < 0,5% residues
Butanol < 0,5%
Methanol < 0,1%
Arsenic Not more than 2 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 2 mg/kg
Copper Not more than 10 mg/kg
E 1404 OXIDISED STARCH
Synonyms
Definition Oxidised starch is starch treated with sodium hypochlorite
EINECS
Chemical name
Chemical formula
Molecular weight
Assay
Description White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
Microscopic Passes test (if not pregelatinised) observation
Iodine Passes test (dark blue to light red colour) staining
Purity
Loss on Not more than 15,0 % for cereal starch
drying Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Carboxyl Not more than 1,1 % (on an anhydrous basis) groups
Sulphur Not more than 50 mg/kg for modified cereal starches (on dioxide an anhydrous basis)
Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg (on an anhydrous basis)
Mercury Not more than 0,1 mg/kg
E 1410 MONOSTARCH PHOSPHATE
Synonyms
Definition Monostarch phosphate is starch esterified with orthophosphoric acid, or sodium or potassium ortho-phosphate or sodium tripolyphosphate
EINECS
Chemical name
Chemical formula
Molecular weight
Assay
Description White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
Microscopic Passes test (if not pregelatinised) observation Iodine Passes test (dark blue to light red colour) staining
Purity
Loss on Not more than 15,0 % for cereal starch drying Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Residual Not more than 0,5 % (as P) for wheat or potato starch (on
phosphate an anhydrous basis)
Not more than 0,4 % (as P) for other starches (on an anhydrous basis)
Sulphur Not more than 50 mg/kg for modified cereal starches (on dioxide an anhydrous basis)
Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg (on an anhydrous basis)
Mercury Not more than 0,1 mg/kg
E 1412 DISTARCH PHOSPHATE
Synonyms
Definition Distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride
EINECS
Chemical name
Chemical formula
Molecular weight
Assay Description White or nearly white powder or granules or (if
pregelatinised) flakes, amorphous powder or coarse particles
Identification
Microscopic Passes test (if not pregelatinised) observation
Iodine Passes test (dark blue to light red colour) staining
Purity
Loss on Not more than 15,0 % for cereal starch drying Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Residual Not more than 0,5 % (as P) for wheat or potato starch (on phosphate an anhydrous basis)
Not more than 0,4 % (as P) for other starches (on an anhydrous basis)
Sulphur Not more than 50 mg/kg for modified cereal starches (on dioxide an anhydrous basis)
Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg (on an anhydrous basis)
Mercury Not more than 0,1 mg/kg
E 1413 PHOSPHATED DISTARCH PHOSPHATE
Synonyms
Definition Phosphated distarch phosphate is starch having undergone a combination of treatments as described for monostarch
phosphate and for distarch phosphate EINECS
Chemical name
Chemical formula
Molecular weight
Assay
Description White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
Microscopic Passes test (if not pregelatinised) observation
Iodine Passes test (dark blue to light red colour) staining
Purity
Loss on Not more than 15,0 % for cereal starch drying Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Residual Not more than 0,5 % (as P) for wheat or potato starch (on
phosphate an anhydrous basis)
Not more than 0,4 % (as P) for other starches (on an anhydrous basis)
Sulphur Not more than 50 mg/kg for modified cereal starches (on dioxide an anhydrous basis)
Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg (on an anhydrous basis) Mercury Not more than 0,1 mg/kg
E 1414 ACETYLATED DISTARCH PHOSPHATE
Synonyms
Definition Acetylated distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and esterified by acetic anhydride or vinyl acetate
EINECS
Chemical name
Chemical formula
Molecular weight
Assay
Description White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
Microscopic Passes test (if not pregelatinised) observation
Iodine Passes test (dark blue to light red colour) staining
Purity
Loss on Not more than 15,0 % for cereal starch drying Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Acetyl Not more than 2,5 % (on an anhydrous basis) groups
Residual Not more than 0,14 % (as P) for wheat or potato starch phosphate (on an anhydrous basis) Not more than 0,04 % (as P) for other starches (on an anhydrous basis)
Vinyl Not more than 0,1 mg/kg (on an anhydrous basis) acetate
Sulphur Not more than 50 mg/kg for modified cereal starches (on
dioxide an anhydrous basis)
Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg (on an anhydrous basis)
Mercury Not more than 0,1 mg/kg
E 1420 ACETYLATED STARCH
Synonyms Starch acetate
Definition Acetylated starch is starch esterified with acetic anhydride or vinyl acetate
EINECS
Chemical name
Chemical formula
Molecular weight
Assay
Description White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
Microscopic Passes test (if not pregelatinised) observation Iodine Passes test (dark blue to light red colour) staining
Purity
Loss on Not more than 15,0 % for cereal starch drying Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Acetyl Not more than 2,5 % (on an anhydrous basis) groups
Vinyl Not more than 0,1 mg/kg (on an anhydrous basis) acetate
Sulphur Not more than 50 mg/kg for modified cereal starches (on
dioxide an anhydrous basis)
Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg (on an anhydrous basis)
Mercury Not more than 0,1 mg/kg
E 1422 ACETYLATED DISTARCH ADIPATE
Synonyms
Definition Acetylated distarch adipate is starch cross-linked with adipic anhydride and esterified with acetic anhydride
EINECS
Chemical name
Chemical formula
Molecular weight Assay
Description White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
Microscopic Passes test (if not pregelatinised) observation
Iodine Passes test (dark blue to light red colour) staining
Purity
Loss on Not more than 15,0 % for cereal starch drying Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Acetyl Not more than 2,5 % (on an anhydrous basis) groups
Adipate Not more than 0,135 % (on an anhydrous basis) groups
Sulphur Not more than 50 mg/kg for modified cereal starches (on
dioxide an anhydrous basis)
Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg (on an anhydrous basis)
Mercury Not more than 0,1 mg/kg
E 1440 HYDROXYPROPYL STARCH
Synonyms
Definition Hydroxypropyl starch is starch etherified with propylene oxide
EINECS
Chemical name
Chemical formula
Molecular weight
Assay
Description White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
Microscopic Passes test (if not pregelatinised) observation
Iodine Passes test (dark blue to light red colour) staining
Purity
Loss on Not more than 15,0 % for cereal starch drying Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Hydroxypro Not more than 7,0 % (on an anhydrous basis) pyl groups
Propylene Not more than 1 mg/kg (on an anhydrous basis) chlorohydrin
Sulphur Not more than 50 mg/kg for modified cereal starches (on
dioxide an anhydrous basis)
Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg (on an anhydrous basis) Mercury Not more than 0,1 mg/kg
E 1442 HYDROXYPROPYL DISTARCH PHOSPHATE
Synonyms
Definition Hydroxypropyl distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and etherified with propylene oxide
EINECS
Chemical name
Chemical formula
Molecular weight
Assay
Description White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
Microscopic Passes test (if not pregelatinised) observation
Iodine Passes test (dark blue to light red colour) staining
Purity
Loss on Not more than 15,0 % for cereal starch drying Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Hydroxypro Not more than 7,0 % (on an anhydrous basis) pyl groups Residual Not more than 0,14 % (as P) for wheat or potato starch phosphate (on an anhydrous basis)
Not more than 0,04 % (as P) for other starches (on an anhydrous basis)
Propylene Not more than 1 mg/kg (on an anhydrous basis) chlorohydrin
Sulphur Not more than 50 mg/kg for modified cereal starches (on
dioxide an anhydrous basis)
Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg (on an anhydrous basis)
Mercury Not more than 0,1 mg/kg
E 1450 STARCH SODIUM OCTENYL SUCCINATE
Synonyms SSOS
Definition Starch sodium octenyl succinate is starch esterified with octenylsuccinic anhydride
EINECS
Chemical name
Chemical formula
Molecular weight
Assay
Description White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
Microscopic Passes test (if not pregelatinised) observation
Iodine Passes test (dark blue to light red colour) staining
Purity
Loss on Not more than 15,0 % for cereal starch drying Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Octenylsucci Not more than 3 % (on an anhydrous basis) nyl groups
Octenylsucci Not more than 0,3 % (on an anhydrous basis) nic acid residue
Sulphur Not more than 50 mg/kg for modified cereal starches (on
dioxide an anhydrous basis)
Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg (on an anhydrous basis)
Mercury Not more than 0,1 mg/kg
E 1451 ACETYLATED OXIDISED STARCH
Synonyms
Definition Acetylated oxidised starch is starch treated with sodium hypochlorite followed by esterification with acetic
anhydride
EINECS
Chemical name
Chemical formula Molecular weight
Assay
Description White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
Microscopic Passes test (if not pregelatinised) observation
Iodine Passes test (dark blue to light red colour) staining
Purity
Loss on Not more than 15,0 % for cereal starch drying Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Carboxyl Not more than 1,3 % (on an anhydrous basis) groups
Acetyl Not more than 2,5 % (on an anhydrous basis) groups
Sulphur Not more than 50 mg/kg for modified cereal starches (on
dioxide an anhydrous basis)
Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg (on an anhydrous basis)
Mercury Not more than 0,1 mg/kg
E 1452 STARCH ALUMINIUM OCTENYL SUCCINATE
Synonyms
Definition Starch aluminium octenyl succinate is starch esterified with octenylsuccinic anhydride and treated with
aluminium sulphate
EINECS
Chemical name
Chemical formula
Molecular weight
Assay
Description White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
Microscopic Passes test (if not pregelatinised) observation
Iodine Passes test (dark blue to light red colour) staining
Purity
Loss on Not more than 21,0 % drying
Octenylsucci Not more than 3 % (on an anhydrous basis) nyl groups
Octenylsucci Not more than 0,3 % (on an anhydrous basis) nic acid residue
Sulphur Not more than 50 mg/kg for modified cereal starches (on
dioxide an anhydrous basis)
Not more than 10 mg/kg for the other modified starches, unless otherwise specified (on an anhydrous basis)
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg (on an anhydrous basis)
Mercury Not more than 0,1 mg/kg
Aluminium Not more than 0,3 % (on an anhydrous basis)
E 1505 TRIETHYL CITRATE
Synonyms Ethyl citrate
Definition
EINECS 201-070-7
Chemical Triethyl-2-hydroxypropan-1,2,3-tricarboxylate
name
Chemical C 12 H 20 O 7 formula
Molecular 276,29 weight
Assay Content not less than 99,0 %
Description Odourless, practically colourless, oily liquid
Identification
Specific 1,135-1,139 gravity (25° C/25 °C )
Refractive [n] 20 D : 1,439-1,441
index
Purity
Water Not more than 0,25 % (Karl Fischer method) content
Acidity Not more than 0,02 % (as citric acid)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg E 1517 GLYCERYL DIACETATE
Synonyms Diacetin
Definition Glyceryl diacetate consist predominantly of a mixture of the 1, 2- and 1,3-diacetates of glycerol, with minor amounts of the mono- and tri-esters
EINECS
Chemical Glyceryl diacetate; 1, 2, 3-propanetriol diacetate name
Chemical C 7 H 12 O 5 formula
Molecular 176,17 weight
Assay Not less than 94,0 %
Description Clear, colourless, hygroscopic, somewhat oily liquid with a slight, fatty odour
Identification
Solubility Soluble in water. Miscible with ethanol
Test for Passes test glycerol
Test for Passes test acetate
Specific 1,175-1,195 gravity (20° C/20 °C )
Boiling Between 259 and 261 °C range
Purity
Total ash Not more than 0,02 %
Acidity Not more than 0,4 % (as acetic acid)
Arsenic Not more than 3 mg/kg Lead Not more than 2 mg/kg
E 1518 GLYCERYL TRIACETATE
Synonyms Triacetin
Definition
EINECS 203-051-9
Chemical Glyceryl triacetate name
Chemical C 9 H 14 O 6
formula
Molecular 218,21 weight
Assay Content not less than 98,0 %
Description Colourless, somewhat oily liquid having a slightly fatty odour
Identification
Test for Passes test acetate
Test for Passes test glycerol
Refractive [n] 25 D between 1,429 and 1,431
index
Specific Between 1,154 and 1,158 gravity (25 °C/25 °C )
Boiling Between 258° and 270 °C range
Purity
Water Not more than 0,2 % (Karl Fischer method) content Sulphated Not more than 0,02 % (as citric acid) ash
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
E 1519 BENZYL ALCOHOL
Synonyms Phenylcarbinol; Phenylmethyl alcohol; Benzenemethanol; Alpha-hydroxytoluene
Definition
EINECS
Chemical Benzyl alcohol; Phenylmethanol name
Chemical C 7 H 8 O
formula
Molecular 108,14 weight
Assay Not less than 98,0 %
Description Colourless, clear liquid with a faint, aromatic odour
Identification
Solubility Soluble in water, ethanol and ether
Refractive [n] 20 D 1,538 - 1,541
index
Specific 1,042 - 1,047 gravity (25° C/25 °C )
Test for Passes test peroxides
Distillation Not less than 95 % v/v distils between 202 and 208 °C range
Purity
Acid value Not more than 0,5
Aldehydes Not more than 0,2 % v/v (as benzaldehyde)
Lead Not more than 2 mg/kg
E 1520 PROPANE-1,2-DIOL
Synonyms Propylene glycol
Definition
EINECS 200-338-0
Chemical 1,2-dihydroxypropane name
Chemical C 3 H 8 O 2 formula
Molecular 76,10 weight
Assay Content not less than 99,5 % on the anhydrous basis
Description Clear, colourless, hygroscopic, viscous liquid
Identification
Solubility Soluble in water, ethanol and acetone
Specific 1,035 - 1,040 gravity (20° C/20 °C )
Refractive [n] 20 D : 1,431 - 1,433
index
Purity
Distillation 99,5% of the product distils between 185 °C - 189 °C. test The remaining 0,5% consists mainly of dimers and traces of trimers from propylene glycol.
Sulphated Not more than 0,07 % ash
Water Not more than 1,0 % (Karl Fischer method) content
Lead Not more than 2 mg/kg
E 1521 POLYETHYLENE GLYCOL
Synonyms PEG; Macrogol; Polyethylene oxide
Definition Addition polymers of ethylene oxide and water usually designated by a number roughly corresponding to the
molecular weight.
Chemical alpha-Hydro-omega-hydroxypoly (oxy-1,2-ethanediol) name
Chemical (C 2 H 4 O) n H 2 O (n = number of ethylene oxide units
formula corresponding to a molecular weight of 6.000, about 140)
Average 380 to 9000 Da Molecular weight
Assay PEG 400: Not less than 95% and not more than 105 %
PEG 3000: Not less than 90% and not more than 110 %
PEG 3350: Not less than 90% and not more than 110 %
PEG 4000: Not less than 90% and not more than 110 %
PEG 6000:Not less than 90% and not more than 110 %
PEG 8000: Not less than 87,5% and not more than 112,5 %
Description PEG 400 is a clear, viscous, colourless or almost colourless hygroscopic liquid
PEG 3000, PEG 3350, PEG 4000, PEG 6000 and PEG 8000 are white or almost white solids with a waxy or paraffin-like appearance
Identification
Melting PEG 400: 4-8°C
range PEG 3000: 50-56°C
PEG 3350: 53-57°C
PEG 4000: 53-59°C
PEG 6000:55-61°C
PEG 8000: 55-62°C
Viscosity PEG 400: 105 to 130 mPa.s at 20 °C
PEG 3000: 75 to 100 mPa.s at 20 °C
PEG 3350: 83 to 120 mPa.s at 20 °C
PEG 4000: 110 to 170 mPa.s at 20 °C
PEG 6000: 200 to 270 mPa.s at 20 °C
PEG 8000: 260 to 510 mPa.s at 20 °C
For polyethylene glycols having a average molecular weight greater than 400, the viscosity is determined on a 50 per cent m/m solution of the candidate substance in
water
Solubility PEG 400 is miscible with water, very soluble in acetone, in alcohol and in methylene chloride, practically insoluble in fatty oils and in mineral oils
PEG 3000 and PEG 3350: very soluble in water and in methylene chloride, very slightly soluble in alcohol,
practically insoluble in fatty oils and in mineral oils
PEG 4000, PEG 6000 and PEG 8000: very soluble in water and in methylene chloride, practically insoluble in
alcohol and in fatty oils and in mineral oils.
Purity
Hydroxyl PEG 400: 264-300 value PEG 3000: 34-42
PEG 3350: 30-38
PEG 4000: 25-32
PEG 6000: 16-22
PEG 8000: 12-16
Sulphated Not more than 0,2 % ash
1,4-Dioxane Not more than 10 mg/kg
Ethylene Not more than 0,2 mg/kg oxide
Ethylene Total not more than 0,25% °w/w individually or in glycol and combination diethylene glycol
Lead Not more than 1 mg/kg
The EU Monitor enables its users to keep track of the European process of lawmaking, focusing on the relevant dossiers. It automatically signals developments in your chosen topics of interest. Apologies to unregistered users, we can no longer add new users.This service will discontinue in the near future.