Explanatory Memorandum to COM(2007)673 - Food additives (presented by the Commission pursuant to Article 250 (2) of the EC Treaty) - Main contents
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| dossier | COM(2007)673 - Food additives (presented by the Commission pursuant to Article 250 (2) of the EC Treaty). |
|---|---|
| source | COM(2007)673  |
| date | 24-10-2007 |
1. On 28th July 2006, the Commission adopted the proposal for a European Parliament and Council Regulation on food additives [Document (COM (2006)0428 final)] as part of a package of four proposals on food improvement agents. The proposal was submitted to the Council and the European Parliament on 28th July 2006.
2. The Economic and Social Committee adopted its opinion on 25th April 2007.
3. The Council has agreed a ‘general approach’ on the proposal at the EPSCO meeting on 31st May 2007.
Contents
- 4. The European Parliament has given in first reading a favourable opinion on the proposal on 10th July 2007
- II. OBJECTIVES OF THE PROPOSAL
- III. OVERVIEW OF THE AMENDMENTS OF THE EUROPEAN PARLIAMENT
- 9. Technical/editorial amendments
- 10. Scope (Article 2)
- 11. Comitology
- 12. Prohibition of non-compliant food additives (Article 5)
- 13. Criteria for authorisation (Article 6)
- 14. Criteria for authorisation (sweeteners) (Article 7)
- 15. Criteria for authorisation (colours) (Article 8)
- 16. Community lists of food additives (Articles 4 and 10, Annexes II and III)
- 17. Relation with Regulation 1829/2003 on GM food and feed (Article 13)
- 18. Labelling (Articles 21 to 24)
- Labelling of food additives sold from business to business or to the final consumer
- 19. Changes in production process or starting materials of a food additive (Article 11)
- 20. Reviews and re-evaluation (Articles 29 and 30)
- 21. Re-evaluation programme
- 22. Transitional provisions (Article 32)
4. The European Parliament has given in first reading a favourable opinion on the proposal on 10th July 2007
5. The present proposal amends the original proposal [COM (2006)0428 – 2006/0145(COD)] so as to take into account the amendments of the European Parliament that were accepted by the Commission.
6. With regard to the original proposal, the European Parliament adopted 59 amendments. Commissioner Kyprianou had indicated to the plenary meeting on 9 July 2007 that the Commission could accept many of the amendments, wholly or in part, and subject to rewording. The amendments that cannot be accepted by the Commission are: 10, 11, 12, 20, 24, 25, 29, 30, 34, 38, 40, 45, 47, 52, 54, 5, 6, 69rev, 73 and78.
7. The amendments in the revised proposal are in bold and underlined . A number of amendments have been reformulated so as to ensure consistency of the terminology used throughout the proposal and the other proposals of the package, or to bring the text in line with the approach of the Council where similar amendments have been proposed.
8. The numbering of the Articles has been adapted to take into account a number of amendments.
The Commission announced in the White Paper on Food Safety (COM (1999) 719 final) that it would up-date and simplify existing Community legislation with regard to food additives (Action 11 in the White Paper).The objectives of this proposal are:
- To simplify food additive legislation by creating a single instrument for principles, procedures and approvals;
- To confer the implementing powers on the Commission to update the Community list of authorised food additives;
- To consult the European Food Safety Authority (EFSA) for the safety evaluation of food additives;
- To set up a re-evaluation programme for existing food additives;
- To require the authorisation of additives that consist of, contain or are produced from genetically modified organism under Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed.
A number of the proposed amendments aim to improve the proposal from a technical and editorial point of view. These amendments have largely been taken over by the Commission although some have been subject to editorial amendment (Amendments concerned: 3, 8, 13, 14, 15, 16, 18, 19, 21, 22, 33 (in part), 36, 37, 39, 42, 43, 44, 46, 48,67rev, 79, 68rev, 80, 51, 55, 56, 57, 58, 59 , 60 and 64rev.)
Amendment 10 cannot be accepted as plant protection products used for post harvest treatment are already subject to separate Community legislation. However if the substance(s) used for post harvest treatment does not fall under the plant protection product definition it would be considered as a food additive if exerting a preservative effect.
In the amended proposal, the Commission has not taken on board amendment 11 which would exclude microbial cultures from the scope of the legislation. Some cultures are added to foods near the end of their manufacture for an intended preservation effect and therefore could be considered to be food additives. It is therefore not appropriate to exclude such substances from food additives legislation.
Since the package was adopted around the time that Decision 2006/512/EC amending Decision 1999/468/EC laying down the procedures for the exercise of implementing powers conferred on the Commission was adopted, the Commission proposal referred to the normal regulatory procedure. Therefore the alignment of the amended proposal with Decision 2006/512/EC is generally endorsed by the Commission.
However amendment 12 introduces the regulatory procedure with scrutiny for deciding whether or not a given substance falls within the scope of the Regulation. The application of this provision is an implementation of the rules contained in the basic act ('food additive' definition) and therefore does not fall within the new regulatory procedure with scrutiny. The normal regulatory procedure should therefore apply. Similarly amendments 40 and 47 cannot be accepted as they also relate to provisions the application of which are an implementation of the rules contained in the basic act and therefore do not fall within the new regulatory procedure with scrutiny.
Amendments 9 and 22 aim to clarify that a food additive or a food in which a food additive is used should not be placed on the market, if the food additive or its use does not comply with the proposed Regulation. This clarification is endorsed in the amended proposal with the inclusion of Article 5.
The Commission proposal sets criteria for the authorisation of food additives. Food additives must be safe; there must be a technological need for their use; and their use must not mislead the consumer. The Commission introduced into the amended proposal in recital 7 the clarification of what is meant by misleading the consumer (amendments 3 and 26 ). The principle of amendment 28 has also been included in recital 8 of the amended proposal which will reiterate that the authorisations of food additives will refer to the consideration of the criteria in the Regulation.
However, amendment 78 requires the authorisation of food additives to be based on the precautionary principle. The precautionary principle and the conditions for its application are already laid down in the General Food Law (Regulation (EC) No 178/2002) and it should not be repeated in the proposed Regulation on food additives.
Amendment 24 proposes to link the technological need of a food additive with the benefit to the consumer. The technological function of a food additive can, in many cases, be beneficial for manufacturers without having a detrimental effect nor a direct benefit for the consumer. An example of this could be when the use of a food additive reduces wastage in a production process.
The environmental impact is not among the general conditions for authorising food additives but it is of course a legitimate factor to be considered. For instance when adverse environmental effects are identified, these can be taken into account during the authorisation or revision of the conditions of use for a food additive. Therefore, although amendment 25 cannot be accepted, other changes can be made to the text to reinforce the environmental aspects. Similarly amendment 7 can be accepted subject to modification to reflect the other principles contained within the General Food Law, i.e. that the rules on food additives used in foods will ensure the effective functioning of the internal market and a high level of protection of human health and protection of consumers' interests, including fair practices in food trade, taking account of the environment.
In relation to amendment 1, the allergenicity of food (including food additives) is covered by labelling under Directive 2000/13/EC. Although the Commission cannot accept an outright restriction on the use of food additives which may be allergenic, the allergenicity can of course be considered as a legitimate factor during the authorisation of a food additive. This principle has therefore been emphasised in recital 7.
Amendments 20 and 29 cannot be accepted. The current criteria of the use of sweeteners restrict their use to foods which are energy reduced or which contain no added sugar. This ensures that consumers have a benefit from the use of such sweeteners in that there is either an appreciable energy reduction (of 30%) or the product contains no added sugars. The new criterion proposed here has the potential to increase the range of foods to which sweeteners can be used and therefore may have an impact on the consumption of such additives. In addition in some instances there may only be a marginal benefit to the consumer from the replacement of 30% sugar.
Sweeteners are not used for the purpose of increasing the shelf life of foods by preservation. However, a consequence of the use of sweeteners can be that the shelf life is increased because of the lack of fermentable sugar which the sweetener has replaced; therefore the Commission is unable to accept amendment 73 .
The general criteria for the use of additives in Article 6 already stipulate that the use of additives should not mislead the consumer. General labelling information also exists to ensure that consumers are aware of the composition of foods in particular with regard to the ingredients present. With regard to the use of colours, these are traditionally used in some foods to identify particular flavours for instance in soft drinks or confectionery. In these instances there is no evidence that consumers are mislead as to the content of the foods. Therefore bearing in mind the principle already contained in Article 6, amendment 30 has not been taken on board in this amended proposal.
Amendment 34 is proposed to include in the Community list a reference to the other food additives which may not be used in combination with the food additive. The Commission has not accepted this amendment as it is considered that such a reference would already be covered under point c which requires the conditions of use to be specified. In such cases, where concerns relating to the use of additives in combination are highlighted in the EFSA evaluation, suitable conditions of use would be stipulated when the additive is authorised.
The Commission proposal aims to cover all food additives including those produced from genetically modified organisms (GMOs) or by (fermentation using) genetically modified micro-organisms (GMMs). Food additives produced using GMMs do not fall under Regulation 1829/2003 on GM food and feed and they will be entirely covered for their assessment and authorisation by the Regulation on food additives. Food additives which fall within the scope of Regulation (EC) No 1829/2003 will be subject to that Regulation with regard to the safety assessment of the genetic modification, while the other aspects of safety, the consideration of the other criteria and the final authorisation will be dealt with under the food additives Regulation. The two evaluations and authorisations can run in parallel.
Amendments 4 and 63 clarify that the two procedures may run simultaneously in accordance with good administrative practice. The proposed clarification is endorsed by the Commission subject to some drafting changes in order to make the provision more compatible with Regulation 1829/2003. Amendment 38 however proposes to introduce additional labelling requirements. The labelling of GMOs is subject to horizontal rules under Regulation 1829/2003, therefore it is not appropriate to introduce specific measures under this vertical legislation on food additives.
Amendment 45 would introduce a requirement for allergen warning where azo dyes are present. The labelling of allergens is addressed horizontally under Directive 2000/13/EC and therefore the issue of allergen labelling should continue to be addressed under that legislation based on scientific evaluations by EFSA.
Amendments 42 , 43 and 44 are acceptable as they introduce some useful aspects to the business to business labelling provisions. In particular amendment 44 provides a practical derogation so that certain information can be included on the accompanying documentation rather than the packaging in the case of bulk delivery of additives (e.g. in tankers).
In its original proposal the Commission aligned the labelling provisions of additives with those of enzymes. The European Parliament made a number of amendments to the enzymes proposal to ensure a new presentation and simplification of the labelling provisions for enzymes sold from business to business or to the final consumer. The Commission has therefore taken on board the spirit of these amendments also in this amended proposal on food additives.
In addition, since food additives intended for sale to the final consumer are considered food and must comply with the relevant labelling provisions of Directive 2000/13/EC relating to the labelling, presentation and advertising of foodstuffs, the text has been further simplified so as not to repeat the provisions of Directive 2000/13/EC.
Amendment 35 would introduce separate limit values for nanoscale food additives; the Commission does not feel that such an amendment is necessary as specific restrictions could already be allocated under the conditions of use if these are deemed necessary.
However as this is an important issue it is useful to amend the text to reiterate and clarify that nanoscale additives would need to be evaluated by EFSA before they could be used as they may behave in a different manner which could affect their safety.
The amended Commission proposal includes a new Article 11 introducing requirements for food additives already included in the Community list which are prepared by production methods or starting materials significantly different from those included in the risk assessment of the Authority. This Article reflects the principle in recital 14 of the Commission proposal.
The Commission has proposed that the current authorisations for food additives will be transferred into the new annexes after a review of the criteria other than safety. This review will take approximately 2 years. At the same time the EFSA has been tasked with a re-evaluation of the safety of all currently permitted food additives, which will take a number of years. If during the EFSA re-evaluation particular concerns are raised, any necessary amendments can be made at any time. Because of the differences in timing, it is not appropriate to bind these two separate reviews together. Additionally for clarity it is appropriate that the annexes are completed at the earliest possible opportunity. Amendments 52 , 6 and 69rev would link these 2 aspects and therefore, for the reasons highlighted above, cannot be accepted by the Commission. The principle of amendment 55 can however be accepted and article 29 has been amended to make clear that when the annex II is populated, food additive uses which are no longer necessary will not be included.
In amendment 57 it has been proposed to amend the definition of carriers to include also substances which are used to dissolve, dilute, disperse or otherwise physically modify nutrients and/or other substances added for nutritional or physiological purposes. Amendment 60 provides provision for such substances to be included in Annex III. The Commission can accept these amendments which widen the scope and further harmonise the area of food additives. The amended proposal has therefore been drafted to reflect these amendments and also some other consequential changes necessary to incorporate these provisions. As this change in scope will be new to the legislation on food additives the entry into force will be delayed as with the other new provisions on food additives in food additives and food enzymes.
Other amendments have also been proposed with a the consequence that the food additives permitted in flavourings will be listed in Annex III rather than Annex II as originally foreseen (amendments 58 and 59 ). The Commission can accept this amendment which will treat food additives used in food additives, food enzymes and flavourings in the same way and has amended the proposal to reflect this change; some consequential amendments to other aspects of the proposal have also been made. The listing of tables in the annex however has been adapted to take into account the different requirements and also in particular the differences in their date of entry into force or completion.
Amendments 5 and 54 would introduce a requirement for a rolling re-evaluation programme. Food additives are subject of continuous observation once they have been authorised and are re-evaluated whenever new scientific data becomes available which may affect the outcome of the previous evaluation. A regular review is therefore not necessary and it would increase the administrative burden for the Commission and EFSA.
As some amendments, in particular to labelling, introduce changes from the current legislation it is appropriate to introduce a transitional provision as proposed in amendment 56 . A suitable provision has therefore been included in Article 32 which will permit food additives which were legally labelled to continue to be marketed until their date of minimum durability.
23. Pursuant to Article 250 i of the EC-Treaty, the Commission amends it proposals in accordance with the lines set out above.