Regulation 2005/1895 - Restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food - Main contents
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official title
Commission Regulation (EC) No 1895/2005 of 18 November 2005 on the restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food| Legal instrument | Regulation |
|---|---|
| Number legal act | Regulation 2005/1895 |
| CELEX number i | 32005R1895 |
| Document | 18-11-2005 |
|---|---|
| Publication in Official Journal | 19-11-2005; Special edition in Croatian: Chapter 13 Volume 032,OJ L 321M , 21.11.2006,Special edition in Bulgarian: Chapter 13 Volume 049,Special edition in Romanian: Chapter 13 Volume 049,OJ L 302, 19.11.2005 |
| Effect | 09-12-2005; Entry into force See Art 8 01-01-2006; Application See Art 8 |
| End of validity | 31-12-9999 |
19.11.2005 |
EN |
Official Journal of the European Union |
L 302/28 |
COMMISSION REGULATION (EC) No 1895/2005
of 18 November 2005
on the restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (1), and in particular Article 5(1) thereof,
After consulting the European Food Safety Authority,
Whereas:
(1) |
To avoid risks to human health and barriers to the free movement of goods, Commission Directive 2002/16/EC of 20 February 2002 on the use of certain epoxy derivatives in materials and articles intended to come into contact with food (2), lays down specific migration limits for 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether (‘BADGE’ i.e. Bisphenol-A DiGlycidyl Ether), bis(hydroxyphenyl)methane bis(2,3-epoxypropyl)ethers (‘BFDGE’ i.e. Bisphenol-F DiGlycidyl Ether) and novolac glycidyl ethers (NOGE) and some of their derivatives. |
(2) |
Directive 2002/16/EC provides that the use and/or the presence of BFDGE and NOGE may only be continued until 31 December 2004. For BADGE the transitional period was extended until 31 December 2005 pending the expected submission of new toxicological data and their evaluation by the European Food Safety Authority (the Authority). |
(3) |
The toxicological data required for BADGE have been transmitted. The Authority concluded that BADGE, BADGE.H2O and BADGE.2H2O do not raise concern about carcinogenicity and genotoxicity in vivo and that a Tolerable Daily Intake of 0,15 mg/kg body weight can be established for BADGE, BADGE.H2O and BADGE.2H2O. Therefore a higher specific migration limit SML(T) can be established for BADGE BADGE.H2O and BADGE.2H2O. As regards the BADGE chlorohydrins, in view of the lack of data on genotoxicity in vivo, the Authority considers that the current specific migration limit of 1 mg/kg of food or food simulants remains appropriate. |
(4) |
Trade in and use of materials and articles containing BADGE in accordance with this Regulation shall therefore be permitted throughout the Community as from 1 January 2006. |
(5) |
The toxicological data required for NOGE and BFDGE have not been transmitted on time to permit their evaluation by the Authority and to continue their use. Therefore the use and/or presence BFDGE and NOGE is no longer permitted as from 1 January 2005 in accordance with Directive 2002/16/EC. However the exhaustion of existing stocks should be permitted. |
(6) |
For large containers, the use and/or presence of BADGE, NOGE and BFDGE are permitted. The high volume/surface area ratio, the repeated use over their long lifetime which reduces migration and the fact that contact with food usually occurs at ambient temperature suggests that it is not necessary to set a migration limit for BADGE, NOGE and BFDGE used in such containers. |
(7) |
Pursuant to Article 16 of Regulation (EC) No 1935/2004 materials and articles covered by specific measures are to be accompanied by a written declaration stating that they comply with the rules applicable to them. That requirement has not yet been included in Directive 2002/16/EC. Therefore it is necessary to introduce this obligation and to provide for a transitional period. |
(8) |
Having regard to the amendments required and in the interest of clarity, Directive 2002/16/EC should be replaced by a new Regulation. |
(9) |
Directive 2002/16/EC provides that its requirements concerning... |
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