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1、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, HavingregardtotheTreatyestablishingtheEuropean Co
2、mmunity, 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 t
3、he 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 deri- vatives in materials and articles intended to come into contact with food (2), lays down spe
4、cific migration limits for2,2-bis(4-hydroxyphenyl)propanebis(2,3-epoxy- propyl)ether(BADGEi.e.Bisphenol-ADiGlycidyl Ether),bis(hydroxyphenyl)methanebis(2,3-epoxypro- pyl)ethers (BFDGE i.e. Bisphenol-F DiGlycidyl Ether) and novolac glycidyl ethers (NOGE) and some of their derivatives. (2)Directive 20
5、02/16/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 Authorit
6、y (the Authority). (3)The toxicological data required for BADGE have been transmitted.TheAuthorityconcludedthatBADGE, 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 beestablishedforBADGE,BAD
7、GE.H2Oand BADGE.2H2O. Therefore a higher specific migration limitSML(T)canbeestablishedforBADGE 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 f
8、ood simulants remains appropriate. (4)Trade in and use of materials and articles containing BADGEinaccordancewiththisRegulationshall 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 perm
9、it their evaluation by the Authority and to continue their use. Therefore the use and/or presence BFDGE and NOGE is nolongerpermittedasfrom1January2005in accordance with Directive 2002/16/EC. However the exhaustion of existing stocks should be permitted. (6)For large containers, the use and/or prese
10、nce 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
11、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 complywiththerulesapplicabletothem.That requirement has not yet been included in Directive 200
12、2/16/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. EN L 302/28Official Journal of the European Union19.11.20
13、05 (1) OJ L 338, 13.11.2004, p. 4. (2) OJ L 51 of 22.2.2002, p. 27. Regulation as amended by Directive 2004/13/EC (OJ L 27, 30.1.2004, p. 46). (9)Directive 2002/16/EC provides that its requirements concerning BADGE, BFDGE and NOGE do not apply to materials and articles brought into contact with food
14、 before 1 March 2003. Those materials and articles may continue to be placed on the market provided that the date of filling appears on them. This date may be replaced by the best before date as provided for by Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on th
15、e approximation of the laws of the Member States relating to the labelling, presentation and advertising of food (1) or another indi- cation, such as the lot number required by Council Directive 89/396/EEC of 14 June 1989 on indications or marks identifying the lot to which a foodstuff belongs (2) f
16、or the food packed in such materials and articles, provided a link is established between this indi- cation and the date of filling so that the latter can always be identified. (10)Directive 2002/16/EC should therefore be repealed. (11)The measures provided for in this Regulation are in accordancewiththeopinionoftheStanding Committee on the Food Chain and Animal Health, HAS ADOPTED THIS REGULATION: Article 1 Scope 1.This Regulation shall apply to materials and articles, including active an
