Materials containing certain epoxy derivatives and coming into contact with foodstuffs

Certain epoxy derivatives are toxic when in contact with foodstuffs. European legislation has limited or prohibited these substances in materials which come into contact with foodstuffs because of their tendency to migrate.

ACT

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 foodstuffs [See amending acts].

3) SUMMARY

Materials and articles containing 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether ("BADGE"), bis(hydroxyphenyl)methane bis(2,3-epoxypropyl)ethers ("BFDGE") and novolac glycidyl ethers ("NOGE") may transfer significant levels of these substances to foodstuffs (migration), particularly when used as additives, and thus represent a potential risk to human health.

The Scientific Committee on Food:

• had given an opinion that the specific migration limit for BADGE and some of its derivatives could be extended for three years pending the submission of further toxicological data for evaluation;
• had examined the data available on BFDGE, which are very similar to the corresponding data obtained for BADGE. Acceptance of the use and/or presence of BFDGE and some of its derivatives may therefore also be continued pending the submission and evaluation of further toxicological data, under certain conditions;
• had stated that, in the absence of information about the potential exposure and toxicological profile of NOGE components, it is not in a position to evaluate the safety of use and/or the presence of corresponding products. The Committee is therefore of the opinion that, at present, it is not appropriate to use NOGE as an additive in materials and articles intended to come into contact with foodstuffs due to its tendency to migrate in this application.

In view of the statements of the Scientific Committee on Food, Directive 2002/16/EC, which applies to plastic materials and articles, materials and articles covered by surface coatings, and adhesives, establishes that:the use and/or presence of BFDGE is prohibited as of 31 December 2004;

• the use and/or presence of BADGE is prohibited as of 31 December 2005;
• as from 1 March 2003, NOGE may no longer be used in materials or articles in excess of the detection limit of 0.2 mg/6 dm2 (analytical tolerance included). In practice, the establishment of this strict limit rules out the use of NOGE as an additive. The use and/or presence of NOGE is prohibited as of 31 December 2004.

Exemptions from the scope of the Directive:

• special surface coatings for containers or storage tanks having a capacity greater than 10 000 litres, due to the low migration level of these recipients and the consequently negligible risk;
• materials and articles which use or contain BFDGE or NOGE, prior to 1 March 2003, may still be placed on the market provided that the date of filling appears on the materials and articles or is identified in another way.

Background

Directive 2002/16/EC repeals Directive 2001/61/EC on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs. Furthermore, Directive 2002/16/EC is an implementing measure of Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with foodstuffs.

RELATED ACTS

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 [Official Journal L 338 of 13.11.2004].

Council Directive 82/711 EEC of 18 October 1982 laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs [Official Journal L 44 of 15.02.1978; corrigendum L 163 of 20.06.1978]

Lays down basic rules for testing migration.

For an overview of the materials in contact with foodstuffs, visit the website of the Directorate-General for Health and Consumer Protection.

Last updated: 24.10.2005