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.
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.
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.
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
|Directive 2002/16/EC||15.03.2002||28.02.2003||OJ L 51 of 22.02.2002|
|Amending act(s)||Entry into force||Deadline for transposition in the Member States||Official Journal|
|Directive 2004/13/EC||20.02.2004||-||OJ L 27 of 30.01.2004|