Restriction of epoxy derivatives in food contact materials
Regulation (EC) No 1895/2005 — restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food
WHAT IS THE AIM OF THE REGULATION?
It bans the use and/or presence of 2 substances (BFDGE* and NOGE*) in materials and articles intended to come into contact with food* made from plastic or covered with a surface coating or food contact adhesives.
It restricts the use of a substance known as BADGE* and its derivatives, with specific migration limits.
It requires that materials containing BADGE are accompanied by a written declaration and appropriate documentation to demonstrate compliance. The test method for ensuring compliance is also specified in the regulation.
It repeals and replaces Directive 2002/16/EC.
Restriction of BADGE
Following an opinion issued by the European Food Safety Authority (EFSA) (set up under Regulation (EC) No 178/2002), the European Commission restricts the use of the group of substances known as BADGE used or present in plastic food-contact materials, food-contact materials with a surface coating or food contact adhesives. The use and/or presence of BADGE was to have been prohibited as of 31 December 2005 by Directive 2002/16/EC, but after analysing the toxicological data, the EFSA concluded that the data do not raise concerns about carcinogenicity and genotoxicity in living organisms.
The specific migration limit for this substance is:
- 9 mg/kg in food or food simulants;
- 9 mg/6dm2 for containers with a capacity of less than 500 ml or more than 10 litres, but also for sheet and film.
In addition, since 1 January 2007, materials and articles containing BADGE must be accompanied by a written declaration stating that they comply with the rules.
Prohibition of BFDGE and NOGE
2 other substances used or present in plastic food contact materials, food contact materials with a surface coating or food contact adhesives have been prohibited: BFDGE and NOGE.
NOGE and BFDGE have been prohibited since 31 December 2004, in accordance with Directive 2002/16/EC, which this regulation repeals. The current regulation maintains this ban, applicable as of 1 January 2005, although it permitted the exhaustion of existing stocks of these products for a transitional period.
Exceptions for large containers
Large containers (capacity greater than 10,000 litres) or pipelines belonging to or connected with them, covered by special coatings called ‘heavy-duty coatings’ are exempt from the requirements of the regulation.
Materials and articles covered by surface coatings and adhesives that did not comply with the specific migration limits for BADGE or prohibitions on NOGE and BFDGE and which were placed on the market before 1 March 2003 were permitted to continue to be marketed, provided the date of filling appeared on them.
The presence and/ or use of NOGE and BFDGE was permitted provided that the articles complied with the previous Directive 2002/16/EC and were brought into contact with food before 1 January 2005.
Written declarations for the purposes of confirming compliance with the regulation concerning BADGE were not required until 1 January 2007.
FROM WHEN DOES THE REGULATION APPLY?
It has applied since 1 January 2006.
For more information, see:
BFDGE: bis(hydroxyphenyl)methane bis(2,3-epoxypropyl) ethers.
NOGE: novolac glycidyl ether.
Materials and articles in contact with food:
- materials and articles made of any type of plastics,
- materials and articles covered by surface coatings,
BADGE: 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether and BADGE.H2O (CAS No = 076002-91-0) and BADGE.H2O (CAS No = 005581-32-8).
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 (OJ L 302, 19.11.2005, pp. 28-32)
Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 12, 15.1.2011, pp. 1-89)
Successive amendments to Regulation (EC) No 10/2011 have been incorporated into the original text. This consolidated version is of documentary value only.
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 (OJ L 338, 13.11.2004, pp. 4-17)
See consolidated version.
last update 09.06.2020