Restriction of epoxy derivatives in food packaging
Some epoxy derivatives (plastics) in contact with food are toxic. European legislation has prohibited two substances (BFGD * and NOGE *) in materials and articles intended to come into contact with food. The use of BADGE and its derivatives has been authorised but with maximum limits.
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.
Authorisation of BADGE
Following the opinion issued by the European Food Safety Authority (EFSA), the European Commission permits the use of the substance known as BADGE * in materials and articles * used in packaging or other articles intended to come into contact with food, including active and intelligent packaging.
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.
(See also "Provisional arrangements" below.)
In addition, materials and articles containing BADGE must be accompanied by a written declaration stating that they comply with the rules. This compulsory declaration will be required as of 1 January 2007.
Two other substances used in manufacturing packaging or other items in contact with food have been prohibited: BFDGE and NOGE.
NOGE and BFDGE had been prohibited since 31 December 2004, in accordance with Directive 2002/16/EC, now repealed. The current Regulation maintains this ban, applicable as of 1 January 2005. However, the Regulation permits the exhaustion of existing stocks of these products (see "Provisional arrangements" below).
Exceptions for large containers
Large containers (capacity greater than 10 000 litres) may continue to use BADGE, NOGE and BFDGE in their special surface coatings without having to comply with limits for migration (or transfer of significant levels of these substances to the products in contact). The level of migration for this type of container is negligible, according to the Regulation.
BADGE, NOGE and BFDGE placed on the market before 1 March 2003 may continue to be marketed, provided the date of filling appears on them.
Materials and articles containing BADGE, BFDGE and NOGE may transfer significant levels of these substances to foodstuffs (migration), particularly when used as additives, which may pose a risk to human health.
The use and/or presence of BADGE had been prohibited as of 31 December 2005 by Directive 2002/16/EC, but Regulation (EC) No 1895/2005, which repeals it, once again permits the use of this group of substances. After analysing the toxicological data transmitted for this group of substances, the European Food Safety Authority (EFSA) concluded that they do not raise concerns about carcinogenicity and genotoxicity in vivo.
|Key terms used in the act|
|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);
BFDGE: bis(hydroxyphenyl)methane bis(2,3-epoxypropyl) ethers;
NOGE: novolac glycidyl ether;
Materials and articles in contact with foodstuffs:
- materials and articles made of any type of plastics,
- materials and articles covered by surface coatings,
|Act||Entry into force - Date of expiry||Deadline for transposition in the Member States||Official Journal|
|Regulation (EC) No 1895/2005||01.01.2006||-||OJ L 302 of 19.11.2005|
For an overview of materials in contact with foodstuffs, please visit the website of the Directorate-General for Health and Consumer Protection.