New EU Regulation for Plastic Materials in Contact with Food Effective May 2011
On January 14, 2011, the European Commission (EC) adopted a new Regulation (No. 10/2011), which applies specific requirements for the safe use of plastic materials and articles intended to come into contact with food.
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Regulation Applies from May 1, Transitional Provisions until Dec 2012
This Regulation entered into force on February 4, 2011 and will apply from May 1, 2011. The Regulation also provides several transitional provisions, including a provision allowing materials and articles that have been lawfully placed on the market before May 1, 2011 to remain on the market until December 31, 2012.
Repeals Past Directive, Expands Scope of Plastic Materials
This new Regulation repeals the previous directive on this topic (Commission Directive 2002/72/EC) adopted in August 2002, which applied to materials and articles purely made of plastics and to plastic gaskets in lids, which were the main use of plastics on the market at the time.
The new regulation is more extensive as it covers plastics also used in combination with other materials in so called multi-material multilayers. The plastics covered by this regulation include: materials and articles and parts thereof consisting exclusively of plastics; plastic multi-layer materials and articles held together by adhesives or by other means; any such materials and articles that are printed and/or covered by a coating; plastic layers or plastic coatings, forming gaskets in caps and closures, that together with those caps and closures compose a set of two or more layers of different types of materials; and plastic layers in multi-material multi-layer materials and articles.
Includes Compliance Declaration, Testing, Authorized Substances, Etc.
Among other things, the new regulation includes the following:
- Testing documentation. In Article 16 (Supporting Documents), the Regulation states that appropriate documentation demonstrating that the materials and articles, products from intermediate stages of their manufacturing, as well as the substances intended for the manufacturing of those materials, comply with the Regulation's requirements. The documentation must contain the conditions and results of testing, calculations, including modeling, other analysis, and evidence on the safety or reasoning demonstrating compliance, and should be made available upon request by relevant authorities.
- Declaration of compliance. In Article 15 of the Regulation (Declaration of Compliance), it is stated that at the marketing stages, other than the retail stage, a written declaration in accordance with Article 16 should be available for all materials listed therein.
- Exclusions. This Regulation will not apply to rubber, silicones, or ion exchange resins, which are placed on the EU market and are intended to be covered by other specific measures.
- Authorized substances. The new Regulation provides a complete list of 885 monomers, other starting substances, additives, polymer production aids, and macromolecules from microbial fermentation in Annex I (Substances), which are authorized at the EU level.
- Migration limits. The Regulation provides a list of substances and their migration limits in which plastic materials and articles should not release in Annex II (Restrictions on Materials and Articles), which include: Barium, Cobalt, Copper, Iron, Lithium, Maganese, Zinc and primary aromatic amines.
- Food Simulants. The Regulation also defines food simulants Ethanol 10%, 20%, and 50%, vegetable oil and poly (2,6-diphenyl-p-phenylene oxide) as to their use within migration testing in Annex III (Food Simulants).