Plastics Regulation (EU) 10/2011 is by far the most comprehensive regulation establishing specific measures and in many respects serves as an example of the criteria to be defined also for other materials. The Regulation applies to single-layer plastic materials, multilayer plastic materials and plastic layers in multi-material multi-layers, plastic coatings on lids of cans, as well as printed or coated plastic materials.
Only the monomers, additives and other starting substances listed in Annex I to Plastics Regulation 10/2011 may be used in the manufacture of plastic material intended to be brought into contact with food.
Annex I sets out for some of the substances listed a specific migration limit (SML) which may not be exceeded when the substance is tested. The total amount of substances that may migrate (OML) is 10 mg per 1 dm2 of the material's contact surface.
Annex II set also out for some substances, primary aromatic amines (PAA) and especially different kind of metals listed, a specific migration limit.
Annexes III and V of the regulation contain instructions for testing food plastics. Plastic food contact material must always be tested for the overall migration and the specific migration of substances allowed with restrictions under conditions that correspond to the conditions of use.
A model for the declaration of conformity of plastic contact materials is given in Annex IV of the regulation. The EU Commission has also drawn up detailed instructions on the content of the declaration of compliance for plastic food contact materials at different trade stages.
You will find instructions of the Plastics Regulation (different language versions), including instructions for drawing up a declaration of compliance, here.
The 16th amendment to the Plastics Regulation (Commission Regulation (EU) 2023/1442) published on 11 July 2023
The amendment has addressed the following issues:
* Permits for wood flour and fibre (FCM 96) and salicylic acid (FCM 121) are revoked,
* The transition limit for multiple phthalates is lowered and a new group restriction is introduced,
* The permit of the substance FCM 1007 is extended
* The following substances (FCM 1076, 1078, 1081, 1082, 1083) are approved.