Plastics Regulation (EU) 10/2011 (always choose the latest consolidated version) 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. It should be noted that the guidelines have not been updated since 2016. As a result, the guidelines are no longer up to date in all respects.
The latest amendment to the Plastics Regulation (EU) 351/2025 has been published on 21.2.2025.
The amendments provide, inter alia, for purity requirements for authorised compounds (including natural substances and recycled materials) and labelling of materials and articles. The content of the declarations of comliance (Annex IV) and the test instructions for plastic materials for repeated use (Annex V) have also been clarified. The amendment also updated the GMP Regulation and repealed the so-called 'positive list' for biocides.
There is a transitional period for the amendment of the Regulation. Plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before the entry into force of this Regulation, and any other relevant Union legislation, which were first placed on the market before 16 September 2026 may continue to be placed on the market until the exhaustion of stocks.
The language versions of the amendment to the plastics regulation can be found here.