The 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.
However, the Plastics Regulation does not apply to the actual coatings, adhesives or printing inks, although they all may be an integral part of the plastic material. Ion exchange resins, rubber and silicon, as well as colorants and solvents used in plastics are not included within the scope of the Regulation either. However, they are always required to meet the general requirements for inertness specified in Article 3 of Framework Regulation 1935/2004.
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. Other manufacturing substances may be used in the plastic under the functional barrier layer, however, provided their migration remains below a limit of 0.01 mg/kg, and they are not mutagenic, carcinogenic or toxic to reproduction. Nanoparticle substances are not authorised either.
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 is 10 mg per 1 dm2 of the material's contact surface. This is referred to as the overall migration limit, OML.
Plastic food contact materials may contain also other substances than those included in the positive list in Annex I to Regulation 10/2011. Such substances include e.g. salts of authorised acids, phenols and alcohols, various mixtures, natural and synthetic polymeric substances of a molecular weight higher than 1000 Da (Dalton), pre-polymers, as well as impurities and reaction and decomposition products generated in the process (= NIAS non-intentionally added substances).
Dual use additives refer to additives and flavourings which are authorised for use in foods and are required to comply with the rules specified for them. The use of dual use additives in food contact materials may not fulfil any technological function in the food and their amount may not exceed the maximum limit. In case they fulfil a technological function, the food contact material is classified as an active contact material for which specific measures have been established, as you may recall from previous slides. Where no maximum limit has been set for the additive or flavouring, a migration limit value of 0.01 mg/kg shall apply.
Article 16 of the Plastics Regulation defines the documents used to demonstrate the compliance of plastic materials. These documents include the actual declaration of compliance, and the supporting documents used to demonstrate compliance. Supporting documents shall contain the conditions and results of testing, calculations, including modelling, other analysis, and evidence on the safety or reasoning demonstrating compliance (result of risk assessment).
The Annexes to the Plastics Regulation are five:
- Annex I union list of authorized substances
- Annex II restrictions on materials and articles (some metals and primary aromatic amines
- Annex III Food simulants A-E, food categories and time and temperature
- Annex IV Declaration of compliance
- Annex V Compliance testing (also standardized testing conditons OM1-OM9)
EU-guidances on Plastic regulation 10/2011 you can find here.