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Food contact materials made from plastics are highly regulated and a central part of Framework Regulation EC (No.) 1935/2004.
On 1 May 2011, Commission Regulation (EU) No. 10/2011 became effective and defined an array of specific requirements for plastic materials and articles intended to come into contact with food. The Plastics Regulation sets the requirements on the substances that can be used in production, on compliance testing and on the issuance of a Declaration of Compliance (DoC)
- List of authorised substances (Monomers, additives, production aids etc). Commission Regulation (EU) No. 10/2011 contains an exhaustive list of the substances that can be used in the production of plastics for food contact (Monomers, additives, production aids etc). The list also contains information on how the substances can be used and if there are specific requirements for them such as a specific migration limit or a limit to the residual content.
- Overall migration limits In an overall migration test, we examine the total amount of substances that have migrated from the material or article into the foodstuff. The specified limit value is 10 mg/dm2. The overall migration is determined by means of different food simulants in accordance with the European standard EN 1186.
- Specific migration limits The migration of remaining monomers, additives, plasticisers and solvents in materials and articles intended to come into contact with food is regulated by Regulation No. 10/2011/EC based on the toxicity of the individual substance. We can calculate the maximum migration of the substances, conduct tests according to the current standards or simulate the migration using migration modelling.
- Non-Intentionally Added Substances (NIAS) The regulation sets requirements to the manufacturer to assess the potential health risks associated with the presence of Non-Intentionally Added Substances (NIAS) in the food contact material. NIAS include, but is not limited to: impurities, degradation products and reaction products from the manufacturing process.
- Declaration of Compliance (DoC) At all the marketing stages other than the retail stage, a written declaration stating compliance with the legislation must be available. A Declaration of Compliance is a piece of documentation that follows a food contact material through the chain of suppliers. The declaration contains information on the quality assurance made by the manufacturer and shows that the product lives up to regulation.