To ensure the safety, quality and compliance of plastic materials, adequate data on the composition of (intermediate) materials has to be communicated via the manufacturing chain, up to but not including the retail stage.įor this purpose a ' Declaration of Compliance' (DoC) needs to be provided. The migration testing is done under standardised time/temperature conditions, representative for a certain food use, and covers the maximum shelf life of packed food. Acetic acid 3 % (w/v) is assigned for acidic foods. These simulants are representative for a food category, e.g. Although migration testing in the food prevails, migration is usually tested using ' simulants'. The Regulation sets out detailed migration testing rules. To ensure the overall quality of the plastic, the overall migration to a food of all substances together may not exceed the Overall Migration Limit (OML) of 60mg/kg food, or 10 mg/dm 2 of the contact material. These are established by EFSA on the basis of toxicity data of each specific substance. For the substances on the Union list the Regulation sets out ' Specific Migration Limits' (SML). These limits specify the maximum amount of substances allowed to migrate to food. Relation between the present Regulation and earlier Directives.Īn important mechanism to ensure the safety of plastic materials is the use of migration limits. The consolidated version however is not legally binding, and a list of specific amendments is given below. The consolidated version should be considered as a tool for your convenience but may not contain all the most recent amendments: Consolidated version of Commission Regulation (EU) No 10/2011 The Regulation also specifies restrictions on the use of these substances and sets out rules to determine the compliance of plastic materials and articles. It sets out rules on the composition of plastic FCMs, and establishes a Union List of substances that are permitted for use in the manufacture of plastic FCMs. The most comprehensive specific EU measure is Commission Regulation (EU) No 10/2011 on plastic materials and articles. There are also specific rules on some starting substances used to produce FCMs. In addition to the general legislation, certain FCMs - ceramic materials, regenerated cellulose film, plastics (including recycled plastic), as well as active and intelligent materials - are covered by specific EU measures. Good manufacturing rules apply to all stages in the manufacturing chain of food contact materials, although the production of starting materials is covered by other legislation.
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