EU Regulation 10/2011 on Plastic Food Contact Materials: Testing Requirements for Comprehensive and Specific Migration

 EU Regulation 10/2011 on Plastic Food Contact Materials: Testing Requirements for Comprehensive and Specific Migration



Overview and Core Principles of EU Regulation 10/2011


EU Regulation 10/2011 was officially published on January 15, 2011, replacing the previous Directive 2002/72/EC. This regulation applies directly to all EU member states and is legally binding. Its core objective is to simplify compliance processes by establishing uniform EU internal market rules, while ensuring the safety of plastic food contact materials. The regulation defines "plastic materials" as functional materials composed of polymers and possibly with added additives or processing aids, primarily applicable to the following categories: single-layer and coated plastic articles, multi-layer composite plastic articles, metal or paper articles with plastic coatings (such as plastic-lined can lids, PE coatings on the inner walls of paper cups), plastic adhesives, and ion exchange resins.


The regulation defines "migration" as the process by which a substance is released from the plastic material and articles of manufacture for its final use into the food or food simulant it comes into contact with. The primary purpose of migration testing is to simulate the performance of materials in real-world use and verify their safety thresholds. Key principles include:


1. Overall Migration Limit (OML): This specifies that the total amount of non-volatile substances released from plastic materials into food simulants cannot exceed 10 mg/dm² (for container products) or 60 mg/kg of food (for infant food contact products and other specified cases). This indicator measures the "inertness" of the material, i.e., the total amount of non-specific small molecules released when the material comes into contact with food.


2. Specific Migration Limit (SML): For each authorized monomer, additive, or starting material, Annex I of the regulations specifies the maximum allowable migration limit (usually in mg/kg of food) into food. For example, the SML for bisphenol A is 0.05 mg/kg, and the total SML for primary aromatic amines is not detectable (detection limit is 0.01 mg/kg food simulant). Specific migration focuses on whether the migration amount of specific toxic or hazardous substances exceeds the safety limit.

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