EU regulations 1935/2004 and 10/2011 ensure food contact materials are safe, setting migration limits, authorized substances, and testing requirements, with manufacturers responsible for compliance and providing Declarations of Compliance.
EU food contact regulations ensure materials in contact with food are safe and do not alter food properties. Food contact materials (FCMs) cover a wide range of materials, including plastics, paper, metal and glass. Regulation (EC) No 1935/2004 provides a harmonized legal EU framework for all FCMs, setting broad safety and compliance principles. Regulation (EU) No 10/2011 is a specific regulation focused on plastic materials and articles intended for food contact, detailing technical requirements like the Union List, migration limits, and testing conditions to supplement Regulation (EC) No 1935/2004.
All FCMs must comply with Regulations (EC) No 1935/2004 on materials and articles intended to come into contact with food when placed on the European market.
Regulation (EC) No 1935/2004
This is the framework regulation governing all FCMs in the EU, ensuring materials and articles intended to come into contact with food (e.g., packaging, kitchenware, utensils, kitchen appliances) are safe for human health.
Key Requirements:
- Materials must not transfer substances into food in quantities that endanger human health, change food composition unacceptably, or alter taste/odor.
- Good Manufacturing Practices (GMP) must be followed.
- Specific materials (e.g., plastics, ceramics) may have additional EU or national rules.
- Labeling requirements include "for food contact" or specific use instructions (e.g., microwave-safe).
- Businesses must provide a Declaration of Compliance (DoC) to confirm adherence to regulations.
Regulation (EU) No 10/2011
A regulation focused on plastic materials and articles (including plastic layers in multi-material articles used in food contact applications) intended for food contact, supplementing Regulation (EC) No 1935/2004.
Key Requirements:
- Union List: Establishes a list of authorized substances that can be used in plastics, with specific migration limits (SMLs) for certain substances.
- Migration Limits: Specify the maximum allowable amount of substances that can transfer from FCMs into food, to ensure substances migrating into food do not pose a risk to human health.
- Overall Migration Limit (OML): Sets the maximum amount of non-volatile substances, 10 mg/dm² or 60 mg/kg (for articles intended for infants or young children) that can migrate from the plastic material into food.
- Specific Migration Limits (SMLs): Set for individual substances the maximum amount of that substance allowed to migrate into food based on toxicological assessments e.g. specific migration of metals, specific migration of PAA e.t.c.
- Testing: Verifies compliance through migration testing under standardized conditions (e.g., temperature, time, food simulants).
- Simulants: Mimic the properties of different types of food (e.g., acidic, fatty, aqueous). This helps in assessing how substances might migrate under various conditions.
- Time and Temperature: Simulate the actual use of the food contact material including storage, cooking, and refrigeration by testing under specific time and temperature conditions.
- Declaration of Compliance (DoC): Needs to be provided based on supporting documentation such as details on substances used, compliance with migration limits, and intended food contact conditions.
Manufacturers, importers, and downstream users must ensure compliance with both regulations, including providing DoCs and maintaining traceability. Non-compliance can lead to product recalls, fines, or market restrictions. Other materials (e.g., paper, metals, ceramics) may be subject to national regulations or specific EU measures (e.g., Directive 84/500/EEC for ceramics).
How We Can Support
Our experts can provide tailored testing plans to meet EU food contact material requirements. We conduct both overall migration and specific migration tests in accordance with EN 1186, EN 13130, and testing conditions in the JRC guidelines. Additionally, we assist in preparation and issuance of Declarations of Compliance (DoC).
Our laboratories also offer testing services for a wide range of materials. We conduct compliance tests on materials including paper, rubber, and metal, in accordance with relevant national standards, such as the German LFGB and the French DGCCRF.
