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EU
The current regulation on food contact materials in the European Union is Regulation (EC) No. 1935/2004, passed by the European Parliament and the Council on November 13, 2004. This regulation not only replaces the previously implemented 80/590/EEC and 89/109/EEC directives, but also inherits and develops previous regulations in terms of content. It is the latest basic framework regulation of the European Union on food contact materials and products, which imposes strict limits on the total amount of substances that can migrate from food contact materials. As of now, there are over 30 EU directives or regulations related to food contact materials and products. The main testing items include comprehensive migration in different food simulation liquids, specific migration of a certain substance in different food simulation liquids, such as formaldehyde, primary aromatic amines, heavy metal elements, etc. The regulatory requirements are detailed as follows:
1. Plastics (EU) No 10/2011 and its amendments
2. Nylon material EU 284/2011
3. Coating Regulation (EU) 2018/213&AP Resolution (2004) 1
4. Metal CM/RES (2013) 9&GUIDELINES ON METAL AND ALLOYS
5. Silicone AP Resolution 2004 (5)
6. Rubber AP Resolution 2004 (4)
7. Ceramic products 84/500/EEC&2005/31/EC
8. Paper/cardboard AP Resolution (2002) 1
9. Aluminum or aluminum alloy EN 601&602
The core regulation of the European Union on Food Contact Materials (FCM) is Regulation (EC) No 1935/2004, which came into effect on November 13, 2004 and replaced the previous directives 80/590/EEC and 89/109/EEC, becoming the latest basic framework regulation for food contact materials in the EU. The following is a detailed explanation of the regulation:
1. Overview of regulations
Regulation (EC) No 1935/2004.
Scope of application: Applicable to all materials and products in contact with food, including plastics, rubber, metals, ceramics, glass, paper, and cardboard.
Core principle: Ensure that food contact materials do not pose a threat to food safety and human health, and do not have adverse effects on the odor, taste, and appearance of food.
2. Main requirements
(1) General requirements
Safety: Food contact materials must not release harmful substances into food and must not pose a threat to human health.
Inert: The material should have sufficient inertness to avoid chemical reactions with food.
Sensory performance: The material must not have adverse effects on the odor, taste, and appearance of the food.
(2) Specific material requirements
The EU has developed specific regulations and directives for different materials, such as:
Plastic: Regulation (EU) No 10/2011.
Ceramics: Directive 84/500/EEC.
Regenerated cellulose film: Directive 2007/42/EC.
Active and intelligent materials: Regulation (EC) No 450/2009.
3. Main testing items
(1) Comprehensive migration testing
Comprehensive migration in different food simulation solutions:
Measure the total amount of all transferable substances in the material to ensure compliance with the overall migration limit (OML).
Common food simulants include water, 3% acetic acid, 10% ethanol, and olive oil.
(2) Specific migration testing
Specific migration of a specific substance in different food simulation solutions:
Detect the migration amount of specific chemicals (such as formaldehyde, primary aromatic amines, heavy metals, etc.) in the material to ensure compliance with specific migration limits (SML).
(3) Heavy metal testing
Heavy metal element migration test:
Detect the migration of heavy metals such as lead, cadmium, nickel, chromium, etc. in materials to ensure compliance with EU limit requirements.
(4) Sensory testing
Sensory evaluation of odor and taste transfer:
Check if the material has any adverse effects on the odor and taste of the food.
4. Labeling and identification requirements
The product must be labeled with the label of "food contact material" or "suitable for food contact".
Please provide instructions for use, including applicable temperature range, cleaning methods, etc.
Manufacturer information, batch number, and production date need to be marked.
5. Punishment and Legal Responsibility
If the product does not comply with the requirements of Regulation (EC) No 1935/2004, it may face penalties such as fines, product recalls, or market bans.
Manufacturers and importers are legally responsible for product compliance.
6. Precautions for exporting to the European Union
Compliance testing: Ensure that the product passes the migration testing, heavy metal testing, and sensory testing required by EU regulations.
Technical documents: Prepare complete technical documents, including test reports, material lists, design drawings, etc.
Labels and instructions: Ensure that product labels and usage instructions comply with EU regulatory requirements.
Certification and Marking: Ensure that products are marked with the CE mark and comply with specific requirements of the European Union.
7. Summary
Regulation (EC) No 1935/2004 is the core regulation for the management of food contact materials in the European Union, which sets strict requirements for the safety, chemical migration, and sensory performance of materials. Food contact material products exported to the European Union must comply with this regulation and specific material regulations. Manufacturers and exporters need to pay special attention to the chemical safety, migration limits, and sensory performance of materials to ensure product compliance.
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