(EU) No 10/2011 is the core EU regulation governing plastic food contact materials (FCMs), effective since May 1, 2011. It replaces previous directives (e.g., 2002/72/EC) and aims to ensure plastic materials do not release harmful substances into food, safeguarding consumer health while harmonizing regulatory standards across EU member states. The regulation operates on a "Positive List" system, specifying approved substances (e.g., monomers, additives, processing aids) and their usage limits, with safety verified through migration testing.
Scope of Application
- Covered materials:
- Products made entirely of plastic (e.g., containers, utensils).
- Multi-layer plastic composites bonded via adhesives or coatings.
- Plastic products with printing or coatings.
- Plastic gaskets and multi-layer composite plastic products.
- Positive List: Only approved raw materials (e.g., polyethylene, polypropylene, specific antioxidants) may be used.
Core Compliance Requirements
- Migration Testing:
- Overall Migration Limit (OML): Total migrated substances ≤ 10 mg/dm² (or 60 mg/kg food).
- Specific Migration Limits (SMLs): Strict limits for substances like plasticizers and heavy metals (e.g., DBP reduced from 0.3 mg/kg to 0.12 mg/kg).
- Testing Conditions: Simulate real-use scenarios (temperature, duration, food simulants like ethanol, acetic acid, or vegetable oil).
- Declaration of Compliance (DOC):
- Suppliers must provide a DOC to downstream clients if materials comply with the Positive List and usage conditions (e.g., SMLs).
- The DOC must include:
- Material composition and CAS numbers.
- Migration test results.
- Manufacturer details and intended use.
- For multi-layer materials: Compliance statements for each layer.
Ongoing Compliance Updates
- DOCs must be updated for regulatory changes, material composition/purity adjustments, or other relevant factors.
How to obtain the list?
- Click here for the latest Positive List.
- Contact us for specific inquiries.
Our Services
- EU FCM compliance assessment.
- EU FCM testing.
- EU FCM Declaration of Compliance drafting/review.
