Framework Regulation (EC) No 1935/2004
The Framework Regulation establishes the fundamental principle of safety for all Food Contact Materials (FCMs). Under normal or foreseeable conditions of use, these materials must not endanger human health, bring about an unacceptable change in the food's composition, or deteriorate its taste or odor.
To prove that a material meets these high standards, businesses must generate and pass down a Declaration of Compliance, acting as a written warranty of safety.
Specific Material Measures and Migration Limits
While the framework applies to all materials, specific materials have detailed, harmonized regulations. The most notable is Regulation (EU) No 10/2011 for plastics. Under this regulation, the DoC must detail conformity with Overall Migration Limits (OML) and Specific Migration Limits (SML).
OML caps the total mass of substances that can transfer to food, while SML restricts the transfer of individual, potentially hazardous chemicals based on toxicological data.
Required Content of the DoC
A valid DoC is highly detailed. It must clearly identify the business operator issuing the document and the operator receiving the materials. It must contain a specific description of the food contact material or article.
Furthermore, it must state the date of the declaration, explicitly confirm compliance with relevant EU or national regulations, and provide adequate information on substances with restrictions, allowing downstream users to ensure final compliance.
- Identity of the manufacturer or importer.
- Clear description of the FCM.
- Confirmation of regulatory compliance.
- Information on restricted substances (SMLs).
Good Manufacturing Practice (GMP)
A DoC is only as reliable as the manufacturing process behind it. The DoC is legally supported by Regulation (EC) No 2023/2006 on Good Manufacturing Practice (GMP).
Businesses issuing a DoC must maintain supporting technical documentation showing that quality assurance and control systems are actively in place to ensure consistent compliance from batch to batch.
Frequently asked questions
Is a Declaration of Compliance required for all food contact materials?
While the framework regulation applies generally, specific formal DoC documents are explicitly mandated for plastics, active/intelligent materials, ceramics, and regenerated cellulose.
How often must a DoC be updated?
The DoC must be updated immediately whenever there are significant changes in the manufacturing process, raw materials, or updates to the relevant EU regulations.
What is the difference between Overall and Specific Migration Limits?
Overall Migration Limits (OML) cap the total amount of all substances that can transfer, while Specific Migration Limits (SML) restrict the transfer of individual, specific chemicals.
Does the DoC go to the final consumer?
No, the DoC travels strictly along the supply chain between businesses (e.g., from resin manufacturer to packaging producer) and is not provided to the end consumer.