European Framework Regulation (EC) 1935/2004 Solutions

Europe has a harmonized legal framework (Regulation (EC) 1935/2004) for the safety of FCMs. Regulation (EC) 1935/2004 requires that all FCMs and articles (manufactured, imported and sold in the EU) intended to come into contact with food, comply with the Framework Regulation. Article 3 of this regulation states that FCMs may not release constituents into food at levels that could endanger human health or bring about changes in the composition, smell, or taste of the food. In addition, all FCMs should be manufactured according to the principles of good manufacturing practices (GMPs) stated in Regulation (EC) 2023/2006.

Certain FCMs such as plastics, ceramics, and regenerated cellulose are covered by independent harmonized regulations at an EU level as a means to demonstrate compliance to the general safety requirements of the Framework Regulation.

For many other materials, however, no harmonized European regulation exists. This includes widely used materials such as paper and board, rubber and silicone elastomers, coatings and printing inks. Individual Member states may adopt national regulations, but the general safety requirement of the Framework Regulation always applies regardless of the presence of a harmonized specific regulation.

All food contact materials covered by a specific measure in Europe need to be accompanied by a written Declaration of Compliance (DoC) stating that they comply with the regulations applicable to them. In addition, supporting documentation and traceability through labelling or documentation in the supply chain should be ensured. Companies should be able to identify one step prior and one step later in the supply chain.

Intertek’s regulatory food contact experts are available on the ground in several EU member states to provide guidance in understanding the various requirements under the European FCM regulations for all types of FCMs and articles.  In addition, we provide support in setting up compliance assessment programs (migration testing) to help our clients demonstrate compliance with the European Framework Regulation.

Compliance Assessments

Our services include:

• Gathering a complete list of all materials and substances used in the manufacturing process of a FCM or article
• Verifying the EU regulations that apply to the materials and articles to achieve compliance on an EU or Member State level
• Determining if industry guidelines or non-binding resolutions are available to support risk assessment towards the Framework Regulation in the absence of a harmonized specific regulation,
• Reviewing the bill of materials (BOM) to assess whether the substances and materials in a formulation are allowed to be used by checking against positive lists. 
  • Investigating if limitations (specific migration limits) or other requirements apply 
• Identifying the food contact application of the materials, what kinds of foodstuffs are intended to come into contact with these materials and under which conditions
• Designing a compliance program which can include migration testing, worst case calculation, modelling, NIAS studies and/or toxicological risk assessments
• Demonstrating that the manufacturing process complies with the GMP regulation (EU 2023/2006)
• Drafting a Declaration of Compliance (DoC) stating compliance with the regulations and ensuring all supporting documentation is in place