In the EU, there is a Framework Regulation—Regulation (EC) No 1935/2004—that sets out the general principles of safety for FCMs. It constitutes safety for the consumer by demanding that that FCMs:
- do not release their constituents into food at levels harmful to human health
- do not alter food composition in an unacceptable way,
- bring about changes in the taste, or odor (organoleptics) of the food.
The Framework Regulation has stipulated 17 groups of materials that require specific measures, however only few of these have actually been implemented EU-wide. Specific EU measures are in place for plastics, processes for recycled plastics, regenerated cellulose film, lead and cadmium in ceramics, and active and intelligent materials and articles.
In the absence of specific EU measures, member states may maintain or adopt their own national provisions on food contact materials.
The European Food Safety Authority (EFSA) evaluates the safety of substances used in FCM. Companies may either submit applications to the national competent authority of a Member State, which forwards the application to EFSA, or submit the application to the EFSA directly. The EFSA also evaluates the safety of the substances continuously and will, when necessary, restrict the use of substances.
A requirement in the Framework Regulation is that food contact materials are produced according to good manufacturing practices (GMP). The GMP Regulation, (EC) 2023/2006, establishes good manufacturing practices for FCMs. Good manufacturing rules apply to all points in the manufacturing chain of food contact materials. The rules are intended to ensure that manufacturing processes are well controlled so that the specifications for FCMs remain in conformity with applicable requirements.
The safety of Food Contact Materials is evaluated by the business operators placing them on the market, and monitored continuously by the competent authorities of the Member States. The European Reference Laboratory for Food Contact Materials (EURL-FCM) maintains scientific knowledge and technical competence on testing methods.
In the EU, information about the composition of FCM materials needs to be communicated through the supply chain via a Declaration of Compliance (DoC). The declarations are intended to provide traceability and transparency throughout the supply chain. The final responsibility lies with the business operator placing the FCM/Packaging on the market. The business operator will use the Declarations to validate the safety of the FCM. Specific DoC requirements exist for plastics, recycled plastics, ceramics, and active and intelligent materials.
The materials available and information provided at the Avery Dennison ADvantage: Complete Compliance site are for informational purposes only and not for the purpose of providing legal advice.