Materials and articles that can come into contact with food during its production, processing, storage, preparation, and serving are regulated as food contact materials (FCMs) in the European Union (EU). This includes direct or indirect contact. FCMs include materials that:
- are intended to be brought into contact with food;
- are already in contact with food; or
- can reasonably be brought into contact with food or transfer their constituents to the food under normal or foreseeable use.
In the EU, there is a Framework Regulation—Regulation (EC) No 1935/2004—that sets out the general principles of safety for FCMs. It requires that FCMs do not release their constituents into food at levels harmful to human health or change food composition, taste, or odor in an unacceptable way.
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. National legislation is in place in the majority of EU Member States, setting out individual rules on different materials and substances. These may differ from one Member State to another.
The European Food Safety Authority (EFSA) evaluates the safety of substances used in FCM. Companies submit applications to the national competent authority of a Member State, which forwards the application to EFSA. 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 tested by the business operators placing them on the market, and 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). Companies need to maintain appropriate documentation and records. Specific DoC requirements exist for plastics, recycled plastics, ceramics, and active and intelligent materials.
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