Commission Regulation (EC) No 1935/2004 provides a harmonised legal EU framework. It sets out the general principles of safety and inertness for all Food Contact Materials (FCMs).

The principles set out in Regulation (EC) No 1935/2004 require that materials do not:

  • Release their constituents into food at levels harmful to human health
  • Change food composition, taste and odour in an unacceptable way

Moreover, the framework provides:

  • for special rules on active and intelligent materials (they are by their design not inert)
  • powers to enact additional EU measures for specific materials (e.g. for plastics)
  • the procedure to perform safety assessments of substances used to manufacture FCMs involving the European Food Safety Authority
  • rules on labelling including an indication for use (e.g. as a coffee machine, a wine bottle, or a soup spoon) or by reproducing the appropriate symbol.
  • for compliance documentation and traceability

Commission Regulation on Good Manufacturing Practices

Commission Regulation (EC) No 2023/2006 ensures that the manufacturing process is well controlled so that the specifications for FCMs remain in conformity with the legislation:

  • premises fit for purpose and staff awareness of critical production stages
  • documented quality assurance and quality control systems maintained at the premises, and
  • selection of suitable starting materials for the manufacturing process with a view to the safety and inertness of the final articles

Good manufacturing rules apply to all stages in the manufacturing chain of food contact materials, although the production of starting materials is covered by other legislation.

In addition to the general legislation, certain FCMs — ceramic materials, regenerated cellulose film, plastics (including recycled plastic), as well as active and intelligent materials — are covered by specific EU measures. There are also specific rules on some starting substances used to produce FCMs.