I. General legislation
The framework Regulation
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 more information, please refer to the following document on Symbols for labelling food contact materials.
for compliance documentation and traceability
Regulation on Good Manufacturing Practices
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.
II. EU legislation on specific materials
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.
III. Other Legislation
Legislation on Specific Substances
- Commission Regulation (EU) 2018/213 - on the use of bisphenol A in varnishes and coatings intended to come into contact with food and amending Regulation (EU) No 10/2011 as regards the use of that substance in plastic food contact materials (Questions & Answers on BPA)
- Regulation 1895/2005/EC - restricting use of certain epoxy derivatives in materials and articles intended to come into contact with food
- Directive 93/11/EEC - release of N-nitrosamines and N-nitrosatable substances from rubber teats and soothers
Products originating or consigned from China or Hong Kong
From 1 July 2011 kitchenware made of melamine or polyamide originating or consigned from China or Hong Kong must comply with the import rules of Regulation EU No 284/2011:
Consignments must be notified to the competent authorities at the entry points at least 2 working days before arrival
Consignments must have a declaration and a laboratory report on the analysis of primary aromatic amines (for polyamide) and formaldehyde (for melamine).
- EU guidelines for the import of polyamide and melamine kitchenware from China and Hong Kong
- Technical Guidelines concerning polyamide and melamine kitchenware including sampling and analytical methods
- Other documents
- Declaration of compliance under Commission Regulation (EU) No 284/2011 - on import of polyamide and melamine plastic kitchenware from China and Hong Kong - Template