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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.msw8(774 kB)

  • 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.

Plastic Materials

The most comprehensive specific EU measure is Regulation (EU) No 10/2011 on plastic materials and articles. It sets out rules on the composition of plastic FCMs, and establishes a Union List of substances that are permitted for use in the manufacture of plastic FCMs. The Regulation also specifies restrictions on the use of these substances and sets out rules to determine the compliance of plastic materials and articles.

An important mechanism to ensure the safety of plastic materials is the use of migration limits. These limits specify the maximum amount of substances allowed to migrate to food. For the substances on the Union list the Regulation sets out 'Specific Migration Limits' (SML). These are established by EFSA on the basis of toxicity data of each specific substance. To ensure the overall quality of the plastic, the overall migration to a food of all substances together may not exceed the Overall Migration Limit (OML) of 60mg/kg food, or 10 mg/dm2 of the contact material.

The Regulation sets out detailed migration testing rules. Although migration testing in the food prevails, migration is usually tested using 'simulants'. These simulants are representative for a food category, e.g. Acetic acid 3 % (w/v) is assigned for acidic foods. The migration testing is done under standardised time/temperature conditions, representative for a certain food use, and covers the maximum shelf life of packed food.

To ensure the safety, quality and compliance of plastic materials, adequate data on the composition of (intermediate) materials has to be communicated via the manufacturing chain, up to but not including the retail stage. For this purpose a 'Declaration of Compliance' (DoC) needs to be provided. The DoC is based on supporting documentation which documents the reasoning on the safety of a plastic food contact material, and which must be provided to enforcement Authorities on their request. The supporting documentation also provides an important link to the manufacturer's responsibility under GMP (Regulation (EC) No 2023/2006).

Guidance on plastic materials:

  • EU Guidancepdf(593 kB) Choose translations of the previous link  on Regulation (EU) No 10/2011 (click on the white balloon for more languages)
    – in support of the implementation of the general requirements of Commission Regulation (EU) 10/2011 on plastic food contact materials and articles
  • EU Guidancepdf(905 kB) Choose translations of the previous link  on information in the plastics supply chain (click on the white balloon for more languages)
    – in support of the implementation of Commission Regulation (EU) 10/2011 on plastic food contact materials as regards the declaration of compliance

Amendments to Regulation (EU) No 10/2011

The amendments below only amend Annex I of Regulation (EU) No 10/2011, thus changing the Union list of authorised substances.

Register and Lists

Active and Intelligent Materials

Active and intelligent materials extend the shelf-life by maintaining or improving the condition of packaged food, by releasing or absorbing substances to or from the food or its surrounding environment.

As a result they are exempted from the general inertness rule in Regulation (EC) No 1935/2004. The specific rules in Regulation (EC) No 450/2009 apply to address their specific purpose, e.g.:

  • absorption of substances from food packaging interior such as liquid and oxygen
  • release of substances into the food such as preservatives
  • indicate expiry of food through labelling that changes colour when maximum shelf life or storage temperature is exceeded

Active materials do not include systems that absorb substances entering from the atmosphere, such as active oxygen barriers.

Regulation (EC) No 450/2009 foresees the establishment of a Union list of substances permitted for the manufacture of active and intelligent materials.

Recycled Plastic Materials

Regulation (EU) No 10/2011 sets out criteria for the composition of new plastic materials. However after these materials have been used, they do not comply anymore to the plastic Regulation, as they may have been contaminated with other substances. Therefore, a separate Regulation exists to control the recycling processes: Regulation (EC) No 282/2008 on recycled plastic materials and articles intended to come into contact with foods


  • Directive 84/500/EEC – approximating EU countries' laws on ceramic articles intended to come into contact with foods

Regenerated Cellulose Film

  • Directive 2007/42/EC - materials and articles made of regenerated cellulose film intended to come into contact with foods

III. Other Legislation

Legislation on Specific Substances

  • 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 pointspdf(39 kB) at least 2 working days before arrival

  • Consignments must have a declarationmsw8 and a laboratory report on the analysis of primary aromatic amines (for polyamide) and formaldehyde (for melamine).