What rules does the Framework Regulation set?

• General principles
• Groups of food contact materials and articles
• Procedure for authorisation
• Establishment of an European Reference Laboratory for food contact materials

General principles of the Framework Regulation

The Regulation - in force since 3 December 2004 - requires that food contact materials:

• Are safe;
• Must not transfer their components into food in quantities that could endanger human health, change food composition in an unacceptable way or deteriorate its taste and odour.
• Are manufactured according to good manufacturing practice
• An article intended for food contact must be labelled or bear the glass-and-fork symbol. This labelling is not obligatory if food contact is obvious by the article's nature e.g. knife, fork, wine glass.
• Labelling, advertising and presentation of food contact materials must not mislead consumers.
• Information on the appropriate use of food contact materials or articles must be provided, if necessary
• Are traceable throughout the production chain.

Framework Regulation EC 1935/2004

Groups of materials and articles

The Regulation establishes 17 groups of materials and articles which may be covered by specific measures. The specific measures may cover also combinations of different materials or recycled materials:

• active and intelligent materials and articles
• adhesives
• ceramics
• cork
• rubbers
• glass
• ion-exchange resins
• metals and alloys
• paper and board
• plastics
• printing inks
• regenerated cellulose
• silicones
• textiles
• varnishes and coatings
• waxes
• wood

There are specific measures for ceramics, regenerated cellulose, plastics, recycled plastics and active and intelligent materials and articles.

The Regulation includes definitions on active and intelligent packaging. If the materials release substances in the food that change the food composition or properties, then these substances must comply with food legislation e.g. food additives.

These materials and articles cannot be used to mask spoilage of food and mislead the consumer.

Procedure for authorisation

The Regulation establishes the authorisation procedure for:

• Substances for use in food contact materials and articles, specifically:
  • Substances used in plastic materials and articles;
  • Substances used for active or intelligent functions in active and intelligent materials
  • Substances used in regenerated cellulose films (cellophane)
• Materials and the articles themselves;
• Manufacturing processes of food contact materials and articles specifically:
  • Chemical recycling processes for plastics to be used in plastic food contact materials

Applicants must:

1. Prepare applications in accordance with the guidance of the European Food Safety Authority (EFSA);
2. Submit applications via a national contact point ;
3. EFSA evaluates them and gives an opinion;
4. Standing Committee on the Food Chain and Animal Health (SCFCAH) gives an opinion.
5. Authorisation is granted by listing the substance in legislation.