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Special Focus

EU Finalizes Framework Regulation on Food Contact Materials

Author: Devon Wm. Hill

The European Union's new Framework Regulation covering materials that are intended to come into contact with food (Regulation (EC) No 1935/2004) was published in the Official Journal of the European Union on November 13, 2004, and became effective December 3, 2004.

The new regulation repealed the former "Framework Directive" (Council Directive 89.109/EEC and provides the basic legislation governing the use of all food contact materials in the European Union. The new Framework Regulation differs from the previous Framework Directive in several important respects:


  • It imposes new requirements relating to the traceability of food contact materials. As has been the case with food and food additives, the new regulation requires stricter standards for the traceability of materials used in contact with food at all stages of the supply chain. The regulation establishes the principle of the "traceability" (Article 17) of food contact materials and articles at all stages of their manufacture, processing and distribution, by requiring that all business operators be able to identify the materials and articles received from and supplied to the previous and next operator in the chain. The regulation does not specify how this objective would be achieved and leaves this to the operators themselves.


  • It provides that requirements for food contact materials at the EU level may be set out as regulations as well as directives. Providing for the possibility of issuing regulations for food-contact materials has the advantage that regulations (as opposed to directives) become immediately effective after they are adopted by the Commission and do not need to be transposed into Member State law.


  • It sets forth definitions for active and intelligent packaging materials as well as certain requirements for the use of these materials in the EU. Namely, the Framework Regulation calls for these materials to be the subject of a specific directive governing their use, and the Regulation sets forth labeling requirements and mandates that their use must not mislead the consumer. A new provision for a specific directive on active and intelligent packaging materials has been proposed by the European Commission.


  • It also codifies the authorization procedure for the review and evaluation of new food-contact materials, including a new requirement that the European Food Safety Authority shall review a petition for a new material within 6 months (with a possible extension for an additional 6 months, provided that an explanation is provided to the petitioner, the Commission, and the Member States).


  • Finally, the Framework Regulation requires that materials and articles be accompanied by a "written declaration stating that they comply with the rules applicable to them" and that "appropriate documentation" to be made available on demand to demonstrate such compliance (Article 16).