Framework regulation (EY) 1935/2004 of food contact materials

Framework Regulation 1935/2004  applies to all materials and articles that come into direct or indirect contact with foods, regardless of the material.

Indirect contact usually refers to outer food packages in where is the inner packaging. Exambles of indirect contact are e.g. a cardboard packaging in which a foodstuff that are already packed in plasticfoil are still packed  or plastic shopping bags, where the already packed foodstuff are going to pack.

Regulation 1935/2004 applies to all food contact materials that are intended to be brought into contact with food, are already in contact with food, or can be expected to be brought into contact with food.

Article 3 of Regulation 1935/2005 specifies general requirements for the chemical stability. These materials and articles may not in foreseeable conditions release to food their constituents in amounts which could endanger human health or change the composition of the food in an unexpected way, or cause changes in the organoleptic characteristics of food. Labels on the consumer packaging of food contact materials must not mislead the consumer.

The regulation provides instructions on applying for approval of new chemical substances used in the manufacture of materials that come into contact with food (Articles 8-12). You can find more information about applying for approval here: Food-sector > packages-and-other-food-contact-materials >rules-for-food-contact-materials > framework-regulation-eu-19352004 > approval-of-ingredients.

Food contact materials must be marked visibly, clearly and permanently in retail sales in accordance with Article 15 of the framework regulation.

  • The words ‘for food contact’, or a specific indication as to their use, such as coffee machine, wine bottle, soup spoon, or the symbol reproduced in Annex II;
    • However, the above-mentioned labelling is not required if the equipment is, due to its characteristics, specifically intended for food contact with food.
  • If necessary, special instructions to be observed for safe and appropriate use;
  • The name or trade name and, in either case, the address or registered office of the manufacturer, processor, or seller responsible for placing on the market;
  • Adequate labelling or identification to ensure traceability of the material or article;
  • In the case of active materials and articles, information on the permitted use or uses and other relevant information.

Labelling can be made on the food contact materials or articles themselves, on their label or packaging. In trade between companies, the same information as in the labelling, can also be presented in documents.

Pursuant to Article 16, food contact materials and articles shall at all marketing stages other than the retail stage be accompanied by documentation demonstrating their compliance. More detailed requirements for the content of such documentation are specified in specific measures. At present, the Plastics Regulation provides the most detailed descriptions of the documents, and the EU Commission has also issued guidance on this matter. Finnish Food Authority provides general instructions regarding the content of these documents, as well, in the Guide on food contact materials published by Finnish Food Authority. You can find general guidance of Ruokavirasto here: Food-sector > packages-and-other-food-contact-materials > safety-and-other-compliance-of-food-contact-materials > declarations-and-documents > general-content-of-a-doc.

Food contact materials and their raw materials shall be traceable one step back (where it came from) and one step forward (where it goes next). This requirement is based on Article 17 of Framework Regulation 1935/2004. The purpose of traceability labelling is to ensure effective recall of products when necessary due to e.g. a defect found in food contact material. Food contact materials shall be traceable also in food premises.

Annex I lists the 17 different contact materials and articles which can be regulated by specific measures

Annex II: The symbol which indicate specific that material or article are for food contact.


Page last updated 10/27/2022