Framework regulation (EU) 1935/2004

Framework Regulation 1935/2004 is, as indicated by its name, a regulation that applies to all materials and articles that come into direct or indirect contact with foods, regardless of the material.

Indirect contact usually refers to food packages that consist of both inner packaging and outer packaging, such as dry food packed in a paper bag packed in a cardboard box, or a tea-bag in cardboard packaging.

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.

The Regulation does not apply to antiques, edible food covering or coating materials (such as cheese rinds), or to fixed public or private water supply equipment.

Article 3 of Regulation 1935/2005 specifies general requirements for the chemical stability, i.e., the inertness of food contact materials.

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, such as odour, taste or appearance.

The labelling of food contact materials shall not mislead the consumers either.

Articles 8-12 of Regulation 1935/2004 discuss applications for authorisation of the chemical substances used in food contact materials, and the processing of the applications. As concerns materials for which specific measures have been established at EU level with a positive list of permitted chemical ingredients and any restrictions to their use incorporated in the measures (in practice, plastics and regenerated cellulose), authorisation shall be sought from the EU Commission for any new substance before the use of the substance is started.

The application is submitted via the authorities of the Member States to the European Food Safety Authority EFSA for a risk assessment. If EFSA's opinion is in favour of the substance, the application proceeds to the EU Commission for an authorisation process. Authorised substances are added in the positive list of the specific measures. The authorisation is generic, and where necessary, can be modified or even revoked if, for example, new scientific information emerges on the risks caused by the substance. Food contact material operators using the authorised substance are obliged to inform the Commission of any new scientific information that comes to their knowledge.

Article 15 of Regulation 1935/2004 provides for the labelling of food contact materials. The required information can be displayed directly on the material or the articles, or on their labels or packaging. In trade between companies, the required information can also be provided on documents.

Labelling shall indicate that the material or article is suitable for use in contact with foods, and labelling shall also provide instructions regarding any restrictions to use, such as temperature restrictions. Use in contact with food can be indicated with the glass and fork symbol presented in the Annex to the Regulation. The use of the symbol is not mandatory, however, if this is indicated in some other manner.

Also, an indication of use in contact with food is not necessary in the labelling for any articles which are clearly intended to come into contact with food, such as forks and knives.

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.

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.

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.