Application in compliance with EU Regulation 1935/2004 for the authorisation of components used in food contact materials

Under EU Regulation 1935/2004, it is possible to lay down specific measures by regulation for each material included in the list of various contact materials and articles in accordance with Annex 1 to the above Regulation.

Where specific measures include a list of materials authorised for use in the manufacture of contact materials, the safety of those materials shall be assessed prior to their authorisation in the list of materials in the legislative act. Currently, special requirements which include a list of authorised materials have been set for plastic (Plastics Regulation 10/2011) and for regenerated cellulose (Decree of the Ministry of Trade and Industry 697/2005).

If a food contact material business operator makes contact materials made of plastic or regenerated cellulose and wishes to use in them a new, previously unauthorised component, authorisation must be applied for this substance.

Authorisation is applied for by informal application, which is sent to the registry of the Finnish Food Authority at P.O. Box 100, FI-00027, Finnish Food Authority, Finland or electronically to kirjaamo@ruokavirasto.fi. A handling charge is made based on the Food Authority’s pricelist. The Food Authority will send the application to the European Food Safety Agency (EFSA) for risk assessment. EFSA has six months in which to assess the application and the safety of the substance for the intended use. After assessment by EFSA, the application will be sent to the European Commission for authorisation.  Authorisation will take into account EFSA’s opinion on the risk assessment of the substance and thus its use or also migration limits may be laid down in legislation.

EFSA has provided guidance on the content of the application. You can find links about applications to EFSA here: (https://www.ruokavirasto.fi/en/companies/food-sector/production/packages-and-other-food-contact-materials/useful-online-links-about-contact-materials/)

Page last updated 7/20/2020