Apply for approval of new substances for regenerated cellulose film in contact with foodstuffs

Materials that come into contact with food are subject to European coordinated legislation.

In good manufacturing practice and under normal conditions, they must not release constituents into the food in quantities which

• endanger human health
• lead to an unacceptable change in the composition of the food, or
• cause an impairment of the organoleptic properties - e.g. taste or odor - of the food.

As a manufacturer of plastic food contact materials, you are responsible for compliance with these requirements. You must ensure that the contact materials are safe for human health.

Food contact materials are materials and articles that are

• are intended to come into contact with foodstuffs
• Are already in contact with food and are intended to be, or
• reasonably foreseeable to come into contact with food or to transfer their constituents to food during normal or foreseeable use.

In the European Union, and thus also in Germany, no approval is required for the finished food contact material, i.e. the finished product.

However, this does not apply to new substances to be used in the manufacture of food contact plastics. Therefore, if your company wants to use new substances for the production of appropriate regenerated cellulose films, you will need an approval.

You can submit the application for approval of a new substance for use in food contact plastics exclusively via the European Commission's online portal E-Submission Food Chain Platform (ESFC).

If the Federal Office of Consumer Protection and Food Safety (BVL), as the national point of contact in Germany, has been selected by the applicant as the point of contact, the BVL will formally check the application, i.e. for completeness and relevance of the documents. The BVL then forwards the application to the European Food Safety Authority (EFSA).

EFSA publishes detailed specifications on the required documents and content requirements in guidance documents on its website.

EFSA reviews your application on the basis of scientific findings. The European Commission decides on the actual approval.

Even in the case of non-authorization, the European Commission will inform you and you will receive a justification.

If the substance meets all the requirements of food law, it is placed on the so-called Union list of authorized substances of the European Union (EU). This means that you and, if applicable, other companies may use the substance for the manufacture of plastic materials that come into contact with food.

You must inform the EU Commission immediately if you have new scientific or technical knowledge that may affect the assessment of the safety of the substance with regard to human health.