Request risk assessment for new substances in food contact materials that are not subject to EU-wide harmonized material-specific regulation.

If no EU-wide harmonized material-specific regulations exist for a food contact material, you can submit a request for risk assessment to the Federal Office of Consumer Protection and Food Safety (BVL).

Food contact materials are subject to European harmonized legislation in Germany. According to this legislation, food contact materials must not release any constituents into the food in quantities which

• could endanger human health
• lead to unacceptable changes in the composition of the food, or
• affect the properties of the food that can be detected by human senses, such as taste, texture or color.

As a manufacturer, you must ensure that regulatory requirements are met - in part by selecting raw materials that are suitable for the manufacture of food contact materials. For some materials, there are already specific regulations on requirements for these substances. This is the case, for example, with plastics and ceramics.

Do you want to use a substance for the manufacture of food contact materials for which no risk assessment has yet been carried out? Then you can submit a request for risk assessment by the European Food Safety Authority (EFSA) to the BVL. The request must be accompanied by background information explaining the scientific problem and the Community interest.

• Your request must include background information explaining the scientific problem and a justification of the Community interest.

Forms available: No

Written form required: No

Informal application possible: Yes

Personal appearance required: No

Online services available: No

• There are no European harmonized regulations yet for the substance you want to use to manufacture a food contact material.

• No legal remedies are provided against the BVL.
• Appeals against a decision must be filed directly with the European Commission.

Send your request for a risk assessment by e-mail to the BVL:

• Include background information explaining the scientific problem and a justification of the community interest with your request.
• The BVL will check for completeness and, if necessary, submit the documents to the Federal Institute for Risk Assessment (BfR) for comment.
• The Federal Ministry of Food and Agriculture (BMEL) decides on the existence of a Community interest and, in the positive case, forwards the application to EFSA. In the case of a positive decision, it forwards the application to EFSA.

There is no deadline.

The duration of the process depends on the documents submitted and the amount of verification required. The process may take longer if further information needs to be requested.

There are no costs involved.

There are no clues or specifics.