Listing of substance in BfR for use in Food Contact Materials

The rules for food contact materials are based on what risk assessed substances are used. The German Federal Institute for Risk Assessment (BfR) publishes recommendations for how paper and other materials can be manufactured and tested to be suitable for food contact. With RISE's various competencies in material development, chemical analyses, toxicological risk assessment and knowledge of the regulations, we can offer assistance in getting new substances listed in these recommendations, or supplementing already listed substances with extended areas of use.

Objective

We offer assistance in preparing an application to BfR to have a substance listed in one of the recommendations for food contact materials. The workflow follows the BfR guideline for the safety assessment of substances for the manufacture of food contact materials and articles.

Method

The assignment starts with an assessment of the idea, including the identification of any similar and already listed substances. An initial health risk assessment of the substance based on already available data is developed. An extended work plan can then be developed.

An application is based on two elements: How much of the substance can be transferred to the food and a toxicological evaluation.

Evaluation of the transfer of the substance to food in the intended use is measured or calculated. Potential impurities in the substance are also identified through analyses.

Based on the level of transfer to the food, a toxicological assessment is performed. This includes at least an assessment of genotoxicity. In addition, the project may include uptake, distribution, metabolism, and excretion, oral sub-chronic toxicity, oral chronic toxicity/carcinogenicity, and reproductive and developmental toxicity.

The results are presented in the form of a report.

The project can be organised in different steps that build on each other. Please contact us to discuss an approach.