The BIOSAFEPAPER project aims at the development, validation and intercalibration of a short-term biological test battery for safety assessment of food contact paper and board. BIOSAFEPAPER is a pre-normative research effort to launch regulatory harmonisation at the EU level on the safety of food contact paper and board. In the project a biological test battery based on short term tests for cellular toxicity and genotoxicity will be developed, validated and intercalibrated. The resulting test battery will be based on toxicological endpoints relevant to consumer safety. The test samples will be prepared using extraction procedures mimicking real-life situations.

The goal of the project is to create scientifically sound recommendations for a harmonised risk evaluation and product testing methodology. This result will ease the task of the regulators and increase the confidence of the consumer in the industrial ambition and ability to provide safe food contact materials.

Objectives :

- To develop a test battery, with a decision-tree approach with end points relevant to consumer safety,
- To develop extraction procedures applicable to paper and board simulating different types of foodstuffs,
- To develop risk assessment procedures based on the scientific evaluation of the results,
- To disseminate the results to consumers, legislators and industry in order to form a basis for regulatory activities.

Expected achievements:

- Tools for asessing the safety of food contact paper and board products,
- Harmonisation of testing procedures applicable both to regulatory purposes and fort the hazard analyses approach in the industry by also satisfying all criteria set by the standardisation body such as CEN,
- The increased confidence of consumers in the will and ability of European industries to continue providing safe food contact materials,
- Improved industrial competitiveness due to development of robust methods of assuring product safety and fitness for us.

Module I: Toxicity testing includes:

· Set up and cross-validation of the tests for sublethal cellular toxicity,
· Comparison of the results of the tests for sublethal toxicity with other available cytotoxicity tests,
· Set-up and cross validation of genotoxicity tests,
· Selection of a flexible, validated test battery as a basis for a decision tree approach for safety evaluation

Module II: Extraction procedures includes:

· Choice of suitable solvents as a vehicle for the extract to the bioassay procedures
· Standard operating procedures (SOP) for extraction protocol
· Provision of control solutions for toxicological testing
· Preparation of actual extracts (from the paper materials) for toxicological testing

Module III: Implementation in risk assessment includes:

· Translation of the toxicological data into risk assessment
· Defining the scientific basis for recommendations on the safety assessment of food contact materials
· Communication and dissemination among industry, authorities and consumers