Updated guidance provides applicants with clearer advice on how to submit dossiers on plastic food contact materials before they can be put on the market in the European Union. Previously covered in one guidance document, EFSA has now published separate scientific and administrative documents.
The scientific guidance includes updated information on the dataset required to assess the genotoxic potential of a substance. These specifications are aligned with the current requirements as described in the 2011 EFSA Scientific Committee opinion on genotoxicity testing strategies.
The administrative guidance details the application procedure and introduces new forms applicants should use when preparing and presenting an application. The document also describes the different ways to interact with EFSA during the evaluation process.
- Note for Guidance for the preparation of an application for the safety assessment of a substance to be used in plastic Food Contact Materials
- Administrative Guidance for the preparation of applications for the safety assessment of substances to be used in plastic Food Contact Materials
Quelle: EFSA