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Biological hazard applications: regulations and guidance

EU legislation and EFSA guidance documents detail how to compile dossiers for submission and the information and studies required for the evaluation. EFSA’s guidance is updated regularly so applicants should check they are using the latest version before applying.

Scientific guidance

Applicable to all applications (submitted before or after 27 March 2021)

Statement of EFSA on technical assistance on the format for applications for new alternative methods for animal by-products

Scientific guidance