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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.

Decontamination substances

Regulatory framework

Administrative guidance and support initiatives

Applicable to applications submitted until 26 March 2021 Applicable to applications submitted as of 27 March 2021
Administrative information is available in the Guidance document on the submission of data for the evaluation of the safety and efficacy of substances for the removal of microbial surface contamination of foods of animal origin intended for human consumption   
Administrative guidance for the processing of applications for regulated products Administrative guidance for the processing of applications for regulated products (update 2021)
EFSA's Catalogue of support initiatives during the life-cycle of applications for regulated products EFSA's Catalogue of support initiatives during the life-cycle of applications for regulated products (update 2021)

Scientific guidance

Applicable to applications submitted until 26 March 2021 Applicable to applications submitted as of 27 March 2021
Guidance document on the submission of data for the evaluation of the safety and efficacy of substances for the removal of microbial surface contamination of foods of animal origin intended for human consumption Guidance document on the submission of data for the evaluation of the safety and efficacy of substances for the removal of microbial surface contamination of foods of animal origin intended for human consumption (update 2021)

Other guidance