Biological hazard and animal welfare applications: regulations and guidance
Last reviewed date:
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.
Alternative processing methods of animal by-products
Regulatory framework
- Regulation 1069/2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation 1774/2002
- Regulation 142/2011 implementing Regulation 1069/2009 laying down health rules as regards animal by-products and derived products not intended for human consumption
Administrative guidance and support initiatives
Applicable to applications submitted as of 27 March 2021
Applicable to applications submitted until 26 March 2021
Scientific guidance
Applicable to all applications (submitted before or after 27 March 2021)
Decontamination substances
Regulatory framework
- Regulation 852/2004 on the hygiene of foodstuffs
- Regulation 853/2004 laying down specific hygiene rules for food of animal origin
- Regulation 2017/625 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products
- Regulation 101/2013 concerning the use of lactic acid to reduce microbiological surface contamination on bovine carcasses
Administrative guidance and support initiatives
Applicable to applications submitted as of 27 March 2021
Applicable to applications submitted until 26 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
- EFSA's Catalogue of support initiatives during the life-cycle of applications for regulated products
Scientific guidance
Applicable to applications submitted as of 27 March 2021
Applicable to applications submitted until 26 March 2021
Stunning methods regarding animal protection at the time of killing
Regulatory framework
Scientific guidance
Applicable to all applications (submitted before or after 27 March 2021)
Vedi anche
- Toolkit
- Biological hazard applications: frequently asked questions
- Authorisation: European Commission’s Directorate-General for Health and Food Safety
- Submission of dossiers on animal by-products: national competent authority of Member States
- Video: Update of sectoral and administrative Guidance Documents to address the Transparency Regulat…