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.
Active substances authorisation and renewal
Regulatory framework
- Regulation EC 1107/2009 concerning the placing of plant protection products on the market including basic substances (art 23)
- Regulation EU 844/2012 on the provisions for the implementation of the renewal procedure for active substances
- Regulation EU 283/2013 on data requirements for active substances, in accordance with Regulation EC 1107/2009 concerning the placing of plant protection products on the market.
- Regulation EU 284/2013 on data requirements for plant protection products, in accordance with Regulation EC 1107/2009 concerning the placing of plant protection products on the market.
Administrative guidance
Scientific guidance
- EC guidance documents on Active substances (European Commission’s Standing Committee on Plants, Animals, Food and Feed – phytopharmaceuticals)
- Guidance for the identification of endocrine disruptors in the context of Regulations EU 528/2012 and EC 1107/2009
- Submission of scientific peer-reviewed open literature for the approval of pesticide active substances
- Assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products
- Risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees)
- Default Q10 value to describe the temperature effect on transformation rates of pesticides in soil
- EC working document on the procedure for application of basic substances to be approved in compliance with Article 23 of Regulation EC 1107/2009 (Application template available from Annex I)
Additional resources
- Outcome of the pesticides peer review meeting on general recurring issues in physical and chemical properties and analytical methods (2017)
- Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology risk assessment (2016)
- Outcome of the pesticides peer review meeting on general recurring issues in mammalian toxicology risk assessment (2018)
- Outcome of the pesticides peer review meeting on general recurring issues in ecotoxicology risk assessment (2015)
- Recommendations on the use of the proportionality approach in the framework of risk assessment for pesticide residues (2018)
Maximum residue levels
Regulatory framework
- Regulation EC 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin.
Scientific guidance
- EC guidance documents on MRLs (European Commission’s Standing Committee on Plants, Animals, Food and Feed – phytopharmaceuticals)
