Pesticide evaluations: 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.

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 2020/1740 on the provisions for the implementation of the renewal procedure for active substances (repealing Regulation EU 844/2012)
• 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
• Regulation EU 2021/428 adopting standard data formats for the submission of applications for the approval or the amendment to the conditions of approval of active substances
• Regulation EU 546/2011 of 10 June 2011 implementing Regulation EC 1107/2009 as regards uniform principles for evaluation and authorisation of plant protection products

Administrative guidance

Scientific guidance

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

• 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
• Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment of plant protection products (Published: 18 January 2022)
• 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 II)

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 physical and chemical properties and analytical methods (2019)
• 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 mammalian toxicology (2020)
• Outcome of the pesticides peer review meeting on general recurring issues in ecotoxicology risk assessment (2015)
• Outcome of the pesticides peer review meeting on general recurring issues in ecotoxicology (2019)
• Recommendations on the use of the proportionality approach in the framework of risk assessment for pesticide residues (2018)
• Outcome of the pesticides peer review meeting on the OECD 106 evaluators checklist (2017)
• JRC FOCUS (the FOrum for Co-ordination of pesticide fate models and their Use) webpage

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.

Administrative guidance and support initiatives

Scientific guidance

EC guidance documents on MRLs (European Commission’s Standing Committee on Plants, Animals, Food and Feed – phytopharmaceuticals)