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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

Applicable to applications submitted until 26 March 2021 Applicable to applications submitted as of 27 March 2021
Administrative guidance on submission of dossiers and assessment reports for the peer‐review of pesticide active substances  Administrative guidance on submission of dossiers and assessment reports for the peer‐review of pesticide active substances and on the maximum residue level (MRL) application procedure 
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 all applications (submitted before or after 27 March 2021)

Additional resources

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

Applicable to applications submitted until 26 March 2021 Applicable to applications submitted as of 27 March 2021
  Administrative guidance on submission of dossiers and assessment reports for the peer‐review of pesticide active substances and on the maximum residue level (MRL) application procedure 
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