Évaluation des pesticides: règlements et documents d’orientation
La législation européenne et les documents d'orientation de l’EFSA expliquent en détail comment compléter les dossiers ainsi que les informations et les études requises pour l'évaluation. Les documents d’orientation de l'EFSA étant mis à jour régulièrement, les demandeurs sont invités à vérifier qu'ils utilisent la dernière version avant de soumettre leur dossier.
Autorisation et renouvellement des substances actives
Cadre réglementaire
- 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
Document d’orientation administratif
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 (update January 2024)
Applicable to applications submitted until 26 March 2021
Documents d'orientation scientifiques
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
- 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 II)
Ressources supplémentaires
- 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
Cadre réglementaire
Regulation EC 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin.
Document d’orientation administratif
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 (update January 2024)
Applicable to applications submitted until 26 March 2021
Documents d'orientation scientifiques
EC guidance documents on MRLs (European Commission’s Standing Committee on Plants, Animals, Food and Feed – phytopharmaceuticals)
Voir aussi
- Pesticide evaluations: frequently asked questions
- Pesticide evaluation: Tools
- Toolkit
- Authorisation: European Commission’s Directorate-General for Health and Food Safety
- Submission of dossiers to national contact points
- Video: Update of sectoral and administrative Guidance Documents to address the Transparency Regulat…