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Guidance documents may be updated or new ones drafted in view of technical and scientific progress or to reflect changes to the regulatory framework. The Standing Committee on Plants, Animals, Food and Feed has agreed on a priority list of guidance documents for which an update or a drafting is envisaged, and to a process to keep this list up to date.
Regulation (EC) No 1107/2009 – Scope and borderline issues – January 2024
- Assessment of The Equivalence of Technical Grade Active Ingredients for Identical Microbial Strains or Isolates - Word version - December 2014
- Guidance Document On Significant And Non-Significant Formulation Changes - November 2012
- Assessment of the Equivalence of Technical Materials of Substances - Word version - July 2012
- Finalisation of the reference specification for technical active substances after the peer review - July 2009
- Guidance on physical, chemical and technical properties - SANCO/10473/2003 – rev.5 - October 2021
- CIPAC code numbers
- Technical Material and Preparations - Analytical methods for Annex II (part A, Section 4) and Annex III (part A, Section 5) - 22 March 2019
- Guidance of EFSA on assessment of exposure - 18 May 2022 (SANTE-10832-2015)
- Acceptable operator exposure levels - 7531 rev 10 - 7 July 2006
- Dermal absorption - 18 April 2012
- Guidance on dermal absorption – Adopted by EFSA on May 2017 and Noted by SCoPAFF on 24 October 2018
- Acute reference dose - 7199/VI/99 - 5 July 2001
- Guidance of EFSA on aneugenicity assessment - 18 May 2022 (PAFF-PPL-May22-Doc.A.07.02)
- Guidance document on protected crops - 14 July 2015
- Guidance document DegT50 - December 2014
- The Working Document on environmental safety evaluation of MBCA - September 2012
- Assessment of the relevance of metabolites in groundwater - rev 10 - for dossiers submitted before 1 May 2022
- Assessment of the relevance of metabolites in groundwater - rev 11 - 21 October 2021
- FOCUS - Forum for the Co-ordination of pesticide fate models and their use
- Soil persistence models and EU registration - February 1997
- Guidance Document on Persistence in Soil 9188/VI/97 rev. 8 - July 2000
- Working Document on Evidence Needed to Identify POP, PBT and vPvB Properties for Pesticides - November 2012
- Guidance document on aged sorption – 22 October 2021
- Guidance document os soil phototransformation products in groundwater – 25 March 2023
- Guidance on impact of water treatment processes – 20 March 2024
- Risk assessment for birds and mammals: EFSA guidance document - EFSA Journal 2009; 7(12): 1438
- Risk assessment for birds and mammals: Joint working group report on the birds and mammals guidance document - 31 July 2009
- Aquatic Ecotoxicology - 5 January 2015
- Terrestrial Ecotoxicology - 17 October 2002
- Risk assessment for birds and mammals - 25 September 2002
Assessment of active substances used on rice - June 2003
- Compendium of conditions of use to reduce exposure and risk from plant protection products - 21 March 2024 (PAFF-PPL-March 2024-Doc.A.07.02)
- Guidance of EFSA on weight of evidence approach - 14 July 2022 (PAFF-PPL-July22-Doc.A.07.01)
- Guidance of EFSA on uncertainty analysis - 14 July 2022 (PAFF-PPL-July22-Doc.A.07.02)
- Guidance of EFSA on biological relevance of data - 14 July 2022 (PAFF-PPL-July22-Doc.A.07.03)
- Stereoisomers - Guidance of EFSA on risk assessments for active substances of plant protection products that have stereoisomers as components or impurities and for transformation products of active substances that may have stereoisomers - Adopted by EFSA on 22 July 2019 and Noted by SCoPAFF on 3 December 2020.
- Guidance to provide justifications as referred in point 1.5 of the Introduction of the Annexes of Regulations (EU) No 283/2013 and No 284/2013: Problem formulation for environmental risk assessment in the context of Regulation (EC) No 1107/2009
Template for Problem Formulation for environmental risk assessment.
- Guidance on the risk assessment of metabolites produced by microbial active substances - March 2024
- Guidance document on Semiochemicals - January 2024
- Format of a draft Registration Report - technical guidelines (v3) - October 2023
- Rules for revision of assessment reports - SANCO/10180/2013 - rev.2 - October 2021
- Administrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances - March 2021
- Basic substances – Working document on the procedure for application of basic substances to be approved in compliance with Article 23 of Regulation (EC) No 1107/2009 – January 2021
- Guidance on the approval and low-risk criteria linked to antimicrobial resistance for microbial active substances - October 2020
- Guidance Document for applicants on preparing dossiers for the approval of a chemical active substance - Word version - June 2019
- Guidance document on preparing list of test and study reports (rev. 3.1); - March 2019
- Templates To Be Used For Assessment Reports and Proposals for Classification - Word Version - March 2019
- Guidance Document for applicants on preparing dossiers for the approval of a microbial active substance - March 2016
- Guidance document on the Interpretation of the Transitional Measures for the Data Requirements for AS and PPPs - October 2015
- dRR templates for chemical plant protection products with report – version 2015
- dRR templates for chemical plant protection products without report – version 2015
- Guidance Document on botanicals rev. 8; - March 2014
- Template for assessment reports - Level 3, Vol. 1 - June 2012
- Template for assessment reports - Level 3, Vol. 1 - June 2012
- Guidance on presenting and evaluating dossiers as per annex III, Directive 91/414/EEC as (draft) Registration Report - Annexes SANCO/6895/2009 rev-1 - 2 October 2009, updated January 2012
- Submission of product dossiers (Risk Envelope Approach) - March 2011
- Presenting and evaluating dossiers as per annex III - Oct. 2009
- Comparison list B (microbials) - Annex II and Annex III points (OECD vs. former EC system) - December 2007
- Comparison list A (chemicals) - Annex II and Annex III points (OECD vs. former EC system) - October 2007
- Good Laboratory Practice - general requirements - 7017/VI/95 - June 1996
- Good Laboratory Practice - detailed requirements for Part A, Annexes II and III - 7109/VI/94 - July 1995
- Terms of reference of the Working Group on Post Approval Issues from the Standing Committee on Animals, Plants, Food and Feed - 23 October 2020
- Notification art.44 template SANCO-2012-12293
- Guidance Document on the Renewal of Authorisations according to Article 43 of Regulation (EC) No 1107/2009 - SANCO/13170/2010 (rev. 14) 7 October 2016
- Comparative Assessment and Substitution of Plant Protection Products in accordance with Regulation (EC) No 1107/2009 - 10 October 2014
- Notification according to Art. 36(3) of Regulation (EC) No 1107/2009
- Guidance on emergency authorisations according to Article 53 (under review)
- Working document on emergency authorisations according to Article 53 - for application submitted before 1 March 2021
- Renewal Guidance on implementation of Regulation (EU) No 844/2012 - March 2019
- Guidance on the evaluation of new active substance data post (renewal of) approval - rev.9 - October 2021
- Zonal Evaluation and Mutual Recognition
- Template to notify intended zonal applications under Article 33 of Regulation (EC) No 1107/2009 (SANCO/12544/2014) rev 2
- Assessment of new isolates of baculovirus species already included in Annex I
- Assessment of new Straight Chain Lepidopteran Pheromones (SCLPs)
- Authorisation of plant protection products following inclusion of an existing active substance - 15 July 2011
- Intra & inter-zonal work-sharing to facilitate the registration and re-registration- 2 October 2009
- Guidance document concerning the parallel trade of plant protection products - SANCO/10524/2012 - 14 July 2015
- Renewal Guidance on implementation of Regulation (EU) No 1141/2010 - 28 October 2010
- Guidance document on submission and assessment of confirmatory information (rev. 6.1). - 20 December 2013
- Guidance on data matching dossier - SANTE/2016/11449 - rev.1.5 - October 2021
- Template for data matching checks(Word version)
List of obsolete Guidance Documents - rev-2 - May 2024