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• Guidance Documents for the implementation of Council Directive 91/414/EEC (Plant Protection Products)
• Guidance Documents (Pesticide Residues)
• Technical Reports

GUIDANCE DOCUMENTS - for the implementation of Council Directive 91/414/EEC (Plant Protection Products)

• Guidance document on Mutual Recognition of Plant Protection Prooducts under Council Diretive 91/414/EEC (doc. SANCO/298/2006 rev 9b), 2 December 2008 (39KB)
• Guidance document on the procedures relating to the authorization of plant protection products following inclusion of an existing active substance in Annex I to Council Directive 91/414/EEC (doc. SANCO/10796/2003 - rev 10.4), 2 October 2009 (59KB)
• Guidance document on the procedures for submission and assessment of confirmatory data following inclusion of an active substance in Annex I to Council Directive 91/414/EEC (doc. SANCO/5634/2009 rev 3), 2 October 2009 (151KB)
• Guidance document on a process for intra & inter-zonal work-sharing to facilitate the registration and re-registration of plant protection products following inclusion of an active substance in Annex I of Council Directive 91/414/EEC (doc. SANCO/6896/2009 rev 1), 2 October 2009 (49KB)
• Guidance document on the presentation and evaluation of dossiers according to annex III of Directive 91/414/EEC in the format of a (draft) Registration Report - General Part (doc. SANCO/6895/2009 rev 1), 2 October 2009 (49KB)
• Guidance document on the presentation and evaluation of dossiers according to annex III of Directive 91/414/EEC in the format of a (draft) Registration Report - Annexes (doc. SANCO/6895/2009 rev 1), 2 October 2009 (879KB)
• Guidance Document on the assessment of new Straight Chain Lepidopteran Pheromones (SCLPs) (67KB)
• Evaluation of Guidance Document on the assessment of new isolates of baculovirus species already included in Annex I of Council Directive 91/414/EEC (doc. SANCO/0253/2008 rev. 2) (122KB)
• Check of Completeness for new active substance dossier submissions under Directive 91/414/EEC
• Evaluation of new Annex II data post Annex I inclusion of an active substance, 15 July 2005 (151KB)
• Acceptable operator exposure levels (doc. 7531 rev 10, 7 July 2006) (160KB)
• Assessment of active substances used on rice (doc. SANCO/1090/2000), June 2003 (6140KB)
• Plant extracts - data requirements (doc 10472), 6 July 2004
• Chemical substances - data requirements (doc 10473), 6 July 2004
• CIPAC code numbers, July 2004
• Assessment of the relevance of metabolites in groundwater (doc. SANCO/221/2000), 25 February 2003 (274KB)
• Dermal Absorption (doc. SANCO/222/2000), 19 March 2004 (206KB) updated
• Dossier submissions instructions for industry (doc. SANCO/3989/2001), 6 December 2001 (116KB)
• Guideline on the Preparation and Presentation of Complete Dossiers for the Inclusion of Active Substances in Annex I of Directive 91/414/EEC (Article 5.3 and 8.2), (doc. SANCO/10518/2004 ), 27 June 2005 (116KB) Updated
• Completeness check evaluation forms
• Parallel trade (doc. SANCO/223/2000), 6 December 2001 (49KB)
• Aquatic Ecotoxicology (doc. SANCO/3268/2001), 17 October 2002 (538KB)
• Borderline concerning Biocidial products and Plant Protection Products(doc. Biocides/26/99), 30 April 2001
• Submission of dossiers for authorisation - Authorization of plant protection products containing existing active substances after their inclusion in Annex I - Submission of an Annex II and Annex III Dossier (doc. SANCO/491/2000), 13 July 2000 (24KB)
• Authorization of Plant Protection Products containing existing active substances after their inclusion in Annex I - Submission of an Annex II & Annex III dossiers (24KB)
• Terrestrial Ecotoxicology (doc. SANCO/10329/2002), 17 Octobre 2002 (377KB)
• Persistence in Soil (doc. 9188/VI/97), 12 July 2000 (80KB)
• Assessment for Birds and Mammals (doc. SANCO/4145/2000), 25 September 2002 (836KB)
• Residues analytical methods - for pre-registration data requirements for Annex II (part A, Section 4) and Annex III (part A, Section 5) (doc. SANCO/3029/99), 11 July 2000 (75KB)
• Technical Material and Preparations - Analytical methods for Annex II (part A, Section 4) and Annex III (part A, Section 5) (doc. SANCO/3030/99), 11 July 2000 (46KB)
• Assessment of the Equivalence of Technical Materials of Substances (doc. SANCO/10597/2003), May 20009. (46KB)
• Residues analytical methods - for post-registration control and monitoring (doc. SANCO/825/00), 17 March 2004
  (53KB)
• NEW active substances procedures for evaluation - Aide mémoire with regard to certain aspects of the procedures for the evaluation in view of a possible inclusion into Annex I (doc. 7860/VI/97), 10 April 2000
• Good Laboratory Practice (GLP) - General requirements (doc. 7017/VI/95), 10 June 1996
• Good Laboratory Practice (GLP) - Detailed requirements, for Part A of Annexes II and III (doc. 7109/VI/94), 14 July 1995 updated
• Formatting of Draft Evaluation Reports (doc. 1654/VI/94), 22 April 1998 (1424 KB)
• FOCUS - Forum for the Co-ordination of pesticide fate models and their use
• Guidelines and criteria for the preparation and presentation of data concerning efficacy - as provided in Annex III, parts A and B, section 6 of Directive 91/414/EEC concerning the placing of plant protection products on the market (biological assessment dossier), (doc. 7600/VI/95), 14 July 1997
• Acute reference dose - (doc. 7199/VI/99), 5 July 2001
• Voluntary mutual recognition of minor use authorizations - (doc. SANCO/2971/2000), 10 October 2000
• Guidance document on the preparation of dossiers and draft assessment reports for substances covered in the fourth stage of the review programme referred to in Article 8(2) of Council Directive 91/414/EEC (Doc SANCO/10393/2004), 8 October 2004
• Comparison list A (Chemicals) between Annex II and Annex III points (OECD vs. former EC system)
• Comparison list B (Microbials) between Annex II and Annex III points (OECD vs. former EC system) Updated
• Guideline developed within the Standing Committee on the Food Chain and Animal Health on the taxonomic level of micro-organisms to be included in Annex I to Directive 91/414/EEC (doc. Sanco/10754/2005), 15 April 2005 updated 14-12-2006
• Guidance document on preparation of lists of studies relied upon with a view to Annex I - inclusion of existing active substances (doc. SANCO/10435/2004), 15 April 2005.
• Guidance document on preparation of Review Report for review Stage 2 substances and new active substances considered by EFSA (doc. SANCO/10696/2004), 15 April 2005
• Guidance document on the finalisation of the reference specification for technical active substances after the peer review (doc. SANCO/6075/2009), July 2009 (32KB)

GUIDANCE DOCUMENTS - Pesticide Residues)

• Introduction to EU pesticide residue legislation (17KB)

• Implementation of Reg. (EC) No 396/2005
• • MRL application form (Doc 4044/2008), 8 December 2008 (182KB)
  • Template Evaluation Report (12 June 2009) (1193KB)

• Import Tolerance
• • Working document guidance notes on "EC Import Tolerances" (Doc. 7196/VI/99) (182KB)

• Guidelines for the generation of data concerning residues as provided in Annex II part A, section 6 and Annex III, part A, section 8 of Directive 91/414/EEC concerning the placing of plant protection products on the market
• • Foreword, (Doc. 1607/VI/97), 10 June 1999 (7KB)
  • Appendix A - Metabolism and distribution in plants, (Doc. 7028/VI/95), 22 July 1997 (51KB)
  • Appendix B - General recommendations for the design, preparation and realization of residue trials, (Doc. 7029/VI/95), 22 July 1997 (195KB)
  • Annex 2 - Classification of (minor) crops not listed in the Appendix of Council Directive 90/642 (136KB)
  • Appendix C - Testing of plant protection products in rotational crops, (Doc. 7524/VI/95), 22 July 1997 (36KB)
  • Appendix D - Comparability, extrapolation, group tolerances and data requirements, (Doc. 7525/VI/95), 1 February 2008 (325KB)
  • Appendix E - Processing studies, (Doc. 7035/VI/95), 22 July 1997 (52KB)
  • Appendix F - Metabolism and distribution in domestic animals, (Doc. 7030/VI/95), 22 July 1997 (17KB)
  • Appendix G - Livestock feeding studies, (Doc. 7031/VI/95), 22 July 1996 (39KB)
  • Appendix H - Storage stability of residue samples, (Doc. 7032/VI/95), 22 July 1997 (23KB)
  • Appendix I - Calculation of maximum residue levels and safety intervals, (Doc. 7039/VI/95), 22 July 1997 (98KB)

• Analytical Methods
• • Residue analytical methods - for post-registration control and monitoring, (doc. SANCO/825/00), 17 March 2004 (53KB)   updated
  • Residues analytical methods - for pre-registration data requirements for Annex II (part A, Section 4) and Annex III (part A, Section 5), (Doc. SANCO/3029/99), 11 July 2000 (53KB)   updated
  • Method Validation and Quality Control procedures for Pesticide Residues ( Doc. SANCO/2007/3131), 31 October 2007 updated 15-11-2007 (387KB)

• OECD recommendations & proposals
• • Minimum Data Requirements for Establishing Maximum Residue Limits (MRLs) including Import Tolerances (Doc. SANCO/3029/99), 29 September 1999 (+/-145KB)

• RASFF - notification criteria for pesticide residues (Doc. SANCO/3346/2001), rev 7 24 July 2004 (+/-255KB)

TECHNICAL REPORTS

• The scope for extending extrapolations to reduce the need for plant protection residues trials on minor crops (783KB)
• Proposals for extending and harmonizing efficacy and crop safety extrapolations to reduce the need for efficacy trials on minor crops (278KB)