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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)

• Evaluation of new Annex II data post Annex I inclusion of an active substance, 15 July 2005 (151KB)
• Plant strengtheners with low risk profile - Data requirements (doc. Sanco/1003/2000), 21 June 2001 (182KB)
• Acceptable operator exposure levels (doc. 7531/VI/95), 10 September 2001 (6140KB)
• 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), 14 December 2005.(46KB)
• Residues analytical methods - for post-registration control and monitoring (doc. SANCO/825/00), 17 March 2004
  (53KB)
• EXISTING 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), 15 July 1998
• 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 (27 KB)
• 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
• Draft guidance document on the re-registration of plant protection products following inclusion of an existing active substance in Annex I to Council Directive 91/414/EEC (Doc SANCO/10796/2003), September 2004 - (Draft guidance document of the working group Legislation.)
• 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
• 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 DOCUMENTS - (Pesticide Residues)

• Introduction to EU pesticide residue legislation (17KB)
• Programme of work on pesticide residue levels (MRLs) (Doc. 9205/VI/97) (163KB)

• MRL: List of the highest maximum residue level(MRL) existing within the European Union for each pesticide/crop combination
• List of highest National MRL REPORT (AS pending_alphabetically) (5642KB) updated 16/12/2005
• List of highest National MRLs REPORT (AS pending_group level) (846KB) updated 16/12/2005
• List of highest National MRLs AS Not included Report (4532KB) updated 16/12/2005


• EU MRLs sorted by pesticide (1265KB) (4200KB) updated 04/11/2004
• EU MRLs sorted by crop group (1430KB) (4200KB) updated 04/11/2004
• EU MRLs sorted by commodity (1430KB) (4200KB) updated 04/11/2004

• 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), 12 June 2001 (196KB)
• 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
• Quality control procedures for pesticide residues analysis (Doc. SANCO/10232/ 2006), 24 March 2006 updated 20-04-2006 (387KB)

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

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)