Agricultural pesticides and biocides

Formats and Guidance Documents for Chemical Pesticide Registration

 

OECD Formats and Guidance Documents for Chemical Pesticide Registration

The agreed guidelines establish two formats:


• one for industry to use when making data submissions (or dossiers)
• one for governments to use when writing their evaluation reports (or monographs)


The formats do not require OECD countries to make the same regulatory decisions. Rather their purpose is to facilitate registration by minimising duplication of effort for both industry and governments.


Benefits for industry
Pesticide producers, who are responsible for testing any pesticide they want to register, usually have to present registration submissions in different formats for different OECD countries. The OECD common format should therefore reduce redundancies in the preparation of submissions by industry.


Benefits for governments
The format for government evaluations should change the way regulatory authorities in OECD countries write their evaluation reports on the tests submitted by industry. It should help improve the quality of review reports by ensuring that they are clear, complete, well-organised and transparent. This enables governments to use each other's reports more easily than in the past, saving time and resources. However, governments continue to apply their own criteria when making decisions.

MONOGRAPH GUIDANCE (FOR GOVERNMENTS)
OECD Guidance for Country Data Review Reports on Plant Protection Products and their Active Substances - Revision 1 March 2001:

Monograph Guidance - Main document, pdf
Appendix 1 - Standard terms and abbreviations, pdf
Appendix 2 - Preparation (formulation) types and codes, pdf
Appendix 3 - Guidance with respect to pagination, lay-out, tables and references, pdf
Appendix 4 - Suggested order for the preparation of each of the four levels and three annexes of the monographs to be prepared by regulatory authorities, pdf
Appendix 5 - Form for use in reporting details of intended uses (GAP information), pdf
Appendix 6 - Format for the listing of end points to be included in the reasoned statement of the overall conclusions drawn by the regulatory authority (Level 2), pdf
Appendix 7 - Format for the listing of test and study reports and other documentation evaluated (Annex A), pdf
Appendix 8 - Format for the listing of test and study reports and other documentation relied on (Annex B), pdf
Appendix 9 - Guidance Notes for Analysis and Evaluation of Particular Types of Studies, pdf

 

DOSSIER GUIDANCE (FOR INDUSTRY)

OECD Guidance for Industry Data Submissions on Plant Protection Products and their Active Substances -Revision 1 March 2001:

Dossier Guidance - Main document, pdf
Appendix 1 - Standard terms and abbreviations, pdf
Appendix 2 - Preparation (formulation) types and codes, pdf
Appendix 3 - Forms for use in reporting: 1. details of intended uses (GAP information); 2. registered uses and actual uses; 3. maximum residue limits (MRLs), pdf
Appendix 4 - Format for compilation of Tier I quality checks, pdf
Appendix 5 - Forms for use in reporting: 1. crop residues data from individual supervised trials in summary form; 2. individual soil dissipation studies (soil residues) in summary form, pdf
Appendix 6 - Format for the listing of test and study reports and other documentation;

  • Parts 1,2 & 3, Listing: 1. by test and study type, 2. by author, 3. of test and study reports and published papers not submitted, pdf
  • Part 4 - OECD, EU, US, Canadian, Japanese and Australian numbering systepdf ms for data and information on active substances, pdf
  • Part 5 - OECD, EU, US, Canadian, Japanese and Australian numbering systems for data and information on formulated product, pdf

Appendix 7 - Format for the compilation of Tier II summaries - active substance -

  • Part 1 - Indentity, Physical and chemical properties, further information, proposals including justification of the proposals for the classification and labelling of the active substance, pdf
  • Part 2 - Analytical methods, pdf
  • Part 3 - Toxicological and metabolism studies on the active substance, pdf
  • Part 4 - Residues in or on treated products, food and feed, pdf
  • Part 5 - Fate and behaviour in the environment, pdf

Appendix 8 - Format for the compilation of Tier II summaries - formulated product -

  • Part 1 - Identity, Physical, chemical and technical properties, Data on application, Further information, Proposals including justification of the proposals for the classification and labelling of the plant protection product, pdf
  • Part 2 - Toxicological Studies and Exposure Data and Information, pdf
  • Part 3 - Ecotoxicological Studies and risk assessment, pdf
  • Part 4 - Efficacy Data and Information, pdf

Appendix 9 - Format for the listing of endpoints to be included in the Tier III overall summary and assessment, pdf
Appendix 10 - Format for the compilation of Tier III overall summaries and assessments, pdf
Appendix 11 - Forms for use in checking dossiers for completeness, pdf

 

 

 

 

 

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