Pesticides agricoles et biocides

Industry Data Submissions for Agricultural Chemical Pesticides

 

DOSSIER GUIDANCE (FOR INDUSTRY)

OECD Guidance for Industry Data Submissions on Plant Protection Products and their Active Substances -Revision 2 May 2005:

Dossier Guidance - Main document
Appendix 1 - Standard terms and abbreviations
Appendix 2 - Preparation (formulation) types and codes
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) 
Appendix 4  - Format for compilation of Tier I quality checks 
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

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,
  • Part 4  - OECD, EU, US, Canadian, Japanese and Australian numbering systems for data and information on active substances
  • Part 5  - OECD, EU, US, Canadian, Japanese and Australian numbering systems for data and information on formulated product


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
  • Part 2 - Analytical methods
  • Part 3 - Toxicological and metabolism studies on the active substance
  • Part 4 - Residues in or on treated products, food and feed
  • Part 5 - Fate and behaviour in the environment

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
  • Part 2 - Toxicological Studies and Exposure Data and Information
  • Part 3  - Ecotoxicological Studies and risk assessment
  • Part 4  - Efficacy Data and Information


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

 

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.