one for governments to use when writing their evaluation reports (or monographs)
one for industry to use when making data submissions (or dossiers)
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.
OECD Guidance for Country Data Review Reports on Plant Protection Products and their Active Substances - Revision 3, April 2008:
Monograph Guidance - Main document Appendix 1 - Standard terms and abbreviations Appendix 2 - Preparation (formulation) types and codes Appendix 3 - Guidance with respect to pagination, lay-out, tables and references 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 Appendix 5 - Form for use in reporting details of intended uses (GAP information) 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) Appendix 7 - Format for the listing of test and study reports and other documentation evaluated (Annex A) Appendix 8 - Format for the listing of test and study reports and other documentation relied on (Annex B) Appendix 9 - Guidance Notes for Analysis and Evaluation of Particular Types of Studies
OECD Guidance For Industry Data Submissions for Pheromones and Other Semiochemicals and their Activie Substances (Dossier Guidance for Pheromones and Other Semiochemicals)
Series on Pesticides No. 16 (2003)
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 systepdf ms 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
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
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
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.
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.
