Regulation (EC) n 1107/2009 -plant protection products- New data requirements for Toxicology active substances & preparations

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1 Regulation (EC) n 1107/2009 -plant protection products- New data requirements for Toxicology active substances & preparations Thierry Mercier French agency for food, environmental and occupational health safety - September-2011

2 Final steps so far Update of the data requirements : kick off in 2003 Several meetings and commenting periods : member states and stakeholders 2 opinions from, EFSA PPR 14 draft versions Last version will be proposed by Commission (DG Sanco) to member states in September 2011

3 Main targets Increase quality & relevance of the evaluation Converge to OECD requirements Used UE OECD guidelines Reduce animal testing (3R)

4 Major changes proposed vs 91/414/EEC : Sanco /11802/2010 Active substance ADME oral and IV Comparison of the AUC after oral and intravenous administration or (oral + biliary excretion) evaluation of systemic bioavailability Comparative in vitro metabolism on animal species used in pivotal studies in order to guide in the interpretation of findings and in further definition of the testing strategy relevance of toxicological animal data base

5 Sanco /11802/2010 Active substance Acute oral (in vivo) : mandatory Acute dermal (in vivo) not mandatory : conditional to oral acute, and dermal absorption % Skin and eye irritation tier approach including in vitro studies Skin sensitisation Local lymph node assay, default method Phototoxicity (in vitro) not mandatory conditional to active substance electromagnetic radiation absorption

6 Sanco /11802/2010 Active substance Short term (mandatory studies) 90-day rat & 90-day dog (no need for 1-year-dog) If nervous system, immune system or endocrine system are specific targets in short term studies at dose levels not producing marked toxicity, additional second tier tests including functional testing should be considered Toxicokinetic data should be included

7 Sanco /11802/2010 Active substance Genotoxicity testing In vitro test : bacterial assay for gene mutation, combined tests for structural and numerical chromosome aberrations in mammalian cells test for gene mutation in mammalian cells

8 Sanco /11802/2010 Active substance Genotoxicity testing In vivo test : results of the in vitro studies are negative, at least one in vivo study must be done equivocal or a positive test result in any in vitro test, nature of additional testing considered on a caseby-case basis in relation with in vitro test reference to dominant lethal assay is deleted

9 Sanco /11802/2010 Active substance Long term studies Long-term rat oral toxicity and carcinogenicity study shall be conducted Long-term mouse oral toxicity and carcinogenicity study shoud be conducted Waiving must be fully justified Alternative carcinogenicity in vivo models such as transgenic mice, when validated, could be used instead of a second carcinogenicity study Determination of blood concentration should be considered

10 Sanco /11802/2010 Active substance Reproductive toxicity Multi-generation studies F1-extended one generation studies should be considered as alternative when validated and adopted as UE/OECD

11 Sanco /11802/2010 Active substance Developmental toxicity studies : both rat & rabbit Potential neurotoxic, immunotoxic effects and effects potentially related to change in hormonal system shall be carefully addressed In order to provide useful information in the design and interpretation of developmental toxicity studies : information on blood concentration of the active substance in parents and fetus/offspring may be included in higher tier studies and reported.

12 Sanco /11802/2010 Supplementary studies In certain cases it can be necessary to carry out supplementary studies to further clarify observed effects. These studies could include: studies on the immunotoxicological potential, studies on absorption, distribution, excretion and metabolism, in a second species a targeted single dose study to derive appropriate acute reference values (ARfD, aaoel), studies on potential effects on the endocrine system

13 Major changes proposed vs 91/414/EEC : Sanco /11803/2010 Plant protection product Studies to be conducted using the plant protection product to be authorised or bridging principles may be applied Before generating studies : take into account possibility to extrapolate results from related preparations or other existing studies Directive 99/45/EC or Regulation (EC) n 1272/2008 where relevant can be invoked for waiving studies

14 Sanco /11803/2010 Plant protection product Acute oral : mandatory Acute dermal Dermal not mandatory : conditional to oral acute, and dermal absorption % Skin and eye irritation tier approach including in vitro studies Skin sensitisation Local lymph node assay, default method

15 Sanco /11803/2010 Plant protection product Dermal absorption Study must be conducted when dermal exposure is a significant exposure route and no acceptable risk is estimated using default absorption value preferably using human skin in vitro Studies should be performed on representative preparation(s)

16 Conclusion Impact of new data requirements, however Further requirements and guidance shall be developed and adopted to address certain issues pesticides which may disrupt the endocrine system cumulative exposure to more than one a.i. Evolution of the data requirements expected in these fields ( to adress the mode of action, exposure,.)

17 Many thanks to colleagues from different organisations for their participation to the project Thank you for your attention

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