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- 8 - 6. Particular conditions to be taken into account on short term basis by Member States in relation to the granting of authorisations of plant protection products containing chlorothalonil On the basis of the proposed and supported uses (as listed in Appendix IV), the following particular issues have been identified as requiring particular and short term attention from all Member States, in the framework of any authorisations to be granted, varied or withdrawn, as appropriate: Member States must pay particular attention to the protection of: - aquatic organisms; - groundwater, in particular with regards to the active substance and its metabolites R417888 and R611965 (SDS46851), when the substance is applied in regions with vulnerable soil and/or climate conditions. Conditions of use should include risk mitigation measures, where appropriate. 7. List of studies to be generated No further studies were identified which were at this stage considered necessary in relation to the inclusion of chlorothalonil in Annex I under the current inclusion conditions. Some endpoints however may require the generation or submission of additional studies to be submitted to the Member States in order to ensure authorisations for use under certain conditions. This may particularly be the case for - A sublethal earthworm study with the lead formulation should be performed by Syngenta and used as confirmatory data. - The main notifier will submit a new study to set a new ARfD. This study can be evaluated at a later stage because there is a safe use with the current ArfD of 0.015 mg/kg bw/day.
- 9 - 8. Information on studies with claimed data protection For information of any interested parties, Appendix III gives information about the studies for which the main data submitter has claimed data protection and which during the re-evaluation process were considered as essential with a view to annex I inclusion. This information is only given to facilitate the operation of the provisions of Article 13 of Directive 91/414/EEC in the Member States. It is based on the best information available to the Commission services at the time this review report was prepared; but it does not prejudice any rights or obligations of Member States or operators with regard to its uses in the implementation of the provisions of Article 13 of the Directive 91/414/EEC neither does it commit the Commission. 9. Updating of this review report The technical information in this report may require to be updated from time to time in order to take account of technical and scientific developments as well as of the results of the examination of any information referred to the Commission in the framework of Articles 7, 10 or 11 of Directive 91/414/EEC. Such adaptations will be examined and finalised in the Standing Committee on the Food Chain and Animal Health, in connection with any amendment of the inclusion conditions for chlorothalonil in Annex I of the Directive.
Page 1 and 2: EUROPEAN COMMISSION HEALTH & CONSUM
Page 3 and 4: - 3 - By letter 6 March 1998 Zeneca
Page 5 and 6: - 5 - Annex I to Directive 91/414/E
Page 7: - 7 - 4. Identity and Physical/chem
Page 11 and 12: CHLOROTHALONIL Melting point 252 °
Page 13 and 14: CHLOROTHALONIL - 4 - APPENDIX II EN
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