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- 6 - particular requirements in sections 4, 5, 6 and 7 of this report, as well as to the implementation of the provisions of Article 4(1) and the uniform principles laid down in Annex VI of Directive 91/414/EEC, for each chlorothalonil containing plant protection product for which Member States will grant or review the authorisation. Furthermore, these conclusions were reached within the framework of the uses which were proposed and supported by the main data submitter and mentioned in the list of uses supported by available data (attached as Appendix IV to this Review Report). Extension of the use pattern beyond those described above will require an evaluation at Member State level in order to establish whether the proposed extensions of use can satisfy the requirements of Article 4(1) and of the uniform principles laid down in Annex VI of Directive 91/414/EEC. With particular regard to residues, the review has established that the residues arising from the proposed uses, consequent on application consistent with good plant protection practice, have no harmful effects on human or animal health. The Theoretical Maximum Daily Intake (TMDI; excluding water and products of animal origin) for a 60 kg adult is 1.4 % of the Acceptable Daily Intake (ADI), based on the FAO/WHO European Diet (August 1994). Additional intake from water and products of animal origin are not expected to give rise to intake problems. The review has identified several acceptable exposure scenarios for operators, workers and bystanders, which require however to be confirmed for each plant protection product in accordance with the relevant sections of the above mentioned uniform principles. The review has also concluded that under the proposed and supported conditions of use there are no unacceptable effects on the environment, as provided for in Article 4 (1) (b) (iv) and (v) of Directive 91/414/EEC, provided that certain conditions are taken into account as detailed in section 6 of this report.
- 7 - 4. Identity and Physical/chemical properties The main identity and the physical/chemical properties of chlorothalonil are given in Appendix I. The active substance shall comply with the FAO specification and there seem not to be reasons for deviating from that specification; the FAO specification is given in Appendix I of this report. The review has established that for the active substance notified by the main data submitter Zeneca Agrochemicals, two of the manufacturing impurities considered are, on the basis of information currently available, of toxicological or environmental concern. In accordance with the provisions of Article 13(5) of Directive 91/414/EEC, RMS is also satisfied, on the basis of the information currently available, that the substances notified by the other data submitters Vischim Srl and Gharda Chemicals Ltd. do not, in the meaning of Article 13(2) and (5) of the Directive, differ significantly in degree of purity and nature of impurities from the composition registered in the dossier submitted by the main data submitter. However it must be noted that the active substance is under re-evaluation by the FAO (started in 2003). 5. Endpoints and related information In order to facilitate Member States, in granting or reviewing authorisations, to apply adequately the provisions of Article 4(1) of Directive 91/414/EEC and the uniform principles laid down in Annex VI of that Directive, the most important endpoints were identified during the re-evaluation process. These endpoints are listed in Appendix II.
Page 1 and 2: EUROPEAN COMMISSION HEALTH & CONSUM
Page 3 and 4: - 3 - By letter 6 March 1998 Zeneca
Page 5: - 5 - Annex I to Directive 91/414/E
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Page 11 and 12: CHLOROTHALONIL Melting point 252 °
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