SHORT REPORT OF THE MEETING OF THE STANDING COMMITTEE ON PLANT HEALTH HELD ON 2 OCTOBER 2001 IN BRUXELLES
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1 SCPH 4/01 SHORT REPORT OF THE MEETING OF THE STANDING COMMITTEE ON PLANT HEALTH HELD ON 2 OCTOBER 2001 IN BRUXELLES President : Canice Nolan Italy was not present at the meeting and was represented by the delegation of Greece. All other Member States were present. 1 Examination and possible vote on a draft Commission Decision recognising the completeness of the dossier submitted for detailed examination with a view to the possible inclusion of novaluron and laminarin in Annex I to Council Directive 91/414/EEC (SANCO/2764/2001 rev2). The Commission presented the draft Decision. Vote : favourable opinion by unanimity. 2 Examination and possible vote on a draft Commission Directive concerning the inclusion of 2,4-D in Annex 1 to Council Directive 91/414/EEC (SANCO/3117/2001 rev.2; Review Report 7599/VI/97-rev. 7). The following declarations were made: Commission: At the adoption of the Uniform Principles by Council in 1997, the Council and Commission agreed to the following declaration: The Council and the Commission note that application of this Directive is without prejudice to the legislation in force concerning the protection of workers. The Council and the Commission state that this principle will be unequivocally clarified in Directive 91/414/EEC on the occasion of the first amendment of that Directive. The Commission intends to submit a proposal for such amendment within one year from the date of notification of this Directive. The Commission can for its part confirm its agreement with this declaration (subject to adequate adaptation of the deadline in the declaration). Sweden: Results from a recently published in vivo study 1 in mouse indicate a genotoxic effect of 2,4-D. Since the study has not yet been evaluated, it is not possible to disregard radical consequences for the risk assessment. For the time being, Sweden is therefore not prepared to vote on the proposal to include 2,4-D in Annex I to Council Directive 91/414/EEC. Commission: The Commission notes that Art. 7 of the Directive provides that on the basis of new scientific evidence any decision can be reviewed. 1 Amer, S.M. and Aly, F.A.E. Genotoxic effect of 2,3-dichlorophenoxy acetic acid and its metabolite 2,4- dichlorophenol in mouse. Mutat. Res. 494 (2001) Rue de la Loi 200, B-1049 Bruxelles/Wetstraat 200, B-1049 Brussel - Belgium - Office: L-86 01/16. Telephone: direct line (+32-2) , switchboard Fax:
2 The Commission presented the draft Directive. Vote : favourable opinion by qualified majority (4 votes abstain) 3 Examination and possible vote on a draft Commission Decision concerning the decision on the possible inclusion of certain active substances into Annex I to Council Directive 91/414/EEC (Sanco/2846/2001 rev. 5). In relation to giving its opinion on the Draft Commission Decision concerning the postponement of the decision on the possible inclusion of certain active substances into Annex I to Directive 91/414/EEC (document SANCO/2846/2001), the Standing Committee on Plant Health takes note of the following data requirements, established by the Commission having consulted the Committee, for the active substances listed in its Annex. Data requirements contained in document : Alachlor Doc. SANCO/4330/2001 rev 0-3 Alpha-cypermethrin Doc. SANCO/4334/2001 rev 0-3 Benalaxyl Doc. SANCO/4350/2000 rev 0-3 Benomyl Doc. 5029/VI/98 rev 4 Bromoxynil Doc. SANCO/4346/2000 rev 0-3 Chlorothalonil Doc. SANCO/4342/2000 rev 0-3 Chlorotoluron Doc. SANCO/4328/2001 rev 0-3 Cypermethrin Doc. SANCO/4332/2000 rev 0-3 Dinocap Doc. SANCO/4344/2000 rev 0-3 Endosululfan Doc. SANCO/4326/2001 rev 0-3 Ioxynil Doc. SANCO/4348/2000 rev 0-3 Methamidophos Doc. SANCO/4340/ rev. 0-3 The following long term studies have been identified as necessary : Alachlor : Benalaxyl : Benomyl : Bromoxynil : Risk assessment on algae and aquatic plants Accumulation potential of metabolites Field lysimeter study Ecotoxicological and toxicological relevance of metabolites Soil accumulation study with the metabolite carbendazime Refined risk assessment for birds and mammals Chlorothalonil : Confirmatory method and validation for residues in animal products Higher tier studies non-target arthropods 2
3 Chlorotoluron : Cypermethrin : Dinocap : Endosulfan : Ioxynil : Sub-lethal study on earthworms Nitrogen and carbon mineralisation Effects of metabolites on organic matter breakdown Storage stability of residues Water/sediment study Analytical methods for surface water and groundwater Risk assessment for birds Aquatic toxicity of aquatic metabolites Metabolism in plants and livestock Phototransformation and quantum yield Analytical methods for plants, products of animal origin, soil and surface water Soil photolysis study Storage stability of residues in oilseed rape Livestock feeding study in dairy cattle Dietary and reproductive toxicity to birds Risk to aquatic organisms Risk to non-target arthropods Risk to soil macro-organisms metabolism study on plants with the isomer 2,6-DNOPC water/sediment study Chronic life-cycle study on a sensitive fish species Field study on earthworms Risk to soil macro-organisms Operator exposure Refined risk assessment for birds and mammals Livestock feeding study Methamidophos : Refined risk assessment for birds and mammals Further studies on non-target arthropods The following declaration was made : Germany: Germany in principle supports the aim of the proposed Commission Decision. However, the current proposal can not be supported, because Germany is of the opinion that there is sufficient information available already at this stage, to enable the Commission to immediately propose decisions concerning the non-inclusion of methamidophos and endosulfan in Annex I of Council Directive 91/414/EEC. The Commission presented the draft Decision. Vote : favourable opinion by qualified majority (10 votes against). The Decision sets timelines for the submission of additional or outstanding information on 12 substances being evaluated under the first review program. 4 Examination of notifications submitted under the third stage of the work programme under Commission Regulation 451/2000/EC. 3
4 The Commission presented an overview report on the admissible notifications under the third phase of the review programme in document Sanco/3523/2001. The Committee took note of the report. 5 Adaptation to technical progress of the Guidance document on aquatic ecotoxicology (Sanco/3268/2001) Germany declares that it was not possible for them to come to a consolidated position within the timeframe available for internal consultations. The Committee took note of the Guidance document, which will be made available to interested parties and published on the internet site of the Directorate General Health and Consumer Protection. 6 Other business 6.1 Corrigendum of minutes from last meeting Under the agenda point " Withdrawal of authorisations for Esfenvalerate in Denmark" the minutes of the Committee meeting on 29 June 2001 should be corrected as follows. The third paragraph under the agenda point should read: "Denmark reached this decision formally on national rules in the absence of Community legislation in force and notes that it is possible that the same decision would also have been reached on the basis of the Directive to include esfenvalerate in Annex I. The decision was based on higher tier studies, for which no strict guidance is provided in the uniform principles. Denmark notes that the decision was not based on any special or accelerated procedure and the treatment was equitable with that of any other product." 6.2 Appendix III to the Review Report of Glyphosate (6511/VI/99-rev. 5) The Rapporteur Member State has now made available the revised Appendix III to the review report, as requested by the Committee at its last meeting. The Committee took note of the revised Appendix III. 6.3 Declaration of The Netherlands In view of the increasing workload on the Commission to take decisions on individual active substances in the coming years, the Dutch delegation urges the Commission to increase their resources / capacity in addition to the foreseen increase in personnel in the new European Food Authority. This declaration was supported by all Member States. The measures on which the Committee has given its opinion are subject to the appropriate procedures for formal adoption by the Commission. A CHECCHI LANG 4
5 Liste des participants à joindre au compte rendu succinct Comité Comité phytosanitaire - legislation Date: 2 octobre 2001 Etat Membre Ministère ou Organisme Nombre de personnes BE Ministry of Agriculture 1 DK Ministry of Environment and Energy 2 DE Bundesministerium für Verbraucherschutz, Ernährung und Landwirtschaft EL Ministry of Agriculture 2 ES Ministerio Agricultura 1 FR Ministry of Agriculture 2 IRL Pesticide Control Service 1 IT Ministero della Sanita 0 L Ministere de l agriculture ASTA 1 NL Ministerie van VROM 1 A Ministerie van LNV 1 Bundesminsterium für Land- und Forstwirtschaft, Umwelt und Wasserwirtschaft PT Ministry of Agriculture 1 FIN Plant Protection Inspection Centre 2 SV National Chemicals Inspection 2 UK Pesticides Safety Directorate 2 COM 4 N Norwegian Agricultural Inspection Service
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