Commission Directive 2010/77/EU of 10 November 2010 amending Council Directive 91/414/EEC as regards the expiry dates for inclusion in Annex I of certain active substances Text with EEA relevance
Commission Directive 2010/77/EUof 10 November 2010amending Council Directive 91/414/EEC as regards the expiry dates for inclusion in Annex I of certain active substances(Text with EEA relevance) THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the marketOJ L 230, 19.8.1991, p. 1., and in particular Article 6(1) thereof,Whereas:(1)The inclusions in Annex I to Directive 91/414/EEC of the active substances listed in the Annex to this Directive expire between 31 May 2011 and 31 December 2012.(2)Article 5(5) of Directive 91/414/EEC provides that the inclusion of an active substance can be renewed, upon request, provided an application is made at the latest two years before the inclusion period is due to lapse. The Commission has received requests regarding renewals of inclusions for all the substances referred to in recital 1.(3)Detailed rules will be needed concerning the submission and evaluation of further information necessary for the renewal of Annex I inclusion. Therefore, it is justified to renew the inclusion of the active substances referred to in recital 1 for a period necessary to enable the applicants to prepare their applications and to enable the Commission to evaluate and decide upon such applications.(4)It is therefore appropriate to amend Directive 91/414/EEC accordingly.(5)The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,HAS ADOPTED THIS DIRECTIVE:
Article 1Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
Article 2Member States shall adopt and publish, by 31 March 2011 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.They shall apply those provisions from 1 April 2011.When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
Article 3Entry into forceThis Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.This Directive is addressed to the Member States.
Done at Brussels, 10 November 2010.For the CommissionThe PresidentJosé Manuel BarrosoANNEXAnnex I to Directive 91/414/EEC is amended as follows:(1)Row 7 is replaced by the following:
Further details on identity and specification of active substances are provided in their review reports.
NoCommon Name, Identification NumbersIUPAC NamePurityEntry into forceExpiration of inclusionSpecific provisions
"7Metsulfuron methylCAS No 74223-64-6EEC No 441Methyl 2-(4-methoxy-6-methyl-1,3,5,-triazin-2-ylcarbamoylsulfamoyl) benzoate960 g/kg1 July 200131 December 2015Only uses as herbicide may be authorised.In their decision making according to the Uniform Principles Member Statesmust pay particular attention to the protection of groundwater;must pay particular attention to the impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.Date of Standing Committee on Plant Health at which the review report was finalised: 16 June 2000."
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Further details on identity and specification of active substances are provided in their review reports.
(2)Rows 9 to 28 are replaced by the following:
Further details on identity and specification of active substances are provided in their review reports.
NoCommon Name, Identification NumbersIUPAC NamePurityEntry into forceExpiration of inclusionSpecific provisions
"9TriasulfuronCAS No 82097-50-5CIPAC No 4801-[2-(2-chloroethoxy)phenylsulfonyl] -3 - (4-methoxy-6-methyl-1,3,5-triazin-2-yl)urea940 g/kg1 August 200131 December 2015Only uses as herbicide may be authorised.In their decision making according to the Uniform Principles Member States:must pay particular attention to the protection of groundwater;must pay particular attention to the impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.Date of Standing Committee on Plant Health at which the review report was finalised: 13 July 2000.
10EsfenvalerateCAS No 66230-04-4CIPAC No 481(S)-α-Cyano-3-phenoxybenzyl-(S)-2-(4-chlorophenyl)-3- methylbutyrate830 g/kg1 August 200131 December 2015Only uses as insecticide may be authorised.In their decision making according to the Uniform Principles Member States:must pay particular attention to the potential impact on aquatic organisms and non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.Date of Standing Committee on Plant Health at which the review report was finalised: 13 July 2000.
11BentazoneCAS No 25057-89-0CIPAC No 3663-isopropyl-(1H)-2,1,3-benzothiadiazin-4-(3H)-one-2,2-dioxide960 g/kg1 August 200131 December 2015Only uses as herbicide may be authorised.In their decision making according to the Uniform Principles Member States must pay particular attention to the protection of groundwater.Date of Standing Committee on Plant Health at which the review report was finalised: 13 July 2000.
12Lambda-cyhalothrinCAS No 91465-08-6CIPAC No 463A 1:1 mixture of:(S)-α-cyano-3-phenoxybenzyl (Z)-(1R,3R)-3-(2-chloro-3,3,3-trifluoropropenyl)-2,2-dimethylcyclopropanecarboxylate,and(R)-α-cyano-3-phenoxybenzyl (Z)-(1S,3S)-3-(2-chloro-3,3,3-trifluoropropenyl)-2,2-dimethylcyclopropanecarboxylate810 g/kg1 January 200231 December 2015Only uses as insecticide may be authorised.In their decision making according to the Uniform Principles Member States:must pay particular attention to operator safety;must pay particular attention to the potential impact on aquatic organisms and non-target arthropods including bees and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;must pay particular attention to the residues in food and especially the acute effects thereof.Date of Standing Committee on Plant Health at which the review report was finalised: 19 October 2000.
13FenhexamidCAS No 126833-17-8CIPAC No 603N-(2,3-dichloro-4-hydroxyphenyl)-1- methylcyclohexanecarboxamide≥ 950 g/kg1 June 200131 December 2015Only uses as a fungicide may be authorized.In decision making according to the Uniform Principles Member States must pay particular attention to the potential impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.Date of Standing Committee on Plant Health at which the review report was finalised: 19 October 2000.
14AmitroleCAS No 61-82-5CIPAC No 90H-[1,2,4]-triazole-3-ylamine900 g/kg1 January 200231 December 2015Only uses as herbicide may be authorisedFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on amitrole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 12 December 2000 shall be taken into account. In this overall assessment Member States:must pay particular attention to the protection of operators;must pay particular attention to the protection of the groundwater in vulnerable areas, in particular with respect to non-crop uses;must pay particular attention to the protection of beneficial arthropods;must pay particular attention to the protection of birds and wild mammals. Use of amitrole during the breeding season may only be authorised when an appropriate risk assessment has demonstrated that there is no unacceptable impact and when the conditions of authorisation include, where appropriate, risk mitigation measures.
15DiquatCAS No 2764-72-9 (ion), 85-00-7 (dibromide)CIPAC No 559,10-dihydro-8a,10a-diazoniaphenanthrene ion (dibromide)950 g/kg1 January 200231 December 2015On the basis of currently available information, only uses as terrestrial herbicide and desiccant may be authorised. Uses in aquatic weed control shall not be authorised.For the implementation of the uniform principles of Annex VI, the conclusions of the Review report on diquat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 12 December 2000 shall be taken into account. In this overall assessment Member States:must pay particular attention to the potential impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;must pay particular attention to operator safety as related to non-professional use and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.
16PyridateCAS No 55512-33.9CIPAC No 4476-chloro-3-phenylpyridazin-4-yl S-octyl thiocarbonate900 g/kg1 January 200231 December 2015Only uses as herbicide may be authorized.For the implementation of the uniform principles of Annex VI, the conclusions of the Review report on Pyridate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 12 December 2000 shall be taken into account. In this overall assessment Member States:must pay particular attention to the protection of groundwater;must pay particular attention to the potential impact on aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.
17ThiabendazoleCAS No 148-79-8CIPAC No 3232-Thiazol-4-yl-1H-benzimidazole985 g/kg1 January 200231 December 2015Only uses as fungicide may be authorised. Foliar spray applications shall not be authorised.For the implementation of the uniform principles of Annex VI, the conclusions of the Review report on thiabendazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 12 December 2000 shall be taken into account. In this overall assessment Member States:must pay particular attention to the protection of aquatic and sediment-dwelling organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.Suitable risk mitigation measures (e.g. depuration with diatom earth or activated carbon) have to be implemented to protect surface waters from unacceptable levels of contamination via wastewater.
18Paecilomyces fumosoroseus Apopka strain 97, PFR 97 or CG 170, ATCC20874Not applicablethe absence of secondary metabolites should be checked in each fermentation broth by HPLC.1 July 200131 December 2015Only uses as an insecticide may be authorised.Each fermentation broth should be checked by HPLC to ensure that no secondary metabolites are present.Date of Standing Committee on Plant Health at which the review report was finalised: 27 April 2001.
19DPX KE 459 (flupyrsulfuron-methyl)CAS No 144740-54-5CIPAC No 5772-(4,6-dimethoxypyrimidin-2-ylcarbamoylsulfamoyl)-6-trifluromethylnicotinate monosodium salt903 g/kg1 July 200131 December 2015Only uses as a herbicide may be authorised.In decision making according to the Uniform Principles Member States must pay particular attention to the protection of groundwater.Date of Standing Committee on Plant Health at which the review report was finalised: 27 April 2001.
20Acibenzolar-s-methylCAS No 135158-54-2CIPAC No 597benzo[1,2,3]thiadiazole-7-carbothioic acid S-methyl ester970 g/kg1 November 200131 December 2015Only uses as a plant activator may be authorised.Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001
21CyclanilideCAS No 113136-77-9CIPAC No 586Not available960 g/kg1 November 200131 December 2015Only uses as a plant growth regulator may be authorised.The maximum content of the impurity 2,4-dichloroaniline (2,4-DCA) in the active substance as manufactured should be 1 g/kg.Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001.
22Ferric phosphateCAS No 10045-86-0CIPAC No 629Ferric Phosphate990 g/kg1 November 200131 December 2015Only uses as a molluscicide may be authorised.Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001.
23PymetrozineCAS No 123312-89-0CIPAC No 593(E)-6-methyl-4-[(pyridin-3-ylmethylene)amino]-4,5-dihydro-2H-[1,2,4]-triazin-3 one950 g/kg1 November 200131 December 2015Only uses as an insecticide may be authorised.In decision making according to the Uniform Principles Member States must pay particular attention to the protection of aquatic organisms.Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001.
24Pyraflufen-ethylCAS No 129630-19-9CIPAC No 605Ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methylpyrazol-3-yl)-4-fluorophenoxyacetate956 g/kg1 November 200131 December 2015Only uses as a herbicide may be authorised.In decision making according to the Uniform Principles Member States must pay particular attention to the protection of algae and aquatic plants and should apply, where appropriate, risk mitigation measures.Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001.
25GlyphosateCAS No 1071-83-6CIPAC No 284N-(phosphonomethyl)-glycin950 g/kg1 July 200231 December 2015Only uses as herbicide may be authorisedFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on glyphosate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 29 June 2001 shall be taken into account. In this overall assessment Member States:must pay particular attention to the protection of the groundwater in vulnerable areas, in particular with respect to non-crop uses.
26Thifensulfuron-methylCAS No 79277-27-3CIPAC No 452Methyl 3-(4-methoxy-6-methyl-1,3,5-triazin-2-ylcarbamoyl-sulfamoyl)thiophene-2-carboxylate960 g/kg1 July 200231 December 2015Only uses as herbicide may be authorisedFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on thifensulfuron-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 29 June 2001 shall be taken into account. In this overall assessment Member States:must pay particular attention to the protection of groundwater;must pay particular attention to the impact on aquatic plants and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.
272,4-DCAS No 94-75-7CIPAC No 1(2,4-dichlorophenoxy) acetic acid960 g/kg1 October 200231 December 2015Only uses as herbicide may be authorisedFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on 2,4-D, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 2 October 2001 shall be taken into account. In this overall assessment Member States:must pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;must pay particular attention to the dermal absorption;must pay particular attention to the protection of non-target arthropods and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.
28IsoproturonCAS No 34123-59-6CIPAC No 3363-(4-isopropylphenyl)-1,1-dimethylurea970 g/kg1 January 200331 December 2015Only uses as herbicide may be authorisedFor the implementation of the uniform principles of Annex VI, the conclusions of the review report on isoproturon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plant Health on 7 December 2001 shall be taken into account. In this overall assessment Member States:must pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions or at use rates higher than those described in the review report and must apply risk mitigation measures, where appropriate;must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures."
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Further details on identity and specification of active substances are provided in their review reports.
(3)Rows 30 to 39 are replaced by the following:
Further details on identity and specification of active substances are provided in their review reports.
NoCommon Name, Identification NumbersIUPAC NamePurityEntry into forceExpiration of inclusionSpecific provisions
"30IprovalicarbCAS No 140923-17-7CIPAC No 620{2-Methyl-1-[1-(4-methylphenyl)ethylcarbonyl]propyl}- carbamic acid isopropylester950 g/kg(provisional specification)1 July 200231 December 2015Only uses as fungicide may be authorised.For the implementation of the uniform principles of Annex VI, the conclusions of the review report on iprovalicarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2002 shall be taken into account. In this overall assessment:the specification of the technical material as commercially manufactured must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossier should be compared and verified against this specification of the technical material;Member States must pay particular attention to the protection of operators.
31ProsulfuronCAS No 94125-34-5CIPAC No 5791-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-3-[2-(3,3,3-trifluoropropyl)-phenylsulfonyl]-urea950 g/kg1 July 200231 December 2015Only uses as herbicide may be authorised.For the implementation of the uniform principles of Annex VI, the conclusions of the review report on prosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2002 shall be taken into account. In this overall assessment Member States:must carefully consider the risk to aquatic plants if the active substance is applied adjacent to surface waters. Risk mitigation measures should be applied where appropriate;must pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions. Risk mitigation measures should be applied where appropriate.
32SulfosulfuronCAS No 141776-32-1CIPAC No 6011-(4,6-dimethoxypyrimidin-2-yl)-3-[(2-ethanesulfonyl-imidazo[1,2-a]pyridine) sulfonyl]urea980 g/kg1 July 200231 December 2015Only uses as a herbicide may be authorised.For the implementation of the uniform principles of Annex VI, the conclusions of the review report on sulfosulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 26 February 2002 shall be taken into account. In this overall assessmentMember States must pay particular attention to the protection of aquatic plants and algae. Where appropriate, risk mitigation measures should be applied;Member States must pay particular attention to the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.
33Cinidon-ethylCAS No 142891-20-1CIPAC No 598(Z)-ethyl 2-chloro-3-[2-chloro-5-(cyclohex-1-ene-1,2-dicarboximido)phenyl]acrylate940 g/kg1 October 200231 December 2015Only uses as herbicide may be authorised.For the implementation of the uniform principles of Annex VI, the conclusions of the review report on cinidon-ethyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment Member States:should pay particular attention to the potential for ground water contamination, when the active substance is applied in regions with vulnerable soil (e.g. soils with neutral or high pH values) and/or climatic conditions;should pay particular attention to the protection of aquatic organisms.Conditions of authorisation must include risk mitigation measures, where appropriate.
34Cyhalofop butylCAS No 122008-85-9CIPAC No 596Butyl-(R)-2-[4(4-cyano-2-fluorophenoxy) phenoxy]propionate950 g/kg1 October 200231 December 2015Only uses as herbicide may be authorised.For the implementation of the uniform principles of Annex VI, the conclusions of the review report on cyhalofop butyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessmentMember States must carefully consider the potential impact of aerial applications to non-target organisms and in particular to aquatic species. Conditions of authorisation must include restrictions or risk mitigation measures, where appropriate.Member States must carefully consider the potential impact of terrestrial applications on aquatic organisms within paddy fields. Conditions of authorisation must include risk mitigation measures, where appropriate.
35FamoxadoneCAS No 131807-57-3CIPAC No 5943-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-dione960 g/kg1 October 200231 December 2015Only uses as fungicide may be authorised.For the implementation of the uniform principles of Annex VI, the conclusions of the review report on famoxadone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment:Member States must pay particular attention to potential chronic risks of the parent substance or metabolites to earthworms;Member States must pay particular attention to the protection of aquatic organisms and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures;Member States should pay particular attention to the protection of operators.
36FlorasulamCAS No 145701-23-1CIPAC No 6162', 6', 8-Trifluoro-5-methoxy-[1,2,4]-triazolo [1,5-c] pyrimidine-2-sulphonanilide970 g/kg1 October 200231 December 2015Only uses as herbicide may be authorised.For the implementation of the uniform principles of Annex VI, the conclusions of the review report on florasulam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment Member States:should pay particular attention to the potential for ground water contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation must include risk mitigation measures, where appropriate.
37Metalaxyl-MCAS No 70630-17-0CIPAC No 580Methyl (R)-2-{[(2,6-dimethylphenyl)methoxyacetyl] amino} propionate910 g/kg1 October 200231 December 2015Only uses as fungicide may be authorised.For the implementation of the uniform principles of Annex VI, the conclusions of the review report on Metalaxyl-M, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment:particular attention should be given to the potential for groundwater contamination by the active substance or its degradation products CGA 62826, and CGA 108906 when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Risk mitigation measures should be applied, where appropriate.
38PicolinafenCAS No 137641-05-5CIPAC No 6394′-Fluoro-6-[(α,α,α-trifluoro-m-tolyl)oxy]picolinanilide970 g/kg1 October 200231 December 2015Only uses as herbicide may be authorised.For the implementation of the uniform principles of Annex VI, the conclusions of the review report on picolinafen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 19 April 2002 shall be taken into account. In this overall assessment Member States:must pay particular attention to the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, where appropriate.
39FlumioxazineCAS No 103361-09-7CIPAC No 578N-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2H-1,4-benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboximide960 g/kg1 January 200331 December 2015Only uses as herbicide may be authorised.For the implementation of the uniform principles of Annex VI, the conclusions of the review report on flumioxazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 June 2002 shall be taken into account. In this overall assessment Member States:must carefully consider the risk to aquatic plants and algae. Conditions of authorisation must include risk mitigation measures, where appropriate."
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Further details on identity and specification of active substances are provided in their review reports.