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
Date: 2010-11-10
Institutions: European Commission
Subjects: administrative formalities, chemical product, marketing, plant health control, plant health product, toxic substance




L_2010293EN.01004801.xml










11.11.2010   


EN


Official Journal of the European Union


L 293/48








            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)


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 market (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 1
Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.


Article 2
Member 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 3

Entry into force

This 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 Commission


The President

José Manuel BARROSO
            





(1)  
            OJ L 230, 19.8.1991, p. 1.




ANNEX
Annex I to Directive 91/414/EEC is amended as follows:






(1)


Row 7 is replaced by the following:











No


Common Name, Identification Numbers


IUPAC Name


Purity (*1)



Entry into force


Expiration of inclusion


Specific provisions




‘7


Metsulfuron methyl
CAS No 74223-64-6
EEC No 441


Methyl 2-(4-methoxy-6-methyl-1,3,5,-triazin-2-ylcarbamoylsulfamoyl) benzoate


960  g/kg


1 July 2001


31 December 2015


Only 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: 16 June 2000.’














(2)


Rows 9 to 28 are replaced by the following:











No


Common Name, Identification Numbers


IUPAC Name


Purity (*2)



Entry into force


Expiration of inclusion


Specific provisions




‘9


Triasulfuron
CAS No 82097-50-5
CIPAC No 480


1-[2-(2-chloroethoxy)phenylsulfonyl] -3 - (4-methoxy-6-methyl-1,3,5-triazin-2-yl)urea


940  g/kg


1 August 2001


31 December 2015


Only 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.




10


Esfenvalerate
CAS No 66230-04-4
CIPAC No 481


(S)-α-Cyano-3-phenoxybenzyl-(S)-2-(4-chlorophenyl)-3- methylbutyrate


830  g/kg


1 August 2001


31 December 2015


Only 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.




11


Bentazone
CAS No 25057-89-0
CIPAC No 366


3-isopropyl-(1H)-2,1,3-benzothiadiazin-4-(3H)-one-2,2-dioxide


960  g/kg


1 August 2001


31 December 2015


Only 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.




12


Lambda-cyhalothrin
CAS No 91465-08-6
CIPAC No 463


A 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-dimethylcyclopropanecarboxylate






810  g/kg


1 January 2002


31 December 2015


Only 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.




13


Fenhexamid
CAS No 126833-17-8
CIPAC No 603


N-(2,3-dichloro-4-hydroxyphenyl)-1- methylcyclohexanecarboxamide


≥ 950 g/kg


1 June 2001


31 December 2015


Only 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.




14


Amitrole
CAS No 61-82-5
CIPAC No 90


H-[1,2,4]-triazole-3-ylamine


900  g/kg


1 January 2002


31 December 2015


Only uses as herbicide may be authorised
For 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.








15


Diquat
CAS No 2764-72-9 (ion), 85-00-7 (dibromide)
CIPAC No 55


9,10-dihydro-8a,10a-diazoniaphenanthrene ion (dibromide)


950  g/kg


1 January 2002


31 December 2015


On 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.








16


Pyridate
CAS No 55512-33.9
CIPAC No 447


6-chloro-3-phenylpyridazin-4-yl S-octyl thiocarbonate


900  g/kg


1 January 2002


31 December 2015


Only 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.








17


Thiabendazole
CAS No 148-79-8
CIPAC No 323


2-Thiazol-4-yl-1H-benzimidazole


985  g/kg


1 January 2002


31 December 2015


Only 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.




18



Paecilomyces fumosoroseus Apopka strain 97, PFR 97 or CG 170, ATCC20874


Not applicable


the absence of secondary metabolites should be checked in each fermentation broth by HPLC.


1 July 2001


31 December 2015


Only 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.




19


DPX KE 459 (flupyrsulfuron-methyl)
CAS No 144740-54-5
CIPAC No 577


2-(4,6-dimethoxypyrimidin-2-ylcarbamoylsulfamoyl)-6-trifluromethylnicotinate monosodium salt


903  g/kg


1 July 2001


31 December 2015


Only 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.




20


Acibenzolar-s-methyl
CAS No 135158-54-2
CIPAC No 597


benzo[1,2,3]thiadiazole-7-carbothioic acid S-methyl ester


970  g/kg


1 November 2001


31 December 2015


Only 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




21


Cyclanilide
CAS No 113136-77-9
CIPAC No 586


Not available


960  g/kg


1 November 2001


31 December 2015


Only 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.




22


Ferric phosphate
CAS No 10045-86-0
CIPAC No 629


Ferric Phosphate


990  g/kg


1 November 2001


31 December 2015


Only uses as a molluscicide may be authorised.
Date of Standing Committee on Plant Health at which the review report was finalised: 29 June 2001.




23


Pymetrozine
CAS No 123312-89-0
CIPAC No 593


(E)-6-methyl-4-[(pyridin-3-ylmethylene)amino]-4,5-dihydro-2H-[1,2,4]-triazin-3 one


950  g/kg


1 November 2001


31 December 2015


Only 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.




24


Pyraflufen-ethyl
CAS No 129630-19-9
CIPAC No 605


Ethyl 2-chloro-5-(4-chloro-5-difluoromethoxy-1-methylpyrazol-3-yl)-4-fluorophenoxyacetate


956  g/kg


1 November 2001


31 December 2015


Only 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.




25


Glyphosate
CAS No 1071-83-6
CIPAC No 284


N-(phosphonomethyl)-glycin


950  g/kg


1 July 2002


31 December 2015


Only uses as herbicide may be authorised
For 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.








26


Thifensulfuron-methyl
CAS No 79277-27-3
CIPAC No 452


Methyl 3-(4-methoxy-6-methyl-1,3,5-triazin-2-ylcarbamoyl-sulfamoyl)thiophene-2-carboxylate


960  g/kg


1 July 2002


31 December 2015


Only uses as herbicide may be authorised
For 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.








27


2,4-D
CAS No 94-75-7
CIPAC No 1


(2,4-dichlorophenoxy) acetic acid


960  g/kg


1 October 2002


31 December 2015


Only uses as herbicide may be authorised
For 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.








28


Isoproturon
CAS No 34123-59-6
CIPAC No 336


3-(4-isopropylphenyl)-1,1-dimethylurea


970  g/kg


1 January 2003


31 December 2015


Only uses as herbicide may be authorised
For 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.’


















(3)


Rows 30 to 39 are replaced by the following:











No


Common Name, Identification Numbers


IUPAC Name


Purity (*3)



Entry into force


Expiration of inclusion


Specific provisions




‘30


Iprovalicarb
CAS No 140923-17-7
CIPAC No 620


{2-Methyl-1-[1-(4-methylphenyl)ethylcarbonyl]propyl}- carbamic acid isopropylester


950  g/kg
(provisional specification)


1 July 2002


31 December 2015


Only 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.








31


Prosulfuron
CAS No 94125-34-5
CIPAC No 579


1-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-3-[2-(3,3,3-trifluoropropyl)-phenylsulfonyl]-urea


950  g/kg


1 July 2002


31 December 2015


Only 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.








32


Sulfosulfuron
CAS No 141776-32-1
CIPAC No 601


1-(4,6-dimethoxypyrimidin-2-yl)-3-[(2-ethanesulfonyl-imidazo[1,2-a]pyridine) sulfonyl]urea


980  g/kg


1 July 2002


31 December 2015


Only 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 assessment






—


Member 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.








33


Cinidon-ethyl
CAS No 142891-20-1
CIPAC No 598


(Z)-ethyl 2-chloro-3-[2-chloro-5-(cyclohex-1-ene-1,2-dicarboximido)phenyl]acrylate


940  g/kg


1 October 2002


31 December 2015


Only 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.




34


Cyhalofop butyl
CAS No 122008-85-9
CIPAC No 596


Butyl-(R)-2-[4(4-cyano-2-fluorophenoxy) phenoxy]propionate


950  g/kg


1 October 2002


31 December 2015


Only 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 assessment






—


Member 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.








35


Famoxadone
CAS No 131807-57-3
CIPAC No 594


3-anilino-5-methyl-5-(4-phenoxyphenyl)-1,3-oxazolidine-2,4-dione


960  g/kg


1 October 2002


31 December 2015


Only 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.








36


Florasulam
CAS No 145701-23-1
CIPAC No 616


2', 6', 8-Trifluoro-5-methoxy-[1,2,4]-triazolo [1,5-c] pyrimidine-2-sulphonanilide


970  g/kg


1 October 2002


31 December 2015


Only 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.








37


Metalaxyl-M
CAS No 70630-17-0
CIPAC No 580


Methyl (R)-2-{[(2,6-dimethylphenyl)methoxyacetyl] amino} propionate


910  g/kg


1 October 2002


31 December 2015


Only 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.








38


Picolinafen
CAS No 137641-05-5
CIPAC No 639


4′-Fluoro-6-[(α,α,α-trifluoro-m-tolyl)oxy]picolinanilide


970  g/kg


1 October 2002


31 December 2015


Only 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.








39


Flumioxazine
CAS No 103361-09-7
CIPAC No 578


N-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2H-1,4-benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboximide


960  g/kg


1 January 2003


31 December 2015


Only 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.’














(*1)  Further details on identity and specification of active substances are provided in their review reports.

(*2)  Further details on identity and specification of active substances are provided in their review reports.

(*3)  Further details on identity and specification of active substances are provided in their review reports.