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Commission Directive 2003/68/EC of 11 July 2003 amending Council Directive 91/414/EEC to include trifloxystrobin, carfentrazone-ethyl, mesotrione, fenamidone and isoxaflutole as active substances (Text with EEA relevance)

Modified by

Commission Directive 2004/65/ECof 26 April 2004amending Directive 2003/68/EC as regards time limits(Text with EEA relevance), 32004L0065, April 28, 2004
Regulation (EC) No 1107/2009 of the European Parliament and of the Councilof 21 October 2009concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC, 32009R1107, November 24, 2009

Commission Directive 2003/68/ECof 11 July 2003amending Council Directive 91/414/EEC to include trifloxystrobin, carfentrazone-ethyl, mesotrione, fenamidone and isoxaflutole as active substances(Text with EEA relevance)

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 2004 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.They shall apply those provisions from 1 April 2004.When Member States adopt those provisions, they shall contain a reference to this Directive or shall 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 31.Member States shall review the authorisation for each plant protection product containing trifloxystrobin, carfentrazone-ethyl, mesotrione, fenamidone or isoxaflutole to ensure that the conditions relating to these active substances set out in Annex I to Directive 91/414/EEC are complied with. Where necessary, they shall amend or withdraw authorisations in accordance with Directive 91/414/EEC by 31 March 2004 at the latest.2.For each authorised plant protection product containing trifloxystrobin, carfentrazone-ethyl, mesotrione, fenamidone or isoxaflutole as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 30 September 2004 at the latest. Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III thereto. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/ 414/EEC. Where necessary and by 31 March 2005 at the latest, they shall amend or withdraw the authorisation for each such plant protection product.

Article 4This Directive shall enter into force on 1 October 2003.

Article 5This Directive is addressed to the Member States.

nullANNEXIn Annex I the following rows are added at the end of the table:

Further details on identity and specification of active substances are provided in the review report."

No	Common name, identification numbers	IUPAC Name	Purity	Entry into force	Expiration of inclusion	Specific provisions
"59	TrifloxystrobinCAS No 141517-21-7CIPAC No 617	Methyl (E)-methoxyimino- {(E)-a-[1-a-(a,a,a-trifluoro-mtolyl)ethylideneaminooxyl]-otolyl}acetate	960 g/kg	1 October 2003	30 September 2013	Only use as fungicide may be authorised.For the implementation of the uniform principles of Annex VI, the conclusions of the review report on trifloxystrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment:Member States should 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 and/or monitoring programs may be initiated where appropriate.
60	Carfentrazone ethylCAS No 128639-02.1CIPAC No 587	Ethyl (RS)-2-chloro-3-[2- chloro-5-(4-difluoromethyl- 4,5-dihydro-3-methyl-5oxo- 1H 1,2,4-triazol-1-yl)-4- fluorophenyl]propionate	900 g/kg	1 October 2003	30 September 2013	Only use as herbicide may be authorised.For the implementation of the uniform principles of Annex VI, the conclusions of the review report on carfentrazone-ethyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment:Member States should 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.
61	MesotrioneCAS No 104206-8CIPAC No 625	2-(4-mesyl-2-nitrobenzoyl) cyclohexane -1,3-dione	920 g/kgThe manufacturing impurity 1-cyano-6-(methylsulfonyl)- 7-nitro-9H-xanthen-9-one is considered to be of toxicological concern and must remain below 0.0002 % (w/w) in the technical product.	1 October 2003	30 September 2013	Only use as herbicide may be authorised.For the implementation of the uniform principles of Annex VI, the conclusions of the review report on mesotrione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on15 April 2003 shall be taken into account.
62	FenamidoneCAS No 161326-34-7CIPAC No 650	(S)-5-methyl-2-methylthio-5-phenyl-3-phenylamino-3,5-dihydroimidazol-4-one	975 g/kg	1 October 2003	30 September 2013	Only use as fungicide may be authorised.For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fenamidone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment Member States:should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions,should pay particular attention to the protection of non-target arthropods,should pay particular attention to the protection of aquatic organisms.Risk mitigation measures should be applied where appropriate.
63	IsoxaflutoleCAS No 141112-29-0CIPAC No 575	5-cyclopropyl-4-(2-methylsulfonyl-4-trifluoromethylbenzoyl) isoxazole	950 g/kg	1 October 2003	30 September 2013	Only use as herbicide may be authorised.For the implementation of the uniform principles of Annex VI, the conclusions of the review report on isoxaflutole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment Member States: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 or monitoring programs should be applied where appropriate.

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Further details on identity and specification of active substances are provided in the review report."

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

Article 4This Directive shall enter into force on 1 October 2003.

Article 5This Directive is addressed to the Member States.

nullANNEXIn Annex I the following rows are added at the end of the table:

Further details on identity and specification of active substances are provided in the review report."

No	Common name, identification numbers	IUPAC Name	Purity	Entry into force	Expiration of inclusion	Specific provisions
"59	TrifloxystrobinCAS No 141517-21-7CIPAC No 617	Methyl (E)-methoxyimino- {(E)-a-[1-a-(a,a,a-trifluoro-mtolyl)ethylideneaminooxyl]-otolyl}acetate	960 g/kg	1 October 2003	30 September 2013	Only use as fungicide may be authorised.For the implementation of the uniform principles of Annex VI, the conclusions of the review report on trifloxystrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment:Member States should 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 and/or monitoring programs may be initiated where appropriate.
60	Carfentrazone ethylCAS No 128639-02.1CIPAC No 587	Ethyl (RS)-2-chloro-3-[2- chloro-5-(4-difluoromethyl- 4,5-dihydro-3-methyl-5oxo- 1H 1,2,4-triazol-1-yl)-4- fluorophenyl]propionate	900 g/kg	1 October 2003	30 September 2013	Only use as herbicide may be authorised.For the implementation of the uniform principles of Annex VI, the conclusions of the review report on carfentrazone-ethyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment:Member States should 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.
61	MesotrioneCAS No 104206-8CIPAC No 625	2-(4-mesyl-2-nitrobenzoyl) cyclohexane -1,3-dione	920 g/kgThe manufacturing impurity 1-cyano-6-(methylsulfonyl)- 7-nitro-9H-xanthen-9-one is considered to be of toxicological concern and must remain below 0.0002 % (w/w) in the technical product.	1 October 2003	30 September 2013	Only use as herbicide may be authorised.For the implementation of the uniform principles of Annex VI, the conclusions of the review report on mesotrione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on15 April 2003 shall be taken into account.
62	FenamidoneCAS No 161326-34-7CIPAC No 650	(S)-5-methyl-2-methylthio-5-phenyl-3-phenylamino-3,5-dihydroimidazol-4-one	975 g/kg	1 October 2003	30 September 2013	Only use as fungicide may be authorised.For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fenamidone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment Member States:should pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climate conditions,should pay particular attention to the protection of non-target arthropods,should pay particular attention to the protection of aquatic organisms.Risk mitigation measures should be applied where appropriate.
63	IsoxaflutoleCAS No 141112-29-0CIPAC No 575	5-cyclopropyl-4-(2-methylsulfonyl-4-trifluoromethylbenzoyl) isoxazole	950 g/kg	1 October 2003	30 September 2013	Only use as herbicide may be authorised.For the implementation of the uniform principles of Annex VI, the conclusions of the review report on isoxaflutole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 April 2003 shall be taken into account. In this overall assessment Member States: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 or monitoring programs should be applied where appropriate.

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Further details on identity and specification of active substances are provided in the review report."