# L_2010058EN.01000501.xml

| 9.3.2010 | EN | Official Journal of the European Union | L 58/5 |
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9.3.2010

EN

Official Journal of the European Union

L 58/5

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COMMISSION DIRECTIVE 2010/15/EU

of 8 March 2010

amending Council Directive 91/414/EEC to include fluopicolide as active substance

(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) | In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 7 May 2004 an application from Bayer CropScience for the inclusion of the active substance fluopicolide in Annex I to Directive 91/414/EEC. Commission Decision 2005/778/EC (2) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC. |
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(1)

In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 7 May 2004 an application from Bayer CropScience for the inclusion of the active substance fluopicolide in Annex I to Directive 91/414/EEC. Commission Decision 2005/778/EC (2) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

| (2) | For that active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 12 December 2005. |
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(2)

For that active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 12 December 2005.

| (3) | The assessment report was peer reviewed by the Member States and the EFSA and presented to the Commission in the format of the EFSA Scientific Report for fluopicolide on 4 June 2009 (3). This report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 27 November 2009 in the format of the Commission review report for fluopicolide. |
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(3)

The assessment report was peer reviewed by the Member States and the EFSA and presented to the Commission in the format of the EFSA Scientific Report for fluopicolide on 4 June 2009 (3). This report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 27 November 2009 in the format of the Commission review report for fluopicolide.

| (4) | It has appeared from the various examinations made that plant protection products containing fluopicolide may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include fluopicolide in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive. |
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(4)

It has appeared from the various examinations made that plant protection products containing fluopicolide may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include fluopicolide in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive.

| (5) | Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that the inclusion of a substance in Annex I may be subject to conditions. It is appropriate, as regards fluopicolide, to require that the notifier submits further information on the relevance of the metabolite M15 for groundwater. |
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(5)

Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that the inclusion of a substance in Annex I may be subject to conditions. It is appropriate, as regards fluopicolide, to require that the notifier submits further information on the relevance of the metabolite M15 for groundwater.

| (6) | Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing provisional authorisations of plant protection products containing fluopicolide to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should transform existing provisional authorisations into full authorisations, amend them or withdraw them in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC. |
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(6)

Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing provisional authorisations of plant protection products containing fluopicolide to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should transform existing provisional authorisations into full authorisations, amend them or withdraw them in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

| (7) | It is therefore appropriate to amend Directive 91/414/EEC accordingly. |
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(7)

It is therefore appropriate to amend Directive 91/414/EEC accordingly.

| (8) | The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(8)

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 30 November 2010 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 December 2010.

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 3

1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing fluopicolide as active substance by 30 November 2010. By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to fluopicolide are met, with the exception of those identified in part B of the entry concerning the active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13(2) of that Directive.

2.   By way of derogation from paragraph 1, for each authorised plant protection product containing fluopicolide 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 31 May 2010 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 to that Directive and taking into account part B of the entry in Annex I to that Directive concerning fluopicolide. 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.

Following that determination Member States shall:

| (a) | in the case of a product containing fluopicolide as the only active substance, where necessary, amend or withdraw the authorisation by 30 November 2011 at the latest; or |
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(a)

in the case of a product containing fluopicolide as the only active substance, where necessary, amend or withdraw the authorisation by 30 November 2011 at the latest; or

| (b) | in the case of a product containing fluopicolide as one of several active substances, where necessary, amend or withdraw the authorisation by 30 November 2011 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest. |
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(b)

in the case of a product containing fluopicolide as one of several active substances, where necessary, amend or withdraw the authorisation by 30 November 2011 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

Article 4

This Directive shall enter into force on 1 June 2010.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 8 March 2010.

For the Commission

The President

José Manuel BARROSO

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

1

(2)  
  OJ L 293, 9.11.2005, p. 26.

2

(3)  EFSA Scientific Report (2009) 299, 1-158, Conclusion regarding the peer review of the pesticide risk assessment of the active substance fluopicolide (finalised: 4 June 2009).

3

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ANNEX

In Annex I to Directive 91/414/EEC, the following entry is added at the end of the table:

| No | Common Name, Identification Numbers | IUPAC Name | Purity (1) | Entry into force | Expiration of inclusion | Specific provisions |
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| ‘303 | Fluopicolide
  CAS No
  239110-15-7
  CIPAC No 787 | 2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]benzamide | ≥ 970 g/kg
  The impurity toluene must not exceed 3 g/kg in the technical material. | 1 June 2010 | 31 May 2020 | PART A
  Only uses as fungicide may be authorised.
  PART B
  For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fluopicolide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009 shall be taken into account.
  In this overall assessment, Member States must pay particular attention to:






  — | the protection of aquatic organisms, |

No

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Entry into force

Expiration of inclusion

Specific provisions

‘303

Fluopicolide

CAS No

239110-15-7

CIPAC No 787

2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]benzamide

≥ 970 g/kg

The impurity toluene must not exceed 3 g/kg in the technical material.

1 June 2010

31 May 2020

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fluopicolide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009 shall be taken into account.

In this overall assessment, Member States must pay particular attention to:

—

the protection of aquatic organisms,

| — | the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions, |
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—

the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions,

| — | to the risk to operators during application, |
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—

to the risk to operators during application,

| — | the potential for long range transport via air. |
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—

the potential for long range transport via air.

Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential accumulation and exposure in vulnerable areas, where appropriate.

The Member States concerned shall ensure that the notifier submits to the Commission further information on the relevance of the metabolite M15 for groundwater by 30 April 2012 at the latest.’

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

1

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