# L_2009091EN.01002001.xml

| 3.4.2009 | EN | Official Journal of the European Union | L 91/20 |
| --- | --- | --- | --- |

3.4.2009

EN

Official Journal of the European Union

L 91/20

---

COMMISSION DIRECTIVE 2009/25/EC

of 2 April 2009

amending Council Directive 91/414/EEC as regards an extension of the use of the active substance pyraclostrobin

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

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 the second indent of the second subparagraph of Article 6(1) thereof,

Whereas:

| (1) | By Commission Directive 2004/30/EC (2) pyraclostrobin was included as active substance in Annex I to Directive 91/414/CEE. |
| --- | --- |

(1)

By Commission Directive 2004/30/EC (2) pyraclostrobin was included as active substance in Annex I to Directive 91/414/CEE.

| (2) | When applying for the inclusion of pyraclostrobin its manufacturer BASF SE (hereinafter the notifier) submitted data on uses to control certain fungi which supported the overall conclusion that it may be expected that plant protection products containing pyraclostrobin will fulfil the safety requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC. Therefore, pyraclostrobin was included in Annex I to that Directive with the specific provision that Member States may only authorise uses as fungicide. |
| --- | --- |

(2)

When applying for the inclusion of pyraclostrobin its manufacturer BASF SE (hereinafter the notifier) submitted data on uses to control certain fungi which supported the overall conclusion that it may be expected that plant protection products containing pyraclostrobin will fulfil the safety requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC. Therefore, pyraclostrobin was included in Annex I to that Directive with the specific provision that Member States may only authorise uses as fungicide.

| (3) | In addition to the control of fungi in certain agricultural uses, the notifier now has applied for an amendment to those specific provisions to allow pyraclostrobin to be used as a plant growth regulator. In order to support such an extension of the use, the notifier submitted additional information. |
| --- | --- |

(3)

In addition to the control of fungi in certain agricultural uses, the notifier now has applied for an amendment to those specific provisions to allow pyraclostrobin to be used as a plant growth regulator. In order to support such an extension of the use, the notifier submitted additional information.

| (4) | Germany evaluated the information and data submitted by the notifier. Germany informed the Commission in October 2008 about its conclusion that the requested extension of use does not cause any risks in addition to those already taken into account in the specific provisions for pyraclostrobin in Annex I to Directive 91/414/EEC and in the Commission review report for that substance. In particular, the extension does not involve a modification of the application parameters, as set out in the specific provisions of Annex I to Directive 91/414/EEC. |
| --- | --- |

(4)

Germany evaluated the information and data submitted by the notifier. Germany informed the Commission in October 2008 about its conclusion that the requested extension of use does not cause any risks in addition to those already taken into account in the specific provisions for pyraclostrobin in Annex I to Directive 91/414/EEC and in the Commission review report for that substance. In particular, the extension does not involve a modification of the application parameters, as set out in the specific provisions of Annex I to Directive 91/414/EEC.

| (5) | Therefore it is justified to modify the specific provisions for pyraclostrobin. |
| --- | --- |

(5)

Therefore it is justified to modify the specific provisions for pyraclostrobin.

| (6) | It is therefore appropriate to amend Directive 91/414/EEC accordingly. |
| --- | --- |

(6)

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

| (7) | The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
| --- | --- |

(7)

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 3 August 2009 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 4 August 2009.

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

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 2 April 2009.

For the Commission

Androulla VASSILIOU

Member of the Commission

---

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

1

(2)  
  OJ L 77, 13.3.2004, p. 50.

2

---

ANNEX

In Annex I to Directive 91/414/EEC, row 82 is replaced by the following:

| ‘82 | Pyraclostrobin
  CAS No 175013-18-0
  CIPAC No 657 | methyl N-(2-{[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxymethyl}phenyl) N-methoxy carbamate | 975 g/kg
  The manufacturing impurity dimethyl sulfate (DMS) is condidered to be of toxicological concern and must not exceed a concentration of 0,0001 % in the technical product. | 1 June 2004 | 31 May 2014 | Only uses as fungicide or plant growth regulator may be authorised.
  For the implementation of the uniform principles of Annex VI, the conclusions of the review report on pyraclostrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003 shall be taken into account. In this overall assessment Member States






  — | should pay particular attention to the protection of aquatic organisms, especially fish, |
| --- | --- | --- | --- | --- | --- | --- | --- |

‘82

Pyraclostrobin

CAS No 175013-18-0

CIPAC No 657

methyl N-(2-{[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxymethyl}phenyl) N-methoxy carbamate

975 g/kg

The manufacturing impurity dimethyl sulfate (DMS) is condidered to be of toxicological concern and must not exceed a concentration of 0,0001 % in the technical product.

1 June 2004

31 May 2014

Only uses as fungicide or plant growth regulator may be authorised.

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on pyraclostrobin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 November 2003 shall be taken into account. In this overall assessment Member States

—

should pay particular attention to the protection of aquatic organisms, especially fish,

| — | should pay particular attention to the protection of terrestrial arthropods and earthworms, |
| --- | --- |

—

should pay particular attention to the protection of terrestrial arthropods and earthworms,

Risk mitigation measures should be applied where appropriate.

The Member States shall inform the Commission in accordance with Article 13(5) on the specification of the technical material as commercially manufactured.’

---