# L_2011190EN.01003301.xml

| 21.7.2011 | EN | Official Journal of the European Union | L 190/33 |
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21.7.2011

EN

Official Journal of the European Union

L 190/33

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COMMISSION IMPLEMENTING REGULATION (EU) No 703/2011

of 20 July 2011

approving the active substance azoxystrobin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) and Article 78(2) thereof,

Whereas:

| (1) | In accordance with Article 80(1)(b) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply to active substances listed in Annex I to Commission Regulation (EC) No 737/2007 of 27 June 2007 on laying down the procedure of the renewal of the inclusion of a first group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances (3), with respect to the procedure and the conditions for approval. Azoxystrobin is listed in Annex I to Regulation (EC) No 737/2007. |
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(1)

In accordance with Article 80(1)(b) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply to active substances listed in Annex I to Commission Regulation (EC) No 737/2007 of 27 June 2007 on laying down the procedure of the renewal of the inclusion of a first group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances (3), with respect to the procedure and the conditions for approval. Azoxystrobin is listed in Annex I to Regulation (EC) No 737/2007.

| (2) | The approval of azoxystrobin, as set out in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (4), expires on 31 December 2011. A notification was submitted in accordance with Article 4 of Regulation (EC) No 737/2007 for the renewal of the inclusion of azoxystrobin in Annex I to Directive 91/414/EEC within the time period provided for in that Article. |
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(2)

The approval of azoxystrobin, as set out in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (4), expires on 31 December 2011. A notification was submitted in accordance with Article 4 of Regulation (EC) No 737/2007 for the renewal of the inclusion of azoxystrobin in Annex I to Directive 91/414/EEC within the time period provided for in that Article.

| (3) | That notification was found to be admissible by Commission Decision 2008/656/EC of 28 July 2008 on the admissibility of the notifications concerning the renewal of the inclusion in Annex I to Council Directive 91/414/EEC of the active substances azimsulfuron, azoxystrobin, fluroxypyr, imazalil, kresoxim-methyl, prohexadione and spiroxamine, and establishing the list of the notifiers concerned (5). |
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(3)

That notification was found to be admissible by Commission Decision 2008/656/EC of 28 July 2008 on the admissibility of the notifications concerning the renewal of the inclusion in Annex I to Council Directive 91/414/EEC of the active substances azimsulfuron, azoxystrobin, fluroxypyr, imazalil, kresoxim-methyl, prohexadione and spiroxamine, and establishing the list of the notifiers concerned (5).

| (4) | Within the time period provided for in Article 6 of Regulation (EC) No 737/2007, the notifier submitted the data required in accordance with that Article together with an explanation as regards the relevance of each new study submitted. |
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(4)

Within the time period provided for in Article 6 of Regulation (EC) No 737/2007, the notifier submitted the data required in accordance with that Article together with an explanation as regards the relevance of each new study submitted.

| (5) | The rapporteur Member State prepared an assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (hereinafter ‘the Authority’) and the Commission on 10 June 2009. In addition to the assessment of the active substance, that report includes a list of the studies the rapporteur Member State relied on for its assessment. |
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(5)

The rapporteur Member State prepared an assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (hereinafter ‘the Authority’) and the Commission on 10 June 2009. In addition to the assessment of the active substance, that report includes a list of the studies the rapporteur Member State relied on for its assessment.

| (6) | The Authority communicated the assessment report to the notifier and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the assessment report available to the public. |
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(6)

The Authority communicated the assessment report to the notifier and to the Member States for comments and forwarded the comments received to the Commission. The Authority also made the assessment report available to the public.

| (7) | At the request of the Commission, the assessment report was peer reviewed by the Member States and the Authority. The Authority presented its conclusion on the peer review of the risk assessment of azoxystrobin (6) to the Commission on 12 March 2010. The assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 17 June 2011 in the format of the Commission review report for azoxystrobin. |
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(7)

At the request of the Commission, the assessment report was peer reviewed by the Member States and the Authority. The Authority presented its conclusion on the peer review of the risk assessment of azoxystrobin (6) to the Commission on 12 March 2010. The assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 17 June 2011 in the format of the Commission review report for azoxystrobin.

| (8) | It has appeared from the various examinations made that plant protection products containing azoxystrobin may be expected to continue to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular as regards the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve azoxystrobin. |
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(8)

It has appeared from the various examinations made that plant protection products containing azoxystrobin may be expected to continue to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular as regards the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve azoxystrobin.

| (9) | In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions not provided for in the first inclusion in Annex I to Directive 91/414/EEC. |
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(9)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions not provided for in the first inclusion in Annex I to Directive 91/414/EEC.

| (10) | Based on the review report, which points out that for the active substance azoxystrobin notified by the main data submitter the manufacturing impurity toluene is of toxicological concern, a maximum level of 2 g/kg should, however, be set for that impurity in the technical material. |
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(10)

Based on the review report, which points out that for the active substance azoxystrobin notified by the main data submitter the manufacturing impurity toluene is of toxicological concern, a maximum level of 2 g/kg should, however, be set for that impurity in the technical material.

| (11) | From the new data submitted, it appears that azoxystrobin may cause risks for aquatic organisms. Without prejudice to the conclusion that azoxystrobin should be approved, it is, in particular, appropriate to require further confirmatory information. |
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(11)

From the new data submitted, it appears that azoxystrobin may cause risks for aquatic organisms. Without prejudice to the conclusion that azoxystrobin should be approved, it is, in particular, appropriate to require further confirmatory information.

| (12) | A reasonable period should be allowed to elapse before approval in order to permit Member States and interested parties to prepare themselves to meet the new requirements resulting from the approval. |
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(12)

A reasonable period should be allowed to elapse before approval in order to permit Member States and interested parties to prepare themselves to meet the new requirements resulting from the approval.

| (13) | Without prejudice to the obligations provided for by Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009 the following should, however, apply. Member States should be allowed a period of 6 months after approval to review authorisations of plant protection products containing azoxystrobin. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the update of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles. |
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(13)

Without prejudice to the obligations provided for by Regulation (EC) No 1107/2009 as a consequence of approval, taking into account the specific situation created by the transition from Directive 91/414/EEC to Regulation (EC) No 1107/2009 the following should, however, apply. Member States should be allowed a period of 6 months after approval to review authorisations of plant protection products containing azoxystrobin. Member States should, as appropriate, vary, replace or withdraw authorisations. By way of derogation from that deadline, a longer period should be provided for the submission and assessment of the update of the complete Annex III dossier, as set out in Directive 91/414/EEC, of each plant protection product for each intended use in accordance with the uniform principles.

| (14) | The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (7) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances. |
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(14)

The experience gained from inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (7) has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I to that Directive or the Regulations approving active substances.

| (15) | In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly. |
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(15)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly.

| (16) | In the interest of clarity, Commission Directive 2010/55/EU of 20 August 2010 amending Annex I to Council Directive 91/414/EEC to renew the inclusion of azoxystrobin as active substance (8) should be repealed. |
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(16)

In the interest of clarity, Commission Directive 2010/55/EU of 20 August 2010 amending Annex I to Council Directive 91/414/EEC to renew the inclusion of azoxystrobin as active substance (8) should be repealed.

| (17) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(17)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

Approval of active substance

The active substance azoxystrobin, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

Article 2

Re-evaluation of plant protection products

1.   Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing azoxystrobin as an active substance by 30 June 2012.

By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in Part B of the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Article 13(1) to (4) of Directive 91/414/EEC and Article 62 of Regulation (EC) No 1107/2009.

2.   By way of derogation from paragraph 1, for each authorised plant protection product containing azoxystrobin as either the only active substance or as one of several active substances all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 31 December 2011 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account Part B of the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product still satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.

Following that determination Member States shall:

| (a) | in the case of a product containing azoxystrobin as the only active substance, where necessary, amend or withdraw the authorisation by 31 December 2015 at the latest; or |
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(a)

in the case of a product containing azoxystrobin as the only active substance, where necessary, amend or withdraw the authorisation by 31 December 2015 at the latest; or

| (b) | in the case of a product containing azoxystrobin as one of several active substances, where necessary, amend or withdraw the authorisation by 31 December 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or substances, whichever is the latest. |
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(b)

in the case of a product containing azoxystrobin as one of several active substances, where necessary, amend or withdraw the authorisation by 31 December 2015 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or substances, whichever is the latest.

Article 3

Amendments to Implementing Regulation (EU) No 540/2011

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Article 4

Repeal

Directive 2010/55/EU is repealed.

Article 5

Entry into force and date of application

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

Official Journal of the European Union

It shall apply from 1 January 2012.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 20 July 2011.

For the Commission

The President

José Manuel BARROSO

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(1)  
  OJ L 309, 24.11.2009, p. 1.

1

(2)  
  OJ L 230, 19.8.1991, p. 1.

2

(3)  
  OJ L 169, 29.6.2007, p. 10.

3

(4)  
  OJ L 153, 11.6.2011, p. 1.

4

(5)  
  OJ L 214, 9.8.2008, p. 70.

5

(6)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance azoxystrobin. EFSA Journal 2010; 8(4):15421542. [110 pp.]. doi:10.2903/j.efsa.2010.1542. Available online: www.efsa.europa.eu

6

(7)  
  OJ L 366, 15.12.1992, p. 10.

7

(8)  
  OJ L 220, 21.8.2010, p. 67.

8

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ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| Azoxystrobin
  CAS No 131860-33-8
  CIPAC No 571 | methyl (E)-2-{2[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl}-3-methoxyacrylate | ≥ 930 g/kg
  Toluene maximum content 2 g/kg
  Z-isomer maximum content 25 g/kg | 1 January 2012 | 31 December 2021 | PART A
  Only uses as fungicide may be authorised.
  PART B
  For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on azoxystrobin and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.
  In this overall assessment Member States shall pay particular attention to:






  (1) | the fact that 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 dossiers should be compared and verified against this specification of the technical material; |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Azoxystrobin

CAS No 131860-33-8

CIPAC No 571

methyl (E)-2-{2[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl}-3-methoxyacrylate

≥ 930 g/kg

Toluene maximum content 2 g/kg

Z-isomer maximum content 25 g/kg

1 January 2012

31 December 2021

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on azoxystrobin and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

(1)

the fact that 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 dossiers should be compared and verified against this specification of the technical material;

| (2) | the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; |
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(2)

the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

| (3) | the protection of aquatic organisms. |
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(3)

the protection of aquatic organisms.

The Member States must ensure that the conditions of authorisation include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of confirmatory information as regards the risk assessment on groundwater and aquatic organisms.

The notifier shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.

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

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ANNEX II

The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

| (1) | in Part A, the entry relating to azoxystrobin is deleted; |
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(1)

in Part A, the entry relating to azoxystrobin is deleted;

| (2) | in Part B, the following entry is added: | Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- | --- | --- |
| ‘4 | Azoxystrobin
  CAS No 131860-33-8
  CIPAC No 571 | methyl (E)-2-{2[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl}-3-methoxyacrylate | ≥ 930 g/kg
  Toluene maximum content 2 g/kg
  Z-isomer maximum content 25 g/kg | 1 January 2012 | 31 December 2021 | PART A
  Only uses as fungicide may be authorised.
  PART B
  For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on azoxystrobin and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.
  In this overall assessment Member States shall pay particular attention to:






  (1) | the fact that 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 dossiers should be compared and verified against this specification of the technical material; |

(2)

in Part B, the following entry is added:

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

‘4

Azoxystrobin

CAS No 131860-33-8

CIPAC No 571

methyl (E)-2-{2[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl}-3-methoxyacrylate

≥ 930 g/kg

Toluene maximum content 2 g/kg

Z-isomer maximum content 25 g/kg

1 January 2012

31 December 2021

PART A

Only uses as fungicide may be authorised.

PART B

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on azoxystrobin and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

(1)

the fact that 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 dossiers should be compared and verified against this specification of the technical material;

| (2) | the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions; |
| --- | --- |

(2)

the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

| (3) | the protection of aquatic organisms. |
| --- | --- |

(3)

the protection of aquatic organisms.

The Member States must ensure that the conditions of authorisation include risk mitigation measures, where appropriate.

The Member States concerned shall request the submission of confirmatory information as regards the risk assessment on groundwater and aquatic organisms.

The notifier shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.’

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

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