# L_2011196EN.01000601.xml

| 28.7.2011 | EN | Official Journal of the European Union | L 196/6 |
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28.7.2011

EN

Official Journal of the European Union

L 196/6

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COMMISSION IMPLEMENTING REGULATION (EU) No 740/2011

of 27 July 2011

approving the active substance bispyribac, 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)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For bispyribac the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2003/305/EC (3). |
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(1)

In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For bispyribac the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2003/305/EC (3).

| (2) | In accordance with Article 6(2) of Directive 91/414/EEC Italy received on 26 February 2002 an application from Bayer CropScience for the inclusion of the active substance bispyribac (also called bispyribac sodium, according to the form in which the active substance is contained in the representative formulation on which the dossier is based) in Annex I to Directive 91/414/EEC. Decision 2003/305/EC 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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(2)

In accordance with Article 6(2) of Directive 91/414/EEC Italy received on 26 February 2002 an application from Bayer CropScience for the inclusion of the active substance bispyribac (also called bispyribac sodium, according to the form in which the active substance is contained in the representative formulation on which the dossier is based) in Annex I to Directive 91/414/EEC. Decision 2003/305/EC 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.

| (3) | 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 1 August 2003. |
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(3)

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 1 August 2003.

| (4) | The draft assessment report was peer reviewed by the Member States and the European Food Safety Authority (EFSA) in the format of the EFSA conclusion on the peer review of the pesticide risk assessment of the active substance bispyribac on 12 July 2010 (4). This report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and was finalised on 17 June 2011 in the format of the Commission review report for bispyribac. |
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(4)

The draft assessment report was peer reviewed by the Member States and the European Food Safety Authority (EFSA) in the format of the EFSA conclusion on the peer review of the pesticide risk assessment of the active substance bispyribac on 12 July 2010 (4). This report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and was finalised on 17 June 2011 in the format of the Commission review report for bispyribac.

| (5) | It has appeared from the various examinations made that plant protection products containing bispyribac 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 approve bispyribac. |
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(5)

It has appeared from the various examinations made that plant protection products containing bispyribac 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 approve bispyribac.

| (6) | 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 bispyribac. 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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(6)

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 bispyribac. 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.

| (7) | 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 (5) 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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(7)

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 (5) 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.

| (8) | In accordance with Article 13(4) of Regulation (EC) No 1107/2009, 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 (6) should be amended accordingly. |
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(8)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, 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 (6) should be amended accordingly.

| (9) | In the interest of clarity, Commission Directive 2011/22/EU of 3 March 2011 amending Council Directive 91/414/EEC to include bispyribac as active substance (7) should be repealed. |
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(9)

In the interest of clarity, Commission Directive 2011/22/EU of 3 March 2011 amending Council Directive 91/414/EEC to include bispyribac as active substance (7) should be repealed.

| (10) | 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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(10)

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 bispyribac, 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 bispyribac as active substance by 31 January 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 Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.

2.   By way of derogation from paragraph 1, for each authorised plant protection product containing bispyribac 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 July 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 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 bispyribac as the only active substance, where necessary, amend or withdraw the authorisation by 31 January 2013 at the latest; or |
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(a)

in the case of a product containing bispyribac as the only active substance, where necessary, amend or withdraw the authorisation by 31 January 2013 at the latest; or

| (b) | in the case of a product containing bispyribac as one of several active substances, where necessary, amend or withdraw the authorisation by 31 January 2013 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 bispyribac as one of several active substances, where necessary, amend or withdraw the authorisation by 31 January 2013 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 2011/22/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 August 2011.

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

Done at Brussels, 27 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 112, 6.5.2003, p. 10.

3

(4)  EFSA Journal (2010) 8(1):1692, Conclusion on the peer review of the pesticide risk assessment of the active substance bispyribac (unless otherwise stated all data evaluated refer to the variant bispyribac-sodium)). doi:10.2903/j.efsa.2010.1692. Available online: www.efsa.europa.eu

4

(5)  
  OJ L 366, 15.12.1992, p. 10.

5

(6)  
  OJ L 153, 11.6.2011, p. 1.

6

(7)  
  OJ L 59, 4.3.2011, p. 26.

7

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ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| Bispyribac
  CAS No
  125401-75-4
  CIPAC No
  748 | 2,6-bis(4,6-dimethoxypyrimidin-2-yloxy)benzoic acid | ≥ 930 g/kg (referred to as bispyribac-sodium) | 1 August 2011 | 31 July 2021 | PART A
  Only uses as herbicide in rice 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 bispyribac, 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 the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.
  Conditions of authorisation shall include risk mitigation measures where appropriate.
  The Member States concerned shall request the submission of further information as regards the possible groundwater contamination by metabolites M03 (2), M04 (3) and M10 (4).
  They shall ensure that the applicant provides such information to the Commission by 31 July 2013. |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Bispyribac

CAS No

125401-75-4

CIPAC No

748

2,6-bis(4,6-dimethoxypyrimidin-2-yloxy)benzoic acid

≥ 930 g/kg (referred to as bispyribac-sodium)

1 August 2011

31 July 2021

PART A

Only uses as herbicide in rice 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 bispyribac, 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 the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.

Conditions of authorisation shall include risk mitigation measures where appropriate.

The Member States concerned shall request the submission of further information as regards the possible groundwater contamination by metabolites M03 (2), M04 (3) and M10 (4).

They shall ensure that the applicant provides such information to the Commission by 31 July 2013.

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

(2)  2-hydroxy-4,6-dimethoxypyrimidine.

(3)  2,4-dihydroxy-6-methoxypyrimidine.

(4)  sodium 2-hydroxy-6-(4-hydroxy-6-methoxypyrimidin-2-yl)oxybenzoate.

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ANNEX II

In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

| ‘1 | Bispyribac
  CAS No
  125401-75-4
  CIPAC No
  748 | 2,6-bis(4,6-dimethoxypyrimidin-2-yloxy)benzoic acid | ≥ 930 g/kg (referred to as bispyribac-sodium) | 1 August 2011 | 31 July 2021 | PART A
  Only uses as herbicide in rice 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 bispyribac, 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 the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.
  Conditions of authorisation shall include risk mitigation measures where appropriate.
  The Member States concerned shall request the submission of further information as regards the possible groundwater contamination by metabolites M03 (*1), M04 (*2) and M10 (*3).
  They shall ensure that the applicant provides such information to the Commission by 31 July 2013. |
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‘1

Bispyribac

CAS No

125401-75-4

CIPAC No

748

2,6-bis(4,6-dimethoxypyrimidin-2-yloxy)benzoic acid

≥ 930 g/kg (referred to as bispyribac-sodium)

1 August 2011

31 July 2021

PART A

Only uses as herbicide in rice 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 bispyribac, 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 the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.

Conditions of authorisation shall include risk mitigation measures where appropriate.

The Member States concerned shall request the submission of further information as regards the possible groundwater contamination by metabolites M03 (*1), M04 (*2) and M10 (*3).

They shall ensure that the applicant provides such information to the Commission by 31 July 2013.

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(*1)  2-hydroxy-4,6-dimethoxypyrimidine.

*1

(*2)  2,4-dihydroxy-6-methoxypyrimidine.

*2

(*3)  sodium 2-hydroxy-6-(4-hydroxy-6-methoxypyrimidin-2-yl)oxybenzoate.’

*3

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