# L_2015009EN.01002201.xml

| 15.1.2015 | EN | Official Journal of the European Union | L 9/22 |
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15.1.2015

EN

Official Journal of the European Union

L 9/22

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COMMISSION IMPLEMENTING REGULATION (EU) 2015/51

of 14 January 2015

approving the active substance chromafenozide, 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 and allowing Member States to extend provisional authorisations granted for that active substance

(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 Articles 13(2) and 78(2) thereof,

1

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 chromafenozide the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2006/586/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 chromafenozide the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2006/586/EC (3).

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| (2) | In accordance with Article 6(2) of Directive 91/414/EEC Hungary received on 12 December 2004 an application from Arysta LifeScience (formerly Calliope SAS) on behalf of Nippon Kayaku for the inclusion of the active substance chromafenozide in Annex I to Directive 91/414/EEC. Decision 2006/586/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 Hungary received on 12 December 2004 an application from Arysta LifeScience (formerly Calliope SAS) on behalf of Nippon Kayaku for the inclusion of the active substance chromafenozide in Annex I to Directive 91/414/EEC. Decision 2006/586/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 and animal 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 19 March 2012. |
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(3)

For that active substance, the effects on human and animal 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 19 March 2012.

| (4) | The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the pesticide risk assessment of the active substance chromafenozide (4) on 31 October 2013. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on Plants, Animals, Food and Feed and finalised on 10 October 2014 in the format of the Commission review report for chromafenozide. |
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(4)

The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the pesticide risk assessment of the active substance chromafenozide (4) on 31 October 2013. The draft assessment report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on Plants, Animals, Food and Feed and finalised on 10 October 2014 in the format of the Commission review report for chromafenozide.

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

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

| (6) | 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. It is, in particular, appropriate to require further confirmatory information. |
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(6)

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. It is, in particular, appropriate to require further confirmatory information.

| (7) | A reasonable period should be allowed to elapse before approval in order to permit Member States and the interested parties to prepare themselves to meet the new requirements resulting from the approval. |
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(7)

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

| (8) | Without prejudice to the obligations provided for in 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 six months after approval to review authorisations of plant protection products containing chromafenozide. 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 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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(8)

Without prejudice to the obligations provided for in 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 six months after approval to review authorisations of plant protection products containing chromafenozide. 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 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.

| (9) | 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 (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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(9)

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 (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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| (10) | In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (6) should be amended accordingly. |
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(10)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (6) should be amended accordingly.

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| (11) | It is also appropriate to allow Member States to extend provisional authorisations granted for plant protection products containing chromafenozide in order to provide them with the time necessary to fulfil the obligations set out in this Regulation as regards those provisional authorisations. |
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(11)

It is also appropriate to allow Member States to extend provisional authorisations granted for plant protection products containing chromafenozide in order to provide them with the time necessary to fulfil the obligations set out in this Regulation as regards those provisional authorisations.

| (12) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(12)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Approval of active substance

The active substance chromafenozide, 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 chromafenozide as an active substance by 30 September 2015.

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 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 chromafenozide 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 March 2015 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 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 chromafenozide as the only active substance, where necessary, amend or withdraw the authorisation by 30 September 2016 at the latest; or |
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(a)

in the case of a product containing chromafenozide as the only active substance, where necessary, amend or withdraw the authorisation by 30 September 2016 at the latest; or

| (b) | in the case of a product containing chromafenozide as one of several active substances, where necessary, amend or withdraw the authorisation by 30 September 2016 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 those substances, whichever is the latest. |
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(b)

in the case of a product containing chromafenozide as one of several active substances, where necessary, amend or withdraw the authorisation by 30 September 2016 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 those 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

Extension of existing provisional authorisations

Member States may extend existing provisional authorisations for plant protection products containing chromafenozide for a period ending on 30 September 2016 at the latest.

Article 5

Entry into force and date of application

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

Official Journal of the European Union

It shall apply from 1 April 2015.

However, Article 4 shall apply from the date of the entry into force of this Regulation.

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

Done at Brussels, 14 January 2015.

For the Commission

The President

Jean-Claude JUNCKER

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

1

(2)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

2

(3)  Commission Decision 2006/586/EC of 25 August 2006 recognising in principle the completeness of the dossiers submitted for detailed examination in view of the possible inclusion of chromafenozide, halosulfuron, tembotrione, valiphenal and Zucchini yellow mosaic virus — weak strain in Annex I to Council Directive 91/414/EEC (OJ L 236, 31.8.2006, p. 31).

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(4)  EFSA Journal 2013;11(12):3461. Available online: www.efsa.europa.eu

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

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

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ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| Chromafenozide
  CAS No 143807-66-3
  CIPAC No 775 | N′-tert-butyl-5-methyl-N′-(3,5-xyloyl)chromane-6-carbohydrazide | ≥ 935 g/kg
  The following relevant impurity must not exceed a certain threshold in the technical material:
  Butyl acetate (n-buthyl acetate, CAS No 123-86-4): ≤ 8 g/kg | 1 April 2015 | 31 March 2025 | 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 chromafenozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014, shall be taken into account.
  In this overall assessment Member States shall pay particular attention to:






  (a) | the risk to groundwater, if the substance is applied under vulnerable soil or climatic conditions; |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Chromafenozide

CAS No 143807-66-3

CIPAC No 775

N′-tert-butyl-5-methyl-N′-(3,5-xyloyl)chromane-6-carbohydrazide

≥ 935 g/kg

The following relevant impurity must not exceed a certain threshold in the technical material:

Butyl acetate (n-buthyl acetate, CAS No 123-86-4): ≤ 8 g/kg

1 April 2015

31 March 2025

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 chromafenozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014, shall be taken into account.

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

(a)

the risk to groundwater, if the substance is applied under vulnerable soil or climatic conditions;

| (b) | the risk to non-target Lepidoptera in off-crop areas; |
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(b)

the risk to non-target Lepidoptera in off-crop areas;

| (c) | the risk to sediment-dwelling organisms. |
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(c)

the risk to sediment-dwelling organisms.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards:

| (1) | the non-significance of the difference between the material used for ecotoxicological testing and the agreed specification of the technical material for the risk assessment; |
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(1)

the non-significance of the difference between the material used for ecotoxicological testing and the agreed specification of the technical material for the risk assessment;

| (2) | the assessment of the risk to sediment dwelling organisms from metabolite M-010; |
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(2)

the assessment of the risk to sediment dwelling organisms from metabolite M-010;

| (3) | the leaching potential of metabolites M-006 and M-023 to groundwater. |
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(3)

the leaching potential of metabolites M-006 and M-023 to groundwater.

The applicant shall submit to the Commission, the Member States and the Authority the relevant information requested under (1) by 30 September 2015 and under (2) and (3) by 31 March 2017.

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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

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

| Number | Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- | --- |
| ‘81 | Chromafenozide
  CAS No 143807-66-3
  CIPAC No 775 | N′-tert-butyl-5-methyl-N′-(3,5-xyloyl)chromane-6-carbohydrazide | ≥ 935 g/kg
  The following relevant impurity must not exceed a certain threshold in the technical material:
  Butyl acetate (n-buthyl acetate, CAS No 123-86-4): ≤ 8 g/kg | 1 April 2015 | 31 March 2025 | 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 chromafenozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014, shall be taken into account.
  In this overall assessment Member States shall pay particular attention to:






  (a) | the risk to groundwater, if the substance is applied under vulnerable soil or climatic conditions; |

Number

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

‘81

Chromafenozide

CAS No 143807-66-3

CIPAC No 775

N′-tert-butyl-5-methyl-N′-(3,5-xyloyl)chromane-6-carbohydrazide

≥ 935 g/kg

The following relevant impurity must not exceed a certain threshold in the technical material:

Butyl acetate (n-buthyl acetate, CAS No 123-86-4): ≤ 8 g/kg

1 April 2015

31 March 2025

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 chromafenozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014, shall be taken into account.

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

(a)

the risk to groundwater, if the substance is applied under vulnerable soil or climatic conditions;

| (b) | the risk to non-target Lepidoptera in off-crop areas; |
| --- | --- |

(b)

the risk to non-target Lepidoptera in off-crop areas;

| (c) | the risk to sediment-dwelling organisms. |
| --- | --- |

(c)

the risk to sediment-dwelling organisms.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit confirmatory information as regards:

| (1) | the non-significance of the difference between the material used for ecotoxicological testing and the agreed specification of the technical material for the risk assessment; |
| --- | --- |

(1)

the non-significance of the difference between the material used for ecotoxicological testing and the agreed specification of the technical material for the risk assessment;

| (2) | the assessment of the risk to sediment dwelling organisms from metabolite M-010; |
| --- | --- |

(2)

the assessment of the risk to sediment dwelling organisms from metabolite M-010;

| (3) | the leaching potential of metabolites M-006 and M-023 to groundwater. |
| --- | --- |

(3)

the leaching potential of metabolites M-006 and M-023 to groundwater.

The applicant shall submit to the Commission, the Member States and the Authority the relevant information requested under (1) by 30 September 2015 and under (2) and (3) by 31 March 2017.’

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

1

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