# L_2015199EN.01000801.xml

| 29.7.2015 | EN | Official Journal of the European Union | L 199/8 |
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29.7.2015

EN

Official Journal of the European Union

L 199/8

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COMMISSION IMPLEMENTING REGULATION (EU) 2015/1295

of 27 July 2015

approving the active substance sulfoxaflor, 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) thereof,

Whereas:

| (1) | In accordance with Article 7(1) of Regulation (EC) No 1107/2009 Ireland received on 1 September 2011 an application from Dow AgroSciences for the approval of the active substance sulfoxaflor. In accordance with Article 9(3) of that Regulation, Ireland, as rapporteur Member State, notified the Commission on 30 September 2011 of the admissibility of the application. |
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(1)

In accordance with Article 7(1) of Regulation (EC) No 1107/2009 Ireland received on 1 September 2011 an application from Dow AgroSciences for the approval of the active substance sulfoxaflor. In accordance with Article 9(3) of that Regulation, Ireland, as rapporteur Member State, notified the Commission on 30 September 2011 of the admissibility of the application.

| (2) | On 23 November 2012 the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the European Food Safety Authority ('the Authority'), assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. |
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(2)

On 23 November 2012 the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the European Food Safety Authority ('the Authority'), assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

| (3) | The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report in January 2014. |
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(3)

The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report in January 2014.

| (4) | On 12 May 2014 the Authority communicated to the applicant, the Member States and the Commission its conclusion on whether the active substance sulfoxaflor can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 (2). The Authority made its conclusion available to the public. |
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(4)

On 12 May 2014 the Authority communicated to the applicant, the Member States and the Commission its conclusion on whether the active substance sulfoxaflor can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 (2). The Authority made its conclusion available to the public.

| (5) | On 11 December 2014 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for sulfoxaflor and a draft Regulation providing that sulfoxaflor is approved. |
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(5)

On 11 December 2014 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for sulfoxaflor and a draft Regulation providing that sulfoxaflor is approved.

| (6) | The applicant was given the possibility to submit comments on the review report. |
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(6)

The applicant was given the possibility to submit comments on the review report.

| (7) | It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. Those approval criteria are therefore deemed to be satisfied. It is therefore appropriate to approve sulfoxaflor. |
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(7)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. Those approval criteria are therefore deemed to be satisfied. It is therefore appropriate to approve sulfoxaflor.

| (8) | 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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(8)

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.

| (9) | In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (3) should be amended accordingly. |
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(9)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (3) should be amended accordingly.

| (10) | 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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(10)

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 sulfoxaflor, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

Article 2

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 3

Entry into force

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

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

Done at Brussels, 27 July 2015.

For the Commission

The President

Jean-Claude JUNCKER

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

1

(2)  
  EFSA Journal 2014;12(5):3692. Available online: www.efsa.europa.eu

2

EFSA Journal

(3)  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).

3

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ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| Sulfoxaflor
  CAS No: 946578-00-3
  CIPAC No: 820 | [methyl(oxo){1-[6-(trifluoromethyl)-3-pyridyl]ethyl}-λ6-sulfanylidene]cyanamide | ≥ 950 g/kg | 18 August 2015 | 18 August 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 sulfoxaflor, and in particular Appendices I and II thereof, shall be taken into account.
  In this overall assessment Member States shall pay particular attention to:






  (a) | the risk to bees and other non-target arthropods; |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Sulfoxaflor

CAS No: 946578-00-3

CIPAC No: 820

[methyl(oxo){1-[6-(trifluoromethyl)-3-pyridyl]ethyl}-λ6-sulfanylidene]cyanamide

≥ 950 g/kg

18 August 2015

18 August 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 sulfoxaflor, and in particular Appendices I and II thereof, shall be taken into account.

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

(a)

the risk to bees and other non-target arthropods;

| (b) | the risk to bees and bumble bees released for pollination, when the substance is applied in glasshouses. |
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(b)

the risk to bees and bumble bees released for pollination, when the substance is applied in glasshouses.

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

The applicant shall submit confirmatory information as regards:

| (a) | the risk to honey bees via the different routes of exposure, in particular nectar, pollen, guttation fluid and dust; |
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(a)

the risk to honey bees via the different routes of exposure, in particular nectar, pollen, guttation fluid and dust;

| (b) | risk to honey bees foraging in nectar or pollen in succeeding crops and flowering weeds; |
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(b)

risk to honey bees foraging in nectar or pollen in succeeding crops and flowering weeds;

| (c) | the risk to pollinators other than honey bees; |
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(c)

the risk to pollinators other than honey bees;

| (d) | the risk to bee brood. |
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(d)

the risk to bee brood.

The applicant shall submit that information to the Commission, the Member States and the Authority by 18 August 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 |
| --- | --- | --- | --- | --- | --- | --- |
| ‘88 | Sulfoxaflor
  CAS No: 946578-00-3
  CIPAC No: 820 | [methyl(oxo){1-[6-(trifluoromethyl)-3-pyridyl]ethyl}-λ6-sulfanylidene]cyanamide | ≥ 950 g/kg | 18 August 2015 | 18 August 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 sulfoxaflor, and in particular Appendices I and II thereof, shall be taken into account.
  In this overall assessment Member States shall pay particular attention to:






  (a) | the risk to bees and other non-target arthropods; |

Number

Common Name, Identification Numbers

IUPAC Name

Purity (*1)

Date of approval

Expiration of approval

Specific provisions

‘88

Sulfoxaflor

CAS No: 946578-00-3

CIPAC No: 820

[methyl(oxo){1-[6-(trifluoromethyl)-3-pyridyl]ethyl}-λ6-sulfanylidene]cyanamide

≥ 950 g/kg

18 August 2015

18 August 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 sulfoxaflor, and in particular Appendices I and II thereof, shall be taken into account.

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

(a)

the risk to bees and other non-target arthropods;

| (b) | the risk to bees and bumble bees released for pollination, when the substance is applied in glasshouses. |
| --- | --- |

(b)

the risk to bees and bumble bees released for pollination, when the substance is applied in glasshouses.

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

The applicant shall submit confirmatory information as regards:

| (a) | the risk to honey bees via the different routes of exposure, in particular nectar, pollen, guttation fluid and dust; |
| --- | --- |

(a)

the risk to honey bees via the different routes of exposure, in particular nectar, pollen, guttation fluid and dust;

| (b) | risk to honey bees foraging in nectar or pollen in succeeding crops and flowering weeds; |
| --- | --- |

(b)

risk to honey bees foraging in nectar or pollen in succeeding crops and flowering weeds;

| (c) | the risk to pollinators other than honey bees; |
| --- | --- |

(c)

the risk to pollinators other than honey bees;

| (d) | the risk to bee brood. |
| --- | --- |

(d)

the risk to bee brood.

The applicant shall submit that information to the Commission, the Member States and the Authority by 18 August 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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