# L_2017054EN.01000601.xml

| 1.3.2017 | EN | Official Journal of the European Union | L 54/6 |
| --- | --- | --- | --- |

1.3.2017

EN

Official Journal of the European Union

L 54/6

---

COMMISSION IMPLEMENTING REGULATION (EU) 2017/358

of 28 February 2017

confirming the conditions of approval of the active substance acrinathrin, as set out in 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)(c) thereof,

Whereas:

| (1) | The active substance acrinathrin was approved in accordance with Regulation (EC) No 1107/2009 by Commission Implementing Regulation (EU) No 974/2011 (2) and is listed in Part B of the Annex to Commission Implementing Regulation (EU) No 540/2011 (3). In accordance with row 19 of Part B of the Annex to Implementing Regulation (EU) No 540/2011, ‘only uses as insecticide and acaricide may be authorised at rates not exceeding 22,5 g/ha per application’. |
| --- | --- |

(1)

The active substance acrinathrin was approved in accordance with Regulation (EC) No 1107/2009 by Commission Implementing Regulation (EU) No 974/2011 (2) and is listed in Part B of the Annex to Commission Implementing Regulation (EU) No 540/2011 (3). In accordance with row 19 of Part B of the Annex to Implementing Regulation (EU) No 540/2011, ‘only uses as insecticide and acaricide may be authorised at rates not exceeding 22,5 g/ha per application’.

| (2) | On 8 May 2012, Cheminova A/S, at whose request acrinathrin had been approved, submitted an application for an amendment to the conditions of approval of the active substance acrinathrin in order to allow uses as insecticide and acaricide to be authorised without rate restriction. That application was accompanied by information relating to the requested extension of uses. It was submitted to France, which had been designated rapporteur Member State by Commission Regulation (EC) No 1490/2002 (4). |
| --- | --- |

(2)

On 8 May 2012, Cheminova A/S, at whose request acrinathrin had been approved, submitted an application for an amendment to the conditions of approval of the active substance acrinathrin in order to allow uses as insecticide and acaricide to be authorised without rate restriction. That application was accompanied by information relating to the requested extension of uses. It was submitted to France, which had been designated rapporteur Member State by Commission Regulation (EC) No 1490/2002 (4).

| (3) | France assessed the information submitted by the applicant and prepared an addendum to the draft assessment report. It submitted that addendum to the Commission, with a copy to the European Food Safety Authority, hereinafter ‘the Authority’, on 5 November 2012. |
| --- | --- |

(3)

France assessed the information submitted by the applicant and prepared an addendum to the draft assessment report. It submitted that addendum to the Commission, with a copy to the European Food Safety Authority, hereinafter ‘the Authority’, on 5 November 2012.

| (4) | The Authority circulated the addendum to the applicant and the Member States and made it available to the public, granting a period of 60 days for the submission of written comments. |
| --- | --- |

(4)

The Authority circulated the addendum to the applicant and the Member States and made it available to the public, granting a period of 60 days for the submission of written comments.

| (5) | Taking into account the addendum to the draft assessment report, the Authority adopted its conclusion on acrinathrin on 21 November 2013 (5), as regards its unrestricted use as an insecticide and an acaricide. |
| --- | --- |

(5)

Taking into account the addendum to the draft assessment report, the Authority adopted its conclusion on acrinathrin on 21 November 2013 (5), as regards its unrestricted use as an insecticide and an acaricide.

| (6) | The Authority communicated its conclusion to the applicant, the Member States and the Commission and made it available to the public. Taking into account the addendum to the draft assessment report by the rapporteur Member State and the conclusion of the Authority, the Commission presented a review report and a draft Regulation to the Standing Committee on Plants, Animals, Food and Feed. |
| --- | --- |

(6)

The Authority communicated its conclusion to the applicant, the Member States and the Commission and made it available to the public. Taking into account the addendum to the draft assessment report by the rapporteur Member State and the conclusion of the Authority, the Commission presented a review report and a draft Regulation to the Standing Committee on Plants, Animals, Food and Feed.

| (7) | The applicant was given the possibility to submit comments on the review report for acrinathrin including the addendum. The applicant submitted its comments, which have been carefully examined. However, despite the arguments put forward by the applicant, the concerns referred to in recital 8 could not be eliminated. |
| --- | --- |

(7)

The applicant was given the possibility to submit comments on the review report for acrinathrin including the addendum. The applicant submitted its comments, which have been carefully examined. However, despite the arguments put forward by the applicant, the concerns referred to in recital 8 could not be eliminated.

| (8) | On the basis of the review report and other factors legitimate to the matter under consideration, it is to be considered that the additional information submitted by the applicant does not permit elimination of the specific concerns that led to the restriction of the use of acrinathrin at rates not exceeding 22,5 g/ha per application. In particular, acrinathrin is very toxic to fish and aquatic invertebrates and its acceptability on the basis of the current rates already require extensive risk mitigation. The new data provided by the applicant failed to demonstrate that the envisaged significant increase of rates, and consequently, of exposure, would still result in an acceptable risk for the concerned aquatic organisms. Finally, on the basis of confirmatory information submitted by the notifier, EFSA concludes that the higher rates would induce a high risk to non-target arthropods which further confirms that these rates cannot be increased. |
| --- | --- |

(8)

On the basis of the review report and other factors legitimate to the matter under consideration, it is to be considered that the additional information submitted by the applicant does not permit elimination of the specific concerns that led to the restriction of the use of acrinathrin at rates not exceeding 22,5 g/ha per application. In particular, acrinathrin is very toxic to fish and aquatic invertebrates and its acceptability on the basis of the current rates already require extensive risk mitigation. The new data provided by the applicant failed to demonstrate that the envisaged significant increase of rates, and consequently, of exposure, would still result in an acceptable risk for the concerned aquatic organisms. Finally, on the basis of confirmatory information submitted by the notifier, EFSA concludes that the higher rates would induce a high risk to non-target arthropods which further confirms that these rates cannot be increased.

| (9) | Consequently, it has not been demonstrated that it may be expected that plant protection products containing acrinathrin satisfy in general the requirements laid down in Article 4(3) of Regulation (EC) No 1107/2009 when used as an insecticide or an acaricide without rate restrictions. |
| --- | --- |

(9)

Consequently, it has not been demonstrated that it may be expected that plant protection products containing acrinathrin satisfy in general the requirements laid down in Article 4(3) of Regulation (EC) No 1107/2009 when used as an insecticide or an acaricide without rate restrictions.

| (10) | The conditions of approval of the active substance acrinathrin, as set out in row 19 of Part B of the Annex to Implementing Regulation (EU) No 540/2011, should, therefore, be confirmed. |
| --- | --- |

(10)

The conditions of approval of the active substance acrinathrin, as set out in row 19 of Part B of the Annex to Implementing Regulation (EU) No 540/2011, should, therefore, be confirmed.

| (11) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(11)

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

Confirmation of the conditions of approval

The conditions of approval of the active substance acrinathrin, as set out in row 19 of Part B of the Annex to Implementing Regulation (EU) No 540/2011, are confirmed.

Article 2

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, 28 February 2017.

For the Commission

The President

Jean-Claude JUNCKER

---

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

1

(2)  Commission Implementing Regulation (EU) No 974/2011 of 29 September 2011 approving the active substance acrinathrin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and 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 Commission Directive 2008/934/EC (OJ L 255, 1.10.2011, p. 1).

2

(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

(4)  Commission Regulation (EC) No 1490/2002 of 14 August 2002 laying down further detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC and amending Regulation (EC) No 451/2000 (OJ L 224, 21.8.2002, p. 23).

4

(5)  Conclusion on the peer review of the pesticide risk assessment of the active substance acrinathrin. EFSA Journal 2013;11(12):3469. Available online: www.efsa.europa.eu/efsajournal.htm

5

EFSA Journal

---