# L_2017036EN.01003901.xml

| 11.2.2017 | EN | Official Journal of the European Union | L 36/39 |
| --- | --- | --- | --- |

11.2.2017

EN

Official Journal of the European Union

L 36/39

---

COMMISSION IMPLEMENTING REGULATION (EU) 2017/239

of 10 February 2017

approving the active substance oxathiapiprolin 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 14 November 2013 an application from DuPont de Nemours (Deutschland) GmbH for the approval of the active substance oxathiapiprolin. In accordance with Article 9(3) of that Regulation, Ireland, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (hereinafter ‘the Authority’) on 16 January 2014 of the admissibility of the application. |
| --- | --- |

(1)

In accordance with Article 7(1) of Regulation (EC) No 1107/2009, Ireland received on 14 November 2013 an application from DuPont de Nemours (Deutschland) GmbH for the approval of the active substance oxathiapiprolin. In accordance with Article 9(3) of that Regulation, Ireland, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (hereinafter ‘the Authority’) on 16 January 2014 of the admissibility of the application.

| (2) | On 1 January 2015, the rapporteur Member State submitted a draft assessment report to the Commission with a copy to 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. |
| --- | --- |

(2)

On 1 January 2015, the rapporteur Member State submitted a draft assessment report to the Commission with a copy to 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 the applicant to 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 on 12 February 2016. |
| --- | --- |

(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 the applicant to 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 on 12 February 2016.

| (4) | On 26 May 2016, the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance oxathiapiprolin can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public. |
| --- | --- |

(4)

On 26 May 2016, the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance oxathiapiprolin can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public.

| (5) | On 6 October 2016 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for oxathiapiprolin and a draft Regulation providing that oxathiapiprolin is approved. |
| --- | --- |

(5)

On 6 October 2016 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for oxathiapiprolin and a draft Regulation providing that oxathiapiprolin is approved.

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

(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 oxathiapiprolin. |
| --- | --- |

(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 oxathiapiprolin.

| (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. |
| --- | --- |

(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. |
| --- | --- |

(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, |
| --- | --- |

(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 oxathiapiprolin, 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, 10 February 2017.

For the Commission

The President

Jean-Claude JUNCKER

---

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

1

(2)  
  EFSA Journal 2016;14(6):4504. 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

---

ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| Oxathiapiprolin
  CAS No:
  1003318-67-9
  CIPAC No: 985 | 1-(4-{4-[(5RS)-5-(2,6-difluorophenyl)-4,5-dihydro-1,2-oxazol-3-yl]-1,3-thiazol-2-yl}-1-piperidyl)-2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]ethanone | ≥ 950 g/kg | 3 March 2017 | 3 March 2027 | 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 oxathiapiprolin, and in particular Appendices I and II thereof, shall be taken into account.
  Conditions of use shall include risk mitigation measures, where appropriate.
  The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:






  (1) | the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities; |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Oxathiapiprolin

CAS No:

1003318-67-9

CIPAC No: 985

1-(4-{4-[(5RS)-5-(2,6-difluorophenyl)-4,5-dihydro-1,2-oxazol-3-yl]-1,3-thiazol-2-yl}-1-piperidyl)-2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]ethanone

≥ 950 g/kg

3 March 2017

3 March 2027

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 oxathiapiprolin, and in particular Appendices I and II thereof, shall be taken into account.

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

The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:

(1)

the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities;

| (2) | the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification. |
| --- | --- |

(2)

the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification.

The applicant shall submit the information requested under points (1) and (2) by 3 September 2017.

---

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

---

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 |
| --- | --- | --- | --- | --- | --- | --- |
| ‘106 | Oxathiapiprolin
  CAS No:
  1003318-67-9
  CIPAC No: 985 | 1-(4-{4-[(5RS)-5-(2,6-difluorophenyl)-4,5-dihydro-1,2-oxazol-3-yl]-1,3-thiazol-2-yl}-1-piperidyl)-2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]ethanone | ≥ 950 g/kg | 3 March 2017 | 3 March 2027 | 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 oxathiapiprolin, and in particular Appendices I and II thereof, shall be taken into account.
  Conditions of use shall include risk mitigation measures, where appropriate.
  The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:






  (1) | the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities; |

Number

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

‘106

Oxathiapiprolin

CAS No:

1003318-67-9

CIPAC No: 985

1-(4-{4-[(5RS)-5-(2,6-difluorophenyl)-4,5-dihydro-1,2-oxazol-3-yl]-1,3-thiazol-2-yl}-1-piperidyl)-2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]ethanone

≥ 950 g/kg

3 March 2017

3 March 2027

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 oxathiapiprolin, and in particular Appendices I and II thereof, shall be taken into account.

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

The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:

(1)

the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities;

| (2) | the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification. |
| --- | --- |

(2)

the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification.

The applicant shall submit the information requested under points (1) and (2) by 3 September 2017.

---

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

1

---