# L_2017163EN.01001001.xml

| 24.6.2017 | EN | Official Journal of the European Union | L 163/10 |
| --- | --- | --- | --- |

24.6.2017

EN

Official Journal of the European Union

L 163/10

---

COMMISSION IMPLEMENTING REGULATION (EU) 2017/1125

of 22 June 2017

withdrawing the approval of the active substance repellents by smell of animal or plant origin/tall oil pitch, 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 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 the second alternative of Article 21(3) and Article 78(2) thereof,

Whereas:

| (1) | Commission Directive 2008/127/EC (2) included repellents by smell of animal or plant origin/tall oil pitch as active substance in Annex I to Council Directive 91/414/EEC (3). Commission Implementing Regulation (EU) No 637/2012 (4) required that Member States concerned ensure that the notifier at whose request repellents by smell of animal or plant origin/tall oil pitch has been included provide further confirmatory information on the equivalence between the specifications of the technical material as commercially manufactured and those of the test material used in the toxicity dossiers and on the toxicological profile of the substance by 1 May 2013 and 31 May 2014 respectively. |
| --- | --- |

(1)

Commission Directive 2008/127/EC (2) included repellents by smell of animal or plant origin/tall oil pitch as active substance in Annex I to Council Directive 91/414/EEC (3). Commission Implementing Regulation (EU) No 637/2012 (4) required that Member States concerned ensure that the notifier at whose request repellents by smell of animal or plant origin/tall oil pitch has been included provide further confirmatory information on the equivalence between the specifications of the technical material as commercially manufactured and those of the test material used in the toxicity dossiers and on the toxicological profile of the substance by 1 May 2013 and 31 May 2014 respectively.

| (2) | Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (5). |
| --- | --- |

(2)

Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (5).

| (3) | On 29 April 2013 and 6 May 2014, the notifier submitted information with a view to complying with the obligation to submit further information as referred to in recital 1, to the rapporteur Member State, Greece. |
| --- | --- |

(3)

On 29 April 2013 and 6 May 2014, the notifier submitted information with a view to complying with the obligation to submit further information as referred to in recital 1, to the rapporteur Member State, Greece.

| (4) | Greece assessed the information submitted by the notifier including some further information related to the initial submission that was submitted during the evaluation process. It submitted its assessment, in the form of addenda to the draft assessment report, to the other Member States, the Commission and the European Food Safety Authority, hereinafter ‘the Authority’ in October 2013 and November 2015. |
| --- | --- |

(4)

Greece assessed the information submitted by the notifier including some further information related to the initial submission that was submitted during the evaluation process. It submitted its assessment, in the form of addenda to the draft assessment report, to the other Member States, the Commission and the European Food Safety Authority, hereinafter ‘the Authority’ in October 2013 and November 2015.

| (5) | The Member States, the applicant and the Authority were consulted and asked to provide comments on the assessment of the rapporteur Member State. |
| --- | --- |

(5)

The Member States, the applicant and the Authority were consulted and asked to provide comments on the assessment of the rapporteur Member State.

| (6) | In the light of the information provided by the notifier, the evaluation of this information by the rapporteur Member State and the comments submitted on the evaluation by Member States and EFSA, the Commission considers that the confirmatory information has not been provided as the information submitted by the notifier is not sufficient to conclude on the equivalence between the specifications of the technical material as commercially manufactured and those of the test material used in the toxicity dossiers nor on the toxicological profile of the substance. |
| --- | --- |

(6)

In the light of the information provided by the notifier, the evaluation of this information by the rapporteur Member State and the comments submitted on the evaluation by Member States and EFSA, the Commission considers that the confirmatory information has not been provided as the information submitted by the notifier is not sufficient to conclude on the equivalence between the specifications of the technical material as commercially manufactured and those of the test material used in the toxicity dossiers nor on the toxicological profile of the substance.

| (7) | The Commission invited the notifier to submit its comments on the considerations of the Commission. |
| --- | --- |

(7)

The Commission invited the notifier to submit its comments on the considerations of the Commission.

| (8) | However, despite the arguments put forward by the notifier, the Commission has come to the conclusion that the information submitted is incomplete and does not allow a conclusion on the equivalence between the specifications of the technical material as commercially manufactured and those of the test material used in the toxicity dossiers nor on the toxicological profile of the substance to be made. |
| --- | --- |

(8)

However, despite the arguments put forward by the notifier, the Commission has come to the conclusion that the information submitted is incomplete and does not allow a conclusion on the equivalence between the specifications of the technical material as commercially manufactured and those of the test material used in the toxicity dossiers nor on the toxicological profile of the substance to be made.

| (9) | Consequently, it is appropriate to withdraw the approval of that active substance. |
| --- | --- |

(9)

Consequently, it is appropriate to withdraw the approval of that active substance.

| (10) | The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. |
| --- | --- |

(10)

The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

| (11) | Member States should be provided with time to withdraw authorisations for plant protection products containing that active substance. |
| --- | --- |

(11)

Member States should be provided with time to withdraw authorisations for plant protection products containing that active substance.

| (12) | For plant protection products containing that active substance, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 14 October 2018. |
| --- | --- |

(12)

For plant protection products containing that active substance, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 14 October 2018.

| (13) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(13)

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

Withdrawal of approval

The approval of the active substance repellents by smell of animal or plant origin/tall oil pitch is withdrawn.

Article 2

Amendment to Implementing Regulation (EU) No 540/2011

In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 251, repellents by smell of animal or plant origin/tall oil pitch is deleted.

Article 3

Transitional measures

Member States shall withdraw authorisations for plant protection products containing repellents by smell of animal or plant origin/tall oil pitch as active substance by 14 October 2017 at the latest.

Article 4

Grace period

Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire by 14 October 2018 at the latest.

Article 5

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, 22 June 2017.

For the Commission

The President

Jean-Claude JUNCKER

---

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

1

(2)  Commission Directive 2008/127/EC of 18 December 2008 amending Council Directive 91/414/EEC to include several active substances (OJ L 344, 20.12.2008, p. 89).

2

(3)  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).

3

(4)  Commission Implementing Regulation (EU) No 637/2012 of 13 July 2012 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances iron sulphate, repellents by smell of animal or plant origin/tall oil crude and repellents by smell of animal or plant origin/tall oil pitch (OJ L 186, 14.7.2012, p. 20).

4

(5)  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).

5

---