# L_2017036EN.01004301.xml

| 11.2.2017 | EN | Official Journal of the European Union | L 36/43 |
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11.2.2017

EN

Official Journal of the European Union

L 36/43

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/240

of 10 February 2017

concerning the non-approval of Satureja montana L. essential oil as a basic substance 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

(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 23(5) in conjunction with Article 13(2) thereof,

Whereas:

| (1) | In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 7 July 2015 an application from the Institut technique de l'agriculture biologique (ITAB) for the approval of Satureja montana L. essential oil as basic substance. That application was accompanied by the information required under the second subparagraph of Article 23(3). |
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(1)

In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 7 July 2015 an application from the Institut technique de l'agriculture biologique (ITAB) for the approval of Satureja montana L. essential oil as basic substance. That application was accompanied by the information required under the second subparagraph of Article 23(3).

| (2) | The Commission asked the European Food Safety Authority (hereinafter ‘the Authority’) for scientific assistance. The Authority presented to the Commission a Technical Report on the substance concerned on 13 June 2016 (2). The Commission presented the review report (3) and the draft of this Regulation on the non-approval of Satureja montana L. essential oil to the Standing Committee on Plants, Animals, Food and Feed on 7 October 2016 and finalised them for the meeting of that Committee on 7 December 2016. |
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(2)

The Commission asked the European Food Safety Authority (hereinafter ‘the Authority’) for scientific assistance. The Authority presented to the Commission a Technical Report on the substance concerned on 13 June 2016 (2). The Commission presented the review report (3) and the draft of this Regulation on the non-approval of Satureja montana L. essential oil to the Standing Committee on Plants, Animals, Food and Feed on 7 October 2016 and finalised them for the meeting of that Committee on 7 December 2016.

| (3) | The documentation provided by the applicant shows that Satureja montana L. essential oil fulfils the criteria of a foodstuff as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (4). |
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(3)

The documentation provided by the applicant shows that Satureja montana L. essential oil fulfils the criteria of a foodstuff as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (4).

| (4) | Specific concerns were identified, in the Technical Report of the Authority, regarding exposure to the essential oil and the components carvacrol and gamma-terpinene specifically through pesticide use and, as a result, the assessment of the risk to operators, workers, bystanders, consumers and non-target organisms could not be finalised. |
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(4)

Specific concerns were identified, in the Technical Report of the Authority, regarding exposure to the essential oil and the components carvacrol and gamma-terpinene specifically through pesticide use and, as a result, the assessment of the risk to operators, workers, bystanders, consumers and non-target organisms could not be finalised.

| (5) | The Commission invited the applicant to submit its comments on the Technical Report of the Authority and on the draft review report. The applicant submitted its comments, which have been carefully examined. |
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(5)

The Commission invited the applicant to submit its comments on the Technical Report of the Authority and on the draft review report. The applicant submitted its comments, which have been carefully examined.

| (6) | However, despite the arguments put forward by the applicant, the concerns related to the substance cannot be eliminated. |
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(6)

However, despite the arguments put forward by the applicant, the concerns related to the substance cannot be eliminated.

| (7) | Consequently, as laid down in the Commission review report, it has not been established that the requirements laid down in Article 23 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to approve Satureja montana L. essential oil as basic substance. |
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(7)

Consequently, as laid down in the Commission review report, it has not been established that the requirements laid down in Article 23 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to approve Satureja montana L. essential oil as basic substance.

| (8) | This Regulation does not prejudice the submission of a further application for the approval of Satureja montana L. essential oil as basic substance in accordance with Article 23(3) of Regulation (EC) No 1107/2009. |
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(8)

This Regulation does not prejudice the submission of a further application for the approval of Satureja montana L. essential oil as basic substance in accordance with Article 23(3) of Regulation (EC) No 1107/2009.

| (9) | 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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(9)

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

The substance Satureja montana L. essential oil is not approved as basic substance.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the 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

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

1

(2)  Outcome of the consultation with Member States and EFSA on the basic substance application for Satureja montana L. for use in plant protection as fungicide and bactericide on various crops. EFSA supporting publication 2016:EN-1051.

2

Satureja montana

(3)  http://ec.europa.eu/food/plant/pesticides/eu-pesticides-database/public/?event=activesubstance.selection&language=EN

3

(4)  Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

4

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