# L_2017064EN.01000401.xml

| 10.3.2017 | EN | Official Journal of the European Union | L 64/4 |
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10.3.2017

EN

Official Journal of the European Union

L 64/4

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/419

of 9 March 2017

approving the basic substance Urtica spp. 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 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 18 August 2015 an application from the Institut Technique de l'Agriculture Biologique (ITAB) for the approval of Urtica spp. as a basic substance. That application was accompanied by the information required by the second subparagraph of Article 23(3). In addition, the Commission received on 5 January 2016 an application from Myosotis for the approval of nettle as a basic substance. Considering that this application also concerns Urtica spp., but with a different proposed use, the Commission merged the assessment of both applications. |
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(1)

In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 18 August 2015 an application from the Institut Technique de l'Agriculture Biologique (ITAB) for the approval of Urtica spp. as a basic substance. That application was accompanied by the information required by the second subparagraph of Article 23(3). In addition, the Commission received on 5 January 2016 an application from Myosotis for the approval of nettle as a basic substance. Considering that this application also concerns Urtica spp., but with a different proposed use, the Commission merged the assessment of both applications.

| (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 28 July 2016 (2). The Commission presented the review report (3) and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 7 December 2016 and finalised them for the meeting of that Committee on 24 January 2017. |
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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 28 July 2016 (2). The Commission presented the review report (3) and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 7 December 2016 and finalised them for the meeting of that Committee on 24 January 2017.

| (3) | The documentation provided by the applicant shows that Urtica spp. 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). Moreover, it is not predominantly used for plant protection purposes but nevertheless is useful in plant protection in a product consisting of the substance and water. Consequently, it is to be considered as a basic substance. |
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(3)

The documentation provided by the applicant shows that Urtica spp. 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). Moreover, it is not predominantly used for plant protection purposes but nevertheless is useful in plant protection in a product consisting of the substance and water. Consequently, it is to be considered as a basic substance.

| (4) | It has appeared from the examinations made that Urtica spp. may be expected to satisfy, in general, the requirements laid down in Article 23 of Regulation (EC) No 1107/2009, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve Urtica spp. as a basic substance. |
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(4)

It has appeared from the examinations made that Urtica spp. may be expected to satisfy, in general, the requirements laid down in Article 23 of Regulation (EC) No 1107/2009, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve Urtica spp. as a basic substance.

| (5) | 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 for the approval which are detailed in Annex I to this Regulation. |
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(5)

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 for the approval which are detailed in Annex I to this Regulation.

| (6) | In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (5) should be amended accordingly. |
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(6)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (5) should be amended accordingly.

| (7) | 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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(7)

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 a basic substance

The substance Urtica spp. as specified in Annex I is approved as a basic substance subject to the conditions laid down in that Annex.

Urtica

Article 2

Amendments to Implementing Regulation (EU) No 540/2011

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, 9 March 2017.

For the Commission

The President

Jean-Claude JUNCKER

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

1

(2)  European Food Safety Authority, 2016. Outcome of the consultation with Member States and EFSA on the basic substance applications for Urtica spp. for use in plant protection as insecticide, acaricide and fungicide. EFSA supporting publication 2016:EN-1075. 72 pp.

2

Urtica

(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).

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(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

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ANNEX I

| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Specific provisions |
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| Urtica spp.
  CAS No 84012-40-8 (Urtica dioica extract)
  CAS No 90131-83-2 (Urtica urens extract) | Urtica spp. | European Pharmacopeia | 30 March 2017 | Urtica spp. shall be used in accordance with the specific conditions included in the conclusions of the review report on Urtica spp. (SANTE/11809/2016) and in particular Appendices I and II thereof. |

Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Specific provisions

Urtica spp.

CAS No 84012-40-8 (Urtica dioica extract)

CAS No 90131-83-2 (Urtica urens extract)

Urtica spp.

European Pharmacopeia

30 March 2017

Urtica spp. shall be used in accordance with the specific conditions included in the conclusions of the review report on Urtica spp. (SANTE/11809/2016) and in particular Appendices I and II thereof.

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(1)  Further details on identity, specification and manner of use of basic substance are provided in the review report.

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ANNEX II

In Part C 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 | Specific provisions |
| --- | --- | --- | --- | --- | --- |
| ‘14 | Urtica spp.
  CAS No 84012-40-8 (Urtica dioica extract)
  CAS No 90131-83-2 (Urtica urens extract) | Urtica spp. | European Pharmacopeia | 30 March 2017 | Urtica spp. shall be used in accordance with the specific conditions included in the conclusions of the review report on Urtica spp. (SANTE/11809/2016) and in particular Appendices I and II thereof.’ |

Number

Common Name, Identification Numbers

IUPAC Name

Purity (*1)

Date of approval

Specific provisions

‘14

Urtica spp.

CAS No 84012-40-8 (Urtica dioica extract)

CAS No 90131-83-2 (Urtica urens extract)

Urtica spp.

European Pharmacopeia

30 March 2017

Urtica spp. shall be used in accordance with the specific conditions included in the conclusions of the review report on Urtica spp. (SANTE/11809/2016) and in particular Appendices I and II thereof.’

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(*1)  Further details on identity, specification and manner of use of basic substance are provided in the review report.

*1

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