# L_2013305EN.01001301.xml

| 15.11.2013 | EN | Official Journal of the European Union | L 305/13 |
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15.11.2013

EN

Official Journal of the European Union

L 305/13

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COMMISSION IMPLEMENTING REGULATION (EU) No 1150/2013

of 14 November 2013

amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance rape seed oil

(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) and 78(2)thereof,

Whereas:

| (1) | The active substance rape seed oil was included in Annex I to Council Directive 91/414/EEC (2) by Commission Directive 2008/127/EC (3) in accordance with the procedure provided for in Article 24b of Commission Regulation (EC) No 2229/2004 (4). Since the replacement of Directive 91/414/EEC by Regulation (EC) No 1107/2009, this substance is deemed to have been approved under that Regulation and is listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (5). |
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(1)

The active substance rape seed oil was included in Annex I to Council Directive 91/414/EEC (2) by Commission Directive 2008/127/EC (3) in accordance with the procedure provided for in Article 24b of Commission Regulation (EC) No 2229/2004 (4). Since the replacement of Directive 91/414/EEC by Regulation (EC) No 1107/2009, this substance is deemed to have been approved under that Regulation and is listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (5).

| (2) | In accordance with Article 25a of Regulation (EC) No 2229/2004, the European Food Safety Authority, hereinafter ‘the Authority’, presented to the Commission its view on the draft review report for rape seed oil (6) on 18 December 2012. The Authority communicated its view on rape seed oil to the notifier. The Commission invited it to submit comments on the draft review report for rape seed oil. The draft review report and the view of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 3 October 2013 in the format of the Commission review report for rape seed oil. |
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(2)

In accordance with Article 25a of Regulation (EC) No 2229/2004, the European Food Safety Authority, hereinafter ‘the Authority’, presented to the Commission its view on the draft review report for rape seed oil (6) on 18 December 2012. The Authority communicated its view on rape seed oil to the notifier. The Commission invited it to submit comments on the draft review report for rape seed oil. The draft review report and the view of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 3 October 2013 in the format of the Commission review report for rape seed oil.

| (3) | It is confirmed that the active substance rape seed oil is to be deemed to have been approved under Regulation (EC) No 1107/2009. |
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(3)

It is confirmed that the active substance rape seed oil is to be deemed to have been approved under Regulation (EC) No 1107/2009.

| (4) | 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 necessary to amend the conditions of approval of rape seed oil as regards the maximum quantity for the toxicologically relevant impurity erucic acid. |
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(4)

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 necessary to amend the conditions of approval of rape seed oil as regards the maximum quantity for the toxicologically relevant impurity erucic acid.

| (5) | The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. |
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(5)

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

| (6) | Member States should be provided with time to amend or withdraw authorisations for plant protection products containing rape seed oil. |
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(6)

Member States should be provided with time to amend or withdraw authorisations for plant protection products containing rape seed oil.

| (7) | A reasonable period of time should be allowed before the entry into force of this Regulation in order to allow Member States, the notifiers and holders of authorisations for plant protection products containing rape seed oil to meet the requirements resulting from amendment to the conditions of the approval. |
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(7)

A reasonable period of time should be allowed before the entry into force of this Regulation in order to allow Member States, the notifiers and holders of authorisations for plant protection products containing rape seed oil to meet the requirements resulting from amendment to the conditions of the approval.

| (8) | For plant protection products containing rape seed oil, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, this period should expire at the latest eighteen months after the entry into force of the Regulation. |
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(8)

For plant protection products containing rape seed oil, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, this period should expire at the latest eighteen months after the entry into force of the Regulation.

| (9) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
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(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS REGULATION:

Article 1

Amendment to Implementing Regulation (EU) No 540/2011

Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.

Article 2

Transitional measures

Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing rape seed oil as active substance by 30 September 2014 at the latest.

Article 3

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 30 September 2015 at the latest.

Article 4

Entry into force

This Regulation shall enter into force on 1 April 2014.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 14 November 2013.

For the Commission

The President

José Manuel BARROSO

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

1

(2)  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).

2

(3)  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).

3

(4)  Commission Regulation (EC) No 2229/2004 of 3 December 2004 laying down further detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC (OJ L 379, 24.12.2004, p. 13).

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

(6)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance plant oil/rape seed oil. EFSA Journal 2013; 11(1)3058 [45 pp.] doi:10.2903/j.efsa.2013.3058. Available online: www.efsa.europa.eu/efsajournal

6

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ANNEX

In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 242 on the active substance rape seed oil is replaced by the following:

| Number | Common name, identification numbers | IUPAC name | Purity | Date of approval | Expiration of approval | Specific provisions |
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| ‘242 | Plant oils/rape seed oil
  CAS No: 8002-13-9
  CIPAC No: not allocated | Rape seed oil | Rape seed oil is a complex mixture of fatty acids
  Relevant impurity: Maximum 2 % of erucic acid | 1 September 2009 | 31 August 2019 | PART A
  Only uses as insecticide and acaricide may be authorised.
  PART B
  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 rape seed oil (SANCO/2623/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.
  Conditions of use shall include, where appropriate, risk mitigation measures.’ |

Number

Common name, identification numbers

IUPAC name

Purity

Date of approval

Expiration of approval

Specific provisions

‘242

Plant oils/rape seed oil

CAS No: 8002-13-9

CIPAC No: not allocated

Rape seed oil

Rape seed oil is a complex mixture of fatty acids

Relevant impurity: Maximum 2 % of erucic acid

1 September 2009

31 August 2019

PART A

Only uses as insecticide and acaricide may be authorised.

PART B

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 rape seed oil (SANCO/2623/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.

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

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