# L_2014251EN.01002401.xml

| 23.8.2014 | EN | Official Journal of the European Union | L 251/24 |
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23.8.2014

EN

Official Journal of the European Union

L 251/24

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COMMISSION IMPLEMENTING REGULATION (EU) No 918/2014

of 22 August 2014

amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance Straight Chain Lepidopteran Pheromones

(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) thereof,

Whereas:

| (1) | The active substance Straight Chain Lepidopteran Pheromones 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 Straight Chain Lepidopteran Pheromones 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 Straight Chain Lepidopteran Pheromones (6) on 13 December 2013. The Authority communicated its view on Straight Chain Lepidopteran Pheromones to the notifier. The Commission invited it to submit comments on the draft review report for Straight Chain Lepidopteran Pheromones. The draft review report and the view of the Authority were reviewed by the Member States and the Commission within the Standing Committee on Plants, Animals, Food and Feed and finalized on 11 July 2014 in the format of the Commission review report for Straight Chain Lepidopteran Pheromones. |
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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 Straight Chain Lepidopteran Pheromones (6) on 13 December 2013. The Authority communicated its view on Straight Chain Lepidopteran Pheromones to the notifier. The Commission invited it to submit comments on the draft review report for Straight Chain Lepidopteran Pheromones. The draft review report and the view of the Authority were reviewed by the Member States and the Commission within the Standing Committee on Plants, Animals, Food and Feed and finalized on 11 July 2014 in the format of the Commission review report for Straight Chain Lepidopteran Pheromones.

| (3) | It is confirmed that the active substance Straight Chain Lepidopteran Pheromones 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 Straight Chain Lepidopteran Pheromones is to be deemed to have been approved under Regulation (EC) No 1107/2009.

| (4) | Straight Chain Lepidopteran Pheromones is a group of pheromones naturally produced by insects of the order of Lepidoptera. They share a common structural definition and mechanism of action. The review report of Straight Chain Lepidopteran Pheromones (SANCO/2633/2008) includes a list of individual compounds having the common structural definition of Straight Chain Lepidopteran Pheromones and being contained in authorised plant protection products. That list will be updated, as appropriate. |
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(4)

Straight Chain Lepidopteran Pheromones is a group of pheromones naturally produced by insects of the order of Lepidoptera. They share a common structural definition and mechanism of action. The review report of Straight Chain Lepidopteran Pheromones (SANCO/2633/2008) includes a list of individual compounds having the common structural definition of Straight Chain Lepidopteran Pheromones and being contained in authorised plant protection products. That list will be updated, as appropriate.

| (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 necessary to amend the conditions of approval of Straight Chain Lepidopteran Pheromones. In particular, it is appropriate to require further confirmatory information. |
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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 necessary to amend the conditions of approval of Straight Chain Lepidopteran Pheromones. In particular, it is appropriate to require further confirmatory information.

| (6) | The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. |
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(6)

The Annex to Implementing Regulation (EU) No 540/2011 should therefore 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

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

Entry into force

This Regulation shall enter into force 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 August 2014.

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).

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(6)  European Food Safety Authority. Conclusion on the peer review of the pesticide risk assessment of the active substance Straight Chain Lepidopteran Pheromones. EFSA Journal 2014;12(1):3524. 537 pp. doi:10.2903/j.efsa.2014.3524. Available online: www.efsa.europa.eu/efsajournal

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ANNEX

In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 255 on the active substance Straight Chain Lepidopteran Pheromones 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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| ‘255 | Straight Chain Lepidopteran Pheromones | Review report (SANCO/2633/2008) | Review report (SANCO/2633/2008) | 1 September 2009 | 31 August 2019 | PART A
  Only uses as attractants 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 straight chain lepidopteran pheromones (SANCO/2633/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed shall be taken into account.
  Conditions of use shall include, where appropriate, risk mitigation measures.
  The notifier shall submit confirmatory information as regards:






  (1) | the genotoxic profile of aldehyde group compounds; |

Number

Common Name, Identification Numbers

IUPAC Name

Purity

Date of approval

Expiration of approval

Specific provisions

‘255

Straight Chain Lepidopteran Pheromones

Review report (SANCO/2633/2008)

Review report (SANCO/2633/2008)

1 September 2009

31 August 2019

PART A

Only uses as attractants 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 straight chain lepidopteran pheromones (SANCO/2633/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed shall be taken into account.

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

The notifier shall submit confirmatory information as regards:

(1)

the genotoxic profile of aldehyde group compounds;

| (2) | exposure of humans and the environment resulting from the different ways of application of Straight Chain Lepidopteran Pheromones as plant protection product, in comparison with natural background levels of those pheromones. |
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(2)

exposure of humans and the environment resulting from the different ways of application of Straight Chain Lepidopteran Pheromones as plant protection product, in comparison with natural background levels of those pheromones.

The applicant shall submit to the Commission, the Member States and the Authority the information set out in point (1) by 31 December 2015 and the information set out in point (2) by 31 December 2016.’

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