# L_2014057EN.01002401.xml

| 27.2.2014 | EN | Official Journal of the European Union | L 57/24 |
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27.2.2014

EN

Official Journal of the European Union

L 57/24

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COMMISSION IMPLEMENTING REGULATION (EU) No 187/2014

of 26 February 2014

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

(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 2007/5/EC (2) included methiocarb as active substance in Annex I to Council Directive 91/414/EEC (3) under the condition that the Member States concerned ensure that the notifier at whose request methiocarb was included in that Annex provides further confirmatory information on the risk for birds, mammals and non-target arthropods. |
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(1)

Commission Directive 2007/5/EC (2) included methiocarb as active substance in Annex I to Council Directive 91/414/EEC (3) under the condition that the Member States concerned ensure that the notifier at whose request methiocarb was included in that Annex provides further confirmatory information on the risk for birds, mammals and non-target arthropods.

| (2) | Active substances included in Annex I of Directive 91/414/EEC are deemed to be approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4). |
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(2)

Active substances included in Annex I of Directive 91/414/EEC are deemed to be approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

| (3) | The notifier submitted additional information taking the form of studies with a view to confirm the risk assessment for birds, mammals and non-target arthropods to the rapporteur Member State the United Kingdom within the time period provided for its submission. |
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(3)

The notifier submitted additional information taking the form of studies with a view to confirm the risk assessment for birds, mammals and non-target arthropods to the rapporteur Member State the United Kingdom within the time period provided for its submission.

| (4) | The United Kingdom assessed the additional information submitted by the notifier. It submitted its assessment, in the form of an addendum to the draft assessment report, to the other Member States, the Commission and the European Food Safety Authority, hereinafter ‘the Authority’, on 5 April 2011. |
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(4)

The United Kingdom assessed the additional information submitted by the notifier. It submitted its assessment, in the form of an addendum to the draft assessment report, to the other Member States, the Commission and the European Food Safety Authority, hereinafter ‘the Authority’, on 5 April 2011.

| (5) | The Commission consulted the Authority which presented its opinion on the risk assessment of methiocarb on 1 June 2012 (5). The draft assessment report, the addendum and the opinion 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 13 December 2013 in the format of the Commission review report for methiocarb. |
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(5)

The Commission consulted the Authority which presented its opinion on the risk assessment of methiocarb on 1 June 2012 (5). The draft assessment report, the addendum and the opinion 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 13 December 2013 in the format of the Commission review report for methiocarb.

| (6) | In the light of the additional information provided by the notifier, the Commission considered that the further confirmatory information required had not been provided. |
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(6)

In the light of the additional information provided by the notifier, the Commission considered that the further confirmatory information required had not been provided.

| (7) | The Commission invited the notifier to submit its comments on the review report for methiocarb. |
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(7)

The Commission invited the notifier to submit its comments on the review report for methiocarb.

| (8) | The Commission has come to the conclusion that a high risk for birds, mammals and non-target arthropods cannot be excluded, even when further risk mitigation measures were to be imposed. |
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(8)

The Commission has come to the conclusion that a high risk for birds, mammals and non-target arthropods cannot be excluded, even when further risk mitigation measures were to be imposed.

| (9) | It is confirmed that the active substance methiocarb is to be deemed to have been approved under Regulation (EC) No 1107/2009. In order to preclude the exposure of birds, mammals and non-target arthropods, it is appropriate to further restrict the uses of this active substance and to withdraw the use as a moluscicide. |
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(9)

It is confirmed that the active substance methiocarb is to be deemed to have been approved under Regulation (EC) No 1107/2009. In order to preclude the exposure of birds, mammals and non-target arthropods, it is appropriate to further restrict the uses of this active substance and to withdraw the use as a moluscicide.

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

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

| (11) | Member States should be provided with time to amend or withdraw authorisations for plant protection products containing methiocarb. |
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(11)

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

| (12) | For plant protection products containing methiocarb, 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 18 months after the entry into force of this Regulation. |
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(12)

For plant protection products containing methiocarb, 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 18 months after the entry into force of this Regulation.

| (13) | 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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(13)

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

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 methiocarb as active substance by 19 September 2014.

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 on 19 September 2015 at the latest.

Article 4

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, 26 February 2014.

For the Commission

The President

José Manuel BARROSO

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

1

(2)  Commission Directive 2007/5/EC of 7 February 2007 amending Council Directive 91/414/EEC to include captan, folpet, formetanate and methiocarb as active substances (OJ L 35, 8.2.2007, p. 11).

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(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).

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(4)  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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(5)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of confirmatory data submitted for the active substance methiocarb. EFSA Journal 2012;10(6):2758. [14 pp.] doi:10.2903/j.efsa.2012.2758. Available online: www.efsa.europa.eu/efsajournal.htm

5

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ANNEX

The column ‘Specific provisions’ of row 148, methiocarb, of Part A of the Annex to Implementing Regulation (EU) No 540/2011 is replaced by the following:

‘PART A

Only uses as repellent in seed treatment and insecticide may be authorised.

PART B

In assessing applications to authorise plant protection products containing methiocarb for uses other than seed treatment in maize Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

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 methiocarb, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 29 September 2006 shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

| — | the protection of birds, mammals and non-target arthropods, ensuring that the conditions of authorisation include risk mitigation measures, where appropriate; |
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—

the protection of birds, mammals and non-target arthropods, ensuring that the conditions of authorisation include risk mitigation measures, where appropriate;

| — | the operator and bystander safety, ensuring that the conditions of use prescribe the application of adequate personal protective equipment; |
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—

the operator and bystander safety, ensuring that the conditions of use prescribe the application of adequate personal protective equipment;

| — | the dietary exposure of consumers.’ |
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—

the dietary exposure of consumers.’

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