# L_2015067EN.01000901.xml

| 12.3.2015 | EN | Official Journal of the European Union | L 67/9 |
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12.3.2015

EN

Official Journal of the European Union

L 67/9

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COMMISSION IMPLEMENTING REGULATION (EU) 2015/405

of 11 March 2015

approving alpha-cypermethrin as an active substance for use in biocidal products for product-type 18

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the third subparagraph of Article 89(1) thereof,

1

Whereas:

| (1) | Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of active substances to be evaluated with a view to their possible approval for use in biocidal products or inclusion into Annex I to Regulation (EU) No 528/2012. That list includes alpha-cypermethrin. |
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(1)

Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of active substances to be evaluated with a view to their possible approval for use in biocidal products or inclusion into Annex I to Regulation (EU) No 528/2012. That list includes alpha-cypermethrin.

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| (2) | Alpha-cypermethrin has been evaluated in accordance with Article 90(2) of Regulation (EU) No 528/2012 for use in biocidal products for product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to Regulation (EU) No 528/2012. |
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(2)

Alpha-cypermethrin has been evaluated in accordance with Article 90(2) of Regulation (EU) No 528/2012 for use in biocidal products for product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to Regulation (EU) No 528/2012.

| (3) | Belgium was designated as evaluating competent authority and submitted an assessment report, together with its recommendations, to the Commission on 17 November 2011 in accordance with paragraphs 4 and 6 of Article 14 of Commission Regulation (EC) No 1451/2007 (3). |
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(3)

Belgium was designated as evaluating competent authority and submitted an assessment report, together with its recommendations, to the Commission on 17 November 2011 in accordance with paragraphs 4 and 6 of Article 14 of Commission Regulation (EC) No 1451/2007 (3).

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| (4) | The opinion of the European Chemicals Agency was formulated on 17 June 2014 by the Biocidal Product Committee, having regard to the conclusions of the evaluating competent authority. |
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(4)

The opinion of the European Chemicals Agency was formulated on 17 June 2014 by the Biocidal Product Committee, having regard to the conclusions of the evaluating competent authority.

| (5) | According to that opinion, biocidal products used for product-type 18 and containing alpha-cypermethrin may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC of the European Parliament and of the Council (4) provided that certain specifications and conditions relating to its use are satisfied. |
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(5)

According to that opinion, biocidal products used for product-type 18 and containing alpha-cypermethrin may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC of the European Parliament and of the Council (4) provided that certain specifications and conditions relating to its use are satisfied.

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| (6) | It is therefore appropriate to approve alpha-cypermethrin for use in biocidal products for product-type 18 subject to compliance with certain specifications and conditions. |
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(6)

It is therefore appropriate to approve alpha-cypermethrin for use in biocidal products for product-type 18 subject to compliance with certain specifications and conditions.

| (7) | Since the evaluations did not address nanomaterials, the approval should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012. |
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(7)

Since the evaluations did not address nanomaterials, the approval should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012.

| (8) | A reasonable period should be allowed to elapse before an active substance is approved, in order to permit interested parties to take the preparatory measures necessary to meet the new requirements. |
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(8)

A reasonable period should be allowed to elapse before an active substance is approved, in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.

| (9) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
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(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1

Alpha-cypermethrin shall be approved as an active substance for use in biocidal products for product-type 18, subject to the specifications and conditions set out in the Annex.

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.

Official Journal of the European Union

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

Done at Brussels, 11 March 2015.

For the Commission

The President

Jean-Claude JUNCKER

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(1)  OJ L 167, 27.6.2012, p. 1.

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(2)  Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).

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(3)  Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).

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(4)  Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).

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ANNEX

| Common Name | IUPAC Name
  Identification Numbers | Minimum degree of purity of the active substance (1) | Date of approval | Expiry date of approval | Product type | Specific conditions (2) |
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| Alpha-cypermethrin | IUPAC Name:
  Reaction mass of (S)-α-cyano-3-phenoxybenzyl-(1R,3R)-3-(2,2 dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate and (R)-α-cyano-3-phenoxybenzyl-(1S,3S)-3-(2,2-dichlorovinyl)-2,2 imethylcyclopropanecarboxylate (1:1)
  EC No: Not available
  CAS No: 67375-30-8 | 930 g/kg
  Sum of the isomers in a 1:1 ratio | 1 July 2016 | 30 June 2026 | 18 | The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance.
  For biocidal products, authorisations are subject to the following conditions:






  (1) | For professional users, safe operational procedures and appropriate organisational measures shall be established. Where exposure cannot be reduced to an acceptable level by other means, products shall be used with appropriate personal protective equipment. |

Common Name

IUPAC Name

Identification Numbers

Minimum degree of purity of the active substance (1)

Date of approval

Expiry date of approval

Product type

Specific conditions (2)

Alpha-cypermethrin

IUPAC Name:

Reaction mass of (S)-α-cyano-3-phenoxybenzyl-(1R,3R)-3-(2,2 dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate and (R)-α-cyano-3-phenoxybenzyl-(1S,3S)-3-(2,2-dichlorovinyl)-2,2 imethylcyclopropanecarboxylate (1:1)

EC No: Not available

CAS No: 67375-30-8

930 g/kg

Sum of the isomers in a 1:1 ratio

1 July 2016

30 June 2026

18

The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance.

For biocidal products, authorisations are subject to the following conditions:

(1)

For professional users, safe operational procedures and appropriate organisational measures shall be established. Where exposure cannot be reduced to an acceptable level by other means, products shall be used with appropriate personal protective equipment.

| (2) | To prevent risks for the aquatic compartment, for the treament of surfaces prone to frequent wet cleaning, products shall only be used to treat crack and crevices, unless it can be demonstrated in the application for product authorisation that risks for the aquatic compartment can be reduced to an acceptable level. |
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(2)

To prevent risks for the aquatic compartment, for the treament of surfaces prone to frequent wet cleaning, products shall only be used to treat crack and crevices, unless it can be demonstrated in the application for product authorisation that risks for the aquatic compartment can be reduced to an acceptable level.

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(1)  The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU) No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.

(2)  For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/environment/chemicals/biocides/index_en.htm.

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