COMMISSION IMPLEMENTING REGULATION (EU) 2016/1094

of 6 July 2016

approving copper, granulated, as an active substance for use in biocidal products of product-type 8

(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 90(2) thereof,

Whereas:

(1) France received on 30 August 2013 an application, in accordance with Article 11(1) of Directive 98/8/EC of the European Parliament and of the Council(2), for the inclusion of the active substance copper, granulated, in Annex I to that Directive for use in products of product-type 8, wood preservatives, as described in Annex V to that Directive, which correspond to product-type 8 as described in Annex V to Regulation (EU) No 528/2012.

(2) France submitted the assessment report together with its recommendations on 3 April 2015 in accordance with Article 90(2) of Regulation (EU) No 528/2012.

(3) The opinion of the European Chemicals Agency was formulated on 9 December 2015 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.

(4) According to that opinion, biocidal products of product-type 8 and containing copper, granulated, may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.

(5) It is therefore appropriate to approve copper, granulated, for use in biocidal products of product-type 8, subject to compliance with certain specifications and conditions.

(6) 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.

(7) 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

Copper, granulated, is approved as an active substance for use in biocidal products of product-type 8, 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

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

Done at Brussels, 6 July 2016.

For the Commission

The President

Jean-Claude JUNCKER

(1)

OJ L 167, 27.6.2012, p. 1

(2) 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

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

Copper, granulated

IUPAC Name:

Copper

EC No: 231-159-6

CAS No: 7440-50-8

99 % w/w

1 January 2017

31 December 2026

The authorisations of biocidal products are subject to the following conditions.

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

(2)

In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to:

(a)	industrial and professional users;

(b)	surface water and sediment where there is direct release during the service life of treated wood.

(3)

In view of the risks identified for surface and groundwater, labels and, where provided, safety data sheets of products authorised shall indicate that industrial or professional application shall be conducted within a contained area or on impermeable hard standing with bunding, and that freshly treated timber shall be stored after treatment under shelter or on impermeable hard standing, or both, to prevent direct losses to soil or water, and that any losses from the application of the product shall be collected for reuse or disposal.

(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 90(2) 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.