COMMISSION IMPLEMENTING REGULATION (EU) 2016/1934

of 4 November 2016

approving coco alkyltrimethylammonium chloride (ATMAC/TMAC) as an existing 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 89(1) thereof,

Whereas:

(1) Commission Delegated Regulation (EU) No 1062/2014(2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes coco alkyltrimethylammonium chloride (ATMAC/TMAC).

(2) Coco alkyltrimethylammonium chloride (ATMAC/TMAC) has been evaluated in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council(3) for use in products of product-type 8, wood preservatives, as described in Annex V to that Directive, which corresponds to product-type 8 as described in Annex V to Regulation (EU) No 528/2012.

(3) Italy was designated as evaluating competent authority and submitted the assessment reports together with its recommendations on 20 November 2007 and 10 June 2010.

(4) In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 14 April 2016 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.

(5) According to that opinion, biocidal products of product-type 8 containing coco alkyltrimethylammonium chloride (ATMAC/TMAC) may be expected to satisfy the requirements of Article 5 of Directive 98/8/EC, provided that certain specifications and conditions concerning their use are complied with.

(6) It is therefore appropriate to approve coco alkyltrimethylammonium chloride (ATMAC/TMAC) for use in biocidal products of product-type 8, subject to compliance with certain specifications and conditions.

(7) 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.

(8) 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

Coco alkyltrimethylammonium chloride (ATMAC/TMAC) 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, 4 November 2016.

For the Commission

The President

Jean-Claude JUNCKER

(1)

OJ L 167, 27.6.2012, p. 1

(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

(3) 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

Coco alkyltrimethylammonium chloride (ATMAC/TMAC)

IUPAC Name:

coco alkyltrimethylammonium chloride

EC No: 263-038-9

CAS No: 61789-18-2

96,6 % w/w

1 May 2018

30 April 2028

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)	soil and groundwater for wood in service that will be exposed to frequent weathering.

(3)

In view of the risks identified for soil, surface and ground water, 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 evaluated in accordance with Article 89(1) 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 to be technically equivalent to the evaluated active substance.