Commission Implementing Decision (EU) 2017/802 of 10 May 2017 not approving PHMB (1600; 1.8) as an existing active substance for use in biocidal products for product-type 5 (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^f1, and in particular the third subparagraph of Article 89(1) thereof,

Whereas:

Commission Delegated Regulation (EU) No 1062/2014^f2 establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes PHMB (1600; 1.8).

PHMB (1600; 1.8) has been evaluated for use in products of product-type 5, drinking water, as defined in Annex V to Regulation (EU) No 528/2012.

France was designated as evaluating competent authority and submitted the assessment report together with its recommendations on 23 November 2015.

In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 12 October 2016 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.

According to that opinion, biocidal products used for product-type 5 and containing PHMB (1600; 1.8) may not be expected to satisfy the requirements laid down in Article 19(1)(b) of Regulation (EU) No 528/2012. For that product-type, the scenarios evaluated in the environmental risk assessments identified unacceptable risks.

It is therefore not appropriate to approve PHMB (1600; 1.8) for use in biocidal products for product-type 5.

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

HAS ADOPTED THIS DECISION: