COMMISSION IMPLEMENTING REGULATION (EU) 2016/2291

of 16 December 2016

approving L(+) Lactic acid as an active substance for use in biocidal products of product-type 1

(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 Article 90(2) thereof,

Whereas:

(1) Germany received on 29 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 L(+) Lactic acid in Annex I to that Directive for use in products of product-type 1, human hygiene, as described in Annex V to that Directive, which correspond to product-type 1 as described in Annex V to Regulation (EU) No 528/2012.

(2) Germany submitted the assessment report together with its recommendations on 5 February 2015 in accordance with Article 90(2) of Regulation (EU) No 528/2012.

(3) The opinion of the European Chemicals Agency was formulated on 10 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 1 and containing L(+) Lactic acid 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 L(+) Lactic acid for use in biocidal products of product-type 1, 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

L(+) Lactic acid is approved as an active substance for use in biocidal products of product-type 1, 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, 16 December 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

L(+) Lactic acid

IUPAC Name:

(S)-2-Hydroxypropanoic acid

EC No: 201-196-2

CAS No: 79-33-4

95,5 % w/w

1 July 2017

30 June 2027

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 non-professional users.

(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.