EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/11135/2016 (POOL/E4/2016/11135/11135-EN.doc) […](2016) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving L(+) Lact ic acid as an active substance for use in biocidal products of 
product-type 1 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving L(+) Lactic acid as an active substance for use in bi ocidal 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 avai lable 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 appl ication, in accordance with Article 11(1) 
of Directive 98/8/EC of the Europ ean 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 describe d in Annex V to that Directive, which 
correspond to product-type 1 as descri bed 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 spec ifications 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 sp ecifications 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 th e new requirements. 
(7) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
                                                
 
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).  
EN 3   EN HAS ADOPTED THIS REGULATION: 
Article 1 
L(+) Lactic acid is approved as an active subs tance 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, 
 For the Commission 
 The President  Jean-Claude JUNCKER