EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10849/2017 
(POOL/E4/2017/10849/10849-EN.doc) […](2017) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving L(+) lactic  acid as an existing active substa nce for use in biocidal products of 
product-types 2, 3 and 4 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving L(+) lactic acid as an existing acti ve substance for use in biocidal products of 
product-types 2, 3 and 4 
(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 the third subpa ragraph of Article 89(1) thereof, 
Whereas: (1) Commission Delegated Re gulation (EU) No 1062/2014
2 establishes a list of existing 
active substances to be evaluated for thei r possible approval for use in biocidal 
products. That list includ es L(+) lactic acid. 
(2) L(+) lactic acid has been ev aluated for use in products of product-type 2, disinfectants 
and algaecides not intended for direct app lication to humans or animals, product-type 
3, veterinary hygiene, and product type 4, food  and feed area, as described in Annex V 
to Regulation (EU) No 528/2012. 
(3) Germany was designated as evaluating competent authority and submitted the 
assessment reports together with  its recommendations on 3 May 2016. 
(4) In accordance with Article 7(2) of De legated Regulation (EU) No 1062/2014, the 
opinions of the European Chemicals Agency were formulated on 27 April 2017 by the Biocidal Products Committee, having regard  to the conclusions of the evaluating 
competent authority. 
(5) According to those opinions, biocidal products of product-types 2, 3 and 4 and 
containing L(+) lactic acid may be expected to satisfy the cr iteria of Article 19(1)(b) of 
Regulation (EU) No 528/2012, provided that certain spec ifications and conditions 
concerning their use are complied with. 
(6) It is therefore appropriate to approve L(+) lactic acid for use in biocidal products of 
product-types 2, 3 and 4, subject to compli ance with certain sp ecifications 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 th e new requirements. 
                                                 
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 substan ces 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).  
EN 3   EN (8) The measures provided for in this Regulati on 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-
types 2, 3 and 4, subject to the specifica tions 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