EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10940/2021 
(POOL/E4/2021/10940/10940 -EN.docx)  
[…](2022) XXX  draft 
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving L -(+)-lactic acid as an existing active substance for use in biocidal products of 
product -type 6 in accordance with Regulation (EU) No 528/2012 of the European 
Parliament and of the Council  
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving L -(+)-lactic acid as an existing  active substance for use in biocidal products of 
product -type 6 in accordance with Regulation (EU) No 528/2012 of the European 
Parliament and of the Council  
(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 
products1, and in particular Article  89(1) , third subparagrap h, thereof,  
Whereas:  
(1) Commission Delegated Regulation (EU) No  1062/20142 establishes a list of existing 
active substances to be evaluated for their possible approval for use in biocidal 
products. That list includes L-(+)-lactic acid . 
(2) L-(+)-lactic acid  has been evaluated for use in biocidal products of product -type 6, 
preservatives for products during storage , as described in Annex  V to Regulation (EU) 
No 528/2012.  
(3) Germany was  designated as the rapporteur Member State and its evaluating competent 
author ity submitted the assessment report  together with its conclusions  to the 
European Chemicals Agency (‘the Agency’) on 3 September 2020.  
(4) In accordance with Article 75(1) , point (a),  of Regulation (EU) No 528/2012, the 
Biocidal Products Committee prepares the  opinion of the Agency regarding the 
applications for approval of active substances. In accordance with Article 7(2) of 
Delegated Regulation  (EU) No  1062/2014, the Biocidal Products Committee adopted 
the opinion  of the Agency3 on 15 June 2021, having regard to the conclusions of the 
evaluating competent authority.  
(5) According to  that opinion , the biocidal products of product -type 6 containing L-(+)-
lactic acid  may be expected to satisfy the criteria laid down in Article  19(1) , point (b),  
of Regulation (E U) No 528/2012, provided that conditions concerning their use are 
complied with.  
                                                 
1 OJ L  167, 27.6.2012, p.  1. 
2 Commission Delegated Regula tion (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 Biocidal Products Committee  Opinion on the application for approval of the active substance : L-(+)-
lactic acid , Product type: 6 ; ECHA/BPC/280/2021 , adopted on  15 June 2021.   
EN 2  EN (6) Taking into account the opinion of the Agency, i t is appropriate to approve L-(+)-
lactic acid  for use in biocidal products of product -type 6 subject to compliance with 
certain  conditions.  
(7) In particular, s ince L-(+)-lactic acid  is classified for skin corrosion /irritation , sub-
category 1C , and eye damage  and irritation , Category 1 , as specified in Part 3 of 
Annex VI to  Regulation (EC) No 1272/2008 of the European Parliament and of the 
Council4, the person responsible for placing on the market of substances or mixtures 
treated with or incorporating the active substance at concentrations leading to  
classification for skin corrosion /irritation or eye damage / eye irritation  should  ensure 
that exposure to the general public is minimi sed by appropriate  risk mitigation 
measures . 
(8) Since L -(+)-lactic acid meets the criteria for classification as corrosive to the 
respiratory tract as specifie d in Part 3  of Annex VI to Regulation (EC) No 1272/2008, 
the person responsible for placing on the market of substances or mixtures treated with 
or incorporating the active substance at a concentration leading to classification for 
corrosion of the respiratory tract should  ensure that exposure to the general public is 
minimi sed by appropriate risk mitigation measures.  
(9) In order t o guarantee a safe use of biocidal products containing L-(+)-lactic acid  in 
treated articles and enable users  of treate d articles to make informed choices, the 
person responsible for the placing on the market of a treated article  treated with or 
incorporating L -(+)-lactic acid should  ensure that the label of that treated article 
provides the information listed in Article 58(3) , second subparagraph,  of Regulation 
(EU) No 528/2012 . Furthermore , Member States competent authorities or, in the case 
of a Union authorisation , the Commission should  specify in the summary of the 
biocidal p roduct characteristics of a biocidal product containing L -(+)-lactic acid the 
relevant instructions for use and precautions to be included on the label of the treated 
articles under Article 58(3) , point (e), of Regulation (EU) No 528/2012.  
(10) 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.  
(11) The measures provided for i n 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 6, subject to the 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 . 
                                                 
4 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 
1).  
EN 3  EN This Regulation shall be binding in its entirety and directly applicable  in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
          Ursula von der Leyen