EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10940/2021 ANNEX 
(POOL/E4/2021/10940/10940 -EN 
ANNEX.docx)  
[…](2022) XXX  draft 
ANNEX  
 
ANNEX  
to the  
COMMISSION IMPLEMENTING REGULATION (EU) .../...  
approving L -(+)-lactic acid as an existing active substance for use in biocidal products of 
product -type 6 in accordance to Regulation (EU) No 528/2012 of the EU Parliament and 
of the Council       
   
EN 1  EN ANNEX  
Common Name  IUPAC Name  
Identification Numbers  Minimum degree 
of purity of the 
active substance1 Date of 
approval  Expiry date of 
approval  Product 
type Specific conditions  
L-(+)-lactic acid  IUPAC Name:   
(2S)-2-Hydroxypropanoic acid  
 
EC No: 201 -196-2 
CAS No: 79 -33-4 ≥ 955 g/kg (dry 
weight)  1 
November 
2023  31 October 
2033  6 The authorisation of biocidal products is subject to the 
following condition s: 
1) The product assessment shall pay particular 
attention to the exposures, the risks and the 
efficacy linked to any uses covered by an 
application for authorisation, but not addressed in 
the Union -level risk assessment2 of the active 
substance.  
2) In view of the risks identified for the uses 
assessed, the product assessment shall pay 
particular attention to:  
(a) industrial and professional users;  
(b) non-professional users . 
 
The placing on the market of treated articles is subject to 
the following conditions:  
1) The person responsible for the placing on the market of 
a substance or mixture treated with or incorporating L -(+)-
lactic acid at concentration s in the substance or mixture 
leading to classification for :  
(a) local effects concerning skin corrosion / irritation or 
eye damage / eye irritation , in accordance with Regulation 
(EC) No 1272/2008, shall ensure that exposure to the 
general public is minimised by appropriate risk mitigation  
measures. Those measures may include using  a gel-like 
                                                 
1 The purity indicated in this column was the minimum degree of purity of the active substance evaluated . 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 . 
2 Biocidal Products Committee Opinion on the application for approval of th e active substance: L -(+)-lactic acid, Product type: 6; ECHA/BPC/280/2021, adopted on 15 June 
2021.  
  
EN 2  EN formulation, a pa ckaging with dosing aid or a packaging 
with a self -dissolving shell ; 
(b) acute toxicity regarding corrosivity to the respiratory 
tract,  in accordance with Regulation (EC) No 1272/2008 , 
shall ensure that airborne exposure to the general public is 
minimised  by appro priate risk mitigation measures.  Those 
measures may include a label to indicate: no entry in the 
treated area until dry, or no application  in the presence of 
the/in proximity to  general public.  
2) The person responsible for the placing on the market of 
a treated article treated with or incorporating L -(+)-lactic 
acid shall ensure that the label of that treated article 
provides the information listed in Article 58(3) , second 
subparagraph,  of Regulation (EU) No 528/2012.  
3) Member States competen t authorities or, in the case of  a 
Union authorisation, the Commission shall  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 indicated  on the 
label of the treated articles under Article 58(3) , point (e), 
of Regulation (EU) No 528/2012.