EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/1279/2023 
(POOL/E4/2023/1279/1279 -EN.docx)  
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving formic acid as an existing active substance for use in biocidal products of 
product -types 2, 3, 4 and 5 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 formic acid as an existing active substance for use in biocidal products of  
product -types 2, 3, 4 and 5 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 subparagraph, 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 formic acid  for product -types 2, 3, 4 and 5.  
(2) Formic acid  has been evaluated for use in biocidal products of product -types 2 
(disinfectants and algaecides not intended for direct application to humans or animals ), 
3 (veterinary hygiene ), 4 (f ood and feed area ) and 5 (d rinking water ), as described  in 
Annex V to Regulation (EU) No 528/2012 . 
(3) Belgium  was designated as the rapporteur Member State and its evaluating competent 
authority submitted the assessment report s together with the conclusions of it s 
evaluation  to the European Chemicals Agency (the ‘Agency’)  on 15 September 2021. 
The Agency discussed the assessment reports and the conclusions in technical 
meetings.  
(4) In accordance with  Article 75(1) , second subparagraph, point (a),  of Regulation (EU) 
No 528/2012, the Biocidal Products Committee prepares the opinion of the Agenc y 
regarding the applications for approval of active substances.  In accordance with 
Article 7(2) of Delegated Regulation (EU) No 1062/2014 read in conjunction with 
Article 75(1) and (4) of Regulation (EU) No 528/2012 , the Biocidal Products 
Committee adopted  the opinion s of the Agency3 on 8 June 2022, having regard to the 
conclusions of the evaluating competent authority.  
                                                 
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 s on the application for approval of the active substance  formic 
acid, Product -types 2, 3, 4  and 5; ECHA/BPC/325/2022 , ECHA/BPC/326/2022 , ECHA/BPC/32 7/2022  
and ECHA/BPC/32 8/2022 .   
EN 2  EN (5) In those opinion s, the Agency concludes that  biocidal products of product -types 2, 3, 4  
and 5 containing  formic acid  may be expected to satisfy the criteria laid down in  
Article 19(1), point (b), of Regulation (EU) No 528/2012, provided that certain 
conditions concerning their use are complied with.  
(6) Taking into account the opinion s of the Agency, it is appropriate to approve formic 
acid as an active substance  for use in bi ocidal products of product -types 2, 3, 4  and 5 
subject to compliance with certain 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 the new requirements.  
(8) 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  
Formic acid  is appr oved as an active substance for use in biocidal products of product -types 2, 
3, 4 and 5, 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 . 
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