EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/1279/2023 ANNEX 
(POOL/E4/2023/1279/1279 -EN 
ANNEX.docx)  
[…](2023) XXX  draft  
ANNEX  
 
ANNEX  
to the  
COMMISSION IMPLEMENTING REGULATION (EU) .../...  
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    
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  
Formic acid  Methanoic Acid  
EC No: 200-579-1 
CAS No: 64-18-6 99 % w/w  
 
 
 
  1 
November  
2024 31 October   
2034 2 The authorisation of biocidal products is subject to the 
following conditions:  
(1) the product assessment pays 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 assessment 
of the active substance;  
(2)        the product assessment pays particu lar attention to:  
(i) professional  users ; 
(ii) non-professional users;  
(iii) secondary exposure of the general public and 
children.   
3 The authorisation of biocidal products is subject to the 
following conditions:  
(1) the product assessment pays 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 assessment 
of the active substance;  
(2) the product assessment pays particular atten tion to  
professionals  users ; 
(3) for products that may lead to residues in food or 
feed, it shall be assessed whether new maximum 
residue levels ( ‘MRLs’) need to be set or the 
                                                 
1 The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance i n 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.    
EN 2  EN existing MRLs need to be amended  in accordance 
with Regulation (EC) No 470/2009 of the European 
Parliament and of the Council2 or Regulation (EC) 
No 396/2005 of the European Parliament and of the 
Council3, and any appropriate risk mitigation 
measures shall be taken to ensure that such MR Ls 
are not exceeded.  
4 The authorisation of biocidal products is subject to the 
following condition s: 
(1) the product assessment pays 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 assessment 
of the active substance;  
(2) the product assessment pays particular attenti on to  
professional  users; 
(3) for products that may lead to residues in food or 
feed, it shall be assessed whether new maximum 
residue levels (MRLs)  need to be set or the existing 
MRLs need to be amended in accordance with 
Regulation (EC) No 470/2009 of the European 
Parliament and of the Council2 or Regulation (EC) 
No 396/2005 of the European Parliament and of the 
Council3, and any appropriate risk mi tigation 
measures shall be taken to ensure that such MRLs 
are not exceeded.  
                                                 
2 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of 
pharmaco logically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Direct ive 2001/82/EC of the European 
Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).  
3 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pe sticides in or on food and feed of plant 
and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).   
EN 3  EN 5 The authorisation of biocidal products is subject to the 
following condition s: 
(1) the product assessment pays 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 assessment 
of the active substance;  
(2) the product assessment pays particular attenti on to:  
(i) professional  users; 
(ii) the environment: soil compartment ; 
(3) for products that may lead to residues in food or 
feed, it shall be assessed whether new maximum 
residue levels (MRLs)  need to be set or the existing 
MRLs need to be amended in accordan ce with 
Regulation (EC) No 470/2009 of the European 
Parliament and of the Council2 or Regulation (EC) 
No 396/2005 of the European Parliament and of the 
Council3, and any appropriate risk mitigation 
measures shall be taken to ensure that such MRLs 
are not e xceeded.