EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10386/2020 ANNEX 
(POOL/E4/2020/10386/10386 -EN 
ANNEX.docx)  
[…](2020) XXX  draft  
ANNEX  
 
ANNEX  
to the  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
approving formaldehyde as an existing active substance for use in biocidal products of 
product -types 2 and 3    
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  
Formaldehyde  IUPAC Name:  
Methanal  
 
EC No: 200-001-8 
CAS No: 50-00-0 25 – 55,5% 
formaldehyde in 
aqueous solution 
(minimum purity 
87,5% w/w with 
regard to 
formaldehyde)  1 
February   
2022 31 January  
2025  2 Formaldehyde  is considered a candidate for substitution in 
accordance with point (a) of Article 10(1)  of Regulation (EU) 
No 528/2012.  
 
The authorisations of biocidal products are subject to the 
following conditions:  
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 assessment of the active 
substance. In addition, pursuant to point 10 of Annex VI 
to Regulation (EU) No 528/2012, the product assessment 
shall include an evaluation as to whether the conditions of 
Article 5(2) of Regulation (EU) No 528/2012 can be 
satisfied.  
2) Products shall only be authorised for use in Member 
States where at least one of the conditions set i n Article 
5(2) of Regulation (EU) No  528/2012  is met.  
3) In view of the risks identified for the uses assessed, the 
product assessment s hall pay particular attention to : 
i) professional users for products used for 
disinfection by mopping and wiping of surfaces ; 
ii) secondary exposure of the general public and 
children ; 
iii) the aquatic environment for products used for 
room disinfection by fumigation in epidemic 
cases . 
 
                                                 
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 .  
EN 2  EN The placing on the market of treated articles is subject to the 
following condition  that t he person responsible for the placing 
on the market of a treated article treated with or incorporating 
formaldehyde  shall ensure that the label of that treated article 
provides the information listed in the second subparagraph of 
Article 58(3) of Regulatio n (EU) No  528/2012.  
3 Formaldehyde is considered a candidate for substitution in 
accordance with point (a) of Article 10(1) of Regulation (EU) 
No 528/2012.  
 
The authorisations of biocidal products are subject to the 
following conditions:  
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 assessment of the active 
substance. In addition, pursuant to po int 10 of Annex VI 
to Regulation (EU) No 528/2012, the product assessment 
shall include an evaluation as to whether the conditions of 
Article 5(2) of Regulation (EU) No 528/2012 can be 
satisfied.  
2) Products shall only be authorised for use in Member 
States w here at least one of the conditions set in Article 
5(2) of Regulation (EU) No  528/2012  is met.  
3) In view of the risks identified for the uses assessed, the 
product assessment s hall pay particular attention to : 
i) professional users for products used for 
disinfection by spraying of animal housing and of 
vehicles in epidemic cases;  
ii) secondary exposure of the general public;  
iii) surface water, sediment, soil and groundwater 
following use of products for disinfection of 
vehicles and disinfection of animal’s feet by 
bathing or dipping.  
4) For products  that may lead to residues in food or feed, it 
shall be verified whether new maximum residue levels  
EN 3  EN (MRLs) need to be set or the existing MRLs need to be 
amended in accordance with Regulation (EC) 
No 470/2009 of the Europ ean 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 the 
applicable MRLs are not exceeded.  
 
The placing on the market o f treated articles is subject to the 
condition that t he person responsible for the placing on the 
market of a treated article treated with or incorporating 
formaldehyde  shall ensure that the label of that treated article 
provides the information listed in the second subparagraph of 
Article 58(3) of Regulation (EU) No  528/2012.  
 
                                                 
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 
pharmacologically active substances in foodstuffs of animal origin, repealing Council Regula tion (EEC) No 2377/90 and amending Directive 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 pesticides 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 ).