EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10386/2020 
(POOL/E4/2020/10386/10386 -EN.doc)  
[…](2020) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving formaldehyde as an existing active substance for use in biocidal products of 
product -types 2 and 3  
(Text with EEA relevance)   EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving formaldehyde as an existing active substance for use in biocidal products of 
product -types 2 and 3  
(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 concern ing the making available on the market and use of biocidal 
products1, and  in particular the third subparagraph of Article  89(1) thereof , 
Whereas:  
(1) Commission Delegated Regulation (EU) No 1062/20142 establishes a list of existing 
active substances to be eval uated for their possible approval for use in biocidal 
products. That lists includes formaldehyde . 
(2) Formaldehyde  has been evaluated for use in biocidal products of product -type 2, 
private area and public health area disinfectants and other biocidal products , and 
product -type 3, veterinary hygiene biocidal products , as described in Annex V to 
Directive 98/8/EC of the European Parliament and of the Council3, which correspond  
respectively to product -types 2 and 3 as described in Annex V to Regulation (EU) No 
528/2012.  
(3) The evaluating competent authority of Germany  submitted the assessment report s 
together with its conclusions  to the Commission o n 29 July 2013.  
(4) In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the 
opinion s of the European Chemicals Agency4 (the ‘Agency’) were adopted  on 10 
December  2019 by  the Biocidal Products Committee, having regard to the conclusions 
of the evaluating competent authority.  
(5) It can be derived from Article  90(2) of Regulation (EU) No 528/20 12 that substances 
for which the Member States' evaluation has been completed  by 1  September 2013 
should be evaluated in accordance with the provisions of Directive  98/8/EC.  
                                                 
1 OJ L  167, 27.6.2012, p.  1. 
2 Commission Delegated Regulation (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 a nd of the Council (OJ L 294, 10.10.2014, 
p. 1). 
3 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the 
placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).  
4 Biocidal Products Committee (BPC)  opinion on the application for approval of the active substance 
Formaldehyde , Product type: 2, ECHA/BPC/2 32/2019, adopted on 10 December  2019 ; Biocidal 
Products Committee (BPC) opinion on the application for approval of the active substance 
Formaldehyde , Product type: 3, ECHA/BPC/233 /2019, adopted on 10 December 2019.  EN 2  EN (6) According to the opinion s of the Agency , biocidal products of product -types 2 and 3 
containing formaldehyde may be expected to satisfy the requirements of Article  5 of 
Directive  98/8/EC , provided that certain specifications and conditions concerning their 
use are complied with.  
(7) It is therefore  appropriate to approve formaldehyde  for use in  biocidal products of 
product -types 2 and 3, subject to compliance with certain specifications and 
conditions . 
(8) The opinions of the Agency conclude that formaldehyde  meets the criteria for 
classification  as carcinogen  category 1B  in accordance with Regulation (EC) 
No 1272/2008 of the European Parliament and of the Council5.  
(9) Since formaldehyde  should be approved under the terms of Directive  98/8/EC, taking 
into account that property , the period of approval should be considerably shorter  than 
10 years , in accordance with the latest practice establish ed under that Directive. In 
addition, s ince formaldehyde  has benefitted from the transitional period provided for  
in Article 89 of Regulation (EU) No 528/2012 since 14 May 2000 and has been under 
peer revie w since 29 July 2013 , and with the view to examine at Union level as soon 
as possible in the context of a potential renewal of approval whether the conditions of 
Article 5(2) of Regulation (EU) No 528/2012 can be satisfied for formaldehyde , the 
period of a pproval should be three years.  
(10) Furthermore, pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the 
competent authorities of the Member States should evaluate whether the conditions of 
Article 5(2) of that Regulation can be  satisfied  in their territories  in order  to decide 
whether a biocidal product containing formaldehyde  can be authorised . 
(11) For the purpose s of Article  23 of Regulation (EU) No  528/2012 , formaldehyde  meets 
the conditions laid down in  point (a) of Article 10(1)  of that Regulation and should 
therefore be considered a candidate for substitution.  The competent authorities  of the 
Member States  should therefore  perform a comparative assessment as part of the 
evaluation of an application for authorisation or for renewal of aut horisation of a 
biocidal product containing formaldehyde . 
(12) Since , as concluded by the Agency,  formaldehyde  meets the criteria for classification 
as carcinoge n category 1B and as skin sensitiser category 1  in accordance 
with Annex  I to Regulation (EC) No  1272/2008, treated articles treated with or 
incorporating formaldehyde  should be appropriately labelled when placed on the 
market.  
(13) This Regulation does not affect the application of Union law in the area of health and 
safety a t work, in particular Council Directives 89/391/EEC6 and 98/24/EC7, and  
Directive 2004/37/EC of the European Parliament and of the Council 8. 
                                                 
5 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). 
6 Council Directive 89/391/EEC of 12 June 1989 on the introd uction of measures to encourage  
improvements in the safety and health of workers at work (OJ L 183, 29.06.1989, p. 1).  
7 Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from 
the risks related to chemical agents at work (fourteenth individual Directive within the meaning of 
Article 16(1) of Directive 89/391/EEC) (OJ L 131, 05.5.1998, p. 11).  EN 3  EN (14) A reasonable period should be allowed to elapse before an active substance is 
approved in order to permit interest ed parties to take the preparatory measures 
necessary to meet the new requirements.  
(15) 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 
Forma ldehyde  is approved  as an active substance for use in biocidal products of product -types 
2 and 3, subject to the specifications and 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  
                                                                                                                                                         
8 Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection 
of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual 
Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (OJ L 158, 30.4.2004).