EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
[…](2022) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament 
and of the Council as regards formaldehyde and formaldehyde releasers  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament 
and of the Council as regards formaldehyde and formaldehyde releasers  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the 
Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending 
Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission 
Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission 
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC1, and in particular Article 
68(1)  thereof,  
Whereas:  
(1) Formaldehyde  is a highly reactive gas at ambient temperature and atmospheric 
pressure  conditions . It is classified in Part 3 of Annex VI to Regulation (EC) No 
1272/2008 of the European Parliament and of the Council2 as carcinogen category 1B, 
mutagen category 2, acute toxicant  category  3, skin corrosive category 1B and skin 
sensitiser category 1.  
(2) Formaldehyde is a high production volume chemical with a wide array of uses . It is 
also produced endogenously in humans and animals , and it is an essential metabolic 
intermediate in all cells. 9 8 % of the formaldehyde manufactured or imported in the 
Union is used as a  chemical intermediate in the production of formaldehyde -based 
resins , thermoplastics and other chemicals, which are further used in a  broad range of 
applications.  Formaldehyde -based resins are used in the pr oduction  of a wide variety  
of art icles, which, as a r esult, may release formaldehyde . The primary use of 
formaldehyde -based resins is in the manufacturing  of wood -based panels, where they 
act as a bonding agent for wood particles. Such resins are also used  in the production 
of other wood -based products like furniture  and flooring,  and for wallpapers, foams, 
parts for vehicles and aeroplanes, textile and leather products .  
(3) On 20  December 20173, pursuant to Article 69(1) of Regulation (EC) No 1907/2006 
the Commission asked  the European Chemicals Agency (‘the Agency’)  to prepare a 
dossier  which con forms to the requirements of Annex XV to that Regulation 
                                                 
1 OJ L 396, 30.12.2006, p. 1.  
2  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). 
3 https://echa.europa.eu/documents/10162/13641/formaldehyde_cion_reqst_axvdossier_en. pdf/11d4a99a -
7210 -839a -921d -1a9a4129e93e    
EN 2  EN (hereinafter ‘the Annex XV dossier’), in order to assess the risk to human health from 
formaldehyde and formaldehyde releasing  substances  in mixtures and articles for 
consumer uses .   
(4) On 11 March 2019 , the Agency  (to be known as ‘the Dossier Submitter’ in the con text 
of submission of a dossier ) submitted the Annex XV dossier4, which demonstrated tha t 
the risk to human health from formaldehyde released from consumer articles in indoor 
environments is not adequately controlled under  all scenarios , and  that action on a 
Union -wide basis is necessary  to address that risk .  
(5) The Dossier Submitter  assessed the  hazard of formaldehyde  by considering the effects 
of the substance on several endpoints , concluding  that the risk  from inhalation leading 
to sensory irritation is  the most sensitive effect in humans . The Annex XV d ossier 
assessed the risks from inhalation of formaldehyde associated to consumer exposure 
against the  World Health Organization ( WHO ) Guideline for Indoor Air Quality for 
formaldehyde (30 -minute average concentration based on sensory irritation in 
humans)5. The Guideline  provides f or a short -term value (0,1 mg/m3) with a view to 
prevent ing detrimental effects on lung function , as well as long -term health effects, 
including nasopharyngeal cancer.  The Dossier Submitter  used that value  as the level 
above which humans should not be expo sed ( derived no -effect level (‘DNEL’)  and to 
calculate the proposed emission limit of 0 ,124 mg/m3. 
(6) Based on available literature and the outcome of the exposure estimation, the Dossier 
Submitter concluded that human health risks from formaldehyde release from  mixtures 
for consumer use are adequately controlled .  
(7) The Annex XV dossier therefore proposed  to prohibit  the placing on the market of  
formaldehyde  and formaldehyde releasing substances  in articles generating  consumer 
exposure where the formaldehyde release s lead to concentrations  exceed ing 
0,124 mg/m3 in the air of a test chamber . Moreover, the Annex XV dossier specified 
that formaldehyde in road vehicles and aircraft, where formaldehyde or formaldehyde  
releasing substances were intentionally added during  their production, should not be 
placed on the market if the formaldehyde measured in their interior exceeds a 
concentration of 0,1  mg/m3 and where exposure of formaldehyde to consumers can 
occur there.   
(8) The Dossier Submitter’s original  proposal esta blished EN 717 -1 as the standard 
method to measure in a test chamber the emission s for formaldehyde released from 
wood based  panels . To clarify that other suitable test methods can also be used and to 
cover articles other than wood -based panels, the Dossie r Submitter replaced the 
reference to standard EN 717 -1 in its proposal  by a wider description of conditions and 
methods. Ambient conditions may have an influence on formaldehyde emissions from 
articles and therefore relevant testing parameters  were also l isted  in the Annex XV 
dossier .  
(9) On 13 March 2020 , the Agency’s Committee for Risk Assessment (‘RAC’) adopted its 
opinion . In its opinion,  RAC considered  the WHO guideline value not sufficiently 
protective for the general population and concluded in particu lar that short -term 
sensory irritation effects in humans cannot be used to predict long -term effects  such as 
cancer . RAC instead set a DNEL of 0 ,05 mg/m3 derived from data on chronic effects 
                                                 
4 https://echa.europa.eu/registry -of-restriction -intentions/ -/dislist/details/0b0236e182439477  
5 WHO 2010 -WHO Guidelines for Indoor Air quality: Selected Pollutants. Geneva. World Health 
Organization, p. 103.  
EN 3  EN in animal s for the inhalation route and concluded that  a limit value of 0,05 mg/m3 for 
formaldehyde released from articles and for formaldehyde in the interior of road 
vehicles  was needed to control the risk .  
(10) RAC concluded that the risk to passengers from formaldehyde in aircraft is adequately  
controlled.  
(11) RAC recommended a  transitional period of 24 months  from the entry into force until 
the application of the proposed restriction , compared to the 12 months suggested by 
the Dossier Submitter, as a longer time  was consider ed necessary to allow for the 
development of standard analytical methods  in all sectors affected . RAC concluded 
that the proposed restriction , as modified by RAC,  is the most appropriate Union -wide 
measure to address the identified risks to human health arising from consumer 
exposure to formaldehyde , in terms of its effectiveness in reducing the risk, its 
practicality and the manner in which it can be monitor ed. 
(12) On 17 September 20 20, the Agency’s  Committee for Socio -Economic Analysis 
(‘SEAC’)  adopted its opinion , concluding on the Dossier Submitter’s proposed 
restriction and the modifications proposed by RAC.  
(13) In its opinion, SEAC acknowledged that the Dossier Submitter’s proposal entail s costs 
in terms of  production,  sampling, testing and enf orcement in the order of tens of 
millions of euros . However, SEAC concluded that those costs are expected to be 
limited for the concerned sectors,  as most of the articles , including road vehicles,  
placed on the market  in the Union today are already complia nt with the proposed limit 
value . SEAC also concluded that benefits from the Dossier Submitter’s proposed 
restriction would result from  restricting the placing on the market of articles  emitting  
high concentration s of formaldehyde , including imports . The restriction  would result  
in reduced adverse health effects related to irritation of the eyes, upper airways and 
nasopharyngeal cancer, mainly for individuals living in new dwellings.  
(14) SEAC considered that the benefits deriving from limiting formaldehyde emission from 
consumer articles indoors and in the interior of vehicles , as proposed , could be 
achieved at limited costs for society. Therefore, SEAC concluded that the Dossier 
Submitter ’s proposal is the most appropriate Union-wide measure to address the 
identified  risk to human health , in terms of its socio -economic benefits and its socio -
economic costs , if certain derogations  are included and proposed testing conditions 
accepted.  
(15) To provide sufficient time for stakeholders to implement the restriction , SEAC 
recommended a deferral of 24 month s for all sectors  as regards the application of the 
restriction. For tr ucks and buses , however, SEAC recommended 36 months due to the 
need to develop standard analytical methods  for measuring formaldehyde  
concentrations in the interior  of these vehicles . 
(16) SEAC conclud ed further that the proposed restriction , as modified  by RAC, entail s 
major socio -economic costs , in the order of tens of billions of euros, in terms of 
investment in research and development, new technologies, higher production costs, 
sampling and testing costs, as well as job losses. Furthermore, it potentially has 
negative effects on recycling sectors and the circular e conomy. SEAC recognised that 
to achieve the limit proposed by RAC, technically feasible alternatives  exist  for certain 
applications;  however,  they require far -reaching technological changes  and, in specific  
cases , the use of less sustainable alternatives .  
EN 4  EN (17) SEAC acknowledged  that RAC ’s proposal has potential additional benefits in terms of 
reduced exposure that may lead to a greater reduction in eye and upper airway 
irritation and nasopharyngeal cancers  compared to the Dossier Submitter’s proposal . 
However , RAC did not quantify the risk reduction associated with lowering the limit 
value ; hence,  the magnitude of the additional health benefits remain s unknown. 
Furthermore, a s part of its assessment, SEAC carried out a n analysis by which it 
calculat ed that, given  the high socio -economic costs , the incidence of nasopharyngeal 
cancer among the population in the Union living in new dwellings would have to be 
200 times higher than the actual observed incidence , for the RAC proposal to break  
even. Taking into account this break -even analysis, the information received from  
industry  during  the consultations , and the absence of data  or information  that would 
allow t he quantif ication of  additional health benefits , SEAC concluded that the 
restriction based on the limit valu e proposed by RAC  does not appear to be an 
appropriate measure  to address  the identified risk  in terms of socio -economic benefits 
and socio -economic costs.  
(18) The Forum for Exchang e of Information on Enforcement  was consulted on the Dossier 
Submitter’s proposal and its recommendations on its implementability and 
enforceability have been taken into account ; the Forum did not consider the 
modifications recommended by RAC , as they were presented  after the consultation of 
the Forum . 
(19) On 23 February 2021 , the Agency submitted the opinions of RAC and SEAC to the 
Commission6. The opinions of RAC and SEAC  conclude d that there is a risk to the 
health  of consumers that is not adequately controlled and needs to be addressed on a 
Union -wide basis due to the emissions of formaldehyde from articles in to indoor air  
and from road vehicles in to their interior .  
(20) The Commission notes that, while the  proposed restriction  by the Dossier Submitter as 
well as the opinions by RAC and SEAC refer to consumers, the assessment 
underpinning the proposal address es the risk  to the population  that could be exposed  to 
formaldehyde in indoor air other than workers , including persons that are not direct 
consumers. For the sake of legal cl arity, it is therefore appropriate to refer to the 
general public as the population targeted by the restriction.   
(21) The Commission , taking into account the Annex XV dossier as well as the RAC and 
SEAC opinions,  considers that there is an unacceptable risk  to human health  arising 
from formaldehyde released from articles , and that a restriction establishing an 
emission limit for articles emitting formaldehyde to decrease exposure  of the general 
public  to formaldehyde via inhalation is the most appropriate Union -wide measure to 
address the risk . 
(22) The Commission agrees with the Dossier Submitter that the proposed limit value of 
0,124 mg/m3 prevents articles that emit high amounts of formaldehyde from bein g 
placed on the market in the Union and that it is appropriate to limit exposure to 
formaldehyde in indoor environments. However, the Commission considers that the 
risk reduction realised by achieving the WHO Guideline value is modest because of 
existing v oluntary and national emission limits and the fact that the majority of articles 
placed on the market today are already expected to be compliant with the limit value 
                                                 
6 Compiled version prepared by the ECHA secretar iat of RAC’s opinion (adopted 12  March 2020) and 
SEAC opinion (adopted 17 September 2020 )  
https://echa.europa.eu/documents/10162/f10b57af -6075 -bb34 -2b30 -4e0651d0b52f  
  
EN 5  EN of 0,124 mg/m3. Achieving the WHO guideline value would also be insufficient to 
address th e risk identified, taking into account RAC’s opinion. Likewise, current 
interior  concentrations in road vehicles  mostly comply with the proposed limit va lue 
of 0,1 mg/m3.  
(23) The Commission also acknowledges , based on SEAC ’s conclusion s on the socio -
economic assessment , that the limit value of 0,05 mg/m3 , as proposed by RAC,  would 
entail  major socio -economic impacts for the Union ; and that such  a limit value 
requires , in specific cases,  shifting to less sustainable alternatives with negative  effects 
on the circular economy and recycling , in particular in view of the absence of a n 
assessment  of the additional health benefits of such a limit  compared to the limit 
proposed by the Dossier Submitter .  
(24) The Commission therefore examined  the appropriateness of the intermediate limit 
values of 0,08 mg/m3 and 0 ,062 mg/m3 that had been partly assessed by SEAC b ased 
on input received from stakeholders in the c onsultations . The Commission  concluded 
that the adoption of such intermediate value s would entail a higher prote ction of 
human health, in particular that of vulnerable populations , compared to the limit 
proposed by the Dossier S ubmitter , while entailing  a lower  socio -economic burden 
and fewer techn ological challenges than the limit proposed by RAC , particularly if 
taken in combination with  adequate transition al period s and specific derogations . 
(25) The Commission recognises the exponential increase in costs when lowering the limit 
value, and that the estimated combined costs for industry would be at minimum in the 
range  of hundreds of millions of euros for the limit value of 0,08 mg/m3 , compared 
with billions of euros for the limit value of 0,062 mg/m3. The Commission has further 
analyse d the break -even analysis by SEAC, which calculates  that, for the limit value 
of 0,062 mg/m3 to break  even, the incidence of nasopharyngeal cancer among the 
population in the Union living in new dwellings would have to be 70 times higher than 
the actual observed incidence, and 30 times higher for the limit value of 0,08 mg/m3. 
However, th e Commission also considers that formaldehyde is a carcinogenic 
substance , for which the limit value of 0,062 mg/m3 would provide higher health 
benefits to the population in the Union. The Commission, although recognising that 
the differences in costs betw een the two values are significant, considers, in view of 
the potential additional health benefits, in particular to vulnerable groups such as 
children, that the higher costs for the lower limit value are justified for articles 
contributing the most to ind oor air quality .  
(26) In its consideration, the Commission takes into account that wood -based panels and 
articles made of wood -based panels or other wood -based articles , as well as furniture 
that contain s wood  or other materials , to which formaldehyde has been intentionally  
added during their production, are the main emission sources of formaldehyde in 
indoor air, in particular in newly built homes. Therefore, the Commission considers 
that a lower emission limit for such articles  and such products composed  of more than 
one article (‘complex products ') that are the biggest sources of formaldehyde in indoor 
air is appropriate and provides for increased protection  of the general public , while 
limiting the socio -economic costs for those sectors that do not cont ribute to the same 
extent to the emissions.  
(27) Likewise, it is appropriate to establish a lower limit for the presence of formaldehyde 
in the interior of road vehicles where the general public  is present to ensure adequate 
protection in particular of vulnerab le population s also in the worst -case scenarios.   
EN 6  EN (28) The Commission therefore concludes that the most appropriate Union -wide measure to 
address the risk of formaldehyde in indoor air and in the interior of road vehicles is a 
restriction setting the limit value of 0,062 mg/m3 for wood -based articles and furniture , 
applied to the whole complex product , as well as in the interior of road vehicles ; and 
of the limit value of 0,08 mg/m3 for all other articles . 
(29) In order to mitigate the negative impacts and to lower the costs for the affected sectors, 
as well as to provide sufficient time for stakeholders to implement the restriction, the 
Commission considers appropriate a deferral of 36 months for all sectors as regards 
the application of the restriction. For road vehicles , however, a deferral of 48 months 
is deemed appropriate due to the long development and marketing time for vehicles, 
the high material requirements in the automotive industry, the complex supply chains 
including original equipment manufactu rers, as well as the time need ed to implement 
the standard analytical method for measuring emissions  for trucks and buses7. 
(30) Articles that are exclusively used in outdoor environments under reasonably 
foreseeable conditions should  not be included in the sco pe of the restriction,  as they do 
not contribute to exposure to formaldehyde in indoor air .  
(31) Articles that are exclusively for industrial or professional use should  not be included in 
the scope  of the restriction , as long as  these use s do not lead to  exposure  of the general 
public . Furthermore , exposure of industrial and professional workers to formaldehyde 
is already regulated by Council Directive 98/24/EC8, and Directive 2004/37/EC of the 
European Parliament and of the Council9. 
(32) Formaldehyde emission s from articles are expected to decrease over time due to ‘off -
gassing’ of residual formaldehyde.  Therefore, s econd -hand articles should  not be 
included in the scope  of the restriction . Moreover, the Forum for Exchange of 
Information on Enforcement also  recommended a dero gation for second -hand articles , 
as enforcing the restriction with regard to second -hand articles  may be difficult . 
(33) The following products are already subject to Union rules on limit values to 
formaldehyde and should  therefore  not be included in the scope of th e restriction : 
articles within the scope of entry 72 of Annex XVII to Regulation (EC) No 1907/2006 , 
articles that are biocidal products within the scope of Regulation (EU) 528/2012 of the 
European Parliament and of the Council10, devices within the scope of Regulation 
(EU) 2017/745 of the European Parliament and of the Council11, and personal 
protective equipment within the scope of Regulation (EU) 2016/425 of the European 
Parliament and of the Council12. 
                                                 
7 12219 -10: Interior air of road vehicles — Part 10: Whole vehicle test chamber — Specification and 
methods for the determination of volatile organic compounds in cabin interiors — Trucks and buses . 
8 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 agent s at work (fourteenth individual Directive within the meaning of Article 16(1) 
of Directive 89/391/EEC)  (OJ L 131, 5.5.1998, p. 11).  
9 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, p. 50).  
10 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 products  (OJ L 167, 27.6.2012, p. 1 ). 
11 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical 
devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and 
repealing Council Directives 90/385/EEC and 93/42/EEC  (OJ L 117, 5.5.2017, p. 1).  
12 Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal 
protective equipment and repealing Council Directive 89/686/EEC  (OJ L 81, 31.3.2016, p. 51).   
EN 7  EN (34) Commission Regulation (EU) No 10/201113 establishes a  limit value for formaldehyde 
for plastic materials and articles intended to come into contact with food . Although 
Union law does not set a specific formaldehyde limit  for other materials  and articles in 
contact with food , producer s must be able to demonstrate their safety to the competent 
authorities. The requirements  of food contact materials  aim to protect human health by 
addressing the potential migration of substances into food . As due to those 
requirements  significant release of formaldehyde  from articles intended to come into 
contact with food , within the meaning of Regulation (EU) 1935/2004 of the European 
Parliament and the Council14, into the surrounding atmosphere  is highly unlikely , the 
Commission considers that those arti cles should not be included in the scope of th e 
restriction . 
(35) The Dossier Submitter, RAC and SEAC proposed a derogation for toys covered by 
Directive 2009/48/EC of the European Parliament and of the Council15 which  sets a 
limit of 0, 1 mg/m3 for formaldehyde emissions in resin -bonded wooden toys for 
children younger than 3  years . However , the Commission considers such a derogation 
not appropriate because children should not be protected less strictly than any other 
part of the population . The limit value for formaldehyde emissions into indoor air 
should  therefore apply to toys for children of all ages.  
(36) Regulation (EC) No 1907/2006 should therefore be amended accordingly.  
(37) The measures provided for in this Regulation are in accordance with the opinion of 
the Committee  established by Article 133 (1) of Regulation (EC) No 1907/2006 , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex XVII to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to 
this Regulation.  
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  
                                                 
13 Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended 
to come into contact with food ( OJ L 12, 15.1.2011,  p. 1).  
14 Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on 
materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 
89/109/EEC (OJ L 338, 13.11.2004, p. 4).  
15 Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of 
toys (OJ L 170, 30.6.2009, p. 1).