EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2022) XXX  draft  
ANNEX  
 
ANNEX  
 
to the  
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    
EN 1  EN ANNEX  
Annex XVII to Regulation (EC) No 1907/2006 is amended as follows:  
(1) the following entry is added:  
‘xx. Formaldehyde  
CAS No 50 -00-0 
EC No 200 -001-8 
and fo rmaldehyde releasing 
substances   
 
  
1. Shall not be placed on the market in 
articles, after [OP, please insert the date: 36 
months after the date of entry into force of this 
amending Regulation ] where formaldehyde or 
formaldehyde releasing substances have been 
intentionally added during  their production , if, 
under the test conditions specified in 
Appendix [X], the concentration  of 
formaldehyde released from those articles  
exceeds : 
(a) 0,062  mg/m3 for wood -based articles  and 
furniture ;  
(b) 0,08 mg/m3 for articles other than wood -
based articles and furniture . 
The first subparagraph shall not apply to:  
(a) articles that are only for outdoor use under 
reasonably foreseeable conditions;  
(b) articles  exclusively for industrial or 
professional use unless formaldehyde released 
from them leads to exposure of the general 
public under foreseeable conditions of use;  
(c) articles within the scope of entry 72 of this 
Annex;  
(d) articles that are biocidal products with in 
the scope of Regulation (EU) 528/2012 of the 
European Parliament and of the Council *; 
(e) devices within the scope of Regulation 
(EU) 2017/745;  
(f) personal protective equipment within the 
scope of Regulation (EU) 2016/425;  
(g) articles intended to come into contact 
directly or indirectly with food  within the 
scope of Regulation (EC) No 1935/2004;  
(h)  second -hand articles.  
 
2. Shall not be placed on the market in road  
EN 2  EN vehicles  after [ OP, please insert the date: 48 
months after the  date of  entry into force of this 
amending Regulation ] where formaldehyde or 
formaldehyde releasing substances have been 
intentionally added during  their production, if, 
under the test conditions specified in 
Appendix [X], the concentration of 
formaldehyde in the interior of those vehicles  
exceeds 0,062 mg/m3. 
The first subparagraph  shall not apply to:  
(a) road vehicles exclusively for industrial or 
professional use unless the concentration of 
formaldehyde in the interior of those vehicles 
leads to exposure of the general public under 
foreseeable conditions of use;  
(b) second -hand vehicles.’  
 
* 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). ’; 
 
 
(2) the following Appendix [X ] is added:  
 
‘Appendix [X ] 
 
1. Measurement of formaldehyde released  to indoor air  from articles referred to in  
paragraph 1 , first subparagraph , of entry [xx]  
1.1 Reference conditions   
The formaldehyde released from articles referred to in paragraph 1,  first subparagraph  of 
entry [xx] shall be measured in the air of a test chamber under the following reference 
conditions : 
(a) the temperature in the test chamber shall be (23 ± 0 ,5) ⁰C ;  
(b) the relative humidity in the test chamber shall be (45 ± 3) % ;   
EN 3  EN (c) the loading factor, expressed as the ratio of the total surface area of the test piece to the 
volume of the test chamber, shall be (1 ± 0 ,02) m2/m3; in cases where such a loading factor is 
clearly not realistic under reaso nably foreseeable conditions of use, loading factors in 
accordance with Section 4.2.2 of EN 165161 may be used ; 
(d) the air exchange rate in the test chamber shall be (1 ± 0 ,05) h-1;  
(e) an appropriate analytical procedure ,  to measure the formaldehyde co ncentration in the test 
chamber shall be used ;  
(f) an appropriate method for sampling of the test pieces shall be used ;  
(g) the formaldehyde concentration in the air of the test chamber shall be measured at least 
twice per day throughout the test with a time interval between two consecutive samplings of 3 
hours at a minimum ; the measurement shall be repeated until sufficient dat a are available to 
determine the steady state concentration ;  
(h) the duration of the test shall be sufficiently long to allow the determination of the steady 
state concentration and shall not exceed 28 days ;  
(i) the steady state concentration of formalde hyde measured in the test chamber shall be used 
to verify  the compliance with the limit value of formaldehyde released from articles  referred 
to in paragraph 1 , first subparagraph,  of entry [xx] .  
Formaldehyde released from articles referred to in paragrap h 1, first subparagraph , of entry 
xx] may also be measured in the air of a test chamber under the reference conditions that are 
more stringent than the ones listed in the first paragraph of this point; higher temperature 
and/or higher relative humidity and /or higher loading factor and/or lower air exchange rate 
shall be considered to be more stringent conditions.  
1.2. Non-reference conditions  
If data from a test method using the reference conditions specified in Section 1.1 are not 
available, data obtained  from a test method using non -reference conditions may be used , 
where there is a correlation between the results of the test method used and the reference 
conditions specified in Section 1.1.  
Suppl iers of articles may, where applicable , apply  existing correlations to the specific articles 
and test methods considered, to calculate the formaldehyd e releases under the reference 
conditions specified in Section 1.1 in order to demonstrate compliance with paragraph 1 , first 
subparagraph,  of entry [xx] .  
If relevant correlation data are not available, they may be generated on a case -by-case basis. 
Correlation data may be generated , by perform ing measurements of formaldehyde released 
from articles or samples of articles using a method with non -reference conditio ns and, in 
parallel, to measure the formaldehyde released from samples of the same articles under the 
                                                 
1  EN 16516: Construction products – Assessment of release of dangerou s substances – Determination of 
emissions into indoor air .  
EN 4  EN reference conditions  specified  in Section 1.1. Sufficient repeat testing shall be conducted to 
ensure the reliability of such derived correlation.  
Where a correlation is evident, it shall only be necessary to undertake the testing  to verify  the 
compliance with the limit value of formaldehyde  using the method with non -reference 
conditions. Parallel measurements shall only need to be repeated in case o f variations in the 
characteristics of the article , such as  material, size, and production process , that may 
foreseeably affect  the release of formaldehyde.  
2. Measurement of formaldehyde concentration in the interior of vehicles referred to in  
paragraph 2, first subparagraph,  of entry [xx]  
For road vehicles, including trucks  and buses, the formaldehyde concentration shall be 
measured in accord ance with  the conditions specified in ISO 12219 -12, ISO 12219 -103 or an 
equivalent method , and the concentration measured shall be used to verify the complian ce 
with the limit value referred to  in paragraph 2, first subparagraph,  of entry [xx].’. 
 
                                                 
2  ISO 12219 -1: Interior air of road vehicles – Part 1: Whole vehicle test chamber – Specification and 
method for the determination of volatile organic compounds in cabin interiors . 
3  ISO 12219 -10: Interior air of road vehicles — Part 10: Whole vehicle test chamber — Specification and 
methods for the determination of volatile organic compounds in cab in interiors — Trucks and buses .