EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2021) XXX  draft 
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending the preamble of Annex V to Regulation (EC) No 1223/2009 of the European 
Parliament and of the Council on cosmetic products  
(Text with EEA relevance)    
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending the preamble of Annex V to Regulation (EC) No 1223/2009 of the European 
Parliament and of the Council on cosmetic products  
(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 1223/2009 of the European Parliament and of the 
Council of 30 November  2009 on cosmetic products1, and in particular Article 31(1) thereof,  
Whereas:  
(1) The substance formaldehyde  (CAS No . 50-00-0, EC No. 200 -001-8) has been 
classified as a carcinogen (Category 1B ) and a skin sensitizer (Category 1)  in Part 3 of 
Annex VI to Regulation (EC) No 1272/20082. According to  Article 15 of Regulation 
(EC) No 1223/2009 , substances classified as carcinogenic of category 1B in that 
Annex are to be prohibited  from use in cosmetic products . Therefore , the use of 
formaldehyde as such has be en prohibited in cosmetic products  and is currently listed  
in entry 1577 of Annex II  to Regulation (EC) No 1223/2009 ). 
(2) Annex V to Regulation (EC) No 1223/2009 contains a list of substances allowed for 
use in cosmetic products as preservatives. Certain  of those preservatives  are gradually 
releasing formaldehyde in order to fulfil a preserving function in the final cosmetic 
product (so called formaldehyde releasers ). Formaldehyde releasers  are used in both 
leave -on and rinse -off cosmetic products . 
(3) In order to inform consumers sensitised to formaldehyde  about  the presence of 
formaldehyde that  may trigger an allergic reaction , it is set out  in point 2 of the 
preamble of Annex V  to Regulation  (EC) No 1223/2009  that all finished products 
containing substances which are listed in that Annex and which release formaldehyde 
are to be labelled with the specific warning  ‘contains formaldehyde’  where the 
concentration of formaldehyde in the finished product exceeds 0 ,05 % . 
(4) The Scientific Committee on Consumer Safety (SCCS) concluded, in its scientific 
advice  of 7 May 20213, that the present threshold of 0,05 % (500 ppm) does not 
sufficiently protect consumers  sensitised to formaldehyde . The SCCS further 
concluded  that in ord er to protect the vast majority of those consumers , the current  
threshold for the labelling requirement should be reduced to 0 ,001 % (10 ppm) , which 
                                                 
1 OJ L 342, 22.12.2009, p. 59.  
2 Regulation (EU) 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 amen ding Regulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, 
p.1). 
3 SCCS (Scientific Committee on Consumer Safety), Scientific advice on the threshold for the warning 
‘contains formaldehyde’ in Annex V, preamble point 2 for formaldehyde -releasing substances, final 
version of 7 May 2021, SCCS/1632/21 .  
EN 2  EN should apply to the total formaldehyde  released  irrespective of whether a product 
contains one or more formaldehyde releaser(s).  
(5) In light of the SCCS opinion , it can be concluded  that the potential risk to human 
health arising from the  use of certain substances that realease formaldehyde in finished 
cosmetic products justify a lower threshold regarding the requirement to label such 
products with the specific warning  ‘contains formaldehyde’ than the one currently 
applicable. That threshold should be decreased as proposed by the SCCS.  Regulation 
(EC) No 1223/2009 should therefore be amended accordingly.  
(6) The in dustry should be allowed a reasonable period of time to adapt to the new 
requirements by making the necessary adjustments to labelling, as well as to product 
formulations that are necessary to ensure that only cosmetic products complying with 
the new requi rements are placed on the market. Economic operators should also be 
allowed a reasonable period of time to withdraw cosmetic products which do not 
comply with the new requirements from the market  and which were placed on the 
market before the new labelling  provision becomes applicable . Therefore, considering 
the relatively low risk assoc iated to formaldehyde releasers and the large number of 
cosmetic products concerned the transition period should be 2 4 and 48 months, 
respectively.  
(7) The measures provided fo r in this Regulation are in acc ordance with the opinion of the  
Standing Committee on Cosmetic Products,  
HAS ADOPTED THIS REGULATION:  
Article 1 
Point 2 to the Preamble of Annex V to Regulation (EC) No 1223/2009  is replaced by the 
following:   
‘2. All finished products containing substances which are listed in this Annex and which 
release formaldehyde shall be labelled with the warning ‘releases formaldehyde’ where the 
total concentration of formaldehyde released in the finished product exceeds 0 ,001 % (10 
ppm) , irrespective of whether the finished product contains one or more substances releasing 
formaldehyde.  
However, all finished products containing substances referred to in the first subparagraph 
which comply with Regulation (EC) No 1223/2009 as applicable on [ OP please insert the date 
= the day before the date of entry into force of this Regulation]  may be placed on the Union 
market until [OP please insert date = 24 months after the date of entry into force of this 
Regulation] and be made availab le on the Union market until [OP please insert the date = 48 
months after the date of entry into force of this Regulation] .’  
 
  
 
Article  2 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journa l of the European Union .  
EN 3  EN 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