EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2022) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council 
as regards the use in cosmetic products of certain substances classified as carcinogenic, 
mutagenic or toxic for reproduction and correcting that Regulation  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council 
as regards the use in cosmetic products of certain substances classified as carcinogenic, 
mutagenic or toxic for reproduction and correcting that Regulation  
(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 15(1) and 
Article 15(2) , fourth subparagraph, thereof,  
Whereas:  
(1) Regulation (EC) No 1272/2008 of  the European Parliament and of the Council2 
provides for a harmonised classification of substances as carcinogenic, mutagenic or 
toxic for reproduction (CMR) based on a scientific assessment by the Risk Assessment 
Committee of the European Chemicals Agenc y. The substances  are classified as CMR 
substances of category 1A, CMR substances of category 1B or CMR substances of 
category 2 depending on the level of evidence of their CMR properties.  
(2) Article 15 of Regulation (EC) No 1223/2009 provides that substances  which have 
been classified as CMR substances of category 1A, category 1B or category 2 under 
Part 3 of Annex VI to Regulation (EC) No 1272/2008 (CMR substances) are to be 
prohibited from use in cosmetic products. A CMR substance may however be used in 
cosmetic products where the conditions laid down in Article 15(1) , second sentence,  of 
Regulation (EC) No 1223/2009  or in Article 15(2) , second subparagraph,  of that 
Regulation are fulfilled.  
(3) In order to uniformly implement the prohibition of CMR substances w ithin the internal 
market, to ensure legal certainty in particular for economic operators and national 
competent authorities , and to ensure a high level of protection of human health, all 
CMR substances should be included in the list of prohibited substanc es in Annex II to 
Regulation (EC) No 1223/2009 and, where relevant, deleted from the lists of restricted 
or allowed  substances in Annexes III to VI  to that Regulation. Where the conditions  
laid down in Article 15(1) , second sentence,  of Regulation (EC) No 1223/2009 or in 
Article 15(2) , second subparagraph,  of that Regulation are fulfilled, the lists of 
restricted or allowed substances in Annexes III to VI to that Regulation should be 
amended accordingly.  
                                                 
1 OJ L 342, 22.12.2009, p. 59.  
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). EN 2  EN (4) This Regulation covers substances classified as CMR substances of categories 1A, 1B 
or 2 by Delegated Regulation (EU) 202 1/8493, which will apply from 17 December 
2022.  
(5) With regard to the substance ‘methyl 2 -hydroxybenzoate ’ (CAS No. 119 -36-8), with 
Intern ational Nomenclature Cosmetics of Ingredient (INCI)  name ‘Methyl Salicylate ’, 
which has been classified as a CMR substance of category 2 (Toxic for Reproduction ), 
a request for the application of Article 15(1) , second sentence, of Regulation (EC) No 
1223/2009 was submitted  on 25 May 2021  concerning use of that substance as a 
fragrance ingredient in various cosmetic products .   
(6) Methyl Salicylate is used  as a fragrance ingredient , flavouring agent and smoothing 
agent in  various cos metic  products  and is currently not listed in the  Annex es to 
Regulation (EC) No 1223/2009 .   
(7) In accordance with Article 15(1 ), second sentence , of Regulation (EC) No 1223/2009 , 
CMR  substances  of category 2 may be used in cosmetic products where the substance 
has been  evaluated by the Scientific Committee on Consumer Safety (SCCS ) and 
found safe for use in such products .  
(8) The SCCS concluded in its opinion of 2 6-27 October 20214 that Methyl Salicylate can 
be considered safe as an ingredient  in cosmetic  products  up to the maximum 
concentrations provided by the applicant . In light of the classification of Methyl 
Salicylate as a CMR substance of category 2 and the SCCS opinion  in its final version, 
Methyl Salicylate should be added to the list of substances restricted in cosmetic 
products in Annex III to Regulation (EC) No 1223/2009.  
(9) With  regard to all substances other than Methyl Salicylate , which were classified as 
CMR substances pursuant to Regulation (EC) No 1272/2008 by Delegated Regulation 
(EU) 202 1/849, no request for use in cosmetic products by way of exception has been 
submitted. Consequently, the CMR substances that are not already listed in Annex II 
to Regulation (EC) No 1223/2009 should be added to the list of substances prohibited 
in co smetic products in that Annex.   
(10) The substance Sodium N -(hydroxymethyl)glycinate  (CAS No 701-61-44-3) was 
classified as  carcinogenic of category 1B and mutagenic of category 2 by Delegated 
Regulation (EU) 2020/11825. It follows from notes 8 and 9 to t hat classification  that it 
is only applicable if it cannot be shown that the maximum theoretical concentration of 
releasable formal dehyde, irrespective of the source, in the mixt ure as placed on the 
market is less than 0,1 % . In Commission Regulation (EU) 2021 /19026, ‘Sodium N -
                                                 
3 Commission Delegated Regulation (EU) 2021/849 of 11 March 2021 amending, for the purposes of its 
adaptation to technical and scientific progress, Part 3 of Annex VI to Regulation (EC) No 1272/2008 of 
the Europea n Parliament and of the Council on classification, labelling and packaging of substances and 
mixtures (OJ L 188, 28.5.2021, p. 27).  
4 SCCS (Scientific Committee on Consumer Safety), Opinion on methyl salicylate (methyl 2 -
hydroxybenzoate), preliminary versi on of 24 -25 June, final version of 26 -27 October 2021, 
SCCS/1633/21 .  
5 Commission Delegated Regulation (EU) 2020/1182 of 19 May 2020 amending, for the purposes of its 
adaptation to technical and scientific progress, Part 3 of Annex VI to Regulation (EC) N o 1272/2008 of 
the European Parliament and of the Council on classification, labelling and packaging of substances and 
mixtures  (OJ L 261, 11.8.2020, p. 2 ). 
6 Commission Regulation (EU) 2021/1902 of 29 October 2021 amending Annexes II, III and V to 
Regulat ion (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in 
cosmetic products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction  
(OJ L 387, 3.11.2021, p. 120 ). EN 3  EN (hydroxymethyl)glycinate ’ was erroneously added as entry 1669 in the list of 
prohibited substances in Annex II to Regulation (EC) No 1223/2009, despite the fact 
that it was already listed in entry 51 of Annex V to that Regulati on under the chemical 
name/INN  ‘Sodium hydroxymethylamino acetate’  as a preservative allowed in 
cosmetic products under certain conditions . A substance should not be listed in both 
Annex II  and Annex V  to Regulation (EC) No 1223/2009  and entry 1669 should 
therefore  be deleted from Annex II to that Regulation .  
(11) The additional condition that was introduced in column h of e ntry 51 of Annex  V to 
Regulation (EC)  No 1223/2009  by Commission Regulation (EU) 2021/1902  
concerning the maximum theoretical concentration of formaldehyde  was erroneously 
given a slightly different wording than the condition set out in notes 8 and 9 to the 
CMR classification  of ‘Sodium N -(hydroxymethyl)glycinate ’. In order to correctly 
reflect the prohibition of that substance  in cosmetic produc ts on the basis of the CMR 
classification , the wording of the conditions should be the aligned and entry 51 should 
be adapted accordingly . 
(12) Entry 51 of Annex V to Regulation (EC) 1223/2009 also contains an error in column b 
with regard to the chemical name of the substance. The correct name of the substance 
is ‘Sodium N -(hydroxymethyl)glycinate ’, as referred to in Delegated Regulation (EU) 
2020/1182 . 
(13) Regulation (EC) 1223/2009 should therefore be amended and corrected accordingly.   
(14) The amendments to Regulation (EC) No 1223/2009 that are based on the 
classification s of the relevant substances as CMR substances by Delegated Regulation 
(EU) 2021 /849 should  apply from the same  date as those classifications.  
(15) The measures provided for in t his Regulation are in accordance with the opinion of the 
Standing Committee on Cosmetic Products,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annexes II  and III to Regulation (EC) No 1223/2009 are amended in accordance with Annex 
I to this Regulation.  
Article 2 
Annexes II and V to Regulation (EC) No 1223/2009  are corrected in accordance with Annex 
II to this Regulation.  
Article  3  
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European  Union . 
Article  1 shall apply from 17 December 2022 .  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  EN 4  EN Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen