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  
 
(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  
 
(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 Agency. The substances  are classi fied 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 con ditions 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 within 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 substances 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 by Delegated 
Regula tion (EU) 202 2/6923 (‘the relevant substances’). Delegated Regulation (EU) 
2022/692  will apply from 1 December 2023. 
(5) No request   for use in cosmetic products by way of exception has been submitted for 
the relevant substances.  
(6) The relevant substances   are currently neither restricted in Annex III to Regulation 
(EC) No 1223/2009, nor allowed in Annexes IV, V or VI to that Regulation.  
(7) The substance 2 -ethylhexanoic acid (CAS No. 149 -57-5) is currently listed in entry 
1024 of Annex II to Regulation (EC) No 1223/2009. However, the salts of that 
substance, which have been classified as CMR substances [of category 1B] by 
Delegated Regulation (EU) 2022/692, are not included in that entry. None of the other 
relevant substances are currently listed    in Annex II to Regulation (EC) No 
1223/2009. Therefore, those substances should be added to the list of substances 
prohibited in cosmetic products in Annex II to Regulation (EC) No 1223/2009 and the 
salts of the substance 2 -ethylhexanoic acid should be added in entry 1024 of that 
Annex.  
(8) Regulation (EC) 1223/2009 should therefore be amended accordingly.  
(9) The amendments to Regulation (EC) No 1223/2009 are based on the classifications of 
the relevant substances as CMR substances and should therefore apply from the same 
date as those classifications.  
(10) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Cosmetic Products , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Annexes II to Regulation (EC) No 1223/2009 is amended in ac cordance 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 . 
It shall apply from 1 December  2023.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
                                                 
3 Commission Delegated Regulation (EU) 2022/692 of 16 February 2022 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 Euro pean Parliament and of the Council on classification, labelling and packaging of substances 
and mixtures (OJ L 129, 3.5.2022, p. 1–17).  
EN 3  EN Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen