EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2021) XXX  draft 
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II, III and V to 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 releva nce)   
EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II, III and V to 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 products(1), and in particular Article 15(1) and the 
fourth subparagraph of Article 15(2) thereof,  
Whereas:  
(1) Regulation (EC) No 1272/ 2008 of the European Parliament and of the Council(2) 
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 Chemic als Agency. 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 s ubstances 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 us ed in 
cosmetic products where the conditions laid down in the second sentence of Article 
15(1) of Regulation (EC) No 1223/2009 or in the second subparagraph of Article 
15(2) 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 the second sentence of Article 15(1 ) of Regulation (EC) No 1223/2009 or 
the second subparagraph of Article 15(2) 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 Regula tion (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 
1).  
EN 2  EN (4) This Regulation covers the substances classified as CMR substances by Commission 
Regulation (EU) No 2020/1182(3), which will apply from 1 March 2022.  
(5) With regard to the substance (T-4)- bis[1 -(hydroxy -.kappa.O)pyridine -2(1H) - 
thionato -.kappa.S]zinc , with t he International Nomenclature of Cosmetic Ingredients 
name Zinc Pyrithione , which has been classified as a CMR substance of category 1B 
(Toxic for Reproduction ), a request for an exception  under the second subparagraph of 
Article 15(2) was submitted  on 11 April 2019  concerning use as an anti -dandruff 
ingredient in rinse -off hair products in a concentration of up to 1 %. No request for an 
exception  has been made for any other use of Zinc Pyrithione.  
(6) Zinc Pyrithione is currently listed in entry 8 of Annex V t o Regulation (EC) No 
1223/2009  as an allowed  preservative in rinse -off hair products in a concentration of 
up to 1 % and in other rinse -off products that are not oral hygiene products in a 
concentration of up to 0,5 % . Zinc Pyrithione is also listed in entry 101 of Annex III to 
Regulation (EC) No 1223/200 9 as a restricted substance only allowed, when used for 
purposes other than preservative, in leave -on hair products in a concentration of up to 
0,1 %. 
(7) In accordance with t he second subparagraph  of Article 15(2) of Regulation (EC) No 
1223/2009 , substances classified as CMR  substances  of category 1A or 1B may be 
used in cosmetic products by way of exception  where  certain conditions are fulfilled, 
including the conditions that no suitable alternati ve substances are available , as 
documented in an analysis of alternatives,  and that the substance has been evaluated 
and found safe by the Scientific Committee on Consumer Safety (SCCS ).  
(8) The SCCS concluded in its opinion of 3 -4 March 2020(4) that Zinc Pyr ithione can be 
considered safe when used as an anti -dandruff  ingredient  in rinse -off hair products up 
to a maximum concentration of 1  %. However, since it has not been established that 
there are no suitable alternative  substances  available with regard to anti-dandruff 
ingredient s in rinse -off hair products , Zinc Pyrithione should be deleted from the list 
of restricted substances in Annex III to Regulation (EC) No 1223/2009 and from the 
list of preservatives allowed in cosmetic products in Annex V to that R egulation. It 
should also be added to the list of substances prohibited in cosmetic products in Annex 
II to Regulation (EC) No 1223/2009.  
(9) With  regard to all substances other than Zinc Pyrithione, which were classified as 
CMR substances pursuant to Regulati on (EC) No 1272/2008 by Regulation (EU) No 
2020/1182, no request for use in cosmetic products by way of exception  has been 
submitted. None of those substances are currently restricted in Annex III to Regulation 
(EC) No 1223/2009 or allowed in Annexes IV, V  or VI to that Regulation. Two of 
those substances are currently listed in Annex II to that Regulation. The 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 cosmetic products in that Annex.  
(10) Regulation (EC) No 1223/2009 should therefore be amended accordingly.  
                                                 
3 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) No 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).  
4 SCCS Opinion on Z inc Pyrithione (ZPT) (CAS No 13463 -41-7) – Submission III - SCCS/1614/19 .  
EN 3  EN (11) The amendments to Regulation (EC) No 1223/2009 are based on the classifications of 
the relevant substances as CMR substances by Regulation (EU) No 2020/1182 and 
should therefore apply from the same date as those classifications.  
(12) 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  
Anne xes II, III and V  to Regulation (EC) No 1223/2009 are 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 . 
It shall ap ply from  1 March 2022.  
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Comm ission  
 The President  
 Ursula von der Leyen