EN   EN  
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2020) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending and correcting Annex II and amending Annexes III, IV and VI 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 and correcting Annex II and amending Annexes III, IV and VI 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 15(1), the 
fourth subparagraph of Article 15(2) and Article 31(1) thereof ,  
Whereas:  
(1) Regulation (EC) No 1272/2008 of the European Parliament and of the Council2 
provide s for a harmonised classification of substances as carcinogenic, mutagenic or 
toxic for reproduction (CMR) based on a n opinion prepared by the Committee for 
Risk Assessment of the European Chemicals Agency. The substances are classified as 
CMR substances o f 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 
prohibited from use in cosmetic products. A CMR substance may however be used in 
cosmetic products where the conditions laid down in the second sentence of Article 
15(1) or in the second subparagraph of Article 15(2) of Regulation (EC) No 
1223/2009 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,  CMR 
substances should be included in the list of prohibited or, as applicable, restricted 
substances in Annex II or Annex III , respectively, to Regulation (EC) No 1223/2009 
and, where relevant, deleted from the lists of restricted or authorised substances in 
Annexes III to VI to that Regulation. Where the conditions laid down in the second 
sentence of Article 15(1) or the second subparagraph of Article 15(2) of Regulation 
(EC) No 1223/2009 are fulfilled, the lists of restricted or authorised substances in 
Annexes III to V I 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) By Commission Delegated Regulation (EU) 2020/2173, which is to apply from 
1 October 20214, certain  substances have been classified as CMR substances in 
accordance with Regulation (EC) No 1272/2008. It is therefore necessary  to prohibit 
the use of those CMR substances in cosmetic products  from the same date. 
(5) In particular, Delegated Regulation (EU) 2020/217 provides for a classification of the 
substance TiO 2 (INCI name : titanium d ioxide ) as ‘Carcinogen  Category 2 
(inhalation) ’, that applies to titanium d ioxide in powder form containing 1 % or more 
of particles with aerodynamic diameter of ≤ 10 µm.  
(6) Titanium d ioxide is currently listed in  entry 143 of Annex IV to Regulation (EC) No 
1223/2009 and allowed f or use as colorant in cosmetic products, provided that it 
complies with the purity criteria as set out in entry  E 171 (titanium dioxide) of the 
Annex to Commission Regulation (EU) No 231/20125. Titanium d ioxide is also listed 
in entries 27 and 27a (nano form) of Annex VI to Regulation (EC) No 1223/2009 as 
UV filter and only allowed in cosmetic products in concentr ations of up to 25%. In 
addition, t itanium dioxide (nano) is allowed in ready for use preparation, except in 
applicatio ns that may lead to exposure of the end user’s lungs by inhalation and 
subject to the other conditions listed in that entry.  
(7) Following the classification of titanium dioxide as a CMR substance, a request for its 
use in cosmetic products by way of exception pursuant to the second sentence of 
Article 15(1) of Regulation (EC) No 1223/2009 was  submitted on 28 January 2020.  
(8) On 6 October  2020, the Scientific Committee on Consumer Safety ( SCCS ) adopted  a 
scientific opinion on titanium d ioxide6 (“the SCCS opinion” ) for the purpose of the 
adoption of the necessary measures in accordance with Article 15(1) of Regulation 
(EC) No 1223/2009. That opinion, which cover ed titanium dioxide (inhalable) in 
powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10  μm, 
conclude d that, based on the available data, TiO 2 was safe for general consumers 
when used in face products in powder form up to a maximum concentration of 25 % 
and in hair product s in aerosol dispenser (spray)  form up to a maximum concentration 
of 1.4 % . As regards professional use, TiO 2 was considered safe when used in hair 
products in aerosol dispenser (spray) form  up to a maximum concentration of 1.1 %.  
(9) Finally , the SCCS concluded that those results were drawn from  cosmetic products  
based on only one type  of titanium dioxide material (pigmentary, anatase, surface-
treated) and that , in the absence of more information , it could not be established 
whether those conclusions would be also applicable to other cosmetic applications 
containi ng other types of titanium dioxide not explicitly covered by th at opinion.  
                                                 
3 Commission Delegated Regulation (EU) 2020/217 of 4 October 2019 amending, for the purposes of its 
adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European 
Parliament and of t he Council on classification, labelling and packaging of substances and mixtures and 
correcting that Regulation (OJ L 44, 18.2.2020, p. 1).  
4 Corrigendum to Commission Delegated Regulation (EU) 2020/217 of 4 October 2019 amending, for 
the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the 
European Parliament and of the Council on classification, labelling and packaging of substances and 
mixtures and correcting that Regulation (OJ L 51, 25.2.2020, p. 13).  
5 Commission Regulation (EU) No  231/2012 of 9  March 2012 laying down specifications for food 
additives listed in Annexes II and III to Regulation (EC) No  1333/2008 of the European Parliament and 
of the Council  (OJ L 83, 22.3.2012, p. 1).  
6 SCCS (Scientific Committee on Consumer Safety), Opinion on Titanium dioxide (TiO 2), preliminary 
version of 7 August 2020, final version of 6 October 2020, SCCS/1617/20.   
EN 3  EN (10) In the light of th e SCCS conclusions, t itanium dioxide in powder form containing 1 % 
or more of particles with aerodynamic diameter ≤ 10 μm  should not be authorised for 
use in appli cations that may give rise to inhalation exposure by the end user and 
should, therefore, be added to the list of restricted substances in Annex III to 
Regulation (EC)  No 1223/2009 and its use should be allowed only in   face products in 
powder form and in hair product s in aerosol dispenser (spray) as indicated in those  
conclusions . In addition to the inclusion of titanium dioxide in Annex III to Regulation 
(EC) No 1223/2009, i t should be provided that the use of titanium dioxid e as colorant 
in accordance wi th entry 143 of Annex IV  to that Regulation, as well as the use of 
titanium d ioxide as UV  filter in accordance with  entry 27 of Annex VI to that 
Regulation should be allowed without prejudice to its restrict ed use under  Annex III to 
that Regulation. As reg ards the use of t itanium dioxide (nano) as UV f ilter in 
accordance with  entry 27a of Annex VI to Regulation (EC) No 1223/2009, no 
additional measures are required, as entry 27a already provides that titanium dioxide 
(nano) is not to be used in applications  that may lead to exposure of the end- user's 
lungs by inhalation.  
(11) With regard to substances other than titanium d ioxide, which were classified as CMR 
substances pursuant to Regulation (EC) No 1272/2008 by Delegated Regulation (EU) 
2020/217, no request for use in cosmetic products by way of exception has been 
submitted. This concerns cobalt, metaldehyde  (ISO), methylmercuric chloride, 
benzo[rst]pentaphene, dibenzo[b,def]chrysene; dibenzo[a,h]pyrene, ethanol, 2,2’ -
iminobis -,N-(C13 -15-branched and linear alkyl ) derivs, cyflumetofen (ISO), 
diisohexyl phthalate, halosulfuron- methyl (ISO), 2 -methylimidazole, metaflumizone 
(ISO), dibutylbis(pentane -2,4-dionato- O,O’)tin , nickel bis(sulfamidate) and ethylene 
oxide . Those substances are currently neither subject to th e restrictions laid down in 
Annex III n or authorised in accordance with Annexes IV, V or VI to Regulation (EC) 
No 1223/2009. Two of those substances , namely nickel bis(sulfamidate) and ethylene 
oxide , are currently listed in Annex II to that Regulation. The substances that are not 
yet 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. 
(12) Commission Regulation (EU) 2019/19667, that was adopted to uniformly implement 
the prohibition of substances classified as CMR, pursuant to Regulation (EC) No 
1272/2008, by Commission Regulation (EU) 2018/14808, introduced changes to entry 
98 of Annex III to Regulation (EC) No 1223/2009 with regard  to the substance 
benzoic acid , 2-hydroxy-  (INCI name : salicylic acid ). In order to fully align those  
changes with the conclusion of the original SCCS opinion9, it is appropriate to 
authorise th e use of that  substance , for purposes other than preservative  function,  in 
body lotion, eye shadow, mascara, eyeliner, lipstick and roll -on deodorant  in a 
concentration of up to 0,5 % . Entry 98 of Annex III to Regulation (EC) No 1223/2009 
should therefore be amended accordingly.  
                                                 
7 Commission Regulation (EU) 2019/1966 of 27 November 2019 amending and correcting Annexes II, 
III and V  to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic 
products (OJ L 307, 28.11.2019, p. 15).  
8 Commission Regulation (EU) 2018/1480 of 4 October 2018 amending, for the purposes of its 
adaptation to technical and scient ific progress, Regulation (EC) No 1272/2008 of the European 
Parliament and of the Council on classification, labelling and packaging of substances and mixtures and 
correcting Commission Regulation (EU) 2017/776 (OJ L 251, 5.10.2018).  
9 SCCS (Scientific Com mittee on Consumer Safety), Opinion on salicylic acid, Corrigendum of 20 -21 
June 2019, SCCS/1601/18 .  
EN 4  EN (13) Additionally, t he substance nickel bis(tetrafluoroborate) ( CAS number: 14708- 14-6) 
has been introduced twice by error in Annex II to Regulation (EC) No 1223/2009 
(entries 1401 and 1427) by Commission Regulation (EU) 2019/83110, that was 
adopted to uniformly implement the prohibition of substances classified as CMR, 
pursuant to  Regulation (EC) No 1272/2008, by Commission Regulation (EU) 
2017/77611. The second of those e ntries is therefore redundant and should be removed.  
(14) Regulation (EC) No 1223/2009 should therefore be amended and corrected 
accordingly.  
(15) The amendments to Regulation (EC) No 1223/2009 provided for in this Regulation 
that are based on the classifications of the relevant substances as CMR substances by 
Delegated  Regulation (EU) 2020/217  should apply from the sa me date as that 
Delegated Regulation . 
(16) 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 , III, IV and VI  to Regulation (EC) No 1223/2009 are amended in accordance with 
the Annex to this Regulation.  
Article 2  
In Annex II to Regulation (EC) No 1223/2009, the entry 1427, corresponding to the substance 
nickel bis(tetrafluoroborate) (CAS number: 14708 -14-6), is deleted . 
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  1 October 2021 with respect to points (1), (2) (b), (3)  and (4) of the 
Annex. 
This Regul ation 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  
                                                 
10 Commission Regulation (EU) 2019/831 of 22 May 2019 amending Annexes II, III and V to Regulation 
(EC) No 1223/2009 of the European Parliament and of the C ouncil on cosmetic products (OJ L 137, 
23.5.2019, p. 29).  
11 Commission Regulation (EU) 2017/776 of 4 May 2017 amending, for the purposes of its adaptation to 
technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the 
Council on classification , labelling and packaging of substances and mixtures (OJ L 116, 5.5.2017, p. 
1).