EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2017) 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 on cosmetic products   EN 2   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 on cosmetic products  
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 
provides for a harmonised clas sification 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 classified as CMR 
substances of category 1A, CMR subs tances 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 Artic le 
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 opera tors and national 
competent authorities, and to ensure consistency throughout the different industrial 
sectors, such as the sectors for biocides and plant protection products , where  the 
Commission systematically adopts specific measures to explicitly prohi bit the use of 
those substances , 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 authorised substances in Annexes III and V 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 and V to t hat 
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 3   EN (4) This Regulation covers the substances which have been classified as CMR substances 
pursuant to Regulation (EC) No 1272/2008 as at 1 January 2017 , when Commission 
Regulation (EU) No 2015/12213 became applicable . 
(5) Concerning certain CMR substances for which a request for use in cosmetic products  
by way of exception has been submitted, it has not been established that all the 
conditions provided for in the second sentence of Article 15(1) or the second 
subparagraph of Article 15(2) of Regulation (EC) No 1223/2009 are fulfilled. This 
concerns Quaternium -15, Chloracetamide , Dichloromethane, Formaldehyde , Perboric 
acid and Sodium  perborates . 
(6) The substance Methenamine 3 -chloroallylochloride, with the International 
Nomenclature of Cosmetic Ingredients (INCI) name Quaternium -15, is currently listed 
in entry 31 of Annex V to Regulation (EC) No 1223/2009 as allowed in a 
concentration of up to 0,2 % in a ready for  use preparation. Quaternium -15 is a 
mixture of isomers of which the cis -isomer has been classified as a CMR substance of 
category 2 by Commission Regulation (EC)  No 790/20094. The classification became 
applicable on 1 December 2010. In accordance with the  second sentence of Article 
15(1) of Regulation (EC) No 1223/2009, a substance classified in 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 cosmetic products.  
On 13 and 14 December 2011, the SCCS issued a scientific opinion on Quaternium -15 
(cis-isomer)5, which concluded that on the basis of the available data the safety of 
Quaternium -15 for use in cosmetic products cannot be established . In l ight of the 
classification of the cis -isomer present in Quaternium -15 as a CMR substance of 
category 2 and the opinion of the SCCS, Quaternium -15 should be deleted from the 
list of preservatives allowed in cosmetic products in Annex  V to Regulation (EC) No  
1223/2009 and added to the list of substances prohibited in cosmetic products in  
Annex II to that Regulation.  
(7) The substance 2 -Chloracetamide, with the INCI name Chloracetamide, is currently 
listed in entry 41 of Annex V to Regulation (EC) No  1223/2009 as allowed in a 
concentration of up to 0,3 % in ready for use preparation. Chloracetamide has been 
classified as a CMR substance of category 2 under Regulation (EC) No 1272/ 2008 . 
The classification became applicable before 1 December 2010 , at which date Titles II, 
III and IV of Regulation (EC) No 1272/2008 became applicable in respect of 
substances . In accordance with the second sentence of Article 15(1) of  Regulation 
(EC) No 1223/2009 , a substance classified in category  2 may be used in cosmetic 
products  where the substance has been evaluated by the SCCS and found safe for use 
in such products. On 22 March 2011, the SCCS issued a scientific opinion on 
Chloroacetamide6 which concluded that, on the basis of the available data, the 
substance is not safe for consumers when used in a concentration of up to  0,3 % w/w 
                                                 
3 Commission Regulation (EU) 2015/1221 of 24 July 2015 amending Regulation (EC) No 1272/2008 of 
the European Parliament and of the Council on classification, labelling and packaging of substances and 
mixtures, for  the purposes of its adaptation to technical and scientific progress  (OJ L 197, 25.7.2015, p. 
10). 
4 Commission Regulation (EC) No 790/2009 of 10 August 2009 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 235, 5.9.2009, p. 1 ). 
5 SCCS/1344/10, http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_077.pdf .  
6 SCCS/1360/10, http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_053.pdf . EN 4   EN in cosmetic products. In light of the classification as a CMR substance of category 2 
and the opinion of the SCCS, Chloroacetamide should be deleted from the list of 
preservatives allowed in cosmeti c products in Annex V to Regulation (EC) No 
1223/2009 and added to the list of substances prohibited in cosmetic products in 
Annex II to that Regulation.  
(8) The substance Dichloromethane is currently listed in entry 7 of Annex III to 
Regulation (EC) No  1223/2 009 as allowed in cosmetic products in a concentration of 
up to 35 % in  ready for use preparation s. Dichloromethane has been classified as a 
CMR substance of category 2 under Regulation (EC) No 1272/2008. The classification 
became applicable before 1 December  2010 . In accordance with the second sentence 
of Article 15(1) of that Regulation, a substance classified in category  2 may be used in 
cosmetic products where the substance has been evaluated by the SCCS and found 
safe for use in such products. On 11 December 2012, t he SCCS issued a scientific 
opinion  on Dichloromethane7.  On 25 March  2015 , the SCCS issued a new opinion8 
which was revised on 28 October 2015.  In that revised opinion the SCCS concluded 
that the use of Dichloro methane in a concentration of up to 35  % in hair sp rays and its 
use in spray formulations  in general is not considered safe for the consumer. In light of 
the classification as a CMR substance of category 2 and the opinion of the SCCS, and 
since no other uses of Dichlor omethane in cosmetic products are known and have been 
covered by the SCCS opinion, the substance should be deleted from the list of 
restricted substances in Annex III to Regulation (EC) No 1223/2009 and added to the 
list of substances prohibited in cosmeti c products in Annex II to that Regulation.  
(9) The substance Formaldehyde  is currently listed in entry 13 of Annex III to Regulation 
(EC) No 1223/2009 as allowed in nail hardening products in a concentration of up to 5 
% in ready for use preparation s. It is a lso currently  listed  in entry 5 of Annex V to 
Regulation (EC) No 1223/2009 as allowed in oral products in a concentration of up to 
0,1 % and in other products in a concentration of up to 0,2  %. This substance has been 
classified as a CMR substance of categ ory 1B by Commission Regulation (EU) No 
605/20149. The classification became applicable on 1 January 2016. In accordance 
with the 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, subsequent to their classification as 
CMR substances, certain conditions are fulfilled, including the condition s that no 
suitable alternative substances are available  and that an application  is made for a 
particular use of the product category . Since Formaldehyde has been classified as  a 
CMR substance of category 1B and since it has not been established that there are no 
suitable alternative substances available for the purpose of hardening nails, 
Formaldehyde should be deleted from the list of restricted substances in Annex III to 
Regulation (EC) No 1223/2009 . Since no application was made for other uses of 
Formaldehyde, the substance should be deleted  from the list of preservatives allowed 
in cosmetic products in Annex V to that Regulation. Formaldehyde  should also be 
added to the list of substances prohibited in cosmetic products in Annex II to 
Regulation (EC) No 1223/2009.  
                                                 
7  SCCS/1408/11, https ://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_118.pdf  
8  SCCS/1547/15, https://ec.europa.eu/health/scientific_committees/consume r_safety/docs/sccs_o_170.pdf   
9 Commission Regulation (EU) No 605/2014 of 5 June 2014 amending, for the purposes of introducing 
hazard and precautionary statements in the Croatian language and 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 167, 6.6.2014, p. 3 6). EN 5   EN (10) Perboric acid and Sodium perborate compounds are covered by the hydr ogen peroxide 
releasing substances currently listed in entry 12 of Annex III to Regulation  (EC) No 
1223/2009 . They have been classified as CMR substances of category 1B by 
Commission Regulation (EC) No  790/2009. The classification became applicable on  1 
December 2010 . A request  for the application of the second subparagraph  of Article 
15(2) of Regulation (EC) No 1223/2009  was submitted for the use of those substances 
in oxidative hair dye formulations up to a maximum on head concentration of 3 %. 
Since Pe rboric acid and Sodium perborate s have been classified as CMR substances of 
category 1B and since it has not been established that there are no suitable alternative 
substances to Perboric acid and S odium perborates available for the purpose of 
oxidati on of  hairs , Perboric acid and S odium perborate s should be deleted from the list 
of restricted substances in Annex III to Regulation (EC) No 1223/2009 and added to 
the list of substances prohibited in cosmetic products in Annex II to that Regulation.  
(11) Concerning  certain substances which were classified as CMR substances under 
Regulation (EC) No 1272/2008  and for which a request for the application of the 
second sentence of Article 15(1) of Regulation (EC) No 1223/2009 has been  
submitted , it has been established that the condition provided for in that provision is 
fulfilled. This concerns Trimethylbenzoyl diphenylphosphine oxide , Furfural and 
Polyaminopropyl biguanide.  
(12) The substance Diphenyl(2,4,6 -trimethylbenzoyl)phosphine oxide, with th e INCI name 
Trimethylbenzoyl diphenylphosphine oxide (TPO ), is currently not included in the 
Annexes to Regulation (EC) No  1223/2009.  TPO has been classified as a CMR 
substance of category 2 by Commission Regulation (EU) No 618/201210. The 
classification be came applicable on 1 December 2013.  On 27 March 2014, the SCCS 
issued a scientific opinion11 which concluded that TPO is safe when used as a nail 
modelling product in a concentration of up to 5 ,0 % but that it is however  a moderate 
skin sensitizer.  Consider ing the skin sensitising properties of TPO and the high risk of 
exposure through skin contact in case of self -application of nail products, the use of 
TPO should be restricted to professionals only.  In light of th ose elements , TPO should 
be added to the li st of restricted substances in  Annex III to Regulation (EC) No 
1223/2009  for professional use in artificial nail systems with a maximum 
concentration of 5 % . 
(13) The substance 2-Furaldehyde , with the INCI name Furfural , is used as a fragrance or 
flavour ingredient in cosmetic products and is currently not  included in the Annexes to 
Regulation (EC) No  1223/2009 . It has been classified as a CMR substance of category 
2 under Regulation (EC) No 1272/2008.  The classification became appl icable before 1 
December 2010. On 27 March 2012 , the SCCS concluded in its opinion12 that the use 
of Furfural in a concentration of up to 10 ppm (0,001 %) in  ready for use preparations , 
including oral products, does not pose risk to the health of  the consumer. In light of the 
classification of Furfural  as a CMR substance of category 2 and the opinion of the 
SCCS , Furfural should be added to the list of restricted substances in Annex III to 
Regulation (EC) No 1223/2009 with a maximum concentration  of 0,001  %.  
                                                 
10 Commission Regulation (EU) No 61 8/2012 of 10 July 2012 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 179, 11.7.2012, p. 3 ). 
11 SCCS/1528/14, http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_149.pdf . 
12 SCCS/1461/12 ,https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_083.pdf  EN 6   EN (14) The substance Polyhexamethylene biguanide hydrochloride (PHMB), with the INCI 
name Polyaminopropyl Biguanide, is currently listed as a preservative in entry 28 of 
Annex V to Regulation (EC) No 1223/2009 with a m aximum concentration  of 0,3 % . 
It has been classified as a CMR substance of category 2 by Commission Regulation 
(EU) No 944/201313. The classification became applicable on 1 January 2015. On 18 
June 2014, the SCCS adopted an opinion14 which concluded that on the basis of the 
data available, PHMB is not safe for consumers when used as a preservative in all 
cosmetic products at the maximum concentration of 0,3 %. However, the SCCS 
opinion also concluded that the safe use could be based o n a lower use concentration 
and/or restrictions with regard to cosmetic products' categories and that dermal 
absorption studies on additional representative cosmetic formulations are needed. On 7 
April 2017, the SCCS adopted a new opinion15 which concluded that, based on the 
data provided, the use of PHMB as a preservative in all cosmetic products up to 0,1 % 
is safe but that its use in sprayable formulations is not advised. In light of the 
classification of PHMB as a CMR substance of category 2 and  of the new SCCS 
opinion , PHMB should be authorised as a preservative in all cosmetic products, except 
in sprayable formulations, with a maximum concentration  of 0,1 %. The conditions set 
out in Annex V should be adapted accordingly.  
(15) Concerning a large group of sub stances which were classified as CMR substances 
under Regulation (EC) No 1272/2008 , no request for use in cosmetic products  has 
been submitted. Those 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 authorised substances in Annexes III and V to that 
Regulation. This concerns inter alia certain boron compounds currently listed in 
entries 1a and 1b of Annex III to Regulation (EC) No 1223/ 2009 . 
(16) Article 31(1) of Regulation (EC) No 1223/2009 provides that where there is a 
potential risk to human health, arising from the use of substances in cosmetic products, 
which needs to be addressed on a Community -wide basis, the Commission may, after 
consulting the SCCS, amend Annexes II to VI to that Regulation accordingly. The 
Commission has consulted the SCCS on the safety of certain substances which are 
similar from a chemical perspective to substances classified as CMR substances of 
categories 1A , 1B or 2. This concerns certain boron compounds as well as 
Paraformaldehyde and Methylene Glycol.  
(17) Some of the boron compounds currently listed in entries 1a and 1b of Annex III to 
Regulation (EC) No 1223/2009 have not been  classified as CMR substances. On 12 
December 2013, the SCCS issued an opinion  on borates, tetraborates and 
octaborates16, where it concluded that th ose substances , as well as other boric acid 
salts or esters, break into boric acid  and that therefore the general restrictions 
applicable to b oric acid should apply to the whole group of borates , tetraborates and 
octaborates . Boric acid has been classified as a CMR substance of category 1B . In 
                                                 
13  Commission Regulation (EU) No 944/2013 of 2 October 2013 amending, for the purposes of its 
adaptation to technical and scientifi c 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 261, 3.10.2013, p. 5).  
14  SCCS/1535/14 ,https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_157.pdf  
15  SCCS/1581/16 ,  
https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_204.pd
f 
16 SCCS/1523/13, https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_146.pdf  EN 7   EN light of the opinion of the SCCS, there is a potential risk to human health arising from 
the use of bor ates, tetraborates and octaborates in cosmetic products. Those substances 
should  therefore be deleted from the list of restricted substances in Annex III to 
Regulation (EC) No 1223/2009 and added to the list of substances prohibited in 
cosmetic products in Annex II to that Regulation. For the remaining substances 
covered by entries 1a and 1b in Annex III to Regulation (EC) No 1223/2009, the 
reference for the calculation of the maximum allowed concentrations in ready for use 
preparations, should not refer to  Boric acid, which is prohibited, but to Boron and the 
percentages should be adapted accordingly.  
(18) The substance Paraformaldehyde is currently listed in entry 5 of Annex V to 
Regulation (EC) No 1223/2009 but, contrary to Formaldehyde, it has not been 
classi fied as a CMR substance. The substance Methylene Glycol is currently not 
included in the Annexes to Regulation (EC) No 1223/2009. On 26 –27 June 2012, the 
SCCS adopted an opinion on Methylene Glycol17 which established that Methylene 
Glycol is continuously c onverted in Formaldehyde in aqueous solution and that 
Paraformaldehyde can easily be shifted to Formaldehyde by heating or drying . In light 
of the opinion of the SCCS , there is a potential risk to human health arising from the 
use of those substances in cosmetic products. Paraformaldehyde should therefore be 
deleted from the list of preservatives allowed in cosmetic products in Annex V to 
Regulation (EC) No 1223/2009 an d Paraformaldehyde and Methylene Glycol should 
be added to the list of substances prohibited in cosmetic products in Annex II to that 
Regulation . 
(19) Regulation (EC) No 1223/2009 should therefore be amended accordingly.  
(20) The measures provided for in this Regula tion are in accordance with the opinion of 
the Standing Committee  on Cosmetic Products , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Annexes 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 . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 […] 
                                                 
17  SCCS/1483/12, https://ec.europa .eu/health/scientific_committees/consumer_safety/docs/sccs_o_097.pdf