EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2019) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
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  
(Text with EEA relevance)   EN 1  EN COMMISSION REGULATION (EU) …/…  
of XXX  
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  
(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 Nove mber 2009 on cosmetic products1, 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 Council2 
provides for a harmonised classification of substanc es 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 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, 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 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) All substances which were classified as CMR substances pursuant to Regulation (EC) 
No 1272/2008 as at 1 December 2018, when Commission Regulation (EU) No 
2017/776 became applicable, were intended to be covered by Commission Regulation 
(EU) 2019/8313. This Regulation covers the substances classified  as CMR substances 
by Commission Regulation ( EU) No 2018 /14804, which will apply from 1 May 2020 . 
(5) With regard to the substance 2 -hydroxy -benzoic acid, with the International 
Nomenclature of Cosmetic Ingredients (INCI) name Salicylic acid, which has been 
classified as a CMR substance of category 2, a request for the application of the 
second sentence of Article 15(1) of R egulation (EC) No 1223/2009 has been submitted 
and it has been established that the condition provided for in that provision is fulfilled.  
(6) Salicylic acid and its salts  are currently listed in entry 3 of Annex V to Regulation 
(EC) No 1223/2009 as preservati ves  allowed in cosmetic products in a concentration 
of up to 0,5 % (acid).  
(7) Salicylic  acid is also listed in entry 98 of Annex III to that Regulation as a restricted 
substance only allowed, when used for purposes other than preservat ive, in rinse -off 
hair products in  a concentration of up to 3,0 % and in other products in a concentration 
of  up to 2,0 %.  
(8) In accordance with the second sentence of Article 15(1) of Regulation (EC) No 
1223/2009, a substance classified as a CMR substance of category  2 may be u sed 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.   
(9) On 21 December 2018 , the SCCS issued a scientific  opinion  on Salicylic acid5 (“the 
SCCS opinion” ) which concluded that , on the basis of the available  data, the substance 
is safe for consumers when used as a preservative in cosmetic products  in a 
concentration of up to 0,5 % (acid)  considering its current restrictions in place . The 
SCCS opinion is  not applicable to any oral  products with the exception of lipsticks , 
nor to sprayable products that could lead to exposure of the consumer's lung s by 
inhalation.    
(10) The SCCS also concluded that Salicylic acid is safe when used for purposes other than 
prese rvative in a concentration of up to 3,0 % for rinse -off hair products and up to 2,0 
% for other products , considering its current restrictions in place , except for body 
lotion, eye shadow, mascara, eyeliner, lipstick and roll on deodorant applications.  The 
SCCS opinion is not applicable to any oral products, nor to sprayable products that 
could lead to exposure of the consumer’s lungs by inhalation.   
(11) Finally, t he SCCS concluded that Salicylic acid is an eye irritant with the potential to 
cause serious dama ge to the eye s and pointed out that specific tests are currently on -
going to assess whether salicylic acid has endocrine disrupting properties and that 
depending the outcome of these tests, the potential endocrine disrupting properties of 
salicylic acid in  cosmetics may need to be considered.   
                                                 
3 Commission Regulation (EU) 2019/831 of 22 May 2019  amending Annexes II, III and V to Regulation 
(EC) N o 1223/2009 of the European Parliament and of the Council  on cosmetic products  (OJ L 137, 
23.5.2019, p. 29 ). 
4 Commission Regulation (EU) 201 8/1480 of 4 October 2018 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 pack aging of substances and mixtures  and correcting 
Commission Regulation (EU) 2017/776, (OJ) L 251, 5.10.2018, p.1).  
5 SCCS/ 1601 /18, 
http://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_223.pdf  EN 3  EN (12) In light of the classification of Salicylic acid as a CMR substance of category 2  and as 
an eye irritant which may cause serious eye damage and of the SCCS opinion, the 
substance should be authorised as a preservative  in cosmetic products  in a 
concentration of up to 0,5 % (acid),  considering its current restrictions , except for oral 
products other than lipsticks  and for applications that ma y lead to exposure of the end -
user's lungs by inhalation. It should also be authorised , with regard to non preservative 
use, in rinse -off hair products in a concentration of  up to  3,0 % and in other products 
except for body lotion, eye shadow, mascara, eyeliner, lipstick and roll on deodorant 
applications , in a concentration of up to 2,0 %. It should not, in any case, be authorised 
in applications that may lead to exposure of the end user’s lungs by inhalation. 
Considering the conclusion of the SCCS that Salicylic acid is an eye irritant, the 
current restriction and condition stating t hat the substance is not to be used in products 
for children under 3 years of age, except for shampoos, should be modified so that 
they cover all products for children under 3 years of age.  The restrictions set out in 
Annex III to Regulation (EC) No 1223/2 009 and the conditions set out in Annex V to 
that Regulation should be adapted accordingly.  
(13) With regard to all other substances than Salicylic acid which were classified as CMR  
substances pursuant to Regulation (EC) No 1272/2008 by Commission Regulation 
(EU) No 2018/1480 , no request for use in cosmetic products by way of exception has 
been submitted. None of th ose substances are currently restricted or authorised in 
Annex es III or V to Regulation (EC) No 1223/2009.  Three 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 . 
(14) The substance cis-1-(3-chlorallyl) -3,5,7 -triaza -1-azoniaadamantane chloride  (cis-
CTAC) , with the I NCI name Quaternium -15, has been classified as a CMR substance 
of category 2 by Regulation (EC) No 790/2009 of 10 August 2009  and has been added 
to the list of prohibited substances in Annex II to Regulation (EC ) No 1223/2009 by 
Regulation (EU ) No 2019 /831. The substance was, however, erroneously listed twice 
in that Annex, namely in entry 1385 and entry 1386.  Therefore entry 1 386 of Annex 
II to Regulation (EC) No 1223/2009 should be  deleted .  
(15) The substance 8-hydroxyquinoline ; quinolin -8-ol, with the INCI name Oxyquinoline, 
has been classified as a CMR substance of category 1B by Regulation (EU) 2017/776 
while its sulphate form,  the substance Bis(8-hydroxyquinoli nium) sulphate, with the 
INCI name Oxyquinoline  sulphate , has not been classified as a CMR substance. Both 
substances  were listed in entry 395 of Annex II to Regulation (EC) 1223/2009  at the 
time when the classification of  Oxyquinoline as a CMR substance started to apply and 
were prohibited for use in cosmetic products except under the conditions laid down in 
entry 51  of  Annex III to that Regulation. Having being classified as a CMR 
substance, Oxyquinoline should have been removed from entry 51 of Annex III to 
Regulation (EC) No 1223/2009 . By Regulation (EU ) 2019 /831 Oxyquinoline was 
however erroneously deleted in its entirety, including the reference to that entry in 
entry 395 of Annex II to Regulation 1223/2009.  In or der to correctly reflect the 
prohibition of Oxyquinoline in cosmetic products on the basis of its classification as a 
CMR substance, entry 51 should be re -introduced for that substance in Annex III to 
Regulation (EC) No 1223/2009  and entry 395 in Annex II to that Regulation should be 
adapted accordingly.  
(16) The substance 4-methyl -o-phenylenediamine ; 3,4-Diaminotoluene, with the I NCI 
name  Diaminotoluene , has been classified as a CMR substance of category 1B under EN 4  EN Regulation (EC) No 1272/2008  and  has been added  to the list of prohibited substances 
in Annex II to Regulation (EC) No 1223/2009  by Regulation (E U) 2019 /831. 
Diaminotoluene is also part of the large group of su bstances listed  as restricted 
substances  in entry 9 of Annex III  to Regulation (EC) No 1223/2 009 and should 
consequently , since no request for use in cosmetic products by way of exception has 
been submitted, have also been deleted from that Annex. In order to avoid ambiguity 
and to correctly reflect the prohibition of Diaminotoluene in cosmetic pr oducts on the 
basis of its classification as a CMR substance, it should be  removed from entry 9 of 
Annex III to Regulation  (EC) No 1223/2009 . 
(17) Moreover, 19 substances or group s of substances classified as CMR substances by 
Regulation (EU) No 2016 /1179 , which became applicable on 1 March 2018 , have by 
error not been included in Regulation (EU) 2019 /831, despite the fact that n o request 
for use in cosmetic products has been submitted for those substances or group s of 
substances . Those 19 substances and g roups of substances should therefore be added 
to the list of substances prohibited in cosmetic products in Annex  II to Regulation 
(EC) No 1223/2009 .  
(18) Regulation (EC) No 1223/2009 should therefore be amended and corrected 
accordingly.  
(19) The amendments to Regu lation (EC) No 1223/2009 are based on the classifications of 
the relevant substances as CMR substances by Regulation (EU) No 2018 /1480 and 
should therefore apply from the same date as those classifications.  
(20) In order to avoid any discontinuity and legal unc ertainty for economic operators, the 
correction of the error introduced by Regulation (EU) 2019 /831 with regard to the 
substance Oxyquinoline should apply retroactively from the date of entry into force of 
that Regulation . 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 and V to Regulation (EC) No 1223/2009 are amended in accordance with 
Annex I to this Regulation.  
Article 2  
Annexes II and III 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 Europe an Union . 
Article 1 shall apply from 1 May 2020.  
Points (1)(a) and (2) (c) of Annex II shall apply from 11 June 2019 . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  EN 5  EN Done at Brussels,  
 For the Commission  
 The P resident   
 Jean -Claude JUNCKER