EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2023) 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 of Vitamin A, Alpha -Arbutin and Arbutin and certain substances 
with potential endocrine disrupting properties in cosmetic products  
(Text with EEA relevan ce)   
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 of Vitamin A, Alpha -Arbutin and Arbutin and certain substances 
with potential endocrine disrupting properties in 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 31(1) thereof,  
Whereas:  
(1) The substances ‘ (2E,4E,6E,8E) -3,7-dimethyl -9-(2,6,6 -trimethylcyclohexen -1-yl)nona -
2,4,6,8 -tetraen -1-ol’ (CAS No.  11103 -57-4/68-26-8), ‘[(2E,4E,6E,8E) -3,7-dimethyl -9-
(2,6,6 -trimethylcyclohexen -1-yl)nona -2,4,6,8 -tetraenyl] acetate ’ (CAS No. 127-47-9), 
and ‘ [(2E,4E,6E,8E) -3,7-dimethyl -9-(2,6,6 -trimethylcyclohexen -1-yl)nona -2,4,6,8 -
tetraenyl]  hexadecanoate ’ (CAS No. 79-81-2), which have been assigned the names 
‘Retinol’, ‘Retinyl Acetate’ and ‘Retinyl Palmitate’ , respectively, under the 
International Nomenclature of Cosmetic Ingredients (INCI) and which are collectively 
known as vitamin A, are not regulated under Regulation (EC) No 1223/2009. Th ose 
substances are u sed in cosmetic products as skin conditionin g agen ts. 
(2) The Scientific Committee for Consumer Safety ( SCCS ) concluded , in its opinion of 6 
October 20162, that the use of vitamin A  is safe but recognised that the population’s 
overall exposure to vitamin A could exceed the upper intake level established by the 
European Food Safety Authority . On 24-25 October 2022 , the SCCS adopted a  revised  
scientific opinion  on vitamin A3 concluding that vitamin A  is safe in cosmetic  
product s up to concentrations of 0 ,05 % Retinol Equivalent (RE) in body lotion and 
0,3 % RE  in other leave -on and rinse -off products. The SCCS added that the 
contribution of vitamin A from cosmetic  product s to the overall consumer exposure, 
although low, may be of concern for consumers with the highest exposure to vitamin 
A (5 % of the total pop ulation) from food and food supplements.  
(3) In light of the SCCS opinion, it can be concluded that there is a potential risk to human 
health arising from the use of vitamin A in cosmetic products when its concentration 
exceeds certain levels. Therefore, the use of Retinol, Retinyl Acetate  and Retinyl 
Palmitate  should be restricted to  a maximum concentration of 0,05 % RE in body 
                                                 
1 OJ L 342, 22.12.2009, p. 59.  
2 SCCS (Scientific Committee on Consumer Safety), Opinion on Vitamin A (Retinol, Retinyl Acetate, 
Retinyl Palmitate), SCCS/1576/16, 20 April 2016, final version of 6 October 2016, CORRIGENDUM 
on 23 December 2016 , SCCS/1576/16 . 
3 SCCS (Scientific Committee on Consumer Safety), revision of the scientific Opinion (SCCS /1576/16) 
on vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate), preliminary version of 10 December 2021, 
final version of 24 -25 October 2022, SCCS/1639/21SCCS/1639/21 .  
EN 2  EN lotion and 0 ,3 % RE in other leave -on and rinse -off products . In addition,  a warning 
should be included to inform consumers alrea dy exposed to vitamin A from food and 
food supplements  of the possibility of overexposure from the use of such compounds .  
(4) The substances  ‘4-Hydroxyphenyl -alpha -D-glucopyranoside ’ (CAS No. 84380 -01-8) 
and ‘ 4-Hydroxyphenyl -beta-D-glucopyranoside ’ (CAS No. 497-76-7), which have 
been assigned the INCI names ‘Alpha -Arbutin’ and ‘Arbutin’ , respectively, are not 
regulated under Regulation (EC) No 1223/2009. Those substances are u sed in 
cosmetic products as  skin bleaching and skin conditioning  agents . 
(5) The SCCS concluded in its opinion of  27 May 20 15 on Alpha -Arbutin4 and in its 
opinion of 26 March 20 15 on Arbutin5 that both substances , when used in limited 
concentrations , were safe for consumers in cosmetic products.  However, it stressed 
that the potential combined use of those substances  and other hydroquinone releasing 
substances  in cosmetic products was not evaluated,  and that it could be of concern.  On 
31 January  2023, the SCCS adopted a n opinion  on the safety of Alpha-Arbutin  and 
Arbutin  in cosmetic products6 confirming its previous conclusion  that Alpha-Arbutin 
used in face creams up to a maximum concentration of 2 % and in body lotions up to a 
concentration of 0,5 % is safe and that Arbutin used in face creams up to a maximum 
concentration of 7 % is  safe. The SCCS also concluded that the a ggregate exposure of 
Alpha-Arbutin with Arbutin  are considered safe  for consumers. The SCCS also 
stressed that the presence of Hydroquinone  (CAS No. 123 -31-9) should remain as low 
as possible in formulations contain ing Alpha-Arbutin  and Arbutin and should not be 
higher than the unavoidable trace  level s.  
(6) In light of the SCCS opinion, it can be concluded that there is a potential risk to human 
health arising from the use of Alpha-Arbutin and Arbutin in cosmetic products when 
the concentration of th ose substance s exceeds certain levels. Therefore,  the use of 
Alpha-Arbutin should be restricted to a maximum concentration of 2  % in face creams 
and to a maximum concentration of 0 ,5 % in body lotions , while t he use of Arbutin 
should be restricted to a maximum concentration of 7 % in face creams . The level of 
Hydroquinone  in cosmetic products containing Alpha-Arbutin or Arbutin should not 
be higher than the unavoidable trace  level . 
(7) The substance ‘ 3-(4'-methylbenzylidene) -camphor ’ (CAS No. 36861 -47-9/38102 -62-
4), which has been assigned the INCI name ‘ 4-Methylbenzylidene Camphor ’, is listed 
under entry 18 of Annex VI to Regulation (EC) No 1223/2009 and is therefore 
allowed for use as a UV -filter in cosmetic products with a maximum concentration of 
4 % in ready for use preparation s. 4-Methylbenzylidene Camphor has additional 
reported functions  as a ‘UV-absorber’ and a ‘light stabiliser’ , which are allowed 
pursuant to Article 14 (1), point (e)(ii),  of Regulation (EC) No 1223/2009  up to a 
concentration of 4 % .  
(8) The substance s ‘Genisteol 4',5,7 -Trihydroxyisoflavone ’ (CAS No. 446-72-0), 
‘Daidzeol 7,4' - Dihydroxyisoflavone ’ (CAS No. 486-66-8) and ‘ 5-Hydroxy -2-
(hydroxymethyl) -4H-pyrane -4-one’ (CAS No. 501-30-4), which ha ve been assigned 
the INCI name s ‘Genistein’ , ‘Daidzein’  and ‘ Kojic Acid ’, respectively , are not 
                                                 
4 SCCS (Scientific Committee on Consumer Safety), Opinion on α -arbutin, 27 May 201 5, 
SCCS/1552/15 . 
5 Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on β -arbutin, 
SCCS/1550/15, 25 March 2015 . 
6 SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of alpha - (CAS No. 84380 -
018, EC No. 617-561-8) and beta -arbutin (CAS No. 497 -76-7, EC No. 207 -8503) in cosmetic products, 
preliminary version of 15 -16 March 2022, final version of 31 January 2023, SCCS/1642/22 .     
EN 3  EN regulated under Regulation (EC) No 1223/2009. Genistein  and Daidzein  are used in 
cosmetic products as skin conditioning  agents, protecting agents and antioxidant s, 
whereas Kojic Acid  is used in cosmetic products as a skin lightening  agent, a 
whitening agent,  or a depigmenting agent . 
(9) The substance  ‘5-Chloro -2-(2,4-dichlorophenoxy)phenol ’ (CAS No. 3380 -34-5), 
which has been assigned the INCI name  ‘Triclosan ’, is currently  listed under entry 25 
of Annex V to Regulation (EC) No 1223/2009 and is therefore allowed for use as a 
preservative in cosmetic products with a maximum concentration of 0,3 % in 
toothpastes, hand soaps, body soaps/shower gels, deodorants (non -spray ), face 
powders and blemish concealer s, and in  nail products for cleaning the fingernails and 
toenails before the application of artificial nail systems , and with a maximum 
concentration of 0,2 % in mouthwashes . 
(10) The substance ‘ 1-(4-Chlorophenyl) -3-(3,4-dichlorophenyl)urea ’ (CAS No. 101-20-2), 
which has been assigned the INCI name ‘ Triclocarban’ , is currently listed under entry 
23 of Annex V to Regulation (EC) No 1223/2009 and is therefore allowed for use as a 
preservative in cosmetic pr oducts with a maximum concentration of 0,2 %. In 
addition, Triclocarban is listed under entry 100 of Annex III to that Regulation and is 
therefore allowed for purposes other than inhibiting the development of micro -
organisms in rinse -off products with a ma ximum concentration of 1,5 %. 
(11) In light of concerns related to potential endocrine disrupting properties of ‘4-
Methylbenzylidene Camphor ’, ‘Genistein’, ‘Daidzein’, ‘ Kojic Acid ’, ‘Triclosan’ and 
‘Triclocarban’ , the Commission launched a public call for data in 2019. The i ndustry 
submitted scientific evidence to demonstrate the safety of those substances when used  
in cosmetic products . The Commission requested the SCCS to carry out a safety 
assessment of those substances in view of the information provided  by the industry . 
(12) In its opinion of 29 April 20227, the SCCS could not conclude on the safety of 4-
Methylbenzylidene Camphor  because the information provided was insufficient to 
fully evaluate potential genotoxi city. The SCCS observe d, however,  that there is 
sufficient evidence that 4-Methylbenzylidene Camphor  may act as an endocrine 
disruptor and has effects on both the thyroid and estrogen systems  and that it is not 
possible to derive a maximum concentration for safe use of the substance. In light of 
the SCCS opinion, it can be concluded that there is a potential risk to human health 
arising from the use of 4-Methylbenzylidene Camphor  as a UV-filter in cosmetic 
products.  The substance should , therefore , no longer be allowed as a UV -filter in 
cosmetic products . In addition, there is no scientific basis that the conclusions of the 
SCCS on the safety of 4-Methylbenzylidene Camphor would not apply when th at 
substance i s used in cosmetic products with the additional reported functions as ‘UV-
absorber’ and ‘light stabiliser’  agent. To ensure that 4 -Methylbenzylidene Camphor 
does not continue to be used  in cosmetic products for purposes other than as a UV -
filter, which wou ld also present a potential risk to human health as identified in the 
SCCS opinion , the substance should be prohibited for all use in cosmetic products . 
(13) The SCCS concluded in its opinion of 1 6 September8  that both Genistein and 
Daidzein are safe for use in cosmetic products up to a maximum concentration of 
                                                 
7 SCCS (Scientific Committee on Consumer Safety), scientific opinion on 4 -Meth ylbenzylidene camphor 
(4-MBC), preliminary version of 22 December, final version of 29 April 2022, SCCS/1640/21 . 
8 SCCS (Scientific Committee on Consumer Safety), Scientific opinion on genistein and daidzein, 
preliminary version of 12 January 2022, final version of 16 September 2022, corrigendum of 11 
October 2022, SCCS/1641/22 .  
EN 4  EN 0,007  % and 0,02  %, respectively.  Considering  the SCCS opinion, it can be concluded 
that there is a potential risk to human health arising from the use of Genistein and 
Daidzein in cosmetic prod ucts when the concentration of those substances exceeds 
certain levels. Therefore, the use of Genistein and Daidzein in cosmetic products 
should be restricted to a maximum concentration of 0,007  % and 0,02  %, respectively.  
(14) The SCCS concluded in its opinio n of 15-16 March 20229 that Kojic Acid is safe 
when used as a skin lightening agent  in cosmetic products up to a maximum 
concentration of 1 %. Considering the SCCS opinion, it can be concluded that there is 
a potential risk to human health arising from the use of Kojic Acid in cosmetic 
products when its concentration exceeds certain levels. Therefore, Kojic Acid should 
be restricted to use as a skin lightening a gent in face and hand products  with a 
maximum concentration of 1 %.  
(15) The SCCS  concluded in a scientific advice on Triclosan adopted on  24-25 October  
202210 that use of Triclosan as a preservative in dermally applied cosmetic product s is 
safe up to a maximum  concentration of 0 ,3 % for both children (0 ,5-18 years) and 
adults , with the ex ception of body lotion. It also concluded that the use of Triclosan  as 
a preservative in toothpaste at a concentration of 0,3 % is safe for both children (0,5 -
18 years) and adu lts but that the use of the substance as a preservative in toothpaste  is 
not safe for children under 3 years of age when used in combination with other 
cosmetic products containing Triclosan . According to SCCS , the use of Triclosan  as a 
preservative in mou thwash is safe  for adults at a maximum concentration of 0 ,2 % 
when used individually but not when used in combination with other cosmetic 
products containing Triclosan , while f or children and adolescents, it is not safe at 0 ,2 
% in mouthwash , even when use d individually .  
(16) In light of the SCCS scientific advice, it can be concluded that there is a potential risk 
to human health arising from the use of Triclosan in cosmetic products when its 
concentration exceeds certain levels , when there is a combined use of different 
cosmetic products containing that substance and whe n it is used by certain age groups. 
Therefore, the use of Triclosan as a preservative  in cosmetic products should remain 
restricted to a maximum concentration of 0,3 % for toothpastes, han d soaps, body 
soaps/shower gels, deodorants (non -spray), face powders  and blemish concealer s, nail 
products for cleaning the fingernails and toenails before the application of artificial 
nail systems . Triclosan should n either be allowed for use in mouthwas h, nor in 
toothpaste intended for children under 3 years of age. Labelling requirements should 
also be introduced , to further enhance the protection of consumers and facilitate 
market surveillance activities in Member States.  
(17) The SCCS concluded in a scientific advice on Triclocarban adopted  on 24-25 October 
202211 that the use of Triclocarban as a preservative up to a maximum concentration 
of 0,2 % is safe in dermally applied cosmetic products for both children (0 ,5-18 years) 
                                                 
9 SCCS (Scientific Committee on Consumer Safety), scientific opinion on Kojic acid, preliminary 
version of 26 -27 October 2021, final version of 15 -16 March 2022, Corrigendum of 10 June 2022, 
SCCS/1637/2 . 
10 SSCCS (Scientific Committee on Consumer Safety), Request for a scientific advice on the safety of 
triclocarban (CAS No. 101 -20-2, EC No. 202 -924-1) and triclosan (CAS No. 3380 -34-5, EC No. 222 -
182-2) as substances with potential e ndocrine disrupting properties used in cosmetic products, 
preliminary version of 15 -16 March 2022, final version of 24 -25 October 2022, SCCS/1643/22 . 
11 SSCCS (Scientific Committee on Consumer Safety), Request for a scientific advice on the safety of 
triclo carban (CAS No. 101 -20-2, EC No. 202 -924-1) and triclosan (CAS No. 3380 -34-5, EC No. 222 -
182-2) as substances with potential endocrine disrupting properties used in cosmetic products, 
preliminary version of 15 -16 March 2022, final version of 24 -25 October 2022, SCCS/1643/22 .  
EN 5  EN and adults  but is n either  safe in mouthwash  for adults and children , nor in toothpaste 
for children under  6 years of age . The SCCS also concluded that Triclocarban used f or 
purposes other than inhibiting the development of micro -organisms  is safe up to a 
maximum concentration of 1 ,5 % in rinse -off product s for both children (0 ,5-18 years) 
and adults .  
(18) In light of the SCCS scientific advice, it can be concluded that there is a potential risk 
to human health arising from the use of Triclocarban in cosmetic products when its 
concentration exceeds certain levels  in some cosmetic products and when it is used for 
certain age groups. Therefore, the use of Triclocarban as a preservative in cosmetic 
products should remain restricted to a maximum concentration of 0,2 %, while it  
shou ld not be allowed for use in mouthwash . The use of Triclocarban in cosmetic 
products for other purposes should remain restricted to a maximum concentration of 
1,5 % in rinse -off products . In addition, it should not be allowed in toothpaste for 
children under 6 years  of age . Labelling requirements should also be introduced , to 
further enhance the protection of consumers and facilitate market surveillance 
activities in Member States . 
(19) Regulation (EC) 1223/2009 should therefore be amended accordingly.  
(20) The industry should be allowed reasonable periods of time to adapt to the new 
requirements, including by making the necessary adjustments to product formulations 
to ensure that only cosmetic products complying with the new requirements are placed 
on the ma rket. The industry should also be allowed a reasonable period of time to 
withdraw cosmetic products which do not comply with those requirements. In 
particular for  the prohibition of  4-Methylbenzylidene Camphor , the reformulation of 
products containing that  UV-filter is technically challenging in view of the shrinking 
palette of available UV -filters, while it is necessary to measure the efficacy of the sun 
protection factor of the reformulated products. Therefore, longer transition periods 
should be allowed for the industry to ensure compliance of products containing 4-
Methylbenzylidene Camphor . In addition, longer transition periods  to ensure 
compliance of cosmetic products that contain  Retinol, Retinyl Acetate and Retinyl 
Palmitate should be allowed , since  there are no immediate health concern s for th ose 
substances, since the ir use  concentrations in cosmetic products currently available on 
the market do not exceed the concentrations that the SCCS considers safe  and since 
shorter deadlines would lead to with drawals and destruction of cosmetic products with 
disproportionate financial and environmental costs.  
(21) 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  
Annex es II, III, V and VI  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.   
EN 6  EN Point (4) of the Annex shall apply from … [OP please insert the date = first day of the month 
following 12 months after the date of entry into force of this Regulation ]  
This Regulation shall be binding in its entirety a nd directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen