EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2022) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes III and VI to Regulation (EC) No 1223/2009 of the European 
Parliament and of the Council  
 
(Text with EEA relevance)    
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 Butylated Hydroxytoluene, Acid Yellow 3, Homosalate and 
HAA299 in cosmetic products  and correcting that Regulation as regards the use of 
Resorcinol in cosmetic products  
 
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regar d 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 i n particular Article 31 (1) thereof , 
Whereas:  
(1) The substance ‘2,6-Di-Tert-Butyl -4-Methylphenol ’ (CAS No 128 -37-0), which has 
been assigned the name Butylated Hydroxytoluene  under the International 
Nomenclature of Cosmetic Ingredients (INCI) , is currently not regulated under 
Regulation (EC) No 1223/2009. Butylated Hydroxytoluene  is a synthetic antioxidant  
that helps maintain the properties and performance of products when exposed to air 
and is widely used in cosmetic s.  
(2) In light of concerns related to potential endocrine disrupting properties of Butylated 
Hydroxytoluene , the Commission launched a public call for data in 2019. The industry 
submitted scientific evidence to demonstrate the safety of Butylated Hydroxytoluene  
when used  in cosmetic products. The Commission requested the  Scientific Committee 
for C onsumer Safety  (SCCS ) to carry out a safety assessment of Butylated 
Hydroxytoluene  in view of the information provided.   
(3) The SCCS concluded in its opinion of 2 December 20212 that Butylated 
Hydroxytoluene  is safe as an ingredient up to a maximum concentration of 0 ,001 % in 
mouthwash , 0,1 % in toothpaste and 0 ,8 % in other leave -on and rinse -off products , 
when th ose product categories are used individually or together .  
(4) In light of the SCCS opinion, it can be concluded that there is a potential ris k to human 
health arising from the use of Butylated Hydroxytoluene  in mouthwash, toothpaste and 
other leave -on and rinse off products when the concentration of that substance exceeds 
certain levels. Therefore, the use of Butylated Hydroxytoluene in those p roducts 
should be restricted  to a maximum concentration of 0,001 %, 0,1 % and 0,8 % 
respectively .  
                                                 
1 OJ L 342, 22.12.2009, p. 59.  
2 SCCS (Scientific Committee on Consumer Safety), scientific o pinion on Butylated Hydroxytoluene 
(BHT), preliminary version of 27 September 2021 , final version of 2 December 2021, SCCS/1636/21  
https://ec.europa.eu/health/publications/butylated -hydroxytoluene -bht_en    
EN 2  EN (5) The substance  ‘1H-Indene -1,3(2H) -dione, 2 -(2-quinolinyl) -, sulfonated, sodium salts ’ 
(CAS No 8004 -92-0), which has been assigned the INCI name Acid Yellow 3 , is 
currently listed under entry 82 of Annex IV to Regulation (EC) No 1223/2009 and is 
therefore allowed for use as a colorant in cosmetic products  without any maximum 
concentration . 
(6) Based on data provided  by the industry on the use of Acid Yellow 3 in non -oxidative 
hair colouring products , the SCCS concluded in its opinion of 23 July 20213 that Acid 
Yellow 3 is safe when used in such products at on -head concentrations of up to 0 ,5 %. 
(7)  In light of the SCCS opinion , it can be concluded that there is a potent ial risk to 
human health arising from the use of  Acid Yellow 3  in non -oxidative hair colouring 
products when the concentration of that substance exceeds a certain level. Therefore, 
the use of Acid Yellow 3 in those products should be restricted to a maximu m 
concentration of 0,5 %.  
(8) The substance ‘Benzoic acid, 2 -hydroxy -, 3,3,5 -trimethylcyclohexyl ester ’ (CAS No 
118-56-9), which has been assigned the INCI name Homosalate, is listed under entry 3 
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 10 % in ready for use 
preparation . 
(9) In light of concerns related to potential endocrine disrupting properties of Homosalate , 
the Commission launched a public  call for data i n 2019. The industry submitted 
scientific evidence to demonstrate the safety of Homosalate when used  in cosmetic 
products. The Commission requested the SCCS to carry out a safety assessment of 
Homosalate in view of the information provided.  
(10) The SCCS concl uded in its opinion of 24-25 June 20214 that Homosalate  is not safe 
when used as a UV -filter in cosmetic products at concentrations of up to 10  %. The 
SCCS found that the use of H omosalate as a UV filter in cosmetic products is safe for 
the consumer only up to a maximum concentration of 0 ,5 % in the final product.  
(11) On 30 July 2021, to ensure broad availability of UV -filters and consequently adequate 
sun protection for consumers, industry submitted a re -calculation of the margin of 
safety based  only on the us e of Homosalate in face products (face cream and pump -
spray products) . On the basis of the information provided by industry , and considering 
the concerns related to potential endocrine disrupting properties of Homosalate, the 
SCCS issued scientific advice on 2 December 20215, where it concluded  that 
Homosalate is safe as a UV -filter at concentrations up to 7 ,34% when used in face  
products  in the form of cream and pump spray. Therefore, the use of Homosalate 
should be restricted to face products (non -spray and pump spray products) only , up to 
a maximum concentration of 7 ,34 %. The combined use of Homosalate up to 0,5% in 
all cosmetic products and up to 7,34% in face products is not considered safe by the 
SCCS since the margin of safety of such combined use i s below 100 .  
                                                 
3 SCCS (Scientific Committee on Consumer Safety), Opinion on Acid Yellow 3 – C054 (CAS No. 8004 -
92-0, EC No 305 -897-5), final version of 23 July 2021 , SCCS/16 31/21  
https://ec.europa.eu/health/publications/acid -yellow -3-c054 -cas-no-8004 -92-0-ec-no-305-897-5-
submission -ii_en   
4 SCCS (Scientific Committee on Consumer Safety), Opinion on Homosalate , (CAS No 118 -56-9, EC 
No 204 -260-8), preliminary version of 27 -28 October 2020,  final version of 24-25 June  2021, 
SCCS/1622/20 , https://ec.europa.eu/health/publications/homosalate_en   
5  SCCS ( Scientific Committee on Consumer Safety), Scientific Advice on the safety of Homosalate 
(CAS No 118 -56-9, EC No 204 -260-8) as a UV -filter in cosmetic products, final version of 2  December 
2021, SCCS/1638/21, https://ec.europa.eu/health/system/files/2021 -12/sccs_o_260.pdf     
EN 3  EN (12) 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 Homosalate as a UV filter in cosmetic 
products in the concentration currently allowed. Therefore , the use of Ho mosalate 
should be restricted to face products (non -spray and pump spray products) only up to a 
maximum concentration of 7 ,34 %.     
(13) The substance ‘1,1'-(1,4-piperazinediyl)bis[1 -[2-[4-(diethylamino) -2-
hydroxybenzoyl]phenyl] -methanone ’, which has been assigned the INCI name Bis -
(Diethylaminohydroxybenzoyl Benzoyl) Piperazine (HAA299), is a cosmetic 
ingredient with the reported functions of a UV-filter. HAA299 is currently not 
regulated under Regulation (EC) No 1223/2009 . 
(14) In 2009, the Commission received a dossier from  the industry to support the safe use 
of HAA299 (micronised and non -micronised) in cosmetic products, which was further 
substantiated with additional information in 2012. SCCS concluded in an opinion of 
23 September 20146 that the use of HAA299  in non-nano  form  (micronised or non -
micronised, with median particle size distribution around 134 nm or larger) at a 
concentration up to 10  % as a UV -filter in cosmetic products does not pose a risk  of 
systemic toxicity in humans . In addition, the SCCS stated that its opinion did  not cover 
the safety evaluation of HAA299 whic h is composed of nano particles . 
(15) In view of that opinion on the non-nano  form o f HAA299, the industry submitted in 
September 2020 additional data and  requested  an assessment of the safety of HAA299 
in nano form  intended to be used as a UV-filter up to a maximum concentration of 
10 %. 
(16) The SCCS concluded in its opinion of 26 and 27 October 20217 that HAA299 in nano  
form , as covered within the provided characteristics (minimum purity equal to or 
above 97  %, median particle size in terms of particle number equal to or above 50 
nm), is safe when used as a UV -filter in dermally applied cosmetic products up to a 
maximum concentration of 10  %. Considering  the inflammatory ef fects on the lung 
after acute inhalation exposure to  products containing HAA299 (nano), the SCCS did 
not recommend the use of HAA299 (nano) in applications that could lead to exposure 
of the consumer’s lungs via inhalation.  
(17) The SCCS finally concluded that it had not been provided with any data that would 
merit a revision of its previous opinion  and that HAA299  therefore can be considered 
safe both in its non-nano and in its nano form, when used as a UV -filter in cosmetic 
products up to a maximum concentrati on of 10  %. The SCCS also considers that the 
combined maximum concentration of non -nano and nano forms of HAA299 should 
not exceed 10  % in a cosmetic product.  
(18) In light of the SCCS opinion, it can be concluded that there is a potential risk to human 
health arising from the use of HAA299 as a UV -filter in cosmetic products when the 
concentration of that substance exceeds a certain level. Therefore, the use of HAA299 
in those products should be restricted to a maximum concentration of 10 %.  With 
                                                 
6 SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of 2-(4-(2-(4-Diethylamino -
2-hydroxy -benzoyl) -benzoyl) -piperazine -1-carbonyl) -phenyl) -(4-diethylamino -2-hydroxyphenyl) -
methanone, HAA299 as UV filter in sunscreen products , 18 June 2014 , SCCS/1533/14 , revision of 23 
September 2014 ,  
7 SCCS (Scientific Committ ee on Consumer Safety), Opinion on HAA299 (nano) , preliminary opinion 
22 July 2021 , final opinion  of 26-27 October 2021 , SCCS/1634/ 2021, 
https://ec.europa.eu/health/publications/haa299 -nano_en   
EN 4  EN regard to HAA 299 (nano), a condition should be introduced regarding its use in 
applications that may lead to exposure of the lungs.  
(19) Regulation (EC) No 1223/2009 should therefore be amended and corrected 
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 
in order to ensure that only cosmetic products complying with the new requirements 
are placed on the market. The industry should also be allowed a  reasonable period of 
time to withdraw cosmetic products which do not comply with those requirements.  As 
regards the new restrictions for Homosalate, the reformulation of products containing 
that UV filter is technically challenging and 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 Homosalate with the new restrictions .   
(21) The substance ‘1,3 -benzenediol’ (CAS No 108 -46-3), which has been assigned the 
INCI name Resorcinol, is currently listed under entry 22 of Annex III to Regulation 
(EC) No 1223/2009 as allowed for use in oxidative hair dye products, products 
intended for colouring eyelashes an d hair lotions and shampoos with certain 
restrictions. With regard to oxidative hair dye products, the label is to contain the 
following warning: ‘Do not use to dye eyelashes or eyebrows’.  
(22) According to the definition of the term ‘hair product’ in Regulati on (EC) No 
1223/2009, which became applicable on 11 July 2013, a hair product means a 
cosmetic product that is intended to be applied on the hair of head or face, except eye 
lashes. The exclusion of eyelashes was motivated by the fact that the level of ris k is 
different when cosmetic products are applied on the hair on the head and on eyelashes 
respectively.  
(23) Entry 22 in Annex III to Regulation (EC) No 1223/2009 was amended by Commission 
Regulation (EU) No 1197/20138 to allow professional use of Resorcinol in products 
intended for colouring eyelashes. At that time, the warning concerning the use for 
eyebrows should have been deleted, since the use of Resorcinol in products intended 
for colouring eyebrows, considering the new definition, was allowed as includ ed in the 
product type ‘oxidative hair dye products’. That error should be corrected.  
(24) 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  
Amendments  
Annexes III and VI to Regulation (EC) No 1223/2009 are amended in accordance with the 
Annex to this Regulation.  
 
Article 2  
                                                 
8  Commission Regulation (EU) No 1197/2013 of 25 November 2013 amending Annex III to Regulation 
(EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (OJ L 315, 
26.11.2013, p. 34 ).  
EN 5  EN Correction  
In Annex III to Regulation (EC) No 1223/2009 , in the row for entry 22, column i, point (a), 
the last sentence is replaced by the following:  
‘Do not use to dye eyelashes .’. 
Article 3 
Entry into force  
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 s hall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen