EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2021) 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 certain UV filters in cosmetic products  
(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 certain UV filters 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 2-Hydroxy -4-methoxybenzophenone/Oxybenzone (CAS no 131 -57-7), 
which has been assigned the name Benzophenone -3 under the International 
Nomenclature of C osmetic Ingredients (INCI),  and 2-Cyano -3,3-diphenyl acrylic acid, 
2-ethylhexyl ester/Octocr ylene (CAS no 6197 -30-4), which has been assigned the 
name Octocrylene  under the INCI , are currently allowed  as UV filters in cosmetic 
products  and listed  in entries 4 and 10, respectively, of Annex VI to Regulation (EC) 
No 1223/2009.  
(2) In light of concerns related to potential endocrine disrupting properties of 
Benzophenone -3 and Octocrylene,  when  used as UV filters in cosmetic products , a 
call for data was launched in 2019. Stakeholders submitted scientific evidence to 
demonstrate the safety of Benzophenone -3 and Octocrylene as UV  filters in cosmetic 
products. The Commission requested the  Scientific Committee for Consumer Safety  
(SCCS ) to carry out a safety assessmen t of both substances in view of the information 
provided.  
(3) Based on the safety assessment and considering the concerns related to potential 
endocrine disrupting properties of Benzophenone -3, the SCCS concluded in its 
opinion of 30 -31 March 20212 that Benzophenone -3 is not safe for the consumer  when 
used as a UV  filter  up to the current  maximum concentration of 6  % in sunscreen 
products, either in the form of body cream, sunscreen propellant spray or pump spray.  
(4) The SCCS further concluded  that Be nzophenone -3 is safe for the consumer  when used 
as a UV  filter up to a maximum concentration of 6  % in face cream, hand cream, and 
lipsticks , and that the use of Benzophenone -3 up to 0 ,5 % in cosmetic products to 
protect the cosmetic formulation is safe for the consumer .  
                                                 
1 OJ L 342, 22.12.2009, p. 59.  
2 SCCS (Scientific Committee on Consumer Safety), Opinion on Benzophenone -3 (CAS No 131-57-7, 
EC No 205 -031-5), preliminary version of 15 December  2020, final version of 30 -31 March 2021, 
SCCS/1625/20  
https://ec.europa.eu/health/sites/default/files/scientific_committees/  
consumer_safety/docs/sccs_o_247.pdf  EN 2  EN (5) The SCCS  also found  that the use of Benzophenone -3 as a UV  filter is safe for the 
consumer  up to a maximum concentration of 2,2 % in body creams, in propellant 
sprays and  in pump sprays, if there is no additional use of Benzophenone -3 at 0,5 % in 
the same formulation for protecting the cosmetic formulation. It further concluded 
that, w here Benzophenone -3 is also used at 0,5 % in the same formulation, the levels 
of Benzophenone -3 used as a UV filter should not exceed 1 ,7 % in body creams, in 
propellant sprays and in pump sprays.  
(6) With regard to the substance Octocrylene , the SCCS concluded,  based on the safety 
assessment and considering the concerns related to its potential endocrine disrupting 
properties , in its opinion of 30 -31 March 20213 that Octocrylene is safe as a UV -filter 
at concentrations up to 10  % in cosmetic products when used individually.  
(7) The SCCS also found  that the use of Octocrylene is safe for a com bined use of 
sunscreen cream or lotion, sunscreen pump spray, face cream, hand cream and lipstick 
at a concentration up to 10  %, which is line with current restrictions , but that  the use of 
Octocrylene at  concentrations of  10 % or above in sunscreen propellant spray is not 
safe for the combined use.  The SCCS considered the use of Octocrylene in such 
products safe when its concentration does not exceed 9 %, when used together with 
face cream, hand cream, or lipstick containing 10 % Octocrylene.  
(8) In ligh t of the SCCS opinion s, it can be concluded that there is potential risk to human 
health arising from the use of Benzophenone -3 and Octocrylene  as UV filters in 
cosmetic products  in the concentrations currently allowed . Therefore, the use of 
Benzophenone -3 and Octocrylene  should be restricted to the maximum concentration s 
proposed by the SCCS .  
(9) Regulation (EC) No 1223/2009 should therefore be amended accordingly.  
(10) 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.  
(11) 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 VI to Regulation (EC)  No 1223/2009 is 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 . 
                                                 
3 SCCS (Scientific Committee on Consumer Safety), Opinion on Octocrylene (CAS No 6197 -30-4, EC 
No 228 -250-8), preliminary version of 15 January 2021, final version of 30 -31 March 2021, 
SCCS/1627/21  https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/  
docs/sccs_o_249.pdf  EN 3  EN This Regulation shall be bindin g in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen