EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2020) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annexes II and III 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 Annexes II and III 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 November 2009 on co smetic products1, and in particular Article 31(1) thereof , 
Whereas:  
(1) The substance 4 -[(tetrahydro -2H-pyran -2-yl)oxy]phenol ( common name: 
deoxyarbutin , INCI  name : Tetrahydropyranyloxy Phenol ), currently not regulated in 
Regulation (EC) No 1223/2009 , results in the release of 1,4 -Dihydroxybenzene ( INCI 
name: H ydroquinone). Hydroquinone is included among the substance s prohibited for 
use in cosmetic products, listed under entry 1339 of Annex II to Regulation (EC) No 
1223/2009, with the exception of ent ry 14 of Annex III to that Regulation .  
(2) The use of d eoxyarbutin in cosmetic products was assessed by  the Scientific 
Committee on Consumer Safety (SCCS). In its opinion adopted on  25 June 20152, the 
SCCS concluded  that due to  safet y concerns raised with regard  to the life -cycle of  
products containing that substance, the  use of deoxyarbutin up to 3% in face creams 
cannot be considered as  safe3.  
(3) Based on th at opinion , deoxyarbutin should be prohibited for use in cosmetic products 
and added to the list of p rohibited substances in Annex II to Regulation (EC) No 
1223/2009.  
(4) The substance  1,3-Dihydroxy -2-propanone (INCI name: Dihydroxyacetone) is a 
cosmetic ingredient with the reported functions of skin conditioning  and tanning. 
Dihydroxyacetone  is currently  not regulated under Regulation (EC) No 1223/2009.  
(5) In its opinion adopted on  3-4 March 20204, the SCCS consider ed Dihydroxyacetone 
safe when used as a hair colouring ingredient in leave -on applications (non -oxidative) 
up to a maximum concentration of 6.25%.  Furthermore, the SCCS concluded in th at 
opinion  that the use of Dihydroxyacetone as a hair colouring ingredient in leave -on 
applications (non -oxidative) up to a maximum concentration of 6.25%  together with 
                                                 
1 OJ L 342, 22.12.2009, p. 59.  
2 SCCS (Scientific Committee on Consumer Safety), Opinion on de oxyarbutin - Tetrahydropyranyloxy 
Phenol, 25 June 2015, SCCS/1554/15 .  
3  See point 4 of the opinion.  
4 SCCS (Scientific Committee on Consumer Safet y), Opinion on Dihydroxyacetone - DHA , 3-4 March 
2020, SCCS/1612/19 .  
 EN 2  EN the use of self -tanning lotion and face cre am containing up to a maximum 
concentration of 10% Dihydroxyacetone is also considered safe.  
(6) Based on those conclusions , it is necessary to add a new entry in Annex III to 
Regulation (EC) No 1223/2009 that will allow for a restricted use of 
Dihydroxyaceton e in non -oxidative hair dye products and in self -tanning products 
only, in a maximum concentration of up to 6.25% and 10% respectively.  
(7) Regulation (EC) No 1223/2009 should therefore be amended accordingly.  
(8) It is appropriate to provide for reasonable peri ods of time in order for the industry to 
adapt to the new requirements  on the use of Dihydroxyacetone in cosmetic products  
and to phase out the placing and making available on the market of cosmetic products 
which do not comply with those requirements.  
(9) The measures provided for in this Regulation are in ac cordance with  the opinion 
of the Standing Committee on Cosmetic Products , 
HAS ADOPTED THIS REGULATION:  
Article 1  
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 . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Br ussels,  
 For the Commission  
 The President  
 Ursula von der Leyen