EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2015) XXX  draft  
  
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and 
of the Council on cosmetic products  
(Text with EEA relevance)    
EN 2   EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending  Annex VI 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 Regulatio n (EC) No 1223/2009 of the European Parliament and of the 
Council of 30 November 2009 on cosmetic products1, and in particular Article 31(2)  thereof,  
Whereas:  
(1) Titanium dioxide is authorized both as a colorant under entry 143 of Annex IV to 
Regulation (EC) No 1223/2009 and as a UV -filter under entry 27 of Annex VI  to that 
Regulation . In accord ance with point (3) of the Preamble to Annexes II to VI  to 
Regulation (EC) No 1223/2009 , the substances listed in Annexes III to VI  to that 
Regulation  do not cover nano materials, except where specifically mentioned . Titanium 
dioxide  (nano)  is currently not regulated.  
(2) According to the opinion of the  Scientific Committee on Consumer Safety ("SCCS")  
of 22 July 2013, which was revised on 22 April 20142, the use of titanium dioxide 
(nano)  as a UV-filter in sunscreens , with the characteristics as indicated  in the opinion, 
and at a concentration up to 25  %, can be considered to not pose any risk of adverse 
effects in humans after application on healthy, intact or sunburn t skin.  In addition, 
considering the absence of a systemic exposure, the SCCS considers that the use of 
titanium dioxide (nano)  in dermally applied cosmetic products should  not pose any 
significant risk  to the consumer.  
(3) The characteristics indicated by the  SCCS in its opinion concern the physico -chemical 
properties of the material  (such as purity, structure and physical appearance, particle 
number size distribution, aspect ratio, volume specific surface area and photocatalytic 
activity) and  whether it is un coated or coated with specific chemicals. Therefore, these 
physico -chemical properties and requirements regarding coatings should be reflected 
in Regulation (EC) No 1223/2009.  
(4) The SCCS also considered that, on the basis of available information, the use of  
titanium dioxide (nano) in spray products cannot be considered safe. In addition, the 
SCCS indicated, in a further opinion of 23 September 2014 for clarification of the 
meaning of the term 'sprayable application s/products ' for the nano forms of carbon 
black CI 77266, titanium dioxide and zinc oxide3, that its concern is limi ted to spray 
                                                 
1 OJ L 342, 22.12.2009, p. 59.  
2 SCCS/1516/13  Revision of 22 April 2014 , 
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_136.pdf . 
3 SCCS/1539/14 23 September 2014 Revision of 25 June 2015 
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_163.pdf .    
EN 3   EN applications that might  lead to exposure of the consumer’s lungs to titanium dioxide 
(nano) by inhalation.  
(5) In light of the SCCS opinions mentioned above, titaniu m dioxide (nano) , according to 
the SCCS’s specifications, should be authorized for use as a UV -filter in cosmetic 
products at a maximum concentration of 25  %, except in applications that may lead to 
exposure of the  end user’s lungs by inhalation .    
(6) Annex VI to Regulation (EC) No 1223/2009 should be amended for the purpose of 
adapting it to technical and scientific progress.  
(7) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Cosmetic Products,  
HAS AD OPTED 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 Jo urnal of the European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude Juncker