EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2016) 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) 2,2'-Methylene -bis(6 -(2H-benzotriazol -2-yl)-4-(1,1,3,3 -tetramethyl -butyl)phenol) / 
Bisoctrizole with the International Nomenclature of Cosmetic Ingredients name 
Methylene Bis -Benzotriazolyl Tetramethylbutylphenol (MBBT) is authori sed for use 
as a UV -filter in cosmetic products under  entry 23 of Annex VI to Regulation (EC) No 
1223/2009. The use of MBBT  (nano)  as a UV -filter in cosmetic products is currently 
not regulated.  
(2) In its opinion of 25 March 20152, the  Scientific Committee on Consumer Safety 
(SCCS)  concluded that the use of MBBT (nano) as a UV -filter , with the characteristics 
as indicated in the opinion  and at a concentration up to 10  % w/w in dermally applied 
cosmetic products does not pose a risk to human health  after application on healthy, 
intact skin . The characteristics indicated by the SCCS in that opinion relate to  the 
physico -chemical properties of the material (such as purity, median particle size, 
number size distribution).  
(3) The SCCS also considered  that the conclusions of its opinion of 25 March 2015  do not 
apply to applications that might lead to the exposure of the  end user’s lungs to MBBT 
(nano) by inhalation.  
(4) In light of the SCCS opinion and in order to take into account technical and scientific 
progress , the use of MBBT (nano)  as a UV -filter in cosmetic products , according to 
the SCCS's specifications, should be authori sed at a maximum concentration of 10 %  
w/w, except in applications that may lead to  the exposure of the end user's  lungs to 
MBBT (nano) by inhalation.  
(5) Annex VI to Regulation (EC) No 1223/2009 should therefore be amended 
accordingly . 
(6) The measures pro vided for in this Regulation are in accordance with the opinion of 
the Standing Committee  on Cosmetic Products , 
                                                 
1 OJ L 342, 22.12.2009, p. 59.  
2 SCCS/1546/15, Revision of 25 June 2015: 
http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_168.pdf . EN 3   EN 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 . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Br ussels,  
 For the Commission  
 The President  
 Jean -Claude Juncker