EN   EN  
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2019) 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 1  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  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(2)  thereof,  
Whereas:  
(1) Titanium dioxide is currently allowed as a UV -filter in cosmetic products , including in 
the form of nanomaterial . Titanium dioxide (nano) i s listed in entry 27a of Annex VI 
to Regulation (EC) No 1223/2009. It is allowed  at a maximum concentration of 25 % 
in ready for use preparation , except in applications that may lead to exposure of the 
end user’s  lungs by inhalation  and subject to the characteristics listed  in the entry.  
(2) The characteristics listed  in entry 27a of Annex VI concern the allowed physico -
chemical properties of titanium dioxide (nano) and the substances with which it can  be 
coated.   
(3) The Scientific Committee on Consumer Safety (SCCS) concluded in an opinion of 7 
March 2017, corrected on 22 June 20182, that the use of the three forms of titanium 
dioxide (nano) under assessment , coated with either silica and cetyl phosphate (up to 
16 % and 6  %, respectively),  alumina and manganese dioxide ( up to 7 % and 0,7 % ,  
respectively),  or alumina and triethoxycaprylylsilane (up to 3  % and 9  %, 
respectively), can be considered safe for use in cosmetic products intended for 
application on he althy, intact or sunburnt skin. The SCCS added that t his conclusion , 
however, does not apply to applications that might lead to exposure of the consumer's 
lungs to the titanium dioxide  nanoparticles through the inhalation route (such as 
powders or sprayabl e products) . 
(4) The SCCS also concluded that the ingredients used in some type of products (e.g. in 
lipsticks) may be incidentally ingested. The potential harmful effects of manganese 
dioxide should therefore be taken into account if the manganese dioxide -coated 
nanomaterials are to be used for applications that could lead to oral ingestion.  
(5) In light of the SCCS opinion and in order to take into account technical and scientific 
progress, the three  combinations of coatings at their respective concentration limits as 
assessed by the SCCS  should be allowed  for use with titanium dioxide (nano) as a 
                                                 
1 OJ L 342, 22.12.2009, p. 59.  
2 SCCS/1580/16 , final version of 7 March 2017 , corrigendum of 22 June 2018 . EN 2  EN UV-filter , subject to the other conditions listed in entry 27a of Annex VI  to Regulation 
(EC) No 1223/2009 . 
(6) However, the re is a  potential risk to human health arising from  the ingestion of 
manganese dioxide . Therefore, the combination of coatings alumina and manganese 
dioxide should not be allowed for use in lip products , as they are ingested  to some 
extent . Moreover, consumers may also apply some face products, such as sunscreens 
intended for application on the face, on the lips under reasonably foreseeable 
conditions of use. The application of  face products on the lips  leads to ingestion  of the 
product to some extent . Therefore, face products containing the combination of 
coatings alumina and manganese dioxide should bear a warning against  the use of 
these  products on the lips.  
(7) Regulation (EC) No 1223/2009 should therefore be amended accordingly.  
(8) 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 Regulat ion 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 Brussels,  
 For the Commi ssion  
 The President  
 Jean -Claude Juncker