COMMI SSION REGUL ATION (EU) 2019/1857 
of 6 November 2019 
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 EUR OPEAN COMMISSION, 
Havi ng regar d to the Treaty on the Functioning of the European Union, 
Havi ng regar d to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on 
cosmetic products (1), and in particular Article 31(2) thereof, 
Whereas: 
(1) Titanium dioxide is currently allowe d as a UV-filter in cosmetic products, including in the form of nanomater ial. 
Titanium dioxide (nano) is listed in entr y 27a of Annex VI to Regulation (EC) No 1223/2009. It is allowed at a 
maximum concentration of 25 % in ready for use preparation, excep t in applications that may lead to exposure of 
the end user ’s lungs by inhalation and subject to the character istics listed in the entr y. 
(2) The charact eristics listed in entr y 27a of Annex VI concer n the allowe d physico-chem ical proper ties of titanium 
dioxide (nano) and the substances with which it can be coated . 
(3) The Scientific Committe e on Consumer Safety (SCCS) concluded in an opinion of 7 Marc h 2017, corrected on 
22 June 2018 (2), that the use of the three forms of titanium dioxide (nano) under assessment, coat ed 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 trietho xycapr ylylsilane (up to 3 % and 9 %, respectively), can be 
considered safe for use in cosmetic products intended for application on healthy , intact or sunbur nt skin. The 
SCCS added that this conclusion, how ever , does not apply to applications that might lead to exposure of the 
consumer ’s lungs to the titanium dioxide nanopar ticles through the inhalation route (such as pow ders or 
spra yable products). 
(4) The SCCS also concluded that the ingredients used in some type of products (e.g. in lipsticks) may be incidentally 
inge sted. The potential harmful effects of manganese dioxide should theref ore be taken into account if the 
manganese dioxide-coat ed nanomate rials 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 scientifi c 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 UV-filter, subject to the other conditions listed in entr y 27a of Annex VI to 
Regulation (EC) No 1223/2009. 
(6) However , there is a potential risk to human health arising from the inge stion of mang anese dioxide. Theref ore, the 
combination of coatings alumina and manganese dioxide should not be allowe d for use in lip products, as they are 
inge sted to some extent. Moreo ver, 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 inge stion of the product to some extent. Theref ore, face products containing the combination of 
coatings alumina and mang anese dioxide should bear a warning against the use of these products on the lips. 
(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 Offi cial Jour nal of the European Union 7.11.2019                                                                                                                                           L 286/3   (7) Regulation (EC) No 1223/2009 should theref ore be amended according ly. 
(8) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Cosmetic Products, 
HAS ADOPTED THIS REGUL ATION: 
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 followi ng 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, 6 November 2019.  
For the Commission 
The President 
Jean-Claude JUNCKER     EN Offi cial Jour nal of the European Union L 286/4                                                                                                                                           7.11.2019   ANNEX 
Entr y 27a of Annex VI to Regulation (EC) No 1223/2009 is replaced by the follo wing entr y:                                                               
Reference 
Number Substance identif ication Conditions Wording of conditions of use and 
warnings 
Chemical name/ 
INN/XAN Name of Common 
Ingredients 
Glossar y CAS number EC number Product type, 
body parts Maximum 
concentration in 
ready for use 
preparation Other  
a b c d e f g h i 
‘27a Titanium di­
oxide  (*)  Titanium Dioxide 
(nano) 13463- 
67-7/1317- 
70-0/1317- 
80-2 236-675- 
5/215-280- 
1/215-282-2  25 %  (**)  Not to be used in applications that 
may lead to exposure of the end- 
user ’s lungs by inhalation. 
Only nanomat erials having the 
followi ng charact eristics are al­
lowe d: 
— purity ≥ 99 %, 
— rutile form, or rutile with up 
to 5 % anatase, with crystal­
line structure and physical ap­
pearance as clusters of sphe­
rical, needle, or lanceolate 
shapes, 
— median particle size based on 
number size distr ibution ≥ 30 
nm, 
— aspect ratio from 1 to 4,5, and 
volume specifi c surface area 
≤ 460 m2/cm3, 
— coated with Silica, Hydrated 
Silica, Alumina, Aluminium 
Hydro xide, Aluminium 
Steara te, Stearic Acid, Tri­
metho xycapr ylylsilane, Gly­
cerin, Dimethicone, Hydro­
gen Dimethicone, 
Simethicone, For face products containing Tita­
nium Dioxide (nano) coated with 
the combination Alumina and 
Mangan ese Dioxide: 
Not to be used on the lips. EN Offi cial Jour nal of the European Union 7.11.2019                                                                                                                                           L 286/5   Reference 
Number Substance identif ication Conditions Wording of conditions of use and 
warnings 
Chemical name/ 
INN/XAN Name of Common 
Ingredients 
Glossar y CAS number EC number Product type, 
body parts Maximum 
concentration in 
ready for use 
preparation Other  
a b c d e f g h i 
or coate d with one of the follo w­
ing combinations: 
—Silica at a maximum concen­
tration of 16 % and Cetyl 
Phosphat e at a maximum 
concentration of 6 %, 
—Alumina at a maximum con­
centration of 7 % and Manga ­
nese Dioxide at a maximum 
concentration of 0,7 % (not 
to be used in lip products), 
—Alumina at a maximum con­
centration of 3 % and 
Trietho xycapr ylylsilane at a 
maximum concentration of 
9 %, 
— photocatalytic activity ≤ 10 % 
compare d to corresponding 
non-coat ed or non-doped re­
ference, 
— nanopar ticles are photostable 
in the final formulation. 
(*)  For use as a colorant, see Annex IV, No 143. 
(**)  In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit given in column g.’   EN Offi cial Jour nal of the European Union L 286/6                                                                                                                                           7.11.2019