# Commission Regulation (EU) 2016/1143 of 13 July 2016 amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance), Annex

Extent: E+W+S+N.I.

Annex VI to Regulation (EC) No 1223/2009 is amended as follows:
(1) entry 27 is replaced by the following entry:
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.’;
Substance Identification
Conditions
Reference number
Chemical name/INN/XAN
Name of Common Ingredients Glossary
CAS number
EC number
Product type, Body parts
Maximum concentration in ready for use preparation
Other
Wording of conditions of use and warnings
a
b
c
d
e
f
g
h
i
‘27
Titanium dioxide
Titanium Dioxide
13463-67-7/
1317-70-0/
1317-80-2
236-675-5/
215-280-1/
215-282-2
25 %
(2) entry 27a is inserted:
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.’
Substance Identification
Conditions
Reference number
Chemical name/INN/XAN
Name of Common Ingredients Glossary
CAS number
EC number
Product type, Body parts
Maximum concentration in ready for use preparation
Other
Wording of conditions of use and warnings
a
b
c
d
e
f
g
h
i
‘27a
Titanium dioxide
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 nanomaterials having the following characteristics are allowed:
purity ≥ 99 %,
rutile form, or rutile with up to 5 % anatase, with crystalline structure and physical appearance as clusters of spherical, needle, or lanceolate shapes,
median particle size based on number size distribution ≥ 30 nm,
aspect ratio from 1 to 4,5, and volume specific surface area ≤ 460 m2/cm3,
coated with Silica, Hydrated Silica, Alumina, Aluminium Hydroxide, Aluminium Stearate, Stearic Acid, Trimethoxycaprylylsilane, Glycerin, Dimethicone, Hydrogen Dimethicone, Simethicone;
photocatalytic activity ≤ 10 % compared to corresponding non-coated or non-doped reference,
nanoparticles are photostable in the final formulation.

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Source: https://www.legislation.gov.uk/eur/2016/1143/annex (the official version)
Page: https://openlegislation.uk/eu-regulation-2016-1143/annex
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.