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Commission Regulation (EU) 2016/1143Show full title

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)

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Changes over time for: Commission Regulation (EU) 2016/1143 (Annexes only)

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ANNEXU.K.

Annex VI to Regulation (EC) No 1223/2009 is amended as follows:

(1)

entry 27 is replaced by the following entry:

a

For use as a colorant, see Annex IV, No 143.

b

In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit given in column g.’;

Substance IdentificationConditions
Reference numberChemical name/INN/XANName of Common Ingredients GlossaryCAS numberEC numberProduct type, Body partsMaximum concentration in ready for use preparationOtherWording of conditions of use and warnings
abcdefghi
‘27Titanium dioxideaTitanium Dioxide

13463-67-7/

1317-70-0/

1317-80-2

236-675-5/

215-280-1/

215-282-2

25 %b
(2)

entry 27a is inserted:

a

For use as a colorant, see Annex IV, No 143.

b

In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit given in column g.’

Substance IdentificationConditions
Reference numberChemical name/INN/XANName of Common Ingredients GlossaryCAS numberEC numberProduct type, Body partsMaximum concentration in ready for use preparationOtherWording of conditions of use and warnings
abcdefghi
‘27aTitanium dioxideaTitanium Dioxide (nano)

13463-67-7/

1317-70-0/

1317-80-2

236-675-5/

215-280-1/

215-282-2

25 %b

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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