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Annex

United Kingdom

Original text. Later amendments are not shown.

Entry 27a of Annex VI to Regulation (EC) No 1223/2009 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.’

ReferenceNumberSubstance identificationConditionsWording of conditions of use and warnings
Chemical name/INN/XANName of Common Ingredients GlossaryCAS numberEC numberProduct type, body partsMaximum concentration in ready for use preparationOther
abcdefghi
‘27aTitanium dioxide f1 Titanium Dioxide (nano)13463-67-7/1317-70-0/1317-80-2236-675-5/215-280-1/215-282-225 % f2

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,

or coated with one of the following combinations:

  • Silica at a maximum concentration of 16 % and Cetyl Phosphate at a maximum concentration of 6 %,

  • Alumina at a maximum concentration of 7 % and Manganese Dioxide at a maximum concentration of 0,7 % (not to be used in lip products),

  • Alumina at a maximum concentration of 3 % and Triethoxycaprylylsilane at a maximum concentration of 9 %,

  • photocatalytic activity ≤ 10 % compared to corresponding non-coated or non-doped reference,

  • nanoparticles are photostable in the final formulation.

For face products containing Titanium Dioxide (nano) coated with the combination Alumina and Manganese Dioxide:

Not to be used on the lips.

Annotations

Footnotes

f1

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

f2

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