
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 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, 6 November 2019.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX

Entry 27a of Annex VI to Regulation (EC) No 1223/2009 is replaced by the following entry:

ReferenceNumber Substance identification Conditions Wording of conditions of use and warnings
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 
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,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.

