
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, 13 July 2016.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX

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

((1)) entry 27 is replaced by the following entry:

 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:

 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 inhalationOnly 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. 


