ANNEXSupplementary provisions
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 ( *1 ) Titanium Dioxide 13463-67-7/ 1317-70-0/ 1317-80-2 236-675-5/ 215-280-1/ 215-282-2 25 % ( *2 ) (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 ( *3 ) Titanium Dioxide (nano) 13463-67-7/ 1317-70-0/ 1317-80-2 236-675-5/ 215-280-1/ 215-282-2 25 % ( *4 ) 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 m 2 /cm 3 , — 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. ( *1 ) For use as a colorant, see Annex IV, No 143. ( *2 ) In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit given in column g.’; ( *3 ) For use as a colorant, see Annex IV, No 143. ( *4 ) In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit given in column g.’