Annex

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

1. (1)

   entry 27 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.’;
   	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 dioxidef1	Titanium Dioxide	13463-67-7/ 1317-70-0/ 1317-80-2	236-675-5/ 215-280-1/ 215-282-2		25 %f2

2. (2)

   entry 27a is inserted:

   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.’
   	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 dioxidef3	Titanium Dioxide (nano)	13463-67-7/ 1317-70-0/ 1317-80-2	236-675-5/ 215-280-1/ 215-282-2		25 %f4	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.