Annex

The following entries are added to Annex VI to Regulation (EC) No 1223/2009 as reference numbers 30 and 30a:

In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit given in column g.’
Reference number	Substance identification				Conditions			Wording of conditions of use and warnings
	Chemical name/INN	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
‘30	Zinc oxide	Zinc Oxide	1314-13-2	215-222-5		25 %f1	Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation.
30a	Zinc oxide	Zinc Oxide (nano)	1314-13-2	215-222-5		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 ≥ 96 %, with wurtzite crystalline structure and physical appearance as clusters that are rod-like, star-like and/or isometric shapes, with impurities consisting only of carbon dioxide and water, whilst any other impurities are less than 1 % in total, median diameter of the particle number size distribution D50 (50 % of the number below this diameter) > 30 nm and D1 (1 % below this size) > 20 nm, water solubility < 50 mg/L uncoated, or coated with triethoxycaprylylsilane, dimethicone, dimethoxydiphenylsilanetriethoxycaprylylsilane cross-polymer, or octyl triethoxy silane.