Commission Regulation (EU) 2016/621 of 21 April 2016 amending Annex VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance)

ANNEXU.K.

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

Reference number	Substance identification				Conditions			Wording of conditions of use and warnings
^a 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	Chemical name/INN	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
‘30	Zinc oxide	Zinc Oxide	1314-13-2	215-222-5		25 %^a	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 %^a	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.