ANNEXSupplementary provisions
ANNEX 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 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 % ( *1 ) 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 % ( *1 ) 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. ( *1 ) In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit given in column g.’