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 % | 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. |