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Substance : Zinc oxide (nano)

Substance Zinc oxide (nano) 
CAS # 1314-13-2 
EC # 215-222-5 
Name of Common Ingredients Glossary ZINC OXIDE (NANO) 
Regulation (EU) 2016/621
Other Directives/Regulations
Annex/Ref # VI/30a
Product Type, body parts  
Maximum concentration in ready for use preparation 25%

- In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit of 25% 
Wording of conditions of use and warnings 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.  
SCCS opinions
Chemical/IUPAC Name Zinc oxide (nano) 
Identified INGREDIENTS or substances e.g.  
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