
Article 1 
Annex VI to Regulation (EC) No 1223/2009 is amended in accordance with the Annex to this Regulation.
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 21 April 2016.
For the Commission
The President
Jean-Claude JUNCKER
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 % 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. 

