# 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), Annex

Extent: E+W+S+N.I.

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.

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Source: https://www.legislation.gov.uk/eur/2016/621/annex (the official version)
Page: https://openlegislation.uk/eu-regulation-2016-621/annex
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.