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)

• CELEX: Regulation (EU) 2016/621
• Articles: 3

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 .

Schedules & Appendices

ANNEX

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.’