Commission Regulation (EU) 2019/1857 of 6 November 2019 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) 2019/1857
• 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

Entry 27a of Annex VI to Regulation (EC) No 1223/2009 is replaced by the following entry:

Reference

Number

Substance identification

Conditions

Wording of conditions of use and warnings

Chemical name/

INN/XAN

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

‘27a

Titanium dioxide  ( *1 )

Titanium Dioxide (nano)

13463-67-7/1317-70-0/1317-80-2

236-675-5/215-280-1/215-282-2

25 %  ( *2 )

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 ≥ 99 %,

—

rutile form, or rutile with up to 5 % anatase, with crystalline structure and physical appearance as clusters of spherical, needle, or lanceolate shapes,

—

median particle size based on number size distribution ≥ 30 nm,

—

aspect ratio from 1 to 4,5, and volume specific surface area ≤ 460 m 2 /cm 3 ,

—

coated with Silica, Hydrated Silica, Alumina, Aluminium Hydroxide, Aluminium Stearate, Stearic Acid, Trimethoxycaprylylsilane, Glycerin, Dimethicone, Hydrogen Dimethicone, Simethicone,

or coated with one of the following combinations:

—

Silica at a maximum concentration of 16 % and Cetyl Phosphate at a maximum concentration of 6 %,

—

Alumina at a maximum concentration of 7 % and Manganese Dioxide at a maximum concentration of 0,7 % (not to be used in lip products),

—

Alumina at a maximum concentration of 3 % and Triethoxycaprylylsilane at a maximum concentration of 9 %,

—

photocatalytic activity ≤ 10 % compared to corresponding non-coated or non-doped reference,

—

nanoparticles are photostable in the final formulation.

For face products containing Titanium Dioxide (nano) coated with the combination Alumina and Manganese Dioxide:

Not to be used on the lips.

( *1 )   For use as a colorant, see Annex IV, No 143.

( *2 )   In case of combined use of Titanium Dioxide and Titanium Dioxide (nano), the sum shall not exceed the limit given in column g.’