JavaScript is disabled. Please enable to continue!
Mobile search icon
Media Centre >> News >> Newsflash | Europe | Amending Annex V and VI of Cosmetics Regulation

Newsflash | Europe | Amending Annex V and VI of Cosmetics Regulation

Sidebar Image

Monday, November 11, 2019

Eurofins newsflash Cosmetics and Personal Care

 

Europe

 

Amending Annex V and VI of Cosmetics Regulation

 

On 7th November 2019, the European Commission published the following two amendments:

 

“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”  with reference C/2019/7911.

 

The main point in this amendment is:

 

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

 

Chemical name/INN

Name of Common Ingredients Glossary

CAS number

EC number

Maximum concentration in ready for use preparation

Other

Wording of conditions of use and warnings

Titanium dioxide (*)

Titanium Dioxide (nano)

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

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

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 ≥ 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 m2/cm3
  • 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.

 

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

 

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

 

And the second publication is:

 

“Commission Regulation (EU) 2019/1858 of 6 November 2019 amending Annex V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products” with reference C/2019/7910.

 

The main point in this amendment is:

 

  • The entry 60 in Annex V to Regulation (EC) No 1223/2009:

 

Chemical name/INN

Name of Common Ingredients Glossary

CAS number

EC number

Product type, Body parts

Maximum concentration in ready for use preparation

Wording of conditions of use and warnings

4-(3-ethoxy-4-hydroxyphenyl)butan-2-one

Hydroxyethoxyphenyl Butanone

569646-79-3

933-435-8

 

0,7 %’

 

 

These Regulations shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.