Omnibus III Regulation

Introduction

On May 26th, 2021, the European Commission published a new amendment to the European Cosmetics Regulation (EU No 2021/850, so-called “OMNIBUS III”). The provisions of this regulation will be implemented on October 1st, 2021. This piece of legislation includes a number of modifications in Annexes II, III, IV, and VI of the European Cosmetic Regulation.

Cosmetic Ingredients Prohibited (Addition to Annex II):

Substances Cas number EC number
Cobalt 7440-48-4 231-158-0
Metaldehyde (ISO); 2,4,6,8-tetramethyl- 1,3,5,7-
tetraoxacyclooctane
108-62-3 203-600-2
Methylmercuric chloride 115-09-3 204-064-2
Benzo[rst]pentaphene 189-55-9 205-877-5
Dibenzo[b,def]chrysene; dibenzo[a,h]pyrene 189-64-0 205-878-0
Ethanol, 2,2’-iminobis-, N- (C13-15-branched and linear
alkyl) derivs.
97925-95-6 308-208-6
Cyflumetofen (ISO); 2-methoxyethyl (RS)-2- (4-tertbutylphenyl)-
2-cyano-3-oxo-3-(α,α,α-trifluoro-otolyl)
propionate
400882-07-7
Diisohexyl phthalate 71850-09-4 276-090-2
halosulfuron-methyl (ISO); methyl 3-chloro-5-{[(4,6-
dimethoxypyrimidin-2-yl) carbamoyl]sulfamoyl}-1- methyl-
1H-pyrazole-4- carboxylate
100784-20-1
2-methylimidazole 693-98-1 211-765-7
Metaflumizone (ISO);
(EZ)-2’-[2-(4-cyanophenyl)-1-(α,α,α -trifluoro-mtolyl)
ethylidene]-[4-(trifluoromethoxy)phenyl] carbanilohydrazide [E-isomer ≥ 90 %, Z-isomer ≤ 10 % relative content]; [1](E)-2’-[2-(4-cyanophenyl)- 1-(α,α,α -trifluoro-m-tolyl)
ethylidene]-[4-(trifluoromethoxy)phenyl]carbanilohydrazide [2]
139968-49-3 [1]852403-68-0 [2]
Dibutylbis(pentane-2,4- dionato-O,O’)tin 22673-19-4 245-152-0

Cosmetic Ingredients Further Restricted (Addition to Annex III):

Salicylic Acid:

This ingredient will now be allowed to be used up to 0.5% when used for another function than preservative for the following categories of cosmetics:

  • Body Lotion
  • Eye Shadow
  • Mascara
  • Eye liner
  • Lipstick
  • Roll-on deodorant

For information, previous limitations for those categories only allowed to use salicylic up to 0.5% for preservative purpose.

For other categories and when used as preservative, previous restrictions on this ingredient remain applicable.

Titanium Dioxide

A new entry will be added on the Annex III concerning the Titanium Dioxide in powder form containing 1% or more of particles with aerodynamic diameter ≤ 10 µm.

The ingredient will be allowed to be used in the form of pigmentary, anatase and surface-treated for:

  • Face products in powder form up to 25%
  • Hair products in aerosols dispenser (spray) up to 1.4% (for general consumers)
  • Hair products in aerosols dispenser (spray) up to 1.1% (for professional use)

In what concerns the other categories of products, the ingredient will not be limited in concentration but will be prohibited when application may lead to exposure of the end-user’s lungs by inhalation.

Colorants Further Restricted (Addition to Annex IV):

Titanium Dioxide

The ingredient when used as colorant and containing 1% or more of particles with aerodynamic diameter ≤ 10 µm must comply with the new entry of the Annex III (see above) and the entry IV/143 (Respect of purity criteria as set out in Commission Directive 95/45/ (E 171) and colorant must be white).

UV Filters Further Restricted (Addition to Annex VI):

Titanium Dioxide

The ingredient when used as UV filter and containing 1% or more of particles with aerodynamic diameter ≤ 10 µm must comply with the new entry of the Annex III (see above) and the entry VI/27.

Limitation of 25% will be applied to products that are not limited in the Annex III and which contain Titanium Dioxide as UV filters. This limitation applies to the sum of any forms of titanium dioxide present in the product.

Conclusion

How Work if my Product Contains Titanium Dioxide

  1. Check the product type: Is it inhalable (powder, spray, etc.)?
  2. If yes: check the particle size distribution below 10µm
  3. If at least 1% of the particles have a size ≤10µm:
    1. If it is a face loose powder: only in the pigmentary form at max 25%
    2. If it is a hair aerosol spray: only in the pigmentary form at max 1.4% for general consumer use and max 1.1% for professional use
    3. If it is another product that may lead to exposure of the end user’ lungs by inhalation: forbidden.
  4. Follow as usual the restrictions and purity criteria set out in annex VI/27 and VI/27a if it is used as an UV filter and in annex IV/143 if it is used as a colorant.

We hope that this letter will be of help. Don’t hesitate to contact us for more info since Biorius can help you to cope with the challenging and fast-moving regulatory environment and keeps you updated on the compliance status of your product portfolio.

Author: Pierre Verachten

 

Visit our regulatory blog to be updated about topics that have an impact on your cosmetics business

Author

  • Frédéric Lebreux

    Dr. Frédéric Lebreux is Biorius's Chief Executive Officer and has worked in the cosmetic industry for more than 13 years. He is regularly invited as a speaker or Professor to cosmetic events.

    View all posts