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European Union Issues Amendments to Omnibus III Annexes

July 20, 2021 by Ithos Global Regulatory Team

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The European Commission has published an amendment, as of May 26, 2021, to the European Cosmetics Regulation (EU) No 2021/850. It amends and corrects Annexes II, III, IV, and VI of the European Cosmetic Regulation. The effective date is October 1, 2021.

Changes to annex II include the following listings to Annex II:

  • Cobalt 
  • Metaldehyde (ISO); 2,4,6,8-tetramethyl- 1,3,5,7-tetraoxacyclooctane 
  • Methylmercuric chloride 
  • Benzo[rst]pentaphene 
  • Dibenzo[b,def]chrysene; dibenzo[a,h]pyrene
  •  Ethanol, 2,2′-iminobis-, N- (C13-15-branched and linear alkyl) derivs. 
  • Cyflumetofen (ISO); 2-methoxyethyl (RS)-2- (4-tert-butylphenyl)-2-cyano-3-oxo-3-(α,α,α-trifluoroo-tolyl)propionate 
  • Diisohexyl phthalate 
  • halosulfuron-methyl (ISO); methyl 3-chloro-5-{[(4,6- dimethoxypyrimidin-2-yl) carbamoyl] sulfamoyl}-1- methyl-1H-pyrazole-4- carboxylate 
  • 2-methylimidazole 
  • Metaflumizone (ISO); (EZ)-2′-[2-(4-cyanophenyl)-1-(α,α,α -trifluoro-m- tolyl)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 
  • Dibutylbis(pentane-2,4- dionato-O,O’)tin

Also entry 1427, corresponding to the substance nickel bis(tetrafluoroborate) (CAS number: 14708-14-6), is deleted.

The following changes have been made to the other listed annexes:

Annex III

  • Salicylic Acid is now allowed at 0.5% in body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant
  • Titanium dioxide in powder form containing 1 % or more of particle with aerodynamic diameter ≤ 10 μm are not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation’

Annex IV (Colorants) & Annex V (UV Filters)

  • Titanium Dioxide entries are aligned to the above Annex III restrictions.

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  • Ingredients
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  • European Union

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