Omnibus V

From December 17, 2022., the application of the Omnibus V Cosmetic Regulation begins.

What does this regulation bring?

According to this regulation, 14 ingredients are banned.

They will be added to the list of Annex II (Annex II of our rulebook) of the Cosmetic Regulation. The list includes:

  • Tetrafluoroethylene;
  • 6,6′-di-tert-butyl-2,2′-methylenedi-p-cresol; [DBMC];
  • (5-chloro-2-methoxy-4-methyl-3-pyridyl)(4,5,6-trimethoxy-o-tolyl)methanone; pyriophenone;
  • (RS)-1-{1-ethyl-4-[4-mesyl-3-(2-methoxyethoxy)-o-toluoyl]pyrazol-5-yloxy}ethyl methyl carbonate; tolpyralate;
  • Azamethiphos (ISO); S-[(6-chloro-2-oxooxazolo[4,5-b]pyridin-3(2H)-yl)methyl] O,O-dimethyl thiophosphate;
  • 3-methylpyrazole;
  • N-methoxy-N-[1-methyl-2-(2,4,6-trichlorophenyl)-ethyl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide; pydiflumethofen;
  • N-{2-[[1,1′-bi(cyclopropyl)]-2-yl]phenyl}-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide; sedaxane;
  • 4-methylpentan-2-one; isobutyl methyl ketone (MIBK);
  • Dimethomorph (ISO); (E,Z)-4-(3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl)morpholine;
  • Imazamox (ISO); (RS)-2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-5-methoxymethylnicotinic acid; • Thiamethoxam (ISO); 3-(2-chloro-thiazol-5-ylmethyl)-5-methyl[1,3,5]oxadiazinan-4-ylidene-N-nitroamine;
  • Triticonazole (ISO); (RS)-(E)-5-(4-chlorobenzylidene)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-methyl)cyclopentanol;
  • Desmedipham (ISO); ethyl 3-phenylcarbamoyloxyphenylcarbamate.

 

Methyl salicylate has been added to the list of Annex III of the Cosmetic Regulation. 

Methyl salicylate is a substance that has several functions in cosmetic formulations: fragrance, soothing ingredient. In 2021, ECHA classified Methyl salicylate as a CMR substance of category 2. This practically means that it is suspected to be toxic to reproduction. That's why officials from the cosmetic industry requested that methyl salicylate be subject to an exception procedure, according to which substances classified as CMR 2 can be used in cosmetics but under certain exceptions.

As a result, the SCCS has issued its official opinion on methyl salicylate and safe concentrations for use. Restrictions apply to:

  • Up to 0.06% in products that remain on the skin (except for decorative cosmetics, spray/aerosol body lotions, spray/aerosol deodorants and fragrances based on alcohol solutions) and products that remain on the hair for a longer time (spray/aerosol products).
  • Up to 0.05% in decorative cosmetics (except lip, eye and make-up remover products)
  • Up to 0.002% in decorative eye cosmetics and make-up removers
  • Up to 0.009% in leave-on spray/aerosol products
  • Up to 0.003% in spray/aerosol deodorants
  • Up to 0.4% in body lotion spray/aerosol
  • Up to 0.06% in skin rinse products (except hand wash) and hair rinse products
  • Up to 0.6% in hand wash products, alcohol-based fragrances, mouthwash products intended for children over 10 years and adults
  • Up to 0.03% in lip care products
  • Up to 2.52% in toothpastes
  • Up to 0.1% in mouthwash products for children aged 6-10 years
  • Up to 0.65% in mouth sprays
  • Products for children under 6 must not contain methyl salicylate