“Omnibus VI” Regulation

The European Commission has notified the draft regulation “OMNIBUS VI” to the World Trade Association (WTO) on November 17th, 2022. This OMNIBUS VI regulation incorporate substances classified CMR by the regulation EEC 2022/692 aka ATP 18th of the CLP Regulation into the European Cosmetic Regulation 1223/2009. The aim of this amendment is to implement the ban of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR).

What changes does Omnibus VI entail?

  • Among the prohibited ingredients, 30 new entries will be added to annex II. The main impact on the cosmetic industry will be the prohibition of Margoza Extract, Theophylline, Pentasodium Pentetate, Pentetic Acid, Trimethylolpropane Triacrylate and Benzophenone and cumene (both mainly used as or present in fragrance ingredients).
  • The entry 1024 will be slightly modified to include “salts of 2-ethylhexanoic acid, unless authorized by annex VI”.

(see full list of changes below with main cosmetic ingredients highlighted in yellow)

The application deadline:

As for every OMNIBUS, the application date is the same for product placed on the market AND product already on the market. Non-compliant products (containing forbidden ingredients) must be withdrawn from the market on December 1 st 2023.

For more details, our team of toxicologists, cosmetologists and regulatory affairs specialists are at your service to ensure your company a safe growth by alleviating your regulatory burden and preventing any legal threat. Feel free to contact us at: info@biorius.com

Modification of the annex II

Reference NumberChemical Name/INNCas NumberEC Number
‘10242-ethylhexanoic acid
and its salts with the
exception of those
specified elsewhere in
Annex VI to Regulation
(EC) No 1272/2008
149-57-5/-149-57-5/-

Addition to the annex II

Reference NumberChemical Name/INNCas NumberEC Number
‘XAmmonium bromide12124-97-9235-183-8
‘XDibutyltin bis(2-ethyl
hexanoate)
2781-10-4220-481-2
‘XDibutyltin di(acetate)1067-33-0213-928-8
‘XTellurium dioxide7446-07-3231-193-1
‘XBarium diboron tetraoxide13701-59-2237-222-4
‘X2,2-dimethylpropan-1-
ol,tribromo derivative;
3-bromo-2,2-bis(bromo
methyl)propan-1-ol
36483-57-5
1522-92-5
253-057-0
‘X2,4,6-tri-tert-butylphenol732-26-3211-989-5
‘X4,4’-sulphonyldiphenol;
bisphenol S
80-09-1201-250-5
‘XBenzophenone119-61-9204-337-6
‘XQuinoclamine (ISO);
2-amino-3-chloro-1,4-
naphthoquinone
2797-51-5220-529-2
XPerfluoroheptanoic acid;
tridecafluoroheptanoic acid
375-85-9206-798-9
‘Xmethyl N-(isopropoxy
carbonyl)-L-valyl- (3RS)-3-(4-
chlorophenyl)-β-alaninate;
valifenalate
283159-90-0608-192-3
‘X6-[C12-18-alkyl-(branched,
unsaturated)-2,5-
dioxopyrrolidin-1-
yl]hexanoic acid, sodium
and tris(2-hydroxyethyl)
ammonium salts
701-271-4
‘X6-[(C10-C13)-alkyl-
(branched, unsaturated)-
2,5-dioxopyrrolidin-1-yl]
hexanoic acid
2156592-54-8701-118-1
‘X6-[C12-18-alkyl-(branched,
unsaturated)-2,5-dioxopyrrolidin
1-yl] hexanoic acid
701-162-1
‘XTheophylline; 1,3 -di methyl
-3,7 -dihydro 1H purine -2,6-dione
58-55-9200-385-7
‘X1,3,5-triazine-2,4,6-
triamine; melamine
108-78-1203-615-4
‘XFluopicolide (ISO);
2,6-dichloro-N-[3-chloro5
(trifluoromethyl)-2-
pyridylmethyl]benzamide
607-285-6239110-15-7
‘XN-(2-nitrophenyl)
phosphoric triamide
874819-71-3477-690-9
‘XN-(5-chloro-2-isopropyl
benzyl)-N cyclopropyl-3-
(difluoromethyl)-5-fluoro-1-
methyl-1H-pyrazole-4-
carboxamide; isoflucypram
1255734-28-1811-438-4
‘XReaction mass of 3-
(difluoromethyl)-1-methyl
N-[(1RS,4SR,9RS)-1,2,3,4
tetrahydro-9-isopropyl-1,4
methanonaphthalen-5-
yl]pyrazole-4-carboxamide
and 3- (difluoromethyl)-1-
methyl-N-[(1RS,4SR,9SR)
1,2,3,4-tetrahydro-9-
isopropyl-1,4-methano
naphthalen-5-yl]pyrazole-4-
carboxamide [>78% syn
isomers
881685-58-1632-619-2
‘XMargosa, ext. [from the
kernels of Azadirachta
indica extracted with water
and further processed with
organic solvents]
84696-25-3283-644-7
‘XCumene98-82-8202-704-5
‘X2-ethyl-2-[[(1
oxoallyl)oxy]methyl]-1,3-
propanediyl diacrylate; 2,2-
bis(acryloyloxymethyl)butyl
acrylate;
trimethylolpropane
triacrylate
15625-89-5239-701-3
‘XPentapotassium
2,2’,2’’,2’’’,2’’’’-(ethane-1,2-
diylnitrilo)pentaacetate
7216-95-7404-290-3
‘XNcarboxymethyliminobis
(ethylenenitrilo)tetra(acetic
acid); Pentetic Acid (INCI)
67-43-6200-652-8
‘XPentasodium
(carboxylatomethyl)
iminobis(ethylenenitrilo)te
traacetate; Pentasodium
Pentetate (INCI)
140-01-2205-391-3
‘XAcetamiprid (ISO); (1E)-N-
[(6-chloropyridin3-
yl)methyl]-N’-cyano-
Nmethylethanimidamide;
(E)-N1-[(6-chloro-3-
pyridyl)methyl]-N2-cyano-
N1-methylacetamidine
135410-20-7
160430-64-8
603-921-1
682-791-8
‘XPendimethalin (ISO); N-(1-
ethylpropyl)-2,6- dinitro-
3,4-xylidene
40487-42-1254-938-2
‘XBentazone (ISO); 3-
isopropyl-2,1,3-benzothia
diazine-4-one-2,2-dioxide
25057-89-0246-585-8’

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