On 15 September 2022, the European Commission published the "CMR Omnibus V", formally EU Regulation 2022/1531, which is based on the 17th ATP (Adaptation to Technical Progress) of the CLP chemicals legislation.

The new rules for changes in Annex II (prohibitions) and Annex III (restrictions) enter into force on 17 December 2022, in accordance with the date specified in 17 ATP to CLP. As always, the rules lack a transition period when it comes to CMR Omnibuses.

CMR substances

In Annex II, the following entries are added:

• Tetrafluoroethylene, CAS no 116-14-3
• 6,6′-di-tert-butyl-2,2′-methylenedi-p-cresol;[DBMC] , CAS no 119-47-1
• (5-chloro-2-methoxy-4-methyl-3-pyridyl)(4,5,6-trimethoxy-otolyl)methanone; pyriofenone, CAS no 688046-61-9
• (RS)-1-{1-ethyl-4-[4-mesyl-3-(2-methoxyethoxy)-o-toluoyl]pyrazol-5-yloxy}ethyl methyl carbonate; tolpyralate, CAS no 1101132-67-5
• Azamethiphos (ISO); S-[(6-chloro-2-oxooxazolo[4,5-b]pyridin-3(2H)-yl)methyl] O,O-dimethyl thiophosphate, CAS no 35575-96-3
• 3-methylpyrazole, CAS no 1453-58-3
• N-methoxy-N-[1-methyl-2-(2,4,6-trichlorophenyl)-ethyl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide; pydiflumetofen, CAS no 1228284-64-7
• N-{2-[[1,1′-bi(cyclopropyl)]-2-yl]phenyl}-3-(difluoromethyl)-1-methyl1H-pyrazole-4-carboxamide; sedaxane, CAS no 874967-67-6
• 4-methylpentan-2-one; isobutyl methyl ketone (MIBK), CAS no 108-10-1
• Dimethomorph (ISO); (E,Z)-4-(3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl)morpholine, CAS no 110488-70-5
• Imazamox (ISO); (RS)-2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-5-methoxymethylnicotinic acid, CAS no 114311-32-9
• Thiamethoxam (ISO); 3-(2-chloro-thiazol-5-ylmethyl)-5-methyl[1,3,5]oxadiazinan-4-ylidene-N-nitroamine, CAS no 153719-23-4
• Triticonazole (ISO); (RS)-(E)-5-(4-chlorobenzylidene)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-methyl)cyclopentanol, CAS no 138182-18-0
• Desmedipham (ISO); ethyl 3-phenylcarbamoyloxyphenylcarbamate , CAS no 13684-56-5

Methyl Salicylate

Methyl Salicylate (CAS no 119-36-8) is added in Annex III as follows, based on the conclusion of the SCCS opinion (SCCS/1633/21). Note that it cannot be used in preparations for children under 6 years of age with the exception of "Toothpaste".

• Leave-on skin products (except face makeup, spray/aerosol body lotion, spray/aerosol deodorant, and hydroalcoholic-based fragrances) and leave-on hair products (except spray/aerosol products): Maximum 0.06%
• Face makeup (except lip products, eye makeup and makeup remover): Maximum 0.05%
• Eye makeup and makeup remover: Maximum 0.002%
• Leave-on hair product (spray/aerosol): Maximum 0.009%
• Deodorant Spray/aerosol: Maximum 0.003%
• Body lotion spray/aerosol: Maximum 0.04%
• Rinse-off skin products (except hand wash) and rinse-off hair products: Maximum 0.06%
• Hand wash: 0.6%
• Hydroalcoholic-based fragrances: Maximum 0.6%
• Lip products: Maximum 0.03%
• Toothpaste: Maximum 2.52%
• Mouthwash intended for children aged 6-10 years: Maximum 0.1%
• Mouthwash intended for children above 10 years of age and adults: Maximum 0.6%
• Mouth spray: Maximum 0.65%

Sodium Hydroxymethylglycinate

Sodium Hydroxymethylglycinate (CAS no 70161-44-3) is deleted from Annex II, and thus is kept in Annex V as a preservative under the following restrictions:

• Maximum concentration of 0.5% and
• Not to be used if it cannot be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is ≤0.1% w/w.