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EU Amends Prohibition and Restriction List for Cosmetic Ingredients in Response to New CMR Substance Classifications

October 3 2022

European Commission adds 14 prohibition entries, restricts one new substance and amends one entry for an allowed preservative in the Cosmetics Regulation following Regulation (EU) 2022/1531.

European Commission adds 14 prohibition entries, restricts one new substance and amends one entry for an allowed preservative in the Cosmetics Regulation following Regulation (EU) 2022/1531.

On September 15, 2022, the European Commission published Regulation (EU) 2022/1531 to amend Cosmetics Regulation (EC) No. 1223/2009 for the use of certain ingredients classified as carcinogenic, mutagenic or toxic for reproduction (CMR substances) in cosmetic products. The amendment is based on Commission Delegated Regulation (EU) 2021/849 to Regulation (EC) No. 1272/2008, which covers substances classified as CMR substances of categories 1A, 1B or 2.

Commission Regulation (EU) 2022/1531 will be enforced from October 6, 2022, with the new requirements being applied from December 17, 2022.

Per Article 15 of Cosmetics Regulation (EC) 1223/2009, substances classified as CMR of categories 1A, 1B or 2 under Regulation (EC) No. 1272/2008 are to be prohibited, unless the substance could fulfil the conditions laid down in Article 15(1) or Article 15(2) of Cosmetics Regulation.

Provisions include:

    1. Methyl salicylate/Methyl 2-hydroxybenzoate (CAS No. 119-36-8) is now classified as a category 2 CMR substance as toxic for reproduction. It is currently not listed in any Cosmetics Regulation annexes. Following SCCS final opinion (SCCS/1633/21) of October 26-27, 2021, it is considered safe in cosmetic products if the maximum level of use conforms to defined limits relating to each product category.

      Therefore, Methyl salicylate will be included in Annex III of the Cosmetics Regulation with the following restrictions and maximum concentration of use limits:

      1. 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): 0.06%
      2. Face makeup (except lip products, eye makeup and makeup remover): 0.05%
      3. Eye makeup and makeup remover: 0.002%
      4. Leave-on hair products (spray/aerosol): 0.009%
      5. Deodorant spray/aerosol: 0.003%
      6. Body lotion spray/aerosol: 0.04%
      7. Rinse-off skin products (except hand wash) and rinse-off hair products: 0.06%
      8. Hand wash: 0.6%
      9. Hydroalcoholic-based fragrances: 0.03%
      10. Lip products: 0.03%
      11. Toothpaste: 2.52%
      12. Mouthwash intended for children aged 6-10 years: 0.1%
      13. Mouthwash intended for children above 10 years of age and adults: 0.6%
      14. Mouth spray: 0.65%

Note: Methyl salicylate must not be used in preparations for children under six years of age, with the following exception (k) “Toothpaste”

    1. All other substances classified as CMR in Regulation (EU) 2021/849, except Methyl salicylate, are prohibited and added to Annex II of Regulation (EC) 1223/2009 as no requests for exemption were submitted. The new entries are:

      • 1681: Tetrafluoroethylene (CAS 116-14-3)
      • 1682: 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol; [DBMC] (CAS 119-47-1)
      • 1683: (5-chloro-2-methoxy-4-methyl-3-pyridyl)(4,5,6-trimethoxy-o-tolyl)methanone; pyriofenone (CAS 688046-61-9)
      • 1684: (RS)-1-{1-ethyl-4-[4-mesyl-3-(2-methoxyethoxy)-o-toluoyl]pyrazol-5-yloxy}ethyl methyl carbonate; tolpyralate (CAS 1101132-67-5)
      • 1685: Azamethiphos (ISO); S-[(6-chloro-2-oxooxazolo[4,5-b]pyridin-3(2H)-yl)methyl] O,O-dimethyl thiophosphate (CAS 35575-96-3)
      • 1686: 3-methylpyrazole (CAS 1453-58-3)
      • 1687: N-methoxy-N-[1-methyl-2-(2,4,6-trichlorophenyl)-ethyl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide; pydiflumetofen (CAS 1228284-64-7)
      • 1688: N-{2-[[1,1'-bi(cyclopropyl)]-2-yl]phenyl}-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide; sedaxane (CAS 874967-67-6)
      • 1689: 4-methylpentan-2-one; isobutyl methyl ketone (MIBK) (CAS 108-10-1)
      • 1690: Dimethomorph (ISO); (E,Z)-4-(3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl)morpholine (CAS 110488-70-5)
      • 1691: Imazamox (ISO); (RS)-2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-5-methoxymethylnicotinic acid (CAS 114311-32-9)
      • 1692: Thiamethoxam (ISO); 3-(2-chloro-thiazol-5-ylmethyl)-5-methyl[1,3,5]oxadiazinan-4-ylidene-N-nitroamine (CAS 153719-23-4)
      • 1693: Triticonazole (ISO); (RS)-(E)-5-(4-chlorobenzylidene)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-methyl)cyclopentanol (CAS 138182-18-0)
      • 1694: Desmedipham (ISO); ethyl 3-phenylcarbamoyloxyphenylcarbamate (CAS 13684-56-5)

    2. Sodium n-(hydroxymethyl)glycinate (CAS No 70161-44-3) is classified as a carcinogenic category 1B and mutagenic category 2 CMR substance. This applies only when it cannot be shown that the maximum theoretical concentration of releasable formaldehyde in the mixture is less than 0.1%.

      Currently it is listed in Annex II and Annex V as an allowed preservative. These Annexes are therefore corrected as follows:

      • Amended – Annex V entry 51: Sodium hydroxymethylglycinate/Sodium N-(hydroxymethyl) glycinate is restricted to a maximum concentration of use of 0.5% and must not be used unless it can be shown that the maximum theoretical concentration of releasable formaldehyde in the mixture as placed on the market, irrespective of the source, is <0.1% w/w

      • Deleted – Annex II entry 1669 Sodium N-(hydroxymethyl)glycinate; [formaldehyde released from sodium N-(hydroxymethyl)glycinate]

Reference source:

    1. Commission Delegated Regulation (EU) 2021/849
    2. Regulation (EU) 2022/1531
    3. SCCS/1633/21 opinion on 26-27 October 2021

Next step

For new formulations, we suggest you follow the new requirements that will applied at the end of the year. For existing formulations, we suggest a quick review of your formulation to ensure compliance.

Queenie Tse
Cosmetics & Hygiene - Technical Service Manager


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