The European Union published Regulation 2022/1531, the 5th annual text aiming to ban or regulate substances recently classified as CMR.
This Regulation deals with substances classified as CMR by Regulation 2021/849 (17th ATP to CLP), which will apply from 17 December 2022.
14 new substances entry in Annex II (banned substances) to the Cosmetics Regulation 1223/2009, provides for new use restrictions for Methyl Salicylate and corrects Annexes II and V for the entries concerning Sodium hydroxymethylglycinate (preservative).
Annexes II and III of the Regulation (EC) No 1223/2009 are amended as follows.
In Annex II, the following entries are added.
| Reference number |
Substance | ||
| Chemical name/INN | CAS number | EC number | |
| 1681 | Tetrafluoroethylene INCI: – |
116-14-3 | 204-126-9 |
| 1682 | 6,6’-di-tert-butyl-2,2’-methylenedi-p-cresol; [DBMC] INCI: Methylene Di-T-Butylcresol |
119-47-1 | 204-327-1 |
| 1683 | (5-chloro-2-methoxy-4-methyl-3-pyridyl)(4,5,6-trimethoxy-otolyl)methanone; pyriofenone INCI: – |
688046-61-9 | 692-456-8 |
| 1684 | (RS)-1-{1-ethyl-4-[4-mesyl-3-(2-methoxyethoxy)-o-toluoyl]pyrazol-5-yloxy}ethyl methyl carbonate; tolpyralate INCI: – |
1101132-67-5 | 701-225-3 |
| 1685 | Azamethiphos (ISO); S-[(6-chloro-2-oxooxazolo[4,5-b]pyridin-3(2H)-yl)methyl] O,O-dimethyl thiophosphate INCI: – |
35575-96-3 | 252-626-0 |
| 1686 | 3-methylpyrazole INCI: – |
1453-58-3 | 215-925-7 |
| 1687 | N-methoxy-N-[1-methyl-2-(2,4,6-trichlorophenyl)-ethyl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide; pydiflumetofen INCI: – |
1228284-64-7 | 817-852-1 |
| 1688 | N-{2-[[1,1’-bi(cyclopropyl)]-2-yl]phenyl}-3-(difluoromethyl)-1-methyl1H-pyrazole-4-carboxamide; sedaxane INCI: – |
874967-67-6 | 688-331-2 |
| 1689 | 4-methylpentan-2-one; isobutyl methyl ketone (MIBK) INCI: MIBK |
108-10-1 | 203-550-1 |
| 1690 | Dimethomorph (ISO); (E,Z)-4-(3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl)morpholine INCI: – |
110488-70-5 | 404-200-2 |
| 1691 | Imazamox (ISO); (RS)-2-(4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl)-5-methoxymethylnicotinic acid INCI: – |
114311-32-9 | 601-305-7 |
| 1692 | Thiamethoxam (ISO); 3-(2-chloro-thiazol-5-ylmethyl)-5-methyl[1,3,5]oxadiazinan-4-ylidene-N-nitroamine INCI: – |
153719-23-4 | 428-650-4 |
| 1693 | Triticonazole (ISO); (RS)-(E)-5-(4-chlorobenzylidene)-2,2-dimethyl-1-(1H-1,2,4-triazol-1-methyl)cyclopentanol INCI: – |
138182-18-0 | – |
| 1694 | Desmedipham (ISO); ethyl 3-phenylcarbamoyloxyphenylcarbamate INCI: – |
13684-56-5 | 237-198-5 |
In Annex III, the following entry is added.
INCI: Methyl Salicylate
CAS number: 119-36-8, EC number: 204-317-7
Restrictions
- a) Leave-on skin products (except face makeup, spray/aerosol body lotion, spray/aerosol deodorant and hydro alcoholic-based fragrances) and leave-on hair products (except spray/aerosol products)
- b) Face makeup (except lip products, eye makeup and makeup remover)
- c) Eye makeup and makeup remover
- d) Leave-on hair products (spray/aerosol)
- e) Deodorant spray/aerosol
- f) Body lotion spray/aerosol
- g) Rinse-off skin products (except hand wash) and rinse-off hair products
- h) Hand wash
- i) Hydro alcoholic-based fragrances
- j) Lip products
- k) Toothpaste
- l) Mouthwash intended for children aged 6–10 years
- m) Mouthwash intended for children above 10 years of age and adults
- n) Mouth spray
- Maximum concentration in ready use preparation
- a) 0.06%
- b) 0.05%
- c) 0.002%
- d) 0.009%
- e) 0.003%
- f) 0.04%
- g) 0.06%
- h) 0.6%
- i) 0.6%
- j) 0.03%
- k) 2.52%
- l) 0.1%
- m) 0.6%
- n) 0.65%
- Other
Not to be used in preparations for children under 6 years of age, with the exception of (k) “Toothpaste”.
Annexes II and V to Regulation (EC) No 1223/2009 are corrected as follows.
1) In Annex II, entry 1669 is deleted.
2) In Annex V, entry 51 is replaced by the following.
Reference number
- 51
INCI: Sodium Hydroxymethylglycinate
CAS number: 70161-44-3, EC number: 274-357-8
- Maximum concentration in ready use preparation: 0.5%
- Other
Not to be used unless it can 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.
Source
• Commission Regulation (EU) 2022/1531 of 15 September 2022 amending Regulation (EC) No.1223/2009 of the European Parliament and of the Council as regards the use in cosmetic products of certain substances classified as carcinogenic, mutagenic or toxic for reproduction and correcting that Regulation, Official Journal of the European Union, L 240/3, 16 September 2022.