Europe to enforce and extend list of banned toxic chemicals in cosmetic regulations
27 Sep 2022 --- The European Commission (EC) has ramped up its restrictions on cosmetic substances classified as carcinogenic, mutagenic or reprotoxic (CMR), with additions and amendments to its existing regulations. Regulation 2022/1531, which outlines the substances, has been published to amend Annex II, III and V of the Cosmetics Regulation EC 1223/2009.
The amended regulation will enter into force 20 days after publication, on October 6, and the restrictions on CMR will be applied on December 17, 2022.
“The substances are classified as CMR substances of category 1A, CMR substances of category 1B or CMR substances of category 2 depending on the level of evidence of their CMR properties,” outlines the EC.
Category 1A means that substances are evidenced to be CMR to humans. Category 1B means that substances are evidenced to be CMR to animals and are presumed to be CMR to humans. Category 2 substances are suspected of CMR from little evidence on humans and animals.
The restrictions on CMR will be applied on December 17, 2022.
Safe but toxic for reproduction?
Methyl salicylate is used as a fragrance ingredient, flavoring agent and soothing agent in various cosmetic products and was not listed in Regulation 1223/2009.
Methyl 2-hydroxybenzoate (CAS No 119-36-8), or methyl salicylate as known in the International Nomenclature Cosmetics of Ingredient (INCI), has been classified as a CMR substance of category 2 (Toxic for Reproduction).
However, the Scientific Committee on Consumer Safety (SCCS) found a safe use for the compound as Article 15 (1) of Regulation 1223/2009 allows the use of CMR substances in cosmetics where the substance has been evaluated.
Safe concentrations for methyl salicylate
In October last year, SCCS concluded that methyl salicylate could be considered safe in cosmetic products when use is within set limits. So the ingredient and its application limits were added to Annex III of Regulation 1223/2009.
The maximum concentration of methyl salicylate is 0.06% in leave-on skin products (except face makeup, spray or aerosol body lotion, spray or aerosol deodorant and hydroalcoholic-based fragrances) and leave-on hair products (except spray or aerosol products).
In addition, the compound’s maximum concentration for face makeup (except lip products, eye makeup and makeup remover) is 0.05%. For eye makeup and makeup remover, the maximum concentration is 0.02% and for leave-on hair products (spray or aerosol), it is 0.009%.
Methyl salicylate’s maximum concentration for deodorant spray or aerosol is 0.003%, whereas body lotion spray or aerosol is 0.04%. For rinse-off skin products (except hand wash) and rinse-off hair products, it is 0.06%. For hand washing, it is 0.6%. 
Category 1A means that substances are evidenced to be CMR to humans.
The maximum concentration for hydroalcoholic-based fragrances is 0.6%. For lip products, it is 0.03% and for toothpaste, it is 2.52%.
For mouthwash intended for children aged six to ten years of age and adults, methyl salicylate’s maximum concentration is 0.1%. In contrast, for mouthwash intended for children above ten years of age and adults, it is 0.6%. In mouth spray, it is 0.65%.
CMR substances added and revised
In Annex II of Regulation 1223/2009, 14 substances classified as CMR Category 1A, 1B or 2 have been added.
Some include tetrafluoroethylene, DBMC, methanone; pyriofenone and ethyl methyl carbonate; tolpyralate. Also, O,O-dimethyl thiophosphate, 3-methylpyrazole, pydiflumetofen, sedaxane and isobutyl methyl ketone have been added.
The last few include dimethomorph, imazamox, thiamethoxam, triticonazole and desmedipham.
Additionally, entry 1669 has been deleted in Annex II.
In Annex IV, entry 51 has been replaced by sodium N-(hydroxymethyl)glycinate. “[It is] 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’,” states the EC.
Last week, the EC outlined 56 ingredients to be added to Regulation 1223/2009 – which include more than 80 fragrances – individually required to be declared as allergens “if their concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products.”
By Venya Patel
