There are more novelties in the cosmetic law ahead of us. On September 15th, the Commission Regulation (EU) 2022/1531 was published, introducing the above-mentioned changes – more about them below.
There has been a lot of hype around methyl salicylate (INCI: Methyl Salicylate) for some time. This ingredient is used in cosmetics as a fragrance ingredient, flavouring agent and soothing agent. However, studies have shown that it has the potential to be toxic to reproduction, leading to the classification of methyl salicylate as CMR (carcinogenic, mutagenic or toxic for reproduction) category 2.
The Scientific Committee on Consumer Safety (SCCS) has assessed methyl salicylate and found it safe for use in certain cosmetic products (opinion no. SCCS / 1633/21). Therefore, Methyl Salicylate was included in the Annex III of the Cosmetics Regulation, ie the list of restricted substances. So far, this substance has not been subject to any restrictions of use in cosmetics. Now, methyl salicylate will take the position 324 in the Annex III. There are 14 categories of cosmetics in which it will be possible to use this compound together with the maximum allowable concentrations. In addition, methyl salicylate will not be used in formulations for children under 6 years of age, with the exception of toothpastes. For convenience, the conditions for using salicylate in each product category are presented in the table below.
|Product category||Maximum allowable concentration|
|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%|
|Face makeup (except lip products, eye makeup and makeup remover)||0,05%|
|Eye makeup and makeup remover||0,002%|
|Leave-on hair products (spray/aerosol)||0,009%|
|Body lotion spray/aerosol||0,04%|
|Rinse-off skin products (except hand wash) and rinse-off hair products||0,06%|
|Mouthwash intended for children aged 6–10 years||0,1%|
|Mouthwash intended for children above 10 years of age and adults||0,6%|
Corrigendum regarding sodium hydroxymethylglycinate
In Commission Regulation (EU) 2021/1902, sodium N-(hydroxymethyl)glycinate (INCI: Sodium Hydroxymethylglycinate) was incorrectly added to the list of prohibited substances in Annex II as entry 1669 to Regulation (EC) No 1223/2009. This compound is already listed in entry 51 of Annex V to the Cosmetics Regulation as ” Sodium hydroxymethylamino acetate” as a preservative allowed in cosmetic products. The substance should not be listed both as banned in Annex II and as an allowed preservative in Annex V. Therefore entry 1669 will be deleted from Annex II of the Cosmetics Regulation.
In addition, the list of permitted preservatives (Annex V), which includes Sodium Hydroxymethylglycinate, also needs to be corrected. Entry 51 in Annex V contains an error in column (b) with regard to the chemical name of the substance. The correct name for the compound is Sodium N-(hydroxymethyl)glycinate (previously it was: Sodium hydroxymethylamino acetate). The additional condition in column (h) regarding the maximum theoretical concentration of formaldehyde was also incorrectly worded: “Not to be used if the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, if the mixture as placed on the market is ≥ 0,1 % w/w“. The correct wording has now been changed to: ” 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’“.
New banned substances
The regulation also provides the introduction of 14 new prohibited substances in Annex II. These substances were previously classified as CMRs. Annex II of the Cosmetics Regulation will already contain 1694 compounds. The new substances banned from use in cosmetics include for example:
- 6,6′-Di-tert-butyl-2,2′-methylenedi-p-cresol [DBMC],
- 4-Methylpentan-2-one; isobutyl methyl ketone (MIBK),
- Desmedipham (ISO); ethyl 3-phenylcarbamoyloxyphenylcarbamate.
The new regulation concerning methyl salicylate and new banned substances will apply from December 17th, 2022. Cosmetic products that do not comply with the new rules will not be allowed to be made available in the supply chain from December 17 this year and will have to be withdrawn. Regarding the correction to Sodium Hydroxymethylglycinate, it will apply from the twentieth day after the publication of Regulation 2022/1531 in the Official Journal of the European Union.
Regulation 2022/1531 can be found at: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022R1531&from=EN
The SCCS opinion on methyl salicylate can be found here: https://health.ec.europa.eu/system/files/2022-08/sccs_o_255.pdf