Regulation (EC) No 1272/2008, commonly known as CLP Regulation, provides for a harmonized classification of substances as carcinogenic, mutagenic or toxic for reproduction (CMR) based on an opinion prepared by the Committee for Risk Assessment of the European Chemicals Agency (ECHA). Depending on the level of evidence of their CMR properties, substances are classified as CMR substances of category 1A, 1B or category 2.
By default, the use of substances classified as CMR under the CLP Regulation is banned according to Article 15 of the European Cosmetics Regulation (EC) No. 1223/2009. Nevertheless, a CMR substance may be used in cosmetic products, by way of exception, if specific conditions are fulfilled.
With the aim of implementing the prohibition of CMR substances, ensure legal compliance (particularly for economic operators and national competent authorities) and to ensure a high level of protection of human health, these compounds are included in Annex II (List of Substances Prohibited in Cosmetics Products) or Annex III (List of Substances Which Cosmetic Products Must Not Contain Except Subject to the Restrictions Laid Down) of the European Cosmetics Regulation. A CMR substance may also be deleted from Annexes III to VI of the Regulation for these purposes.
The European Commission has published the Commission Regulation (EU) 2022/1531, which amends the Regulation (EC) No 1223/2009 as regards the use in cosmetic products of certain substances classified as CMR, by adding new entries to Annex II and Annex III and revising an entry in Annex V.
To Annex II (List of Substances Prohibited in Cosmetic Products), this Commission Regulation adds 14 new substances. For example, Methylene di-t-butylcresol/[DBMC] (CAS number: 119-47-1) and MIBK (CAS number: 108-10-1) are now prohibited in cosmetic products.
The substance Sodium Hydroxymethylglycinate (CAS number: 70161-44-3) was classified as carcinogenic of category 1B and mutagenic of category 2 by the Commission Delegated Regulation (EU) 2020/1182, and included in Annex VI of the CLP Regulation (Harmonised Classification and Labelling for Certain Hazardous Substances). Sodium Hydroxymethylglycinate is included in Annex V (List of Preservatives Allowed in Cosmetic Products, entry 51) of the European Cosmetics Regulation and may be used up to a maximum concentration of 0.5% in the finished product. However, this ingredient shall not be used in cosmetic products 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 (see previous publication). Previously, this substance was erroneously included in Annex II (List of Substances Prohibited in Cosmetic Products). The wording of this condition was adapted by the Commission Regulation (EU) 2022/1531 to correctly reflect the prohibition of the substance in cosmetic products. As a substance should not be listed in both Annex II and Annex V, the European Commission deleted this substance from Annex II (entry 1669).
Methyl Salicylate (CAS number: 119-36-8) is the ester of methyl alcohol and salicylic acid and is used, in cosmetics and personal care products, as a denaturant, flavouring, oral care, perfuming and soothing agent. This substance was classified as toxic for reproduction (CMR substance, category 2) under the CLP Regulation, but, until now, it was not included in the Annexes to Regulation (EC) No 1223/2009. In October 2021, the Scientific Committee on Consumer Safety (SCCS) issued its final opinion on Methyl Salicylate. The Committee concluded that Methyl Salicylate is considered safe when used in cosmetics up to the maximum concentration provided in the dossier submitted (see previous post). Considering its classification as a CMR substance of category 2 and the SCCS opinion, the European Commission concluded that Methyl Salicylate should be added to the List of Substances Restricted in Cosmetic Products (Annex III to Regulation, entry 324), in accordance with the following table:
Table 1 – Restrictions applied to the use of Methyl Salicylate in cosmetic products.
|Product type, Body parts||Maximum concentration in ready for use preparation|
|a) 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)||0,06%|
|b) Face makeup (except lip products, eye makeup and makeup remover||0,05%|
|c) Eye makeup and makeup remover||0,002%|
|d) Leave-on hair products (spray/aerosol)||0,009%|
|e) Deodorant spray/aerosol||0,009%|
|f) Body lotion spray/aerosol||0,04%|
|g) Rinse-off skin products (except hand wash) and rinse-off hair products||0,06%|
|h) Hand wash||0,6%|
|i) Hydroalcoholic-based fragrances||0,6%|
|j) Lip products 0||0,03%|
|l) Mouthwash intended for children aged 6–10 years||0,1%|
|m) Mouthwash intended for children above 10 years of age and adults||0,6%|
|n) Mouth spray||0,65%|
The amendments to the European Cosmetic Regulation are applicable from 17 December 2022 onwards. Products must be compliant from this date.
1. Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
2. Regulation (EU) 2022/1531 adding new entries to Annex II and Annex III and revising an entry in Annex V of Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products.