EU regulatory move threatens certain substances used in cosmetics due to toxicity risks
14 Jul 2022 --- The European Union (EU) has revised the Classification, Labeling and Packaging (CLP) of Substances and Mixtures, which outlines the use of chemicals, 12 of which are relevant for cosmetics use and six of which are classified as carcinogenicity, mutagenicity and reproductive toxicity (CMR).
“The Regulation (EU) 2022/692 or ATP 18 classifies the substances listed as CMR, so the companies that have cosmetic products containing these substances have to reformulate their products to avoid the presence of these substances,” Elisa Esteve, regulatory affairs manager and media content creator at Cosmeservice, tells PersonalCareInsights.
“Also, the products available on the market have to be withdrawn. The classification of the substances at CLP directly applies to all products, cosmetics or not.”
The Regulation will enter into force this month and will be applied on November 23, 2023.
CMR1 substances include Benzophenone, Theophylline, Pentasodium Pentetate and Pentetic Acid.
Moreover, the European Commission (EC) yesterday spoke with PersonalCareInsights on the limitations of other potentially harmful UV filter chemicals used in cosmetics.
“Cosmetics containing concentrations that are above the maximum concentrations found safe for Benzophenone-3 and Octocrylene used in the respective product categories will be banned. The ban will be implemented gradually,” they state.
Chemicals in question
The chemicals classified as CMR1 include Benzophenone as a carcinogen and Theophylline, Pentasodium Pentetate and Pentetic Acid, which are listed as reproductive toxins.
According to the National Center for Biotechnology Information (NCBI), Benzophenone is an additive in fragrances, cosmetics, toiletries, laundry and household cleaning products. Pentasodium Pentetate and Pentetic Acid are used as chelating agents in cosmetics.
Hazardous CMR2 substances include the carcinogen Melamine and the reproductive toxins Azadirachta Seed extract and Trimethylolpropane Triacrylate.
Human and environmental safety
Esteve shares that CLP Regulation (EC) No 1272/2008 is based on the United Nations’ Globally Harmonized System, and its purpose is to ensure a high level of protection for health and the environment, as well as the free movement of substances, mixtures and articles.
“These types of classifications are always made to keep the consumers safe. Sometimes the industry is greatly affected but, in the end, consumer safety is more important, and the cosmetic industry has a great power to reinvent itself and is constantly changing, so it will be easy this time.”
“Manufacturers, importers or downstream users have to (self)classify and label hazardous substances and mixtures to ensure a high level of protection of human health and the environment,” they outline.
The concern of prioritizing human safety comes as the personal care industry faces inconsistent animal testing regulations between chemicals and cosmetics. The European Chemicals Agency (ECHA) and EC previously spoke to us about using animal testing as a last resort, while Unilever, The Body Shop and Peta claimed otherwise. 
CMR2 substances include Melamine, Azadirachta Seed extract and Trimethylolpropane Triacrylate.
Processing the act with ECHA
Esteve explains that the EC is assisted by the expert group CARACAL (Competent Authorities for the REACH and CLP Regulations), who prepare a delegated act for the classification and labeling of the substances concerned, following the CLP Regulation and with the consultation of stakeholders.
“The EC adopts the delegated act and notifies the Council and the European Parliament, who, after a period of objection, include the substances in Part 3 of Annex VI to the CLP Regulation. Delegated Acts are published in the Official Journal after the expiry of the objection period.”
After that, all manufacturers, importers and downstream users of the substance in the EU must classify the substance following the entry in Annex VI, Esteve continues.
“At this time, if the substance is classified at CLP as a CMR substance, it cannot be used in cosmetic products, as Regulation 1223/2009 on cosmetic products prohibits its use with Article 15 stating that ‘The use in cosmetic products of substances classified as CMR substances, of category 1A or 1B, or category 2, under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be prohibited’,” concludes Esteve.
By Venya Patel
