New EU CMR list to ban 15 ingredients, four more under review by ECHA

The European Union (EU) has added 15 prohibited substances and two restricted substances to its updated list of chemical ingredients recently classified as carcinogenic, mutagenic, or toxic for reproduction (CMR). The amendment will enter into force on February 2, 2026, and will take effect across the EU on May 1, 2026, by which beauty companies must be compliant.

Alongside these restrictions, the European Chemicals Agency (ECHA) has published proposals for the harmonized classification and labeling (CLH) of four cosmetic ingredients, including maleic acid, ammonium vanadate, 1,4-butanediol, and dimethyl imidazolidinone.

Maleic acid and ammonium vanadate are often used in cosmetics for pH adjustments, 1,4-butanediol is a cosmetic solvent and skin conditioner, while dimethyl imidazolidinone is used as a skin and hair conditioning agent and moisturizer. These substances primarily pose a health risk when ingested, when in contact with the eyes, or through prolonged exposure, such as absorption.

Maleic acid, when applied to the skin for six weeks, has caused acute vascular dermatitis in 17 out of 50 subjects and has been recorded to lead to inflammatory responses on the skin at 24 and 48 hour markers. Similarly, the concern around ammonium vanadate use stems from its highly toxic form in large quantities and the adverse effects it may pose as a consequence of long-term exposure. 

Studies on risks associated with low-volume exposure to 1,4-butanediol are ongoing. However, tentative findings suggest that genetically dependent toxic reactions occur with prolonged topical exposure. Dimethyl imidazolidinone is another typically toxic chemical that is used in cosmetics in small quantities, which may pose a long-term threat. ECHA will determine the safety of these substances in the quantities that they are featured in day-to-day cosmetics.

While the proposed CLH classifications are still pending, interested parties can track updates on the status of the ingredient’s classifications via the ECHA database. 

Overview of new CMR ingredients

Fifteen of the substances included in the EU’s new list are categorized as 1B CMR, which bans them from use in cosmetic products. 

The report consolidates several ingredients under the umbrella of perboric acid and other related salts due to their similar chemical properties and biological activity.

These substances share a common borate core and release hydrogen peroxide upon dissolution in water. Depending on the concentration and type of exposure, hydrogen peroxide exposure in humans and the environment can lead to respiratory issues if inhaled, topical irritation on the skin, organ damage when ingested, and permanent damage with ocular exposure. The effects of hydrogen peroxide can vary from mildly irritating to fatal. Despite the potential severity of its adverse effects, it is not considered a carcinogen.

The EU has prohibited or restricted silver depending on its physical form, such as powder particle size, and volume.

Several cosmetic ingredients are under EU review due to potential long-term health risks.In nano [1 nm < particle diameter ≤ 100 nm] and massive forms [particle diameter ≥ 1 mm], silver is classified as a category 2 CMR substance. The EU attributes its decision to toxicological evidence indicating suspected reproductive toxicity with prolonged exposure, especially in nano and massive forms.

In powder form, it is listed in Annex III and is thus restricted but not prohibited. The updated CMR classification of silver in powder form allows for an exemption in oral care products, such as toothpaste and mouthwash, with a maximum concentration of 0.05%. In lip products and eye products, it can be used as a colorant with a maximum concentration of 0.2%. 

Implications for cosmetics

The EU mandates that CMR classified ingredients and their restrictions must be adhered to within 15 months of their classification. All ingredients classified as CMR 1A or 1B are automatically prohibited.

Ingredients classified as category 2 may be prohibited or restricted. To use these ingredients after their prohibition is illegal under Article 15 of the cosmetics regulation in EU law and can lead to mandatory product recalls, sales bans, fines, and criminal liability in certain cases.

Companies concerned with these ingredients are strongly encouraged to prepare for regulatory enforcement in advance.