Regulatory changes in EU Cosmetics Law: Regulation (EU) 2026/78

The European Commission has adopted Regulation (EU) 2026/78, amending the EU’s Cosmetics Regulation regarding which substances should be classified as carcinogenic, mutagenic or reprotoxic (CMR). With these new rules, the Commission is taking a further step towards strengthening the EU’s legal framework for consumer protection in the field of cosmetics. The Regulation came into force on 1 May 2026.

Background

Cosmetic products available in the EU market are regulated by Regulation (EC) No 1223/2009 on cosmetic products (the Cosmetics Regulation). The regulatory framework applies to all products in the Member States, regardless of whether the products are manufactured in the EU or imported from third countries. A key principle of the Cosmetics Regulation is that, as a general rule, substances classified as carcinogenic, mutagenic or reprotoxic, known as CMR substances, are prohibited in cosmetic products.

Scientific knowledge regarding the hazards of chemical substances is constantly evolving, meaning that the regulatory framework needs to be updated accordingly. In autumn 2024, a number of new substances were classified as CMR substances through Commission Delegated Regulation (EU) 2024/2564. The new classifications triggered a need to amend the annexes to the Cosmetics Regulation. The European Commission therefore adopted Regulation (EU) 2026/78 on 12 January 2026, the latest in a series of what are known as Omnibus regulations that will gradually adapt the safety requirements for cosmetic products to current scientific knowledge. The updates include new prohibitions, stricter limit values and restrictions on the use of CMR substances.

New CMR substances prohibited from cosmetic products

Several substances have been classified as CMR substances and are consequently now prohibited, meaning they can no longer be used in cosmetic products sold in the EU. The new prohibited substances include, but are not limited to, multi-walled carbon nanotubes, acetone oxime, trimethyl borate and particular forms of silver. These substances are commonly used in products such as deodorants, mascaras and other makeup products, including eyeshadows and lip products.

Merger of entries relating to Perboric acid and its salts

Perboric acid and its salts have previously been prohibited in cosmetic products but listed under three different entries. They remain prohibited, but Perboric acid and its salts are all perborate derivatives and structurally closely related. Given that the substances share a common mode of action and pose similar health risks, they have now been merged into the same entry in the interests of clarity, legal certainty and simplification.

Amendments in the regulation of silver

Prior to the new regulation, the substance silver (CAS No 7440-22-4) was classified as reprotoxic. In the new regulation, silver massive (when its particle diameter is 1 mm or larger) and silver nano (when its particle diameter is larger than 1 nm and smaller than or equal to 100 nm) are prohibited. Silver powder (when its particle diameter is larger than 100 nm and smaller than 1mm) may however be used under specific conditions. Silver powder is only permitted as a colourant in lip products and eye shadow at a maximum concentration of 0.2%. Silver powder may also be used in toothpaste and mouthwash at a maximum concentration of 0.05%.

Restrictions on the use of Hexyl Salicylate

The substance hexyl 2-hydroxybenzoate (INCI name Hexyl Salicylate), commonly used in perfumes, has been classified as a CMR substance. However, it has now been concluded that Hexyl Salicylate can be considered safe under specific conditions of use in cosmetic products. It may therefore now be used in some cosmetic products in limited concentrations, but in most cases not in products intended for children under the age of 3.

Amended provisions concerning o-Phenylphenol and Sodium o-Phenylphenate as preservatives

The substance biphenyl-2-ol (INCI name o-Phenylphenol) has been classified as a CMR substance but is a permitted preservative in rinse-off and leave-on products, with a maximum permitted concentration of 0.2% and 0.15%, respectively. The sodium salt of the substance, Sodium o-Phenylphenate, has previously not been listed. It has now been concluded that both o-Phenylphenol and Sodium o-Phenylphenate can be considered safe under specific conditions of use in cosmetic products.

Conclusion

While the updates to the Cosmetic Regulation reflect the latest scientific knowledge regarding CMR substances, they also entail changes in the regulatory landscape for businesses in the cosmetics sector. The changes apply to all cosmetics currently marketed within the EU, and cosmetics companies should already have adapted their businesses to these changes.

Please do not hesitate to contact Setterwalls if you have any questions about the new rules or what they mean for your business.