Regulation (EU) 2026/78: CMR substances in the Cosmetics Regulation newly regulated

On 12 January 2026, the Commission adopted Regulation (EU) 2026/78, amending Annexes II, III, IV and V of the Cosmetics Regulation (EC) No 1223/2009. The reason is the new classification of substances as CMR (carcinogenic, mutagenic or toxic for reproduction) under Delegated Regulation (EU) 2024/2564. The changes apply from 1 May 2026.

What is the background

Under Article 15 of Regulation (EC) No 1223/2009, substances classified as CMR substances of category 1A, 1B or 2 in Annex VI, Part 3 of the CLP Regulation (EC) No 1272/2008 may generally not be used in cosmetic products. Use remains possible only if the exemption conditions of Article 15 are met. Regulation (EU) 2026/78 implements this system for the substances newly classified under Delegated Regulation (EU) 2024/2564. CMR substances for which no application for use has been submitted are added to Annex II (prohibited substances). For three substances, SCCS opinions are available that permit restricted use.

Silver: differentiation by particle size

Silver (CAS No. 7440-22-4) has been classified as a category 2 CMR substance (toxic for reproduction). The classification distinguishes according to particle diameter. In its opinion of 27 March 2024 (SCCS/1665/24), the SCCS concluded that silver particles in the micrometre range can be considered safe under certain conditions. The Regulation implements this in a differentiated manner:

• Annex II, entry 1727 (prohibited): silver as nanomaterial (1 nm < diameter ≤ 100 nm) and bulk silver (diameter ≥ 1 mm).
• Annex III, entry 379 (restricted): silver (powder, 100 nm < diameter < 1 mm) in toothpaste and mouthwash, each up to 0.05 %.
• Annex IV, entry 142 (colorant): silver (powder, CI 77820) in lip products and eye shadow, each up to 0.2 %.

Hexyl Salicylate newly added to Annex III

Hexyl 2-hydroxybenzoate (CAS No. 6259-76-3), listed under the INCI name Hexyl Salicylate, has been classified as a category 2 CMR substance (toxic for reproduction). The substance was not previously covered by the Cosmetics Regulation. Based on the SCCS opinion of 25 October 2024 (SCCS/1668/24), Hexyl Salicylate is added to Annex III (entry 380). The maximum concentrations are tiered by product type:

The entry includes the warning not to use the substance in products for children under 3 years, except for toothpaste and the products listed under point f (shower gels, hand cleansers, shampoos, hair conditioners, skin care products, lipsticks/lip balm and fragrance products for children under 3 years).

o-Phenylphenol and perboric acid

Biphenyl-2-ol (CAS No. 90-43-7, INCI o-Phenylphenol) has been classified as a category 2 carcinogen. The substance is already listed in Annex V (preservatives) as entry 7, with a maximum content of 0.2 % in rinse-off products and 0.15 % in leave-on products (each calculated as phenol). Based on the SCCS opinion of 25 October 2024 (SCCS/1669/24), the entry is extended to cover the sodium salt Sodium o-Phenylphenate (CAS No. 132-27-4). If both substances are used together, the total concentration (as phenol) must not exceed 0.2 % or 0.15 % respectively. The entry also prohibits use in applications that may lead to exposure of the lungs of the end user by inhalation, as well as in oral hygiene products, and includes the instruction to avoid contact with the eyes.

Entries 1397, 1398 and 1399 in Annex II relate to structurally related perborate derivatives. The Regulation consolidates these entries: entry 1397 is reworded and now also covers the content of former entries 1398 and 1399, which are deleted. In addition, Annex II is supplemented with new entries 1752 to 1766. These include, among others, multi-walled carbon tubes, acetone oxime (CAS No. 127-06-0), 1,4-dichloro-2-nitrobenzene (CAS No. 89-61-2) and trimethyl borate (CAS No. 121-43-7). No application for use of these substances in cosmetic products has been submitted, which is why they are added to the list of prohibited substances.

Deadlines and open questions

Regulation (EU) 2026/78 entered into force on the twentieth day following its publication in the Official Journal. It applies from 1 May 2026. The changes thus coincide in time with the entry into effect of the underlying CMR classifications from Delegated Regulation (EU) 2024/2564. The text of the Regulation does not specify separate sell-through or transitional periods for existing stock.

Formulations containing the substances mentioned, or carrying them as an impurity, are affected. A sensible first step is to compare the INCI declaration and raw material specifications against the new entries, in particular for silver (where particle size is decisive), Hexyl Salicylate and o-Phenylphenol. For substances newly added to Annex II, it should be checked whether they occur in formulations at all. The full legal text is available in the Official Journal of the EU (EUR-Lex). The consolidated base Regulation is also available via EUR-Lex.