New CMR Substances Banned: EU Cosmetic Regulation 2025/877

May 15, 2025

The European Commission has officially published Commission Regulation (EU) 2025/877, amending Regulation (EC) No 1223/2009 on cosmetic products. This new update prohibits the use of multiple substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) listed at Omnibus VII, reinforcing the EU’s long-standing precautionary principle in consumer safety.

The amendment was adopted on the 12^th of May 2025 and will apply from the 1^st of September 2025. Cosmetic products containing the newly banned substances may no longer be placed on the EU market from that date, and the products on the market containing these substances must be withdrawn.

Background: CMR Classification and Cosmetic Regulation 1223/2009

Under Article 15 of Regulation 1223/2009, substances classified as CMR under the CLP Regulation (Regulation (EC) No 1272/2008) are strictly regulated in cosmetics. Unless an exemption is granted under specific conditions (e.g., safe use demonstrated and authorised for use in food), their inclusion in cosmetic products is automatically prohibited.

The EU updates Annex II of Regulation 1223/2009 periodically to reflect the latest CMR classifications, typically known as “Omnibus Acts”. Regulation 2025/877 is the transposition of the seventh such update, often referred to as the Omnibus Act VII.

Substances Banned Under Regulation (EU) 2025/877

The newly prohibited substances, now listed in Annex II (list of substances prohibited in cosmetic products), include well-known raw materials and complex reaction masses, some of which may still be present in legacy formulations. These include:

diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide (75980-60-8).
2,2′,6,6′-tetrabromo-4,4′-isopropylidenediphenol; tetrabromobisphenol-A (79-94-7)
transfluthrin (ISO); 2,3,5,6-tetrafluorobenzyl (1R,3S)-3-(2,2-dichlorovinyl)-2,2- dimethylcyclopropanecarboxylate (118712-89-3)
clothianidin (ISO); (E)-1-(2-chloro-1,3-thiazol-5- ylmethyl)-3-methyl-2-nitroguanidine (210880-92-5)
benzyl(diethylamino)diphenylphosphonium 4- [1,1,1,3,3,3-hexafluoro-2-(4- hydroxyphenyl)propan-2-yl]phenolate (577705-90-9)
benzyltriphenylphosphonium, salt with 4,4′- [2,2,2-trifluoro-1- (trifluoromethyl)ethylidene]bis[phenol] (1:1) (75768-65-9)
reaction mass of 4,4′-[2,2,2-trifluoro-1- (trifluoromethyl)ethylidene]diphenol and benzyl(diethylamino)diphenylphosphonium 4- [1,1,1,3,3,3-hexafluoro-2-(4- hydroxyphenyl)propan-2-yl]phenolate (1:1)
reaction mass of 4,4′-[2,2,2-trifluoro-1- (trifluoromethyl)ethylidene]diphenol and benzyltriphenylphosphonium, salt with 4,4′- [2,2,2-trifluoro-1- (trifluoromethyl)ethylidene]bis[phenol] (1:1)
dimethyl propylphosphonate (18755-43-6)
dibutyltin maleate (78-04-6)
dibutyltin oxide (818-08-6)
reaction mass of 1-(2,3-epoxypropoxy)-2,2-bis ((2,3-epoxypropoxy)methyl) butane and 1-(2,3- epoxypropoxy)-2-((2,3-epoxypropoxy)methyl)-2- hydroxymethyl butane
4,4′-[2,2,2-trifluoro-1- (trifluoromethyl)ethylidene]diphenol; bisphenol AF (1478-61-1)
benfluralin (ISO); N-butyl-N-ethyl-α,α,αtrifluoro-2,6-dinitro-p-toluidin (1861-40-1)
N,N-dimethyl-p-toluidine (99-97-8)
1,4-Benzenediamine, N,N’-mixed Ph and tolyl derivs (68953-84-4)
4-nitrosomorpholine (59-89-2)
difenoconazole (ISO); 1-({2-[2-chloro-4-(4- chlorophenoxy)phenyl]-4-methyl-1,3-dioxolan-2- yl}methyl)-1H-1,2,4-triazole; 3-chloro-4- [(2RS,4RS;2RS,4SR)-4-methyl-2-(1H-1,2,4- triazol-1-ylmethyl)-1,3-dioxolan-2-yl]phenyl 4- chlorophenyl ether (119446-68-3)
4-methylimidazole (822-36-6)
3,3′-dimethylbiphenyl-4,4′-diyl diisocyanate (91-97-4)
foramsulfuron (ISO); 2-{[(4,6- dimethoxypyrimidin-2-yl)carbamoyl]sulfamoyl}- 4-formamido-N,N-dimethylbenzamide; 1-(4,6- dimethoxypyrimidin-2-yl)-3-(2- dimethylcarbamoyl-5- formamidophenylsulfonyl)urea (173159-57-4)
cymoxanil (ISO); 2-cyano-N-[(ethylamino)carbonyl]-2-(methoxyimino)acetamide (57966-95-7)
(2E)-2-cyano-N-[(ethylamino)carbonyl]-2- (methoxyimino)acetamide (166900-80-7)

These ingredients have now been officially added to Annex II of the Cosmetic Regulation, which lists substances strictly prohibited in cosmetic products marketed in the EU.

Compliance Deadline for Regualtion 2025/877

From the 1^st of September 2025, any cosmetic product placed on the EU market must comply with the new restrictions. This means that products containing these ingredients must be removed or reformulated.

Special attention must be given to the substance diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide, with CAS 75980-60-8 and INCI name Trimethylbenzoyl Diphenylphosphine Oxide, as it is no longer listed in Annex III, widely used in nail artificial systems. From September 2025, this substance must be removed from the formulation of nail artificial products, and the products remaining on the market containing the substance must be removed, as now the substance is listed in Annex II

Responsible Persons must update the Product Information File (PIF), Cosmetic Product Safety Report (CPSR), and CPNP notifications of the reformulated products accordingly, and distributors and importers must verify that products in the supply chain meet the updated requirements.

Failure to comply with Regulation 2025/877 may result in market withdrawal, regulatory enforcement actions, or reputational damage.

How Cosmeservice Can Help

At Cosmeservice, we specialise in helping cosmetic brands and manufacturers comply with EU Regulation 2025/877 and its updates. Our services include:

Ingredient risk assessment based on CPR.
Reformulation support and safer alternatives review.
Update of the PIF, CPSR, and product notifications.
Strategic consulting to avoid last-minute non-compliance.

Get in touch with Cosmeservice to ensure your cosmetic products are fully compliant with the latest modifications of the European Regulation. Contact us for a compliance check-up!