Omnibus Act IX – New ingredients banned in the EU from 1 February 2027

On 8 July 2026, the European Commission notified the WTO of an amendment to its Cosmetics Regulation, referred to as Omnibus Act IX. This amendment incorporates into Regulation (EC) No 1223/2009 the substances classified as CMRs under Commission Delegated Regulation (EU) 2025/1222, as well as the latest scientific assessment from the SCCS published between 2025 and 2026.

Commission Delegated Regulation (EU) 2025/1222, the 23rd Adaptation to Technological Progress (ATP), was published in June 2025.

Amendment to Annex II: new banned substances

This amendment adds 16 new substances to Annex II, the list of ingredients prohibited for use in cosmetic products.

The newly banned substances are:

• 2-ethylhexanoic acid, monoester with propane-1,2-diol (CAS No. 85114-00-7)
• α,α’-propylenedinitrilodi-o-cresol (CAS No. 94-91-7)
• ozone (CAS No. 10028-15-6)
• dinitrogen oxide (CAS No. 10024-97-2)
• 9-octadecenoic acid (Z)-, sulfonated, potassium salts [1]; reaction products of fatty acids, C18 (unsaturated) alkyl with sulfur trioxide, potassium salts [2]; 9(or 10)-sulphooctadecanoic acid, potassium salt [3] (CAS Nos. 68609-93-8 [1]; [2]; 67968-63-2 [3])
• 2,3-epoxypropyl isopropyl ether (CAS No. 4016-14-2)
• tetrahydrofurfuryl methacrylate (CAS No. 2455-24-5)
• trimethyl phosphate (CAS No. 512-56-1)
• fluoroethylene (CAS No. 75-02-5)
• 2-bromo-3,3,3-trifluoroprop-1-ene (CAS No. 1514-82-5)
• 2-phenylpropene (α-methylstyrene) (CAS No. 98-83-9)
• 2,4- dihydroxybenzophenone [INCI: Benzophenone-1] (CAS No. 131-56-6)
• 2,2′,4,4′-tetrahydroxybenzophenone [INCI: Benzophenone-2] (CAS No. 131-55-5)
• 8-[(4- 8 Aminophenyl)diazenyl]-7-hydroxy-N,N,N trimethylnaphthalen-2-aminium chloride [INCI: Basic Brown 16] (CAS No. 26381-41-9)
• 3-[(4-amino 6-bromo-5,8-dihydro-1-hydroxy-8 imino-5-oxo-2-naphtyl)amino]-N,N,N trimethylanilinium chloride [INCI: Basic Blue 99] (CAS No. 68123-13-7)
• Prostaglandines and their analogues

Amendment to Annex III: new ingredient restrictions

Omnibus Act IX amends the restrictions applicable to Hydroxyapatite (nano) under entry 372 of Annex III by significantly increasing the maximum concentrations permitted in toothpastes and mouthwashes. The ingredient remains prohibited in all other cosmetic product categories. In addition, the conditions of use and the specifications relating to the particle size differ from those set out in the original entry.

The Regulation also introduces two new Annex III entries:

• Cannabidiol (CBD) (CAS No. 13956-29-1), which may be used in leave-on, rinse-off, and oral care products at a maximum concentration of 0.19%. The presence of Δ9-tetrahydrocannabinol (THC) as an impurity must not exceed 0.00025% (2.5 ppm).
• Butylated Hydroxyanisole (BHA) (CAS No. 25013-16-5), which may be used in leave-on and rinse-off products at a maximum concentration of 0.07%. However, its use is not permitted in oral care products or in products that may result in exposure of the end user’s lungs through inhalation.

Annex V updates: new restrictions, prohibitions, and authorisations for preservatives

Entry 12a of Annex V has been amended to remove Butylparaben and its salts, which are being transferred to a new Entry 12b with specific concentration limits applicable to products intended for children. The existing concentration limits, conditions of use, and warning requirements applicable to Propylparaben and its salts remain unchanged.

In addition, entries 16 and 17 of Annex V have been deleted, marking the completion of the phase-out of mercury-based preservatives in cosmetic products. As a result, the general prohibition of mercury and its compounds under Annex II is extended to all mercury-containing substances without exception, removing the remaining authorisations for preservatives such as Thiomersal (Thimerosal) and phenylmercuric salts. This change is reflected in the amendment to entry 221 of Annex II introduced by this Omnibus Act.

Deadline for compliance

The amendments to Regulation (EC) No 1223/2009 that are based on the classification of the relevant substances as CMR substances under Delegated Regulation (EU) 2025/1222 –  namely the first 11 new entries in Annex II and entry 12b of Annex V – will apply from the same date as those classifications, i.e. 1 February 2027.

The remaining bans and restrictions will be subject to transitional periods:

• From 12 months after the entry into force of the Regulation, non-compliant cosmetic products may no longer be placed on the Union market.
• From 24 months after the entry into force of the Regulation, such products may no longer be made available on the Union market.

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