On 8 July 2026, the European Commission notified the World Trade Organization (WTO) of a draft amendment to Regulation (EC) No 1223/2009 on cosmetic products. Commonly referred to as Omnibus Act IX, the proposal introduces new prohibited substances, updates restrictions for several cosmetic ingredients and changes the rules applicable to certain preservatives.
For cosmetic manufacturers and brands selling products in the European Union, the amendment may require formula reviews and, in some cases, reformulation before the new requirements become applicable.
What is Omnibus Act IX?
Omnibus Acts are used by the European Commission to update the annexes of the EU Cosmetics Regulation.
One important reason for these updates is the classification of substances as carcinogenic, mutagenic or toxic to reproduction, commonly known as CMR substances, under the EU Classification, Labelling and Packaging Regulation (CLP).
Article 15 of Regulation (EC) No 1223/2009 establishes specific rules for the use of CMR substances in cosmetic products. As new harmonised classifications are introduced under the CLP Regulation, the Cosmetics Regulation must be updated accordingly.
Omnibus Act IX incorporates substances classified under Commission Delegated Regulation (EU) 2025/1222, also known as the 23rd Adaptation to Technical Progress (ATP) of the CLP Regulation.
However, the proposed amendment goes further than a standard CMR update. It also introduces regulatory changes based on recent scientific assessments from the Scientific Committee on Consumer Safety (SCCS).
16 New Substances Added to the List of Prohibited Cosmetic Ingredients
The draft amendment proposes adding 16 substances or substance groups to Annex II of the EU Cosmetics Regulation.
Annex II contains substances that are prohibited for use in cosmetic products.
The proposed additions include:
- 2-ethylhexanoic acid, monoester with propane-1,2-diol
- α,α’-propylenedinitrilodi-o-cresol
- Ozone
- Dinitrogen oxide
- Certain sulfonated C18 fatty acid potassium salts
- 2,3-epoxypropyl isopropyl ether
- Tetrahydrofurfuryl methacrylate
- Trimethyl phosphate
- Fluoroethylene
- 2-bromo-3,3,3-trifluoroprop-1-ene
- 2-phenylpropene, also known as α-methylstyrene
- Benzophenone-1
- Benzophenone-2
- Basic Brown 16
- Basic Blue 99
- Prostaglandins and their analogues
One of the most notable changes concerns prostaglandins and their analogues.
These substances have attracted increasing regulatory attention because some prostaglandin analogues are used in cosmetic products marketed for eyelash growth or enhancement.
Under the proposed amendment, prostaglandins and their analogues would be added to Annex II and therefore prohibited in cosmetic products in the European Union.
This is particularly relevant for manufacturers and brands of eyelash serums and similar eye-area cosmetics. Companies marketing these products should carefully review their ingredient lists and raw material documentation.
The proposal also adds Benzophenone-1 and Benzophenone-2 to Annex II.
Benzophenone derivatives have historically been used in cosmetic formulations for functions such as UV absorption or product protection. Under Omnibus Act IX, these two specific substances would no longer be permitted in cosmetic products placed on the EU market once the applicable transition periods have expired.
Manufacturers using these ingredients may therefore need to identify suitable alternatives and conduct the necessary stability, compatibility and safety assessments for reformulated products.
New Restrictions for Cannabidiol (CBD)
Omnibus Act IX also proposes a new entry in Annex III, the list of substances that cosmetic products may contain only under specified restrictions.
Under the draft rules, Cannabidiol (CBD), CAS No. 13956-29-1, would be permitted at a maximum concentration of 0.19% in leave-on, rinse-off and oral care products.
The concentration of Δ9-tetrahydrocannabinol (THC) present as an impurity must not exceed 0.00025%, equivalent to 2.5 ppm.
This change would introduce clear concentration and impurity limits for CBD in EU cosmetic products.
For manufacturers of CBD cosmetics, raw material specifications and analytical documentation will become particularly important. Companies may need to demonstrate that the CBD concentration and THC impurity level comply with the new requirements.
BHA Restricted to a Maximum of 0.07%
The draft amendment also introduces specific restrictions for Butylated Hydroxyanisole (BHA).
BHA would be permitted in leave-on and rinse-off cosmetic products at a maximum concentration of 0.07%.
However, its use would not be permitted in oral care products or in cosmetic products that may result in exposure of the end user’s lungs through inhalation.
This means that manufacturers should assess not only the concentration of BHA in a formulation but also the intended product type and the expected route of consumer exposure.
Updated Rules for Nano Hydroxyapatite
The restrictions applicable to Hydroxyapatite (nano) would also be amended.
Nano hydroxyapatite is regulated under Annex III of the Cosmetics Regulation and is primarily associated with oral care products.
The proposed amendment significantly increases the maximum concentrations permitted in toothpastes and mouthwashes. It also updates the applicable particle specifications and conditions of use.
The ingredient would remain prohibited in other cosmetic product categories.
Manufacturers using nano hydroxyapatite should review the exact technical specifications of their raw material. In nanomaterial regulation, compliance is not determined by the INCI name alone. Particle characteristics, morphology and other specifications may be relevant when assessing whether a material complies with the Annex III entry.
New Rules for Butylparaben in Products for Children
Omnibus Act IX also proposes changes to Annex V, which contains the preservatives authorised for use in cosmetic products.
Butylparaben and its salts would be moved from the existing entry 12a to a new entry 12b with specific concentration limits applicable to products intended for children.
The existing restrictions and warning requirements applicable to Propylparaben and its salts would remain unchanged.
Cosmetic companies manufacturing children’s products should therefore review formulations containing Butylparaben against the new conditions.
Mercury-Based Preservatives Phased Out
Another important change concerns mercury-containing preservatives.
Entries 16 and 17 of Annex V would be deleted, removing the remaining preservative authorisations for substances such as Thiomersal and phenylmercuric salts.
The general prohibition applicable to mercury and its compounds under Annex II would consequently apply without these remaining preservative exceptions.
This effectively completes the phase-out of mercury-based preservatives under the EU Cosmetics Regulation.
When Will Omnibus Act IX Apply?
The compliance timeline depends on the regulatory basis for each amendment.
The changes linked directly to the CMR classifications introduced by Commission Delegated Regulation (EU) 2025/1222 are expected to apply from 1 February 2027, the same date on which the relevant harmonised classifications become applicable.
This includes the first group of new Annex II prohibitions and the new Annex V entry concerning Butylparaben.
For the remaining ingredient bans and restrictions, the draft provides transitional periods.
Non-compliant cosmetic products may no longer be placed on the Union market 12 months after the Regulation enters into force.
After 24 months from the Regulation’s entry into force, non-compliant products may no longer be made available on the Union market.
The distinction is important. “Placing on the market” generally concerns the first supply of a product on the EU market, while “making available” also covers subsequent distribution and sale within the supply chain.
As Omnibus Act IX is currently a draft amendment notified to the WTO, manufacturers should verify the final published Regulation and its exact dates before determining their definitive compliance deadlines.
