Omnibus Act II: New Restrictions for Cosmetic Ingredients in the European Union
- Daniel Jiménez
- 11 hours ago
- 3 min read
The European Union has published Regulation (EU) 2026/909, commonly referred to as Omnibus Act II, which amends Annexes II, III, V and VI of the EU Cosmetics Regulation 1223/2009.
This update introduces new prohibitions, restrictions, concentration limits, conditions of use and purity requirements for several cosmetic ingredients used in products such as fragrances, deodorants, oral care products, make-up, hair dyes, sunscreens and nail products.
The Regulation was published on 28 April 2026 and entered into force on 18 May 2026. However, certain measures include specific transition periods, meaning that each product and ingredient should be assessed individually.
Table of Contents
Ingredients affected
Among the main changes introduced by Omnibus Act II, the following are particularly relevant:
Triphenyl Phosphate
This substance has been added to Annex II and is therefore prohibited in cosmetic products. It has been used in certain nail products, so affected formulations will need to be reformulated.
Benzyl Salicylate, Citral, Geranial and Neral
New restrictions have been introduced for these fragrance-related ingredients. The applicable limits depend on the type of cosmetic product and its intended use. This makes it especially important to review fragrance compositions and obtain updated documentation from suppliers.
Aluminium-containing substances
The Regulation establishes new conditions of use and concentration limits for certain aluminium compounds, which may be present in categories such as antiperspirants, make-up, hair products, toothpaste and other leave-on products.
Water-soluble zinc salts
The conditions of use for these substances have been updated, particularly in relation to oral care products such as toothpaste and mouthwash. The applicable limits may vary depending on the product type and the intended user group.
Acetylated Vetiver Oil
Specific restrictions have been introduced for Acetylated Vetiveria Zizanioides Root Extract and Acetylated Vetiveria Zizanioides Root Oil, including concentration limits and technical requirements for the raw material.
Hair dye ingredients
Omnibus Act II also affects several hair dye ingredients, including HC Blue No 18, HC Red No 18, HC Yellow No 16, Hydroxypropyl-p-phenylenediamine and Hydroxypropyl-p-phenylenediamine 2HCl. These ingredients are now subject to new limits and labelling conditions.
Silver Zinc Zeolite
Ammonium Silver Zinc Aluminium Silicate has been authorised as a preservative under Annex V, but only under specific conditions and for certain product types.
DHHB
The UV filter Diethylamino Hydroxybenzoyl Hexyl Benzoate remains permitted. However, a maximum limit of 10 ppm has been introduced for the impurity Di-n-hexyl phthalate when present as a technically unavoidable trace.
Key dates
For many of the affected ingredients, non-compliant products may no longer be placed on the EU market from 1 January 2027.
Products already made available on the market must generally be withdrawn by 1 July 2028. In some specific cases, such as certain fragrance components, the final deadline may be extended until 1 August 2028.
What cosmetic companies should do?
Companies placing cosmetic products on the EU market should review their formulations and technical documentation in advance.
In particular, it is advisable to:
Check whether any formulations contain ingredients affected by Omnibus Act II.
Confirm the concentrations used and compare them with the new limits.
Request updated documentation from raw material and fragrance suppliers.
Review product labels and any mandatory warnings.
Update the CPSR and Product Information File where necessary.
Plan reformulations or stock management strategies for non-compliant products.
Conclusion
Omnibus Act II introduces relevant changes for many cosmetic product categories and may affect both new products and products already placed on the EU market.
Early review of formulations, labels and technical documentation will be essential to avoid regulatory issues, urgent reformulations or problems during market surveillance inspections.
At Belab Services, we support cosmetic brands with ingredient assessments, formulation reviews, CPSR and PIF updates, label reviews and EU Responsible Person services, helping ensure that products remain compliant with the latest updates to the EU Cosmetics Regulation.
Comments