Omnibus Act IX: New EU Cosmetic Ingredient Restrictions and Bans Expected from 2027
- Daniel Jiménez
- 4 hours ago
- 5 min read
The European Commission has notified a new draft amendment to the EU Cosmetics Regulation, commonly referred to as Omnibus Act IX. This update introduces new bans and restrictions for several cosmetic ingredients, including CMR-classified substances and ingredients recently assessed by the Scientific Committee on Consumer Safety, the SCCS.
Although the text is still in draft form, its impact is expected to be significant for manufacturers, brands, importers and Responsible Persons placing cosmetic products on the EU market. The proposal may affect several product categories, including hair products, hair dyes, eyelash and eyebrow products, CBD cosmetics, oral care products, products for children and formulas containing specific UV stabilisers, antioxidants or preservatives.
What is Omnibus Act IX?
“Omnibus Acts” are periodic updates to Regulation (EC) No 1223/2009 on cosmetic products. Their purpose is to incorporate new harmonised CMR classifications under the CLP Regulation into the Cosmetics Regulation and to update the annexes based on recent SCCS scientific opinions.
Omnibus Act IX includes substances classified as CMR under Commission Delegated Regulation (EU) 2025/1222, corresponding to the 23rd Adaptation to Technical Progress of the CLP Regulation. It also introduces changes following SCCS opinions on ingredients such as Benzophenone-1, Benzophenone-2, BHA, Butylparaben, Basic Brown 16, Basic Blue 99, prostaglandins and prostaglandin analogues, Cannabidiol and Hydroxyapatite (nano).
New substances proposed for prohibition under Annex II
The draft proposes adding several substances to Annex II of the EU Cosmetics Regulation, meaning they would be prohibited in cosmetic products placed on the EU market.
Among the most relevant substances for the cosmetics industry are:
Benzophenone-1
Benzophenone-1 may be used as a light stabiliser in cosmetic products. According to the draft, the SCCS concluded that its use as a light stabiliser in cosmetics is not safe. Therefore, the proposal includes its addition to Annex II.
Benzophenone-2
Benzophenone-2 may be used as a UV filter, light stabiliser or fragrance ingredient. The SCCS was unable to exclude its genotoxic potential and also identified endocrine activity. The draft therefore proposes prohibiting its use in cosmetic products.
Basic Brown 16 and Basic Blue 99
These ingredients are used in non-oxidative hair dye formulations. The SCCS did not consider their use safe due to concerns related to mutagenicity or genotoxicity. As a result, the proposal includes their addition to Annex II.
Prostaglandins and prostaglandin analogues
These ingredients may be found in products intended to support eyelash or eyebrow growth. The SCCS identified safety concerns linked to their pharmacological activity, even at very low concentrations, particularly due to potential adverse effects on eye health. The draft proposes prohibiting the use of prostaglandins and their analogues in cosmetic products.
The proposal also includes other substances such as ozone, dinitrogen oxide, tetrahydrofurfuryl methacrylate, trimethyl phosphate, fluoroethylene, α-methylstyrene and other substances classified or assessed under the relevant CMR framework.
New restrictions under Annex III
The draft also modifies Annex III, introducing new conditions of use for several ingredients.
Hydroxyapatite (nano)
The proposal modifies the conditions applicable to Hydroxyapatite (nano), which is currently regulated under Annex III. The change is particularly relevant for oral care products, including toothpastes and mouthwashes.
This will be important for brands marketing oral care products positioned around remineralisation, whitening or alternative active concepts, as they will need to verify the specific conditions of use, concentration limits and particle-related requirements.
Cannabidiol, CBD
The draft introduces a new entry for Cannabidiol, CBD, allowing its use in leave-on, rinse-off and oral care products up to a maximum concentration of 0.19%.
The presence of Δ9-THC as an impurity would be limited to 0.00025%, equivalent to 2.5 ppm.
This is particularly relevant for cosmetic brands using CBD, as they will need to verify not only the CBD concentration in the final formula, but also the quality of the raw material and the technical documentation supporting THC impurity control.
Butylated Hydroxyanisole, BHA
BHA is proposed to be restricted in cosmetic products. Under the draft, it would be allowed in leave-on and rinse-off products up to a maximum concentration of 0.07%.
However, it would not be allowed in oral care products or in products that may lead to lung exposure through inhalation.
This may affect formulas where BHA is used as an antioxidant, stabiliser or fragrance-related ingredient, requiring brands to review concentration, product category and route of exposure.
Changes to preservatives: Butylparaben and mercury compounds
The proposal also introduces relevant changes to Annex V, which regulates permitted preservatives.
Butylparaben
The draft separates Butylparaben from the existing Propylparaben entry and establishes specific conditions of use, with particular attention to products intended for children.
Companies using Butylparaben should review product type, target consumer group and concentration to confirm whether their formulas remain compliant under the new proposed conditions.
Mercury-containing preservatives
The draft also removes the remaining authorisations for certain mercury-containing preservatives, such as Thiomersal and phenylmercuric salts.
This would complete the removal of the remaining permitted uses of mercury-based preservatives in cosmetic products under the EU Cosmetics Regulation.
Application dates and transition periods
The changes related to substances classified as CMR under Commission Delegated Regulation (EU) 2025/1222 are expected to apply from 1 February 2027, in line with the application date of those harmonised classifications.
For the other bans and restrictions included in the draft, the proposal provides transitional periods. Non-compliant products would no longer be allowed to be placed on the EU market 12 months after the Regulation enters into force, and would no longer be allowed to be made available on the EU market 24 months after the Regulation enters into force.
This means that companies should act early, especially where long manufacturing cycles, international stock, printed packaging or reformulation projects are involved.
What should cosmetic brands do now?
Even though the text is still a draft, companies placing cosmetic products on the EU market should start reviewing their formulas and technical documentation.
Recommended actions include:
Formula review
Identify whether any of the affected ingredients are present in current or upcoming products.
Raw material and supplier documentation review
Request updated technical data sheets, composition details, impurity statements, specifications and regulatory declarations from suppliers.
Category-specific impact assessment
Special attention should be given to hair products, non-oxidative hair dyes, eyelash and eyebrow products, CBD cosmetics, oral care products, products for children, aerosols and products that may involve inhalation exposure.
Reformulation planning
Where necessary, companies should start assessing alternatives, stability testing, compatibility testing, safety evaluation and PIF updates.
PIF, CPSR and labelling review
Regulatory changes may impact the Product Information File, Cosmetic Product Safety Report, product specifications and, in some cases, claims or commercial communication.
Stock and commercial planning
Companies should consider the expected application dates, sell-in and sell-out periods, distributor stock, marketplace listings and international warehouse management.
Conclusion
Omnibus Act IX confirms the European Union’s continued trend towards stricter control of ingredients with toxicological, endocrine, genotoxic or pharmacological concerns.
For cosmetic brands, this type of update should not be treated as a simple technical amendment. It is an opportunity to proactively review formula compliance, reduce regulatory risk and avoid last-minute reformulation or stock issues.
At Belab Services, we support cosmetic brands, manufacturers and importers in assessing the impact of new EU ingredient restrictions, reviewing formulas, updating PIF/CPSR documentation, coordinating reformulation strategies and ensuring that cosmetic products remain compliant and market-ready in the European Union.
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