Reference source : WTO
Cosmetics Regulation Regulation (EC) No 1223/2009 CMR Substances Scientific Committee on Consumer Safety (SCCS) 23rd ATP CLP Regulation Cosmetic Ingredient Restrictions Regulatory Update
On 8 July 2026, the European Commission notified the World Trade Organization (WTO) of a draft Regulation that would amend EU Cosmetics Regulation (EC) No 1223/2009 following recent scientific assessments by the Scientific Committee on Consumer Safety (SCCS) as well as the latest harmonised classifications of carcinogenic, mutagenic and toxic for reproduction (CMR) substances under the CLP Regulation.
The proposal would amend Annex II (prohibited substances), Annex III (restricted substances) and Annex V (permitted preservatives) by introducing new bans on ingredients, updating existing restrictions, and removing the remaining derogations for mercury-containing preservatives. Comments on the draft can be submitted until 6 September 2026, with adoption planned for the fourth quarter of 2026.
The table below summarises the main ingredient-specific changes proposed in the draft Regulation.
|
Substance (INCI/common name) |
CAS No. |
Annex |
Proposed amendment |
|
Benzophenone-1 |
131-56-6 |
II |
Added as prohibited substance |
|
Benzophenone-2 |
131-55-5 |
II |
Added as prohibited substance |
|
Basic Brown 16 |
26381-41-9 |
II |
Added as prohibited substance |
|
Basic Blue 99 |
68123-13-7 |
II |
Added as prohibited substance |
|
Prostaglandins and their analogues |
Various |
II |
Added as prohibited substances |
|
Thiomersal |
54-64-8 |
II & V |
Annex V exemption removed; prohibited under Annex II |
|
Phenylmercuric salts |
Various |
II & V |
Annex V exemption removed; prohibited under Annex II |
|
Cannabidiol (CBD) |
13956-29-1 |
III |
New restriction |
|
Butylated Hydroxyanisole (BHA) |
25013-16-5 |
III |
New restriction |
|
Hydroxyapatite (nano) |
1306-06-5 / 12167-74-7 |
III |
Existing restriction revised |
|
Butylparaben |
94-26-8 |
V |
Existing preservative entry revised |
New ingredient prohibitions
The draft would amend Annex II by adding several substances to the list of prohibited ingredients following recent SCCS safety assessments. It would also remove the remaining exemptions for mercury-containing preservatives, resulting in a complete prohibition on mercury and its compounds in cosmetic products.
New and revised restrictions
The proposal would also introduce or revise restrictions in Annex III and Annex V for several ingredients, for which the SCCS concluded that safe use could only be demonstrated under specified conditions.
Cannabidiol (CBD) would be permitted in leave-on, rinse-off and oral care products at concentrations of up to 0.19%, provided that tetrahydrocannabinol (THC) is present only as an impurity at levels not exceeding 0.00025% (2.5 ppm).
Butylated hydroxyanisole (BHA) would be restricted to a maximum concentration of 0.07% in leave-on and rinse-off products and would be prohibited in oral care products or products that could lead to inhalation exposure.
The proposal also revises the conditions for butylparaben, including introducing new concentration limits for products intended for children under ten years of age, and prohibiting its use in sprayable products that may lead to inhalation exposure. In addition, the existing restriction for hydroxyapatite (nano) would be updated by introducing revised concentration limits and detailed particle specifications for toothpaste and mouthwash.
CMR updates and transition periods
In addition to the SCCS-based measures, the draft also updates Annex II to implement the CMR-related changes introduced by the 23rd Adaptation to Technical Progress (ATP) to the CLP Regulation (Commission Delegated Regulation (EU) 2025/1222). As no applications for cosmetic-use derogations were submitted, 11 newly classified CMR substances would be added to the list of prohibited ingredients. These CMR-related amendments would apply from 1 February 2027.
For the remaining amendments, the proposal provides transition periods of 12 months after the Regulation enters into force for placing compliant products on the Union market and 24 months for making non-compliant products available on the market. The Regulation will enter into force 20 days after its publication in the Official Journal of the European Union.
