On July 8, 2026, the European Commission notified the World Trade Organization (WTO) of a draft regulation amending Regulation (EC) No 1223/2009 on cosmetic products. The draft was developed in reference to the new classification of Carcinogenic, Mutagenic, or Reprotoxic (CMR) substances introduced under Commission Delegated Regulation (EU) 2025/1222, as well as the latest scientific evaluation results released by the Scientific Committee on Consumer Safety (SCCS) between 2025 and 2026. The public comment period runs through September 6, 2026, with adoption expected in the fourth quarter of 2026.
Revisions and Additions to Annex II (List of Prohibited Substances)
- Mercury and Its Compounds: Shifted from partial exemption (mercury-containing preservatives under Annex V) to a complete ban on any use in cosmetic products.
- Addition of 16 Prohibited Substances:
- 2-ethylhexanoic acid, monoester with propane-1,2-diol
- α,α’-propylenedinitrilodi-o-cresol
- Ozone
- Dinitrogen oxide
- 9-octadecenoic acid (Z)-, sulfonated, potassium salts; reaction products of fatty acids, C18 (unsaturated) alkyl with sulfur trioxide, potassium salts; 9(or 10)-sulphooctadecanoic acid, potassium salt
- 2,3-epoxypropyl isopropyl ether
- Tetrahydrofurfuryl methacrylate
- Trimethyl phosphate
- Fluoroethylene
- 2-bromo-3,3,3-trifluoroprop-1-ene
- 2-phenylpropene; (α-methylstyrene)
- Benzophenone-1
- Benzophenone-2
- Basic Brown 16
- Basic Blue 99
- Prostaglandins and their analogues
Revisions and Additions to Annex III (List of Restricted Substances)
1. Revision of Permitted Conditions and Restrictions for Hydroxyapatite (nano):
| Permitted Product Types and Maximum Concentration in Cosmetics | Other Restrictions |
| Hydroxyapatite (nano) (a) Toothpaste: 29.5% (b) Mouthwash: 10% | For items (a) and (b): – Shall not be used in applications that may lead to exposure of the end-user’s lungs by inhalation. – Only nanomaterials complying with the following characteristics are allowed: • Composed of rod-shaped particles of which at least 87% (by number of particles) have an aspect ratio equal to or lower than 3, and the remaining 13% have an aspect ratio not exceeding 9; • Hydroxyapatite (nano) particles are uncoated or non-surface modified; • Maximum length of Hydroxyapatite (nano) particles is 122 ± 43 nm. |
2. Addition of Restrictions for Cannabidiol (CBD) and Butylated Hydroxyanisole (BHA):
| Permitted Product Types and Maximum Concentration in Cosmetics | Other Restrictions |
| Cannabidiol (CBD) Leave-on products, Rinse-off products, Oral care products: 0.19% | The content of Δ-9-tetrahydrocannabinol (THC) present as an impurity should not exceed 0.00025% (2.5 ppm). |
| Butylated Hydroxyanisole (BHA) Leave-on products, Rinse-off products: 0.07% | Shall not be used in oral care products or in products that may lead to exposure of the end-user’s lungs by inhalation. |
Revisions and Additions to Annex V (List of Preservatives)
1. Revision of Restricted Use Conditions for Propylparaben (Entry 12a) and Its Salts:
| Permitted Product Types and Maximum Concentration in Cosmetics | Other Restrictions |
| Propylparaben and its salts Used alone: 0.14% (expressed as acid) | When mixed with substances under Entry 12 (Methylparaben and its salts) and new Entry 12b (Butylparaben and its salts), the total sum of concentrations shall not exceed 0.8% (expressed as acid), provided that the sum of individual concentrations of Propylparaben and Butylparaben does not exceed 0.14%. Shall not be used in leave-on products designed for the nappy area of children under 3 years of age. |
2. Addition of Restricted Use Conditions for Butylparaben (Entry 12b) and Its Salts:
| Permitted Product Types and Maximum Concentration in Cosmetics | Other Restrictions |
| Butylparaben and its salts (a) General Use: Used alone: 0.14% (expressed as acid) When mixed with substances under Entry 12 (Methylparaben and its salts) and Entry 12a (Propylparaben and its salts), the total sum of concentrations shall not exceed 0.8% (expressed as acid), provided that the sum of individual concentrations of Propylparaben and Butylparaben does not exceed 0.14%. (b) Products intended for children under 10 years of age: – Rinse-off products: 0.14% (expressed as acid) – Leave-on products: 0.002% (expressed as acid) – Oral care products: 0.092% (expressed as acid) When mixed with substances under Entry 12 (Methylparaben and its salts) and Entry 12a (Propylparaben and its salts), the total sum of concentrations shall not exceed 0.8% (expressed as acid), provided that the sum of individual concentrations of Propylparaben and Butylparaben does not exceed 0.14%. | For item (b): – Shall not be used in any spray products (including oral sprays) that may lead to lung exposure. – Shall not be used in leave-on products designed for the nappy area of children under 3 years of age. |
3. Removal of Mercury-Containing Preservatives
Thimerosal and Phenylmercuric salts (including borate) have been deleted from the permitted preservatives list. This completely harmonizes the regulation, establishing an absolute ban on all uses of mercury and its compounds in cosmetics.
Industry Impact and Outlook
This proposed draft revision sends a clear signal of the European Union’s continuously tightening safety supervision over cosmetic ingredients. As the CMR substance classification framework updates and SCCS scientific opinions are applied, enterprises will face multifaceted compliance challenges, including formulation reviews, raw material substitution assessments, supply chain information updates, and adjustments to product labeling and notification files. Cosmetic brand owners, raw material suppliers, and manufacturers should closely track regulatory developments, screen affected ingredients, and establish risk assessment mechanisms early to minimize potential market impacts caused by regulatory changes.
