Background:

On 8 July 2026, the European Commission notified the World Trade Organization (WTO) about the draft Omnibus Act IX, proposing amendments to Annexes II, III, and V of the EU Cosmetics Regulation. This act implements Commission Delegated Regulation (EU) 2025/1222, introducing newly classified CMR (Carcinogenic, Mutagenic or toxic for Reproduction) substances, and incorporates the SCCS’s findings on ingredient safety.

What’s new?

Amendments to Annex II: 

Entry 221 ‘Mercury and its compounds, except those special cases included in Annex V’ will be replaced by ‘Mercury and its compounds’.

The following substances will be added and prohibited:

1. 2-ethylhexanoic acid, monoester with propane-1,2-diol (CAS No. 85114-00-7)
2. α,α’-propylenedinitrilodi-o-cresol (CAS No. 94-91-7)
3. ozone (CAS No. 10028-15-6)
4. dinitrogen oxide (CAS No. 10024-97-2)
5. 9-octadecenoic acid (Z)-, sulfonated, potassium salts [1]; reaction products of fatty acids, C18 (unsaturated) alkyl with sulfur trioxide, potassium salts [2]; 9(or 10)-sulphooctadecanoic acid, potassium salt [3] (CAS Nos. 68609-93-8 [1]; [2]; 67968-63-2 [3])
6. 2,3-epoxypropyl isopropyl ether (CAS No. 4016-14-2)
7. tetrahydrofurfuryl methacrylate (CAS No. 2455-24-5)
8. trimethyl phosphate (CAS No. 512-56-1)
9. fluoroethylene (CAS No. 75-02-5)
10. 2-bromo-3,3,3-trifluoroprop-1-ene (CAS No. 1514-82-5)
11. 2-phenylpropene (α-methylstyrene) (CAS No. 98-83-9)
12. 2,4- dihydroxybenzophenone [INCI: Benzophenone-1] (CAS No. 131-56-6)
13. 2,2′,4,4′-tetrahydroxybenzophenone [INCI: Benzophenone-2] (CAS No. 131-55-5)
14. 8-[(4- 8 Aminophenyl)diazenyl]-7-hydroxy-N,N,N trimethylnaphthalen-2-aminium chloride [INCI: Basic Brown 16] (CAS No. 26381-41-9)
15. 3-[(4-amino 6-bromo-5,8-dihydro-1-hydroxy-8 imino-5-oxo-2-naphtyl)amino]-N,N,N trimethylanilinium chloride [INCI: Basic Blue 99] (CAS No. 68123-13-7)
16. Prostaglandines and their analogues

Amendments to Annex III:

Entry 372 – Hydroxyapatite (nano) – will be replaced by the following:

(a) Toothpaste – maximum 29.5%
(b) Mouthwash – maximum 10%

For (a) and (b):
Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation.
Only nanomaterials having the following characteristics are allowed:

• Composed of rod shaped particles of at least 87% (in particle number) have aspect ratios equal to or less than 3, and the remaining 13% have aspect ratios not exceeding 9;
• Hydroxyapatite (nano) particles are not coated or surface modified;
• Hydroxyapatite (nano) particles with max length of 122 ± 43 nm.’

The following entries will be added:

1. Cannabidiol (CBD) – maximum 0.19% for the following:

(a) Leave-on products
(b) Rinse-off products
(c) Oral care products

The presence of Delta- 9-tetrahydrocannabinol (THC) as an impurity should not exceed 0.00025% (2.5 ppm).’

2. Butylated Hydroxyanisole (BHA) – maximum 0.07% for the following:

(a) Leave-on products
(b) Rinse-off products

Not to be used in oral care or in products that may lead to exposure of the end-user’s lungs by inhalation.

Amendments to Annex V:

Entry 12a – Propylparaben / sodium propylparaben / potassium propylparaben – will be replaced by the following:

• 0,14 % (as acid) for the sum of the individual concentrations
• 0,8 % (as acid) for mixtures of substances mentioned in entries 12, 12a and 12b, where the sum of the individual concentrations of butyl- and propylparaben and their salts does not exceed 0,14 %

Not to be used in leave-on products designed for application on the nappy area of children under three years of age.

For leave-on products designed for children under three years of age: ‘Do not use on the nappy area’’

The following entries is added:

Entry 12b – Butylparaben / sodium butylparaben / potassium butylparaben:

• 0,14 % (as acid) for the sum of the individual concentrations
• 0,8 % (as acid) for mixtures of substances mentioned in entries 12, 12a and 12b, where the sum of the individual concentrations of butyl- and propylparaben and their salts does not exceed 0,14 %

Not to be used in leave-on products designed for application on the nappy area of children under three years of age.

For leave-on products designed for children under three years of age: ‘Do not use on the nappy area’’

Entries 16 and 17 will be deleted from Annex V.

What now?

The draft is open for comments until 6 September 2026.

Omnibus Act IX will apply from 1 February 2027 (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.

References:

WTO (2026), Draft Commission Regulation amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetic products of certain substances, including those classified as carcinogenic, mutagenic or toxic for reproduction.