Omnibus Act IX: 16 New Annex II Bans, CBD/BHA Limits, and a New Butylparaben Entry — What to Check?

Omnibus Act IX

The European Union is preparing regular, routine updates to its cosmetic ingredient restrictions under its periodic Omnibus mechanism. The European Commission notified the World Trade Organization (WTO) under notification G/TBT/N/EU/1219 of a draft Commission Regulation amending Regulation (EC) No 1223/2009. Known across the personal care sector as Omnibus Act IX (combining the 9th CMR Omnibus and the 3rd Omnibus on Ingredients), this regulatory update introduces approximately 16 additions to Annex II, new concentration limits in Annex III (such as for CBD and BHA), and targeted revisions in Annex V.

Under the proposed schedule, bans for substances classified as CMR under the 23rd ATP are expected to take effect on 1 February 2027, while non-CMR provisions (such as restrictions on CBD and BHA) are slated for separate phased transition periods. Consequently, cosmetic brand owners and Responsible Persons are advised to review affected formulations ahead of these deadlines.

Here is a comprehensive breakdown of the regulatory changes introduced by Omnibus Act IX and the concrete steps required to keep your formulations compliant on the EU market.

Core Timelines: The 1 February 2027 CMR Cutover vs. Phased SCCS Transitions

Omnibus Act IX operates on two distinct regulatory tracks, each with its own compliance timeline:

  • The CMR Classification Track (Enforcement: 1 February 2027): This track transposes new Carcinogenic, Mutagenic, or Toxic for Reproduction (CMR) classifications established under Commission Delegated Regulation (EU) 2025/1222 (the 23rd Adaptation to Technical Progress to the CLP Regulation) into Annex II of the EU Cosmetics Regulation. Because industry filed no Article 15 derogation requests for these substances, their prohibition is legally tied directly to the CLP application date of 1 February 2027.
  • The SCCS Scientific Assessment Track (Proposed 12 / 24-Month Transition): For ingredients re-evaluated by the SCCS due to safety concerns (including endocrine disruption, genotoxicity, or ocular toxicity), the draft regulation proposes standard transition periods following its entry into force:
    • 12 months to cease placing non-compliant products on the Union market, and
    • 24 months to cease making them available on retail shelves.

Key takeaway: Do not wait for final publication in the Official Journal to begin reformulation. Formulations containing CMR-classified candidates face a hard stop on 1 February 2027.

The 16 New Annex II Prohibitions: What Ingredients Are Banned?

Omnibus Act IX expands Annex II (the list of substances prohibited in cosmetic products) by adding 16 new ingredient entries, while completely ending historical carve-outs for mercury compounds.

Newly Banned Industrial & Chemical Compounds (CMR Track)

The following 11 chemical substances are added to Annex II following their CMR classifications under Delegated Regulation (EU) 2025/1222:

  1. 2-ethylhexanoic acid, monoester with propane-1,2-diol (CAS 85114-00-7)
  2. α,α’-propylenedinitrilodi-o-cresol (CAS 94-91-7)
  3. Ozone (CAS 10028-15-6)
  4. Dinitrogen oxide (CAS 10024-97-2)
  5. 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 (CAS 68609-93-8 / 67968-63-2)
  6. 2,3-epoxypropyl isopropyl ether (CAS 4016-14-2)
  7. Tetrahydrofurfuryl methacrylate (CAS 2455-24-5)
  8. Trimethyl phosphate (CAS 512-56-1)
  9. Fluoroethylene (CAS 75-02-5)
  10. 2-bromo-3,3,3-trifluoroprop-1-ene (CAS 1514-82-5)
  11. 2-phenylpropene (α-methylstyrene) (CAS 98-83-9)

Newly Banned Cosmetic Actives & UV Filters (SCCS Track)

Following SCCS opinions on human health risks, genotoxicity, and endocrine disruption, 5 major cosmetic ingredient groups are banned under Annex II:

12. Benzophenone-1 (CAS 131-56-6): Previously used as a light stabilizer to protect formulations from UV degradation. The SCCS concluded its use is unsafe due to potential health risks and endocrine activity.

13. Benzophenone-2 (CAS 131-55-5): Used as a UV filter, light stabilizer, and fragrance booster. Prohibited because genotoxic potential could not be excluded, alongside clear evidence of estrogenic endocrine activity.

14. Basic Brown 16 (CAS 26381-41-9): A non-oxidative hair dye ingredient banned due to potential mutagenicity.

15. Basic Blue 99 (CAS 68123-13-7): A non-oxidative hair dye ingredient banned due to evidence of potential genotoxicity.

16. Prostaglandins and Prostaglandin Analogues: Including compounds such as ethyl tafluprostamide, isopropyl cloprostenate, and methylamido-dihydro-noralfaprostal used in eyelash and eyebrow enhancement serums. The SCCS flagged severe ocular health safety concerns and an inability to rule out reproductive and developmental toxicity.

Total Ban on Mercury Compounds

Omnibus Act IX amends Annex II Entry 221, replacing “Mercury and its compounds, except those special cases included in Annex V” with a plain prohibition: “Mercury and its compounds”. Concurrently, Annex V entries 16 (Thiomersal) and 17 (phenylmercuric salts) are deleted, completely eliminating the final preservative exemptions for mercury in EU cosmetics.

Annex III Restrictions: New Limits for CBD, BHA & Nano-Hydroxyapatite

For several widely used cosmetic ingredients, the SCCS established safe conditions of use, leading to new or revised entries under Annex III:

IngredientCAS NumberMaximum Permitted ConcentrationSpecific Usage Restrictions & Impurity Caps
Cannabidiol (CBD)13956-29-10.19% across leave-on, rinse-off, and oral care productsΔ9-THC impurity must not exceed 0.00025% (2.5 ppm) in the final product.
Butylated Hydroxyanisole (BHA)25013-16-50.07% in leave-on and rinse-off formulationsProhibited in oral care products and sprayable/inhalation products.
Hydroxyapatite (nano)1306-06-5 / 12167-74-7Toothpaste: up to 29.5%; Mouthwash: up to 10%Prohibited in sprayable/inhalation applications. Only uncoated, non-surface-modified rod particles (≥ 87% aspect ratio ≤ 3, remaining ≤ 9; max length 122± 43nm) are allowed.

Formulator Focus: Because the statutory 2.5 ppm (0.00025%) Δ9-THC impurity cap applies to the finished cosmetic preparation, formulators must calculate finished-product exposure and verify supplier raw material purity—typically via Certificates of Analysis and batch testing—to ensure final formulations remain compliant.

Preservative Overhaul: The New Butylparaben Entry (Annex V Entry 12b)

Under prior regulations, Butylparaben and Propylparaben shared entry 12a of Annex V. Omnibus Act IX separates them into two distinct preservative entries:

  • Propylparaben (Entry 12a): Its permissible concentration (0.14%) and conditions of use remain substantially unchanged, but the entry is formally amended to remove Butylparaben and update cross-references to the new entry 12b.
  • Butylparaben (New Entry 12b): Maintains a baseline maximum concentration of 0.14% (as acid) for general use and 0.8% in paraben mixtures (with butyl- and propylparaben combined capped at 0.14%), but introduces strict new limits for products intended for children under 10 years of age (0.002% in leave-on, 0.092% in oral care, and 0.14% in rinse-off).

New Strict Exclusions for Butylparaben:

  1. Sprayable Products: Banned in all sprayable products (including mouth sprays) that may lead to end-user lung exposure via inhalation.
  2. Child Care Products (Under 3 Years): Entry 12b carries over the pre-existing 2014 restrictions for children under 3 years of age, prohibiting use in leave-on products designed for the nappy area and requiring the warning label: ‘Do not use on the nappy area’.

Compliance Action Plan: Roadmap for Omnibus Act IX Ahead of 2027 Deadlines

To navigate these amendments without risking distribution halts or market withdrawals, cosmetics companies should execute the following 5-step compliance strategy:

Step 1: SKU & Ingredient Portfolio Audit

Cross-reference every formula in your product catalog against the 16 newly banned Annex II substances. Pay close attention to eyelash growth serums (prostaglandins), non-oxidative hair colorants (Basic Brown 16, Basic Blue 99), and fragrance/UV stabilizer systems using Benzophenone-1 or Benzophenone-2.

Step 2: Raw Material Documentation Verification.

Secure updated Technical Data Sheets (TDS), Safety Data Sheets (SDS), and Certificates of Analysis (CoA):

  • Ensure finished cosmetic formulations containing CBD do not exceed the 2.5 ppm Δ9-THC impurity limit;
  • Verify that BHA concentrations in skin care do not exceed 0.07%;
  • Verify that nano-hydroxyapatite raw materials meet the mandatory uncoated, rod-shaped physicochemical specifications.

Step 3: Reformulation & Stability Testing

Where affected ingredients are identified, initiate alternative raw material screening immediately. Account for testing lead times—including stability testing, PET/challenge testing, and dermatological evaluations.

Step 4: Update Regulatory Documentation & CPNP Notifications

Re-evaluate the Cosmetic Product Safety Report (CPSR) and update Product Information File (PIF). Amend notifications on the EU Notification Portal (CPNP) and update product packaging/artwork to remove banned ingredients from INCI lists and verify compliance with newly adjusted child age limits.

Step 5: Supply Chain & Warehouse Stock Management

Map out product lifecycles to align production runs with the 1 February 2027 CMR deadline. Ensure distributor contracts reflect the 12-month placing on market and 24-month off-shelf availability timelines for non-CMR SCCS items.

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