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Omnibus Ingredient II: what Regulation (EU) 2026/909 changes for your formulations

  • May 12
  • 4 min read

Updated: May 19




Commission Regulation (EU) 2026/909, published in the Official Journal on 28 April 2026, is the second major ingredient restriction update to follow Omnibus VIII. It covers twelve ingredients across fragrance allergens, UV filters, hair dyes, and minerals — and for any brand working with fragrances, deodorants, sunscreens, or hair colour, the exposure may be significant.

This article breaks down what Regulation (EU) 2026/909 changes, which ingredients require a formulation-by-formulation review, and what the compliance timeline looks like.


What Regulation (EU) 2026/909 is — and what it is not

Omnibus Ingredient II is not a CMR regulation. Unlike Omnibus VIII, which implemented bans triggered by new CLP toxicity classifications, EU 2026/909 is a science-led restriction update. It reflects accumulated SCCS opinions on twelve ingredients and translates those safety assessments into new Annex conditions.

Most of these substances remain permitted — but only at defined concentrations in defined product categories. The compliance question is no longer "does my product contain this ingredient?" but "does my product contain it at a level that's still legal in this specific product type after 1 January 2027?" That question requires a different kind of review.


The three ingredients most relevant to indie brands

Benzyl Salicylate — a fragrance staple now subject to category-specific limits

Benzyl Salicylate is ubiquitous in fragrance formulations. Until now, its only regulatory condition was an allergen declaration threshold under EU 2023/1545. As of 1 January 2027, that changes substantially.

Regulation (EU) 2026/909 replaces Annex III entry 75 with a product-type table. Maximum permitted concentrations by category: Fragrance products (hydroalcoholic and non-hydroalcoholic, spray and non-spray): 4% · Shower gel / bath products: 1.3% · Deodorant products (spray / aerosol): 0.91% · Body lotion: 0.7% · Rinse-off skin and hair products (except shower gel / bath): 0.5% · Leave-on skin and hair products, non-spray / non-aerosol (except body lotion): 0.5% · Leave-on hair products (spray / aerosol): 0.5% · Face make-up and make-up remover products: 0.2% · Oral products: 0.004%.

The allergen labelling obligation from EU 2023/1545 remains in parallel. Both obligations now apply simultaneously. A brand with a body care range may have Benzyl Salicylate in multiple products at the same concentration from the same fragrance compound — but each product now has a different legal ceiling. A single fragrance supplier check is not enough. Each SKU needs individual verification.


Citral (including Geranial and Neral) — tighter limits, extended sell-through

Citral is one of the most widely used fragrance allergens in natural and botanical formulations. It is present inherently in citrus oils, lemongrass, and many essential oil blends — which means brands using natural fragrances may have Citral in their products without it appearing by name in their formulation brief.

Regulation (EU) 2026/909 amends Annex III entry 70 to introduce product-type concentration limits, driven by SCCS sensitisation concerns. The compliance deadline for Citral has a specific extension: non-compliant products already on the EU market may be sold through until 1 August 2028. Products placed on the EU market must comply from 1 January 2027.

Brands using natural fragrance blends should request updated IFRA certificates and full analytical data from their fragrance suppliers. A formulation that complies today may not comply after January 2027 if Citral contributes — directly or as Geranial/Neral — above the new category limit.


Aluminium-containing ingredients — the deodorant and antiperspirant sector's compliance task

Regulation (EU) 2026/909 adds a new consolidated entry (379) to Annex III covering all aluminium-containing ingredients not already governed by existing Annex entries, and sets category-specific maximum concentrations expressed as percentage aluminium. Antiperspirants are capped at 7.73% as Al for non-aerosol and 3.24% as Al for aerosol formats. For aerosol applications, the regulation specifies that products must not be used in a way that causes lung exposure.


What else the Regulation covers

Triphenyl Phosphate — banned from all cosmetic use (Annex II). A plasticiser commonly used in nail varnish and nail hardener formulations. Brands should verify whether their supplier's formulation includes TPP as a processing aid.

Water-soluble zinc salts — new oral care age limits. Toothpaste for children under one year: maximum 0.72% as zinc. Mouthwash for users above six years: maximum 0.1% as zinc.

Four new hair dyes — authorised from 18 May 2026. HC Blue No. 18, HC Red No. 18, HC Yellow No. 16, and Hydroxypropyl-p-phenylenediamine and its dihydrochloride salt move to permitted use under specific Annex III conditions.

Ammonium Silver Zinc Aluminium Silicate — moved from Annex II (prohibited) to Annex V (permitted preservative). Authorised for deodorant sprays and powder foundations at up to 1%, provided silver content does not exceed 2.5%.

DHHB (UV filter) — purity requirement. The contaminant di-n-hexyl phthalate (DnHexP) is capped at 10 ppm. Brands using sunscreen formulations with DHHB should confirm the purity specification from their raw material supplier.


The UK divergence on Hexyl Salicylate — a separate compliance track

Brands selling in both the EU and the UK need to be aware of a divergence that affects Hexyl Salicylate. Omnibus VIII restricted it in the EU from 1 May 2026 with no sell-through period.

The UK equivalent — Statutory Instrument 2026/109, published 9 February 2026 — sets its own timeline. Non-compliant products may not be placed on the UK market from 15 August 2026, with sell-through running until 14 February 2027. Same ingredient. Two jurisdictions. Three different dates. If your reformulation plan was built around one of these dates, it may not cover the other.



The compliance picture for brands with fragrance-containing portfolios

A brand with a fragrance-containing product line — particularly one using natural fragrance blends — may be simultaneously managing: Benzyl Salicylate category limit verification (EU 2026/909 · deadline 1 Jan 2027) · Citral / Geranial / Neral category limit verification (EU 2026/909 · deadline 1 Jan 2027) · Aluminium concentration verification for antiperspirants / deodorants (EU 2026/909 · deadline 1 Jan 2027) · Fragrance allergen individual labelling on new product placements (EU 2023/1545 · deadline 31 Jul 2026) · INCI Glossary update across all labels (EU 2025/1175 · mandatory from 30 Jul 2026) · Hexyl Salicylate UK placement-on-market if UK sales active (SI 2026/109 · deadline 15 Aug 2026).

None of these are resolved by a single action. The brands that navigate this well are the ones who have mapped their ingredient exposure across their full product portfolio before each deadline hits — not after.

At Cláritas Regulatory, we work with indie brands and founders to translate these regulatory changes into practical action. If you'd like to understand how EU 2026/909 and the upcoming deadlines affect your specific formulations and documentation, get in touch.

 
 
 

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