Omnibus VI and Omnibus VIII: two regulations, two very different deadlines for indie brands

✅ Updated 30 April 2026 — 18:00 CET. The European Parliament adopted Omnibus VI on 29 April 2026 with a large majority: 540 votes in favour, 60 against, and 45 abstentions. The text now moves to trilogue negotiations between Parliament, Council, and Commission before final adoption.

Omnibus VI was adopted by the European Parliament on 29 April with 540 votes in favour. Omnibus VIII enters into force tomorrow, 1 May 2026. Here's what each one actually means — and what you need to do now.

This week, the European Parliament voted on Omnibus VI — and adopted it. With 540 votes in favour, 60 against, and 45 abstentions, the text passed with a large majority on 29 April 2026. It's been one of the most debated pieces of cosmetics legislation in recent memory — months of headlines, strong positions from both industry groups and NGOs, and a lot of noise about what it actually changes.

But here's what's easy to miss in all of that noise: Omnibus VI is not the regulation with the imminent deadline. Omnibus VIII is. And Omnibus VIII applies from 1 May 2026 — tomorrow.

If you've been following the debate and feeling uncertain about what you need to do right now, this is the practical version. What each regulation does, what was decided, and what you need to pay attention to — and when.

First, the distinction that matters

Omnibus VI and Omnibus VIII are two separate regulations with two separate purposes, and they keep getting conflated in coverage that focuses on the political debate around the first while the deadline for the second arrives quietly.

Omnibus VIII — formally Commission Regulation (EU) 2026/78, published 12 January 2026 — is a content regulation. It bans and restricts specific substances. It applies from 1 May 2026 with no sell-through period and no distinction between new and existing products. Non-compliant products cannot be sold in the EU from that date, full stop.

Omnibus VI is a procedural regulation. It doesn't ban any specific substances — it changes the timeline and process by which future CMR classifications trigger cosmetics restrictions. Adopted on 29 April, it now moves to trilogue before becoming final law. It affects future compliance planning, not your immediate May 1 obligations.

Omnibus VIII: what applies from 1 May 2026

Regulation (EU) 2026/78 adds 18 new substances to the prohibited or restricted list under the EU Cosmetics Regulation. For indie brands, three categories are worth understanding in detail.

Silver — prohibited in nano and bulk forms, restricted as powder

The regulation takes a particle-size-dependent approach to silver, reflecting the SCCS's 2024 scientific opinion:

• Silver nanoparticles (1–100 nm): prohibited as a nanomaterial due to reproductive toxicity concerns.

• Silver in solid bulk form (≥1 mm): explicitly prohibited.

• Micron-sized silver powder (100 nm–1 mm): permitted only under specific conditions, defined product categories, and maximum concentration limits. Not a blanket permission — particle size and product category must be verified.

Hexyl Salicylate — heavily restricted by product type and population

Hexyl Salicylate, a fragrance ingredient found across a wide range of products, is now subject to differentiated concentration limits that vary significantly by category and target population. The range runs from 2% in hydroalcoholic fragrances (excluding products for children under 3) down to 0.001% in oral products such as toothpaste and mouthwash. In products for children under 3, use is prohibited — with two specific exceptions: up to 0.1% in rinse-off and leave-on products such as shampoo, shower gel, body/face cream, and fragrances; and up to 0.001% in toothpaste.

Important: if your formulations contain Hexyl Salicylate, this level of category-specific granularity requires a formulation-by-formulation review — not a single check across your portfolio.

Additional banned substances from 1 May

• Perboric acid and its salts — prohibited across all cosmetic use.

• Carbon nanotubes (specific types) — prohibited.

• Acetone oxime, N,N'-methylenediacrylamide, trimethyl borate — banned from all cosmetic formulations.

Tea Tree Oil — a clearer picture than the headlines suggest

Tea Tree Oil has generated significant anxiety since ECHA classified it as a Category 1B reproductive toxicant in 2023. The SCCS issued its final opinion in November 2025, and what it says is more nuanced than a ban.

The SCCS considers Tea Tree Oil safe as an antimicrobial and anti-seborrheic agent — but only in four specific product types, at defined concentrations, and only with TTO that meets ISO 4730:2017 standards:

• Shampoo (rinse-off) — up to 2%

• Shower gel / body wash (rinse-off) — up to 1%

• Face wash (rinse-off) — up to 1%

• Face cream (leave-on) — up to 0.1%

• Aerosol and spray formats: not covered due to inhalation risk.

The regulatory process to formally incorporate these limits into the Cosmetics Regulation is still ongoing — no Annex amendment has been published as of the date of this article. The direction is clear: conditional permission at defined concentrations, not a blanket ban. Brands using Tea Tree Oil should ensure their formulations are within the SCCS limits and that their PIF documents the ISO-compliant source and stability data.

Omnibus VI: what the plenary vote decided

The European Parliament adopted Omnibus VI on 29 April 2026 with 540 votes in favour, 60 against, and 45 abstentions — a large majority. The compromise text endorsed by the ENVI and IMCO committees on 15 April was approved without changes, with all amendments rejected in plenary.

What it establishes: the baseline withdrawal timeline for newly classified CMR substances extends from 18 months to approximately 2.5 years. An additional derogation of up to 5.5 years is possible, but only for uses with a positive safety opinion from scientific experts — it requires an active application and full review, not an automatic extension.

The topical-use exemption proposed by the Commission — which would have excluded substances classified as CMR through ingestion or inhalation from the cosmetics ban — was firmly rejected. The principle that a CMR classification triggers a cosmetics restriction regardless of exposure route remains intact.

The text now moves to trilogue negotiations between Parliament, Council, and Commission. It is not yet final law. For most indie brands, the practical impact is limited to future compliance planning — Omnibus VI changes nothing about your May 1 obligations, your fragrance allergen labelling deadline in July, or your INCI glossary update due 30 July 2026.

The three deadlines to have in your calendar right now

These don't arrive separately. They compound — three simultaneous compliance actions across formulations, labels, and documentation, all within three months.

• 1 May 2026 — Omnibus VIII (EU 2026/78): specific substances banned or restricted. No sell-through period. Non-compliant products must leave the EU market.

• 30 July 2026 — Updated INCI Glossary mandatory (Regulation EU 2025/1175): 348 new ingredient entries added. Labels must reflect current INCI nomenclature.

• 31 July 2026 — Fragrance allergen labelling (Regulation EU 2023/1545): mandatory individual allergen declarations expand from 26 to 80 substances on new products placed on the EU market.

The brands that manage this well are the ones who've mapped their exposure across all three before the first deadline arrives — not the ones who address them one by one as they hit. If you're not sure where your products stand, that's the conversation to have today — not next week.

At Cláritas Regulatory, we monitor EU cosmetics regulation continuously and translate it into practical action for indie brands. If you'd like to understand how the current regulatory landscape affects your specific formulations and documentation, get in touch.