EU Omnibus VIII (Regulation 2026/78): What It Bans

If you sell cosmetics in the EU, Regulation (EU) 2026/78 — “Omnibus VIII” is one of the most important updates to be aware of in 2026. It bans and restricts a set of substances newly classified as CMR, and unusually it gives no time to clear existing stock. This guide explains what Omnibus VIII does, which products it touches, and why its deadline is stricter than most.

For the wider 2026 picture across both markets, see our pillar guide to cosmetic regulation changes in 2026.

What is Omnibus VIII?

Omnibus VIII is the informal name for Commission Regulation (EU) 2026/78, adopted in January 2026, which amends the EU Cosmetics Regulation (EC) No 1223/2009. Like earlier “Omnibus” acts, it updates the cosmetic annexes to reflect new hazard classifications under the EU's chemicals legislation in this case substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR). When a substance becomes a CMR, EU law generally requires it to be prohibited in cosmetics unless a specific exemption applies.

The regulation amends several annexes the banned list, the restricted list, the colourant list and the preservative list adding new prohibitions and tightening conditions. It applies across all EU member states, and, through the Windsor Framework, in Northern Ireland too.

The key date: 1 May 2026

Omnibus VIII applies from 1 May 2026. What makes it stand out is that it provides no transitional sell-through period. Many cosmetic amendments give a year or more for existing stock to clear the shelves; Omnibus VIII does not. From 1 May 2026, products that do not comply or that contain a newly banned substance may not be placed on the market or made available, regardless of when they were produced.

This absolute cut-off is deliberate, reflecting the seriousness of CMR concerns, and it means brands could not simply run down old inventory. Anyone still holding affected stock on that date faced having to withdraw it. The practical lesson is that CMR-driven changes demand earlier action than ordinary updates.

What it bans and restricts

Omnibus VIII adds roughly fifteen or more newly classified CMR substances to the prohibited list (Annex II). These include a mix of industrial and intermediate chemicals along with some of cosmetic relevance. Notable examples reported include perboric acid and its salts, certain forms of silver, carbon nanotubes, and acetone oxime, among others.

It also restricts rather than bans some substances. Silver is now treated according to particle size, with different rules for nano, powder and larger forms. Hexyl salicylate, a fragrance ingredient newly classified as a CMR, is permitted only under conditions for example a maximum level in certain hydroalcoholic fragrances and not in products for the youngest children. The detail is technical, which is why a formula-by-formula check is essential.

Which products are most affected?

Most ordinary formulas will not contain the banned industrial substances, but a few product areas deserve close attention. Fragrance products may be touched by the hexyl salicylate restriction. Products using silver whether as a functional ingredient or colourant need their silver's particle size checked against the new rules. And any product that happened to use one of the newly banned substances, even as a minor component or impurity, is affected.

Because some of these substances can appear as impurities or in raw material blends rather than as deliberate additions, supplier documentation matters. You need to know not just your headline formula but what is genuinely present, which is where good raw material data earns its keep a theme we cover in our banned ingredients guide.

How to check and respond

The response to Omnibus VIII is a structured ingredient audit: cross-reference every ingredient in every EU product against the updated annexes, identify anything banned or now restricted beyond its limit, and reformulate or withdraw as needed. Where a substance is newly restricted, confirm you are within its conditions; where it is banned, remove it. Then update your documentation to match.

Crucially, reformulation has knock on effects. A changed formula generally needs its CPSR and PIF updated, its safety re-evaluated, and potentially its labelling and notification revised. Treating the ingredient swap in isolation, without updating the dossier, leaves you compliant on paper for the old product but not the new one.

Omnibus VIII and the UK

Omnibus VIII is an EU regulation, so it directly governs the EU market (and Northern Ireland). Great Britain made its own, separate changes in 2026 with different substances and deadlines, covered in our UK 2026 changes guide. Many of the same CMR concerns appear in both, but the timing and detail differ, so EU compliance does not automatically mean GB compliance.

For brands selling on both sides, the takeaway is to treat the two as separate tracks. Check your EU products against Omnibus VIII and your GB products against the UK instrument, and keep the two sets of records distinct.

Why CMR bans move faster than other changes

It helps to understand the logic behind the strict, no-transition approach. Cosmetic law works on the principle that substances classified as carcinogenic, mutagenic or toxic for reproduction have no place in products applied to the body, save in narrow, justified exceptions. Once the chemicals framework assigns a CMR classification, the cosmetics rules follow almost automatically to prohibit the substance. Because the concern is a serious health hazard rather than a quality or labelling matter, regulators are far less willing to allow non-compliant stock to keep selling while it clears.

That is why Omnibus VIII applies as an absolute cut-off rather than with the comfortable year-plus sell-through many makers are used to. The reasoning is straightforward: if a substance is considered unsafe enough to ban, allowing it to remain on shelves for another eighteen months sits uncomfortably with the safety rationale. This pattern repeats with each Omnibus act, so it is wise to assume CMR-driven changes will be stricter on timing than ordinary updates.

The practical consequence is that CMR amendments reward early monitoring. Because there is no grace period to fall back on, brands that watch the pipeline noticing when a substance they use is heading toward CMR classification can reformulate calmly in advance, while those who wait for the final regulation can be caught with stock they must withdraw. Anticipation, not reaction, is the winning approach here.

Omnibus VIII action checklist

• Note the hard 1 May 2026 date — no sell-through.

• Audit every EU product against the updated annexes.

• Check fragrance (hexyl salicylate) and silver-containing products closely.

• Verify raw-material data for banned substances as impurities.

• Reformulate or withdraw affected products.

• Update CPSR, PIF, labelling and CPNP notification after changes.

Frequently asked questions

What is Omnibus VIII?

Commission Regulation (EU) 2026/78, adopted in January 2026, which amends the EU Cosmetics Regulation to ban or restrict substances newly classified as CMR (carcinogenic, mutagenic or toxic for reproduction).

When does Omnibus VIII apply?

From 1 May 2026, with no transitional sell-through period. From that date, non-compliant products may not be placed on or made available on the EU market, including existing stock.

What does it ban?

Around fifteen or more newly classified CMR substances are added to the prohibited list, and others are restricted for example silver is controlled by particle size and hexyl salicylate is allowed only under conditions.

Does Omnibus VIII apply in the UK?

No. It is an EU regulation governing the EU market and, via the Windsor Framework, Northern Ireland. Great Britain made separate changes in 2026 with different substances and deadlines.

What should I do if a product is affected?

Reformulate or withdraw it, and then update the CPSR, PIF, labelling and CPNP notification to reflect the change the ingredient swap alone is not enough.

References: Commission Regulation (EU) 2026/78 (Omnibus VIII), amending Regulation (EC) No 1223/2009 (EUR-Lex); CLP Regulation and Delegated Regulation (EU) 2024/2564; SCCS opinions. General information only, not legal advice; verify current requirements for your products.