Omnibus Act VIII: New prohibited and restricted cosmetic ingredients
On 12 January 2026, the European Commission published Commission Regulation (EU) 2026/78 amending Regulation (EC) No 1223/2009 on cosmetic products. This Regulation is known as the Omnibus Act VIII on CMR substances. It adds 18 new substances to the list of ingredients prohibited or restricted for use in cosmetic products.
The Omnibus Act VIII on CMR substances will take effect on 1 May 2026. It is important to note that there is no distinction between "placing on the market" and "making available on the market". As a result, products containing affected ingredients will be considered non-compliant cosmetic products. They cannot be sold in the EU and must be removed from the market before 1 May.
This update follows the European Commission’s standard regulatory process, under which ingredient safety is continuously reviewed to ensure a high level of consumer protection across the EU.
Substances affected by Omnibus Act VIII
| Substance / INCI | Previous regulatory status | SCCS opinion | Regulatory change under Omnibus VIII |
|---|---|---|---|
| Perboric acid and its salts (perborate derivatives) | Prohibited (Annex II entries 1397–1399) | Not applicable | Entries 1398 & 1399 deleted; as all perborate derivatives, structurally related, have a common mode of action and health risks, they are proposed to be regulated as a group under Annex II entry 1397. |
| Silver (massive) | Not specifically listed | Not applicable | Added to Annex II (prohibited). |
| Silver nano | Already prohibited (Annex II, entry 1727) | Not applicable | Entry 1727 expanded to explicitly include silver nano. |
| Silver powder (micron‑sized) | Permitted as colorant (Annex IV, entry 142) | Safe under conditions (SCCS, 27 Mar 2024) | Permitted only under restricted conditions in Annex IV; also added to Annex III as restricted:
|
| Hexyl 2‑hydroxybenzoate (Hexyl Salicylate) | Not previously regulated | Safe under conditions (SCCS, 25 Oct 2024) | Added to Annex III as restricted substance under the below conditions
|
| Biphenyl‑2‑ol (o‑Phenylphenol); Sodium o‑Phenylphenate | Permitted preservative (Annex V, entry 7) | Safe under conditions (SCCS, 25 Oct 2024) | Annex V entry 7 updated; remains allowed under existing limits:
Not to be used in products with potential inhalation exposure or in oral products. The label should bear the following wording: “avoid contact with eyes”. |
All other substances added to Annex II (list of substances prohibited in cosmetic products)
Substances that were recently classified into CMR categories (1A, 1B, and 2) under Delegated Regulation (EU) 2024/2564 have now been added to Annex II as prohibited cosmetic ingredients. No exemption requests were submitted for any of these remaining substances, resulting in their full restriction from use in cosmetic products. The list of these substances can be found in Omnibus Act VIII on CMR substances.
Regulatory context – how ingredients become restricted or prohibited in cosmetics
The Cosmetics Regulation states that when a substance is classified as carcinogenic, mutagenic or toxic to reproduction (CMR) in Categories 1A, 1B or 2 of the Classification, Labelling and Packaging (CLP) Regulation, it becomes prohibited for use in cosmetics, unless specific exemptions apply.
The CLP Regulations in the EU aim to ensure a high level of protection of human health and the environment by identifying the hazardous properties of substances and mixtures. There are three categories based on the strength of evidence for their hazardous effects:
- CMR1A: substances for which there is clear evidence that they are carcinogenic, mutagenic or toxic to reproduction.
- CMR1B: substances for which these effects are possible but for which there is a need for further research for confirmation of the effects.
- CMR2: substances suspected of having carcinogenic, mutagenic or reprotoxic effects. The risk assessment requires further studies.
For substances classified under the CLP Regulation, the Scientific Committee on Consumer Safety (SCCS) evaluates whether the classified substance can be used safely in cosmetics, and if so, under what limits or with specific label warnings.
The reclassification of hazard class for ingredients under the CLP Regulation can result in changes or additions to Annex II and Annex III of the Cosmetics Regulation. These changes may lead to prohibition or restrictions on the use of the substance in cosmetics, depending on the risk assessment and availability of safer alternatives.
If an ingredient in a cosmetic product is newly classified as hazardous, the manufacturer must reassess its safety. This may require reformulating the product and updating labels to stay compliant with the Cosmetics Regulation and ensure consumer safety.