Regulation (EU) 2026/78, recently published by the European Commission, represents a new amendment to Regulation (EC) No 1223/2009 on cosmetic products. This modification is part of Omnibus VIII, in line with Commission Delegated Regulation (EU) 2024/2564 amending the CLP Regulation, and introduces crucial regulatory updates regarding the use of substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) in cosmetic products placed on the European Union market.
The date of application is set for 1 May 2026, a key milestone for manufacturers, responsible persons, and safety assessors, who will be required to adapt their formulations and safety evaluations in accordance with the new requirements.
What Is Omnibus VIII And Why Is It Relevant
Omnibus Regulations are legislative instruments used by the European Commission to simultaneously update multiple annexes of the Cosmetics Regulation by incorporating new harmonised classifications previously established under the CLP Regulation.
Omnibus VIII continues this approach, introducing amendments that directly affect:
- Annex II (list of prohibited substances)
- Annex III (list of restricted substances)
- Specific conditions for certain ingredients already authorised
These updates do not introduce new cosmetic criteria but rather automatically transfer toxicological decisions already adopted at chemical classification level into the cosmetic regulatory framework.
Omnibus VIII: Prohibition Of Perborates
In line with the precautionary principle and Article 15 of Regulation (EC) No 1223/2009, the new regulation explicitly prohibits the use of certain substances classified as CMR in accordance with the updated CLP Regulation.
This measure follows the established procedure for the automatic incorporation of harmonised classification updates into the cosmetic framework through omnibus regulations, in this case the eighth since their implementation.
One of the key developments in this edition is the unification of perborates under a single entry in Annex II, reinforcing regulatory consistency for substances with similar toxicological profiles. Perborates have been repeatedly questioned due to their ability to release hydrogen peroxide, an oxidising agent that may compromise safety under certain concentrations and conditions of use.
Silver In Cosmetics: Differentiated Approach Based On Physical Form
The case of silver has been subject to detailed assessment by the European Commission and the SCCS. As of Regulation (EU) 2026/78, a differentiated regulatory approach will apply depending on the physical form of the substance.
Nano And Non-Micronised Silver
Nano and bulk (non-micronised) forms of silver are prohibited due to concerns regarding reproductive toxicity (Repr. 2 classification) and potential bioavailability in cosmetic applications. This measure is based on the SCCS opinion, which assessed risks related to dermal penetration and systemic accumulation.
Micronised Silver
By contrast, micronised silver is permitted only under strict conditions of use and concentration, in accordance with the same SCCS opinion. This exception reflects a favourable risk assessment under very specific use scenarios, where systemic exposure is considered minimal.
Silver Powder (CI 77820)
In parallel, the entry for the colourant Silver powder (CI 77820) has been amended. This change affects both its authorisation as a permitted colourant and its technical conditions of use, implying a more stringent assessment of dermal bioavailability and potential accumulation.
Omnibus VIII And Hexyl Salicylate
Another substance subject to restriction is Hexyl salicylate (CAS 6259-76-3), a fragrance ingredient commonly used in cosmetic formulations for its floral olfactory profile.
The substance has undergone toxicological review due to updated data suggesting potential effects on reproductive function. Under the new regulation, its presence will be permitted only within specific concentration limits and exclusively in certain product categories.
Assessment of cumulative exposure, both dermal and inhalation, will be essential to justify its inclusion in cosmetic formulations during safety assessment.
Phenolic Preservatives Under Omnibus VIII
In the area of preservatives, o-Phenylphenate (CAS 132-27-4) has been added as a substance permitted for use as a preservative in cosmetic products.
This decision is based on a favourable evaluation of its safety profile at the proposed concentrations, taking into account both its antimicrobial efficacy and its low sensitisation potential.
In parallel, the conditions of use for the preservative o-Phenylphenol (CAS 90-43-7) have been updated. The new provisions establish a more restrictive framework regarding maximum concentration and authorised product categories, reflecting an updated risk assessment based on cumulative exposure, particularly for leave-on products.
Key Omnibus VIII Changes In Cosmetics
To facilitate identification of the obligations arising from this update, the following table summarises the affected substances, the type of regulatory measure adopted, and the applicable timelines.
Summary Table Of Substances Affected By Regulation (EU) 2026/78
| Substance / Group | Cosmetic Function | Regulatory Measure | Conditions Of Use | Date Of Application |
| Perborates | Oxidising / bleaching agent | Prohibition (Annex II) | Not permitted in cosmetic products | 1 May 2026 |
| Silver (nano and non-micronised) | Preservative / technical function | Prohibition | All forms prohibited | 1 May 2026 |
| Micronised silver | Specific technical use | Restriction | Permitted only for specific uses and under defined limits | 1 May 2026 |
| Silver powder (CI 77820) | Colourant | Modified conditions | Review of authorisation and technical requirements | 1 May 2026 |
| Hexyl salicylate | Fragrance | Restriction | Concentration limits depending on product category | 1 May 2026 |
| o-Phenylphenate | Preservative | Authorisation | Permitted under specific conditions | 1 May 2026 |
| o-Phenylphenol | Preservative | Restriction | New concentration limits and authorised uses | 1 May 2026 |
Impact Of Omnibus VIII On Cosmetic Safety
The entry into force of these amendments requires an immediate review of raw material catalogues and Product Information Files (PIFs).
Responsible companies must ensure that no formulations contain prohibited substances and that restricted substances strictly comply with the established conditions.
In addition, safety assessors must update toxicological and exposure assessments for substances subject to new restrictions, incorporating current data and exposure modelling approaches where necessary.
This approach is essential to ensure compliance with Article 10 of the Cosmetics Regulation and to avoid non-compliance during regulatory inspections or market surveillance activities.
The inclusion of new preservatives or changes to conditions of use may also create reformulation opportunities, particularly for companies seeking to replace controversial preservatives with alternatives offering a more favourable regulatory and toxicological profile.
Why Choose SHAPYPRO
Given the increasing complexity of European regulatory frameworks, working with a specialised technical partner is key to maintaining compliance and competitiveness.
At SHAPYPRO, we support your company in effectively interpreting and implementing the requirements of Regulation (EU) 2026/78 and other relevant legislation. Our technical team guides you through ingredient assessment, safe reformulation, and the updating of PIFs and technical documentation, ensuring that your products meet all requirements before placement or continued distribution on the European market.