Children’s Cosmetics and EU Regulation: What Omnibus VIII Changed and What Brands Need to Fix Now
Commission Regulation (EU) 2026/78 of 12 January 2026 — amending Regulation (EC) No 1223/2009 as regards the use of certain substances classified as carcinogenic, mutagenic or toxic for reproduction — applies from 1 May 2026. It is part of the recurring series of CMR-based amendments to the EU Cosmetics Regulation, informally referred to in the industry as the “Omnibus” series. “Omnibus VIII” is a shorthand used by practitioners; it does not appear in the regulation itself.
From 1 May 2026, non-compliant products may not be placed on the EU market. The regulation does not contain an explicit sell-through provision for products already in the supply chain. Brands with existing non-compliant stock should review their position carefully, as enforcement practice varies by member state.
For most cosmetic categories, the changes are significant. For children’s cosmetics or products intended for children under three, they are even stricter. If you manufacture, import, or act as the Responsible Person for baby washes, nappy creams, children’s toothpaste, or other leave-on products for young skin, this guide explains what has changed and what your documentation needs to reflect now.
Why Children’s Cosmetics Face Stricter Limits Under Omnibus VIII
Children under three are treated as a distinct category in EU cosmetics regulation for good reason. Their skin barrier is still developing, their body surface area relative to weight is higher, and their exposure patterns differ from adults. Products used during nappy changes, bath time, and brushing mean repeated daily contact with the same formulation from birth.
The EU Cosmetics Regulation has always required safety assessments to account for vulnerable groups, but Omnibus VIII tightens the concentration limits for several substances in this age group. These changes are based on SCCS opinions, and the limits are not optional. They are the legal maximum from 1 May 2026 onwards.
The Key Ingredient Changes Affecting Children’s Products
Hexyl Salicylate
Hexyl Salicylate has been reclassified as a CMR Category 2 substance. This means it is considered a suspected carcinogen, mutagen, or reproductive toxin. Under Article 15 of the EU Cosmetics Regulation, CMR Category 2 substances are prohibited unless the SCCS has assessed them and confirmed they are safe under specific conditions.
Commission Regulation (EU) 2026/78 places Hexyl Salicylate in Annex III with defined concentration limits, based on the SCCS opinion SCCS/1668/24 of 25 October 2024, which concluded that Hexyl Salicylate can be considered safe under specific conditions of use. For products intended for children under three, these limits are stricter than for adult formulations. This is not just a labelling issue. If your products for young children contain Hexyl Salicylate, whether as part of a fragrance blend or as a standalone ingredient, reformulation may be required. Updating the label alone will not make a product compliant if it exceeds the permitted limits.
Hexyl Salicylate is used in a wide range of fragrance compounds. If you are working with fragrance mixtures, you need to confirm whether it is present and at what level in the final product, not just in the fragrance concentrate. This requires clear input from suppliers and, in many cases, updated raw material documentation.
Silver — Regulated by Particle Size for the First Time
Under Omnibus VIII, silver is now regulated based on particle size. This marks a clear shift in how compliance is assessed.
Nano silver (particle diameter ≤100 nm) and massive silver (particle diameter ≥1 mm) are no longer allowed in cosmetic products. Micrometre-range silver powder (particle diameter between 100 nm and 1 mm) is still permitted, based on SCCS opinion SCCS/1665/24 of 20 June 2024, but only within strict concentration limits. For toothpaste and mouthwash, including products for children, the limit is 0.05%. For use as a colorant in lip products and eye shadow, the limit is 0.2%. Silver powder is not permitted in other leave-on product categories under Commission Regulation (EU) 2026/78.
In children’s toothpaste, silver has often been used for its antimicrobial or whitening properties. If your formulation includes silver, you need to confirm the particle size with your supplier and ensure it falls within the permitted micrometre range before checking the concentration. Particle size is not usually listed on an INCI label, so you will need a supplier specification or technical data sheet that clearly confirms it.
o-Phenylphenol
o-Phenylphenol has been reclassified as a CMR Category 2 substance and remains listed in Annex V as a permitted preservative, based on SCCS opinion SCCS/1669/24 of 25 October 2024. The concentration limits are 0.2% in rinse-off products and 0.15% in leave-on products, expressed as phenol. Where o-Phenylphenol and Sodium o-Phenylphenate are used together, the combined concentration as phenol must not exceed those same limits. Three mandatory warnings now apply under the Annex V entry: “Avoid contact with eyes”; the product must not be used in applications that may lead to inhalation exposure; and it must not be used in oral products. Sodium o-Phenylphenate is included under the same Annex V entry.
For children’s products, this is relevant because o-Phenylphenol has been used as a preservative in some wash-off formulations. If your product contains it, check that the concentration meets the new limits and ensure the updated warning appears on the label.
What Your Documentation Needs to Reflect
For Responsible Persons, the practical compliance task is not just about the product formula. The entire documentation chain needs to reflect the current legal status of every ingredient.
The Product Information File (PIF) must be updated to reflect the new Annex entries. If it still refers to earlier versions or was last reviewed before Omnibus VIII, it is now out of date. A PIF that does not match the current regulatory status of its ingredients is unlikely to pass a market surveillance check.
The Cosmetic Product Safety Report (CPSR) needs to be reviewed by a qualified safety assessor against the updated limits. This is especially important for children’s products, where the report must clearly address the vulnerability of the intended user group. A CPSR prepared before the reclassification of Hexyl Salicylate or the new rules on silver particle size does not demonstrate compliance with the regulation in its current form.
CPNP notifications will need to be updated if the product formulation has changed as a result of reformulation. A change in an ingredient’s regulatory status alone — without any change to the formulation — does not itself trigger a CPNP update obligation. Compliance with the new limits is a matter handled through the CPSR and PIF. However, if reformulation has occurred to bring a product into compliance, the CPNP notification should be reviewed and updated accordingly.
Retailer requests are already arriving. Major EU retailers are asking Responsible Persons to confirm in writing that children’s product ranges comply with Omnibus VIII. Having your documentation ready in advance is far easier than trying to pull it together under a tight deadline.
A Practical Checklist for Children’s Cosmetic Brands
- Cross-check every INCI in your children’s product range against the new Annex II, III, and V entries introduced by Omnibus VIII
- Verify Hexyl Salicylate levels in any fragrance-containing formulation, including where it appears in a fragrance blend rather than as a standalone ingredient
- Obtain particle size confirmation from your supplier for any product containing silver
- Check o-Phenylphenol concentrations and update warning language where required
- Commission updated CPSR assessments for any product where an ingredient’s regulatory status has changed
- Update PIFs to reflect current annex entries
- Review CPNP notifications for products that have been reformulated
How Euverify Can Help
Euverify’s team works with cosmetic brands and Responsible Persons across the EU and UK. We are currently carrying out Omnibus VIII gap analyses, reviewing product portfolios against the updated Annex entries to identify which products need reformulation, which need documentation updates, and which are already compliant.
If you are based outside the EU and need a Responsible Person to meet your obligations under Article 4 of the EU Cosmetics Regulation, Euverify can support you in that role.
With stricter limits now in place for products intended for children under three, cosmetics compliance for children’s ranges has never been more complex. Having a qualified assessor review your portfolio is the most reliable way to understand your current position. Get in touch to find out how we can help.
Get in touch with the Euverify team to discuss your portfolio.
