EU Draft Regulation 2026: Updated Restrictions On Micron-Sized Silver In Cosmetics

What Cosmetic Companies Need to Know About Silver, SCCS Safety Assessment, Concentration Limits and the Proposed Regulatory Changes

The European Union is reassessing the regulatory status of micro-sized Silver (CAS No. 7440-22-4; EC No. 231-131-3) in cosmetic products following updated scientific advice from the Scientific Committee on Consumer Safety (SCCS).

The latest SCCS scientific advice, SCCS/1687/25, adopted on 26 March 2026 and published in April 2026, concluded that micron-sized particulate Silver with a particle diameter above 100 nm and below 1 mm can be considered safe under specified conditions of use. The assessment is based, among other factors, on new data indicating that these micron-sized particles do not penetrate the skin.

This development is particularly important because Omnibus VIII (Regulation (EU) 2026/78) introduced restrictions on Silver applicable from 1 May 2026. Under the current rules, micron-sized Silver is permitted only in specific cosmetic applications and concentrations.

A further EU regulatory proposal is expected to consider the updated SCCS assessment and potentially broaden the permitted uses of micron-sized Silver.

For brands using Silver in cosmetics, now is the right time to review formulations, particle-size specifications, product categories, safety assessments, PIF documentation and future product-development plans.

Why the Silver Regulatory Update Matters

Silver is used in cosmetic products for different functional and aesthetic purposes, including as a colorant and in certain oral-care and cosmetic formulations.

However, the regulatory assessment of Silver is complicated by differences in particle size and form.

Companies must distinguish between:

• Silver nano
• Micron-sized silver powder
• Massive Silver
• Silver used as CI 77820
• Other Silver-containing materials

These forms should not be treated as automatically equivalent from a regulatory perspective.

The EU's classification and cosmetics legislation distinguish Silver according to particle size, with silver nano and certain larger silver forms subject to prohibition, while micron-sized Silver is subject to specific restrictions.

Therefore, simply identifying an ingredient as "Silver" is not sufficient for regulatory assessment.

What Is Micron-Sized Silver?

For the current SCCS assessment, micron-sized particulate Silver is defined as:

100 nm < particle diameter < 1 mm

This is different from Silver nano, which falls within the 1–100 nm range.

The distinction is critical because Silver nano remains prohibited under the relevant EU cosmetics framework, while micron-sized Silver may be permitted under specified conditions.

Companies should therefore maintain reliable evidence demonstrating the particle-size distribution and physical characteristics of the Silver raw material used in their formulations.

Current EU Regulatory Position

Under Regulation (EU) 2026/78, applicable from 1 May 2026, Omnibus VIII introduced restrictions affecting Silver in cosmetics.

The regulation:

• Prohibits specified Silver forms under Annex II
• Restricts micron-sized Silver under Annex III
• Permits certain uses of micron-sized Silver as a colorant under Annex IV

The current rules permit micron-sized Silver at:

The colourant entry identifies the material as Silver (powder), 100 nm < particle diameter < 1 mm, with CI 77820 applicable to the permitted colourant uses.

This represents the current legal position, rather than the broader uses proposed following the latest SCCS scientific advice.

What Has Changed with the Latest SCCS Advice?

The latest SCCS scientific advice, SCCS/1687/25, provides a broader safety assessment.

The SCCS concluded that micron-sized particulate Silver can be considered safe at:

• 0.2% in rinse-off products
• 0.3% in leave-on products
• 0.2% in oral-hygiene products
• 0.3% in nail products

For products intended for children, the same concentrations were considered safe, except for mouthwash, where 0.05% was considered safe.

The SCCS also clarified that new data show micron-sized Silver does not penetrate the skin, supporting the revised safety assessment.

However, the opinion does not cover propellant-based spray products, because these applications were not included in the assessment submitted to the SCCS.

Proposed Expansion of Permitted Uses

The latest scientific advice creates a potential basis for expanding the regulatory uses of micron-sized Silver.

The proposed direction would potentially allow Silver in a wider range of:

• Rinse-off products
• Leave-on products
• Oral-hygiene products
• Nail products
• Other cosmetic applications covered by the safety assessment

The key proposed concentration levels are expected to reflect the SCCS conclusions:

0.2% for rinse-off products and 0.3% for leave-on products, with specific considerations for oral hygiene, children's products and nail applications.

However, companies should distinguish between SCCS safety advice and legally applicable EU legislation.

A scientific opinion does not itself amend Annexes II–VI of Regulation (EC) No 1223/2009. The European Commission must adopt the corresponding regulatory amendment before new uses become legally available.

Why Omnibus VIII Is Important

Omnibus VIII, formally Regulation (EU) 2026/78, became applicable from 1 May 2026.

It followed the classification of Silver as a CMR category 2 substance for reproductive toxicity under the relevant CLP framework and incorporated restrictions into the Cosmetics Regulation.

The regulation specifically distinguishes between silver forms.

Current provisions include:

• Silver nano: prohibited
• Massive Silver: prohibited under the relevant Annex II entry
• Micron-sized Silver: permitted only under specified restrictions
• Silver as CI 77820: permitted for specified colorant uses

This means companies must conduct a form-specific regulatory assessment, rather than treating all silver ingredients as having the same regulatory status.

Impact on Cosmetic Manufacturers

Companies using micron-sized Silver should review their product portfolios now.

Key review areas include:

1. Ingredient Identity

Confirm:

• INCI name
• CAS number
• EC number
• Raw-material specifications
• Particle-size distribution
• Supplier documentation

2. Product Category

Determine whether the product is:

• Rinse-off
• Leave-on
• Oral hygiene
• Nail product
• Lip product
• Eye product
• Spray product
• Children's product

3. Concentration

Compare the Silver concentration against:

• Current legal limits
• SCCS safety limits
• Potential future regulatory limits

4. Product Information File

Update the PIF where necessary to ensure the regulatory and safety documentation reflects the correct Silver form, concentration and intended use.

5. Safety Assessment

The Cosmetic Product Safety Report should reflect the actual material used, including relevant exposure considerations and particle-size information.

Particle Size Is a Critical Compliance Parameter

One of the most important practical implications is that particle-size evidence becomes a key regulatory document.

Companies should request appropriate documentation from silver suppliers, including:

• Particle-size distribution
• Analytical method
• Material specification
• Batch consistency
• Identification of nano fraction
• Purity information
• Certificate of analysis
• Supplier declaration

If raw material can contain particles within the nano range, the regulatory assessment may become significantly more complex.

Therefore, supplier qualification and raw material control should form part of the compliance strategy.

Impact on Formulation and R&D

The potential regulatory expansion could create opportunities for brands developing Silver-containing products.

R&D teams should consider:

• Target concentration
• Product type
• Particle-size specifications
• Stability
• Compatibility with the formulation
• Consumer exposure
• Safety assessment
• Claims
• Packaging
• Future regulatory limits

Formulators should avoid developing products solely on the assumption that the proposed limits are already legally effective.

Current legislation must remain the basis for commercial launch decisions until the regulatory amendment is formally adopted.

Claims and Marketing Considerations

The regulatory change does not automatically authorize every marketing claim associated with Silver.

Claims such as:

• Antibacterial
• Antimicrobial
• Purifying
• Protective
• Odor-control
• Skin-benefit claims

should be independently assessed for compliance with the EU Cosmetics Regulation and applicable claims principles.

Companies should ensure that marketing claims are supported by appropriate evidence and remain consistent with the product's cosmetic purpose.

A permitted ingredient does not automatically mean that every claim associated with that ingredient is acceptable.

Children's Products Require Additional Attention

SCCS specifically assessed products intended for children.

The advice indicates that micron-sized Silver can be considered safe at the relevant concentrations, with a specific lower limit of 0.05% for children's mouthwash.

Companies marketing children's products should therefore review:

• Age category
• Product type
• Concentration
• Exposure assumptions
• Safety assessment
• Labelling
• Claims

Special attention should also be given to oral products because exposure pathways differ from ordinary topical cosmetics.

Spray Products: Important Limitation

Companies should not assume that the SCCS opinion covers every spray application.

SCCS specifically stated that its assessment does not apply to propellant-based spray products because those applications were not included in the submitted assessment.

Therefore, companies with Silver-containing aerosol or propellant-based spray products should undertake a separate regulatory assessment before relying on the new SCCS conclusions.

Regulatory Action Plan for Cosmetic Companies

Companies should consider the following roadmap:

1. Identify all Silver-containing products.
2. Confirm the exact Silver material and particle-size range.
3. Review current EU regulatory status.
4. Compare concentrations with current Annex III/IV limits.
5. Identify products that could benefit from future expanded limits.
6. Review supplier documentation.
7. Update PIF and safety documentation were necessary.
8. Review CPSR exposure and safety assessments.
9. Assess children's products separately.
10. Review spray products carefully.
11. Reassess Silver-related claims.
12. Monitor the proposed EU amendment.
13. Update formulas and artwork only when legally appropriate.
14. Maintain change-control documentation.

Current vs Potential Future Position

Current legal limits derive from Regulation (EU) 2026/78, while the broader values represent the SCCS scientific safety assessment and should not be treated as legally effective until incorporated into EU legislation.

Common Compliance Mistakes

Companies should avoid:

• Treating all Silver forms as equivalent
• Confusing nano Silver with micron-sized Silver
• Assuming the SCCS opinion is already law
• Using future concentration limits prematurely
• Failing to verify particle-size specifications
• Relying on incomplete supplier declarations
• Ignoring children's exposure
• Applying the SCCS opinion to propellant sprays
• Updating formulas without regulatory review
• Making unsupported antimicrobial claims
• Failing to update the CPSR/PIF
• Overlooking change-control requirements

What This Means for Your Cosmetic Portfolio

The latest scientific advice creates a potentially more flexible regulatory environment for micron-sized Silver, but companies should manage the transition carefully.

Products currently compliant with Omnibus VIII should continue to be assessed against the legally applicable limits.

For products outside the current permitted categories, companies can begin preparing regulatory strategies based on the SCCS safety assessment while monitoring the EU legislative process.

This is particularly relevant for brands considering:

• New Silver-containing formulations
• Higher Silver concentrations
• Leave-on products
• Rinse-off products
• Nail products
• Oral-care products
• Children's formulations

How Maven Regulatory Solutions Can Help

Maven Regulatory Solutions can support companies with:

• EU cosmetic regulatory assessment
• Silver ingredient regulatory review
• Particle-size documentation review
• Formula and concentration assessment
• SCCS opinion impact assessment
• CPSR and PIF review
• Ingredient compliance
• Claims assessment
• Product portfolio gap analysis
• Supplier documentation review
• Regulatory change monitoring
• Reformulation strategy
• Market-readiness assessment
• EU Cosmetics Regulation Compliance

A structured regulatory review can help companies understand which products are affected, what documentation needs updating, and how to prepare for potential changes without prematurely implementing future requirements.

Frequently Asked Questions

1. Is micron-sized Silver currently allowed in EU cosmetics?

Yes, but only under specific conditions and concentration limits established by the current Cosmetics Regulation.

2. What is the current limit?

Under the current rules, micron-sized Silver is permitted at 0.05% in toothpaste and mouthwash and 0.2% in lip products and eye shadow.

3. What did the latest SCCS opinion change?

SCCS/1687/25 concluded that micron-sized Silver can be considered safe at 0.2% in rinse-off and 0.3% in leave-on products, with additional conclusions for oral hygiene, nail and children's products.

4. Is the new 0.3% leave-on limit already legally applicable?

Not merely because the SCCS issued its scientific advice. The relevant EU Cosmetics Regulation must be formally amended before the new limit becomes legally applicable.

5. Is nano Silver permitted?

No. Silver nano remains subject to prohibition under the applicable Cosmetics Regulation framework.

6. Are Silver sprays covered?

Propellant-based sprays were not covered by the SCCS assessment and therefore require regulatory caution.

7. Should companies review their existing products?

Yes. Companies should compare their formulations, particle-size specifications, concentrations and product categories against both the current legislation and the latest SCCS scientific advice.

8. Can companies immediately reformulate to 0.3% Silver?

Not solely because of the SCCS opinion. Companies should wait for the applicable legislative amendment before commercializing products based on future limits.

Conclusion

The EU regulatory landscape for micron-sized Silver in cosmetics is evolving rapidly.

The current framework introduced through Omnibus VIII allows certain uses of micron-sized Silver but imposes specific restrictions. The latest SCCS/1687/25 scientific advice provides a broader safety assessment, supporting concentrations of up to 0.2% in rinse-off and 0.3% in leave-on products, together with specific conclusions for oral hygiene, nail and children's products.

For cosmetic companies, the priority should be to distinguish current legal requirements from proposed future changes.

Businesses using Silver should review particle size, formulation concentration, product category, supplier documentation, CPSR/PIF information, claims and portfolio exposure.

Regulatory readiness today can make future implementation faster, more efficient and less disruptive.

Why Choose Maven Regulatory Solutions?

Maven Regulatory Solutions supports cosmetic companies with EU ingredient compliance, SCCS regulatory assessments, formulation review, CPSR/PIF support, claims assessment, regulatory intelligence, portfolio gap analysis, supplier-documentation review, reformulation strategy and lifecycle compliance.

Our regulatory approach helps brands understand evolving EU requirements and prepare practical strategies for compliant cosmetic product development and market access.