The European Union is significantly tightening regulations on Silver (CAS No. 7440-22-4) in cosmetic products. Following the entry into force of the Omnibus Act VIII (Commission Regulation (EU) 2026/78) on May 1, 2026, stricter prohibitions and concentration limits took effect.
However, because the Scientific Committee on Consumer Safety (SCCS) published an updated final opinion on April 24, 2026, further urgent amendments are already underway. Cosmetic manufacturers exporting to the EU must quickly adapt to this evolving multi-tiered regulatory framework.
I. Core Framework of the New Regulations
The EU has categorized silver restrictions according to its physical form and particle size (granulometry), as toxicological risks vary significantly by physical structure.
The original provisions of the Omnibus Act VIII implemented on May 1, 2026, include:
- Annex II (Prohibited Substances): Full bans have been placed on:
- Nano-scale silver ($1\text{ nm} < \text{particle diameter} \le 100\text{ nm}$).
- Massive silver ($\text{particle diameter} \ge 1\text{ mm}$).
- Annex III (Restricted Substances) — New Entry 379: Micron-sized silver ($100\text{ nm} < \text{particle diameter} < 1\text{ mm}$) is banned in general cosmetics and permitted only in oral care:
- Toothpaste: Maximum concentration of 0.05%
- Mouthwash: Maximum concentration of 0.05%
- Annex IV (Permitted Colorants) — Entry 142: Micron-sized silver used as a colorant (CI 77820) is restricted to:
- Lip products: Maximum concentration of 0.2%
- Eye shadows: Maximum concentration of 0.2%
II. The 2026 SCCS Safety Reassessment (SCCS/1687/25)
The initial, highly restrictive regulations above were based on an older 2024 SCCS evaluation. However, the industry subsequently submitted new, comprehensive ex vivo dermal penetration studies using advanced technologies like Time-of-Flight Secondary Ion Mass Spectrometry (ToF-SIMS).
These new studies successfully demonstrated that micron-sized silver particles remain strictly confined to the upper stratum corneum and do not penetrate into the living dermis or viable epidermis.
Consequently, the SCCS adopted a updated Final Opinion (SCCS/1687/25) on April 24, 2026, widening the safe thresholds for micron-sized silver ($100\text{ nm} < \text{particle diameter} < 1\text{ mm}$):
| Cosmetic Product Category | Newly Recommended Safe Concentration Limit |
| Produtos de aplicação imediata | Maximum 0.3% |
| Produtos com enxaguamento | Maximum 0.2% |
| Oral hygiene products | Maximum 0.2% (except children’s mouthwash, capped at 0.05%) |
| Nail products | Maximum 0.3% |
Critical Exclusion: These relaxed thresholds do not apply to propellant-based spray or aerosol products, as the dossier did not cover inhalation safety data. Therefore, silver remains prohibited in aerosol sprays.
III. Emergency Legislative Adjustments and the Compliance Path
The positive scientific conclusion from the SCCS does not automatically overwrite the active law that took effect on May 1, 2026. This creates a temporary “regulatory lag” that requires strategic planning from exporters:
- Immediate Compliance with Omnibus VIII: Until Annex III is formally amended, enforcement authorities will monitor products against the current limits (e.g., silver powder is technically prohibited in general leave-on or rinse-off lotions/gels outside of eye, lip, and oral categories).
- Activation of the Emergency Procedure: The European Commission is currently leveraging the emergency procedure under Article 32(4) of the EU Cosmetics Regulation. This mechanism allows the Commission to bypass standard lengthy legislative reviews and fast-track an urgent revision of Entry 379 to reflect the newer, broader 0.2%/0.3% limits as soon as possible.
- Audit of Raw Material Specifications: Brands must immediately demand detailed granulometry (particle size) certificates, SDS, and technical data sheets from suppliers to verify that their silver raw materials fall strictly into the permitted $100\text{ nm}$ to $1\text{ mm}$ micron range, ensuring they contain zero nano-scale fractions ($<100\text{ nm}$).
IV. Conclusion
While the expansion of the silver ban initially sent shockwaves through the industry, the latest April 2026 SCCS final opinion provides a clear path forward for its safe use as an antibacterial and aesthetic conditioning agent. Exporters should maintain close contact with their Responsible Persons (RP) in the EU to seamlessly manage product compliance as the regular updates merge into the emergency revision.
On April 24, 2026, Inmetro published Public Consultation No. 8 in the Diário Oficial da União (Brazil’s Federal Official Gazette), introducing a new draft of the MERCOSUR Metrological Technical Regulation on the Quantitative Indication for Cosmetics (Draft Resolution No. 02/25).
This draft is designated to replace the long-standing GMC Resolution No. 50/00, which has been in effect since 2000, bringing regional requirements in line with modern market developments and international standards under Working Subgroup No. 3 (SGT-3).
II. Core Requirements: Strict Division by Physical State
According to the new draft, net content declarations on cosmetic packaging must be rigorously separated by the physical characteristics and states of the product formulation:
1. Solids, Semi-Solids, and Solid-Liquid Mixtures $rightarrow$ Must Use Mass
- Required Units: Grams or kilograms (g / kg)
- Produtos aplicáveis: Creams, hair waxes, clay masks, paste-like skincare products, and solid-liquid mixed scrubs.
2. Liquids $rightarrow$ Must Use Volume
- Required Units: Milliliters or liters (mL / L)
- Produtos aplicáveis: Shampoos, shower gels, body mists, toners, and liquid serums.
3. Gels $rightarrow$ Mass, Volume, or Both (Major Shift!)
- This is the most significant breakthrough of the revision. Gel-based products are no longer bound to a single mandatory unit. Instead, brands can choose the declaration method that best reflects the nature of their formulation (whether fluid or viscous) or align with international practices:
- By mass (g)
- By volume (mL)
- Dual-declaration (g + mL)
- Produtos aplicáveis: Hair gels, shampoo jellies, gel cleansers, and gel-based serums.
III. Public Feedback: 60-Day Consultation Period
Inmetro is actively seeking comments and suggestions from public stakeholders, industry organizations, and consumer groups to refine the regional draft before it is locked into national legal frameworks across MERCOSUR member states:
- Consultation Window: 60 days starting from April 24, 2026.
- Deadline for Submissions: June 23, 2026.
- Submission Channel: Contributions must be filed exclusively through the Brazilian government’s platform “Participa + Brasil” (Brasil Participativo via https://brasilparticipativo.presidencia.gov.br).
- Crucial Note: Comments submitted through any alternative or unofficial channels will not be legally accepted.
Summary and Industry Outlook
A tiny line of text on cosmetic packaging involves international trade rules, consumer rights protection, and market agility. This modernization of the MERCOSUR quantitative labeling rules reflects an active response to industry needs, adding flexibility for gel-formulation manufacturers.
Exporters, manufacturers, and private-label brand owners supplying Brazil and the wider MERCOSUR market should monitor this draft closely. Once approved at the MERCOSUR level, the text will be internalized into the domestic laws of individual member nations without further structural modifications.
