On July 30, 2026, the European Union notified the World Trade Organization (WTO) of the latest draft amendment to the EU Cosmetics Regulation. Based on the latest safety assessment from the Scientific Committee on Consumer Safety (SCCS), the draft significantly relaxes restrictions and expands the permitted scope of micro-sized silver powder as both a restricted substance and a colorant in cosmetics, retroactive to May 1, 2026. This article provides an in-depth analysis of the core aspects of this regulatory update.
For cosmetic enterprises targeting the European market, regulatory compliance for “Silver” has reached a major positive turning point. On July 30, 2026, the European Commission formally submitted a notification to the WTO proposing major amendments to Annex III (List of Restricted Substances) and Annex IV (List of Permitted Colorants) of the EU Cosmetics Regulation (EC) No 1223/2009. Compared with previous stringent restrictions, this revision substantially broadens the applicable cosmetic categories for silver powder and raises the maximum allowed concentration limits for various product types.
I. Background: From Strict Restrictions to Science-Based Relaxation
Previously, under Omnibus Act VIII published in 2025, the EU included micro-sized silver powder [100 nm < particle size < 1 mm] (CAS No. 7440-22-4) in the Annex III restricted list (Entry 379) for the first time, permitting its use strictly in toothpaste and mouthwash at a maximum concentration capped at 0.05%.
However, in August 2025, the European Commission received an updated technical dossier containing new dermal absorption test data for micro-sized silver powder.
Following an in-depth evaluation of the new data, the SCCS published its latest scientific opinion in April 2026, confirming that silver powder featuring specific structural characteristics maintains a favorable safety profile at higher concentrations and across a broader array of product categories. The European Commission adopted these conclusions and formally notified the draft amendment to the WTO on July 30, 2026.
II. Key Amendments to Annex III (Restricted Substances)
The draft comprehensively reshapes the restriction parameters under Entry 379 of Annex III for silver powder:
1. Broadened Product Categories and Increased Concentration Limits
| Categoria do Produto | Proposed Maximum Concentration | Previous Provision under Omnibus Act VIII |
| Produtos de enxágue | 0.2% | Prohibited (Not listed) |
| Oral products (excluding children’s mouthwash) | 0.2% | Restricted to 0.05% (Toothpaste/Mouthwash only) |
| Children’s mouthwash | 0.05% | 0.05% |
| Produtos sem enxágue | 0.3% | Prohibited (Not listed) |
| Produtos de unhas | 0.3% | Prohibited (Not listed) |
2. Structural Requirements and Inhalation Restrictions
- Structural Specification: The relaxed conditions apply exclusively to micro-sized silver powder [100 nm < particle size < 1 mm] exhibiting a porous and sintered particle structure.
- Inhalation Ban: Strictly prohibited in product formats that may lead to lung exposure via inhalation by the end user (e.g., aerosol sprays, powders).
III. Expanded Scope in Annex IV (Permitted Colorants)
In addition to its functional and restricted uses, silver powder (Colour Index No. 77820) under Entry 142 of Annex IV (List of Permitted Colorants) has also received significant expansions:
- Previous Provision: Permitted only in lip products and eyeshadows, capped at a maximum concentration of 0.2%.
- New Draft Provision: Permitted for use as a colorant in all leave-on products e nail products, with the maximum allowable concentration raised to 0.3%!
Note: Silver powder used as a colorant must likewise meet the prerequisite of possessing a “porous and sintered particle structure” and must not be used in product forms presenting inhalation exposure risks.
IV. Entry into Force and Retroactivity
The draft revision will enter into force on the date of its official publication in the Official Journal of the European Union (OJEU).
Crucially, the new provisions will apply retroactively from May 1, 2026 (the implementation date of Omnibus Act VIII). This retroactive arrangement ensures seamless regulatory transition and prevents enterprises from facing unnecessary compliance risks during the regulatory crossover period.
V. Compliance Recommendations for Brands and Exporters
Adjust Formulations and CPSRs: Formulate leave-on and nail care products according to the updated concentration thresholds (up to 0.3%), and coordinate with compliance agencies in a timely manner to update Cosmetic Product Safety Reports (CPSRs) for the EU market.
Verify Raw Material Specifications: Confirm the physical morphology of raw silver powder to ensure it possesses a porous and sintered particle structure with a particle size between 100 nm and 1 mm.
Avoid Inhalable Formats: Exclude product delivery forms prone to lung exposure during product R&D, such as aerosols, pump sprays, and loose powders.
