On July 30, the European Commission submitted notification G/TBT/N/EU/1227 to the WTO regarding a draft commission regulation amending Cosmetic Regulation (EC) No 1223/2009 which updates the use of micron-sized silver in cosmetic products. The draft regulation aims to align the restrictions on micron-sized silver with the latest scientific opinion of the Scientific Committee on Consumer Safety (SCCS), thereby expanding its permitted scope of use.
Currently, the draft is under public consultation. Stakeholders may submit feedback by 28 September 2026. The draft is expected to be formally adopted in the 4th quarter of 2026 and enter into force 20 days following its publication in the Official Journal of the European Union. Should the draft be successfully adopted, the relevant revised regulatory provisions shall apply retroactively from 1 May 2026. CIRS Group has summarized the main content below for your reference.
Background
The substance silver (CAS No 7440-22-4) has been classified as a CMR substance of category 2 (toxic for reproduction) by Delegated Regulation (EU) 2024/2564, when its particle diameter is:
- equal to or larger than 1 mm (silver massive);
- larger than 100 nm and smaller than 1 mm (silver powder) ;
- larger than 1 nm and smaller than or equal to 100 nm (silver nano).
Following this classification, the Commission adopted Commission Regulation (EU) 2026/783. This regulation amended entry 1727 of Annex II to Regulation (EC) No 1223/2009 to include silver nano [1 nm < particle diameter ≤ 100 nm] and silver massive [particle diameter ≥ 1 mm].
Furthermore, Regulation (EU) 2026/78 made two revisions to Regulation (EC) No 1223/2009:
- It added micron-sized silver (silver powder) [100 nm < particle diameter < 1 mm] to the list of substances restricted in cosmetic products in Annex III to Regulation (EC) No 1223/2009;
- It amended entry 142 of Annex IV to that Regulation to allow the use of micron-sized silver (silver powder) [100 nm < particle diameter < 1 mm] as a colorant only at certain conditions considered safe by the Scientific Committee on Consumer Safety (SCCS).
CIRS Interpretation: EU Updates Cosmetic Regulation: Further Strengthening of CMR Substance Controls
The SCCS published a scientific opinion on silver on 24 April 2026, in the light of the new data provided, indicating that micron-sized particulate Silver does not penetrate the skin, the SCCS considers micron-sized particulate Silver [100nm<particle diameter<1 mm] safe when used up to a maximum concentration of 0.2% in rinse-off and 0.3% in leave-on cosmetic products. It is also considered safe when used up to 0.2% in oral hygiene products and up to 0.3% in nail products.
For cosmetic products intended for children use, micron-sized particulate Silver is also considered safe at the same concentrations, except in mouthwash that is considered safe at a concentration up to 0.05%.
CIRS Interpretation: SCCS Issued Final Opinion on Micron-sized Particulate Silver Used in Cosmetic Products
In light of the scientific development, it is appropriate to amend entries 379 and 142 in Annex III and Annex IV, respectively, to Regulation (EC) No 1223/2009 in order to reflect the latest scientific knowledge and ensure a high level of protection of human health while avoiding unnecessary restrictions on safe uses.
Regulatory Revisions
1. In Annex III, entry 379 is replaced by the following:
| Reference number | Substance identification | Conditions | Wording of conditions of use and warnings | |||||
| Chemical name/INN | Name of Common Ingredients Glossary | CAS number | EC number | Product type, Body parts | Maximum concentration in ready for use preparation | Other | ||
| a | b | c | d | e | f | g | h | i |
| 379 | Silver (powder) [100 nm < particle diameter < 1 mm] | Silver | 7440-22-4 | 231-131-3 |
(a) Rinse-off products (b) Oral products with the exception of (c) (c) mouthwash for children (d) Leave-on products (e) Nail products |
(a): 0,2 % (b): 0,2 % (c): 0,05 % For both (d) and (e): 0,3 % |
Only silver powder with porous andsintered particle structure. |
Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. |
2. In Annex IV, entry 142 is replaced by the following:
| Reference number | Substance identification | Conditions | Wording of conditions of use and warnings | ||||||
| Chemical name | Colour index Number/Name of Common Ingredients Glossary | CAS number | CAS number | Color | Product type, Body parts | Maximum concentration in ready for use preparation | Other | ||
| a | b | c | d | e | f | g | h | i | j |
| 142 | Silver (powder) [100 nm < particle diameter < 1 mm] | 77820 | 7440-22-4 | 231-131-3 | White |
(a) Leave-on products (b) Nail products |
For both (a) and (b): 0,3 % |
Only silver powder with porous and sintered particle structure. |
Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. |
CIRS Reminder
The proposed EU regulation relaxes restrictions on micron-sized silver powder (100 nm < particle diameter < 1 mm) based on scientific evidence, expanding its permitted scope of use in rinse-off, leave-on, oral, and nail products.
Relevant enterprises should take note of the following:
- Distinguish between the different forms of silver: Silver nano (≤100 nm) and silver massive (≥1 mm) remain prohibited under Annex II; only micron-sized silver powder is permitted, subject to Entry 379 of Annex III and Entry 142 of Annex IV. Verify the particle size form of silver used in your formulations.
- Comply with concentration limits and conditions of use: Up to 0.2% in rinse-off and oral products (only 0.05% in mouthwash for children), and up to 0.3% in leave-on and nail products. Only silver powder exhibiting a porous sintered particulate structure is permitted, and it must not be used in applications that may lead to end-user exposure by inhalation via the lungs.
- Note the retroactive application date: The draft regulation is intended to apply retroactively from May 1, 2026. Stakeholders may submit comments via the WTO TBT notification (G/TBT/N/EU/1227) by September 28, 2026.
- Enterprises with silver-containing products should review their formulations in light of the above requirements, verify that particle size, structure, and concentration fall within the permitted scope, and update their safety assessments and labeling accordingly.
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
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