EU: Updates to the Cosmetics Regulation as regards silver 

The EU Commission has published draft updates to the Cosmetics Regulation as regards silver.  

The name of the regulation is: Draft Commission Regulation amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use in cosmetic products of silver. 

The draft measure proposes to regulate Silver in cosmetic products, considering the latest opinion (SCCS/1687/25) of the Scientific Committee on Consumer Safety (SCCS), published on 24 April 2026, addressing the concerns related to its potential impact on human health. Given that Silver was previously regulated via Commission Regulation (EU) 2026/78 that applies from 1 May 2026 and that the conditions laid down therein do not fully reflect the most recent scientific assessment of the SCCS, it is necessary to amend the relevant entries without delay. 

Hintergrund:  

Silver (CAS No. 7440-22-4) was classified as a category 2 CMR substance (toxic for reproduction) by Commission Delegated Regulation (EU) 2024/2564 based on particle size. The classification applies to silver massive (particle diameter ≥ 1 mm), silver powder (particle diameter > 100 nm and < 1 mm), and silver nanoparticles (particle diameter > 1 nm and ≤ 100 nm). 

Following this classification, Commission Regulation (EU) 2026/783 amended Annex II to Regulation (EC) No 1223/2009 by adding silver nanoparticles (1 nm < particle diameter ≤ 100 nm) and silver massive (particle diameter ≥ 1 mm) to the list of prohibited substances in cosmetic products. In addition, micron-sized silver (silver powder; 100 nm < particle diameter < 1 mm) was included in Annex III as a restricted substance, while entry 142 of Annex IV was revised to permit its use as a colorant only under the specific conditions considered safe by the Scientific Committee on Consumer Safety (SCCS). 

In August 2025, industry submitted new data supporting the safety of micron-sized silver (powder) in certain cosmetic applications. After evaluating these data, the SCCS adopted a scientific opinion on 24 April 2026, providing a comprehensive safety assessment based on additional exposure scenarios and updated toxicological evidence. 

In its opinion of 24 April 2026, the Scientific Committee on Consumer Safety (SCCS) concluded that the use of micron-sized particulate silver under specified conditions is safe for consumers, including in applications that go beyond the conditions currently laid down in Regulation (EU) 2026/783. The SCCS found that, as micron-sized particulate silver (100 nm < particle diameter < 1 mm) does not penetrate the skin, it can be safely used at concentrations of up to 0.2% in rinse-off cosmetic products, 0.3% in leave-on cosmetic products, 0.2% in oral exposure products, and 0.3% in nail products. For cosmetic products intended for children, the SCCS confirmed that the same concentration limits are safe, except for mouthwash products, where a maximum concentration of 0.05% was considered safe. 

In light of these scientific findings, it is appropriate to amend entries 379 of Annex III and 142 of Annex IV to Regulation (EC) No 1223/2009 to reflect the latest scientific evidence, maintain a high level of human health protection, and avoid unnecessary restrictions on uses that have been demonstrated to be safe. As the restrictions introduced by Regulation (EU) 2026/783 apply from 1 May 2026 but do not fully reflect the SCCS’s most recent safety assessment, those provisions should be revised without delay. 

To ensure the smooth functioning of the internal market and prevent unnecessary restrictions or withdrawals of cosmetic products containing micron-sized silver that are considered safe under the updated SCCS assessment, this Regulation should enter into force as a matter of urgency. Given its objective of aligning the regulatory framework with the latest scientific evidence while easing certain restrictions, it should enter into force on the day of its publication and apply retroactively from 1 May 2026, thereby ensuring seamless application alongside Regulation (EU) 2026/783. 

To find out more about product compliance in EU and compliance for cosmetics, please do not hesitate to contact the Product Compliance Institute directly.