Vastuskiri

Dear Cecilia

Thank You for your question it’s really interesting. I looked at this SCCS Opinion on the Safety of Silver and by now I can answer You as following:

I also looked at RAC opinion on classification on Silver, which You can find on ECHA webpage:

https://echa.europa.eu/documents/10162/5b4397d9-7339-251a-98e6-c67774664204

All in ECHA available documents You can find at webpage: https://echa.europa.eu/et/registry-of-clh-intentions-until-outcome/-/dislist/details/0b0236e183963736

This is the basic documents which SCCS also use to conclude on this substance in cosmetics.

Usually after publishing the opinion the legislative process starts and firstly the discussions have to be held in Cosmetics Working group (Cosmetics Europe also participates) and Standing Committee meetings. Next meeting will be in November 2024.

And after the voting and adoption on Standing Committee meeting the process will go further and afterwards usually publication takes time up to several months. As it was with Colloidal Silver (nano) voted on SC meeting on the 7th of November 2023, published on 15.3.2024 (2024/858

COMMISSION REGULATION (EU) 2024/858 of 14 March 2024) https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=OJ:L_202400858

With the transitional period: From 1 February 2025 cosmetic products containing that substance shall not be placed on the Union market. From 1 November 2025 cosmetic products containing that substance shall not be made available on the Union market.

The market surveillance take measures after this transitional periods.

In this SCCS opinion the main point is the micron-sized particulate Silver, so it depends a lot on particle size.

Also in the cosmetic regulation we see Silver of food grade purity criteria as a colorant in Annex IV p.145, which is allowed

From my point of view we have to look on the particle size and MoS have to be over 100 and it’s up to safety assessor to prove the safety of cosmetic product.

I think the SCCS opinion will be certainly discussed at mentioned meetings and we’ll get more clear understanding of the issue and we’ll get the answers to our questions. I marked with yellow the questionable issues to me also. The text “considered not safe at the concentrations up to....” confuse me (I can understand not safe over 0,2% and 0,3%), but the wording used is “up to” and it is not clearly understandable.

I think we’ll have more clear understanding during the future discussions.

Hope it helps,

Kind regards

Natali Promet

Chief specialist

Chemicals Safety Department

+372 794 3533

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Hello,

I have a doubt about the new SCCS Opinion on the Safety of Silver of the 20th June, published the 3^rd July (https://health.ec.europa.eu/publications/sccs-opinion-safety-silver-casec-no-7440-22-4231-131-3-used-cosmetic-products_en).

Is Silver considered not safe, no matter the size of the particles, and no matter the concentration? Even if the MoS is over 100?

Since the conclusion of the Opinion says the following:

"In light of the data provided and taking under consideration the classification as toxic for reproduction Cat. 2, the SCCS considers micron-sized particulate Silver not safe at concentrations up to 0.2 % in rinse-off and 0.3 % in leave-on cosmetic products when used alone or in combination."

Could we consider that a concentration over those stated can be considered safe?

 Kind regards,