The SCCS adopted SCCS/1629/21 Opinion on Gold (nano), Colloidal Gold (nano), Gold Thioethylamino Hyaluronic Acid (nano) and Acetyl heptapeptide-9 Colloidal gold (nano) at its plenary meeting on 24-25 June 2021.
Primary name and/or INCI name:
- A. Gold Gold (nano) / CI 77840 Aqua, Gold (nano) Colloidal Gold Colloidal Gold (nano) Colloidal Gold [nano]
- B. Gold Thioethylamino Hyaluronic Acid
Some of the notifications indicated that the information related to the INCI name is “not available”.
- A. Gold (nano) and Colloidal Gold (nano)
- B. Gold thioethylamino hyaluronic Acid (nano); Gold 4-deoxy-4-((2-mercaptoethyl) amino) hyaluronate complexes (nano)
The SCCS has considered all the information provided by the Notifiers and is of the opinion that it is not possible to carry out safety assessment of the nanomaterials (Gold, Colloidal Gold and Surface Modified Gold) due to limited or missing essential information. Much of the information provided on toxicity relates to gold as such, and it is not possible to determine the relevance of the data for nano-forms of any of the materials under the current evaluation due to the absence of full study reports.
Detailed data and information need to be provided on physicochemical characterisation and toxicological evaluation, along with experiment performance to allow safety assessment of the nanomaterials.
In regard to surface modified gold, all notifications relating to Acetyl heptapeptide-9 Colloidal gold (nano) were withdrawn by the Notifiers and therefore only Gold Thioethylamino Hyaluronic Acid has been considered in this Opinion.
The information obtained from scientific literature suggests possible systemic uptake of gold nanoparticles which may lead to accumulation in certain organs - notably the liver and spleen. In addition, the available data from literature indicate potential mutagenic/genotoxic effects of gold nanomaterials. These indications raise an alert that warrants further safety evaluation of gold nanomaterials when used as cosmetic ingredients. In the absence of sufficient data to allow safety assessment, the SCCS has considered these aspects and has concluded that there is a basis for concern that the use of Gold (nano), Colloidal Gold (nano) and Surface Modified Gold (nano) materials in cosmetic products can pose a risk to the consumer. The SCCS concerns for consumer safety in this regard are detailed in Annex II.
SCCS SCCS/1629/21 Final Opinion can be consulted here.