Monday, April 26, 2021SCCS

Gold, Platinum: Preliminary Opinions of the SCCS on 7 nano-ingredients

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Following the mandate given by the European Commission to the SCCS in November 2019, within the framework of the evaluation of ingredients listed as nanomaterials, the Scientific Committee has just published its Preliminary Opinions on the safety of seven ingredients derived from gold and platinum. They were adopted at the CSSC plenary meeting of 30-31 March 2020 and are open for comments until 14 June 2021.

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Gold [nano], Colloidal Gold [nano], Gold Thioethylamino Hyaluronic Acid [nano] and Acetyl heptapeptide-9, Colloidal gold [nano]

Background

The Commission services received under Article 16 of the Cosmetics Regulation via the Cosmetic Product Notification Portal (CPNP):
• 236 notifications for cosmetic products containing Gold (68 notifications) and Colloidal Gold (168 notifications)
• 11 notifications for cosmetic products containing Gold Thioethylamino Hyaluronic Acid
• 18 notifications for cosmetic products containing Acetyl heptapeptide-9, Colloidal gold
The Commission has concerns on the use of Gold - Colloidal Gold, Gold Thioethylamino Hyaluronic Acid and Acetyl heptapeptide-9, Colloidal gold in nano form because of the potential for nanoparticles to be absorbed dermally or across a mucous membrane and to enter cells.

For an exhaustive background information, see the article
Nanos (Gold, Platinum): Requests for Opinions to SCCS, CosmeticOBS, 25 November 2019

Opinion

1. In view of the above, and taking into account the scientific data provided, does the SCCS consider the nanomaterials Gold and Colloidal Gold, Gold Thioethylamino Hyaluronic Acid and Acetyl Heptapeptide-9 Colloidal Gold are safe when used in leave-on skin cosmetic products according to the maximum concentrations and specifications, taking into account reasonably foreseeable exposure conditions?

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.

2. Does the SCCS have any further scientific concerns with regard to the use of materials A (Gold and Colloidal Gold), B (Gold Thioethylamino Hyaluronic Acid) and C (Acetyl Heptapeptide-9 Colloidal Gold) in nano form in cosmetic products?

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 to this Opinion. The SCCS will be ready to assess any evidence provided to support safe use of the materials in cosmetic products.

Platinum [nano], Colloidal Platinum [nano] and Acetyl tetrapeptide-17 Colloidal Platinum [nano]

Background

The Commission services received under Article 16 of the Cosmetics Regulation via the Cosmetic Product Notification Portal (CPNP):
• 18 notifications for cosmetic products containing Platinum (10 notifications) and Colloidal Platinum (8 notifications)
• 13 notifications for cosmetic products containing Acetyl Tetrapeptide-17 Colloidal Platinum
The Commission has concerns on the use of Platinum - Colloidal Platinum and Acetyl tetrapeptide-17 Colloidal Platinumin in nano form because of the potential for nanoparticles to be absorbed dermally or across a mucous membrane and to enter cells.

Opinion

1. In view of the above, and taking into account the scientific data provided, does the SCCS consider the nanomaterials A (Platinum and Colloidal Platinum) and B (Acetyl Tetrapeptide-17 (and) Colloidal Platinum) are safe when used in leave-on cosmetic products according to the maximum concentrations and specifications reported, taking into account reasonably foreseeable exposure conditions?

Having considered all the information provided by the Notifiers, and that obtained from other sources, the SCCS is of the opinion that it is not possible to carry out a safety assessment of any of the notified platinum nanomaterials due to limited or missing essential information.
The limited amount of data provided by the Notifiers also does not correspond to the requirements and data standards as indicated in the SCCS Guidance (SCCS 1611/19), and the SCCS Memorandum (SCCS/1524/13).
To enable safety assessment by the SCCS, the Notifiers need to provide the necessary information, a summary of which is provided in Annex I to this Opinion.

2. Does the SCCS have any further scientific concerns with regard to the use of materials A and B in nano form in cosmetic products?

In the absence of sufficient data to allow safety assessment, the SCCS has considered the different aspects of platinum nanomaterials that could raise a concern over consumer safety.
As detailed in Annex II to this opinion, the SCCS has concluded that there is a basis for concern that the use of platinum, colloidal platinum, and acetyl tetrapeptide-17 colloidal platinum (nano) in cosmetic products can pose a risk to the consumer. The SCCS will be ready to assess any evidence provided to support safe use of the materials in cosmetic products.

LW
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