September 19, 2021

Volume XI, Number 262

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EC Committee Needs More Data to Assess Safety of the Nanomaterials Gold, Colloidal Gold, and Surface Modified Gold

The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published a final opinion on June 28, 2021, on gold (nano), colloidal gold (nano), gold thioethylamino hyaluronic acid (nano), and acetyl heptapeptide-9 colloidal gold (nano). The EC asked SCCS whether the nanomaterials gold, 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. SCCS states that it 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.” According to SCCS, 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 nanoforms of any of the materials under the current evaluation due to the absence of full study reports. To conduct a safety assessment of the nanomaterials, detailed data and information need to be provided on physicochemical characterization and toxicological evaluation. The final opinion states that with regard to surface modified gold, all notifications relating to acetyl heptapeptide-9 colloidal gold (nano) were withdrawn by the notifiers and therefore only gold thioethylamino hyaluronic acid is considered in the opinion.

The EC also asked whether SCCS has any further scientific concerns with regard to the use of materials in nanoform in cosmetic products. According to SCCS, the information obtained from the scientific literature suggests possible systemic uptake of gold nanoparticles that may lead to accumulation in certain organs. In addition, the available data from literature indicate potential mutagenic/genotoxic effects of gold nanomaterials. SCCS states that “[t]hese 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, SCCS 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. According to the final opinion, “SCCS will be ready to assess any evidence provided to support safe use of the materials in cosmetic products.”

©2021 Bergeson & Campbell, P.C.National Law Review, Volume XI, Number 182
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About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy process allows her to develop client-focused strategies whether...

202-557-3801
Carla Hutto, Bergeson Campbell PC environmental law regulatory analyst,Toxic Substances Control Act law attorney
Regulatory Analyst

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client...

202-557-3809
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