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EC Scientific Committee’s Preliminary Opinions for Certain Gold and Platinum Nanomaterials Open for Comment

On April 16, 2021, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) posted two preliminary opinions for comment:  Opinion on Gold (nano), Colloidal Gold (nano), Gold Thioethylamino Hyaluronic Acid (nano) and Acetyl heptapeptide-9 Colloidal gold (nano) and Opinion on Platinum (nano), Colloidal Platinum (nano) and Acetyl tetrapeptide-17 Colloidal Platinum (nano).  The EC asked SCCS whether 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.  SCCS states that it considered the information provided by the notifiers and is of the opinion that it is not possible to carry out a safety assessment of the nanomaterials due to limited or missing essential information.  The preliminary opinion states that “[m]uch 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.”  To complete a safety assessment of the nanomaterials, detailed data and information need to be provided on physicochemical characterization and toxicological evaluation, along with experiment performance.  The preliminary opinion notes that in regard to surface modified gold, all notifications relating to acetyl heptapeptide-9 colloidal gold (nano) were withdrawn by the notifiers and therefore only gold thioethylamino hyaluronic acid is considered in the opinion.  The EC asked SCCS if it has any further scientific concerns with regard to the use of materials in nano form in cosmetic products.  SCCS states that information obtained from the scientific literature indicates that there is a need for further evaluation of the safety of gold nanomaterials when used as cosmetic ingredients. In the absence of sufficient data to allow a safety assessment, SCCS 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 EC asked SCCS whether 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.  SCCS states that having considered all the information provided by the notifiers, and obtained from other sources, 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.”  SCCS notes that 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).  The EC also asked if SCCS has any further scientific concerns with regard to the use of materials A and B in nano form in cosmetic products.  According to the preliminary opinion, in the absence of sufficient data to allow a safety assessment, SCCS considered the different aspects of platinum nanomaterials that could raise concern for consumer safety.  SCCS “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.”

Comments on both preliminary opinions are due June 14, 2021.

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©2021 Bergeson & Campbell, P.C.National Law Review, Volume XI, Number 109
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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...

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Carla Hutto, Bergeson Campbell PC environmental law regulatory analyst,Toxic Substances Control Act law attorney
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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...

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