January 26, 2021

Volume XI, Number 26

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EC Committee Preliminary Opinions on Hydroxyapatite (Nano) and Copper (Nano) and Colloidal Copper (Nano) Available for Comment

On November 9, 2020, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) published two draft opinions for public comment.  In the preliminary opinion on hydroxyapatite (nano), SCCS considered whether the nanomaterial hydroxyapatite is safe when used in leave-on and rinse-off dermal and oral cosmetic products according to the reported maximum concentrations and specifications, taking into account reasonably foreseeable exposure conditions.  SCCS states that having considered the data provided, as well as other relevant information available in the scientific literature, it cannot conclude whether hydroxyapatite composed of rod-shaped nanoparticles for use in oral-care cosmetic products at the maximum concentrations and specifications is safe.  According to SCCS, this is because the available data and information are insufficient to exclude concerns over the genotoxic potential of hydroxyapatite (nano).  The EC also asked if SCCS has any further scientific concerns with regard to the use of hydroxyapatite in nano form in cosmetic products.  SCCS responded that although its preliminary opinion considers rod-shaped hydroxyapatite nanoparticles, it is aware that needle-shaped hydroxyapatite nanoparticles may also be produced.  SCCS states that the available information indicates that hydroxyapatite nanoparticles in needle-shaped form are of concern in relation to potential toxicity and should not be used in cosmetic products.

In the preliminary opinion for copper (nano) and colloidal copper (nano), SCCS states that it is unable to carry out a safety assessment of the nanomaterials copper and colloidal copper when used in leave-on and rinse-off dermal and oral cosmetic products, including skin, nail and cuticle, hair and scalp, and oral hygiene products, at a maximum concentration of one percent.  According to SCCS, it considered all 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 copper and colloidal copper due to the limited or missing essential information.  SCCS notes that much of the information provided on toxicity relates to copper as such, and in the absence of full study reports, it is not possible to determine the relevance of the data for nanoforms of copper under the current evaluation.  The EC asked whether SCCS has any further scientific concerns with regard to the use of copper and colloidal copper in nanoform in cosmetic products.  SCCS states that the information provided by the notifiers and obtained from the scientific literature suggests possible systemic uptake of copper nanoparticles (and/or ionic copper), which may lead to accumulation in certain organs.  In addition, according to SCCS, the available literature indicates potential mutagenic/genotoxic and immunotoxic/nephrotoxic effects of copper nanomaterials, raising an alert that warrants further safety evaluation of copper nanomaterials used as cosmetic ingredients.

Comments on both preliminary opinions are due January 4, 2021.

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©2020 Bergeson & Campbell, P.C.National Law Review, Volume X, Number 315
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Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
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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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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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