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EC Committee Concludes Hydroxyapatite (Nano) in Cosmetic Products Can Pose a Risk to Consumers

On April 12, 2021, the European Commission (EC) Scientific Committee on Consumer Safety (SCCS) published its final opinion on hydroxyapatite (nano).  The EC asked whether SCCS considers the nanomaterial hydroxyapatite safe when used in leave-on and rinse-off dermal and oral cosmetic products according to the maximum concentrations and specifications reported, taking into account reasonably foreseeable exposure conditions.  SCCS states that having considered the data provided, and other relevant information available in scientific literature, it “cannot conclude on the safety of the hydroxyapatite composed of rod-shaped nanoparticles for use in oral-care cosmetic products at the maximum concentrations and specifications given in this Opinion.”  This is because the available data and information are not sufficient to exclude concerns over the genotoxic potential of hydroxyapatite (nano).  The EC also asked whether SCCS has any further scientific concerns with regard to the use of hydroxyapatite in nano form in cosmetic products.  The opinion states that although the particle shape of the nanomaterial considered in this opinion is reported as rod-shaped, “SCCS is aware that, depending on the manufacturing process, needle-shaped HAP nanoparticles may also be produced.”  According to the opinion, the available information indicates that hydroxyapatite (nano) in needle-shaped form “is of concern in relation to potential toxicity” and “should not be used in cosmetic products.”  SCCS concluded that there is a basis for concern that the use of hydroxyapatite (nano) in cosmetic products “can pose a risk to the consumer.”

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©2021 Bergeson & Campbell, P.C.National Law Review, Volume XI, Number 103
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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
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...

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