August 9, 2022

Volume XII, Number 221

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August 09, 2022

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August 08, 2022

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EC Requests SCCS for a Scientific Opinion on “Hydroxyapatite (Nano)”

On March 17, 2022, the European Commission (EC) requested that the Scientific Committee on Consumer Safety (SCCS) prepare a scientific opinion on “hydroxyapatite (nano).” As reported in our April 13, 2021, blog item, SCCS issued a final opinion in 2021 stating 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). According to the EC, in February 2022, industry submitted additional information to support the safety of hydroxyapatite (nano) in oral products, specifically addressing its potential genotoxicity. The EC asks whether SCCS considers hydroxyapatite (nano) safe when used in oral cosmetic products according to the maximum concentrations and specifications as reported in the submission, taking into account reasonably foreseeable exposure conditions. The EC also asks if SCCS has any further scientific concerns with regard to the use of hydroxyapatite (nano) in oral cosmetic products. The deadline for the scientific opinion is six months.

©2022 Bergeson & Campbell, P.C.National Law Review, Volume XII, Number 82
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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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