June 1, 2023

Volume XIII, Number 152


June 01, 2023

Subscribe to Latest Legal News and Analysis

May 31, 2023

Subscribe to Latest Legal News and Analysis

May 30, 2023

Subscribe to Latest Legal News and Analysis

EC Committee Issues Final Opinion on Hydroxyapatite (Nano) in Oral Cosmetic Products

The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published its final opinion on hydroxyapatite (nano) on March 23, 2023. As reported in our April 13, 2021, blog item, SCCS releasedfinal opinion in 2021 on the safety of hydroxyapatite (nano) 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. In its 2021 final opinion, SCCS stated 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.”

In 2022, the EC asked SCCS whether hydroxyapatite (nano) is safe when used in oral cosmetic products according to the maximum concentrations and specifications as reported in the industry submission, taking into account reasonably foreseeable exposure conditions. According to the March 2023 final opinion, based on the data provided, SCCS considers hydroxyapatite (nano) safe when used at concentrations up to ten percent in toothpaste, and up to 0.465 percent in mouthwash.

The final opinion notes that this safety evaluation applies only to hydroxyapatite (nano) with the following characteristics: composed of rod-shaped particles of which at least 95.8 percent (in particle number) have an aspect ratio less than three, and the remaining 4.2 percent have an aspect ratio not exceeding 4.9; and the particles are not coated or surface modified. The EC also asked if SCCS has any further scientific concerns with regard to the use of hydroxyapatite (nano) in oral cosmetic products. SCCS notes that its final opinion is not applicable to hydroxyapatite (nano) composed of needle-shaped particles. The final opinion states: “Although the use of hydroxyapatite (nano) is indicated also for breath spray, no data were provided to allow assessment of consumer safety from inhalation exposure. Therefore, this Opinion is not applicable to sprayable products that might lead to exposure of the consumer’s lungs to nanoparticles by inhalation.”

©2023 Bergeson & Campbell, P.C.National Law Review, Volume XIII, Number 84

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...

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...