On January 11, 2023, EU Scientific Committee on Consumer Safety (SCCS) released the preliminary opinion SCCS/1648/22 on Hydroxyapatite (CAS No. 1306-06-17) in nano form. Considering the information received during the commenting period, SCCS released the final opinion on March 23, 2023. 1
Hydroxyapatite commonly serves as an abrasive, bulking, oral care and skin-conditioning agent in cosmetics. Currently, it is not regulated under Regulation (EC) No 1223/2009, while there is a number of products containing Hydroxyapatite (nano) being notified via the Cosmetic Product Notification Portal (CPNP). To ensure cosmetic’s safe use, the European Commission requested SCCS to make an evaluation on this substance. Based on the data submitted via the notification portal, additional information provided by the industry, and other relevant information in scientific literature, SCCS conducted a safety assessment on Hydroxyapatite (nano), and released this opinion.
In the opinion, SCCS considers it safe when Hydroxyapatite (nano) is used at concentrations up to 10% in toothpaste, and up to 0.465% in mouthwash. Moreover, SCCS emphasizes that the opinion only applies to the substance with the following characteristics:
Composed of rod-shaped particles of which at least 95.8% (in particle number) have an aspect ratio less than 3, and the remaining 4.2% have an aspect ratio not exceeding 4.9;
The particles are not coated or surface modified.
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