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November 18, 2015

EC Scientific Committee Releases Opinion on Hydroxyapatite (Nano) for Comment

Lynn L. Bergeson Carla N. Hutton

The European Commission (EC) Scientific Committee on Consumer Safety (SCCS) has posted for comment its opinion on hydroxyapatite (nano).  According to the opinion, the EC received 35 notifications of cosmetic products containing hydroxyapatite in nano form.  The opinion states that, according to the applicants, the ingredient is used in nano uncoated form both in leave-on and rinse-off oral cosmetics products, including toothpastes, tooth whiteners, and mouth washes with a maximum reported concentration limit of ten percent and specifications.  The opinion states that the EC has concerns because of the potential for nanoparticles of hydroxyapatite to be absorbed and enter into the cells.  It requested from the SCCS a safety assessment of the nano form of hydroxyapatite covered in the notifications, in the above-mentioned categories of products, taking into account the reasonably foreseeable exposure conditions.  The SCCS states that applicants provided only a limited amount of data that corresponded to the SCCS Guidance on Safety Assessment of Nanomaterials in Cosmetics and that the provided data were also not in line with the SCCS Memorandum on Relevance, Adequacy and Quality of Data in Safety Dossiers on Nanomaterials.  To facilitate the assessment, the SCCS also considered additional information gathered through a search of the published scientific literature.  The SCCS concluded, however, that the evidence “is insufficient to allow drawing a conclusion on the safety of nano-hydroxyapatite when used in oral cosmetic products.”  The SCCS states that it will need “toxicological data specific for the materials included in the submission for safety assessment, unless a close similarity with the materials used in the available studies can be demonstrated to allow data read-across.”  The SCCS also concluded that the available data indicate that “nano-hydroxyapatite in needle form is of concern in relation to potential toxicity.”  The opinion states that “needle-shaped nano-hydroxyapatite should not be used in cosmetic products.”  Comments are due January 8, 2016.