Description
Hydroxyapatite (nano) is hydroxyapatite in the form of a nanomaterial. In the regulatory data it also appears under the name HYDROXYAPATITE.
Under Regulation (EC) No 1223/2009, the ingredient is included in Annex III with reference 372, corresponding to the list of substances that may only be used subject to the restrictions laid down. The maximum authorized concentration is "(a) 10 %" for the product type "Toothpaste" and "(b) 0,465 %" for the product type "Mouthwash". The additional conditions applicable state literally: "For (a) and (b): Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation. Only nanomaterials having the following characteristics are allowed: — [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". No additional mandatory labelling warnings are established in the annex entry, and the ingredient has no CMR classification.
The use of this ingredient in toothpastes and mouthwashes is subject to strict compliance with the morphological and compositional parameters defined by the applicable regulation. The information presented is for technical reference only and does not constitute a recommendation for use or an efficacy claim.