Nano-Hydroxyapatite – is it safe?

On October 16th, 2015, the SCCS published an Opinion on the safety of Hydroxyapatite in its nano form. The opinion will be open for comments until January 8th, 2016.

What is nano-Hydroxyapatite?

Nano-Hydroxyapatite is a cosmetic ingredient used as abrasive, bulking and emulsion stabilizing in the nano uncoated form, in leave-on and rinse-off oral cosmetic products, such as toothpastes, tooth whiteners and mouthwashes.

It is commonly used up to a concentration of 10% in these categories of products.

Is nano-Hydroxyapatite safe?

There are concerns on the safety of nano-Hydroxyapatite arising from the fact that the nanoparticles can be absorbed and enter into the cells.

For that reason, an Opinion on the safety of nano-Hydroxyapatite when used up to 10% in oral cosmetic products was requested to the SCCS.

 Conclusion

After the analysis of all submitted data, the SCCS considers that the safety of nano-Hydroxyapatite when used up to 10% in oral cosmetic products cannot be established. Nevertheless, that does not mean that it was regarded as unsafe.

There is currently a limited amount of information to allow a definitive conclusion on the safety of nano-Hydroxyapatite in oral cosmetic products. More studies are needed. However, it is known that nano-Hydroxyapatite in needle form is not safe and should not be used in cosmetics.

Nanomaterials are permanently on the spot. As ingredients with inherent safety concerns, their use in cosmetics is strictly regulated.

This new SCCS Opinion on nano-Hydroxyapatite was not conclusive but at the same time it opened the path to further research on its safety.

Cosmetic ingredients used in Europe are often under review by the SCCS. As such, probably more data will come up soon to allow a better clarification on the safety of nano-Hydroxyapatite in cosmetics and its conditions of use.

Cosmetics manufacturers and their Responsible Person should closely follow the updates from the SCCS to take the right decisions towards continuous compliance of their products on the EU market.

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