FLUIDINOVA’s Commitment to Nano-Safety and Responsible Innovation

Nano-hydroxyapatite is a form of calcium phosphate, the same compound that makes up 97% of tooth enamel and 70% of dentin and bone. This gives nano-HAp inherent advantages in terms of bioactivity and safety over other engineered nanomaterials. In oral care, these nano-sized particles can be incorporated into the dentin tubules, helping to reduce dental hypersensitivity. At the same time, they can bind to the enamel surface, promoting remineralization and contributing to a whitening effect.  

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At FLUIDINOVA, safety and innovation go hand in hand. The nanoXIM nano-hydroxyapatite is widely used across medical, dental, cosmetic, and even food applications — and they’re not just high-performance, they’re responsibly developed and rigorously tested.

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And if it’s accidentally swallowed? No problem!

nanoXIM nano-hydroxyapatite dissolves rapidly in the stomach's acidic environment, breaking down into harmless calcium and phosphorus ions. According to a 2018 safety assessment published in the Cosmetics journal here, nanoXIM nano-HAp does not cross into other organs, effectively eliminating any risk of systemic absorption.

Additionally, the study shows that nano-HAp does not penetrate or damage oral tissues, including the gums and inner cheeks. Basically, the nano-HAp either occludes and attaches to the dentin tubules and remineralizes the enamel, or, if for some reason it is swallowed, it will dissolve in the stomach. There’s no way that the nano-HAp can get into the bloodstream and migrate to other organs in the body.

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Furthermore, a 2018 review led by Prof. M. Epple from the University of Duisburg-Essen concluded that:

There is no risk from oral uptake of calcium phosphate nanoparticles due to their rapid dissolution in the stomach.

Epple further stated that, at the doses typically used in cosmetics and health products, the risk is extremely low, if present at all, and concluded that the calcium nanoparticles are safe for humans.

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Since entering the oral care market in 2010, FLUIDINOVA reports zero safety incidents linked to its nano-hydroxyapatite.

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Approval by the Scientific Committee on Consumer Safety

FLUIDINOVA’s nanoXIM•CarePaste, which consists of a highly dispersed synthetic nano-hydroxyapatite aqueous suspension, containing 15.5%wt. of nano-hydroxyapatite, isn’t just safe: it’s the only nano-hydroxyapatite in the world approved for oral care cosmetics by the Scientific Committee on Consumer Safety (SCCS) under EU regulation.

In its 2023 opinion (SCCS/1648/22), the SCCS declared nano-HAp safe for:

• Use up to 10% in toothpaste (64.5% nanoXIM•CarePaste);
• Use up to 0.465% in mouthwash (3% nanoXIM•CarePaste).

This safety evaluation only applies to nano-hydroxyapatite with the characteristics of nanoXIM•CarePaste.

The nanoXIM•CarePaste product is also compliant with the restrictions outlined in reference number 372 of Annex III of Regulation (EC) No 1223/2009 of the European Parliament and of the Council regarding the use of the hydroxyapatite nanomaterial in cosmetics products, as it is:

• Composed of rod-shaped particles, with over 95.8% having an aspect ratio below 3, and the remaining 4.2% have an aspect ratio not exceeding 4.9;
• Uncoated and non-surface modified.

Please note that this safety opinion does not apply to needle-shaped nano-HAp particles, which nanoXIM•CarePaste is not composed of.

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‍Safe by Nature, Proven by Science

As industries embrace innovative nanomaterials, FLUIDINOVA makes sure to lead the way in delivering safe, high-quality nano-hydroxyapatite solutions. Backed by regulatory approvals, rigorous testing, and a responsible manufacturing ethos, nanoXIM products represent the gold standard in nano-safety.

So the next time you brush your teeth, remember: if nanoXIM•CarePaste is on the label, safety is built into every single particle.

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