Update based on a revised Final Opinion of nano Hydroxyapatite (nHAP) by the European Union's SCCS issued March 21st, 2023.
If you are currently using (or considering using) a toothpaste with nHAP in it, we encourage you to educate yourself and apply critical thinking skills so you can make an informed decision that you feel is right for you and your family.
For us this is a great reminder to always read the data and the methods used, not just the author’s conclusions — And look for potential conflicts of interest.
In summary the SCCS's revised Final Opinion states —
“Based on the data provided, the SCCS considers hydroxyapatite (nano) as safe when used at concentrations up to 10% in toothpaste, and up to 0.465% in mouthwash”
This safety evaluation only applies to the hydroxyapatite (nano) 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.
Sounds pretty technical and it is. We dug into it as we do with everything and after careful analysis, a review of the studies, and the application of our own critical thinking, below are a few key things to consider:
There are no long-term safety data - this is the big concern with synthetic nano-particles in general - due to a lack of scientific studies, we just don't know the long-term effects. However, we do know that the human body’s immune system responds to synthetic ingredients in general.
This “Revised Final Opinion” does not address other concerns voiced by independent scientists, e.g. that it may cause cellular breakdown in kidney cells and potentially have a negative impact on human blood cells.
The SCCS only approved the rod-shaped synthetic nano-particle, not the needle-shaped synthetic nano-particle. How will this be regulated? How will a customer know they are getting rod-shaped vs needle-shaped in their toothpaste or powder? Will brands be transparent and provide detailed/certified information regarding nHAP particle shape?
The studies reviewed in the SCCS “Final Opinion” were provided by Fluidinova, a nano-particle manufacturer. This poses a clear/potential conflict of interest. And is analogous to a large pharmaceutical company like Pfizer conducting all of the clinical trials for their products and submitting them to the FDA. No independent testing was done.
How well was the trial designed? The new tests provided by Fluidnova were in vitro and for 4 hours. Hmmm. nHAP particles were not tested against a.) real world and b.) daily use in human subjects and/or long-term use of toothpaste.
Back in March of 2021, the SCCS stated that the safety was not proven against the possibility of genotoxicity. But, upon appeal by Fluidinova (the manufacturer and supplier of synthetic nano-hydroxyapatite) submitted additional studies, using their patented product, CarePaste.
After reviewing the studies the SCCS stated that nHAP/CarePaste “does not induce gene mutations or chromosome breaks under the experimental conditions used.”
Did the conditions adequately represent regular, longtime use of the product in humans? Are there plans for ongoing studies that begin to assess the safety of longtime use?
- A few very important details regarding the new tests/studies provided:
- An in vitro study (i.e. test tube study) on Mouse Lymphoma Assay using their product, CarePaste, showed no cytotoxicity after 4 hours. And the SCCS agreed that CarePaste "did not induce gene mutations in the MLA assay under the experimental conditions used".
- From this, the SCCS considers "the test valid and agrees with the Notifier's (Fluidinova) conclusion that nanoXIM-CarePaste does not induce chromosome breaks and/or gain or loss under the experimental conditions used".
Based on all of this we are still applying the precautionary principle both personally (and professionally) and steering clear of nHAP in any oral care products.
Below is our original blog post from Aug 2022 — worth reading. Our summary at the end remains the same.
Vince Cobb & Marni Shymkus
Original post from August 2022
There is a surge of new kinds of toothpaste and toothpowders on the market that promote the use of Hydroxyapatite (HAP) or Nano-hydroxyapatite (nHAP) as the latest and greatest remineralizer and enamelizer. Some studies have shown promising results for remineralizing teeth and reducing caries using nHAP. But is it natural? And has it been proven safe?
What is Hydroxyapatite?
Hydroxyapatite (HAP) is a crystalline form of Calcium Phosphate (also known as Calcium Apatite). It is the form made by our bodies, to produce teeth and bones. Teeth are comprised of 97% Hydroxyapatite (HAP) and only about 1.5% proteins (mainly collagen), and 1.5% water.
Is it natural?
Well, that all depends on which form we are talking about. Hydroxyapatite (HAP) is indeed a natural form of Calcium and Phosphorus typically from animal bones or other natural elements. However, Nano-hydroxyapatite (nHAP) is a synthetic nanoparticle and definitely NOT NATURAL. It is a biomimetic version made in a lab out of synthetic calcium and synthetic phosphorus.
Nano-hydroxyapatite was used by NASA in the 1970s as a medical application for astronauts that had severely demineralized teeth and bones. The patent was later acquired by a Japanese company that started using it in toothpaste. nHAP protects the teeth with the creation of a new layer of synthetic enamel around the tooth.
Unfortunately, many news sources (like CNN), social media, and even oral care brand websites talk about the effectiveness and safety of “Hydroxyapatite” but they don’t delineate between natural forms and synthetic nanoparticle forms. This poses a problem for consumers that want to avoid potentially harmful synthetic ingredients.
In addition, many toothpaste brands that use natural Hydroxyapatite in their formulas link to studies that show the effectiveness of synthetic Nano-hydroxyapatite, not the natural forms. So claims of "natural Hydroxyapatite" being "clinically proven" are misleading.
Are natural forms of Hydroxyapatite (HAP) safe?
The purity, source, extraction method, and particle size are important. Natural HAP is extracted from animal bones, fish, shells, some plants and minerals (eg. limestone). Some natural sources of HAP may contain trace minerals and additional macro minerals (which is ideal). The processing (which depends on the source) varies widely and can impact purity (eg heavy metals). In its natural state, it has low solubility and is not well absorbed or utilized, but micronized HAP has better absorption in the mouth. For more information on natural hydroxyapatite, this article looks at Syntheses of hydroxyapatite from natural sources and compares sources, mineral ratios, bioavailability, uses, and extraction methods.
EWG rates natural Hydroxyapatite as safe (listing "phosphate rock" as the source). If you use a toothpaste or toothpowder with natural hydroxyapatite make sure to check the source and extraction methods.
Is synthetic Nano-hydroxyapatite (nHAP) safe?
The science regarding safety is inconclusive and it has not been proven safe. Below are summaries from a handful of studies.
- This meta-study (study of studies) from October 2018, titled Opinion of the Scientific Committee on Consumer Safety (SCCS) - Revision of the Opinion on hydroxyapatite (nano) in cosmetic products stated:
- A Study in Nature in 2019 attempted to prove its safety again as a rebuttal to SCSS’s 2018 review (above). The Nature study highlighted the findings of previous studies, suggesting that nHAP is safe to have only been in vitro (in test tubes) and only up to a 3-hour period. They have not considered use over time (years), every day, and how it might affect the entire body.
- The SCCS issued a Final Opinion dated March 31, 2021, with the same conclusions from its 2018 meta-study:
- In the late winter / early spring of 2022, based on findings by the SCCS, the European Union announced that it plans to ban several nano-sized materials (including Nano-hydroxyapatite ) for use in cosmetic and oral hygiene applications. The EU’s hesitancy seems warranted for other reasons, too, since some studies suggest that nHAP may cause cellular breakdown in kidney cells and potentially have a negative impact on human blood cells.
- Furthermore, science still does not understand how nanoparticles in general impact the body. In January 2021, the NIH released this study: Safe Nanoparticles Are We There Yet? Which states:
“Despite considerable efforts to understand the toxicity and safety of these nanoparticles, many of these questions are not yet fully answered.”
How does Nano-hydroxyapatite compare to natural sources of minerals (containing calcium and phosphorus) that support remineralizing teeth?
According to this study, Remineralization Effect of Eggshell versus Nano-hydroxyapatite on Caries-like Lesions in Permanent Teeth (In Vitro), there appeared to be no difference in remineralization between Eggshells (naturally high in calcium and phosphorous and other nutrients) and nHAP:
“Eggshell (ES) is a rich source of minerals since it contains calcium, phosphorous, magnesium, strontium, and fluoride. This study sought to compare the efficacy of nano-hydroxyapatite (NHA) and ES for the remineralization of enamel caries-like lesions by pH cycling. Microhardness significantly decreased in all samples after demineralization and significantly increased after exposure to therapeutic solutions. Microhardness of the samples was not significantly different among the therapeutic groups after pH cycling.”
In summary, and in our opinion:
- The use of Nano-hydroxyapatite in oral care products has not been proven safe.
- nHAP is a synthetic, man-made nanoparticle and NOT the same as natural hydroxyapatite. Often both are referred to as "Hydroxyapatite", creating widespread confusion.
Natural hydroxyapatite is OK and can be a good source of Calcium and Phosphorus, but it may not have all of the supporting minerals you need to support remineralization (keep in mind, calcium needs magnesium to work) and it is a highly processed mineral.
You don’t need nHAP or HAP for remineralization to occur. There are many 100% natural sources of high quality, highly absorbable (naturally occurring) macro and trace minerals like non-irradiated raw clays, fulvic acid, or even eggshells that provide the necessary minerals to aid in tooth remineralization.
- If someone was severely demineralized it might make sense to have a medical application of nHAP (just like the astronauts).
We follow the precautionary principle. If any ingredient has the potential for harm, we don’t use it. We use only 100% natural ingredients that are minimally processed from plants and the earth which are good enough to eat and are proven to improve health.
As we see it, Nature is the answer.