Important information about the new Karex toothpaste

Is fluoride beneficial or detrimental to our health?

The new Karex oral care series can do without.

Whether fluoride is beneficial or detrimental to our health is still the subject of great controversy. The use of fluorides in oral care has strict limits. As a result, consumers and dentists have wanted real alternatives with proven efficacy for years. German scientists have now achieved this with Karex.

Detailed consumer information is particularly important to us as the manufacturer of Karex, the fluoride-free toothpaste.

EU Regulation and limits:

Fluoride has been used for decades in oral care to prevent caries. Back in the 1950s, fluoride was proven to have a preventive effect against caries at a suitably high concentration. Today, its use is regulated in the European Cosmetics Directive due to possible side effects, as fluoride is toxic in high doses, particularly if many sources of fluoride are added together. In addition to oral care products, the substance is also found in foodstuffs, such as salt, tea and mineral water. In some countries, fluoride is added to the drinking water. However, more and more countries, including Belgium, have decided over the last few years to discontinue enriching the drinking water. In order to protect consumers from side effects, the EU stipulates strict limits for the fluoride content in toothpastes: [1]

Fluoride in the European Cosmetics Directive

Wording of the application conditions and warnings:

  • Contains sodium fluoride. (*)
  • For any toothpaste with compounds containing fluorine in a concentration of 0.1 to 0.15% calculated as F unless it is already labelled as contra-indicated for children (e.g. "for adult use only") the following labelling is obligatory:
  • "Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor."

(*) Editor's note: In addition to sodium fluoride, there are 16 other fluoride compounds, such as amine fluoride, tin fluoride, sodium monofluorophosphate, etc.

What the media say:

"Does fluoride make us ill?" Spiegel Online, 10.2.2014

"Fluoride in toothpaste: How risky the substance really is," Focus Online, 01.9.2016

"Fluoride - good for enamel, not always good for the brain," WELT Online, 20.10.2017

This article said:

"While many dentists recommend fluoride toothpastes, including for children, the "German Society of Pediatrics and Adolescent Medicine" suggests avoiding the use of fluoride toothpastes in early childhood."

Here is the link to the article "Fluoride - good for enamel, not always good for the brain."

"I would not recommend using fluoride toothpaste during pregnancy,"
said endocrinologist Prof. Helmut Schatz from Bochum in the WRD-Aktuell program on 17.10.2017.

The TV program Galileo on 19.01.2015 discussed the issue of how fluoride made its way into caries prophylaxis: (

What does modern science say?

Due to the growing doubt about the daily use of fluoride toothpastes, modern dentistry has been on the lookout for safe alternatives for years. As such, approaches inspired by nature (biomimetics) in oral care are being developed in particular. An especially promising approach is the use of hydroxyapatite, as this substance was inspired by the natural enamel. [2]

First clinical studies with hydroxyapatite were published in 1987 (preventing sensitive teeth with hydroxyapatite).[3] Caries prevention with a hydroxyapatite toothpaste was shown on children in Japan.[4] The renowned book "Toothpastes" describes hydroxyapatite as an established substance in oral care.[5]

In addition to many of the more recent studies conducted, German scientists were able to prove in a clinical, multicentric study for the first time worldwide that there is a fluoride-free toothpaste that is safe for consumers (with the biomimetic substance hydroxyapatite) that is clinically as effective at preventing caries as fluoride toothpaste. [6]


Oral care with hydroxyapatite offers clinical caries protection that is comparable with conventional fluoride toothpastes. However, hydroxyapatite is a biomimetic substance, whereas fluorides are exogenous and discussed critically.

  1. REGULATION (EC) No. 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products.
  2. Kensche, A. et al. Efficacy of a mouthrinse based on hydroxyapatite to reduce initial bacterial colonisation in situ. Arch. Oral Biol.  80, 18-26 (2017).
  3. Huettemann, R. W. & Doenges, H. Untersuchungen zur Therapie überempfindlicher Zahnhälse mit Hydroxylapatit [Investigations for treating hypersensitive tooth necks with hydroxyapatite]. Dtsch. Zahnärztl. Z. 42, 486-488 (1987).
  4. Kani, K. et al. Effect of apatite-containing dentifrices on dental caries in school children. J. Dent. Health  19, 104-109 (1989).
  5. Loveren, C. v. Toothpastes. Vol. 23 (Karger, 2013).
  6. "Guter Rat" - Das unabhängige Verbrauchermagazin [Good advice - the independent consumer magazine] (12.2016).