Responding to a petition from Australian-based food supplements manufacturer, Blackmores Ltd, EFSA’s Panel on Food Additives and Nutrient Sources added to Food (ANS) concluded there were no major formulation issues after reviewing the available science.
However ANS noted its opinion related only to calcium fluoride as a source of fluoride, and not to fluoride itself.
Only one scenario was highlighted as being of potential concern, among 1-8 year-olds, where combined food, water and food supplement intakes threatened to exceed suggested safe levels. In this scenario, water was considered to be supplemented at 1mg fluoride per litre of water.
Much of the toxicity data ANS assessed came from exposure to soluble forms such as sodium fluoride, where dental fluorosis was considered the most severe, but non-hazardous, reaction.
While there was little toxicity data for calcium fluoride itself, available data suggests it is less toxic than soluble forms of fluoride at equivalent dosages.
Acute exposure to soluble fluoride can induce vomiting, diarrhoea, respiratory arrest, cardiac depression and gastric mucosal changes, but again, these were not considered to be problematic for the general population because acute exposure was extremely rare.
In conclusion, the ANS stated: “These evaluations also indicated that genotoxicity and carcinogenicity are not of concern for fluoride exposure in humans.”
It added: “The Panel concludes that the use of calcium fluoride as food supplement would be of no safety concern provided that fluoride upper tolerable intake level values established in Europe are not exceeded by the combined exposure from food supplements and the diet.”
In Europe, upper tolerable intake levels for fluoride have been set at 1.5mg/day for 1–3 year old children, 2.5mg/day for 4–8 year old children, 5mg/day for 9–15 year old children and 7mg/day for those over 15-years-old.
Blackmores submitted proposed calcium fluoride supplementation at levels of about 1mg, corresponding to approximately 0.5mg fluoride/day.
“However, due to its reported low solubility and bioavailability actual fluoride exposure from calcium fluoride supplementation should be at best about half the anticipated daily amounts (0.25 mg fluoride/day),” ANS stated, adding upper tolerable intake levels would not be exceeded at the suggested supplementation levels.
Adding fluoride to municipal water supplies and many toothpaste products has helped reduce the incidence of dental caries in many countries.
Blackmores submitted its petition under the 2002 Food Supplements Directive (FSD) in 2005 with the intention of having the nutrient form added to annex II of the FSD.