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Dr Robert Verkerk, executive and scientific director of the ANH stated, “How can the people of Europe have any confidence in EFSA’s decisions when the methods it uses seem to be more about political number shuffling than proper science? EFSA shouldn’t be surprised by this criticism—we’ve been outlining the many problems with its approach for over 3 years via public consultations. Yet we’ve not had one government authority ever come back to us to discuss our scientific concerns. We’re ready to send a team of scientists to Parma to dialogue with EFSA at any time—they need only ask.”
BACKGROUND AS PROVIDED BY COMMISSION
The European Community legislation lists substances that may be used for nutritional purposes in certain categories of foods as sources of certain nutrients. The Commission has received a request for the evaluation of calcium fluoride added for nutritional purposes to food supplements.
Fluoride supplementation has been used for years essentially to prevent dental caries, especially if the fluoride concentration from drinking water is low. The widespread use of fluoridated toothpaste in the western world has been associated with an effective decline in caries prevalence. Fluoride compounds have also been used in intervention clinical studies to
prevent and treat age-dependent osteoporosis. (Oh rly?)
The present opinion deals only with the safety of calcium fluoride as a source of fluoride and the bioavailability of the fluoride from this source. The safety of fluoride itself, in terms of amounts that may be consumed, is outside the remit of this Panel.
2. Technical data
Calcium fluoride is described as an inorganic compound with a molecular formula CaF2 and a relative molecular mass of 78.08 g/mol (Technical dossier, 2005). Its CAS Registry number is 7789-75-5. Synonyms: calcium difluoride.
The petitioner provided the following specifications for calcium fluoride: purity 99%, white crystalline and hygroscopic powder, solubility in water 17 mg/l (18 °C). The impurities are sulphates (not more than 100 mg/kg), iron (not more than 100 mg/kg), chloride (not more than 500 mg/kg), arsenic (not more than 5 mg/kg) and lead (not more than 10 mg/kg) (Technical dossier, 2005).
The Panel notes that according to Commission Regulation (EC) No 629/2008 (EC, 2008) the maximum levels of lead, mercury and cadmium in food supplements as sold should be 3 mg/kg, 0.1 mg/kg and 1 mg/kg, respectively.
2.5. Reaction and fate in foods to which the source is added
The petitioner indicated that calcium fluoride is stable in food. However, no supporting data have been provided.
2.6. Case of need and proposes uses
Calcium fluoride is intended to be used in food supplements in the form of tablets, caplets, capsules, chewable tablets, effervescent powders and liquids.
According to the petitioner, the use of calcium fluoride in supplements is intended to supply approximately 1 mg calcium fluoride, equivalent to 0.5 mg fluoride/day (Technical dossier, 2005). The most recent available exposure estimates to fluoride from all sources in Europe show total intakes from 0.5 to 1.2 mg/day, when no fluoridated salt or fluoride containing tooth paste are used, and no supplements are taken (EFSA, 2005a). In the case where fluoridated salt is used and fluoridated water is drunk and used for the preparation of food and tea, the sum of fluoride intake could reach 6 mg/day, without taking into consideration toothpaste use.
2.8. Information on existing authorisations and evaluations
The NDA Panel established upper tolerable intake levels for fluoride of 1.5 mg/day for 1–3 year old children, 2.5 mg/day for 4–8 year old children, 5 mg/day for 9–15 year old children and 7 mg/day for adults (≥ 15 year old) (EFSA, 2005a).
For children, total exposure estimates from food and drinking water in the UK, assuming a fluoride water concentration of 1 mg/l, shows that the 97.5th percentile population of the 1.5 to 4.5 year old and 4 to 6 year old children could exceed upper tolerable intake levels established by the NDA panel to equivalent age ranges (1 to 3 and 4 to 8 year old), if calcium fluoride supplementation was to be added to these intakes (note: food).
The ANS 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.
The Panel concludes that the use of calcium fluoride as food supplement at the proposed use levels would be of no safety concern for adults and children above the age of 8. The Panel notes that according to Commission Regulation (EC) No 629/2008 the maximum levels of lead, mercury and cadmium in food supplements as sold should be 3 mg/kg, 0.1 mg/kg and 1 mg/kg, respectively.