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EFSA has re-assessed the potential risks to consumers from fluoride in drinking water, food, fluoridated table salt, and ingested fluoridated dental care products. The scientific opinion updates the safe/tolerable intakes for all age groups based on the latest scientific studies.
Fluoride is a naturally occurring element that can inhibit tooth decay. In the EU, fluoridating public drinking water is done only in very few Member States but approximately 90% of toothpastes sold contain fluoride. The correct use (i.e. surface only) of fluoridated oral care products does not contribute to exposure, hence only their ingestion was assessed.
No major health concerns
The Chair of EFSA’s Scientific Committee, Susanne Hougaard Bennekou, stated: “We estimated that, in general, with the current concentrations of fluoride in European drinking water, total fluoride exposure does not exceed the new safe and tolerable upper intake levels for almost all age groups and therefore does not pose a health concern.
“The one exception is for children aged 4-8 years. Assuming typical fluoride concentrations in drinking water and a very conservative estimate of 100% ingestion of dental care products, mild fluorosis (tooth discoloration) may occur. In particular, this would affect the molars, which are in development during this age.
“This is unlikely to occur if children spit the toothpaste out properly after brushing their teeth.”
Assessing fluoride ingested from all sources
The European Commission asked EFSA to update its previous consumer risk assessment of fluoride after recent studies suggested a possible link to harmful effects on the developing nervous system of children. EFSA’s experts also looked at the potential effects of fluoride on the thyroid, bones, and teeth.
The Vice-Chair of the Scientific Committee and Chair of the working group on fluoride, Thorhallur Halldorsson, said: “After screening over 20,000 scientific papers up to 2024 we thoroughly reviewed the most relevant human and animal studies to complete our risk assessment.”
Safe intake for 9 years and above
EFSA’s experts set a safe level of intake of 3.3 mg/day for pregnant women and all age groups over 8 years of age.
“This figure”, explained Prof Halldorsson, “is derived from potential effects on the developing central nervous system of the fetus. These occur above drinking water levels of 1.5 milligrams per litre (mg/L), the legal limit in the European Union. However, the concentrations found in drinking water in European countries are usually less than 0.3 mg/L.
“At levels of fluoride below 1.5 mg/L the evidence for potential links is inconsistent and insufficient to draw clear conclusions. The safe level of intake is also protective of other potential adverse effects on bones and the thyroid.”
Dental fluorosis in young children
For young children of 0-8 years of age EFSA’s experts determined that dental fluorosis was the most sensitive effect. The threshold for dental fluorosis is at a slightly lower concentration than for other effects, including potential effects on the central nervous system, bones and the thyroid.
The opinion sets tolerable upper intake levels for infants and young children: 1 milligram per day (mg/day) for infants 0-12 months of age, 1.6 mg/day for children 1-3 years of age, and 2 mg/day for children 4-8 years of age. Although derived from the risk of dental fluorosis, they are protective of all other potential adverse effects for these age groups.
Safe level vs. tolerable upper intake level
Prof Halldorsson said: “A tolerable upper intake is a threshold below which adverse effects are not expected. A safe level of intake is used when there is higher uncertainty about the cutoff point; it is the maximum amount that we conclude poses no risk of adverse effects in the population.
“There is evidence that we can’t ignore linking fluoride to possible effects on the developing nervous system of the fetus. But the evidence is not sufficient to set a threshold.
“Our opinion also recommends research to address these data gaps in the future.”
Next steps
Based on EFSA’s assessment, the European Commission may review the current legal limit for fluoride in drinking water to make sure it provides adequate protection from potential health risks.
EFSA publicly consulted on a draft version of the risk assessment (in 2024) and on the draft protocol on fluoride (in 2022). The outcome of these consultations is available as an annex of the scientific opinion.
** Links to science
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Updated consumer risk assessment of fluoride in food and drinking water including the contribution from other sources of oral exposure
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