Parma, 11 December 2024
EFSA is publicly consulting on our draft assessment of the potential risks from ingestion of fluoride from drinking water, the diet, fluoridated table salt and (ingested) fluoridated dental care products. The assessment excludes the topical (surface) use of fluoridated oral care products.
The public consultation is open until 9 February and follows a previous public consultation on the draft protocol on fluoride carried out in 2022.
The draft proposes a safe level of intake of 3.3 mg/day for pregnant women which applies to all age groups from 9 years of age and above. This figure is derived from potential effects on the developing central nervous system of the fetus.
Our experts provisionally concluded that these effects start to occur at or above drinking water levels of 1.5 milligrams per litre (mg/L), the legal limit in the European Union. At lower levels of fluoride the evidence for potential links is inconsistent and insufficient to draw clear conclusions. The concentrations found in drinking water in European countries are usually less than 0.3 mg/L.
The opinion also proposes 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. These upper levels are linked to the risk of dental fluorosis (tooth discoloration) and are protective of all other potential adverse effects for these age groups.
We were asked by the European Commission to assess risks to human health, therefore the assessment does not address the benefits of fluoride for dental health.
EFSA’s Scientific Committee screened some 20,000 scientific papers from the period 2005-2024 and completed a thorough review of the most relevant 152 human studies and 81 animal studies.
We welcome feedback on the draft assessment, the approach followed, and any additional scientific information that could be used to finalise the risk assessment, currently scheduled for 2025.
- See also: for an explanation of the difference between a ‘safe level of intake’ and a ‘tolerable upper intake level’ see this factsheet
Source – EFSA