After recent studies suggested a possible link between fluoride ingestion and developmental neurotoxicity in children, the European Food Safety Authority (EFSA) reassessed the health risk posed by fluoride to the EU population and updated the tolerable upper intake levels (ULs). The agency concluded there is no major health risk posed to the EU population, considering the revised ULs and current EU drinking water limits for fluoride.

The only exception was found for children aged 4–8 years, for whom dental fluorosis (tooth discoloration) of the molar teeth may occur, assuming typical fluoride concentrations in drinking water and 100 percent ingestion of dental care products—a very conservative assumption. However, if these children refrain from swallowing their toothpaste after brushing, tooth discoloration is unlikely to occur.

Fluoride is a naturally occurring chemical element that can inhibit tooth decay. Human exposure to fluoride occurs through drinking water—which can contain natural concentrations of fluoride or be artificially fluoridated—food, fluoridated salt, and toothpaste. Very few EU Member States fluoridate public drinking water, but the majority of toothpaste contains fluoride.

The Possible Health Effects of Fluoride

Although fluoride prevents tooth decay at all ages, at high intake levels, it can cause adverse effects like dental fluorosis and neurodevelopmental effects in fetuses and babies/young children, bone fractures in old age, and thyroid effects throughout the lifespan. In EFSA’s last assessment of fluoride in 2013, the agency determined the adequate intake required for fluoride’s dental benefits to take effect, and in 2005, EFSA determined ULs for various age groups to prevent different health harms.

At present, the EU legal limit for fluoride concentration in drinking water is 1.5 mg/liter (L). Some studies have shown a possible link between developmental neurotoxicity in children at concentrations below 1.5 mg/L, prompting the reassessment.

Therefore, the 2025 updated risk assessment focused on neurotoxicity and developmental neurotoxicity, as well as effects of fluoride on the thyroid and bone. EFSA systematically reviewed the current literature on fluoride’s health effects, and estimated the EU population’s intake of fluoride from all sources.

No Major Health Risk to EU Population From Fluoride Exposure

EFSA concluded after its latest risk assessment a daily safe fluoride intake for pregnant women of 3.3 milligrams (mg), protective against neurodevelopmental risk to the fetus. Additionally, fluoride ULs were determined for children, to prevent dental fluorosis and other adverse effects:

• 1 mg/day for infants under one year of age
• 1.6 mg/day for toddlers aged 1–3 years
• 2 mg/day for children aged 4–8 years.

There is a difference between safe intake levels and ULs. A safe intake level indicates the maximum amount that can be confidently concluded to pose no risk of adverse effects in the population. A UL indicates the maximum level of total chronic daily intake of a substance from all sources that is judged to be unlikely to pose a risk of adverse health effects in humans.

Moreover, EFSA concluded that the EU population’s total fluoride exposure would not exceed the updated ULs/safe intake level considering fluoride concentrations in drinking water at the EU legal limit. Actual concentrations of fluoride in Member States’ drinking water is much lower than the limit of 1.5 mg/L, however, with data submitted to EFSA indicating that more than 86 percent of samples have levels at less than 0.3 mg/L, and more than 97 percent of samples containing less than 0.7 mg/L.

Regarding next steps, EFSA recommends further research on fluoride's neurodevelopmental effects at water concentration levels below 1.5 mg/L, as well as studies on fluoride’s kinetics and biological activity, and suggests a review of the current EU limit for fluoride in drinking water to ensure it is adequately protective of health.

Read the full EFSA risk assessment on fluoride intake here.