Updated consumer risk assessment of fluoride in food and drinking water including the contribution from other sources of oral exposure
Abstract This updated risk assessment evaluated evidence on potential adverse health effects of fluoride related to all sources of oral exposure as mandated by the European Commission. Fluoride benefit assessment was not included. Effects on the central nervous system, thyroid and bone were prioriti...
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2025-07-01
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| Series: | EFSA Journal |
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| Online Access: | https://doi.org/10.2903/j.efsa.2025.9478 |
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| author | EFSA Scientific Committee Susanne Hougaard Bennekou Ana Allende Angela Bearth Josep Casacuberta Laurence Castle Tamara Coja Amélie Crépet Ron Hoogenboom Helle Knutsen Claude Lambré Søren Saxmose Nielsen Dominique Turck Antonio Vicent Civera Roberto Villa Holger Zorn Jacqueline Castenmiller Karlien Cheyns Keyvin Darney Mary Gilbert Jean‐Charles Leblanc Haakon Meyer Evangelia Ntzani Martin Paparella Marco Vinceti Heather Wallace Maria Anastassiadou Maria Bastaki Irene Cattaneo Luna Greco Anna Lanzoni Francesca Riolo Olaf Mosbach‐Schulz Andrea Terron Thorhallur Halldorsson |
| author_facet | EFSA Scientific Committee Susanne Hougaard Bennekou Ana Allende Angela Bearth Josep Casacuberta Laurence Castle Tamara Coja Amélie Crépet Ron Hoogenboom Helle Knutsen Claude Lambré Søren Saxmose Nielsen Dominique Turck Antonio Vicent Civera Roberto Villa Holger Zorn Jacqueline Castenmiller Karlien Cheyns Keyvin Darney Mary Gilbert Jean‐Charles Leblanc Haakon Meyer Evangelia Ntzani Martin Paparella Marco Vinceti Heather Wallace Maria Anastassiadou Maria Bastaki Irene Cattaneo Luna Greco Anna Lanzoni Francesca Riolo Olaf Mosbach‐Schulz Andrea Terron Thorhallur Halldorsson |
| author_sort | EFSA Scientific Committee |
| collection | DOAJ |
| description | Abstract This updated risk assessment evaluated evidence on potential adverse health effects of fluoride related to all sources of oral exposure as mandated by the European Commission. Fluoride benefit assessment was not included. Effects on the central nervous system, thyroid and bone were prioritised. Evidence from human studies indicates that total fluoride intake is associated with adverse effects on the developing brain at drinking water concentrations > 1.5 mg/L. The evidence of such associations below 1.5 mg/L was not sufficiently consistent to draw conclusions for risk assessment. Using drinking water concentration of 1.5 mg/L as a reference point, a safe level of intake including all sources of oral exposure of 3.3 mg/day was established for pregnant women to protect the fetus. This safe level of intake was extended to apply to other adults and children > 8 years. It is considered protective also against possible adverse effects on thyroid function and bone mineralisation, for which associations have been observed at water concentrations > 1.5 mg/L. Dental fluorosis was considered the most sensitive endpoint for children ≤ 8 years. Tolerable upper intake levels (UL) of 1.0, 1.6 and 2.0 mg/day were established for infants, toddlers and children 4–8 years, respectively. These ULs are considered protective against other possible adverse effects of fluoride, including neurodevelopmental outcomes. Aggregate exposure included intake of fluoride from food, drinking water, discretionary salt and (ingested) dental care products. Aggregate exposure based on the mean concentration of fluoride in EU drinking water (submitted data) was below the above health‐based guidance values (HBGVs) for all age groups. Aggregate exposure exceeds the HBGVs at the 95th percentile of intake in the scenario of the P95 concentration of fluoride in EU drinking water, for all age groups except adolescents. The risk assessment suggests that the current legal limit for drinking water (1.5 mg/L) in the EU is not sufficiently protective. |
| format | Article |
| id | doaj-art-eaf91ff1498d40c48bf11ff662647e27 |
| institution | Kabale University |
| issn | 1831-4732 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj-art-eaf91ff1498d40c48bf11ff662647e272025-08-20T03:58:36ZengWileyEFSA Journal1831-47322025-07-01237n/an/a10.2903/j.efsa.2025.9478Updated consumer risk assessment of fluoride in food and drinking water including the contribution from other sources of oral exposureEFSA Scientific CommitteeSusanne Hougaard BennekouAna AllendeAngela BearthJosep CasacubertaLaurence CastleTamara CojaAmélie CrépetRon HoogenboomHelle KnutsenClaude LambréSøren Saxmose NielsenDominique TurckAntonio Vicent CiveraRoberto VillaHolger ZornJacqueline CastenmillerKarlien CheynsKeyvin DarneyMary GilbertJean‐Charles LeblancHaakon MeyerEvangelia NtzaniMartin PaparellaMarco VincetiHeather WallaceMaria AnastassiadouMaria BastakiIrene CattaneoLuna GrecoAnna LanzoniFrancesca RioloOlaf Mosbach‐SchulzAndrea TerronThorhallur HalldorssonAbstract This updated risk assessment evaluated evidence on potential adverse health effects of fluoride related to all sources of oral exposure as mandated by the European Commission. Fluoride benefit assessment was not included. Effects on the central nervous system, thyroid and bone were prioritised. Evidence from human studies indicates that total fluoride intake is associated with adverse effects on the developing brain at drinking water concentrations > 1.5 mg/L. The evidence of such associations below 1.5 mg/L was not sufficiently consistent to draw conclusions for risk assessment. Using drinking water concentration of 1.5 mg/L as a reference point, a safe level of intake including all sources of oral exposure of 3.3 mg/day was established for pregnant women to protect the fetus. This safe level of intake was extended to apply to other adults and children > 8 years. It is considered protective also against possible adverse effects on thyroid function and bone mineralisation, for which associations have been observed at water concentrations > 1.5 mg/L. Dental fluorosis was considered the most sensitive endpoint for children ≤ 8 years. Tolerable upper intake levels (UL) of 1.0, 1.6 and 2.0 mg/day were established for infants, toddlers and children 4–8 years, respectively. These ULs are considered protective against other possible adverse effects of fluoride, including neurodevelopmental outcomes. Aggregate exposure included intake of fluoride from food, drinking water, discretionary salt and (ingested) dental care products. Aggregate exposure based on the mean concentration of fluoride in EU drinking water (submitted data) was below the above health‐based guidance values (HBGVs) for all age groups. Aggregate exposure exceeds the HBGVs at the 95th percentile of intake in the scenario of the P95 concentration of fluoride in EU drinking water, for all age groups except adolescents. The risk assessment suggests that the current legal limit for drinking water (1.5 mg/L) in the EU is not sufficiently protective.https://doi.org/10.2903/j.efsa.2025.9478boneCNSdental healthdevelopmental neurotoxicity (DNT)exposure assessmentfluoridation |
| spellingShingle | EFSA Scientific Committee Susanne Hougaard Bennekou Ana Allende Angela Bearth Josep Casacuberta Laurence Castle Tamara Coja Amélie Crépet Ron Hoogenboom Helle Knutsen Claude Lambré Søren Saxmose Nielsen Dominique Turck Antonio Vicent Civera Roberto Villa Holger Zorn Jacqueline Castenmiller Karlien Cheyns Keyvin Darney Mary Gilbert Jean‐Charles Leblanc Haakon Meyer Evangelia Ntzani Martin Paparella Marco Vinceti Heather Wallace Maria Anastassiadou Maria Bastaki Irene Cattaneo Luna Greco Anna Lanzoni Francesca Riolo Olaf Mosbach‐Schulz Andrea Terron Thorhallur Halldorsson Updated consumer risk assessment of fluoride in food and drinking water including the contribution from other sources of oral exposure EFSA Journal bone CNS dental health developmental neurotoxicity (DNT) exposure assessment fluoridation |
| title | Updated consumer risk assessment of fluoride in food and drinking water including the contribution from other sources of oral exposure |
| title_full | Updated consumer risk assessment of fluoride in food and drinking water including the contribution from other sources of oral exposure |
| title_fullStr | Updated consumer risk assessment of fluoride in food and drinking water including the contribution from other sources of oral exposure |
| title_full_unstemmed | Updated consumer risk assessment of fluoride in food and drinking water including the contribution from other sources of oral exposure |
| title_short | Updated consumer risk assessment of fluoride in food and drinking water including the contribution from other sources of oral exposure |
| title_sort | updated consumer risk assessment of fluoride in food and drinking water including the contribution from other sources of oral exposure |
| topic | bone CNS dental health developmental neurotoxicity (DNT) exposure assessment fluoridation |
| url | https://doi.org/10.2903/j.efsa.2025.9478 |
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