Opinion of the Scientific Panel on Dietetic Products, Nutrition and Allergies (NDA) on a request from the Commission related to the Tolerable Upper Intake Level of Fluoride

Abstract

SUMMARYFluoride is not essential for human growth and development but is beneficial in the prevention of dental caries (tooth decay) when ingested in amounts of about 0.05 mg/kg body weight per day and when applied topically with dental products such as toothpaste. Dental enamel which contains fluoride is less likely to develop caries, because of greater resistance to ingested acids or to acids generated from ingested sugars by the oral bacteria. In addition, fluoride inhibits sugar metabolism by oral bacteria.Fluoride content of the body is not under physiological control. Absorbed fluoride is partly retained in bone and partly excreted, predominantly via the kidney. In infants retention in bone can be as high as 90% of the absorbed amount, whereas in adults retention is 50% or less. Fluoride is also incorporated into dental enamel during tooth formation.Excessive intake of fluoride during enamel maturation before tooth eruption from birth to eight years of age, when enamel formation is complete, can lead to reduced mineral content of enamel and to dental fluorosis of deciduous but predominantly of permanent teeth. The incidence and severity of dental fluorosis is dose-dependent. Mild dental fluorosis is not readily apparent and is associated with increased resistance to caries. The Panel considered moderate dental fluorosis, which is characterised by staining and minute pitting of teeth, to be an adverse effect. On the basis that the prevalence of moderate dental fluorosis of permanent teeth is less than 5% in populations ingesting 0.08-0.12 mg fluoride/kg body weight/day, the Panel considered that the upper level (UL) for fluoride is 0.1 mg fluoride/kg/day in children aged 1-8 years. This is equivalent to 1.5 and 2.5 mg fluoride per day in children aged 1-3 years and 4-8 years, respectively.Fluoride accretion in bone increases bone density but excessive long term intake reduces bone strength and increases risk of fracture and skeletal fluorosis (stiffness of joints, skeletal deformities). Studies with therapeutic oral administration of fluoride in amounts of 0.6 mg/kg body weight/day in postmenopausal women over several years increased the risk for nonvertebral bone fractures significantly. The Panel applied an uncertainty factor of 5 to derive an UL of 0.12 mg/kg body weight/day. This is equivalent to an UL of 5 mg/day in children aged 9-14 years and 7 mg/day for age 15 years and older, including pregnant and lactating women.The UL for fluoride applies to intake from water, beverages, foodstuffs, including fluoridated salt, dental health products and fluoride tablets for caries prevention.Children aged 1-8 years have fluoride intakes from food and water well below the UL provided the fluoride content of their drinking water is not higher than 1.0 mg/L. An increase

Çocuklarda Florür alımının Dünya Sağlık Örgütü ve Avrupa Birliği Kılavuzlarına Göre Değerlendirilmesi

“…The UL for children between 4 to 8 years of age is 2.5mg/day based on a prevalence of less than 5% of moderate dental fluorosis as the critical endpoint and was used as the reference value for the children between 6 to12 years of age [European Union, 2005].…”

“…The extent to which fluoride intake should generally be in infants between 6 and 12 months of age has not been addressed, as such calculations are not concrete, given that infants are fed different feeding patterns in EU Member States. Therefore, tolerable upper intake levels of fluoride in infants have not been established [European Union, 2005]. In infants younger than 6 months, UK DoH [UK DoH, 1991] states that 0.22mg F/kg BW/day is safe, while US IOM [IOM, 1997] states 0.1mg/kg BW/day UL for fluoride [European Commission, 2011].…”

Element Contents in Three Commercially Important Edible Mollusks Harvested off the Southwestern Coast of Crimea (Black Sea) and Assessment of Human Health Risks from Their Consumption

“…In Table S3, the calculated EDI values are juxtaposed with the tolerable intakes adopted by the US Environmental Protection Agency [54], World Health Organization [50][51][52]72,73], and European Food Safety Authority [53,[73][74][75][76][77]. In the EDI for As, only the toxic inorganic arsenic was taken into account by multiplying the total arsenic content by 0.09 for the mussel and the oyster and by 0.07 for the sea snail [78].…”

Fluoridanwendung zur Kariesprävention

“…Dabei steigt das Risiko mit höherer Fluoridaufnahme, ohne dass es eine feste Grenzdosis gäbe. Risikoabschätzungen wird eine als tolerierbar eingeschätzte tägliche Fluoridaufnahme von 0,1 mg Fluorid prokgKörpergewichtzugrundegelegt(TolerableUpperIntake Level [36]).…”