ID 371 -
Fluor
PL: Fluor
EN: Fluoride
Pdf: fluoride
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claim is fluoride which is a well-recognised nutrient and is measurable in foods by established methods.
Fluoride occurs naturally in water and some foods and is authorised for addition to selected foods and dental products (Annex I of Regulation (EC) No 1925/20064 and Annex I of Directive 2002/46/EC5). This evaluation applies to fluoride naturally present in foods, including drinking water, and to those forms authorised for addition to foods (Annex II of the Regulation (EC) No 1925/2006 and Annex II of Directive 2002/46/EC). The Panel considers that the food constituent, fluoride, which is the subject of the health claim, is sufficiently characterised.
2.2. Utrzymanie prawidłowego stanu kości (ID 371)
The claimed effect is “bone”. The Panel assumes that the target population is the general population. In the context of the proposed wording, the Panel notes that the claimed effect refers to maintenance of normal bone. The Panel considers that maintenance of normal bone is beneficial to human health.
3.2. Utrzymanie prawidłowego stanu kości (ID 371)
The normal mineralisation of bone mainly involves the deposition of calcium and phosphate as essential structural components of the bone mineral. Other minerals can be also incorporated to the apatite crystals, but no structural function in bone has been defined for them. No evidence has been provided in any of the references cited for the substantiation of this claim for a role of fluoride in the deposition of calcium or phosphorus in bone. Fluoride is incorporated into bone and can increase bone mineral density in humans. However, there is evidence for a biphasic effect on bone strength and risk of bone fracture in both animals and humans, and the precise dose response relationship taking into account body burden and time of exposure cannot be defined. Inadequate intakes or status of fluoride contributing to impaired bone health or bone strength cannot be identified. Recommendations for fluoride intake in different population groups are based on dental health outcomes (EFSA, 2005). The Panel concludes that a cause and effect relationship has not been established between the dietary intake of fluoride and maintenance of normal bone.
5. Warunki i możliwe ograniczenia stosowania oświadczenia
The Panel considers that in order to bear the claim a food should be at least a source of fluoride as per Annex to Regulation 1924/2006. Such amounts can be easily consumed as part of a balanced diet. The target population is the general population. Tolerable Upper Intake Levels have been established for fluoride (EFSA, 2005). Excess intake may harm tooth formation during childhood. Tolerable Upper Intake Levels for fluoride at different ages have been defined in the EU.
Warunki i możliwe ograniczenia stosowania oświadczenia
See above