2.1. Utrzymanie mineralizacji zębów (ID 275, 276)

The claimed effects are “tooth and enamel strength” and “tooth remineralisation”. The Panel assumes that the target population is the general population. In the context of the proposed wordings, the Panel notes that the claimed effects refer to the promotion of a beneficial balance between de- and remineralisation of tooth enamel and dentin. The Panel considers that maintenance of tooth mineralisation is beneficial to human health.

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.

3.1. Utrzymanie mineralizacji zębów (ID 275, 276)

Fluoride is a highly electronegative ion, which may replace hydroxyl ions in the hydroxyapatite crystal lattice of tooth tissues (Robinson et al., 2000; ten Cate et al., 2008). Tooth hydroxyapatite crystals are resistant to dissolution at neutral pH, but their solubility drastically increases as pH drops (ten Cate et al., 2008). This drop in pH may lead to a net loss of tooth minerals. Fluoride substituted apatite is less soluble, and hence more resistant to acid exposure (Aoba, 2004). Maintenance of tooth mineralisation is affected by the availability of ionic calcium, phosphate and fluoride at the tooth crystal interface. As long as a state of ionic supersaturation or equilibrium is maintained tooth mineral is not lost and may even be gained. The evidence provided by consensus opinions/reports from authoritative bodies, reviews, and scientific original papers shows that fluoride is beneficial for tooth health in the entire population by counteracting hydroxyapatite demineralisation and supporting remineralisation, i.e. maintenance of tooth mineralisation (Dean, 1942; ten Cate et al., 2008; Benson et al., 2009; Gillespie, 2009; Griffin et al., 2007; Hattab et al., 1989; Hjortsjö et al., 2009; NIH, 2001; ten Cate, 2004; Yeung et al., 2005). The Panel concludes that a cause and effect relationship has been established between the dietary intake of fluoride and maintenance of tooth mineralisation.

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.

4.1. Utrzymanie mineralizacji zębów (ID 275, 276)

The Panel considers that the following wording reflects the scientific evidence: “Fluoride contributes to maintain tooth mineralisation”.