ID 276 - Fluor

PL: Fluor
EN: Fluoride
Pdf: fluoride

Oświadczenie (4)

Oświadczenie (2)

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.

2.1. 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.

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.

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”.

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

Must at least be a source of mineral/s as per annex to regulation 1924/2006 Applicable to both children and adults