ID 83 - Kwas foliowy

PL: Kwas foliowy
EN: Folate
Pdf: folate

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is folate. Folate is measurable in foods by established methods.
Folate is the generic name for a number of derivatives of pteroylglutamic acid (PGA, folic acid). Folic acid is a synthetic folate compound used in food supplements and in food fortification because of its stability, and which becomes biologically active after reduction. Natural (dietary) folates are mostly reduced folates, i.e. derivatives of tetrahydrofolate (SCF, 2000).
Different forms of folate are authorised for addition to foods (Annex II of the Regulation (EC) No 1925/20066 and Annex II of Directive 2002/46/EC7). This evaluation applies to folate naturally present in foods and 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, folate, which is the subject of the health claims, is sufficiently characterised.

2.2. Utrzymanie prawidłowego wzroku (ID 83, 87)

The claimed effects are “eye health” and “eye health, folic acid with vitamin E and C”. The Panel assumes that the target population is the general population.
The Panel considers that maintenance of normal vision is a beneficial physiological effect.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - 

Folates play an important role in the transfer of C1-groups (i.e. methyl-, methylene- and formyl- groups), maintaining the methylation balance (SCF, 2000). Folate coenzymes are involved in numerous reactions that involve DNA synthesis, purine synthesis, generation of formate into the formate pool and amino acid interconversion (IoM, 1998).

3.2. Utrzymanie prawidłowego wzroku (ID 83, 87)

Thirteen references were provided for the substantiation of the claimed effect, including four authoritative body reports, two reviews, one meta-analysis, five human studies and one consensus report.
One reference provided regulatory provisions and most of the references addressed endpoints unrelated to the claimed effect, including pregnancy outcomes, prevention of neural tube defects, human reproduction and antioxidant activity. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
A meta-analysis of case-control studies in patients with retinal vascular occlusive disease (Cahill et al., 2003), a study by Kamburoglu et al. (2006) with patients diagnosed with age-related macular degeneration and a longitudinal study in Pima Indians with Type 2 diabetes (Looker et al., 2003) were not considered to be pertinent to the claimed effect because the Panel considers that the evidence provided does not establish that patients with retinal vascular occlusive disease, patients with age- related macular degeneration or individuals with Type 2 diabetes are representative of the general population with regard to normal vision.
The study of Taylor et al. (2002) evaluated the odds for early age-related cortical and posterior subcapsular lens opacities and long term intake of vitamins and carotenoids in 492 non-diabetic women aged 53–73 years and found that no nutrient intake measure was related to the prevalence of opacities in the total sample. Sub-group analyses, however, indicated that there was a significant correlation between folate intake and posterior subcapsular lens opacities in a subgroup of never- smokers (P=0.02); the Panel notes that the association with folate intake might be explained by the high correlation (r=0.42) between folate and carotenoid intakes in their data-set and that diets high in folate are also generally high in carotenoids.
In weighing the evidence, the Panel noted that the only human study presented was an epidemiological study which did not show any effect of long term intake of folate from foods or supplement use on the primary vision outcome measures.
The Panel concludes that a cause and effect relationship has not been established between the dietary intake of folate and the maintenance of normal vision.

5. Warunki i możliwe ograniczenia stosowania oświadczenia

The Panel considers that in order to bear the claims a food should be at least a source of folate as per Annex to Regulation (EC) No 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 (ULs) have been established for folic acid for children and adults (SCF, 2000).

Warunki i możliwe ograniczenia stosowania oświadczenia

Must meet minimum requirements for use of the claim "source of [name of vitamin/s] and/or [name of mineral/s]" as per Annex to Regulation 1924/2006.