Scientific Opinion on the substantiation of health claims related to folate
and contribution to normal psychological functions (ID 81, 85, 86, 88),
maintenance of normal vision (ID 83, 87), reduction of tiredness and
fatigue (ID 84), cell division (ID 195, 2881) and contribution to normal
amino acid synthesis (ID 195, 2881) pursuant to Article 13(1) of Regulation
(EC) No 1924/2006[sup]1[/sup]
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3
European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe:
Folate
amino acids synthesis
cell division
fatigue
folic acid
health claims
psychological functions
tiredness
vision
vitamin B9
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. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Udział w prawidłowym przebiegu funkcji psychicznych (psychologicznych) (ID 81, 85, 86, 88)
The claimed effects are “mental performance (where mental performance stands for those aspects of brain and nerve functions which determine aspects like concentration, learning, memory and reasoning, as well as resistance to stress)”, “the role of vitamins and minerals in mental performance (where mental performance stands for those aspects of brain and nerve functions which determine aspects like concentration, learning, memory and reasoning)”, “cognitive function” and “cognitive health”. The Panel assumes that the target population is the general population.
The Panel considers that contribution to normal psychological functions, which encompass cognitive and affective domains, is a beneficial physiological effect.
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.
2.3. Zmniejszenie zmęczenia (ID 84)
The claimed effect is “vitamin/mineral supplementation to reduce fatigue and tiredness in situations of inadequate micronutrient status”. The Panel assumes that the target population is the general population.
The Panel considers that reduction of tiredness and fatigue is a beneficial physiological effect.
2.4. Podziały komórek (ID 195, 2881)
The claimed effects are “la folate (vitamin B9) participe au métabolisme des protéines” and “cell division/multiplication: nucleic acids and amino acids synthesis (such as in the gastrointestinal tract)”. The Panel assumes that the target population is the general population.
In the context of the proposed wording, the Panel assumes that the claimed effect refers to normal cell division.
A claim on folate and normal cell division has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2009).
2.5. Udział w prawidłowym tworzeniu aminokwasów (ID 195, 2881)
The claimed effect are “la folate (vitamine B9) participe au métabolisme des protéines” and “cell division/multiplication: nucleic acids and amino acids synthesis (such as in the gastrointestinal tract)”. The Panel assumes that the target population is the general population.
In the context of the proposed wording, the Panel assumes that the claimed effect refers to normal amino acid synthesis.
The Panel considers that contribution to normal amino acid synthesis 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).
3.1. Udział w prawidłowym przebiegu funkcji psychicznych (psychologicznych) (ID 81, 85, 86, 88)
Severe folate deficiency in humans is characterised by macrocytic anaemia which produces symptoms of weakness, fatigue, difficulty in concentrating, irritability, headache, palpitations and shortness of breath (IoM, 1998).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of folate and contribution to normal psychological functions.
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.
3.3. Zmniejszenie zmęczenia (ID 84)
Insufficient intake of folate results in the deficiency condition of macrocytic anaemia. Symptoms of weakness and fatigue typically appear at an advanced stage of anaemia or at milder degrees of anaemia in some subjects (IoM, 1998).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of folate and the reduction of tiredness and fatigue.
3.4. Udział w prawidłowym tworzeniu aminokwasów (ID 195, 2881)
Folate coenzymes are involved in amino acid interconversions, including the catabolism of histidine to glutamic acid, interconversion of serine to glycine and remethylation of homocysteine to methionine (IoM, 1998; FAO/WHO, 2002; Carmel, 2006). Folate-mediated transfer of single-carbon units from serine provides a major source of substrate in single-carbon metabolism. The conversion of homocysteine to methionine serves as a major source of methionine for the synthesis of S-adenosyl- methionine, which participates as the methyl donor in many biological methylation reactions of proteins, nucleoproteins, histones, neurotransmitters and phospholipids (IoM, 1998; Carmel, 2006).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of folate and contribution to normal amino acids synthesis.
4. Uwagi do zaproponowanego brzmienia oświadczenia
4.1. Udział w prawidłowym przebiegu funkcji psychicznych (psychologicznych) (ID 81, 85, 86, 88)
The Panel considers that the following wording reflects the scientific evidence: “Folate contributes to normal psychological functions”.
4.2. Zmniejszenie zmęczenia (ID 84)
The Panel considers that the following wording reflects the scientific evidence: “Folate can contribute to the reduction of tiredness and fatigue”.
4.3. Udział w prawidłowym tworzeniu aminokwasów (ID 195, 2881)
The Panel considers that the following wording reflects the scientific evidence: “Folate contributes to normal amino acid synthesis”.
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).
Wnioski
On the basis of the data presented, the Panel concludes that:
The Panel considers that the food constituent, folate, that is the subject of the health claim is sufficiently characterised.
Contribution to normal psychological functions (ID 81, 85, 86, 88)
The claimed effects are “mental performance (where mental performance stands for those aspects of brain and nerve functions which determine aspects like concentration, learning, memory and reasoning, as well as resistance to stress)”, “the role of vitamins and minerals in mental performance (where mental performance stands for those aspects of brain and nerve functions which determine aspects like concentration, learning, memory and reasoning)”, “cognitive function” and “cognitive health”. The target population is assumed to be the
general population. Contribution to normal psychological functions, which encompass cognitive and affective domains, is a beneficial physiological effect.
A cause and effect relationship has been established between the dietary intake of folate and contribution to normal psychological functions.
The following wording reflects the scientific evidence: “Folate contributes to normal psychological functions”.
Maintenance of normal vision (ID 83, 87)
The claimed effect is “eye health”, “eye health, folic acid with vitamin E and C”. The target population is assumed to be the general population. Maintenance of normal vision is a beneficial physiological effect.
A cause and effect relationship has not been established between the dietary intake of folate and the maintenance of normal vision.
Reduction of tiredness and fatigue (ID 84)
The claimed effect is “vitamin/mineral supplementation to reduce fatigue and tiredness in situations of inadequate micronutrient status”. The target population is assumed to be the general population. Reduction of tiredness and fatigue is a beneficial physiological effect.
A cause and effect relationship has been established between the dietary intake of folate and the reduction of tiredness and fatigue.
The following wording reflects the scientific evidence: “Folate can contribute to the reduction of tiredness and fatigue”.
Cell division (ID 195, 2881)
The claimed effects are “la folate (vitamine B9) participe au métabolisme des protéines” and “cell division/multiplication: nucleic acids and amino acids synthesis (such as in the gastrointestinal tract)”. The target population is assumed to be the general population.
A claim on folate and normal cell division has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2009).
Contribution to normal amino acid synthesis (ID 195, 2881)
The claimed effects are “la folate (vitamin B9) participe au métabolisme des protéines” and “cell division/multiplication: nucleic acids and amino acid synthesis (such as in the gastrointestinal tract)”. The target population is assumed to be the general population. Contribution to normal amino acids synthesis is a beneficial physiological effect.
A cause and effect relationship has been established between the dietary intake of folate and contribution to normal amino acids synthesis.
The following wording reflects the scientific evidence: “Folate contributes to normal amino acid synthesis”.
Conditions and possible restrictions of use
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.
