Scientific Opinion on the substantiation of health claims related to
vitamin C and reduction of tiredness and fatigue (ID 139, 2622),
contribution to normal psychological functions (ID 140), regeneration of
the reduced form of vitamin E (ID 202), contribution to normal energy-
yielding metabolism (ID 2334, 3196), maintenance of the normal function of
the immune system (ID 4321) and protection of DNA, proteins and lipids
from oxidative damage (ID 3331) 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:
Vitamin C
energy
fatigue
health claims
immune system
mental
oxidative damage
psychological
regeneration
tiredness
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claims is vitamin C (L-ascorbic acid, ascorbate), which is a well recognised nutrient and is measurable in foods by established methods.
Vitamin C occurs naturally in foods and is authorised for addition to foods (Annex I of the Regulation (EC) No 1925/20066 and Annex I of Directive 2002/46/EC7). This evaluation applies to vitamin C 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, vitamin C, which is the subject of the health claims, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Zmniejszenie zmęczenia (ID 139, 2622)
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.
In the context of the proposed wording and clarifications provided by Member States, the Panel assumes that the claimed effect refers to the reduction of tiredness and fatigue.
The Panel considers that reduction of tiredness and fatigue is a beneficial physiological effect.
2.2. Udział w prawidłowym przebiegu funkcji psychicznych (psychologicznych) (ID 140)
The claimed effect is “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)”. 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.
2.3. Regeneracja zredukowanej formy witaminy E (ID 202)
The claimed effect is “regeneration of vitamin E, have synergistic effects”. The Panel assumes that the target population is the general population.
In the context of the clarifications provided by Member States, the Panel assumes that the claimed effect refers to the regeneration of the reduced form of vitamin E.
The Panel considers that the regeneration of the reduced form of vitamin E is a beneficial physiological effect.
2.4. Udział w prawidłowym pozyskiwaniu energii w procesach metabolicznych (ID 2334, 3196)
The claimed effect is “invigoration of the body” and “physical health”. The Panel assumes that the target population is the general population.
In the context of the proposed wording and clarifications provided by Member States, the Panel assumes that the claimed effect refers to energy-yielding metabolism.
A claim on vitamin C and energy-yielding metabolism has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2009).
2.5. Utrzymanie prawidłowego funkcjonowania układu odpornościowego (ID 4321)
The claimed effect is “is a rich source of vitamin C that has immunostimulating activities”. 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 the maintenance of the normal function of the immune system.
A claim on vitamin C and the function of the immune system has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2009).
2.6. Ochrona DNA, białek i lipidów przed uszkodzeniem oksydacyjnym (ID 3331)
The claimed effect is “anti oxydant, par sa teneur en vitamine C”. The Panel assumes that the target population is the general population.
The Panel assumes that the claimed effect refers to the protection of DNA, proteins and lipids from oxidative damage.
A claim on vitamin C and the protection of DNA, proteins and lipids from oxidative damage has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2009).
3. Naukowe uzasadnienia wpływu na zdrowie człowieka -
The evidence provided by consensus opinions/reports from authoritative bodies and reviews shows that there is consensus on the role of vitamin C in the body (Bender, 2003; Garrow et al., 2000; IoM, 2000; NNR, 2004; Sadler et al., 1999; Levine et al., 2006; EVM, 2002). Vitamin C is an electron donor, or reducing agent, and its functions are attributable to this action (Levine et al., 2006). Vitamin C acts as a free radical scavenger in the body and as electron donor (and cofactor) for eight human enzymes, three of which participate in the biosynthesis (and cross-linking) of collagen and other components of the connective tissue, two of which are required in the biosynthesis of carnitine, one of which is required in tyrosine metabolism and two of which are required in the biosynthesis of the catecholamines adrenaline and noradrenaline (which act as neurotransmitters) and in the amidation of peptide hormones.
3.1. Zmniejszenie zmęczenia (ID 139, 2622)
The evidence provided by consensus opinions/reports from authoritative bodies and reviews shows that weakness and fatigue are among the symptoms of vitamin C deficiency (IoM, 2000; Lukaski, 2004). These symptoms respond to vitamin C supplementation (Levine et al., 1996).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of vitamin C and reduction of tiredness and fatigue.
3.2. Udział w prawidłowym przebiegu funkcji psychicznych (psychologicznych) (ID 140)
Advanced vitamin C deficiency results in scurvy. The symptoms of scurvy include listlessness and general malaise, sometimes associated with personality changes and psychomotor performance (Bender, 2009). Depression is one of the symptoms associated with scurvy (IoM, 2000).
Among its biological functions, vitamin C modulates neurotransmitter receptors, the function of glutamatergic and dopaminergic neurons, and the formation of glial cells and myelin. Vitamin C, as a co-factor for dopamine-β-hydroxylase, also contributes to catecholamines, norepinephrine (noradrenaline) and epinephrine (adrenaline) biosynthesis (IoM, 2000).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of vitamin C and contribution to normal psychological functions.
3.3. Regeneracja zredukowanej formy witaminy E (ID 202)
Vitamin C is an electron donor, or reducing agent, and its functions are attributable to this action. According to a report on the interaction between ascorbate and alpha-tocopherol (Niki, 1987), vitamin C as a water-soluble antioxidant can regenerate reduced alpha-tocopherol (vitamin E) as a lipid-soluble antioxidant added to liposomes in vitro (Levine et al., 2006).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of vitamin C and the regeneration of the reduced form of vitamin E.
4. Uwagi do zaproponowanego brzmienia oświadczenia
4.1. Zmniejszenie zmęczenia (ID 139, 2622)
The Panel considers that the following wording reflects the scientific evidence: “Vitamin C can contribute to the reduction of tiredness and fatigue”.
4.2. Udział w prawidłowym przebiegu funkcji psychicznych (psychologicznych) (ID 140)
The Panel considers that the following wording reflects the scientific evidence: “Vitamin C contributes to normal psychological functions”.
4.3. Regeneracja zredukowanej formy witaminy E (ID 202)
The Panel considers that the following wording reflects the scientific evidence: “Vitamin C contributes to the regeneration of the reduced form of vitamin E”.
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 vitamin C 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.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, vitamin C, which is the subject of the health claims, is sufficiently characterised.
Reduction of tiredness and fatigue (ID 139, 2622)
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 vitamin C and reduction of tiredness and fatigue.
The following wording reflects the scientific evidence: “Vitamin C can contribute to the reduction of tiredness and fatigue”.
Contribution to normal psychological functions (ID 140)
The claimed effect is “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)”. 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 vitamin C and contribution to normal psychological functions.
The following wording reflects the scientific evidence: “Vitamin C contributes to normal psychological functions”.
Regeneration of the reduced form of vitamin E (ID 202)
The claimed effect is “regeneration of vitamin E, have synergistic effects”. The target population is assumed to be the general population. The regeneration of the reduced form of vitamin E is a beneficial physiological effect.
A cause and effect relationship has been established between the dietary intake of vitamin C and the regeneration of the reduced form of vitamin E.
The following wording reflects the scientific evidence: “Vitamin C contributes to the regeneration of the reduced form of vitamin E”.
Contribution to normal energy-yielding metabolism (ID 2334, 3196)
The claimed effect is “invigoration of the body” and “physical health”. The target population is assumed to be the general population. In the context of the proposed wording and clarifications provided by Member States, the Panel assumes that the claimed effect refers to energy-yielding metabolism.
A claim on vitamin C and energy-yielding metabolism has already been assessed with a favourable outcome.
Maintenance of the normal function of the immune system (ID 4321)
The claimed effect is “is a rich source of vitamin C that has immunostimulating activities”. The target population is assumed to be the general population. In the context of the proposed wording the Panel assumes that the claimed effect refers to the maintenance of the normal function of the immune system.
A claim on vitamin C and the normal function of the immune system has already been assessed with a favourable outcome.
Protection of DNA, proteins and lipids from oxidative damage (ID 3331)
The claimed effect is “anti oxydant, par sa teneur en vitamine C”. The target population is assumed to be the general population. The Panel assumes that the claimed effect refers to the protection of DNA, proteins and lipids from oxidative damage.
A claim on vitamin C and the protection of DNA, proteins and lipids from oxidative damage has already been assessed with a favourable outcome.
Conditions and possible restrictions of use
In order to bear the claims a food should be at least a source of vitamin C 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.
