Scientific Opinion on the substantiation of health claims related to iron and
formation of red blood cells and haemoglobin (ID 374, 2889), oxygen
transport (ID 255), contribution to normal energy-yielding metabolism
(ID 255), reduction of tiredness and fatigue (ID 255, 374, 2889),
biotransformation of xenobiotic substances (ID 258), and “activity of heart,
liver and muscles” (ID 397) 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:
Iron
energy-yielding metabolism
fatigue
haemoglobin
health claims
heart
liver
muscles
oxygen transport
red blood cells
xenobiotics
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claims is iron which is a well recognised nutrient and is measurable in foods by established methods.
Iron occurs naturally in foodstuffs in different oxidation states. The primarily occurring oxidation states in biological systems are +2 (ferrous state) and +3 (ferric state).
Iron occurs naturally in foods in two forms, haem iron which is primarily derived from haemoglobin and myoglobin in meat and non-haem iron from plants in the form of iron complexes (IoM, 2001). Different forms of iron are authorised for addition to foods (Annex II of Regulation (EC) No 1925/20066 and Annex II of Directive 2002/46/EC7). This evaluation applies to iron 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, iron, which is the subject of the health claims, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Tworzenie erytrocytów (czerwonych krwinek) i hemoglobiny (ID 374, 2889)
The claimed effect is “fights against anaemia/ tiredness”. The Panel assumes that the target population is the general population.
The Panel assumes that the claimed effect is related to the formation of red blood cells and haemoglobin.
A claim on iron and normal formation of red blood cells and haemoglobin has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2009).
2.2. Transport tlenu (ID 255)
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 clarifications provided by Member States, the Panel assumes that the claimed effect is related to oxygen transport.
A claim on iron and normal oxygen transport has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2009).
2.3. Udział w prawidłowym pozyskiwaniu energii w procesach metabolicznych (ID 255)
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 clarifications provided by Member States, the Panel assumes that the claimed effect is related to energy-yielding metabolism.
A claim on iron and normal energy-yielding metabolism has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2009).
2.4. Zmniejszenie zmęczenia (ID 255, 374, 2889)
The claimed effects are “vitamin/mineral supplementation to reduce fatigue and tiredness in situations of inadequate micronutrient status” and “fights against anaemia/ tiredness”. The Panel assumes that the target population is the general population.
The Panel considers that the reduction of tiredness and fatigue is a beneficial physiological effect.
2.5. Przemiany substancji ksenobiotycznych (oczyszczanie organizmu, detoksykacja) (ID 258)
The claimed effect is “metabolism of foreign substances”. The Panel assumes that the target population is the general population.
Enzymatic biotransformation reactions of xenobiotic substances after absorption involve Phase I and Phase II biotransformation reactions, which usually work together in a sequential manner to convert xenobiotics into more readily excretable metabolites (Yu, 2005; Buhler and Williams, 1988). Phase I biotransformation reactions include oxidation, reduction, and hydrolysis, while Phase II biotransformation consists essentially of conjugation reactions (Yu, 2005). Whereas biotransformation reactions normally result in detoxification, some chemicals may also be enzymatically converted to highly reactive, electrophilic metabolites which may induce cytotoxic, teratogenic, mutagenic or carcinogenic effects through reaction with various cellular constituents (Buhler and Williams, 1988).
The Panel notes that from the proposed wording it could not be established which xenobiotic substance or which biotransformation reaction related to the elimination of xenobiotic substances is the target for the claim.
In the absence of such information, the Panel considers that the claimed effect is general and non-specific and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.
2.6. Aktywność serca, wątroby i mięśni (ID 397)
The claimed effect is “activity of heart, liver and muscles”. The Panel assumes that the target population is the general population.
“Activity of heart, liver and muscles” is not sufficiently defined and no clarifications have been provided by Member States.
The Panel considers that the claimed effect is general and non-specific and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka -
Iron is an essential trace element that has important metabolic functions, including oxygen transport, and is involved in many redox reactions. Insufficient intake results in the deficiency condition anaemia, adverse outcomes of pregnancy, impaired psychomotor development and cognitive performance and reduced immune function (EFSA, 2004).
3.1. Zmniejszenie zmęczenia (ID 255, 374, 2889)
Insufficient intake of iron results in the deficiency condition anaemia. Most patients with significant anaemia are fatigued and tire easily after exertion (Chitambar and Antony, 2006).
The Panel concludes that a cause and effect relationship has been established between the dietary intake of iron and reduction of tiredness and fatigue.
4. Uwagi do zaproponowanego brzmienia oświadczenia
4.1. Zmniejszenie zmęczenia (ID 255, 374, 2889)
The Panel considers that the following wording reflects the scientific evidence: “Iron can contribute to the reduction of tiredness and fatigue”.
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 iron 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. No Upper Tolerable Intake Levels (UL) have been set for iron (EFSA, 2004).
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, iron, which is the subject of the health claims, is sufficiently characterised.
Formation of red blood cells and haemoglobin (ID 374, 2889)
The claimed effect is “fights against anaemia/tiredness”. The target population is assumed to be the general population. It is assumed that the claimed effect is related to the formation of red blood cells and haemoglobin.
A claim on iron and normal formation of red blood cells and haemoglobin has already been assessed with a favourable outcome.
Oxygen transport (ID 255)
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. In the context of the clarifications provided by Member States, it is assumed that the claimed effect is related to oxygen transport.
A claim on iron and normal oxygen transport has already been assessed with a favourable outcome.
Contribution to normal energy-yielding metabolism (ID 255)
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. In the context of the clarifications provided by Member States, it is assumed that the claimed effect is related to energy-yielding metabolism.
A claim on iron and normal energy-yielding metabolism has already been assessed with a favourable outcome.
Reduction of tiredness and fatigue (ID 255, 374, 2889)
The claimed effects are “vitamin/mineral supplementation to reduce fatigue and tiredness in situations of inadequate micronutrient status” and “fights against anaemia/tiredness”. 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 iron and reduction of tiredness and fatigue.
The following wording reflects the scientific evidence: “Iron can contribute to the reduction of tiredness and fatigue”.
Biotransformation of xenobiotic substances (ID 258)
The claimed effect is “metabolism of foreign substances”. The target population is assumed to be the general population. From the proposed wording, it could not be established which xenobiotic substance or which biotransformation reaction related to the elimination of xenobiotic substances is the target for the claim.
The claimed effect is general and non-specific and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.
“Activity of heart, liver and muscles” (ID 397)
The claimed effect is “activity of heart, liver and muscles”. The target population is assumed to be the general population. “Activity of heart, liver and muscles” is not sufficiently defined and no clarifications have been provided by Member States.
The claimed effect is general and non-specific and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.
Conditions and possible restrictions of use
In order to bear the claims a food should be at least source of iron 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.
