Scientific Opinion on the substantiation of health claims related to various
food(s)/food constituents(s) and “immune function/immune system”
(ID 433, 605, 645, 791, 1384, 1451, 1624, 1743, 1776, 1838, 1851, 1854, 1891,
1895, 3074, 3191, 3211, 3218, 3336, 3341, 3450, 3514, 3658, 3756, 3802,
3805, 3841, 3935, 3979), “contribution to body defences against external
agents” (ID 2344, 3208, 3213, 3270, 3278, 3285, 3294, 3309, 3387, 3424,
3428, 3536, 3537, 3539, 3575, 3577, 3579, 3582, 3603, 3618, 3755, 3776,
3777, 3778, 3801, 3804, 3840, 4367, 4472), reduction of inflammation
(ID 1327, 1391) and decreasing potentially pathogenic gastro-intestinal
microorganisms (ID 2362, 2730, 4064) 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:
Immune
body defences
health claims
inflammation
potentially pathogenic microorganisms
2. Znaczenie oświadczenia dla zdrowia człowieka
1.1. Funkcje układu odpornościowego (ID 433, 605, 645, 791, 1384, 1451, 1624, 1743, 1776, 1838, 1851, 1854, 1891, 1895, 3074, 3191, 3211, 3218, 3336, 3341, 3450, 3514, 3658, 3756, 3802, 3805, 3841, 3935, 3979)
The claimed effects are “immune system”, "immunity", “immune health”, “immune system function”, “immune system/exercise stress”, “natural defences”, “systeme immunitaire, stimule l'immunite”, “systeme immunitaire, immunostimulant”, “it improves the immune system and most biological function” and “support immune defences”. The Panel assumes that the target population is the general population.
The claimed effects were not sufficiently defined and no further details were given in the proposed wording or the information provided in the consolidated list. Given the multiple roles of the immune system, the specific aspect of immune function that is the subject of the health claim has not been indicated in the information provided.
The Panel considers that the claimed effects are general and non-specific and do not refer to any specific health claim as required by Regulation (EC) No 1924/2006.
1.2. Udział w obronie organizmu przed czynnikami zewnętrznymi (ID 2344, 3208, 3213, 3270, 3278, 3285, 3294, 3309, 3387, 3424, 3428, 3536, 3537, 3539, 3575, 3577, 3579, 3582, 3603, 3618, 3755, 3776, 3777, 3778, 3801, 3804, 3840, 4367, 4472)
The claimed effects are “contributes to body defences against external agents”, “contributes to the resistance against external agents” and “resistance system”. The Panel assumes that the target population is the general population.
The claimed effects are not sufficiently defined and no further details were given in the proposed wording or the information provided in the consolidated list.
The Panel notes that several effects/parameters were mentioned for each ID and that it was not possible to establish which specific effect was the target for the claim.
The Panel considers that the claimed effects are general and non-specific and do not refer to any specific health claim as required by Regulation (EC) No 1924/2006.
1.3. Ograniczenie zapalenia (ID 1327, 1391)
The claimed effects are “immune system” and “anti-inflammatoire”. The Panel assumes that the target population is the general population. In the context of the proposed wording, the Panel assumes that the claimed effects refer to the reduction of inflammation.
Inflammation is a non-specific physiological response to tissue damage that is mediated by the immune system. Adequate inflammatory responses are of primary importance for the defence against injury of any origin. Changes in markers of inflammation such as various interleukins do not indicate a beneficial physiological effect per se.
Chronic inflammation is associated with a number of diseases, and under certain circumstances reducing levels of markers of inflammation might indicate a beneficial physiological effect.
Whether or not the reduction of inflammatory markers is considered to be beneficial depends on the context in which the claim is made. The Panel considers that no evidence has been provided in which context the claimed effect could be considered as a beneficial physiological effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) which are the subject of the health claims and a beneficial physiological effect related to the reduction of inflammation.
1.4. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego (ID 2362, 2730, 4064)
The claimed effects are “body's defence system against microorganism” and “immune health”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effects refer to the defence or resistance against harmful microorganisms.
The Panel considers that decreasing potentially pathogenic gastro-intestinal microorganisms might be a beneficial physiological effect.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka
2.1. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego (ID 2362, 2730, 4064)
No human studies have been provided that investigated the effects of the food(s)/food constituent(s) that are the subject of the health claims on outcomes related to decreasing potentially pathogenic gastro-intestinal microorganisms.
The references provided included original articles, general review articles, book chapters, guides, web sites, monographs and reports. Of these references, many were not related to the food(s)/food constituent(s) which are the subject of the health claims but to a combination of ingredients, or they addressed effects not related to the health claim (e.g. cardiovascular effects, inhibition of human cytochrome P450), or they addressed phytotherapy and general medical uses of plants. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
An animal study provided for ID 4064 was focused on the effects of the food/food constituent on antigen-specific immunoglobulin production in rats injected with a novel antigen and then re-exposed. The Panel notes that the outcome studied was not related to the claimed effect and that no conclusions can be drawn from this reference for the scientific substantiation of the claimed effect.
A number of in vitro studies were provided related to the evaluation of the inhibitory activity and the antimicrobial mode of action of the food(s)/food constituent(s) that are the subject of the health claims on potentially pathogenic yeast, fungi, and bacteria. The Panel considers that while effects shown in in vitro studies may be used as supportive evidence, human studies are required for the substantiation of a claim, and that the evidence provided in in vitro studies alone is not sufficient to predict the occurrence of an effect of the consumption of the food(s)/food constituent(s) on decreasing potentially pathogenic gastro-intestinal microorganisms.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the food(s)/constituent(s) which are the subject of the health claims and decreasing potentially pathogenic gastro-intestinal microorganisms.
Wnioski
On the basis of the data presented, the Panel concludes that:
“Immune function/immune system” (ID 433, 605, 645, 791, 1384, 1451, 1624, 1743, 1776, 1838, 1851, 1854, 1891, 1895, 3074, 3191, 3211, 3218, 3336, 3341, 3450, 3514, 3658, 3756, 3802, 3805,
3841, 3935, 3979)
The claimed effects are “immune system”, “immunity”, “immune health”, “immune system function”, “immune system/exercise stress”, “natural defences”, “systeme immunitaire, stimule l’immunite”, “systeme immunitaire, immunostimulant”, “it improves the immune system and most biological function” and “support immune defences”. The target population is assumed to be the general population.
The claimed effects are general and non-specific and do not refer to any specific health claim as required by Regulation (EC) No 1924/2006.
“Contribution to body defences against external agents” (ID 2344, 3208, 3213, 3270, 3278, 3285, 3294, 3309, 3387, 3424, 3428, 3536, 3537, 3539, 3575, 3577, 3579, 3582, 3603, 3618, 3755, 3776, 3777, 3778, 3801, 3804, 3840, 4367, 4472)
The claimed effects are “contributes to body defences against external agents”, “contributes to the resistance against external agents” or “resistance system”. The target population is assumed to be the general population.
The claimed effects are general and non-specific and do not refer to any specific health claim as required by Regulation (EC) No 1924/2006.
Reduction of inflammation (ID 1327, 1391)
The claimed effects are “immune system”, and “anti-inflammatoire”. The target population is assumed to be the general population. No evidence has been provided in which context the claimed effect could be considered as a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) which are the subject of the health claims and a beneficial physiological effect related to the reduction of inflammation.
Decreasing potentially pathogenic gastro-intestinal microorganisms (ID 2362, 2730, 4064)
The claimed effects are “body’s defence system against microorganism” and “immune health”. The target population is assumed to be the general population. Decreasing potentially pathogenic gastro-intestinal microorganisms might be a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) which are the subject of the health claims and decreasing potentially pathogenic gastro-intestinal microorganisms.