1799.pdf

Oryginał 
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  
ID:    1891      3428      1895      1384      3309      1391      1776      3575      3191      4472      3577      3450      3579      3582      3840      3841      3074      645      3336      3208      3979      3211      3213      3341      4367      3218      3603      791      3618      2344      2730      3755      1451      3756      1838      1327      433      3514      2362      3387      1851      1854      3776      3777      3778      3270      3658      3278      1743      3536      3537      3539      3285      1624      3801      3802      3804      3805      605      3294      3935      3424      4064  
Produkty: Ostropest plamisty   Gorzknik kanadyjski   Rabarbar dłoniasty   Lippia trójlistna   Drzewo kajeputowe   Nagietek polny   Buraki   Wątroba chimery   Siara wołowa   Cząber górski   Senna italica   Szałwia muszkatołowa   Olej z wątroby rekina (alkiloglicerol)   Aloes uzbrojony   Kasamarda   Modrzew europejski   Lipa srebrzysta   Babka lancetowata   Kocanka włoska   Dąb szypułkowy   Olej z kiełków pszenicy   Jeżówka wąskolistna   Pszenica zwyczajna   Mleczko pszczele   Mleczko pszczele z pyłkami   Kasztan jadalny   Chrząstka rekina   Liofilizowane mleczko pszczele   Nukleotydy   Głowienka pospolita   Lizat bakteryjny   Drożdże piwne   Glukomannan   Shilajit   Glukozamina   Rabarbar   Stokrotka pospolita   Długołańcuchowe kwasy tłuszczowe Omega-3   Tamaryszek francuski   Szakłak amerykański   Glutamina   Jeżówka blada   Eleuterokok kolczasty   Kruszyna pospolita   Drzewo sandałowca   Kozieradka pospolita   Częściowo hydrolizowana guma guar   Wielkomorszcz gruszkonośny   Undaria pierzastodzielna   Jemioła pospolita   Olsza czarna   Czosnek pospolity   Fosfolipidy z mleka   Brzoza omszona  

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.