Scientific Opinion on the substantiation of health claims related to various
foods/food constituents and “immune function/immune system” (ID 573,
586, 1374, 1566, 1628, 1778, 1793, 1817, 1829, 1939, 2155, 2485, 2486, 2859,
3521, 3774, 3896), “contribution to body defences against external agents”
(ID 3635), stimulation of immunological responses (ID 1479, 2064, 2075,
3139), reduction of inflammation (ID 546, 547, 641, 2505, 2862), increase in
renal water elimination (ID 2505), treatment of diseases (ID 500), and
increasing numbers of gastro-intestinal microorganisms (ID 762, 764, 884)
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
gastro-intestinal microorganisms
health claims
immunological responses
inflammation
renal water
2. Znaczenie oświadczenia dla zdrowia człowieka
1.1. Funkcje układu odpornościowego (ID 573, 586, 1374, 1566, 1628, 1778, 1793, 1817, 1829, 1939, 2155, 2485, 2486, 2859, 3521, 3774, 3896)
The claimed effects are "immunity", "enhances natural resistance", "immune health", "maintenance of immune system", "invigoration the body", "immune support" and "Pleurotus ostreatus and immune 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, the references or the clarifications provided by Member States. Given the multiple roles of
the immune system, the specific aspect of immune function that is the subject of the health claim needs to be specified, but it 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 3635)
The claimed effect is "contributes to body defences against external agents". The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined and no further details were given in the proposed wording, the references or the clarifications 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.
1.3. Stymulacja układu odpornościowego (ID 1479, 2064, 2075, 3139)
The claimed effects are "immune health" and "support of immunity". The Panel assumes that the target population is the general population.
From the clarifications provided by Member States, the Panel assumes that the claimed effects refer to the stimulation of various immunological responses, such as Th1 and Th2 balance, endothelial adhesion molecule regulation, increasing cytokine production, increasing numbers of macrophages, boosting natural killer cell activity, increasing concentrations of some immunocytes (immunocompetent cells), or stimulating components of cellular and humoral immunity.
The Panel considers that the evidence provided does not establish that stimulation of these immunological responses is a beneficial physiological effect per se.
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 stimulation of immunological responses.
1.4. Ograniczenie zapalenia (ID 546, 547, 641, 2505, 2862)
The claimed effects are "regulation of metabolic function", "molecule precursors regulating cell functions (prostaglandins, leucotrienes)", "supportive measure for healthy inflammatory responses", "kidneys health" and "regulation of inflammatory responses in the body". The Panel assumes that the target population is the general population.
In the context of the proposed wordings and the clarifications provided by Member States, the Panel assumes that the claimed effects refer to the reduction of inflammation.
Inflammation is a non-specific physiological response to tissue damage which 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 but should be linked to a beneficial physiological or clinical outcome. The Panel considers that no evidence has been provided to indicate the context in which the claimed effect could be considered to be a beneficial physiological effect.
For ID 2862 the suppression of pro-inflammatory cytokine production (e.g. TNF-α) was mentioned in the clarifications provided, and additional inflammatory markers (e.g. prostaglandin E2,
inhibitor-kappa-B-kinase, IL-8, NFkappaB) were addressed in the in vitro studies provided for the scientific substantiation of the claim. The Panel considers that no evidence has been provided to indicate the context in which the changes in these markers could indicate a beneficial physiological effect in humans.
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.
1.5. Zwiększenie wydalania wody przez nerki (ID 2505)
The claimed effect is "kidneys health". 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 an increase in renal water elimination (i.e. diuresis).
Substances which force diuresis also decrease the extracellular fluid volume by increasing renal sodium and water excretion.
Under normal conditions, fluid balance is tightly regulated over a 24-h period (Subudhi et al., 2005). Water deficits and excesses trigger compensatory changes in either water gains or losses until water balance is re-established (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010). A fall in intravascular volume or extracellular fluid volume will lead through a tightly regulated feedback system to increased renal tubular reabsorption of sodium and water (Shirreffs and Maughan, 2005).
Losses in body water, which are not adequately compensated, will result in dehydration.
The Panel considers that the evidence provided does not establish that an increase in renal water elimination, which could lead to a negative fluid balance, is a beneficial physiological effect for the general healthy population.
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 claim, and a beneficial physiological effect related to an increase in renal water elimination.
1.6. Leczenie chorób (ID 500)
The claimed effect is "a high LNA to LA ratio has positive effects on eicosanoids and thus protects against inflammatory and thrombotic reactions". The Panel assumes that the target population is the general population.
From the clarifications provided by Member States and the references provided, the Panel assumes that the claimed effect refers to the treatment of disease (e.g. rheumatoid arthritis and asthma).
The Panel considers that the claimed effect is related to the treatment of diseases and does not comply with the criteria laid down in Regulation (EC) No 1924/2006.
1.7. Zwiększenie ilości mikroorganizmów w przewodzie pokarmowym (ID 762, 764, 884)
The claimed effects are "helps maintain a healthy immune response in the elderly", "immune support and immune health", and "natural resistance/defence". The Panel assumes that the target population is the general population.
The claimed effects are not sufficiently defined and no further details were provided in the proposed wording. The specific aspect of immune function that is the subject of the health claim has not been indicated in the information provided.
From the clarifications provided by Member States, the Panel assumes that the claimed effects refer to an increase in numbers of bacteria which are considered to be "beneficial".
The numbers/proportions of bacterial groups which would constitute a "balanced or beneficial" gut/intestinal flora have not been established. Increasing the number of any groups of microorganisms, including bifidobacteria, is not in itself considered to be a beneficial physiological effect.
The Panel considers that the evidence provided does not establish that increasing numbers of gastro- intestinal microorganisms is 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 increasing numbers of gastro-intestinal microorganisms.
Wnioski
On the basis of the data presented, the Panel concludes that:
“Immune function/immune system”
The claimed effects are ―immunity‖, ―enhances natural resistance‖, ―immune health‖, ―maintenance of immune system‖, ―invigoration the body‖, ―immune support‖ and ―Pleurotus ostreatus and immune 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.
“Contribution to body defences against external agents”
The claimed effects are ―contributes to body defences against external agents‖. The target population is assumed to be the general population.
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.
Stimulation of immunological responses
The claimed effects are ―immune health‖ and ―support of immunity‖. The target population is assumed to be the general population. From the clarifications provided by Member States, the Panel assumes that the claimed effects refer to the stimulation of various immunological responses. The evidence provided does not establish that the stimulation of immunological responses is a beneficial physiological effect per se.
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 stimulation of immunological responses.
Reduction of inflammation
The claimed effects are ―regulation of metabolic function‖, ―molecule precursors regulating cell functions (prostaglandins, leucotrienes)‖, ―supportive measure for healthy inflammatory responses‖, ―kidneys health‖ and ―regulation of inflammatory responses in the body‖. The target population is assumed to be the general population. In the context of the proposed wordings and the clarifications provided by Member States, the Panel assumes that the claimed effects refer to the reduction of inflammation. No evidence has been provided to indicate the context in which 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.
Increase in renal water elimination
The claimed effect is ―kidney health‖. The target population is assumed to be the general population. The evidence provided does not establish that an increase in renal water elimination, which could lead to a negative fluid balance, is a beneficial physiological effect for the general healthy population.
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 claim, and a beneficial physiological effect related to an increase in renal water elimination.
Treatment of diseases
The claimed effect is ―a high LNA to LA ratio has positive effects on eicosanoids and thus protects against inflammatory and thrombotic reactions‖. The target population is assumed to be the general population. From the clarifications provided by Member States and the references provided, it is assumed that the claimed effect refers to the treatment of disease (e.g. rheumatoid arthritis and asthma).
The claimed effect is related to the treatment of diseases and does not comply with the criteria laid down in Regulation (EC) No 1924/2006.
Increasing numbers of gastro-intestinal microorganisms
The claimed effects are ―helps maintain a healthy immune response in the elderly‖, ―immune support and immune health‖, and ―natural resistance/defence‖. The target population is assumed to be the general population. The evidence provided does not establish that increasing numbers of gastro-intestinal microorganisms is 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 increasing numbers of gastro-intestinal microorganisms.
