2066.pdf

Oryginał 
Scientific Opinion on the substantiation of health claims related to nucleotides and immune defence against pathogens (ID 1623, 1626) 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:
ID:    1623      1626  
Produkty: Nukleotydy  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is nucleotides.
Nucleotides are the basic monomer building block units in the nucleic acids (DNA and RNA). They are also part of the structure of important cofactors in cellular signalling and energy metabolism. These cofactors include coenzyme A, flavin adenine dinucleotide (FAD), flavin mononucleotide (FMN), adenosine triphosphate (ATP), adenosine diphosphate (ADP) and nicotinamide adenine dinucleotide phosphate (NADP). A nucleotide consists of a heterocyclic nucleobase (purines and pyrimidines), a pentose sugar (ribose for RNA, and deoxyribose for DNA) and a phosphate (monophosphate, diphosphate or triphosphate). The metabolic requirements for nucleotides and nucleotide bases can be met either by de novo synthesis from low molecular weight precursors or by dietary intake.
The Panel considers that the food constituent, nucleotides, which is the subject of the health claims, is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka

The claimed effects are “immune health” and “general wellbeing/immunity/digestive health”. The Panel assumes that the target population is the general population.
In the context of the clarifications provided, the Panel assumes that the claimed effect refers to: “enhancing the production of immunoglobulins”, “improve T-cell function”, “higher antibody titers”, “higher natural killer cell activity” and “reduced incidence of loose stools”.
The Panel considers that the evidence provided does not establish that stimulating immunological responses (such as enhancing the production of immunoglobulins, improved T-cell function, higher antibody titers and higher natural killer cell activity) is a beneficial physiological effect per se. The Panel interprets that a reduction of the incidence of loose stools may be related to immune defence against pathogens.
The Panel considers that immune defence against pathogens is a beneficial physiological effect.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Ochrona organizmu przed patogenami

Among the references provided were reviews and a guidance document which did not provide any original data that could be used for the scientific substantiation of the claimed effect. All the human
intervention studies, and a meta-analysis of human trials, examined the effects of enteral nutrition enriched with nucleotides, arginine, glutamine and omega-3 fatty acids in several combinations compared to a standard liquid diet or standard enteral diet in critically ill patients, or of complex dietary supplements including nucleotides, methionine, inositol, lysine, vitamin C, vitamin E, pantothenic acid, folic acid, biotin and vitamin B12 in healthy people. The Panel notes that the formulations used in these studies included a mixture of nutrients, and that no study evaluated the effect of nucleotides alone. The Panel considers that no conclusions can be drawn from studies using a fixed combination for the substantiation of a claim on nucleotides alone.
The Panel notes that no human studies have been provided from which conclusions can be drawn for the scientific substantiation of the claimed effect. The Panel considers that human studies are required for the substantiation of a claim, and that evidence provided in animal and in vitro studies is not sufficient to predict the occurrence of an effect of nucleotide consumption on immune defence against pathogens in humans.
The Panel concludes that a cause and effect relationship has not been established between consumption of nucleotides and immune defence against pathogens.

Wnioski

On the basis of the data presented, the Panel concludes that:
The food constituent, nucleotides, which is the subject of the health claims, is sufficiently characterised.
The claimed effects are “immune health” and “general wellbeing/immunity/digestive health”. The target population is assumed to be the general population. In the context of the clarifications provided, it is assumed that the claimed effect refers to “reduced incidence of loose stools”. A reduction of the incidence of loose stools may be related to immune defence against pathogens. Immune defence against pathogens is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of nucleotides and immune defence against pathogens.