1803.pdf

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Scientific Opinion on the substantiation of health claims related to Lactobacillus gasseri CECT5714 and Lactobacillus coryniformis CECT5711 and “natural defence/immune system” (ID 930) 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: Lactobacillus coryniformis CECT5711   Lactobacillus gasseri CECT5714   health claim   immune defences   pathogens  
ID:    930  
Produkty: Lactobacillus gasseri CECT5714, Lactobacillus coryniformis CECT5711  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is a combination of the strains Lactobacillus gasseri CECT5714 and Lactobacillus coryniformis CECT5711. The strain Lactobacillus gasseri CECT5714 (hereafter L. gasseri CECT5714) species identity as well as the strain identity and characteristics have been determined using phenotypic and genotypic methods as indicated in the references provided (Martin et al., 2003, 2005).
The strain Lactobacillus coryniformis CECT5711 (hereafter L. coryniformis CECT5711) species identity as well as the strain identity and characteristics have been reported in the literature (Martin et al., 2005; Lara-Villoslada et al., 2007). In addition, the lac gene cluster of the strain has been sequenced and the sequence is available in the literature (Corral et al., 2006).
The Panel notes that a culture collection number from the Spanish Type Culture Collection (CECT) is provided for L. gasseri CECT5714 and L. coryniformis CECT5711. CECT accepts deposits as a restricted-access non-public International Depositary Authority under the Budapest Treaty.
The Panel considers that the combination of the strains, Lactobacillus gasseri CECT5714 and Lactobacillus coryniformis CECT5711, which is the subject of the health claim, is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka


2.1. Wzmacnianie systemu immunologicznego i naturalnej obrony organizmu (ID 930)

The claimed effect is “natural defence/immune system”. The Panel assumes that the target population is the general population.
From the clarification provided by Member States, the Panel assumes that the claimed effect refers to increasing/strengthening the immune system and natural defences by stimulating the production of antibodies and cytokines, increasing natural killer cell numbers/activity and increasing the phagocytic activity of granulocytes and monocytes.
The Panel considers that the evidence provided does not establish that changing parameters of the immune system, such as the production of cytokines, increasing natural killer cell numbers/activity and increasing the phagocytic activity of granulocytes and monocytes, is per se a beneficial physiological effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus gasseri CECT5714 and Lactobacillus coryniformis CECT5711 and a beneficial physiological effect related to “natural defence/immune system”.

Wnioski

On the basis of the data presented, the Panel concludes that:
The food constituent, the combination of Lactobacillus gasseri CECT5714 and Lactobacillus coryniformis CECT5711, which is the subject of the health claim, is sufficiently characterised.
The claimed effect is “natural defence/immune system”. The target population is assumed to be the general population. From the clarification provided by Member States, it is assumed that the claimed effect refers to increasing/strengthening the immune system and natural defences by stimulating the production of antibodies and cytokines, increasing natural killer cell numbers/activity and increasing the phagocytic activity of granulocytes and monocytes. The evidence provided does not establish that changing parameters of the immune system, such as the production of cytokines, increasing natural killer cell numbers/activity and increasing the phagocytic activity of granulocytes and monocytes, is per se a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of Lactobacillus gasseri CECT5714 and Lactobacillus coryniformis CECT5711 and a beneficial physiological effect related to “natural defence/immune system”.