1802.pdf

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Scientific Opinion on the substantiation of health claims related to Lactobacillus fermentum CECT5716 and maintenance of the upper respiratory tract defence against pathogens by maintaining immune defences (ID 916) 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 fermentum CECT5716   health claims   immune   pathogens   protective antibodies   respiratory infections  
ID:    916  
Produkty: Lactobacillus fermentum CECT5716  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is Lactobacillus fermentum CECT5716. The species identity, as well as the strain identity and characteristics, of the strain L. fermentum CECT5716 have been determined using phenotypic and genotypic methods as indicated in the references provided (Martín et al., 2003; Martín et al., 2005; Xaus et al., 2003).
A culture collection number from the Spanish Type Culture Collection (CECT) is indicated. CECT accepts deposits as a restricted-access non-public International Depositary Authority under the Budapest Treaty.
The Panel considers that the food constituent, Lactobacillus fermentum CECT5716, which is the subject of the health claims, is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka

The claimed effect is “natural defence/immune system”. The Panel assumes that the target population is the general population.
From the clarifications provided by the Member States, the Panel assumes that the claimed effect refers to maintenance of the upper respiratory tract defence against pathogens by maintaining immune defences.
The Panel considers that maintenance of the upper respiratory tract defence against pathogens by maintaining immune defences is a beneficial physiological effect.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Utrzymanie odporności przeciw patogenom w górnych drogach oddechowych, poprzez utrzymywanie prawidłowego stanu układu odpornościowego

Twenty references were provided in relation to this claim.
The references included general review articles about microbiota/beneficial bacteria of human milk or microbiota and their immunological effects, studies in animal (rat or mouse) models of colitis, and a study on the isolation of lactic acid bacteria from human milk. Two references were only available in abstract form in which the information provided regarding the study design, methodology and statistical analyses was insufficient for a complete scientific evaluation. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
5716 and maintenance of immune upper respiratory tract defence against pathogens by maintaining immune defences
6 EFSA Journal 2010;8(10):1802
A randomised, double-blinded, placebo controlled human study assessed the adjuvant capability of L. fermentum CECT5716 for an anti-influenza vaccine (Olivares et al., 2007). Fifty volunteers (31 male and 19 female, mean age 33 years) were recruited. Twenty-five volunteers received a daily supplementation with methylcellulose (placebo) and 25 with L. fermentum CECT5716 (1010 CFU/d) for two weeks before and two weeks after vaccination with inactivated trivalent influenza viruses. No effect on virus specific hemaglutinin antibody titre was reported. The study also recorded self-reported episodes of influenza-like illness (ILI) for 5 months after the vaccination. Only at the last recording time point, which is 4.5 months after the last intake of the strain, the difference in reported ILIs between placebo and L. fermentum group was statistically significant. The Panel notes that the evidence provided did not establish that the observed effect and the time at which it occurred is related to the consumption of L. fermentum CECT5716.
In the absence of a positive outcome measure in human studies, in vitro studies related to immunomodulatory effects of L. fermentum CECT5716 cannot be used for the scientific substantiation of the claim.
In weighing the evidence, the Panel took into account that the only human study provided did not show any effect of Lactobacillus fermentum CECT5716 consumption on maintenance of the upper respiratory tract defence against pathogens by maintaining immune defences.
The Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus fermentum CECT5716 and maintenance of the upper respiratory tract defence against pathogens by maintaining immune defences.

Wnioski

On the basis of the data presented, the Panel concludes that:
The food constituent, Lactobacillus fermentum CECT5716, 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. Maintenance of the upper respiratory tract defence against pathogens by maintaining immune defences is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of Lactobacillus fermentum CECT5716 and maintenance of the upper respiratory tract defence against pathogens by maintaining immune defences.