ID 1064 - Lactobacillus rhamnosus LB21 NCIMB 40564

PL: Lactobacillus rhamnosus LB21 NCIMB 40564
EN: Lactobacillus rhamnosus LB21 NCIMB 40564
Pdf: Lactobacillus rhamnosus LB21 NCIMB 40564

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is Lactobacillus rhamnosus LB21 NCIMB 40564. Reference to the identification/characterisation of the strain by different genotypic and phenotypic methods was found in the references provided and the literature (Vancanneyt et al., 2006; Grahn Hakansson and Ekbeck 2007).
A culture collection number from the National Collection of Industrial and Marine Bacteria (UK), NCIMB 40564, is indicated and a culture deposited in the LMG under nº 23667 was also found.
The Panel considers that Lactobacillus rhamnosus LB21 NCIMB 40564, which is the subject of the health claims, is sufficiently characterised.

2.1. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów jelitowych (ID 1064)

The claimed effect is “intestinal flora”. The Panel assumes that the target population is the general population.
“Intestinal flora” is not sufficiently defined. In the context of the proposed wording, the Panel assumes that the claimed effect refers to aspects of normalising the bacterial flora in the intestine, balancing and strengthening the bacterial flora in the intestine and supporting a healthy intestinal flora.
The numbers/proportions of bacterial groups that would constitute a “normal/balanced/healthy” intestinal flora have not been established. Changing the number of any groups of bacteria is not in itself considered to be beneficial. The Panel considers that no evidence has been provided that aspects of the claimed effect, “normalising the bacterial flora in the intestine, balancing and strengthening the bacterial flora in the intestine, and supporting a healthy intestinal flora”, are beneficial to human health.
The Panel considers that normalising the bacterial flora in the intestine (or balancing the bacterial flora in the intestine, or supporting a healthy intestinal flora) in the context of decreasing potentially pathogenic intestinal microorganisms might be a beneficial physiological effect.

2.2. Zdrowy układ pokarmowy (podczas biegunki u osób stosujących antybiotyki) (ID 1064)

The claimed effect is “digestive health”. The Panel considers that the claimed effect is not sufficiently defined. In the context of the proposed wording („supporting gastrointestinal conditions during antibiotic treatment‟) and from the references provided, the Panel assumes that the claimed effect relates to acute diarrhoea associated with antibiotic treatment, and that the target group is subjects receiving antibiotic treatment under medical supervision.
The Panel considers that subjects receiving antibiotic treatment under medical supervision do not constitute a sub-group of the general (healthy) population with regard to claims that are related to effects of that treatment.
The Panel considers that the claim does not comply with the criteria laid down in Regulation (EC) No 1924/2006.

2.3. Zmniejszenie ilość bakterii Streptococcus mutans w jamie ustnej (ID 1064)

The claimed effect is “oral flora”. The Panel assumes that the target population is the general population.
“Oral flora” is not sufficiently defined and no more details were provided in the proposed wording. From the references provided, the Panel assumes that the claimed effect relates to the reduction of mutans streptococci in the oral cavity.
The Panel considers that the reduction of mutans streptococci in the oral cavity is a beneficial physiological effect.

3.1. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów jelitowych (ID 1064)

Seven references were cited to substantiate the claimed effect. Only one human study was directly related to L. rhamnosus LB21 consumption (Andersson and Larsson, 1996).
The study by Andersson and Larsson (1996) investigated the effect of L. rhamnosus LB21 in preventing antibiotic associated diarrhoea. The Panel notes that the evidence provided does not establish that a study group receiving antibiotic therapy is representative of the general population in
relation to the claimed effect. The Panel considers that no scientific conclusions can be drawn from this reference for the substantiation of the claimed effect.
The other reference related to L. rhamnosus LB21 is an in vitro study which investigated the effect of the strain on T lymphocytes and production of cytokines by T cells (Elmer, 2007). The Panel considers these endpoints not to be appropriate endpoints for the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus rhamnosus LB21 NCIMB 40564 and decreasing potentially pathogenic intestinal microorganisms.

3.2. Zmniejszenie ilość bakterii Streptococcus mutans w jamie ustnej (ID 1064)

Seven references were cited to substantiate the claimed effect. Only one reference cited was related to the claimed effect and investigated the presence and inhibition capacity against mutans streptococci, in vitro, of natural lactobacilli, habitually occurring in the oral cavity (Simark-Mattsson et al., 2007), but did not specifically relate to Lactobacillus rhamnosus LB21 NCIMB 40564. The Panel notes that the evidence obtained for one strain cannot be extrapolated to another, given the strain-specificity of the effects.
The Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus rhamnosus LB21 NCIMB 40564 and reduction of mutans streptococci in the oral cavity.

Warunki i możliwe ograniczenia stosowania oświadczenia

at least 10^8 cfu/day