ID 945 -
Lactobacillus rhamnosus GR-1 (ATCC 55826), Lactobacillus reuteri RC-14 (ATCC 55845)
PL: Lactobacillus rhamnosus GR-1 (ATCC 55826), Lactobacillus reuteri RC-14 (ATCC 55845)
EN: Lactobacillus rhamnosus GR 1 (ATCC 55826) and Lactobacilus reuteri RC 14 (ATCC 55845)
Pdf: Lactobacillus rhamnosus GR-1
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claim is Lactobacillus rhamnosus GR-1 (ATCC 55826) in combination with Lactobacillus reuteri RC-14 (ATCC 55845).
Reference to the identification and characterisation of the Lactobacillus rhamnosus GR-1 (hereafter L. rhamnosus GR-1) strain by different phenotypic and genotypic methods was found in the references provided (Gardiner et al., 2002a; Yeung et al., 2002; Zhong et al., 1998). The Panel considers that L. rhamnosus GR-1 is sufficiently characterised. A culture collection number from the American Type Culture Collection (ATCC), ATCC 55826, was provided. The strain was also found in the open access catalogues of the BCCM/LMG (Belgian Co-ordinated Collections of Microorganisms) and NCCB (Netherlands Culture Collection of Bacteria) culture collections under numbers LMG 8153 and NCCB 98073.
The strain Lactobacillus reuteri RC-14 (hereafter L. reuteri RC-14), initially known as L. acidophilus RC-14, reclassified in 1998 as L. fermentum RC-14 and finally classified in 2006 by DNA:DNA hybridisation as L. reuteri RC-14 (Cadieux et al., 2008), has been characterised at strain level by using different molecular methods (Gardiner et al., 2002b; Zhong et al., 1998). The Panel considers that L. reuteri RC-14 is sufficiently characterised. A culture collection number from the ATCC, ATCC 55845, was provided.
The Panel considers that the food constituents, Lactobacillus rhamnosus GR-1 (ATCC 55826) and Lactobacillus reuteri RC-14 (ATCC 55845), which are the subject of the health claim, are sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
The claimed effect is “vaginal health/flora”. The Panel assumes that the target population is the general female population.
From the clarifications provided by Member States, the Panel assumes that the claimed effect refers to defence against vaginal pathogens by increasing the number of lactobacilli and/or decreasing potentially pathogenic bacteria and/or yeasts.
Unlike any other anatomical site of the body, most vaginal vaults are dominated by one or more species of Lactobacillus. In over 70 % of women, vaginal microbiota is dominated by lactobacilli (>50 %) (Ling et al., 2010; Ravel et al., 2010; Yamamoto et al., 2009). This microbiota is different from the more complex gut microbiota, where lactobacilli represent less than 3 % of the bacterial population (Franks et al., 1998; Lay et al., 2005; Sghir et al., 2000). The diagnosis of bacterial vaginosis (BV) is currently based on the Nugent score (microscopic examination of Gram stained smear or vaginal discharge for bacteria and „clue‟ cells). Nugent scores are classified into normal (0-3, lactobacilli are present, but not Gardnerella/Bacteroides or curved Gram-negative bacilli), intermediate (4-6, colonisation by Bacteroides/Gardenella and curved Gram-variable rods (Mobiluncus)), and BV (7-10, BV with domination of Gardnerella/Bacteroides or curved Gram-negative bacilli and absence of lactobacilli).
The Panel considers that defence against vaginal pathogens by increasing the proportion of lactobacilli and/or decreasing the proportion of potentially pathogenic bacteria and/or yeasts is a beneficial physiological effect.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Ochrona przed patogenami pochwowymi przez zwiększenie ilości bakterii kwasu mlekowego i/lub zmniejszenie ilości potencjalnie patogennych bakterii i/lub drożdży
The references provided for the scientific substantiation of the claim included narrative reviews and animal studies unrelated to the claimed effect, and in vitro studies about, for example, bacterial adhesion properties, cell surface properties, bacterial binding to cell surfaces, and bactericidal activity. Two references could not be evaluated: a conference abstract which did not provide sufficient detail for a full scientific evaluation, and one reference which was not accessible after every reasonable effort had been made to retrieve it. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
Five human intervention studies performed with intra-vaginal capsules were provided. The Panel notes that the intra-vaginal route of administration is not relevant to human nutrition. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
Five human intervention studies on the effects of orally-administered L. rhamnosus GR-1 in combination with L. reuteri RC-14 on Nugent scores and/or numbers of lactobacilli measured in vaginal swabs were provided. Two of these studies were conducted in women receiving antibiotic therapy (Anukam et al., 2006; Reid et al., 2003a), and three were conducted in healthy women (Reid et al., 2001a; 2003b; 2004). The Panel notes that no (Anukam et al., 2006; Reid et al., 2001a; Reid et al., 2003a) or very limited (Reid et al., 2003b; Reid et al., 2004) information about the methods used for statistical analyses was provided in these publications, and therefore did not allow a full scientific evaluation. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
The evidence provided by human studies (Gardiner et al., 2002b; Morelli et al., 2004; Reid et al., 2001b), as well as animal and in vitro studies, about the survival of the strains through the gastro- intestinal tract and transfer to the vagina is not sufficient to predict the occurrence of an effect of the consumption of L. rhamnosus GR-1 (ATCC 55826) in combination with L. reuteri RC-14 (ATCC 55845) on defence against vaginal pathogens by increasing the proportion of lactobacilli and/or decreasing the proportion of potentially pathogenic bacteria and/or yeasts in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of L. rhamnosus GR-1 (ATCC 55826) in combination with L. reuteri RC-14 (ATCC 55845) and defence against vaginal pathogens by increasing the proportion of lactobacilli and/or decreasing the proportion of potentially pathogenic bacteria and/or yeasts.
Warunki i możliwe ograniczenia stosowania oświadczenia
at least 10[9] cfu/day