Scientific Opinion on the substantiation of health claims related to Lactobacillus rhamnosus LB21 NCIMB 40564 and decreasing potentially pathogenic intestinal microorganisms (ID 1064), digestive health (ID 1064), and reduction of mutans streptococci in the oral cavity (ID 1064) pursuant to Article 13(1) of Regulation (EC) No 1924/2006
Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser-Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen
Acknowledgment
The Panel wishes to thank for the preparation of this opinion: The members of the Working Group on Claims: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Marina Heinonen, Hannu Korhonen, Martinus Løvik, Ambroise Martin, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren and Hans Verhagen. The members of the Claims Sub-Working Group on Gut/Immune: Maria Carmen Collado, Miguel Gueimonde, Daisy Jonkers, Martinus Løvik, Bevan Moseley, Maria Saarela, Seppo Salminen, Stephan Strobel, Hania Szajewska and Hendrik van Loveren.
Contact
nda@efsa.europa.eu
No abstract available
Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to Lactobacillus rhamnosus LB21 NCIMB 40564 and decreasing potentially pathogenic intestinal microorganisms, “digestive health”, and reduction of mutans streptococci in the oral cavity. The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders.
The food constituent that is the subject of the health claims is Lactobacillus rhamnosus LB21 NCIMB 40564. The Panel considers that Lactobacillus rhamnosus LB21 NCIMB 40564 is sufficiently characterised.
Decreasing potentially pathogenic intestinal microorganisms
The claimed effect is “intestinal flora”. The target population is assumed to be the general population. “Intestinal flora” is not sufficiently defined but 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, supporting a healthy intestinal flora. 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.
On the basis of the data presented, 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.
Digestive health
The claimed effect “digestive health” 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 the claim does not comply with the criteria laid down in Regulation (EC) No 1924/2006.
Reduction of mutans streptococci in the oral cavity
The claimed effect is “oral flora”. The target population is assumed to be 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.
On the basis of the data presented, 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.
Lactobacillus rhamnosus LB21 NCIMB 40564, potentially pathogenic microorganisms, digestive health, mutans streptococci, oral cavity, health claims.
