Scientific Opinion on the substantiation of health claims related to Lactobacillus casei DG CNCM I-1572 and decreasing potentially pathogenic gastro intestinal microorganisms (ID 2949, 3061, further assessment) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2012;10(6):2723 [15 pp.].
doi
10.2903/j.efsa.2012.2723
Panel members at the time of adoption
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
Acknowledgements

The Panel wishes to thank the members of the Working Group on Claims for the preparatory work on this scientific opinion: 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.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2012-00182
EFSA-Q-2012-00211
Adopted
26 April 2012
Published
5 June 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

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 in the framework of further assessment related to Lactobacillus casei DG CNCM I-1572 and decreasing potentially pathogenic gastro-intestinal microorganisms. The food constituent that is the subject of the health claim, Lactobacillus casei DG CNCM I-1572, is sufficiently characterised. The claimed effect, decreasing potentially pathogenic gastro-intestinal microorganisms, might be a beneficial physiological effect. The proposed target population is the general population. No human studies were provided from which conclusions could be drawn for the scientific substantiation of the claim. 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 casei DG CNCM I-1572 and decreasing potentially pathogenic gastro‑intestinal microorganisms.

Summary

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. The Commission has agreed with EU Member States that a certain number of Article 13 health claims would be eligible for further assessment by EFSA in order to be able to take a final decision on whether or not to include these claims in the list of permitted health claims. This opinion addresses the scientific substantiation of a health claim in relation to Lactobacillus casei DG CNCM I-1572 and decreasing potentially pathogenic gastro-intestinal microorganisms. The scientific substantiation is based on the information provided by the competent Authority of Italy for further assessment of this claim.

The food constituent that is the subject of the health claim is Lactobacillus casei DG CNCM I-1572. The Panel considers that Lactobacillus casei DG CNCM I-1572 is sufficiently characterised.

The claimed effects, which are proposed for further assessment, relate to “contributes to the rebalancing of intestinal microflora” and “reducing the content of potentially pathogenic microorganism”. The proposed target population is the general population. The Panel considers that decreasing potentially pathogenic gastro-intestinal microorganisms might be a beneficial physiological effect.

Four human intervention studies provided did not assess outcomes related to decreasing potentially pathogenic gastro-intestinal microorganisms. The Panel notes that no conclusions can be drawn from these studies for the scientific substantiation of the claim.

One human intervention study investigated the effect of Lactobacillus casei added as co-adjuvant to quadruple therapy for Helicobacter pylori eradication. The Panel notes that no evidence was provided that results obtained in patients with Helicobacter pylori infection under antibiotics with respect to the treatment of the disease can be extrapolated to healthy subjects with respect to the development of Helicobacter pylori infection. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of a claim on defence against pathogenic gastro-intestinal microorganisms targeted to the general population (i.e. subjects without infections).

The Panel notes that no human studies were provided from which conclusions could be drawn for the scientific substantiation of the claim.

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 casei DG CNCM I-1572 and decreasing potentially pathogenic gastro‑intestinal microorganisms.

Keywords
Lactobacillus casei, DG CNCM I-1572, gastro-intestinal, microorganisms, health claims
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Number of Pages
15