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[sup]1[/sup]
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3
European Food Safety Authority (EFSA), Parma, Italy
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.
© European Food Safety Authority, 2012
Słowa kluczowe:
DG CNCM I-1572
Lactobacillus casei
gastro-intestinal
health claims
microorganisms
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claims is Lactobacillus casei DG CNCM I-1572 (hereafter L. casei DG CNCM I-1572).
A culture collection number from the Collection Nationale de Cultures de Microorganismes (CNCM I-1572) was provided. The CNCM is a restricted-access non-public collection which has the status of an International Depositary Authority under the Budapest Treaty. Data on the identification and characterisation of L. casei DG CNCM I-1572 at species and strain level using both phenotypic (cell morphology, carbohydrate fermentation pattern) and genotypic (16S/23S rRNA intergenic spacer region sequence analysis and ribotyping) methods were provided in the application.
The Panel considers that the food constituent, Lactobacillus casei DG CNCM I-1572, which is the subject of the health claim, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
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Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego
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.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego
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Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego
The references provided comprised five human intervention studies. One study evaluated L. casei DG CNCM I-1572 recovery in faeces after oral administration (Drago et al., 2002). In two studies, the effectiveness of L. casei DG CNCM I-1572, taken together with mesalazine, in preventing recurrence of symptomatic diverticular disease of the colon was investigated (Tursi et al., 2006; 2008) and in another study, D’Incà et al. (2011) evaluated the effect of three types of intervention (oral 5-
aminosalicylic acid (5-ASA) alone, oral 5-ASA+L. casei DG, and oral 5-ASA+rectal L. casei DG) on intestinal microbiota adhering to the sigmoid colon mucosa, on the intestinal mucosal cytokines level, and on toll-like receptor expression in a group of 26 patients with ulcerative colitis. In these studies, no outcomes on reduction of gastro-intestinal pathogens were reported. The Panel considers that no conclusions can be drawn from these studies for the scientific substantiation of the claim.
Tursi et al. (2004) studied the effect of L. casei DG CNCM I-1572 added to quadruple therapy (proton-pump inhibitor + ranitidine bismuth citrate + amoxycillin + tinidazole given for 10 days) vs. quadruple therapy alone as co-adjuvant therapy for Helicobacter pylori eradication. The Panel notes that no evidence was provided that results obtained in patients with H. pylori infection under antibiotics with respect to the treatment of the disease can be extrapolated to healthy subjects with respect to the development of H. 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.
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.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, Lactobacillus casei DG CNCM I-1572, which is the subject of the health claims, is sufficiently characterised.
The claimed effects proposed for further assessment relate to “contributes to the rebalancing of intestinal microflora” and to “reducing the content of potentially pathogenic microorganism”. The proposed target population is the general population. Decreasing potentially pathogenic gastro-intestinal microorganisms might be a beneficial physiological effect.
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.
