ID 2949 - Lactobacillus casei DG CNCM I-1572

PL: Lactobacillus casei DG CNCM I-1572
EN: Lactobacillus casei LC 01(CNCM I-1572)
Pdf: Lactobacillus casei DG CNCM I-1572

1. Charakterystyka żywności / składnika

Introduction on the process used for characterisation of food constituents that are microorganisms: Microorganisms or microbes (e.g. bacteria) are living organisms, and can change over time depending on culture conditions. Correct identification of the microorganism‟s species and strain is of critical importance, as the observed effects are species and strain specific. The appropriate classification, identification and nomenclature of microorganisms constitute the starting point for the assessment of microbial properties. Classification assigns an organism to a known taxonomic group according to its similarity to that group. This allows the prediction of the properties of the microorganism on the basis of what is already known about the taxa. A reliable identification confirms the identity of the strain(s) used in a given process and requires the use of appropriate methods. Traditional phenotypic identification of bacteria is not always reliable since certain species cannot be distinguished by these methods. Molecular techniques have emerged in recent years as a replacement or complement to traditional phenotypic tests. DNA-DNA hybridization has become the generally accepted standard for determination of bacterial species identification. However this technique is difficult to perform and requires an expertise not normally present in the food industry. For these reasons phylogenetically based approaches such as sequence analysis of the 16S rRNA gene has proven to be a useful tool for bacterial identification. The EU-funded PROSAFE project concluded that biochemical tests should not be used as a stand-alone approach for identification of bacterial cultures (Vankerckhoven et al., 2008). The use of 16S rRNA gene sequence analysis was considered the best tool for routine species identification. Moreover, the use of sequence-based methods, such as 16S rRNA gene sequencing, was encouraged given their high reproducibility and data exchangeability (Vankerckhoven et al., 2008). The FAO/WHO expert group (FAO, 2006) recommends that phenotypic tests should be done first, followed by genetic identification, using methods such as DNA-DNA hybridization or 16S rRNA sequence analysis. Nevertheless, it is important to underline that in some cases 16S rRNA sequencing has a limited resolution and it may not be enough for discrimination of closely related species (Felis and Dellaglio, 2007; Vankerckhoven et al., 2008) being necessary to use other methods.
For the strain identification (characterisation of the strain by genetic typing), the FAO/WHO working group also recommended that strain typing has to be performed with a reproducible genetic method or using a unique phenotypic trait (FAO, 2006). DNA macrorestriction followed by Pulsed Field Gel Electrophoresis (PFGE) is considered as the generally accepted standard (FAO, 2006) and it has been extensively used for differentiating commercial microorganism strains. Other discriminatory molecular methods, such as Randomly Amplified Polymorphic DNA (RAPD) or Amplified rDNA restriction analysis (ARDRA) among others, are also available for strain characterisation. Hence, species identification and sufficient characterisation (genetic typing) at strain level by using internationally accepted molecular methods is needed. In addition, strains should be named according to the International Code of Nomenclature. Although there is no direct requirement on deposition of the particular strain in an internationally recognised culture collection, the FAO/WHO (FAO, 2006) recommends that strains should also be deposited in an internationally recognised culture collection (with access number). These will assure the tracking and access of scientists and regulatory authorities to the strain and related information in case it is needed. In the context of the Regulation (EC) nº 1924/2006, the purposes of characterisation are to confirm the identity of the food/constituent that is the subject of the health claim, and to establish that the studies provided for substantiation of the health claim were performed with the food/constituent in respect of which the health claim is made. Although not required for substantiation of a claim, characterisation should also be sufficient to allow control authorities to verify that the food/constituent which bears a health claim is the same one that was the subject of a community authorisation. The Panel has decided to use the following criteria for characterisation of food constituents that are microorganisms, which are the subject of health claims:
 Species identification by DNA-DNA hybridization or 16S rRNA sequence analysis.
 Strain identification by DNA macrorestriction followed by PFGE, RAPD, ARDRA or other internationally accepted genetic typing molecular methods.
Only when these two criteria were fulfilled, the microorganism was considered to be sufficiently characterised. In case of combination of several microorganisms, the Panel considers that if one microorganism used in the combination is not sufficiently characterised, the combination proposed is not sufficiently characterised. The characterisation of food constituents that are microorganisms, which are the subject of health claims pursuant to Article 13 of the Regulation (EC) nº 1924/2006, is based on evaluation of available references up to 31 December 2008, including the following:
 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;
 Generally available data obtained by searching PubMed and Web of Science databases by using the strain name as search term.

1.96. Characterisation of “Lactobacillus casei CNCM I-1572 DG” (ID 2949)

The food constituent that is the subject of the health claim is Lactobacillus casei CNCM I-1572 DG. The only information found in the references provided regarding the identification of the strain Lactobacillus casei CNCM I-1572 DG, also known as Lactobacillus casei DG, related to the use of phenotypic tests (API 50CH) (Drago et al., 2002). No other information was found in the studies provided or in the literature. The Panel considers that Lactobacillus casei CNCM I-1572 DG, which is the subject of the health claim ID 2949, is not sufficiently characterised. A culture collection number from the Collection Nationale de Cultures de Microorganismes (CNCM) is provided. CNCM is a restricted-access non-public collection which has the status of International Depositary Authority under the Budapest Treaty.

2. Znaczenie oświadczenia dla zdrowia człowieka

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

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.

Warunki i możliwe ograniczenia stosowania oświadczenia

at least 10x109 cfu/day