ID 972 - Bifidobacterium pseudolongum ssp pseudolongum THT 010501

PL: Bifidobacterium pseudolongum ssp pseudolongum THT 010501
EN: Bifidobacterium pseudolongum ssp pseudolongum THT 010501
Pdf: various microorganisms

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.

1.4. Bifidobacterium pseudolongum subsp. pseudolongum THT 010501 (ID 971, 972)

The food constituent that is the subject of the proposed health claims is Bifidobacterium pseudolongum subsp. pseudolongum THT 010501.
The strain B. pseudolongum subsp. pseudolongum THT 010501 is the trade name for B. pseudolongum subsp. pseudolongum LMG 11571, which is the type strain of B. pseudolongum subsp. pseudolongum. Culture collection numbers from different internationally recognised culture collections (e.g. LMG 11571, ATCC 25526, DSM 20099) were provided. Data on the identification and characterisation of B. pseudolongum subsp. pseudolongum THT 010501 at species and strain level, by using different genotypic (16S rRNA gene sequence analysis, 16S/23S intergenic spacer region sequence analysis, Hsp60 sequence analysis, Rep-PCR, MLST) methods, were provided (Jian et al., 2001; Leblond- Bourget et al., 1996; Masco et al., 2003; Ventura et al., 2006).
The Panel considers that the food constituent that is the subject of the proposed health claims, B. pseudolongum subsp. pseudolongum THT 010501, is sufficiently characterised.

1.49. Characterisation of “Bifidobacterium pseudolongum ssp pseudolongum THT 010501” (ID 971, 972)

The food constituent that is the subject of the health claim is Bifidobacterium pseudolongum ssp pseudolongum THT 010501. No information regarding the identification/characterisation of the strain Bifidobacterium pseudolongum ssp. pseudolongum THT 010501 was found in the literature. The Panel considers that Bifidobacterium pseudolongum ssp. pseudolongum THT 010501, which is the subject of the health claims ID 971, 972, is not sufficiently characterised. No indication of the deposit of the strain in an internationally recognised culture collection was found in the information provided or the literature.

2.3. Stymulacja odpowiedzi immunologicznej (ID 962, 968, 970, 972, 976, 984, 986, 995, 997, 999, 1007, 1015)

The claimed effect, which is proposed for further assessment, is: “A lot of study is shown an impact of bacteria on immune system. They improve, for example, the immune function by induction of various molecules and by modification of activity of some cells. The bacteria modulate also the natural defences. Indeed, they stimulate the natural defence by their presence or by production of some compounds”. The proposed target population is the general population.
The Panel notes that the claimed effect “modulation of the natural defences” is not sufficiently defined, and assumes that the claimed effect relates to the stimulation of various immunological responses. The Panel notes that stimulation of various immunological responses is not a beneficial physiological effect per se but needs to be linked to a beneficial physiological or clinical outcome.
No human studies which investigated the effect of the food constituent on any aspect of the immune system were provided in relation to any of the claims evaluated in this section.
Most of the references provided were on strains or combination of strains other than those which are the subject of the claims.
For ID 972, one in vitro study on the specific strain that is the subject of the claim, which investigated a health outcome (i.e. inhibitory effect of the strain on the adhesion of Escherichia coli O157:H7 to a
human epithelial cell line) (Gagnon et al., 2004) unrelated to the claimed effect evaluated in this section, was provided.
For ID 976, one study in animals which investigated the effects of the specific strain that is the subject of the claim on antibody production (IgG and IgM) after oral immunisation with recombinant tetanus toxin fragment C (Plant and Conway, 2002), and one in vitro study on the activation pattern of dendritic cells and the impact on T cell-dependent cytokine production from healthy and allergic donors (Ratajczak et al., 2007), were provided.
For ID 999, one in vitro study which investigated the effect of the specific strain that is the subject of the claim on the induction of cytokine secretion from splenic mononuclear cells isolated from mice (Matsuguchi et al., 2003) was provided.
The Panel considers that the evidence provided does not establish that stimulation of these immunological responses is a beneficial physiological effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the food constituents, which are the subject of the claims evaluated in this section, and a beneficial physiological effect related to stimulation of immunological responses.

Warunki i możliwe ograniczenia stosowania oświadczenia

At least 108 CFU/day