ID 942 - Yeo Valley yoghurt products containing the probiotic bacteria Bifidobacterium animalis ssp. lactis BB-12 ® and Lactobacillus acidophilus LA-5 ®

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EN: Yeo Valley yoghurt products containing the probiotic bacteria Bifidobacterium animalis ssp. lactis BB-12 ® and Lactobacillus acidophilus LA-5 ®
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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.

1.40. Characterisation of a combination of “Bifidobacterium animalis ssp. lactis Bb-12 and Lactobacillus acidophilus LA-5” (ID 942)

The food constituent that is the subject of the health claim is of a combination of “Bifidobacterium animalis ssp. lactis Bb-12 and Lactobacillus acidophilus LA-5”. Bifidobacterium animalis ssp. lactis Bb-12 (hereafter B. animalis ssp. lactis Bb-12) - The strain B. animalis ssp. lactis Bb-12, previously known as B. lactis Bb-12 is subjected to reclassification (Masco et al., 2004). The species identity as well as the strain identity and characteristics have been determined using different genotypic methods (Yimin et al., Unpublished; Garrigues et al., 2005; Mayer et al., 2007; Ventura et al., 2001a). It is important to point out that it may not be possible to differentiate commercially available B. animalis ssp. lactis strains from each other on the basis of traditional genetic methods (e.g. PFGE) (Engel et al., 2003; Gueimonde et al., 2004) and may be necessary to use multi-locus sequencing or genome-wide approaches. To this regard the genome of B. animalis ssp. lactis Bb-12 although sequenced (Yimin et al., unpublished) is not publicly available at the databases. The Panel considers that B. animalis ssp. lactis Bb-12, which is the subject of the health claim ID 942, is sufficiently characterised. A culture collection number for the strain referencing to the deposit of the strain at the German culture collection DSMZ under number DSM 15954 was found in the literature (Kajander et al., 2008). In addition several authors consider the strain Bb-12 to be also equal to the strain DSMZ 10140 (Ventura et al., 2001b). This is due to the fact that although the strain owner did not deposit the strain under Bb-12 name, strain DSMZ 10140 was isolated from a yoghurt containing Bb-12 and deposited by Meile et al. (1997). Lactobacillus acidophilus LA-5 - The identification/characterisation of the strain Lactobacillus acidophilus LA-5 is not included in the studies used as reference material. No genotypic information regarding identification/characterisation of the strain was found in the literature, only some limited information regarding phenotypic tests was found (Nighswonger et al., 1996). The Panel considers that Lactobacillus acidophilus LA-5, which is the subject of the health claim ID 942, 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. The Panel considers that the combination of “Bifidobacterium animalis ssp. lactis Bb-12 and Lactobacillus acidophilus LA-5”, which is the subject of the health claim ID 942, is not sufficiently characterised.

Warunki i możliwe ograniczenia stosowania oświadczenia

Consumption of a minimum 1 x 10e9 cfu of BB-12® and LA-5® per day