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.

1.95. Characterisation of a combination of “Lactobacillus acidophilus, Bifidobacterium (BB46), Bifidobacterium (BB02), Bifidobacterium breve Bbr8 (LMG P-17501), Lactobacillus rhamnosus ATCC53103 (LGG), Lactobacillus casei 101/37 (LMG P-17504), Lactobacillus delbrueckii ssp. bulgaricus AY/CSL (LMG P-17224)” (ID 2948)

The food constituent that is the subject of the health claim is a combination of “Lactobacillus acidophilus, Bifidobacterium (BB46), Bifidobacterium (BB02), Bifidobacterium breve Bbr8 (LMG P-17501), Lactobacillus rhamnosus ATCC53103 (LGG), Lactobacillus casei 101/37 (LMG P-17504), Lactobacillus delbrueckii ssp. bulgaricus AY/CSL (LMG P-17224)”. Lactobacillus acidophilus - No strain identification or name is provided. The Panel considers that Lactobacillus acidophilus, which is the subject of the health claim ID 2948, is not sufficiently characterised.
Bifidobacterium (BB46) - No species name is provided. The Panel considers that Bifidobacterium (BB46), which is the subject of the health claim ID 2948, is not sufficiently characterised. Bifidobacterium (BB02) - No species name is provided. The Panel considers that Bifidobacterium (BB02), which is the subject of the health claim ID 2948, is not sufficiently characterised. Bifidobacterium breve Bbr8 (LMG P-17501) - The only information found on identification/characterisation of the strain regarded identification by PCR (Bianchi et al., 2004); no other information regarding identification/characterisation was found in the literature. The Panel considers that Bifidobacterium breve Bbr8 (LMG P-17501), which is the subject of the health claim ID 2948, is not sufficiently characterised. A culture collection number from the LMG culture collection is provided. LMG is a non-public International Depositary Authority under the Budapest Treaty. Lactobacillus rhamnosus ATCC53103 (LGG) - The strain Lactobacillus rhamnosus GG species identity as well as the strain identity and characteristics have been clearly established by using both phenotypic and genotypic methods (Tynkkynen et al., 1999; Charteris et al., 2001; Janoir et al., unpublished). The Panel considers that Lactobacillus rhamnosus ATCC53103 (LGG), which is the subject of the health claim ID 2948, is sufficiently characterised. This strain is deposited in a recognised international culture collection (ATCC under nº 53103, also available at LMG under nº 18243). Lactobacillus casei 101/37 (LMG P-17504) - The identification/characterisation of the strain Lactobacillus casei 101/37 is not reported in the references provided and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus casei 101/37 (LMG P-17504), which is the subject of the health claim ID 2948, is not sufficiently characterised. A culture collection number from the LMG culture collection is provided. In the LMG, which is a non-public International Depositary Authority under the Budapest Treaty, cultures can be deposited in a restricted-access collection as Patent deposits. Lactobacillus delbrueckii ssp. bulgaricus AY/CSL (LMG P-17224) - The only reference to the identification/characterisation of the strain Lactobacillus delbrueckii ssp. bulgaricus AY/CSL found in the studies provided as reference material is the identification by sugar fermentation profiles (Bianchi-Salvadori et al., 1984). No other information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus delbrueckii ssp. bulgaricus AY/CSL (LMG P-17224), which is the subject of the health claim ID 2948, is not sufficiently characterised. A culture collection number from the LMG culture collection is provided. In the LMG, which is a non-public International Depositary Authority under the Budapest Treaty, cultures can be deposited in a restricted-access collection as Patent deposits. The Panel considers that the combination of “Lactobacillus acidophilus, Bifidobacterium (BB46), Bifidobacterium (BB02), Bifidobacterium breve Bbr8 (LMG P-17501), Lactobacillus rhamnosus ATCC53103 (LGG), Lactobacillus casei 101/37 (LMG P-17504), Lactobacillus delbrueckii ssp. bulgaricus AY/CSL (LMG P-17224)”, which is the subject of the health claim ID 2948, is no sufficiently characterised.

Oświadczenia zdrowotne

ID 2948 - Lactobacillus acidophilus, Bifidobacterium (BB46); Bifidobacterium (BB02),Bifidobacterium Breve(Bbr8 LMG P-17501)CSL, Lactobacillus Rhamnosus ATC C53103 (LGG), Lactobacillus casei 101/37(Img P-17504), Lactobacillus delbruekii spp bulgaricus AY/CSL (LMG P1

1. Charakterystyka żywności / składnika

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