ID 2952 - Lactobacillus delbrueckii P 18805

PL: Lactobacillus delbrueckii P 18805
EN: Lactobacillus delbrueckii P 18805
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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.

1.97. Characterisation of “Lactobacillus delbrueckii P 18805” (ID 2951, 2952)

The food constituent that is the subject of the health claim is Lactobacillus delbrueckii P 18805. The phenotypic identification of the strain is reported in the references provided (Dondi, 2000; BCCM/LMG Report 04/02/99). However no other information regarding the strain identification/characterisation was found in the literature. The Panel considers that Lactobacillus delbrueckii P 18805, which is the subject of the health claims ID 2951, 2952, is not sufficiently characterised. According to the patent application by Dondi (Dondi, 2000) the strain is deposited at the LMG under nº LMG P-18805. 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.

2.4. Zmniejszenie ilości krążących we krwi komórek CD34+ (ID 2947, 2952, 2975)

The claimed effect, which is proposed for further assessment, is: “Increases the immune defences/response by reducing the CD34+ cells; Necessary to maintain the natural defences/helps to maintain a balanced immune system (reducing the CD34+ cells)”. The proposed target population is the general population.
The Panel notes that the claimed effect, “increases the immune defences/necessary to maintain the natural defences/maintain a balanced immune system”, is not sufficiently defined and assumes that the claimed effect relates to the reduction in numbers of circulating CD34+ cells.
The Panel notes that reduction in numbers of circulating CD34+ cells is not a beneficial physiological effect per se, but needs to be linked to a beneficial physiological or clinical outcome.
Most of the references provided in relation to the claim were on methodologies for bacterial strain identification. One open-label, non-randomised and non-controlled human study (Mastrandrea et al., 2004) investigated the effects of a combination of L. acidophilus P-18806, L. delbrueckii P-18805 and S. thermophilus P-18807 on the numbers of circulating CD34+ human progenitor cells in 14 subjects with atopic disorders (clinical symptoms of asthma and/or conjunctivitis, rhinitis, urticaria, atopic dermatitis, food allergy) and/or irritable bowel syndrome.
The Panel considers that the evidence provided does not establish that reduction in numbers of circulating CD34+ cells is a beneficial physiological effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of a combination of L. acidophilus BCCM/LMG P-18806, L. delbrueckii BCCM/LMG P-18805 and S. thermophilus BCCM/LMG P-18807 and a beneficial physiological effect related to reduction in numbers of circulating CD34+ cells.

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