ID 2972 - Lactobacillus paracasei I1688, Lactobacillus salivarius I1794 (PSMIX®)

PL: Lactobacillus paracasei I1688, Lactobacillus salivarius I1794 (PSMIX®)
EN: PSMIX® (Lactobacillus paracasei I1688 and Lactobacillus salivarius I1794)
Pdf: a combination of Lactobacillus paracasei CNCM I-1688

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.

1.104. Characterisation of a combination of “Lactobacillus paracasei I1688, Lactobacillus salivarius I1794” (ID 2972, 2973)

The food constituent that is the subject of the health claim is a combination of “Lactobacillus paracasei I1688, Lactobacillus salivarius I1794”. Lactobacillus paracasei I1688 - Information on the strain identification/characterisation by sugar fermentation and plasmidic profile of the strain was found in the references provided (Pedraglio, 2004; Morelli, 1996). RAPD and ARDRA for this strain were also performed in a study (Bonetti et al., 2002). No other information regarding the identification/characterisation of the strain Lactobacillus paracasei I1688 was found in the literature. The Panel considers that Lactobacillus paracasei I1688, which is the subject of the health claims ID 2972, 2973, is not sufficiently characterised. According to a patent cited in the references provided as reference the strains is deposited at the Collection Nationale de Cultures de Microorganismes (CNCM), as Lactobacillus paracasei CNCM I-1688 (Pedraglio, 2004). The CNCM is a restricted-access non-public collection which has the status of International Depositary Authority under the Budapest Treaty. Lactobacillus salivarius I1794 - Information on the strain identification/characterisation by sugar fermentation and plasmidic profile of the strain was found in the references provided (Pedraglio, 2004; Morelli, 1996). RAPD and ARDRA for this strain were also performed in a study (Bonetti et al., 2002). No other information regarding the identification/characterisation of the strain Lactobacillus salivarius I1794 was found in the literature. The Panel considers that Lactobacillus salivarius I1794, which is the subject of the health claims ID 2972, 2973, is not sufficiently characterised.
According to a patent cited in the references provided as reference the strains is deposited at the Collection Nationale de Cultures de Microorganismes (CNCM), as Lactobacillus salivarius CNCM I-1794 (Pedraglio, 2004). The CNCM is a restricted-access non-public collection which has the status of International Depositary Authority under the Budapest Treaty. The Panel considers that the combination of “Lactobacillus paracasei I1688, Lactobacillus salivarius I1794”, which is the subject of the health claims ID 2972, 2973, is not sufficiently characterised.

2.1. Zmniejszenie dolegliwości ze strony przewodu pokarmowego (ID 2972)

The claimed effect which is proposed for further assessment is: “Is a probiotic; Contributes to a healthy digestive system by supporting the gut flora through an increased number of positive lactobacillus in the intestine; useful to maintain a healthy intestinal flora by adhering to the mucosa; Improves intestinal barrier function by competing (steric encumbrance) against pathogens; Reduces
gastro-intestinal discomfort; Necessary to maintain a healthy digestive system by production of specific enzymes (eg: beta-galactosidase)”. The proposed target population is the general population.
The Panel considers that reduction of gastro-intestinal discomfort is a beneficial physiological effect.

2.2. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego (ID 2972)

The claimed effect which is proposed for further assessment is: “Is a probiotic; Contributes to a healthy digestive system by supporting the gut flora through an increased number of positive lactobacillus in the intestine; useful to maintain a healthy intestinal flora by adhering to the mucosa; Improves intestinal barrier function by competing (steric encumbrance) against pathogens; Reduces gastro-intestinal discomfort; Necessary to maintain a healthy digestive system by production of specific enzymes (eg: beta-galactosidase)”. The proposed target population is the general population.
The Panel notes that it is not possible to define the exact number of the different microbial groups which constitute a normal/healthy microbiota. Increasing the number of any groups of microorganisms, including lactobacilli, is not in itself considered to be a beneficial physiological effect.
The Panel assumes that the claimed effect refers to decreasing potentially pathogenic gastro- intestinal microorganisms. The Panel considers that decreasing potentially pathogenic gastro- intestinal microorganisms might be a beneficial physiological effect.

2.3. Poprawa trawienia laktozy (ID 2972)

The claimed effect which is proposed for further assessment is: “Is a probiotic; Contributes to a healthy digestive system by supporting the gut flora through an increased number of positive lactobacillus in the intestine; useful to maintain a healthy intestinal flora by adhering to the mucosa; Improves intestinal barrier function by competing (steric encumbrance) against pathogens; Reduces gastro-intestinal discomfort; Necessary to maintain a healthy digestive system by production of specific enzymes (eg: beta-galactosidase)”. The proposed target population is the general population.
The Panel assumes that the claimed effect refers to improved lactose digestion, and that the target population is individuals with lactose maldigestion. Lactose maldigestion is a common condition caused by reduced levels of intestinal lactase.
The Panel considers that improved lactose digestion is a beneficial physiological effect for individuals with lactose maldigestion

3.1. Zmniejszenie dolegliwości ze strony przewodu pokarmowego (ID 2972)

The references provided in relation to this claim were related to methodologies for bacterial strain identification (Jensen et al., 1993; Ventura et al., 2000); patents for the use of two Lactobacillus strains (L. gasseri P-17632 and/or L. salivarius CNCM I-1794) other than the combination that is the subject of the claim against Candida albicans (Dondi, 2004, 2007); a patent on a method for the selection of Lactobacillus strains, including L. paracasei CNCM I-1688 and L. salivarius CNCM I-1794, indicated to be useful for the treatment of various disorders of the gastro-intestinal tract because of their capability to produce lactic acid (Pedraglio, 2004); and a human intervention study on the viability of the combination of the strains that is the subject of the claim through the human intestinal tract (Bonetti et al., 2002). The Panel notes that these studies did not address outcome measures related to the claimed effect, and considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
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 the combination of L. paracasei CNCM I-1688 and L. salivarius CNCM I-1794 and reduction of gastro-intestinal discomfort.

3.2. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego (ID 2972)

The references provided in relation to this claim were related to methodologies for bacterial strain identification (Jensen et al., 1993; Ventura et al., 2000); a patent on a method for the selection of Lactobacillus strains, including L. paracasei CNCM I-1688 and L. salivarius CNCM I-1794, indicated to be useful for the treatment of various disorders of the gastro-intestinal tract because of their capability to produce lactic acid (Pedraglio, 2004); and a human intervention study on the viability of the combination of the strains that is the subject of the claim through the human intestinal tract (Bonetti et al., 2002). The Panel notes that these studies did not address outcome measures related to the claimed effect, and considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
Two patents for the use of L. gasseri P-17632 and/or L. salivarius CNCM I-1794 against Candida albicans (Dondi, 2004, 2007) were also provided. The Panel notes that only one of the strains mentioned in the patents is part of the combination of strains that is the subject of the claim, and that no primary data were provided that could be used for the substantiation of the claim. The Panel considers that no conclusions can be drawn from these patents for the scientific substantiation of the claim.
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 the combination of L. paracasei CNCM I-1688 and L. salivarius CNCM I-1794 and decreasing potentially pathogenic gastro-intestinal microorganisms.

3.3. Poprawa trawienia laktozy (ID 2972)

The references provided in relation to this claim were related to methodologies for bacterial strain identification (Jensen et al., 1993; Ventura et al., 2000); patents for the use against Candida albicans of two Lactobacillus strains (Lactobacillus gasseri P-17632 and/or L. salivarius CNCM I-1794) other than the combination that is the subject of the claim (Dondi, 2004, 2007); a patent on a method for the selection of Lactobacillus strains, including L. paracasei CNCM I-1688 and L. salivarius CNCM I-1794, indicated to be useful for the treatment of various disorders of the gastro-intestinal tract because of their capability to produce lactic acid (Pedraglio, 2004); and a human intervention study on the viability of the combination of the strains hat is the subject of the claim through the human intestinal tract (Bonetti et al., 2002). The Panel notes that these studies did not address outcome measures related to the claimed effect, and considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
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 a combination of L. paracasei CNCM I-1688 and L. salivarius CNCM I-1794 and improved lactose digestion.

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