1. Charakterystyka żywności / składnika

Introduction on the process used for characterisation of food constituents that are bacteria and yeasts:
Correct identification of the bacterium's and yeast's species and strain is of critical importance, as the observed effects in the host 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 a microorganism to a known taxonomic group according to its similarity to that group. This classification allows the prediction of the general properties of the microorganism on the basis of what is already known about the taxon. A reliable identification confirms the identity of the strain(s) used in a given process and requires the use of appropriate methods.
Bacteria - Traditional phenotypic identification of bacteria is not always reliable as certain species cannot be distinguished by these methods. Molecular techniques have emerged as a replacement or complement to traditional phenotypic tests in recent years. DNA-DNA hybridisation has become the generally accepted standard for determination of bacterial species identification. Phylogenetic approaches based on sequence analysis of the 16S rRNA gene have also 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., 2008b). 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., 2008a). The FAO/WHO expert group (FAO/WHO, 2006) recommends that phenotypic tests should be done first, followed by genetic identification, using methods such as DNA-DNA hybridisation or 16S rRNA gene sequence analysis. Nevertheless, it is important to underline that in some cases 16S rRNA gene sequencing has a limited resolution and it may not be enough for discriminating closely related species (Felis and Dellaglio, 2007; Vankerckhoven et al., 2008a) making it 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. DNA macrorestriction followed by Pulsed Field Gel Electrophoresis (PFGE) is considered as the generally accepted standard (FAO/WHO, 2006) and it has been extensively used for differentiating
4 Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. OJ L 404, 30.12.2006, p. 9–25.
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commercial microorganism strains. Other discriminatory molecular methods, such as Randomly Amplified Polymorphic DNA (RAPD) among others, are also available for strain characterisation.
Yeasts - Traditional phenotypic characterisation of yeasts is not always reliable for species and strain identification. Currently, the available molecular techniques complement and replace traditional phenotypic tests for this purpose, because they have higher discrimination power and are independent of growth conditions. Strains of the species Saccharomyces cerevisiae are widely distributed in nature and used for different food fermentation processes (wine, beer, cider, bread, etc.) (Moreno-Arribas et al., 2005; Coton et al., 2006; Legras et al., 2007). This species can also be a saprophytic coloniser of human mucosal surfaces and has been isolated from the digestive tract, vagina, skin and oropharynx of healthy individuals (Aucott et al., 1990). Although the taxonomic designation of Saccharomyces cerevisiae var boulardii to the species Saccharomyces cerevisiae is controversial, currently the former is not accepted as a distinct species (Mitterdorfer et al., 2002).
Some of the most useful molecular methods to identify yeasts are based on the spacer regions between the highly conserved rRNA genes (rDNA). The spacer regions between the rDNA subunits (internal transcribed spacer; ITS) and between the repeats (non-transcribed spacer; NTS) are highly variable between and within species, which allows their use for taxonomy purposes with different discrimination power (Baleiras Couto et al., 1996). One of the widely accepted techniques used for the adscription of yeasts to the species Saccharomyces cerevisiae is the restriction fragment length polymorphisms (RFLP) analysis of the PCR products of the 5.8S-ITS region (Mitterdorfer et al., 2002; De Llanos et al., 2004, 2006). Other alternative molecular techniques used for identification of yeast species is the sequence analysis of the D1 and D2 domains of 26S rDNA (Kurtzman and Robnett, 1998; Coton et al., 2006) and rDNA spacer regions (Posteraro et al., 2005).
For identification of strains, diverse molecular typing techniques are available, including chromosome length polymorphism analysis by PFGE, RAPD, and microsatellite DNA polymorphism analysis (Mitterdorfer et al., 2002; van der Aa Kühle et al., 2005; Posteraro et al., 2005).
Hence, species identification and sufficient characterisation (genetic typing) at strain level of the bacteria/yeasts 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/WHO, 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 bacteria, which are the subject of health claims:
 Species identification by DNA-DNA hybridisation or 16S rRNA gene sequence analysis.
 Strain identification by DNA macrorestriction followed by PFGE, RAPD, or other internationally accepted genetic typing molecular methods.
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Only when these two criteria were fulfilled, the bacterium was considered to be sufficiently characterised.
The Panel has decided to use the following criteria for characterisation of food constituents that are yeasts, which are the subject of health claims:
 Species identification of by restriction fragment length polymorphism analysis (RFLP) (e.g. RFLP of PCR products the 5.8S rDNA internal transcribe spacer [ITS] region) or by sequencing analysis of DNA taxonomic markers (e.g. the D1 and D2 domains of 26S rDNA or ITS regions).
 Strains identification by chromosome length polymorphism (PFGE), RAPDs, microsatellite DNA polymorphism analysis or other internationally accepted genetic typing molecular techniques.
Only when these two criteria were fulfilled, the yeast was considered to be sufficiently characterised.
In the case of combination of several bacteria and/or yeasts, 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 bacteria and yeasts, 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.

1.1. Characterisation of “Bifidobacterium breve BR 03 (DSM 16604)” (ID 2936)

The food constituent that is the subject of the health claim is Bifidobacterium breve BR 03 (DSM 16604). A culture collection number from the DSMZ (DSM 16604) is provided. In the DSMZ, 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 identification/characterisation of the strain Bifidobacterium breve BR 03 is not included in the studies provided as reference material and no information was found in the literature. The Panel considers that Bifidobacterium breve BR 03 (DSM 16604), which is the subject of the health claim ID 2936, is not sufficiently characterised.

1.2. Characterisation of “Bifidobacterium breve BL 03 (DSM 16603)” (ID 2937)

The food constituent that is the subject of the health claim is Bifidobacterium breve BL 03 (DSM 16603). A culture collection number from the DSMZ (DSM 16603) is provided. In the DSMZ, 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 identification/characterisation of the strain Bifidobacterium breve BL 03 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Bifidobacterium breve BL 03 (DSM 16603), which is the subject of the health claim ID 2937, is not sufficiently characterised.
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1.3. Characterisation of a combination of “Bifidobacterium breve BR 03 (DSM 16604) and Lactobacillus plantarum LP 01 (LMG P-21021)” (ID 2938)

The food constituent that is the subject of the health claim is a combination of “Bifidobacterium breve BR 03 (DSM 16604) and Lactobacillus plantarum LP 01 (LMG P-21021)”. For Bifidobacterium breve BR 03 (DSM 16604), a culture collection number from the DSMZ (DSM 16604) is provided. In the DSMZ, which is a non-public International Depositary Authority under the Budapest Treaty, cultures can be deposited in a restricted-access collection as Patent deposits. For Lactobacillus plantarum LP 01 (LMG P-21021), 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.
Bifidobacterium breve BR 03 (DSM 16604) - The identification/characterisation of the strain Bifidobacterium breve BR 03 is not included in the studies provided as reference material and no information was found in the literature. The Panel considers that Bifidobacterium breve BR 03 (DSM 16604) is not sufficiently characterised.
Lactobacillus plantarum LP 01 (LMG P-21021) - The identification/characterisation of the strain Lactobacillus plantarum LP 01 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus plantarum LP 01 (LMG P-21021) is not sufficiently characterised.
The Panel considers that the combination of “Bifidobacterium breve BR 03 (DSM 16604) and Lactobacillus plantarum LP 01 (LMG P-21021)”, which is the subject of the health claim ID 2938, is not sufficiently characterised.

1.4. Characterisation of a combination of “Bifidobacterium infantis Bi1 (LMG P-17502), Bifidobacterium breve Bbr8 (LMG P-17501) and Bifidobacterium longum Bl10 (LMG P-17500)” (ID 2939)

The food constituent that is the subject of the health claim is a combination of “Bifidobacterium infantis Bi1 (LMG P-17502), Bifidobacterium breve Bbr8 (LMG P-17501), and Bifidobacterium longum Bl10 (LMG P-17500)”. For Bifidobacterium infantis Bi1 (LMG P-17502), 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. For Bifidobacterium breve Bbr8 (LMG P-17501), 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. For Bifidobacterium longum Bl10 (LMG P-17500), 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.
Bifidobacterium infantis Bi1 (LMG P-17502) (hereafter B. infantis Bi1 (LMG P-17502)) - No information regarding the identification/characterisation of the strain B. infantis Bi1 (LMG P-17502) was provided. The only information found on identification/characterisation of the strain regarded identification by PCR (polymerase chain reaction) (Bianchi et al., 2004). No other information regarding identification/characterisation was found in the literature. The species B. infantis has been reclassified as subspecies of Bifidobacterium longum, Bifidobacterium longum ssp. infantis (Sakata et al., 2002). The Panel considers that Bifidobacterium infantis Bi1 (LMG P-17502) 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
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other information regarding identification/characterisation was found in the literature. The Panel considers that Bifidobacterium breve Bbr8 (LMG P-17501) is not sufficiently characterised.
Bifidobacterium longum Bl10 (LMG P-17500) - 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 longum B110 (LMG P-17500) is not sufficiently characterised.
The Panel considers that the combination of “Bifidobacterium infantis Bi1 (LMG P-17502), Bifidobacterium breve Bbr8 (LMG P-17501) and Bifidobacterium longum Bl10 (LMG P-17500)”, which is the subject of the health claim ID 2939, is not sufficiently characterised.

1.5. Characterisation of “Bifidobacterium lactis BS 01 (LMG P-21384)” (ID 2940)

The food constituent that is the subject of the health claim is Bifidobacterium lactis BS 01 (LMG P-21384). 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.
No information regarding the identification/characterisation of the strain Bifidobacterium lactis BS 01 (LMG P-21384) was found in the references provided or in the literature. The species Bifidobacterium lactis has been reclassified as Bifidobacterium animalis ssp. lactis (Masco et al., 2004). It is important to point out that it may not be possible to differentiate the commercially available Bifidobacterium 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 that it may be necessary to use multi-locus sequencing or genome-wide approaches. The Panel considers that Bifidobacterium lactis BS 01 (LMG P-21384), which is the subject of the health claim ID 2940, is not sufficiently characterised.

1.6. Characterisation of a combination of “Bifidobacterium lactis BS 01 (LMG P-21384), Lactobacillus rhamnosus LR 04 (DSM 16605) and Lactobacillus plantarum LP 02 (LMG P-21020)” (ID 2941)

The food constituent that is the subject of the health claim is a combination of “Bifidobacterium lactis BS 01 (LMG P-21384), Lactobacillus rhamnosus LR 04 (DSM 16605) and Lactobacillus plantarum LP 02 (LMG P-21020)”. For Bifidobacterium lactis BS 01 (LMG P-21384), 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. For Lactobacillus rhamnosus LR 04 (DSM 16605), a culture collection number from the DSMZ is provided. In the DSMZ, which is a non-public International Depositary Authority under the Budapest Treaty, cultures can be deposited in a restricted-access collection as Patent deposits. For Lactobacillus plantarum LP 02 (LMG P-21020), 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.
Bifidobacterium lactis BS 01 (LMG P-21384) - No information regarding the identification/characterisation of the strain Bifidobacterium lactis BS 01 (LMG P-21384) was found in the references provided or in the literature. The species Bifidobacterium lactis has been reclassified as Bifidobacterium animalis ssp. lactis (Masco et al., 2004). It is important to point out that it may not be possible to differentiate the commercially available Bifidobacterium 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 that it may be necessary to use multi-locus sequencing or genome-wide
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approaches. The Panel considers that Bifidobacterium lactis BS 01 (LMG P-21384) is not sufficiently characterised.
Lactobacillus rhamnosus LR 04 (DSM 16605) - The identification/characterisation of the strain Lactobacillus rhamnosus LR 04 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus rhamnosus LR 04 (DSM 16605) is not sufficiently characterised.
Lactobacillus plantarum LP 02 (LMG P-21020) - The identification/characterisation of the strain Lactobacillus plantarum LP 02 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus plantarum LP 02 (LMG P-21020) is not sufficiently characterised.
The Panel considers that the combination of “Bifidobacterium lactis BS 01 (LMG P-21384), Lactobacillus rhamnosus LR 04 (DSM 16605), and Lactobacillus plantarum LP 02 (LMG P-21020)”, which is the subject of the health claim ID 2941, is not sufficiently characterised.

1.7. Characterisation of a combination of “Lactobacillus acidophilus bar 13 (CNCM I-3857) and Bifidobacterium longum bar 33 (CNCM I-3858)” (ID 2942)

The food constituent that is the subject of the health claim is a combination of “Lactobacillus acidophilus bar 13 (CNCM I-3857) and Bifidobacterium longum bar 33 (CNCM I-3858)”. For Lactobacillus acidophilus bar 13 (CNCM I-3857), a culture collection number from the Collection Nationale de Cultures de Microorganismes (CNCM) is provided. The CNCM is a restricted-access non-public collection which has the status of International Depositary Authority under the Budapest Treaty. For Bifidobacterium longum bar 33 (CNCM I-3858), a culture collection number from the Collection Nationale de Cultures de Microorganismes (CNCM) is provided. The CNCM is a restricted-access non-public collection which has the status of International Depositary Authority under the Budapest Treaty.
Lactobacillus acidophilus bar 13 (CNCM I-3857) - No information regarding the identification/characterisation of the strain Lactobacillus acidophilus bar 13 CNCM I-3857 was found in the studies provided as reference material or in the literature. The Panel considers that Lactobacillus acidophilus bar 13 (CNCM I-3857) is not sufficiently characterised.
Bifidobacterium longum bar 33 (CNCM I-3858) - No information regarding the identification/characterisation of the strain Bifidobacterium longum bar 33 (CNCM I-3858) was found in the studies provided as reference material or the literature. The Panel considers that Bifidobacterium longum bar 33 (CNCM I-3857) is not sufficiently characterised.
The Panel considers that the combination of “Lactobacillus acidophilus bar 13 (CNCM I-3857) and Bifidobacterium longum bar 33 (CNCM I-3858)”, which is the subject of the health claim ID 2942, is not sufficiently characterised.

1.8. Characterisation of “Lactobacillus acidophilus K8 (LMG P-17503)” (ID 2943)

The food constituent that is the subject of the health claim is Lactobacillus acidophilus K8 (LMG P-17503). A culture collection number from the LMG culture collection is provided. LMG is a non-public International Depositary Authority under the Budapest Treaty.
The identification/characterisation of the strain Lactobacillus acidophilus K8 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus acidophilus K8 (LMG P-17503), which is the subject of the health claim ID 2943, is not sufficiently characterised.
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1.9. Characterisation of a combination of “Lactobacillus acidophilus LA 02 (LMG P-21381) and Lactobacillus plantarum LP 01 (LMG P-21021)” (ID 2944)

The food constituent that is the subject of the health claim is a combination of “Lactobacillus acidophilus LA 02 (LMG P-21381) and Lactobacillus plantarum LP 01 (LMG P-21021)”. For Lactobacillus acidophilus LA 02 (LMG P-21381), a culture collection number from the LMG culture collection is provided. LMG is a non-public International Depositary Authority under the Budapest Treaty. For Lactobacillus plantarum LP 01 (LMG P-21021), a culture collection number from the LMG culture collection is provided. LMG is a non-public International Depositary Authority under the Budapest Treaty.
Lactobacillus acidophilus LA 02 (LMG P-21381) - The identification/characterisation of the strain Lactobacillus acidophilus LA 02 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus acidophilus LA 02 (LMG P-21381) is not sufficiently characterised.
Lactobacillus plantarum LP 01 (LMG P-21021) - The identification/characterisation of the strain Lactobacillus plantarum LP 01 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus plantarum LP 01 (LMG P-21021) is not sufficiently characterised.
The Panel considers that the combination of “Lactobacillus acidophilus LA 02 (LMG P-21381) and Lactobacillus plantarum LP 01 (LMG P-21021)”, which is the subject of the health claim ID 2944, is not sufficiently characterised.

1.10. Characterisation of “Lactobacillus acidophilus LA1 (LMG P-21904)” (ID 2945)

The food constituent that is the subject of the health claim is Lactobacillus acidophilus LA1 (LMG P-21904). A culture collection number from the LMG culture collection is provided. LMG is a non-public International Depositary Authority under the Budapest Treaty.
The identification/characterisation of the strain Lactobacillus acidophilus LA1 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus acidophilus LA1 (LMG P-21904), which is the subject of the health claim ID 2945, is not sufficiently characterised.

1.11. Characterisation of “Lactobacillus paracasei I1687” (ID 2960, 2961)

The food constituent that is the subject of the health claim is Lactobacillus paracasei I1687. According to a patent the strains is deposited in the Collection Nationale de Cultures de Microorganismes (CNCM), as Lactobacillus paracasei CNCM I-1687 (Pedraglio et al., 2004). The CNCM is a restricted-access non-public collection which has the status of International Depositary Authority under the Budapest Treaty.
The only information on the strain identification/characterisation was the sugar fermentation profile of the strain included in the reference material provided (Pedraglio et al., 2004) and the plasmidic profile (Morelli, 1997). No other information regarding the identification/characterisation of the strain Lactobacillus paracasei I1687 was found in the literature. The Panel considers that Lactobacillus paracasei I1687, which is the subject of the health claims ID 2960 and 2961, is not sufficiently characterised.
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1.12. Characterisation of “Lactobacillus plantarum LP 01 (LMG P-21021)” (ID 2965)

The food constituent that is the subject of the health claim is Lactobacillus plantarum LP 01 (LMG P-21021). 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 identification/characterisation of the strain Lactobacillus plantarum LP 01 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus plantarum LP 01 (LMG P-21021), which is the subject of the health claim ID 2965, is not sufficiently characterised.

1.13. Characterisation of “Lactobacillus rhamnosus” (ID 2968)

The food constituent that is the subject of the health claim is Lactobacillus rhamnosus. No strain identification or name is provided. The Panel considers that Lactobacillus rhamnosus, which is the subject of the health claim ID 2968, is not sufficiently characterised.

1.14. Characterisation of “Lactobacillus rhamnosus LR 04 (DSM 16605)” (ID 2969)

The food constituent that is the subject of the health claim is Lactobacillus rhamnosus LR 04 (DSM 16605). A culture collection number from the DSMZ is provided. In the DSMZ, 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 identification/characterisation of the strain Lactobacillus rhamnosus LR 04 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus LR 04 (DSM 16605), which is the subject of the health claim ID 2969, is not sufficiently characterised.

1.15. Characterisation of “Streptococcus thermophilus P18807” (ID 2974, 2975)

The food constituent that is the subject of the health claim is Streptococcus thermophilus P18807. According to the patent application by Dondi (2008), the strain is deposited in the LMG under nº LMG P-18807. In the LMG, which is a non-public International Depositary Authority under the Budapest Treaty, cultures can also be deposited in a restricted-access collection as Patent deposits.
Reference to phenotypic identification of the strain (sugar fermentation and SDS-PAGE profiles) was found in the references provided (Dondi, 2008; BCCM/LMG, 1999). No other information regarding the identification/characterisation of the strain was found in the literature. The Panel considers that Streptococcus thermophilus P18807, which is the subject of the health claims ID 2974 and 2975, is not sufficiently characterised.

1.16. Characterisation of “Lactobacillus salivarius W24” (ID 2977, 2978, 2979, 2980)

The food constituent that is the subject of the health claim is Lactobacillus salivarius W24. No indication of the deposit of the strain in an internationally recognised culture collection was found in the information provided or the literature.
The identification/characterisation of the strain Lactobacillus salivarius W24 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus salivarius W24, witch is the subject of the health claims ID 2977, 2978, 2979, 2980, is not sufficiently characterised.
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1.17. Characterisation of “Lactobacillus casei W56” (ID 2981)

The food constituent that is the subject of the health claim is Lactobacillus casei W56. No indication of the deposit of the strain in an internationally recognised culture collection was found in the information provided or the literature.
The identification/characterisation of the strain Lactobacillus casei W56 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus casei W56, which is the subject of the health claim ID 2981 is not sufficiently characterised.

1.18. Characterisation of “Lactobacillus casei W58” (ID 2982)

The food constituent that is the subject of the health claim is Lactobacillus casei W58. No indication of the deposit of the strain in an internationally recognised culture collection was found in the information provided or the literature.
The identification/characterisation of the strain Lactobacillus casei W58 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus casei W58, which is the subject of the health claim ID 2982 is not sufficiently characterised.

1.19. Characterisation of “Lactobacillus casei W61” (ID 2983)

The food constituent that is the subject of the health claim is Lactobacillus casei W61. No indication of the deposit of the strain in an internationally recognised culture collection was found in the information provided or the literature.
The identification/characterisation of the strain Lactobacillus casei W61 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus casei W61, which is the subject of the health claim ID 2983, is not sufficiently characterised.

1.20. Characterisation of “Lactococcus lactis W58” (ID 2984)

The food constituent that is the subject of the health claim is Lactococcus lactis W58. No indication of the deposit of the strain in an internationally recognised culture collection was found in the information provided or the literature.
The identification/characterisation of the strain Lactococcus lactis W58 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactococcus lactis W58, which is the subject of the health claim ID 2984, is not sufficiently characterised.

1.21. Characterisation of “Lactococcus lactis W61” (ID 2985)

The food constituent that is the subject of the health claim is Lactococcus lactis W61. No indication of the deposit of the strain in an internationally recognised culture collection was found in the information provided or the literature.
The identification/characterisation of the strain Lactococcus lactis W61 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactococcus lactis W61, which is the subject of the health claim ID 2985, is not sufficiently characterised.
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1.22. Characterisation of “Lactococcus lactis W64” (ID 2986)

The food constituent that is the subject of the health claim is Lactococcus lactis W64. No indication of the deposit of the strain in an internationally recognised culture collection was found in the information provided or the literature.
The identification/characterisation of the strain Lactococcus lactis W64 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactococcus lactis W64, which is the subject of the health claim ID 2986, is not sufficiently characterised.

1.23. Characterisation of “Bifidobacterium lactis W52” (ID 2987, 2988, 2989, 2990)

The food constituent that is the subject of the health claim is Bifidobacterium lactis W52. No indication of the deposit of the strain in an internationally recognised culture collection was found in the information provided or the literature.
The identification/characterisation of the strain Bifidobacterium lactis W52, formerly known as Bifidobacterium infantis W52, is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The species Bifidobacterium lactis has been reclassified as Bifidobacterium animalis ssp. lactis (Masco et al., 2004). It is important to point out that it may not be possible to differentiate the commercially available Bifidobacterium 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 that it may be necessary to use multi-locus sequencing or genome-wide approaches. The Panel considers that Bifidobacterium lactis W52, which is the subject of the health claims ID 2987, 2988, 2989, 2990, is not sufficiently characterised.

1.24. Characterisation of “Bifidobacterium lactis Bi-07” (ID 2992, 2993, 3008)

The food constituent that is the subject of the health claim is Bifidobacterium lactis Bi-07. According to the information provided, this strain is deposited at the American Type Culture Collection (ATCC) under number ATCC SD5220.
The identification/characterisation of the strain Bifidobacterium lactis Bi-07, formerly known as Bifidobacterium infantis Bi-07, is not included in the studies provided as reference material. Some phenotypic features of the strain are known (Ding and Shah, 2007), but no information regarding genotypic identification/characterisation was found in the literature. The species Bifidobacterium lactis has been reclassified as Bifidobacterium animalis ssp. lactis (Masco et al., 2004). It is important to point out that it may not be possible to differentiate the commercially available Bifidobacterium 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 that it may be necessary to use multi-locus sequencing or genome-wide approaches. The Panel considers that Bifidobacterium lactis Bi-07, which is the subject of the health claims ID 2992, 2993, 3008, is not sufficiently characterised.

1.25. Characterisation of “Bifidobacterium lactis Bl-04” (ID 2994, 2995)

The food constituent that is the subject of the health claim is Bifidobacterium lactis Bl-04. According to the information provided, this strain is deposited at the American Type Culture Collection (ATCC) under number ATCC SD5219.
The identification/characterisation of the strain Bifidobacterium lactis Bl-04, formerly known as Bifidobacterium lactis BL-01 and Bifidobacterium longum BI-04, is not included in the studies provided as reference material. Some phenotypic features of the strain are known (Ding and Shah,
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2007), but no information regarding genotypic identification/characterisation was found in the literature.
The species Bifidobacterium lactis has been reclassified as Bifidobacterium animalis ssp. lactis (Masco et al., 2004). It is important to point out that it may not be possible to differentiate the commercially available Bifidobacterium 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 that it may be necessary to use multi-locus sequencing or genome-wide approaches. The Panel considers that Bifidobacterium lactis Bl-04, which is the subject of the health claims ID 2994, 2995, is not sufficiently characterised.

1.26. Characterisation of “Probiotic supplement. Winclove 500” (ID 2996)

The food constituent that is the subject of the health claim is Probiotic supplement, Winclove 500. No strains names are provided. The Panel considers that Probiotic supplement, Winclove 500, which is the subject of the health claim ID 2996, is not sufficiently characterised.

1.27. Characterisation of “Probiotic supplement. Lactobact omni FOS” (ID 2997, 2998)

The food constituent that is the subject of the health claim is Probiotic supplement, Lactobact omni FOS. No strains names are provided. The Panel considers that Probiotic supplement, Lactobact omni FOS, which is the subject of the health claims ID 2997, 2998, is not sufficiently characterised.

1.28. Characterisation of “Lactobacillus acidophilus LA-5” (ID 2999, 3000, 3001)

The food constituent that is the subject of the health claim is Lactobacillus acidophilus LA-5. Reference to the deposit of the strain in an internationally recognised culture collection was not found in the information provided or the literature.
The identification/characterisation of the strain Lactobacillus acidophilus LA-5 is not included in the studies provided 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 claims ID 2999, 3000, 3001, is not sufficiently characterised.

1.29. Characterisation of “Bifidobacterium lactis W51” (ID 3002, 3003)

The food constituent that is the subject of the health claim is Bifidobacterium lactis W51. No indication of the deposit of the strain in an internationally recognised culture collection was found in the information provided or the literature.
The identification/characterisation of the strain Bifidobacterium lactis W51 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The species Bifidobacterium lactis has been reclassified as Bifidobacterium animalis ssp. lactis (Masco et al., 2004). It is important to point out that it may not be possible to differentiate the commercially available Bifidobacterium 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 that it may be necessary to use multi-locus sequencing or genome-wide approaches. The Panel considers that Bifidobacterium lactis W51, which is the subject of the health claims ID 3002, 3003, is not sufficiently characterised.
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1.30. Characterisation of “Lactobacillus paracasei Lpc-37 (ATCC SD5275)” (ID 3007, 3031, 3032)

The food constituent that is the subject of the health claim is Lactobacillus paracasei Lpc-37 (ATCC SD5275). According to information provided, the strain is deposited at the American Type Culture Collection (ATCC) under number ATCC SD5275.
No information regarding strain Lactobacillus paracasei Lpc-37 species identification/characterisation was found in the information provided or the literature. The Panel considers that Lactobacillus paracasei Lpc-37, which is the subject of the health claims ID 3007, 3031, 3032 is not sufficiently characterised.

1.31. Characterisation of a combination of “Lactobacillus acidophilus ATCC SD5221 and Bifidobacterium lactis ATCC SD5219” (ID 3010)

The food constituent that is the subject of the health claim is a combination of “Lactobacillus acidophilus ATCC SD5221 and Bifidobacterium lactis ATCC SD5219”. For Lactobacillus acidophilus ATCC SD5221, a culture collection number from the American Type Culture Collection (ATCC) is provided for this strain. For Bifidobacterium lactis ATCC SD5219, a culture collection number from the American Type Culture Collection (ATCC) is provided.
Lactobacillus acidophilus ATCC SD5221 - The strain Lactobacillus acidophilus ATCC SD5221, also known as Lactobacillus acidophilus NCFM, species identity as well as the strain identity and characteristics have been established by using both phenotypic and genotypic methods (Sanders and Klaenhammer, 2001). In addition, the genome Lactobacillus acidophilus NCFM (ATCC SD5221) is publicly available at the NCBI database (Altermann et al., 2005) (accession nº NC_006814). The Panel considers that Lactobacillus acidophilus ATCC SD5221 is sufficiently characterised.
Bifidobacterium lactis ATCC SD5219 - The identification/characterisation of the strain Bifidobacterium lactis ATCC SD5219, also known as Bifidobacterium lactis Bl-04, is not included in the studies provided as reference material. Some phenotypic features of the strain are known (Ding and Shah, 2007), but no information regarding identification/characterisation was found in the literature. The species Bifidobacterium lactis has been reclassified as Bifidobacterium animalis ssp. lactis (Masco et al., 2004). It is important to point out that it may not be possible to differentiate the commercially available Bifidobacterium 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 that it may be necessary to use multi-locus sequencing or genome-wide approaches. The Panel considers that Bifidobacterium lactis ATCC SD5219 is not sufficiently characterised.
The Panel considers that the combination “Lactobacillus acidophilus ATCC SD5221 and Bifidobacterium lactis ATCC SD5219”, which is the subject of the health claim ID 3010, is not sufficiently characterised.

1.32. Characterisation of a combination of “Lactobacillus helveticus CNCM I-1722, Bifidobacterium bifidum CNCM I-3426 and Bifidobacterium infantis CNCM I-3424” (ID 3016)

The food constituent that is the subject of the health claim is a combination of “Lactobacillus helveticus CNCM I-1722, Bifidobacterium bifidum CNCM I-3426 and Bifidobacterium infantis CNCM I-3424”. For Lactobacillus helveticus CNCM I-1722, a culture collection number from the Collection Nationale de Cultures de Microorganismes (CNCM) is erroneously provided, as it refers to another strain, i.e. Lactobacillus acidophilus, under the same collection number (CNCM I-1722) included in a patent (Durand and Panes, 2001). For Bifidobacterium bifidum CNCM I-3426, a culture collection number from the Collection Nationale de Cultures de Microorganismes (CNCM) is
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provided. The CNCM is a restricted-access non-public collection which has the status of International Depositary Authority under the Budapest Treaty. For Bifidobacterium infantis CNCM I-3424, a culture collection number from the Collection Nationale de Cultures de Microorganismes (CNCM) is provided. The CNCM is a restricted-access non-public collection which has the status of International Depositary Authority under the Budapest Treaty.
Lactobacillus helveticus CNCM I-1722 - The identification/characterisation of the strain Lactobacillus helveticus CNCM I-1722 is not included or cited in the studies provided as reference material and no information regarding the strain identification/characterisation was found in the literature. The Panel considers that Lactobacillus helveticus CNCM I-1722 is not sufficiently characterised.
Bifidobacterium bifidum CNCM I-3426 - The identification/characterisation of the strain Bifidobacterium bifidum CNCM I-3426 is not included or cited in the studies provided as reference material and no information regarding strain Bifidobacterium bifidum CNCM I-3426 identification/characterisation was found in the literature. The Panel considers that Bifidobacterium bifidum CNCM I-3426 is not sufficiently characterised.
Bifidobacterium infantis CNCM I-3424 - The identification/characterisation of the strain Bifidobacterium infantis CNCM I-3424 is not included or cited in the studies provided as reference material and no information regarding the strain identification/characterisation was found in the literature. The species Bifidobacterium infantis has been reclassified as subspecies of Bifidobacterium longum, Bifidobacterium longum ssp. infantis (Sakata et al., 2002). The Panel considers that Bifidobacterium infantis CNCM I-3424 is not sufficiently characterised.
The Panel considers that the combination of “Lactobacillus helveticus CNCM I-1722, Bifidobacterium bifidum CNCM I-3426 and Bifidobacterium infantis CNCM I-3424”, which is the subject of the health claim ID 3016, is not sufficiently characterised.

1.33. Characterisation of a combination of “Lactobacillus helveticus CNCM I-1722, Lactobacillus rhamnosus CNCM I-1720, Bifidobacterium longum CNCM I-3470 and Saccharomyces cerevisiae boulardii” (ID 3017)

The food constituent that is the subject of the health claim is a combination of “Lactobacillus helveticus CNCM I-1722, Lactobacillus rhamnosus CNCM I-1720, Bifidobacterium longum CNCM I-3470 and Saccharomyces cerevisiae boulardii”. For Lactobacillus helveticus CNCM I-1722, a culture collection number from the Collection Nationale de Cultures de Microorganismes (CNCM) is erroneously provided, as it refers to another strain, i.e. Lactobacillus acidophilus, under the same collection number (CNCM I-1722) included in a patent (Durand and Panes, 2001). For Lactobacillus rhamnosus CNCM I-1720, a culture collection number from the Collection Nationale de Cultures de Microorganismes (CNCM) is provided. The CNCM is a restricted-access non-public collection which has the status of International Depositary Authority under the Budapest Treaty. For Bifidobacterium longum CNCM I-3470, a culture collection number from the Collection Nationale de Cultures de Microorganismes (CNCM) is provided. The CNCM is a restricted-access non-public collection which has the status of International Depositary Authority under the Budapest Treaty.
Lactobacillus helveticus CNCM I-1722 - The identification/characterisation of the strain Lactobacillus helveticus CNCM I-1722 is not included or cited in the studies provided as reference material and no information regarding the strain identification/characterisation was found in the literature. The Panel considers that Lactobacillus helveticus CNCM I-1722 is not sufficiently characterised.
Lactobacillus rhamnosus CNCM I-1720 - The identification/characterisation of the strain Lactobacillus rhamnosus CNCM I-1720, also known as Lactobacillus rhamnosus R0011 (Mesnage et
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al., 2007), is not included or cited in the studies provided as reference material and no information regarding the strain identification/characterisation was found in the literature. The Panel considers that Lactobacillus rhamnosus CNCM I-1720 is not sufficiently characterised.
Bifidobacterium longum CNCM I-3470 - The identification/characterisation of the strain Bifidobacterium longum CNCM I-3470 is not included or cited in the studies provided as reference material and no information regarding the strain identification/characterisation was found in the literature. The Panel considers that Bifidobacterium longum CNCM I-3470 is not sufficiently characterised.
Saccharomyces cerevisiae boulardii - No strain identification or name is provided. The Panel considers that Saccharomyces cerevisiae boulardii is not sufficiently characterised.
The Panel considers that the combination of “Lactobacillus helveticus CNCM I-1722, Lactobacillus rhamnosus CNCM I-1720, Bifidobacterium longum CNCM I-3470 and Saccharomyces cerevisiae boulardii”, which is the subject of the health claim ID 3017, is not sufficiently characterised.

1.34. Characterisation of “Lactobacillus delbrueckii (lactis)” (ID 3020, 3021)

The food constituent that is the subject of the health claim is Lactobacillus delbrueckii (lactis). No strain identification or name is provided. The Panel considers that Lactobacillus delbrueckii (lactis), which is the subject of the health claims ID 3020, 3021, is not sufficiently characterised.

1.35. Characterisation of “Bacillus subtilis Natto” (ID 3022, 3023, 3024)

The food constituent that is the subject of the health claim is Bacillus subtilis Natto. No indication of the deposit of the strain in an internationally recognised culture collection was found.
No data on the identification/characterisation of the strain Bacillus subtilis Natto was provided as reference material. The Panel considers that Bacillus subtilis Natto, which is the subject of the health claims ID 3022, 3023, 3024, is not sufficiently characterised.

1.36. Characterisation of a combination of “Lactobacillus acidophilus, Bifidobacterium infantis and Bifidobacterium bifidum” (ID 3028, 3029, 3030)

The food constituent that is the subject of the health claim is a combination of “Lactobacillus acidophilus, Bifidobacterium infantis and Bifidobacterium bifidum”.
Lactobacillus acidophilus - No strain identification or name is provided. The Panel considers that Lactobacillus acidophilus is not sufficiently characterised.
Bifidobacterium infantis- No strain identification or name is provided. The Panel considers that Bifidobacterium infantis is not sufficiently characterised.
Bifidobacterium bifidum - No strain identification or name is provided. The Panel considers that Bifidobacterium bifidum is not sufficiently characterised.
The Panel considers that the combination of “Lactobacillus acidophilus, Bifidobacterium infantis and Bifidobacterium bifidum”, which is the subject of the health claims ID 3028, 3029, 3030, is not sufficiently characterised.
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1.37. Characterisation of “Lactobacillus casei 101/37 (LMG P-17504)” (ID 3034)

The food constituent that is the subject of the health claim is Lactobacillus casei 101/37 (LMG P-17504). 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 also be deposited in a restricted-access collection as Patent deposits.
The identification/characterisation of the strain Lactobacillus casei 101/37 is not included in the studies provided as reference material 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 3034, is not sufficiently characterised.

1.38. Characterisation of “Bifidobacterium adolescentis BA 02 (DSM 17103)” (ID 3035)

The food constituent that is the subject of the health claim is Bifidobacterium adolescentis BA 02 (DSM 17103). A culture collection number from the DSMZ (DSM 17103) is provided. In the DSMZ, 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 identification/characterisation of the strain Bifidobacterium adolescentis BA 02 is not included in the studies provided as reference material and no information was found in the literature. The Panel considers that Bifidobacterium adolescentis BA 02 (DSM 17103), which is the subject of the health claim ID 3035, is not sufficiently characterised.

1.39. Characterisation of “Bifidobacterium adolescentis EI-3-MB 239 (DSM 18350)” (ID 3036)

The food constituent that is the subject of the health claim is Bifidobacterium adolescentis EI-3-MB 239 (DSM 18350). A culture collection number from the DSMZ (DSM 18350) is provided. In the DSMZ, 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 identification/characterisation of the strain Bifidobacterium adolescentis EI-3-MB 239 is not included in the studies provided as reference material and no information was found in the literature. The Panel considers that Bifidobacterium adolescentis EI-3-MB 239 (DSM 18350), which is the subject of the health claim ID 3036, is not sufficiently characterised.

1.40. Characterisation of “Bifidobacterium adolescentis EI-18-MB 227-BA05 (DSM 18352)” (ID 3037)

The food constituent that is the subject of the health claim is Bifidobacterium adolescentis EI-18-MB 227-BA05 (DSM 18352). A culture collection number from the DSMZ (DSM 18352) is provided. In the DSMZ, 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 identification/characterisation of the strain Bifidobacterium adolescentis EI-18-MB 227-BA05 is not included in the studies provided as reference material and no information was found in the literature. The Panel considers that Bifidobacterium adolescentis EI-18-MB 227-BA05 (DSM 18352), which is the subject of the health claim ID 3037, is not sufficiently characterised.
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1.41. Characterisation of “Bifidobacterium pseudocatenulatum EI-20-MB 116 (DSM 18353)” (ID 3038)

The food constituent that is the subject of the health claim is Bifidobacterium pseudocatenulatum EI-20-MB 116 (DSM 18353). A culture collection number from the DSMZ (DSM 18353) is provided. In the DSMZ, 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 identification/characterisation of the strain Bifidobacterium pseudocatenulatum EI-20-MB 116 is not included in the studies provided as reference material and no information was found in the literature. The Panel considers that Bifidobacterium pseudocatenulatum EI-20-MB 116 (DSM 18353), which is the subject of the health clam ID 3038, is not sufficiently characterised.

1.42. Characterisation of “Bifidobacterium adolescentis EI-15-ALB 1 (DSM 18351)” (ID 3039)

The food constituent that is the subject of the health claim is Bifidobacterium adolescentis EI-15-ALB 1 (DSM 18351). A culture collection number from the DSMZ (DSM 18351) is provided. In the DSMZ, 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 identification/characterisation of the strain Bifidobacterium adolescentis EI-15-ALB 1 is not included in the studies provided as reference material and no information was found in the literature. The Panel considers that Bifidobacterium adolescentis EI-15-ALB 1 (DSM 18351), which is the subject of the health claim ID 3039, is not sufficiently characterised.

1.43. Characterisation of “Lactobacillus fermentum LF 10 (DSM 19187)” (ID 3040)

The food constituent that is the subject of the health claim is Lactobacillus fermentum LF 10 (DSM 19187). A culture collection number from the DSMZ (DSM 19187) is provided. In the DSMZ, which is a non-public International Depositary Authority under the Budapest Treaty, cultures can be deposited in a restricted-access collection as Patent deposits.
Information regarding identification/characterisation of the strain Lactobacillus fermentum LF 10 was not found in the literature. The Panel considers that Lactobacillus fermentum LF 10 (DSM 19187), which is the subject of the health claim ID 3040, is not sufficiently characterised.

1.44. Characterisation of “Lactobacillus fermentum LF 11 (DSM 19188)” (ID 3041)

The food constituent that is the subject of the health claim is Lactobacillus fermentum LF 11 (DSM 19188). A culture collection number from the DSMZ (DSM 19188) is provided. In the DSMZ, which is a non-public International Depositary Authority under the Budapest Treaty, cultures can be deposited in a restricted-access collection as Patent deposits.
Information regarding identification/characterisation of the strain Lactobacillus fermentum LF 11 was not found in the literature. The Panel considers that Lactobacillus fermentum LF 11 (DSM 19188), which is the subject of the health claim ID 3041, is not sufficiently characterised.

1.45. Characterisation of “Lactobacillus paracasei subsp. paracasei LPC 00 (LMG P-21380)” (ID 3042)

The food constituent that is the subject of the health claim is Lactobacillus paracasei subsp. paracasei LPC 00 (LMG P-21380). A culture collection number from the LMG culture collection is
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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.
Information regarding identification/characterisation of the strain Lactobacillus paracasei subsp. paracasei LPC 00 was not found in the literature. The Panel considers that Lactobacillus paracasei subsp. paracasei LPC 00 (LMG P-21380), which is the subject of the health claim ID 3042, is not sufficiently characterised.

1.46. Characterisation of “Lactobacillus gasseri CRL-1259” (ID 3043)

The food constituent that is the subject of the health claim is Lactobacillus gasseri CRL-1259. A culture collection number from the collection of the research institute in which the strain was isolated is given (CERELA, Argentina). However, this is not an internationally recognised culture collection.
The only information provided on identification/characterisation of the strain Lactobacillus gasseri CRL-1259 by genotypic methods reports the use of ARDRA (Tomas et al., 2005) for strain characterisation. No other studies on genetic identification of the strain have been found in the literature. The Panel considers that Lactobacillus gasseri CRL-1259, which is the subject of the health claim ID 3043, is not sufficiently characterised.

1.47. Characterisation of “Lactobacillus crispatus CRL-1251” (ID 3044)

The food constituent that is the subject of the health claim is Lactobacillus crispatus CRL-1251. A culture collection number from the collection of the research institute in which the strain was isolated is given (CERELA, Argentina). However, this is not an internationally recognised culture collection.
The only information provided on identification/characterisation of the strain Lactobacillus crispatus CRL-1251 by genotypic methods reports the use of ARDRA (Tomas et al., 2005) for strain characterisation. No other studies on genetic identification of the strain have been found in the literature. The Panel considers that Lactobacillus crispatus CRL-1251, which is the subject of the health claim ID 3044, is not sufficiently characterised.

1.48. Characterisation of “Lactobacillus salivarius subsp. salivarius CRL-1328” (ID 3045)

The food constituent that is the subject of the health claim is Lactobacillus salivarius subsp. salivarius CRL-1328. A culture collection number from the collection of the research institute in which the strain was isolated is given (CERELA, Argentina). However, this is not an internationally recognised culture collection.
The only information found on identification/characterisation of the strain Lactobacillus salivarius subsp. salivarius CRL-1328 regards the phenotypic identification of the strain by the use of sugar fermentation profiles (Ocana et al., 1999). No other studies on identification/characterisation of the strain have been found in the literature. The Panel considers that Lactobacillus salivarius subsp. salivarius CRL-1328, which is the subject of the health claim ID 3045, is not sufficiently characterised.

1.49. Characterisation of “Lactobacillus paracasei subsp. paracasei CRL-1289” (ID 3046)

The food constituent that is the subject of the health claim is Lactobacillus paracasei subsp. paracasei CRL-1289. A culture collection number from the collection of the research institute in which the strain was isolated (CERELA, Argentina) is given. However, this is not an internationally recognised culture collection.
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The only information provided on identification/characterisation of the strain Lactobacillus paracasei subsp. paracasei CRL-1289 regarded phenotypic identification of the strain by the use of sugar fermentation profiles (Ocana et al., 1999). No other studies on identification/characterisation of the strain have been found in the literature. The Panel considers that Lactobacillus paracasei subsp. paracasei CRL-1289, which is the subject of the health claim ID 3046, is not sufficiently characterised.

1.50. Characterisation of a combination of “Lactobacillus plantarum LP 01 (LMG P-21021), Lactobacillus plantarum LP 02 (LMG P-21020), Lactobacillus rhamnosus LR 04 (DSM 16605), Lactobacillus rhamnosus LR 05 (DSM 19739) and Bifidobacterium lactis BS 01 (LMG P-21384)” (ID 3047, 3048)

The food constituent that is the subject of the health claim is a combination of “Lactobacillus plantarum LP 01 (LMG P-21021), Lactobacillus plantarum LP 02 (LMG P-21020), Lactobacillus rhamnosus LR 04 (DSM 16605), Lactobacillus rhamnosus LR 05 (DSM 19739) and Bifidobacterium lactis BS 01 (LMG P-21384)”. For Lactobacillus plantarum LP 01 (LMG P-21021), 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 also be deposited in a restricted-access collection as Patent deposits. For Lactobacillus plantarum LP 02 (LMG P-21020), 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 also be deposited in a restricted-access collection as Patent deposits. For Lactobacillus rhamnosus LR 04 (DSM 16605), a culture collection number from the DSMZ is provided. In the DSMZ, which is a non-public International Depositary Authority under the Budapest Treaty, cultures can be deposited in a restricted-access collection as Patent deposits. For Lactobacillus rhamnosus LR 05 (DSM 19739), a culture collection number from the DSMZ is provided. In the DSMZ, which is a non-public International Depositary Authority under the Budapest Treaty, cultures can be deposited in a restricted-access collection as Patent deposits. For Bifidobacterium lactis BS 01 (LMG P-21384), 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 also be deposited in a restricted-access collection as Patent deposits.
Lactobacillus plantarum LP 01 (LMG P-21021) - The identification/characterisation of the strain Lactobacillus plantarum LP 01 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus plantarum LP 01 (LMG P-21021) is not sufficiently characterised.
Lactobacillus plantarum LP 02 (LMG P-21020) - The identification/characterisation of the strain Lactobacillus plantarum LP 02 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus plantarum LP 02 (LMG P-21020) is not sufficiently characterised.
Lactobacillus rhamnosus LR 04 (DSM 16605) - The identification/characterisation of the strain Lactobacillus rhamnosus LR 04 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus rhamnosus LR 04 (DSM 16605) is not sufficiently characterised.
Lactobacillus rhamnosus LR 05 (DSM 19739) - The identification/characterisation of the strain Lactobacillus rhamnosus LR 05 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus rhamnosus LR 05 (DSM 19739) is not sufficiently characterised.
Bifidobacterium lactis BS 01 (LMG P-21384) - No information regarding the identification/characterisation of the strain Bifidobacterium lactis BS 01 (LMG P-21384) was found
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in the references provided or in the literature. The species Bifidobacterium lactis has been reclassified as Bifidobacterium animalis ssp. lactis (Masco et al., 2004). It is important to point out that it may not be possible to differentiate the commercially available Bifidobacterium 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 that it may be necessary to use multi-locus sequencing or genome-wide approaches. The Panel considers that Bifidobacterium lactis BS 01 (LMG P-21384) is not sufficiently characterised.
The Panel considers that the combination of “Lactobacillus plantarum LP 01 (LMG P-21021), Lactobacillus plantarum LP 02 (LMG P-21020), Lactobacillus rhamnosus LR 04 (DSM 16605), Lactobacillus rhamnosus LR 05 (DSM 19739) and Bifidobacterium lactis BS 01 (LMG P-21384)”, which is the subject of the health claims ID 3047, 3048, is not sufficiently characterised.

1.51. Characterisation of a combination of “Lactobacillus plantarum LP 01 (LMG P-21021) and Bifidobacterium adolescentis EI-18-MB 227-BA05 (DSM 18352)” (ID 3049, 3050)

The food constituent that is the subject of the health claim is a combination of “Lactobacillus plantarum LP 01 (LMG P-21021) and Bifidobacterium adolescentis EI-18-MB 227-BA05 (DSM 18352)”. For Lactobacillus plantarum LP 01 (LMG P-21021), 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 also be deposited in a restricted-access collection as Patent deposits. For Bifidobacterium adolescentis EI-18-MB 227-BA05 (DSM 18352), a culture collection number from the DSMZ (DSM 18352) is provided. In the DSMZ, 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 plantarum LP 01 (LMG P-21021) - The identification/characterisation of the strain Lactobacillus plantarum LP 01 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus plantarum LP 01 (LMG P-21021) is not sufficiently characterised.
Bifidobacterium adolescentis EI-18-MB 227-BA05 (DSM 18352) - The identification/characterisation of the strain Bifidobacterium adolescentis EI-18-MB 227-BA05 is not included in the studies provided as reference material and no information was found in the literature. The Panel considers that Bifidobacterium adolescentis EI-18-MB 227-BA05 (DSM 18352) is not sufficiently characterised.
The Panel considers that the combination of “Lactobacillus plantarum LP 01 (LMG P-21021) and Bifidobacterium adolescentis EI-18-MB 227-BA05 (DSM 18352)”, which is the subject of the health claims ID 3049, 3050, is not sufficiently characterised.

1.52. Characterisation of a combination of “Lactobacillus plantarum LP 01 (LMG P-21021) and Bifidobacterium lactis BS 01 (LMG P-21384)” (ID 3051, 3052)

The food constituent that is the subject of the health claim is a combination of “Lactobacillus plantarum LP 01 (LMG P-21021) and Bifidobacterium lactis BS 01 (LMG P-21384)”. For Lactobacillus plantarum LP 01 (LMG P-21021), 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 also be deposited in a restricted-access collection as Patent deposits. For Bifidobacterium lactis BS 01 (LMG P-21384), 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 also be deposited in a restricted-access collection as Patent deposits.
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Lactobacillus plantarum LP 01 (LMG P-21021) - The identification/characterisation of the strain Lactobacillus plantarum LP 01 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus plantarum LP 01 (LMG P-21021) is not sufficiently characterised.
Bifidobacterium lactis BS 01 (LMG P-21384) - No information regarding the identification/characterisation of the strain Bifidobacterium lactis BS 01 (LMG P-21384) was found in the references provided or in the literature. The species Bifidobacterium lactis has been reclassified as Bifidobacterium animalis ssp. lactis (Masco et al., 2004). It is important to point out that it may not be possible to differentiate the commercially available Bifidobacterium 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 that it may be necessary to use multi-locus sequencing or genome-wide approaches. The Panel considers that Bifidobacterium lactis BS 01 (LMG P-21384) is not sufficiently characterised.
The Panel considers that the combination of “Lactobacillus plantarum LP 01 (LMG P-21021) and Bifidobacterium lactis BS 01 (LMG P-21384)”, which is the subject of the health claims ID 3051, 3052, is not sufficiently characterised.

1.53. Characterisation of a combination of “Lactobacillus paracasei subsp. paracasei LPC 00 (LMG P-21380), Lactobacillus rhamnosus LR 04 (DSM 16605) and Bifidobacterium breve BR 03 (DSM 16604)” (ID 3053, 3054)

The food constituent that is the subject of the health claim is a combination of “Lactobacillus paracasei subsp. paracasei LPC 00 (LMG P-21380), Lactobacillus rhamnosus LR 04 (DSM 16605) and Bifidobacterium breve BR 03 (DSM 16604)”. For Lactobacillus paracasei subsp. paracasei LPC 00 (LMG P-21380), 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 also be deposited in a restricted-access collection as Patent deposits. For Lactobacillus rhamnosus LR 04 (DSM 16605), a culture collection number from the DSMZ is provided. In the DSMZ, which is a non-public International Depositary Authority under the Budapest Treaty, cultures can be deposited in a restricted-access collection as Patent deposits. For Bifidobacterium breve BR 03 (DSM 16604), a culture collection number from the DSMZ (DSM 16604) is provided. In the DSMZ, 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 paracasei subsp. paracasei LPC 00 (LMG P-21380) - Information regarding identification/characterisation of the strain Lactobacillus paracasei subsp. paracasei LPC 00 was not found in the literature. The Panel considers that Lactobacillus paracasei subsp. paracasei LPC 00 (LMG P-21380) is not sufficiently characterised.
Lactobacillus rhamnosus LR 04 (DSM 16605) - The identification/characterisation of the strain Lactobacillus rhamnosus LR 04 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus rhamnosus LR 04 (DSM 16605) is not sufficiently characterised.
Bifidobacterium breve BR 03 (DSM 16604) - The identification/characterisation of the strain Bifidobacterium breve BR 03 is not included in the studies provided as reference material and no information was found in the literature. The Panel considers that Bifidobacterium breve BR 03 (DSM 16604) is not sufficiently characterised.
The Panel considers that the combination of “Lactobacillus paracasei subsp. paracasei LPC 00 (LMG P-21380), Lactobacillus rhamnosus LR 04 (DSM 16605) and Bifidobacterium breve BR 03
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(DSM 16604)”, which is the subject of the health claims ID 3053, 3054, is not sufficiently characterised.

1.54. Characterisation of “Lactobacillus paracasei LPC 01 (CNCM I-1390)” (ID 3055)

The food constituent that is the subject of the health claim is Lactobacillus paracasei LPC 01 (CNCM I-1390). A culture collection number from the Collection Nationale de Cultures de Microorganismes (CNCM) is provided. The CNCM is a restricted-access non-public collection which has the status of International Depositary Authority under the Budapest Treaty.
Information regarding identification/characterisation of the strain Lactobacillus paracasei LPC 01 was not found in the literature. The Panel considers that Lactobacillus paracasei LPC 01 (CNCM I-1390), which is the subject of the health claim ID 3055, is not sufficiently characterised.

1.55. Characterisation of “Bifidobacterium longum W11 (LMG P-21586)” (ID 3056)

The food constituent that is the subject of the health claim is Bifidobacterium longum W11 (LMG P-21586). 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 also be deposited in a restricted-access collection as Patent deposits.
Information regarding identification/characterisation of the strain Bifidobacterium longum W11 was not found in the literature. The Panel considers that Bifidobacterium longum W11 (LMG P-21586), which is the subject of the health claim ID3056, is not sufficiently characterised.

1.56. Characterisation of a combination of “Streptococcus thermophilus FP4 (DSM 18616), Lactobacillus acidophilus LA 02 (LMG P-21381), Lactobacillus delbrueckii subsp. bulgaricus LDB 01 (DSM 16606) and Lactobacillus rhamnosus LR 04 (DSM 16605)” (ID 3057)

The food constituent that is the subject of the health claim is a combination of “Streptococcus thermophilus FP4 (DSM 18616), Lactobacillus acidophilus LA 02 (LMG P-21381), Lactobacillus delbrueckii subsp. bulgaricus LDB 01 (DSM 16606) and Lactobacillus rhamnosus LR 04 (DSM 16605)”. For Streptococcus thermophilus FP4 (DSM 18616), a culture collection number from the DSMZ (DSM 18616) is provided. In the DSMZ, which is a non-public International Depositary Authority under the Budapest Treaty, cultures can be deposited in a restricted-access collection as Patent deposits. For Lactobacillus acidophilus LA 02 (LMG P-21381), 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 also be deposited in a restricted-access collection as Patent deposits. For Lactobacillus delbrueckii subsp. bulgaricus LDB 01 (DSM 16606), a culture collection number from the DSMZ (DSM 16606) is provided. In the DSMZ, which is a non-public International Depositary Authority under the Budapest Treaty, cultures can be deposited in a restricted-access collection as Patent deposits. For Lactobacillus rhamnosus LR 04 (DSM 16605), a culture collection number from the DSMZ is provided. In the DSMZ, which is a non-public International Depositary Authority under the Budapest Treaty, cultures can be deposited in a restricted-access collection as Patent deposits.
Streptococcus thermophilus FP4 (DSM 18616) - The identification/characterisation of the strain Streptococcus thermophilus FP4 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Streptococcus thermophilus FP4 (DSM 18616) is not sufficiently characterised.
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Lactobacillus acidophilus LA 02 (LMG P-21381) - The identification/characterisation of the strain Lactobacillus acidophilus LA 02 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus acidophilus LA 02 (LMG P-21381) is not sufficiently characterised.
Lactobacillus delbrueckii subsp. bulgaricus LDB 01 (DSM 16606) - The identification/characterisation of the strain Lactobacillus delbrueckii subsp. bulgaricus LDB 01 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus delbrueckii subsp. bulgaricus LDB 01 (DSM 16606) is not sufficiently characterised.
Lactobacillus rhamnosus LR 04 (DSM 16605) - The identification/characterisation of the strain Lactobacillus rhamnosus LR 04 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus rhamnosus LR 04 (DSM 16605) is not sufficiently characterised.
The Panel considers that the combination of “Streptococcus thermophilus FP4 (DSM 18616), Lactobacillus acidophilus LA 02 (LMG P-21381), Lactobacillus delbrueckii subsp. bulgaricus LDB 01 (DSM 16606) and Lactobacillus rhamnosus LR 04 (DSM 16605)”, which is the subject of the health claim ID 3057, is not sufficiently characterised.

1.57. Characterisation of a combination of “Bifidobacterium breve BR 03 (DSM 16604) and Lactobacillus plantarum LP 01 (LMG P-21021)” (ID 3058)

The food constituent that is the subject of the health claim is a combination of “Bifidobacterium breve BR 03 (DSM 16604) and Lactobacillus plantarum LP 01 (LMG P-21021)”. For Bifidobacterium breve BR 03 (DSM 16604), a culture collection number from the DSMZ (DSM 16604) is provided. In the DSMZ, which is a non-public International Depositary Authority under the Budapest Treaty, cultures can be deposited in a restricted-access collection as Patent deposits. For Lactobacillus plantarum LP 01 (LMG P-21021), 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 also be deposited in a restricted-access collection as Patent deposits.
Bifidobacterium breve BR 03 (DSM 16604) - The identification/characterisation of the strain Bifidobacterium breve BR 03 is not included in the studies provided as reference material and no information was found in the literature. The Panel considers that Bifidobacterium breve BR 03 (DSM 16604) is not sufficiently characterised.
Lactobacillus plantarum LP 01 (LMG P-21021) - The identification/characterisation of the strain Lactobacillus plantarum LP 01 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus plantarum LP 01 (LMG P-21021) is not sufficiently characterised.
The Panel considers that the combination of “Bifidobacterium breve BR 03 (DSM 16604) and Lactobacillus plantarum LP 01 (LMG P-21021)”, which is the subject of the health claim ID 3058, is not sufficiently characterised.

1.58. Characterisation of a combination of “Bifidobacterium lactis BS 01 (LMG P-21384), Lactobacillus rhamnosus LR 04 (DSM 16605) and Lactobacillus plantarum LP 02 (LMG P-21020)” (ID 3059)

The food constituent that is the subject of the health claim is a combination of “Bifidobacterium lactis BS 01 (LMG P-21384), Lactobacillus rhamnosus LR 04 (DSM 16605) and Lactobacillus plantarum LP 02 (LMG P-21020)”. For Bifidobacterium lactis BS 01 (LMG P-21384), a culture collection
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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 also be deposited in a restricted-access collection as Patent deposits. For Lactobacillus rhamnosus LR 04 (DSM 16605), a culture collection number from the DSMZ is provided. At the DSMZ cultures can be deposited at a restricted-access collection as Patent deposits, being a non-public International Depositary Authority under the Budapest Treaty. For Lactobacillus plantarum LP 02 (LMG P-21020), 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 also be deposited in a restricted-access collection as Patent deposits.
Bifidobacterium lactis BS 01 (LMG P-21384) - No information regarding the identification/characterisation of the strain Bifidobacterium lactis BS 01 (LMG P-21384) was found in the references provided or in the literature. The species Bifidobacterium lactis has been reclassified as Bifidobacterium animalis ssp. lactis (Masco et al., 2004). It is important to point out that it may not be possible to differentiate the commercially available Bifidobacterium 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 that it may be necessary to use the multi-locus sequencing or genome-wide approaches. The Panel considers that Bifidobacterium lactis BS 01 (LMG P-21384) is not sufficiently characterised.
Lactobacillus rhamnosus LR 04 (DSM 16605) - The identification/characterisation of the strain Lactobacillus rhamnosus LR 04 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus rhamnosus LR 04 (DSM 16605) is not sufficiently characterised.
Lactobacillus plantarum LP 02 (LMG P-21020) - The identification/characterisation of the strain Lactobacillus plantarum LP 02 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus plantarum LP 02 (LMG P-21020) is not sufficiently characterised.
The Panel considers that the combination of “Bifidobacterium lactis BS 01 (LMG P-21384), Lactobacillus rhamnosus LR 04 (DSM 16605) and Lactobacillus plantarum LP 02 (LMG P-21020)”, which is the subject of the health claim ID 3059, is not sufficiently characterised.

1.59. Characterisation of a combination of “Lactobacillus acidophilus LA 02 (LMG P-21381) and Lactobacillus plantarum LP 01 (LMG P-21021)” (ID 3060)

The food constituent that is the subject of the health claim is a combination of “Lactobacillus acidophilus LA 02 (LMG P-21381) and Lactobacillus plantarum LP 01 (LMG P-21021)”. For Lactobacillus acidophilus LA 02 (LMG P-21381), 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 also be deposited in a restricted-access collection as Patent deposits. For Lactobacillus plantarum LP 01 (LMG P-21021), 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 also be deposited in a restricted-access collection as Patent deposits.
Lactobacillus acidophilus LA 02 (LMG P-21381) - The identification/characterisation of the strain Lactobacillus acidophilus LA 02 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus acidophilus LA 02 (LMG P-21381) is not sufficiently characterised.
Lactobacillus plantarum LP 01 (LMG P-21021) - The identification/characterisation of the strain Lactobacillus plantarum LP 01 is not included in the studies provided as reference material and no
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information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus plantarum LP 01 (LMG P-21021) is not sufficiently characterised.
The Panel considers that the combination of “Lactobacillus acidophilus LA 02 (LMG P-21381) and Lactobacillus plantarum LP 01 (LMG P-21021)”, which is the subject of the health claim ID 3060, is not sufficiently characterised.

1.60. Characterisation of “Lactobacillus casei LC 01 (CNCM I-1572)” (ID 3061)

The food constituent that is the subject of the health claim is Lactobacillus casei LC 01 (CNCM I-1572). A culture collection number from the Collection Nationale de Cultures de Microorganismes (CNCM) is provided. The CNCM is a restricted-access non-public collection which has the status of International Depositary Authority under the Budapest Treaty.
No information regarding genetic identification/characterisation of the strain Lactobacillus casei LC 01 (CNCM I-1572), also known as Lactobacillus casei DG, was found in the studies provided as reference material or in the literature. The only information found regarded the use of phenotypic tests (Drago et al., 2002). The Panel considers that Lactobacillus casei LC 01 CNCM I-1572, which is the subject of the health claim ID 3061, is not sufficiently characterised.

1.61. Characterisation of “Lactobacillus rhamnosus LR 04 (DSM 16605)” (ID 3062)

The food constituent that is the subject of the health claim is Lactobacillus rhamnosus LR 04 (DSM 16605). A culture collection number from the DSMZ is provided. In the DSMZ, 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 identification/characterisation of the strain Lactobacillus rhamnosus LR 04 is not included in the studies provided as reference material and no information regarding identification/characterisation was found in the literature. The Panel considers that Lactobacillus rhamnosus LR 04 (DSM 16605), which is the subject of the health claim ID 3062, is not sufficiently characterised.

1.62. Characterisation of a combination of “Bifidobacterium animalis ssp. lactis Bb-12, Lactobacillus acidophilus LA-5, Lactobacillus bulgaricus LBY-27 and Streptococcus thermophilus STY-31” (ID 4227)

The food constituent that is the subject of the health claim is a combination of “Bifidobacterium animalis ssp. lactis Bb-12, Lactobacillus acidophilus LA-5, Lactobacillus bulgaricus LBY-27 and Streptococcus thermophilus STY-31”. For Bifidobacterium animalis ssp. lactis Bb-12, reference to the deposit of the strain in a culture collection, 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 the Bb-12 name, strain DSMZ 10140 was isolated from a yoghourt containing Bb-12 and deposited by Meile et al. (1997). For Lactobacillus acidophilus LA-5, no reference to the deposit of the strain in internationally recognised culture collection was found in the information provided or the literature. For Lactobacillus bulgaricus LBY-27, no indication of the deposit of the strain in an internationally recognised culture collection was found in the information provided or the literature. For Streptococcus thermophilus STY-31, no indication of the deposit of the strain in an internationally recognised culture collection was found in the references provided or the literature.
Bifidobacterium animalis ssp. lactis Bb-12 - The strain Bifidobacterium animalis ssp. lactis Bb-12 (previously known as Bifidobacterium lactis Bb-12 but subjected to reclassification (Masco et al., 2004) species identity as well as the strain identity and characteristics have been determined using
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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 Bifidobacterium 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 that it may be necessary to use multi-locus sequencing or genome-wide approaches. To this regard the genome of Bifidobacterium animalis ssp. lactis Bb-12 although sequenced (Yimin et al., Unpublished) is not publicly available at the databases. The Panel considers that Bifidobacterium animalis ssp. lactis Bb-12 is sufficiently characterised.
Lactobacillus acidophilus LA-5 - The identification/characterisation of the strain Lactobacillus acidophilus LA-5 is not included in the studies provided 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 is not sufficiently characterised.
Lactobacillus bulgaricus LBY-27 - The identification/characterisation of the strain Lactobacillus bulgaricus LBY-27 is not included in the studies provided as reference material. The strain species identity (using a strain isolated from a product containing Lactobacillus bulgaricus LBY-27) has been confirmed by sequentiation of the 16S rRNA (Tabasco et al., 2007) and PCR, but no information regarding the strain characterisation was found in the literature. The Panel considers that Lactobacillus bulgaricus LBY-27 is not sufficiently characterised.
Streptococcus thermophilus STY-31 - The identification/characterisation of the strain Streptococcus thermophilus STY-31 is not included in the studies provided as reference material. The strain species identity (using a strain isolated from a product containing Streptococcus thermophilus STY-31) has been confirmed by sequentiation of the 16S rRNA (Tabasco et al., 2007) and PCR, but no information regarding the strain characterisation was found in the literature. The Panel considers that Streptococcus thermophilus STY-31 is not sufficiently characterised.
The Panel considers that the combination of “Bifidobacterium animalis ssp. lactis Bb-12, Lactobacillus acidophilus LA-5, Lactobacillus bulgaricus LBY-27 and Streptococcus thermophilus STY-31”, which is the subject of the health claim ID 4227, is not sufficiently characterised.

1.63. Characterisation of “Lactobacillus johnsonii La-1/ACD-1/CLbA22” (ID 4229)

The food constituent that is the subject of the health claim is Lactobacillus johnsonii La-1/ACD-1/CLbA22. No indication of the deposit of the strain in an internationally recognised culture collection is given the information provided. However, the strain was found at the open catalogue of the LMG under number LMG 24394.
Information regarding the identification/characterisation of the strain Lactobacillus johnsonii La-1/ACD-1/CLbA22 was not found. The Panel considers that Lactobacillus johnsonii La-1/ACD-1/CLbA22, which is the subject of the health claim ID 4229, is not sufficiently characterised.

1.64. Characterisation of “Lactobacillus johnsonii La-19/CLbA5” (ID 4230)

The food constituent that is the subject of the health claim is Lactobacillus johnsonii La-19/CLbA5. No indication of the deposit of the strain in an internationally recognised culture collection is provided. However, the strain was found at the open catalogue of the LMG culture collection as Lactobacillus johnsonii LMG 24393.
No reference to strain Lactobacillus johnsonii La-19 or CLbA5 species identification/characterisation is indicated in the references provided and no information regarding the strain
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identification/characterisation was found in the literature. The Panel considers that Lactobacillus johnsonii La-19/CLbA5, which is the subject of the health claim ID 4230, is not sufficiently characterised.

1.65. Characterisation of a combination of “Bifidobacterium animalis ssp. lactis Bf-6/Bif-6/CB111 and Lactobacillus johnsonii La-1/ACD-1/CLbA22 (A/B-61)” (ID 4231)

The food constituent that is the subject of the health claim is a combination of “Bifidobacterium animalis ssp. lactis Bf-6/Bif-6/CB111 and Lactobacillus johnsonii La-1/ACD-1/CLbA22 (A/B-61)”. For Bifidobacterium animalis ssp. lactis Bf-6/Bif-6/CB111, no indication of the deposit of the strain in an internationally recognised culture collection is given as reference material. However, according to Mayer et al. (2007) the strain is deposited at the open catalogue of the DSMZ culture collection as DSMZ 20105 (available also at the ATCC; ATCC 27536). For Lactobacillus johnsonii La-1/ACD-1/CLbA22 (A/B-61), no indication of the deposit of the strain in an internationally recognised culture collection is given in the information provided. However, the strain was found at the open catalogue of the LMG under number LMG 24394.
Bifidobacterium animalis ssp. lactis Bf-6/Bif-6/CB111 - No reference to strain Bifidobacterium animalis ssp. lactis Bf-6, Bif-6 or CB111 species identification/characterisation is indicated in the references provided. However, reference to Bifidobacterium animalis Bf-6 strain identification/characterisation by different genotypic methods was found in the literature. It is important to point out that it may not be possible to differentiate commercially available Bifidobacterium animalis ssp. lactis strains from each other on the basis of traditional genetic methods (e.g. PFGE) (Mayer et al., 2007; Engel et al., 2003; Gueimonde et al., 2004) and that it may be necessary to use multi-locus sequencing or genome-wide approaches. To this regard the genome of Bifidobacterium animalis ssp. lactis Bf-6/Bif-6/CB111 is not available. The Panel considers that Bifidobacterium animalis ssp. lactis Bf-6/Bif-6/CB111 is not sufficiently characterised.
Lactobacillus johnsonii La-1/ACD-1/CLbA22 (A/B-61) - Information regarding the identification/characterisation of the strain Lactobacillus johnsonii La-1/ACD-1/CLbA22 was not found. The Panel considers that Lactobacillus johnsonii La-1/ACD-1/CLbA22 is not sufficiently characterised.
The Panel considers that the combination of “Bifidobacterium animalis ssp. lactis Bf-6/Bif-6/CB111 and Lactobacillus johnsonii La-1/ACD-1/CLbA22 (A/B-61)”, which is the subject of the health claim ID 4231, is not sufficiently characterised.

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