1. Charakterystyka żywności / składnika

1.1. Bifidobacterium animalis subsp. lactis THT 010801 (ID 960, 961, 962)

The food constituent that is the subject of the proposed health claims is Bifidobacterium animalis subsp. lactis THT 010801.
The strain B. animalis subsp. lactis THT 010801 is the trade name for B. animalis subsp. lactis LMG 18314, which is the type strain of B. animalis subsp. lactis. Culture collection numbers from different internationally recognised culture collections (e.g. LMG 18314, DSM 10140) were provided. Data on the identification and characterisation of B. animalis subsp. lactis THT 010801 at species and strain level, by using different phenotypic (carbohydrate fermentation pattern, PAGE) and genotypic (DNA- DNA hybridisation, 16S rRNA gene sequence analysis, 16S/23S intergenic spacer region sequence analysis, plasmidic profile, species-specific PCR, ARDRA, Rep-PCR, AFLP, ribotyping, MLST, RAPD and PFGE) methods, were provided (Alander et al., 2001; Crittenden et al., 2001; Duez et al., 2000; Masco et al., 2004; Matto et al., 2004; Roy and Sirois, 2000; Ventura and Zink, 2002; Ventura et al., 2006).
The Panel considers that the food constituent that is the subject of the proposed health claims, B. animalis subsp. lactis THT 010801, is sufficiently characterised.

1.2. Bifidobacterium longum subsp. infantis THT 010201 (ID 967, 968)

The food constituent that is the subject of the proposed health claims is Bifidobacterium longum subsp. infantis THT 010201.
For B. longum subsp. infantis THT 010201, a culture collection number from the Belgian Co-ordinated Collections of Microorganisms (LMG 25627) was provided. The BCCM/LMG is an
internationally recognised culture collection which has the status of an International Depositary Authority under the Budapest Treaty. In the LMG, cultures can be deposited in a restricted-access collection for safe deposit or for patent purposes. Data on the identification and characterisation of B. longum subsp. infantis THT 010201 at species and strain level, by using different phenotypic (cell morphology, enzymatic activities) and genotypic (16S rRNA gene sequence analysis and AFLP) methods, were provided in the applications for further assessment and in the accompanying references (BCCM/LMG, 2011a, unpublished).
The Panel considers that the food constituent that is the subject of the proposed health claims, B. longum subsp. infantis THT 010201, is sufficiently characterised.

1.3. Bifidobacterium longum subsp. longum THT 010301 (ID 969, 970)

The food constituent that is the subject of the proposed health claims is Bifidobacterium longum subsp. longum THT 010301.
For B. longum subsp. longum THT 010301, a culture collection number from the Belgian BCCM/LMG, LMG 26652, was provided. Data on the identification and characterisation of B. longum subsp. longum THT 010301 at species and strain level, by using different phenotypic (cell morphology, enzymatic activities) and genotypic (16S rRNA gene sequence analysis, AFLP) methods, were provided in the applications for further assessment and in the accompanying references (BCCM/LMG, 2011a, unpublished).
The Panel considers that the food constituent that is the subject of the proposed health claims, B. longum subsp. longum THT 010301, is sufficiently characterised.

1.4. Bifidobacterium pseudolongum subsp. pseudolongum THT 010501 (ID 971, 972)

The food constituent that is the subject of the proposed health claims is Bifidobacterium pseudolongum subsp. pseudolongum THT 010501.
The strain B. pseudolongum subsp. pseudolongum THT 010501 is the trade name for B. pseudolongum subsp. pseudolongum LMG 11571, which is the type strain of B. pseudolongum subsp. pseudolongum. Culture collection numbers from different internationally recognised culture collections (e.g. LMG 11571, ATCC 25526, DSM 20099) were provided. Data on the identification and characterisation of B. pseudolongum subsp. pseudolongum THT 010501 at species and strain level, by using different genotypic (16S rRNA gene sequence analysis, 16S/23S intergenic spacer region sequence analysis, Hsp60 sequence analysis, Rep-PCR, MLST) methods, were provided (Jian et al., 2001; Leblond- Bourget et al., 1996; Masco et al., 2003; Ventura et al., 2006).
The Panel considers that the food constituent that is the subject of the proposed health claims, B. pseudolongum subsp. pseudolongum THT 010501, is sufficiently characterised.

1.5. Lactobacillus casei THT 030401 (ID 975, 976)

The food constituent that is the subject of the proposed health claims is Lactobacillus casei THT 030401.
The strain L. casei THT 030401 is the trade name for L. casei LMG 6904, which is the type strain of L. casei. Culture collection numbers from different internationally recognised culture collections (e.g. LMG 6904, ATCC 393, DSM 20011) were provided. Data on the identification and characterisation of L. casei THT 030401 at species and strain level, by using different phenotypic (carbohydrate fermentation profile and PFGE) and genotypic (DNA-DNA hybridisation, 16S/23S rRNA intergenic spacer region sequence analysis, recombinase A and elongation factor tuf gene sequence analyses, species–specific PCR and RAPD) methods, were provided (Chavagnat et al., 2002; Dicks et al., 1996; Felis et al., 2001; Song et al., 2000; Wayne, 1994).
The Panel considers that the food constituent that is the subject of the proposed health claims, L. casei THT 030401, is sufficiently characterised.

1.6. Lactobacillus gasseri THT 031301 (ID 983, 984)

The food constituent that is the subject of the proposed health claims is Lactobacillus gasseri THT 031301.
For L. gasseri THT 031301, a culture collection number from the BCCM/LMG, LMG 26661, was provided. Data on the identification and characterisation of L. gasseri THT 031301 at species and strain level, by using different phenotypic (cell morphology, enzymatic activities) and genotypic (16S rRNA gene sequence analysis and AFLP) methods, were provided in the applications for further assessment and in the accompanying references (BCCM/LMG, 2011b, unpublished).
The Panel considers that the food constituent that is the subject of the proposed health claims, L. gasseri THT 031301, is sufficiently characterised.

1.7. Lactobacillus helveticus THT 031102 (ID 985, 986)

The food constituent that is the subject of the proposed health claims is Lactobacillus helveticus THT 031102.
For L. helveticus THT 031102, a culture collection number from the BCCM/LMG, LMG 26307, was provided. Data on the identification and characterisation of L. helveticus THT 031102 at species and strain level, by using different phenotypic (cell morphology, enzymatic activities) and genotypic (16S rRNA gene sequence analysis and AFLP) methods, were provided in the applications for further assessment and in the accompanying references (BCCM/LMG, 2011a, unpublished).
The Panel considers that the food constituent that is the subject of the proposed health claims, L. helveticus THT 031102, is sufficiently characterised.

1.8. Lactobacillus plantarum THT 030701 (ID 994, 995)

The food constituent that is the subject of the proposed health claims is Lactobacillus plantarum THT 030701.
For L. plantarum THT 030701, a culture collection number from the BCCM/LMG, LMG 26654, was provided. Data on the identification and characterisation of L. plantarum THT 030701 at species and strain level, by using different phenotypic (cell morphology, enzymatic activities) and genotypic (16S rRNA gene sequence analysis and AFLP) methods, were provided in the applications for further assessment and in the accompanying references (BCCM/LMG, 2011a, unpublished).
The Panel considers that the food constituent that is the subject of the proposed health claims, L. plantarum THT 030701, is sufficiently characterised.

1.9. Lactobacillus plantarum THT 030707 (ID 996, 997)

The food constituent that is the subject of the proposed health claims is Lactobacillus plantarum THT 030707.
For L. plantarum THT 030707, a culture collection number from the BCCM/LMG, LMG 26655, was provided. Data on the identification and characterisation of L. plantarum THT 030707 at species and strain level, by using different phenotypic (cell morphology, enzymatic activities) and genotypic (16S rRNA gene sequence analysis and AFLP) methods, were provided in the applications for further assessment and accompanying references (BCCM/LMG, 2011a, unpublished).
The Panel considers that the food constituent that is the subject of the proposed health claims, L. plantarum THT 030707, is sufficiently characterised.

1.10. Lactobacillus reuteri THT 030802 (ID 998, 999)

The food constituent that is the subject of the proposed health claims is Lactobacillus reuteri THT 030802.
The strain L. reuteri THT 030802 is the trade name for L. reuteri LMG 9213, which is the type strain of L. reuteri. Culture collection numbers from different internationally recognised culture collections (e.g. LMG 9213, ATCC 23272, DSM 20016) were provided. Data on the identification and characterisation of L. reuteri THT 030802 at species and strain level, by using different phenotypic (carbohydrate fermentation profiles) and genotypic (16S rRNA gene sequence analysis, 16S/23S intergenic spacer region sequence analysis, elongation factor tuf gene sequence analysis, species- specific PCR, REA, Rep-PCR and RAPD) methods, were provided (Chavagnat et al., 2002; Johansson et al., 1995; Kostinek et al., 2005; Kwon et al., 2004; Song et al., 2000; Yeung et al., 2002).
The Panel considers that the food constituent that is the subject of the proposed health claims, L. reuteri THT 030802, is sufficiently characterised.

1.11. Lactobacillus salivarius THT 031001 (ID 1006, 1007)

The food constituent that is the subject of the proposed health claims is Lactobacillus salivarius THT 031001.
The strain L. salivarius THT 031001 is the trade name for L. salivarius LMG 9477, which is the type strain of L. salivarius. Culture collection numbers from different internationally recognised culture collections (e.g. LMG 9477, DSM 20555) were provided. Data on the identification and characterisation of L. salivarius THT 031001 at species and strain level, by using different phenotypic (carbohydrate fermentation profiles) and genotypic (16S rRNA gene sequence analysis, 16S/23S intergenic spacer region sequence analysis, chaperoin groEL gene sequence analyses, PFGE) methods, were provided (Li et al., 2006; Rogosa et al., 1953; Takizawa et al., 1994).
The Panel considers that the food constituent that is the subject of the proposed health claims, L. salivarius THT 031001, is sufficiently characterised.

1.12. Streptococcus thermophilus THT 070102 (ID 1014, 1015)

The food constituent that is the subject of the proposed health claims is Streptococcus thermophilus THT 070102.
For S. thermophilus THT 070102, a culture collection number from the BCCM/LMG, LMG 26656, was provided. Data on the identification and characterisation of S. thermophilus THT 070102 at species and strain level, by using different phenotypic (cell morphology, enzymatic activities) and genotypic (16S rRNA gene sequence analysis and AFLP) methods, were provided in the applications for further assessment and in the references provided (BCCM/LMG, 2011a, unpublished).
The Panel considers that the food constituent that is the subject of the proposed health claims, S. thermophilus THT 070102, is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka

2.1. Zmiany w funkcjach jelita (ID 960, 961, 967, 969, 971, 975, 983, 985, 994, 996, 998, 1006, 1014)

The claimed effects, which are proposed for further assessment, are: “The micro-organisms are known, for a long time, for their intestinal impact. Indeed, the bacteria promote the digestive health by
several ways. Among other thing, they degrade indigestible substances (sugars, etc.) into lactic acid and volatile fatty acids. They participate in mobility intestinal. They contribute to the secretion and absorption of nutrients”, and “The micro-organisms are known, for a long time, for their intestinal impact. Indeed, the bacteria improve the intestinal transit, especially by their participation in mobility intestinal. In more, they participate to the degradation of some indigestible substances and their absorption by the bowel.” The proposed target population is the general population.
The Panel notes that the claimed effect “contribute to the secretion and absorption of nutrients” is not sufficiently defined, and from the references provided it was not possible to establish for which nutrients an improved digestion and absorption is claimed.
The Panel assumes that the claimed effect “degrade indigestible substances (sugars, etc.) into lactic acid and volatile fatty acids” refers to changes in short chain fatty acid (SCFA) and lactic acid production. The Panel considers that changes in SCFA and lactic acid production in the gastro-intestinal tract are not beneficial physiological effects per se, but need to be linked to a beneficial physiological or clinical outcome.
The Panel assumes that the claimed effects “they participate in mobility intestinal” and “improve the intestinal transit” refer to changes in bowel function. The Panel considers that changes in bowel function such as reduced transit time, more frequent bowel movements, increased faecal bulk, or softer stools may be a beneficial physiological effect, provided that these changes do not result in diarrhoea.

2.2. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego (ID 960, 967, 969, 971, 975, 983, 985, 994, 996, 998, 1006, 1014)

The claimed effect, which is proposed for further assessment, is: “The bacteria modulate also intestinal flora. They have a protective function by competitive inhibition on pathogen (competing for growth). They inhibit too the adhesion of these pathogens by site occupation and by production of anti- microbial substances”. The proposed target population is the general population.
The Panel assumes that the claimed effect refers to a decrease in potentially pathogenic gastro-intestinal microorganisms. The Panel considers that decreasing potentially pathogenic gastro- intestinal microorganisms might be a beneficial physiological effect.

2.3. Stymulacja odpowiedzi immunologicznej (ID 962, 968, 970, 972, 976, 984, 986, 995, 997, 999, 1007, 1015)

The claimed effect, which is proposed for further assessment, is: “A lot of study is shown an impact of bacteria on immune system. They improve, for example, the immune function by induction of various molecules and by modification of activity of some cells. The bacteria modulate also the natural defences. Indeed, they stimulate the natural defence by their presence or by production of some compounds”. The proposed target population is the general population.
The Panel notes that the claimed effect “modulation of the natural defences” is not sufficiently defined, and assumes that the claimed effect relates to the stimulation of various immunological responses. The Panel notes that stimulation of various immunological responses is not a beneficial physiological effect per se but needs to be linked to a beneficial physiological or clinical outcome.
No human studies which investigated the effect of the food constituent on any aspect of the immune system were provided in relation to any of the claims evaluated in this section.
Most of the references provided were on strains or combination of strains other than those which are the subject of the claims.
For ID 972, one in vitro study on the specific strain that is the subject of the claim, which investigated a health outcome (i.e. inhibitory effect of the strain on the adhesion of Escherichia coli O157:H7 to a
human epithelial cell line) (Gagnon et al., 2004) unrelated to the claimed effect evaluated in this section, was provided.
For ID 976, one study in animals which investigated the effects of the specific strain that is the subject of the claim on antibody production (IgG and IgM) after oral immunisation with recombinant tetanus toxin fragment C (Plant and Conway, 2002), and one in vitro study on the activation pattern of dendritic cells and the impact on T cell-dependent cytokine production from healthy and allergic donors (Ratajczak et al., 2007), were provided.
For ID 999, one in vitro study which investigated the effect of the specific strain that is the subject of the claim on the induction of cytokine secretion from splenic mononuclear cells isolated from mice (Matsuguchi et al., 2003) was provided.
The Panel considers that the evidence provided does not establish that stimulation of these immunological responses is a beneficial physiological effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the food constituents, which are the subject of the claims evaluated in this section, and a beneficial physiological effect related to stimulation of immunological responses.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka -

3.1. Zmiany w funkcjach jelita (ID 960, 961, 967, 969, 971, 975, 983, 985, 994, 996, 998, 1006, 1014)

Most of the references provided in relation to these claims were on bacterial strains or combinations of strains other than those which are the subject of the claims, or on strains in combination with other substances or on microorganisms for which information on the genus only was given. Narrative reviews on the survival of bacterial strains through the stomach and small intestine, on the isolation and selection of bacterial strains, and on the potential use of recombinant dietary lactic acid bacteria for the production of oral vaccines, which were unrelated to the claim, were also provided. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
One human intervention study on detection of the bacterial strain in faeces (Duez et al., 2000); animal or in vitro studies on induction of cytokine expression (Matsuguchi et al., 2003), inhibition of Escherichia coli urinary tract infections (Asahara et al., 2001), inhibition of Escherichia coli O157:H7 adhesion to human epithelial cells (Gagnon et al., 2004), protection against Listeria monocytogenes infection (Sato, 1984)); and/or animal and in vitro studies which addressed the potential use of a recombinant bacterial strain as carrier of proteins of immunological interest to intestinal mucosa mainly for the production of oral vaccines (Araujo Aires et al., 2006; Hazebrouck et al., 2006; Oliveira et al., 2006; Pant et al., 2006); and/or in vitro studies on the properties of the bacterial strains (e.g. survival capacity, growth at different temperatures and pH levels, viability in simulated gastro- intestinal, bile or pancreatic conditions; adhesion to human epithelial cells or to mucus from pig small intestine) (Crittenden et al., 2001; Crociani et al., 1995; Gagnon et al., 2004; Jonsson et al., 2001; Matsumoto et al., 2004; Matto et al., 2004; McMaster et al., 2005; Miyoshi et al., 2006; Todoriki et al., 2001) were also provided. The Panel notes that these studies did not address outcome measures related to the claimed effect, and considers that no conclusions can be drawn from these studies for the scientific substantiation of the claim.
The Panel notes that no human studies were provided from which conclusions could be drawn for the scientific substantiation of the claims evaluated in this section.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the food constituents which are the subject of the claims evaluated in this section and changes in bowel function.

3.2. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego (ID 960, 967, 969, 971, 975, 983, 985, 994, 996, 998, 1006, 1014)

Most of the references provided in relation to these claims were on bacterial strains or combinations of strains other than those which are the subject of the claims, or on strains in combination with other substances. Narrative reviews on the survival of bacterial strains through the stomach and small intestine, on the isolation and selection of bacterial strains, and on the potential use of recombinant dietary lactic acid bacteria for the production of oral vaccines, which were unrelated to the claim, were also provided. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
Animal studies on induction of cytokine expression (Matsuguchi et al., 2003), on inhibition of Escherichia coli urinary tract infections (Asahara et al., 2001), and/or in vitro studies on the properties of the bacterial strains (i.e. survival capacity, growth at different temperatures and pH levels, viability in simulated gastro-intestinal, bile or pancreatic conditions; adhesion to human epithelial cells or to mucus from pig small intestine) (Crittenden et al., 2001; Crociani et al., 1995; Gagnon et al., 2004; Jonsson et al., 2001; Matsumoto et al., 2004; Matto et al., 2004; McMaster et al., 2005; Miyoshi et al., 2006; Todoriki et al., 2001), were also provided. In vitro and in vivo studies in animals which addressed the potential use of recombinant bacterial strains as carriers of proteins of immunological interest to intestinal mucosa mainly for the production of oral vaccines (Araujo Aires et al., 2006; Hazebrouck et al., 2006; Oliveira et al., 2006; Pant et al., 2006) were provided for ID 975. The Panel notes that these studies did not address outcome measures related to the claimed effect, and considers that no conclusions can be drawn from these studies for the scientific substantiation of the claim.
The Panel notes that no human studies were provided from which conclusions could be drawn for the scientific substantiation of the claims evaluated in this section.
For ID 971, an in vitro study investigated the inhibition of Escherichia coli O157:H7 adhesion to a human epithelial cell line in the presence of the bacterial strain that is the subject of the claim (Gagnon et al., 2004). For ID 975, a study in animals investigated the protective activity of the bacterial strain that is the subject of the claim against Listeria monocytogenes infection (Sato, 1984). The Panel considers that in the absence of evidence for an effect on decreasing potentially pathogenic gastro- intestinal microorganisms in humans, evidence provided in animal and in vitro studies cannot be used alone for the scientific substantiation of a claim on decreasing potentially pathogenic gastro-intestinal microorganisms.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the food constituents which are the subject of the claims evaluated in this section and decreasing potentially pathogenic gastro-intestinal microorganisms.

Wnioski

On the basis of the data presented, the Panel concludes that:
The following food constituents are sufficiently characterised:
Bifidobacterium animalis subsp. lactis THT 010801 (ID 960, 961, 962),
Bifidobacterium longum subsp. infantis THT 010201 (ID 967, 968),
Bifidobacterium longum subsp. longum THT 010301 (ID 969, 970),
Bifidobacterium pseudolongum subsp. pseudolongum THT 010501 (ID 971, 972),
Lactobacillus casei THT 030401 (ID 975, 976),
Lactobacillus gasseri THT 031301 (ID 983, 984),
Lactobacillus helveticus THT 031102 (ID 985, 986),
Lactobacillus plantarum THT 030701 (ID 994, 995),
Lactobacillus plantarum THT 030707 (ID 996, 997),
Lactobacillus reuteri THT 030802 (ID 998, 999),
Lactobacillus salivarius THT 031001 (ID 1006, 1007),
Streptococcus thermophilus THT 070102 (ID 1014, 1015).
Changes in bowel function, and digestion and absorption of nutrients (ID 960, 961, 967, 969, 971, 975, 983, 985, 994, 996, 998, 1006, 1014)
The claimed effects proposed for further assessment relate to “contribute to the secretion and absorption of nutrients”, “degrade indigestible substances (sugars, etc.) into lactic acid and volatile fatty acids”, “they participate in mobility intestinal” and “improve the intestinal transit”. The claimed effect “contribute to the secretion and absorption of nutrients” is not sufficiently defined and it was not possible to establish for which nutrients an improved digestion and absorption is claimed. The claimed effect “degrade indigestible substances (sugars, etc.) into lactic acid and volatile fatty acids” is assumed to refer to changes in short chain fatty acid (SCFA) and lactic acid production. Changes in SCFA and lactic acid production in the gastro-intestinal tract are not beneficial physiological effects per se, but need to be linked to a beneficial physiological or clinical outcome. The claimed effects “they participate in mobility intestinal” and “improve the intestinal transit” are assumed to refer to changes in bowel function. The proposed target population is the general population. Changes in bowel function such as reduced transit time, more frequent bowel movements, increased faecal bulk, or softer stools may be a beneficial physiological effect, provided that these changes do not result in diarrhoea.
A cause and effect relationship has not been established between the consumption of the food constituents which are the subject of the claims and changes in bowel function.
Decreasing potentially pathogenic gastro-intestinal microorganisms (ID 960, 967, 969, 971, 975, 983, 985, 994, 996, 998, 1006, 1014)
The claimed effect proposed for further assessment relates to a decrease in potentially pathogenic gastro-intestinal microorganisms. The proposed target population is the general population. Decreasing potentially pathogenic gastro-intestinal microorganisms might be a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of the food constituents which are the subject of the claims and decreasing potentially pathogenic gastro- intestinal microorganisms.
Stimulation of immunological responses (ID 962, 968, 970, 972, 976, 984, 986, 995, 997, 999, 1007, 1015)
The claimed effect proposed for further assessment relates to the stimulation of various immunological responses. The proposed target population is the general population. The evidence provided did not establish that stimulation of immunological responses is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of the food constituents, which are the subject of the claims, and a beneficial physiological effect related to stimulation of immunological responses.

Oświadczenia zdrowotne

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