Scientific Opinion on the substantiation of health claims related to a combination of Lactobacillus acidophilus BCCM/LMG P-18806, Lactobacillus delbrueckii BCCM/LMG P-18805 and Streptococcus thermophilus BCCM/LMG P-18807 and reduction of gastro-intestinal discomfort (ID 2946, 2951, 2974), decreasing potentially pathogenic gastro- intestinal microorganisms (ID 2946, 2951, 2974), improved lactose digestion (ID 2946, 2951, 2974), and reduction in numbers of circulating CD34+ cells (ID 2947, 2952, 2975) (further assessment) pursuant to Article 13(1) of Regulation (EC) No 1924/2006[sup]1[/sup] EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3 European Food Safety Authority (EFSA), Parma, Italy ABSTRACT Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide a scientific opinion on health claims pursuant to Article 13 of Regulation (EC) No 1924/2006 in the framework of further assessment related to a combination of Lactobacillus acidophilus BCCM/LMG P-18806, Lactobacillus delbrueckii BCCM/LMG P-18805 and Streptococcus thermophilus BCCM/LMG P-18807 and reduction of gastro-intestinal discomfort, decreasing potentially pathogenic gastro- intestinal microorganisms, improved lactose digestion, and reduction in numbers of circulating CD34+ cells. The food constituent that is the subject of the health claim, a combination of L. acidophilus BCCM/LMG P-18806, L. delbrueckii BCCM/LMG P-18805 and S. thermophilus BCCM/LMG P-18807, is sufficiently characterised. The evidence provided did not establish that the proposed claimed effect, reduction in numbers of circulating CD34+ cells, is a beneficial physiological effect. The claimed effect, reduction of gastro-intestinal discomfort, is a beneficial physiological effect for the general population. The claimed effect, a decrease in potentially pathogenic gastro-intestinal microorganisms, might be a beneficial physiological effect for the general population. The claimed effect, improved lactose digestion, is a beneficial physiological effect for individuals with lactose maldigestion. No human intervention studies were provided from which conclusions could be drawn for the scientific substantiation of the above-mentioned claims. On the basis of the data provided, the Panel concludes that a cause and effect relationship has not been established between the consumption of a

Słowa kluczowe: CD34+ cells Lactobacillus acidophilus P-18806 Lactobacillus delbrueckii P-18805 Streptococcus thermophilus P-18807 gastro-intestinal discomfort health claims lactose digestion pathogens

Produkty: Lactobacillus delbrueckii P 18805 Streptococcus thermophilus P 18807 Lactobacillus acidophilus P 18806

1. Charakterystyka żywności / składnika

The food constituent that was the subject of the health claims in the initial assessment was Lactobacillus acidophilus P-18806 (ID 2946, 2947), Lactobacillus delbrueckii P-18805 (ID 2951, 2952) or Streptococcus thermophilus P-18807 (ID 2974, 2975), individually. For further assessment, and from the proposed wording and conditions of use, the Panel assumes that the food constituent that is the subject of the health claims is a combination of Lactobacillus acidophilus BCCM/LMG P-18806, Lactobacillus delbrueckii BCCM/LMG P-18805 and Streptococcus thermophilus BCCM/LMG P-18807.
For L. acidophilus BCCM/LMG P-18806 a culture collection number from the Belgian Co-ordinated Collections of Microorganisms (BCCM/LMG) (P-18806) 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 L. acidophilus BCCM/LMG P-18806 at species and strain level, by using different phenotypic (cell morphology, carbohydrate fermentation profile, PAGE) and genotypic (16S rRNA gene sequence analysis, ARDRA, Rep-PCR, PFGE) methods, were provided in the applications for further assessment and in the accompanying references (AAT, 2011a, unpublished; BCCM/LMG, 1999, unpublished; Dondi, 2000). The Panel considers that L. acidophilus BCCM/LMG P-18806 is sufficiently characterised.
For L. delbrueckii BCCM/LMG P-18805, a culture collection number from the BCCM/LMG, P-18805, was provided. Data on the identification and characterisation of L. delbrueckii BCCM/LMG P-18805 at species and strain level, by using different phenotypic (carbohydrate fermentation profiles, PAGE) and genotypic (16S rRNA gene sequence analyses, ARDRA, Rep-PCR, AFLP) methods, were provided in the applications for further assessment and in the accompanying references (AAT, 2011b, unpublished, 2011c, unpublished; BCCM/LMG, 1999, unpublished; Dondi, 2000). The Panel considers that L. delbrueckii BCCM/LMG P-18805 is sufficiently characterised.
For S. thermophilus BCCM/LMG P-18807, a culture collection number from the BCCM/LMG, P-18807, was provided. Data on the identification and characterisation of S. thermophilus BCCM/LMG P-18807 at species and strain level, by using different phenotypic (carbohydrate
fermentation profile, PAGE) and genotypic (16S rRNA gene sequence analysis, ARDRA, Rep-PCR, PFGE) methods, were provided in the applications for further assessment and in the accompanying references (AAT, 2011d, unpublished; BCCM/LMG, 1999, unpublished; Dondi, 2000). The Panel considers that S. thermophilus BCCM/LMG P-18807 is sufficiently characterised.
The Panel considers that the food constituent, a combination of L. acidophilus BCCM/LMG P-18806, L. delbrueckii BCCM/LMG P-18805 and S. thermophilus BCCM/LMG P-18807, which is the subject of the claims, is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka

2.1. Zmniejszenie dolegliwości ze strony przewodu pokarmowego (ID 2946, 2951, 2974)

2.2. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego (ID 2946, 2951, 2974)

The claimed effect, which is proposed for further assessment, is: “Is a probiotic; Contributes to a healthy digestive system by supporting the gut flora through an increased number of positive lactobacillus in the intestine; useful to maintain a healthy intestinal flora by adhering to the mucosa; Improves intestinal barrier function by competing (steric encumbrance) against pathogens; Reduces gastro-intestinal discomfort; Necessary to maintain a healthy digestive system by production of specific enzymes (e.g.: beta-galactosidase)”. The proposed target population is the general population.
The Panel notes that it is not possible to define the exact number of the different microbial groups which constitute a normal microbiota. Increasing the number of any groups of microorganisms, including lactobacilli, is not in itself considered to be a beneficial physiological effect.
The Panel assumes that the claimed effect refers to 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. Poprawa trawienia laktozy (ID 2946, 2951, 2974)

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

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

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

3. Naukowe uzasadnienia wpływu na zdrowie człowieka -

3.1. Zmniejszenie dolegliwości ze strony przewodu pokarmowego (ID 2946, 2951, 2974)

Most of the references provided were on L. acidophilus strains other than the one which is part of the combination of microorganisms (Bernet et al., 1994), and on methodologies for bacterial strain identification (Giraffa et al., 1998; Jensen et al., 1993; Miteva et al., 2001; Moschetti et al., 1998; Ventura et al., 2000). A patent on methods for selection of Lactobacillus strains with ability to adhere to human mucosa (Dondi, 2000), by which the strains that are the subject of the claim were isolated, and a human intervention study on the viability of yogurt bacteria (e.g. L. delbrueckii subsp. bulgaricus and S. thermophilus) through the human intestinal tract (Elli et al., 2006) were also provided. The Panel notes that these studies did not address effects of the combination of strains that is the subject of the claim, 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 concludes that a cause and effect relationship has not been established between the consumption of a combination of L. acidophilus BCCM/LMG P-18806, L. delbrueckii BCCM/LMG P-18805 and S. thermophilus BCCM/LMG P-18807 and reduction of gastro-intestinal discomfort.

3.2. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego (ID 2946, 2951, 2974)

Most of the references provided were on L. acidophilus strains other than the one which is part of the combination of microorganisms (Bernet et al., 1994), and on methodologies for bacterial strain identification (Giraffa et al., 1998; Jensen et al., 1993; Miteva et al., 2001; Moschetti et al., 1998; Ventura et al., 2000). A patent on methods for selection of Lactobacillus strains with ability to adhere to human mucosa (Dondi, 2000), by which the strains that are the subject of the claim were isolated,
was also provided. In the patent it was only indicated how the mucosa-adhesion ability of the lactic acid bacterial strains and pathogens was measured. A human intervention study on the viability of yogurt bacteria (e.g. L. delbrueckii subsp. bulgaricus and S. thermophilus) through the human intestinal tract (Elli et al., 2006) was also provided. The Panel notes that these studies did not address effects of the combination of strains that is the subject of the claim, notes that they 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 concludes that a cause and effect relationship has not been established between the consumption of a combination of L. acidophilus BCCM/LMG P-18806, L. delbrueckii BCCM/LMG P-18805 and S. thermophilus BCCM/LMG P-18807 and decreasing potentially pathogenic gastro- intestinal microorganisms.

3.3. Poprawa trawienia laktozy (ID 2946, 2951, 2974)

Most of the references provided were on L. acidophilus strains other than the one which is part of the combination of microorganisms (Bernet et al., 1994), and on methodologies for bacterial strain identification (Giraffa et al., 1998; Jensen et al., 1993; Miteva et al., 2001; Moschetti et al., 1998; Ventura et al., 2000). A patent on methods for selection of lactobacilli strains with ability to adhere to human mucosa (Dondi, 2000), by which the strains that are the subject of the claim were isolated and a human intervention study on the viability of yogurt bacteria (i.e. L. delbrueckii subsp. bulgaricus and S. thermophilus) through the human intestinal tract (Elli et al., 2006) were also provided. The Panel notes that these studies did not address effects of the combination of strains that is the subject of the claim, notes that they 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 concludes that a cause and effect relationship has not been established between the consumption of a combination of L. acidophilus BCCM/LMG P-18806, L. delbrueckii BCCM/LMG P-18805 and S. thermophilus BCCM/LMG P-18807 and improved lactose digestion.

Wnioski

On the basis of the data presented, the Panel concludes that:
The food constituent, a combination of L. acidophilus BCCM/LMG P-18806, L. delbrueckii BCCM/LMG P-18805 and S. thermophilus BCCM/LMG P-18807, which is the subject of the health claims, is sufficiently characterised.
Reduction of gastro-intestinal discomfort (ID 2946, 2951, 2974)
The claimed effect proposed for further assessment relates to a reduction of gastro-intestinal discomfort. The proposed target population is the general population. Reduction of gastro-intestinal discomfort is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of a combination of L. acidophilus BCCM/LMG P-18806, L. delbrueckii BCCM/LMG P-18805 and S. thermophilus BCCM/LMG P-18807 and reduction of gastro-intestinal discomfort.
Decreasing potentially pathogenic gastro-intestinal microorganisms (ID 2946, 2951, 2974)
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 a combination of L. acidophilus BCCM/LMG P-18806, L. delbrueckii BCCM/LMG P-18805 and S. thermophilus BCCM/LMG P-18807 and decreasing potentially pathogenic gastro- intestinal microorganisms.
Improved lactose digestion (ID 2946, 2951, 2974)
The claimed effect proposed for further assessment relates to improved lactose digestion. Improved lactose digestion is a beneficial physiological effect for individuals with lactose maldigestion.
A cause and effect relationship has not been established between the consumption of a combination of L. acidophilus BCCM/LMG P-18806, L. delbrueckii BCCM/LMG P-18805 and S. thermophilus BCCM/LMG P-18807 and improved lactose digestion.
Reduction in numbers of circulating CD34+ cells (ID 2947, 2952, 2975)
The claimed effect proposed for further assessment relates to a reduction in numbers of circulating CD34+ cells. The proposed target population is the general population. The evidence provided did not establish that reduction in numbers of circulating CD34+ cells is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of a combination of L. acidophilus BCCM/LMG P-18806, L. delbrueckii BCCM/LMG P-18805 and S. thermophilus BCCM/LMG P-18807 and a beneficial physiological effect related to reduction in numbers of circulating CD34+ cells.

Oświadczenia zdrowotne

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