Scientific Opinion on the substantiation of health claims related to
Lactobacillus paracasei LMG P-22043 and decreasing potentially
pathogenic gastro-intestinal microorganisms (ID 2964) and reduction of
gastro-intestinal discomfort (ID 2964) 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
Słowa kluczowe:
Lactobacillus paracasei LMG P-22043
gastro-intestinal discomfort
health claims
potentially pathogenic microorganisms
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claims is Lactobacillus paracasei LMG P-22043.
Reference to the identification/characterisation of the strain Lactobacillus paracasei LMG P-22043, also known as L. paracasei IMPC 2.1 (Lavermicocca et al., 2004), is included or cited in the studies provided as reference material (Lavermicocca et al., 2004; 2005). The strain has been identified/characterised by PCR, REP-PCR, ARDRA and 16S rRNA-gene sequencing (sequence deposited in Genbank with accession number EU187503).
A culture collection number from the BCCM/LMG (Belgian Co-ordinated Collections of Microorganisms) culture collection is provided. In the BCCM/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 Panel considers that the food constituent, Lactobacillus paracasei LMG P-22043, which is the subject of the health claims, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego (ID 2964)
The claimed effect is “intestinal flora”. The Panel assumes that the target population is the general population.
In the context of the proposed wording, the Panel assumes that the claimed effect refers to changing the number of gastro-intestinal microorganisms.
The numbers/proportions of bacterial groups which would constitute a “healthy or beneficial intestinal flora” have not been established. Increasing the number of any groups of microorganisms is not in itself considered to be a beneficial physiological effect. The Panel considers that the evidence
provided does not establish that increasing numbers of gastro-intestinal microorganisms is a beneficial
physiological effect.
The Panel considers that decreasing potentially pathogenic gastro-intestinal microorganisms might be a beneficial physiological effect.
2.2. Zmniejszenie dolegliwości ze strony przewodu pokarmowego (ID 2964)
The claimed effect is “intestinal flora”. The Panel assumes that the target population is the general population.
In the context of the clarifications provided by Member States, the Panel assumes that the claimed effect refers to the reduction of gastro-intestinal discomfort.
The Panel considers that reduction of gastro-intestinal discomfort is a beneficial physiological effect.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka
3.1. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego (ID 2964)
A total of five references were cited in relation to this claim. One was a letter from an authoritative body about the enrichment of vegetable products with “probiotics” and their labelling. Three references were not related to the claimed effect, i.e. one review and one in vitro study described the suitability of vegetable carriers to deliver “probiotic” species into the human gastro-intestinal tract and one paper reported on the in vitro and in vivo survival and transit tolerance of “probiotic” strains carried by artichokes in the gastro-intestinal tract. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
An in vitro study screened the antagonistic activity of various Lactobacillus strains, including L. paracasei LMG P-22043, against the ureolytic pathogen Yersinia enterocolitica. The Panel considers that while effects shown in in vitro studies may be used as supportive evidence, human studies are required for the substantiation of a claim, and that evidence provided in in vitro studies alone is not sufficient to predict the occurrence of an effect of L. paracasei LMG P-22043 consumption on decreasing potentially pathogenic gastro-intestinal microorganisms in humans.
No human studies were provided which addressed outcomes related to the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus paracasei LMG P-22043 and decreasing potentially pathogenic gastro-intestinal microorganisms.
3.2. Zmniejszenie dolegliwości ze strony przewodu pokarmowego (ID 2964)
A total of five references were cited in relation to this claim (see also section 3.1). None of the references addressed outcomes related to gastro-intestinal discomfort. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus paracasei LMG P-22043 and reduction of gastro-intestinal discomfort.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, Lactobacillus paracasei LMG P-22043, which is the subject of the health claim, is sufficiently characterised.
Decreasing potentially pathogenic gastro-intestinal microorganisms (ID 2964)
The claimed effect is “intestinal flora”. The target population is assumed to be the general population. In the context of the proposed wording, it is assumed that the claimed effect refers to changing the number of gastro-intestinal microorganisms. 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 Lactobacillus paracasei LMG P-22043 and decreasing potentially pathogenic gastro-intestinal microorganisms.
Reduction of gastro-intestinal discomfort (ID 2964)
The claimed effect is “intestinal flora”. The target population is assumed to be the general population. In the context of the clarifications provided by Member States, it is assumed that the claimed effect refers to the reduction of gastro-intestinal discomfort. Reduction of gastro- intestinal discomfort is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of Lactobacillus paracasei LMG P-22043 and reduction of gastro-intestinal discomfort.
