1237.pdf

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Scientific Opinion on the substantiation of health claims related to Lactobacillus casei F19 (LMG P-17806) and bowel motor function (ID 893) pursuant to Article 13(1) of Regulation (EC) No 1924/2006[sup]1[/sup] EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2 European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe: Lactobacillus casei F19 (LMG P-17806)   bowel motor function   health claims  
ID:    893  
Produkty: Lactobacillus casei F19 (LMG P- 17806)  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is Lactobacillus casei F19 (LMG P- 17806). Data regarding phenotypic and molecular characterisation of the strain were reported in the literature (Charteris et al., 2001; Björneholm et al., 2002).
The Panel notes that a culture collection number from the LMG (BCCM/LMG Belgian Co-ordinated Collections of Microorganisms) culture collection is given. In the LMG, which is being a non-public International Depositary Authority under the Budapest Treaty, cultures can be deposited in a restricted-access collection as Patent deposits.
The Panel considers that the food constituent, Lactobacillus casei F19 (LMG P-17806), which is the subject of the health claim, is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka

The claimed effect is “digestive health, intestinal flora and gut function”. The Panel assumes that the target population is the general population.
“Digestive health, intestinal flora and gut function” is not sufficiently defined. In the context of the proposed wording, the Panel assumes that the claimed effect refers to aspects of:
“normalises/promotes bowel movement/activity/regularity”. Changes in bowel function within the normal range e.g. reduced transit time, increased frequency of bowel movements or bulk of stools might be interpreted as improvement of bowel motor function.
The Panel considers that improvement of bowel motor function within the normal range is beneficial to human health.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Poprawa motoryki jelit

Thirty references were cited to substantiate the claimed effect. The references provided include 11 human intervention studies, 16 review articles (focusing on “probiotics”, “prebiotics”, lactic acid bacteria, intestinal bacteria, antibiotic-associated diarrhoea, constipation and gut health and immunity) and 3 meta-analyses (on acute diarrhoea or antibiotic-associated diarrhoea). The review articles and meta-analyses did not relate to Lactobacillus casei F19 (LMG P-17806).
In one human intervention studies, Lactobacillus casei F19 was found in faecal samples after oral ingestion, demonstrating survival in healthy infants, adults and elderly people (Crittenden et al., 2002). In addition, the strain transiently could be recovered from the colonic mucosa (Crittenden et al., 2002). Two other intervention studies investigated the effect of Lactobacillus casei F19 alone or with inulin on lactobacilli, bifidobacteria and Clostridium difficile in the intestinal microflora in elderly and children (Sullivan et al., 2001; Sullivan et al., 2002). The Panel notes that no evidence has been provided to show that the changes in the parameters measured are improving bowel motor function.
The other human intervention studies included either a mixture of bacterial strains (2 studies) or did not include Lactobacillus casei F19 (6 studies).
The Panel notes that none of the references provided addressed the relationship between the consumption of Lactobacillus casei F19 (LMG P-17806) and bowel motor function and did not provide any scientific data that could be used to substantiate the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of Lactobacillus casei F19 (LMG P-17806) and improvement of bowel motor function within the normal range.

Wnioski

On the basis of the data available, the Panel concludes that:
The food constituent, Lactobacillus casei F19 (LMG P-17806), which is the subject of the health claim is sufficiently characterised.
The claimed effect is “digestive health, intestinal flora and gut function”. The target population is assumed to be the general population. Improvement of bowel motor function within the normal range is beneficial to human health.
A cause and effect relationship has not been established between the consumption of Lactobacillus casei F19 (LMG P-17806) and improvement of bowel motor function within the normal range.