1244.pdf

Oryginał 
Scientific Opinion on the substantiation of health claims related to Lactobacillus rhamnosus HN001 (AGAL NM97/09514) and decreasing potentially pathogenic intestinal microorganisms (ID 908) 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 rhamnosus HN001 (AGAL NM97/09514)   gut health   health claims   intestinal flora   potentially pathogenic microorganisms  
ID:    908  
Produkty: Lactobacillus rhamnosus HN001 AGAL NM97/09514  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is Lactobacillus rhamnosus HN001 AGAL NM97/09514 (hereafter L. rhamnosus HN001 AGAL NM97/09514). The strain L. rhamnosus HN001 (also known as L. rhamnosus DR20) species identity as well as the strain identity and characteristics have been determined using phenotypic and genotypic methods as indicated in the references provided (Prasad et al., 1998). The Panel notes that a culture collection number from the Australian Government Analytical Laboratories (AGAL) is provided. The AGAL is a restricted-access non- public International Depositary Authority under the Budapest Treaty.
The Panel considers that the food constituent, Lactobacillus rhamnosus HN001 (AGAL NM97/09514), which is the subject of the health claim, is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka

The claimed effect is “gut health”. The Panel assumes that the target population is the general population.
“Gut health” is not sufficiently defined. In the context of the proposed wording, the Panel assumes that the claimed effect refers to aspects of: “probiotic, improve the level of natural good bacteria, maintain the balance of a healthy microflora, and beneficially affect the intestinal flora”.
The numbers/proportions of bacterial groups that would constitute a “balanced/healthy intestinal flora” have not been established. Increasing the number of any groups of bacteria is not in itself considered as beneficial. The Panel considers that no evidence has been provided that aspects of the claimed effect, “probiotic” and “improve the level of natural good bacteria”, are beneficial to human health.
The Panel considers that “maintain the balance of a healthy microflora/beneficially affect the intestinal flora” in the context of decreasing potentially pathogenic intestinal microorganisms might be beneficial to human health.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Zmniejszenie ilość potencjalnie patogennych bakterii jelitowych

Thirty-two references were cited to substantiate the claimed effect.
One reference refers to a human intervention study (Tannock et al., 2000). The study evaluates the effect of six months intervention with daily consumption of 1.6 × 109 cfu Lactobacillus rhamnosus DR20 (also known as L. rhamnosus HN001) on intestinal microbiota composition of ten healthy volunteers. Survival of the strain during gastrointestinal transit and counts of intestinal lactobacilli and enterococci levels were reported. The intervention did not affect other faecal biochemical or bacteriological factors, including potentially pathogenic intestinal microorganisms.
The other references provided include reviews, numerous in vitro studies focusing on strain identification/characterisation and in vitro safety evaluation and animal studies assessing safety as well as studies on the effects of the strain on infection after oral challenge experiments, and one study related to examination of lactobacillus colonisation in infants. The Panel notes that these references did not provide any scientific data that could be used to substantiate the claimed effect.
The Panel notes that none of the references provided evidence for a relationship between the consumption of Lactobacillus rhamnosus HN001 (AGAL NM97/09514) and decreasing potentially pathogenic intestinal microorganisms.
The Panel concludes that a cause and effect relationship has not been established between the consumption of L. rhamnosus HN001 (AGAL NM97/09514) and decreasing potentially pathogenic intestinal microorganisms.

Wnioski

On the basis of the data available, the Panel concludes that:
The food constituent, Lactobacillus rhamnosus HN001 (AGAL NM97/09514), which is the subject of the health claim, is sufficiently characterised.
The claimed effect is “gut health. The target population is assumed to be the general population. Decreasing potentially pathogenic intestinal microorganisms might be beneficial to human health.
A cause and effect relationship has not been established between the consumption of L. rhamnosus HN001 (AGAL NM97/09514) and decreasing potentially pathogenic intestinal microorganisms.