ID 806 - Laktuloza

PL: Laktuloza
EN: LACTULOSE
Pdf: lactulose

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is lactulose which is an artificial disaccharide with the chemical formula 4-O-β-D-Galactopyranosyl-β-D-fructofuranose. Lactulose can be generated by alkaline isomerisation of lactose or by enzyme-catalysed synthesis (Schuster-Wolff- Buhring et al., 2010). Lactulose is a well-characterised food constituent.
The Panel considers that the food constituent, lactulose, which is the subject of the health claims, is sufficiently characterised.

2.1. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego (ID 806)

The claimed effect is “probiotic/bifidogenic”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effect refers to the capacity of the food constituent to increase the numbers of bacteria that are considered to be “healthy/balanced/good”.
The numbers/proportions of bacterial groups that would constitute a “healthy/balanced/good gut flora or microflora” have not been established. Increasing the number of any groups of microorganisms, including lactobaccilli and/or bifidobacteria, is not in itself considered to be a beneficial physiological effect.
The Panel considers that the evidence provided does not establish that increasing the 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.

3.1. Zmniejszenie ilości potencjalnie patogennych mikroorganizmów przewodu pokarmowego (ID 806)

The references cited consisted of seven studies in human subjects. Two human studies investigated yoghurt supplemented with a specific Bifidobacterium strain and lactulose, while two other human studies related to lactulose did not address changes in pathogens. The Panel notes that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
In the study by Terada et al. (1992), the effect of dietary lactulose was evaluated in eight healthy volunteers at the level of 3 g/day. The study reported on potentially pathogenic bacteria (lecithinase- positive Clostridium perfringens). However, the Panel notes the weaknesses of the study including the methodology used for microbiological analyses, the small number of subjects, and that the study was not blinded, which limits its value as a source of data to substantiate an effect of the consumption of lactulose on decreasing potentially pathogenic gastro-intestinal microorganisms.
In the study by Tuohy et al. (2002), 10 g of lactulose was given to 10 healthy volunteers and a further 10 healthy volunteers received a 5 g glucose and 5 g lactose dose for 22-33 days. The dose of lactulose used in the study was significantly higher than the dose proposed in the conditions of use. Using culture methods, clostridia were analysed. No other changes were reported. The Panel notes that clostridia represent a large group of bacteria that are part of the commensal intestinal microbiota and that the study did not provide evidence of their characterisation as pathogens. In another study in 36 healthy volunteers (Ballongue et al., 1997), the effects of lactulose, lactitol, and placebo consumption (2 x 10 g/day) on the composition of the faecal microbiota were determined, including analyses of the following bacterial groups Bacteroides, Clostridium, Bifidobacterium, coliforms, Eubacterium, Lactobacillus and Streptococcus. The Panel notes that the bacterial groups analysed in this study are also part of the commensal intestinal microbiota and the study did not provide evidence of the characterisation of any of these groups as pathogens. The Panel considers that no conclusions can be drawn from these studies 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 lactulose and decreasing potentially pathogenic gastro-intestinal microorganisms.

5. Warunki i możliwe ograniczenia stosowania oświadczenia

The Panel considers that in order to obtain the claimed effect at least 10 g of lactulose per day should be consumed in a single serving. The target population is the general population.

Warunki i możliwe ograniczenia stosowania oświadczenia

2,5 g/day