Lactitol and the maintenance of normal defecation: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006: (Scientific Opinion)
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Lactitol and the maintenance of normal defecation: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 : (Scientific Opinion). / EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA).
In: E F S A Journal, Vol. 13, No. 10, 4252, 13.10.2015.Research output: Contribution to journal › Journal article › Commissioned › peer-review
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TY - JOUR
T1 - Lactitol and the maintenance of normal defecation: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006
T2 - (Scientific Opinion)
AU - EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)
AU - Sjödin, Anders Mikael
N1 - EFSA 2015 4252
PY - 2015/10/13
Y1 - 2015/10/13
N2 - Following an application from DuPont Nutrition BioSciences ApS, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to lactitol and the maintenance of normal defecation. The food constituent that is the subject of the claim is lactitol. The Panel considers that the food constituent lactitol, which is the subject of the claim, is sufficiently characterised. The Panel considers that the maintenance of normal defecation is a beneficial physiological effect. A total of 15 human intervention studies were identified as pertinent to the health claim. Twelve studies with various methodological limitations consistently showed that consumption of at least 10 g/day lactitol increases stool frequency; five out of six studies found that lactitol softens stool consistency; and two studies showed that lactitol increases stool bulk. The Panel also acknowledges the plausible mechanisms of action by which lactitol could exert the claimed effect. The dose of 10 g/day lactitol does not induce diarrhoea. The Panel concludes that a cause and effect relationship has been established between the consumption of lactitol and the maintenance of normal defecation. The following wording reflects the scientific evidence: “lactitol can contribute to normal defecation”. To obtain the claimed effect, 10 g of lactitol should be consumed daily. The target population is the general adult population.
AB - Following an application from DuPont Nutrition BioSciences ApS, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to lactitol and the maintenance of normal defecation. The food constituent that is the subject of the claim is lactitol. The Panel considers that the food constituent lactitol, which is the subject of the claim, is sufficiently characterised. The Panel considers that the maintenance of normal defecation is a beneficial physiological effect. A total of 15 human intervention studies were identified as pertinent to the health claim. Twelve studies with various methodological limitations consistently showed that consumption of at least 10 g/day lactitol increases stool frequency; five out of six studies found that lactitol softens stool consistency; and two studies showed that lactitol increases stool bulk. The Panel also acknowledges the plausible mechanisms of action by which lactitol could exert the claimed effect. The dose of 10 g/day lactitol does not induce diarrhoea. The Panel concludes that a cause and effect relationship has been established between the consumption of lactitol and the maintenance of normal defecation. The following wording reflects the scientific evidence: “lactitol can contribute to normal defecation”. To obtain the claimed effect, 10 g of lactitol should be consumed daily. The target population is the general adult population.
KW - Faculty of Science
KW - Lactitol
KW - Defecation
KW - Bowel function
KW - Health claim
U2 - 10.2903/j.efsa.2015.4252
DO - 10.2903/j.efsa.2015.4252
M3 - Journal article
VL - 13
JO - E F S A Journal
JF - E F S A Journal
SN - 1831-4732
IS - 10
M1 - 4252
ER -
ID: 187583800