Scientific Opinion on the substantiation of a health claim related to beta-palmitate and contribution to softening of stools pursuant to Article 14 of Regulation (EC) No 1924/2006

TY - JOUR

T1 - Scientific Opinion on the substantiation of a health claim related to beta-palmitate and contribution to softening of stools pursuant to Article 14 of Regulation (EC) No 1924/2006

AU - Tetens, Inge

AU - Sjödin, Anders Mikael

AU - EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)

PY - 2014/2/1

Y1 - 2014/2/1

N2 - Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to beta-palmitate and contribution to softening of stools. The food constituent, beta-palmitate, that is the subject of the health claim, is sufficiently characterised. Contribution to softening of stools is a beneficial physiological effect for infants. In weighing the evidence the Panel took into account that, out of two human intervention studies with important methodological limitations, one suggested a stool-softening effect of beta-palmitate whereas the second did not, that one animal study did not support a stool-softening effect of beta-palmitate, and that the evidence provided for a mechanism by which beta-palmitate could contribute to the softening of stools is weak. The Panel concludes that a cause and effect relationship has not been established between the consumption of beta-palmitate and softening of stools.

AB - Following an application from Specialised Nutrition Europe (formerly IDACE), submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to beta-palmitate and contribution to softening of stools. The food constituent, beta-palmitate, that is the subject of the health claim, is sufficiently characterised. Contribution to softening of stools is a beneficial physiological effect for infants. In weighing the evidence the Panel took into account that, out of two human intervention studies with important methodological limitations, one suggested a stool-softening effect of beta-palmitate whereas the second did not, that one animal study did not support a stool-softening effect of beta-palmitate, and that the evidence provided for a mechanism by which beta-palmitate could contribute to the softening of stools is weak. The Panel concludes that a cause and effect relationship has not been established between the consumption of beta-palmitate and softening of stools.

KW - Faculty of Science

KW - Beta-palmitate

KW - Stools

KW - Infant formula

KW - Helath claims

U2 - 10.2903/j.efsa.2014.3578

DO - 10.2903/j.efsa.2014.3578

M3 - Journal article

SN - 1831-4732

VL - 12

JO - E F S A Journal

JF - E F S A Journal

IS - 2

M1 - 3578

ER -