Back to Search Start Over

Safety of alginate-konjac-xanthan polysaccharide complex (PGX) as a novel food pursuant to Regulation (EC) No 258/97.

Authors :
Turck D
Bresson JL
Burlingame B
Dean T
Fairweather-Tait S
Heinonen M
Hirsch-Ernst KI
Mangelsdorf I
McArdle HJ
Naska A
Neuhäuser-Berthold M
Nowicka G
Pentieva K
Sanz Y
Siani A
Sjödin A
Stern M
Tomé D
Vinceti M
Willatts P
Engel KH
Marchelli R
Pöting A
Poulsen M
Schlatter JR
Turla E
Van Loveren H
Source :
EFSA journal. European Food Safety Authority [EFSA J] 2017 May 08; Vol. 15 (5), pp. e04776. Date of Electronic Publication: 2017 May 08 (Print Publication: 2017).
Publication Year :
2017

Abstract

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on alginate-konjac-xanthan polysaccharide complex (PGX) as a novel food (NF) submitted pursuant to Regulation (EC) No 258/97. The NF is an off-white granular powder composed of three non-starch polysaccharides: konjac glucomannan, xanthan gum and sodium alginate. The information provided on the composition, the specifications, the batch-to-batch variability and the stability of the NF is sufficient and does not raise safety concerns. The production process is sufficiently described and does not raise concerns about the safety of the NF. The applicant intends to add the NF to a variety of foods as well as to market the NF in capsules. The recommended maximum daily intake of the NF from fortified foods and food supplements is 15 g. The target population proposed by the applicant is adults from 18 to 64 years of age. Considering the no observed adverse effect level of 1.8 g/kg body weight (bw) per day in a subchronic toxicity study with PGX and the highest mean and 95th percentile anticipated daily intake of NF from fortified foods, the margin of exposure (MoE) is 12 and 6, respectively, whereas the MoE for the NF from food supplements is 9. The Panel concludes that the safety of the novel food, PGX, for the intended uses and use levels as proposed by the applicant, has not been established.<br /> (© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)

Details

Language :
English
ISSN :
1831-4732
Volume :
15
Issue :
5
Database :
MEDLINE
Journal :
EFSA journal. European Food Safety Authority
Publication Type :
Academic Journal
Accession number :
32625482
Full Text :
https://doi.org/10.2903/j.efsa.2017.4776