Open AccessSafety of alginate‐konjac‐xanthan polysaccharide complex ( PGX ) as a novel food pursuant to Regulation ( EC ) No 258/97
Author(s) -
Turck Dominique,
Bresson JeanLouis,
Burlingame Barbara,
Dean Tara,
FairweatherTait Susan,
Hein Marina,
HirschErnst Karen Ildico,
Mangelsdorf Inge,
McArdle Harry J,
Naska Androniki,
NeuhäuserBerthold Monika,
Nowicka Grażyna,
Pentieva Kristina,
Sanz Yolanda,
Siani Alfonso,
Sjödin Anders,
Stern Martin,
Tomé Daniel,
Vinceti Marco,
Willatts Peter,
Engel KarlHeinz,
Marchelli Rosangela,
Pöting Annette,
Poulsen Morten,
Schlatter Josef Rudolf,
Turla Emanuela,
Van Loveren Henk
Publication year - 2017
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2017.4776
Subject(s) - xanthan gum , food science , food safety , european commission , food additive , polysaccharide , population , chemistry , microbiology and biotechnology , business , medicine , biology , european union , environmental health , biochemistry , materials science , rheology , composite material , economic policy
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.