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

• Published in: EFSA journal Vol. 15; no. 5; pp. e04776 - n/a
• Main Authors: Turck, Dominique, Bresson, Jean‐Louis, Burlingame, Barbara, Dean, Tara, Fairweather‐Tait, Susan, Heinonen, Marina, Hirsch‐Ernst, Karen Ildico, Mangelsdorf, Inge, McArdle, Harry J, Naska, Androniki, Neuhäuser‐Berthold, Monika, Nowicka, Grażyna, Pentieva, Kristina, Sanz, Yolanda, Siani, Alfonso, Sjödin, Anders, Stern, Martin, Tomé, Daniel, Vinceti, Marco, Willatts, Peter, Engel, Karl‐Heinz, Marchelli, Rosangela, Pöting, Annette, Poulsen, Morten, Schlatter, Josef Rudolf, Turla, Emanuela, Van Loveren, Henk
• Format: Journal Article
• Language: English
• Published: Hoboken John Wiley & Sons, Inc 01.05.2017; John Wiley and Sons Inc; Wiley
• Subjects: Adults; Alginic acid; Allergies; Body weight; Competent authority; Diet; Dietary supplements; Food; Food fortification; Food safety; Fortified foods; ingredient; konjac glucomannan; Non-starch polysaccharides; novel food; Novel foods; Nutrition research; PGX; Polysaccharides; Saccharides; Safety; Scientific Opinion; Sodium alginate; Toxicity; Viscosity; Xanthan; Xanthan gum; Ireland
• DOI: 10.2903/j.efsa.2017.4776
• ISSN: 1831-4732

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.