Open AccessSafety of the extension of use of galacto‐oligosaccharides as a Novel food pursuant to Regulation ( EU ) 2015/2283
Author(s) -
Turck Dominique,
Bohn Torsten,
Castenmiller Jacqueline,
De Henauw Stefaan,
HirschErnst Karen Ildico,
Maciuk Alexandre,
Mangelsdorf Inge,
McArdle Harry J,
Naska Androniki,
Pelaez Carmen,
Pentieva Kristina,
Siani Alfonso,
Thies Frank,
Tsabouri Sophia,
Vinceti Marco,
Cubadda Francesco,
Frenzel Thomas,
Hein Marina,
Marchelli Rosangela,
NeuhäuserBerthold Monika,
Poulsen Morten,
Prieto Maradona Miguel,
Schlatter Josef Rudolf,
van Loveren Henk,
Colombo Paolo,
Knutsen Helle Katrine
Publication year - 2021
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.2021.6844
Subject(s) - european union , lactose , food science , european commission , percentile , food safety , chemistry , business , mathematics , statistics , economic policy
Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens ( NDA ) was asked to deliver an opinion on the extension of use of galacto‐oligosaccharides ( GOS ) as a novel food ( NF ) pursuant to Regulation ( EU ) 2015/2283. The NF is a syrup containing ≥ 57% w/w GOS (w/w dry matter), consisting of different galactosyl residues linked to a terminal glucose by a β‐glycosidic bond and also containing lactose and the constituent monomers of lactose (galactose and glucose). The NF is already authorised and included in the Union list of NF s and is produced according to the same production process. This application is limited to an assessment of the extension of use as a food ingredient in dairy confectionary, cheese and processed cheese, butter and spreads. There is a 10–30% increase in total GOS intake from the requested extension of use compared to the currently authorised uses at the highest 95th percentile. It is noted that the total intake at the highest mean (8.7–22.0 g/day) is below the adequate intake ( AI ) of 25 g/day for dietary fibre set to ensure a normal laxation in adults, while the highest 95th percentile (27.2–41.6 g/day) is higher than the AI . When the maximum use as a food supplement is added to the highest 95th percentile combined intake from all proposed and authorised food categories a total intake up to 58 g GOS /day is estimated. This highest intake level would exceed the AI for dietary fibre; however, no tolerable upper intake level for dietary fibre has been set and only transient gastrointestinal symptoms may be related to high intake of fibre. The Panel concludes that the NF , that is composed of ≥ 57% GOS dry matter, lactose and related saccharides, is safe under the proposed extension of use.