Assessment of the Novel Food D-tagatose for a Change to the Conditions of Use (RP1652)

The Food Standards Agency (FSA) and Food Standards Scotland (FSS) received an application from Bonumose, Inc., U.S.A (“the applicant”) for a change to the conditions of use of D-tagatose as a novel food to each nation of Great Britain in July 2022. D-tagatose was first authorised in 2005 following an application pursuant to Regulation (EC) No. 258/97 Article 4.2 applicable to the UK (and EU) and is currently authorised as a novel food in Great Britain (GB) under assimilated Commission Regulation (EU) 2017/2470. The novel food is an epimer of fructose and a sugar monosaccharide, with 75-92% the sweetness of sucrose “table sugar”. D-tagatose is produced via enzymatic conversion followed by purification to obtain a dried crystalline product. This application seeks to modify the conditions of use to permit a new novel food source, maltodextrin, and a modified enzymatic conversion production method. The applicant seeks to amend the specifications and include additional labelling options to use “tagatose” as a name of the novel food in the specified labelling for its authorisation. The FSA and FSS in their evaluation of the application reviewed the safety dossier and supplementary information provided by the applicant. The FSA and FSS did not consider any potential health benefits or claims arising from consuming the food, as the focus of the novel food assessment is to ensure the change in the conditions of use to extend the food is safe, and not putting consumers at a nutritional disadvantage. The FSA and FSS concluded that the applicant had provided sufficient information to assure that the change in the conditions of use for D-tagatose in its production is safe under the intended conditions of use. The safety assessment represents the opinion of the FSA and FSS.