D-Tagatose. EC No. 61

March 2005: Application from Bioresco, acting on behalf of Arla Food Ingredients to approve D-Tagatose as a novel food ingredient. Authorised December 2005


D-Tagatose is a sugar, with a similar structure to fructose, and is naturally present in heat-treated dairy products. The applicant proposed to market D-Tagatose as a novel food ingredient in the EU in a variety of products, including selected varieties of baked goods, beverages, confectionery and ready-to-eat cereals. It is slightly less sweet than table sugar and provides less energy. Approval was sought under Novel Foods Regulation (EC) No. 258/97. 

Legal Backgroud

Before a novel food can be marketed legally in EU it requires a pre-market safety assessment under the Novel Food Regulation (EU) 2015/2283, previously 258/97 (EC). This is the Regulation establishes the legal basis for novel foods and the process for submitting a novel food authorisation(s).

One of the major changes under the revised Regulation, was the centralisation of the authorisation process at the EU level. Prior to this, applications for new novel foods were underwent initial assessment in a Member State to achieve an EU wide authorisation. This application was received by the UK under Regulation 258/97 EC and was assessed by our independent experts the Advisory Committee on novel foods and processes.

Application Status: Authorised

 On 15 August 2005 the Food Standards Agency issued its initial assessment report, having obtained expert advice from the Advisory Committee on Novel Foods and Processes (ACNFP), the committee that advises the Agency on all novel food issues. This report concluded that D-Tagatose meets the criteria for acceptance of a novel food, as defined in Article 3(1) of the Regulation.

The Committee published its positive opinion. This opinion was shared with the other Member States resulting in the product being authorised by the EU subject to the conditions specified in the authorisation.

Application Files