Produced through a joint venture of Denmark's Arla Foods and Germany's Nordzucker, the sweetener is already approved and enjoying gains in major markets, such as the US since 2003 and Australia from 2004.
But since tagatose has not been consumed to date in significant amounts in the EU, it is regarded as a novel food.
The FSA (Food Standards Agency)'s independent expert advisers on novel foods, the advisory committee on novel foods and processes (ACNFP), have scrutinised and consulted twice on the application and have now agreed the application should be approved, subject to labelling conditions.
D-Tagatose is chemically similar to fructose and is naturally present at low levels in heat-treated dairy products. As a precaution, the ACNFP has said that D-Tagatose must be labelled as being derived from milk as some people are allergic to proteins in cows' milk, which may be present in D-Tagatose at low levels.
Following the approval, Arla is likely to see if production capacity for tagatose can be increased. Per pound high intensity sweeteners are considerably more expensive than tagatose (about $2.50 per pound), although food formulators use less in their recipes.
In addition, food formulations integrating tagatose for the European market are likely to maximise on recent science that highlights the ingredient's slow glycaemic (GI) response, an index increasingly used by dieters as a form of carbohydrate control.
A low GI food will cause a small rise in blood sugar levels, whereas a higher GI food may trigger a large increase. In addition, Arla is optimistic that its low cal sweetener about three times the price of sugar can bring cost savings to food manufacturers in their flavour formulations.
Before any new food product can be introduced on the European market it must be rigorously assessed for safety. In the UK, the assessment of novel foods is carried out by an independent committee of scientists appointed by the FSA , the advisory committee on novel foods and processes (ACNFP).
Following an initial public consultation period and the discussion of this application by the Advisory Committee on Novel Foods and Processes (ACNFP) at its 30 March and 19 May 2005 meetings, and by post, the UK Competent Authority formulated an initial opinion on this novel food ingredient.
The UK's initial opinion was forwarded by the European Commission to Member States for a 60-day period to comment or provide reasoned objections. As no objections were received during this period, on 14 December 2005 the Agency wrote to the applicant, informing them that D-Tagatose may now be marketed in the EU.