The ruling advises that a level of no more than 20 grams (g) per day of the replacement bulk sweetener can be used for the adult population.
“The proposed use level of the novel food lactitol in powder form in the same food category corresponds to the maximum level that is currently authorised,” the notification outlined.
“Therefore, it is appropriate to amend the conditions of use of lactitol to authorise its use in powder form at the existing maximum authorised level.”
Lactitol is a sugar alcohol used as a sugar replacement ingredient for low calorie foods. Its role in dietary supplements extends towards the promotion of gut mobility in constipated individuals.
Approved as a Novel Food (Decision 2017/450) and listed in the Union List (Regulation 2017/2470), its inclusion means lactitol can be marketed as a food supplement in capsule and tablet form with a maximum intake of 20 g/day.
DuPont Nutrition Biosciences’ application, dated 22 March 2018, served to overcome the practical issue of tablet or capsule size, which is limited to 1g.
By requesting the inclusion of sachets as an allowed vehicle, customers are thus able to add the 20g of lactitol to a beverage for example.
Strong safety profile
DuPont said no changes were made in production, specification, safety aspects or any other scientific data in the application.
Its strong safety profile was cited by the Commission as the reason a request was not made to the European Food Safety Authority (EFSA) for its opinion in accordance with Article 10(3).
“The amendment of the conditions of use of the novel food lactitol by including powder, as an allowed form of lactitol to be used in food supplements, is not liable to have an effect on human health,” they said.
Available via DuPont subsidiary Dansico, the firm’s OsmoAid lactitol offers a solution to constipation by lowering colonic pH and stimulating peristalsis.
The ingredient also increases the osmotic pressure in the intestinal lumen, resulting in an increase in faecal volume.
Available in a sweet-tasting, odourless crystalline powder, OsmoAid is has been approved by both the Food and Agriculture Organisation (FAO) and World Health Organisation (WHO).
As well as Danisco, other producers of lactitol include Dutch firm Purac Biochem (Corbion) and Japanese firms Mitsubishi Shoji Food Tech and B-Food Science.