Safety of betaine as a novel food pursuant to Regulation (EU) 2015/2283

betaine, novel food, intake assessment
First published in the EFSA Journal
5 aprile 2019
Adopted
14 marzo 2019
Type
Scientific Opinion

Abstract

In 2017, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) concluded that betaine as a novel food (NF) is safe to be used at a maximum intake level of 6 mg/kg body weight per day in addition to the intake from the background diet. Following the present request from the European Commission, the EFSA NDA Panel was asked to deliver a scientific opinion on betaine by carrying out the assessment for the revised uses and use levels of betaine as proposed by the applicant. Thus, EFSA performed an intake assessment based on individual data from the EFSA Comprehensive European Food Consumption Database and the new proposed uses of the NF for the general population. The resulting ranges for the mean and high‐level estimated intakes of betaine for the general population do not exceed the safe level of intake previously established. The Panel concludes that the NF, betaine, is safe under the new proposed conditions of use.

Panel members at the time of adoption

Dominique Turck, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch‐Ernst, John Kearney, Helle Katrine Knutsen, Alexandre Maciuk, Inge Mangelsdorf, Harry J McArdle, Androniki Naska, Carmen Pelaez, Kristina Pentieva, Alfonso Siani, Frank Thies, Sophia Tsabouri, Marco Vinceti.
Panel on Nutrition, Novel Foods and Food Allergens
Contact
nda [at] efsa.europa.eu
doi
10.2903/j.efsa.2019.5658
EFSA Journal 2019;17(4):5658
Question Number
On request from
European Commission following an application by DuPont Nutrition Biosciences ApS