On your marks: EFSA takes second look at DuPont’s betaine novel application
The application was filed by DuPont Nutritional Biosciences, according to EFSA’s register of questions.
The original rejected application was filed by Finnfeeds Finland back in 2003, a company owned by DuPont since 2011.
At the time EFSA said available human study data was “insufficient” for it to rule out the safety concerns of member states.
“Based on these studies, a number of safety questions remain unresolved. Animal studies showed treatment-related effects that were observed at all tested doses of betaine the biological or toxicological significance of which have not been satisfactorily clarified,” EFSA said at the time.
“Since the available studies do not allow the derivation of a no observed adverse effect level (NOAEL) for betaine and data on reproduction and developmental toxicity are lacking, an acceptable daily intake cannot be established.”
Despite its novel status, betaine does have an approved health claim in the EU, which reads: “Betaine contributes to normal homocysteine metabolism.”
DuPont claims to be the world's largest supplier of betaine for food, feed and industrial applications.
Within food it markets BetaPower – a form of anhydrous betaine from sugar beets it says can improve strength, power and muscle endurance during physical performance.
The company has funded a number of studies in this area.
One such study published in 2013 suggested one week of drinking a betaine-dosed sports drink helps boost cyclist power and performance by around 6%.
Another published the same year suggested daily betaine supplements may improve body composition, performance and power of strength-trained men.
The company did not respond to our request for comment in time for the publication of this article.
