Citicoline has won EU novel foods approval for use in food supplements and medical foods after appeasing member state concerns about the phospholipid precursor being a medicine.
Applicant Kyowa Hakko Europe welcomed the July 1 affirmation in EU law books that permits its use in food supplements at 500 mg/day and in medical foods at 250 mg/day with a maximum recommended daily intake of 1000 mg/day across the European Union’s 28 member states.
Kyowa Hakko has been able to market the ingredient on its cognitive benefits although the European Food Safety Authority (EFSA) did not back such benefits when it looked at the available science a few years ago.
EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) backed citicoline for lipid and homocysteine metabolism and liver function but not brain function.
Path to shelf
The novel foods application stalled after the Irish food agency gave approval in 2012 when member states raised the medicines question.
The European Commission passed the matter to EFSA which issued a positive safety opinion late last year, making special mention that citicoline should not be consumed with certain medicines and never by children.
It also acknowledged that in some cases citicoline could be classified as both a medicine and a food.
Citicoline is the generic name for CDP-choline (choline cytidine 5’-pyrophosphate), a precursor to the likes of phosphatidylcholine, phosphatidylserine and phosphatidyl-ethanolamine which all have been linked to brain health.
Citicoline has been used by the Kyowa Hakko and others in the US since the 1980s and the nutrient also won Generally Recognized As Safe (GRAS) status in 2009 from the US Food and Drug Administration (FDA).
That approval was for levels of 250 mg per serving in categories including beverages, breakfast cereals, chewing gum, pastas, hard candies, milk products, fruit juices and soft candy.