dsm-firmenich secures 3-FL HMO market access in Europe

The European Commission’s approval of 3-FL for use as a novel food ingredient in the EU is a result of a Novel Food application by Glycom A/S.

The firm says this breakthrough represents “a major step towards enhancing market access for a wider portfolio of high-quality HMO products for use in the early life nutrition, conventional food and dietary supplement segments”.

This milestone follows the recent publication of a positive Scientific Opinion from the European Food Safety Authority (EFSA) Panel on Nutrition, Novel Foods and Food Allergens adopted on 27 April 2023​.

This opinion validates 3-FL produced by a derivative strain of Escherichia coli​ K-12 DH1 as a novel food in accordance with Regulation 2015/2283​.

dsm-firmenich’s 3-FL, commercially marketed as GlyCare 3FL 9001, received authorisation for use in a variety of foods, including infant formula, follow-on formula, conventional foods, food for special medical purposes and food supplements.

Notably, dsm-firmenich’s 3-FL ingredient has been granted a higher maximum use level of 1.75 g/L for use in infant and follow-on formula, compared to levels approved previously for other 3-FL manufacturers, which ranged from 0.85 – 1.20 g/L.

The distinction between different approved use levels in these food categories will remain in force for the duration of the five-year exclusive approval period that has been granted to dsm-firmenich’s 3-FL. Only after the exclusivity period ends, the highest approved use level will apply across all different sources of approved 3-FL.