Amendment to specifications for the novel food food 2'-Fucosyllactose derivative strain of Escherichia coli BL-21
European Union
Jul 31, 2024
With implementing Regulation (EU) 2024/2102 of 30 July 2024, the Commission amended Implementing Regulation (EU) 2017/2470 as regards the conditions of use of the novel food 2'-Fucosyllactose and as regards the specifications of the novel food 2'-Fucosyllactose produced with a derivative strain of Escherichia coli BL-21.
The applicant requested to increase the residual endotoxins for 2'-FL produced by fermentation using a derivative strain of Escherichia coli BL-21 to align them to those of the already authorised 2'-FL produced with a derivative strain of Escherichia coli K-12, which is authorised under the same conditions of use, and that of other authorised human identical milk oligosaccharides which are also authorised at identical or similar residual endotoxin levels in infant formulae and follow-on formulae.
The information provided in the applications and the Authority’s existing opinions give sufficient grounds to establish that the changes in the conditions of use of 2'-FL to increase its maximum use levels in infant formulae and follow-on formulae and the changes in the specifications of 2'-FL produced by fermentation using a derivative strain of Escherichia coli BL-21 to modify the levels of residual endotoxins, are in accordance with the conditions of Article 12 of Regulation (EU) 2015/2283 and should be approved.
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