Assessment of a Modification of Specifications of 2’-Fucosyllactose (2’-FL) Produced by a Genetically Modified Strain of <i>Escherichia Coli</i> BL21 (RP2257)

The Food Standards Agency (FSA) and Food Standards Scotland (FSS), in August 2024, received an application from Chr. Hansen A/S, Denmark (‘the applicant’) for a change to the conditions of use of the novel food 2’-fucosyllactose (2’-FL), produced by a genetically modified strain of Escherichia coli BL21 (DE3). 2’-FL has been the subject of several prior applications in the EU, under the previous novel food Regulation (EC) 258/97 and assimilated Regulation (EU) 2015/2283 applicable to GB. 2’-FL is currently authorised for use in several food and drinks categories for the general population and for infants and young children, including infant formula and follow-on formula. This application seeks to harmonise the specifications of 2’-FL with other authorised human milk oligosaccharides, including synthetic 2’-FL and 2’-FL produced by other organisms, as included in the Great Britain register of novel foods. The FSA and FSS concluded that the applicant had provided sufficient information to assure that the change in the conditions of use of 2’-FL, produced by a genetically modified strain of E. coli BL21, is safe under the intended conditions of use. The safety assessment represents the opinion of the FSA and FSS.