Assessment on 2’-Fucosyllactose (2’-FL) Derived From Genetically Modified <i>Corynebacterium Glutamicum</i> APC199 as a Novel Food for Use in Food and Food Supplements (RP2119)

Advanced Protein Technologies Corp. (“the applicant”) submitted a novel food application for the authorisation of 2’-Fucosyllactose (2’-FL) as a novel food to each nation of Great Britain in August 2023. The novel food is intended to be used as a source of human identical milk oligosaccharide, 2’-FL, and is manufactured by microbial fermentation using a genetically modified strain of Corynebacterium glutamicum APC199. This new application is seeking to use the novel food produced by a new production organism within food, infant and follow-on formula, and food supplements. This novel food had its application for authorisation assessed by the European Food Safety Authority (EFSA) which was published in December 2022. The Food Standards Agency (FSA) and Food Standards Scotland (FSS) have reviewed the information available, including the EFSA opinion, and confirmed that 2’-FL was safe under the proposed conditions of use. The anticipated intake levels and proposed use in food and food supplements was not considered to be nutritionally disadvantageous. This safety assessment represents the opinion of the FSA and FSS.