,Food Standards Australia New Zealand has approved an amendment to the Australia New Zealand Food Standards Code to permit the use of 2?-fucosyllactose (2?-FL) produced from a new genetically modified (GM) source organism in infant formula products. The application was submitted by Cataya Bio (Shanghai) Company Limited, seeking authorization for its ingredient marketed under the brand name XINFU 2?-FL.
The approved 2?-FL is produced using Corynebacterium glutamicum genetically engineered to express the alpha-1,2-fucosyltransferase gene derived from Corynebacterium urealyticum. This modification enables biosynthesis of 2?-FL, a human milk oligosaccharide naturally present in breast milk.
FSANZs scientific risk assessment concluded that the ingredient does not raise any public health or safety concerns when used in accordance with existing regulatory limits. The substance is considered chemically, structurally, and functionally identical to naturally occurring 2?-FL found in human milk. Consequently, its previously established health benefits remain applicable, including:
Anti-pathogenic activity
Immunomodulatory effects
Promotion of beneficial gut microbiota, particularly Bifidobacteria
The approval introduces a 15-month exclusive use period for the applicant, during which only the branded product XINFU 2?-FL may be used under this authorization. This exclusivity is incorporated into Schedule 26 of the Code alongside specific conditions of use.
Additionally, FSANZ has updated the identity and purity specifications under Schedule 3 (section S351) to clarify permitted genetic sources. The revised specification now explicitly allows the alpha-1,2-fucosyltransferase gene to originate from either C. urealyticum (newly permitted) or Pseudopedobacter saltans, ensuring regulatory consistency with previously approved 2?-FL sources.
The ingredient must comply with all applicable maximum permitted levels2?-FL in infant formula It may be added alone, or in combination with Lacto-N-neotetraose (LNnT) to infant formula products as a nutritive substance up to a maximum amount of 96 mg per 100 kJ (2.4 g/L) and labelling requirements established under the Code for infant formula products. These conditions align with existing permissions for 2?-FL derived from other GM organisms.
Following a public consultation period (OctoberNovember 2025), during which five submissions were received and reviewed, FSANZ finalized the approval without modifications to the draft variation.
Overall, this regulatory update expands the range of permitted sources for 2?-FL in infant nutrition, supporting innovation in formula composition while maintaining established safety and quality standards.
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