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Australia and New Zealand Approves the Use of 2’-FL from New GM Source in Infant Formula

In infant formula products, the maximum usage level of 2’-FL sourced from the new genetically modified Escherichia coli strain is 2.4 g/L. The applicant, Friesland Campina Ingredients, has a 15-month exclusive use permission for the 2’-FL mentioned in the Application A1233.

On May 6, 2022, Food Standards Australia New Zealand (FSANZ) announced the approval of Application A1233, that is, FSANZ permitted the sale and use of 2ʹ-fucosyllactose (2′-FL) derived from a new genetically modified Escherichia coli strain as a nutritive substance used in infant formula products (infant formula, follow-on formula, and infant formula products for special dietary use). Its usage is subject to the following requirements:

  • The maximum addition level of 2’-FL in infant formula products is 2.4 g/L.

  • It is not allowed to use 2′-FL with galacto-oligosaccharides and inulin-type fructans in infant formula products.

  • It is prohibited from claiming  ‘human milk identical oligosaccharide’ or ‘human milk oligosaccharide’, and abbreviations ‘HMO’, ‘HiMO’, or using any words or expressions or abbreviations having the same or similar effect for infant formula products containing the 2’-FL.

  • The applicant (Friesland Campina Ingredients) has a 15-month exclusive use permission for the 2’-FL mentioned in the Application A1233, commencing from the date of official promulgation. During that 15-month period, the permission for this 2′-FL would apply exclusively to the use of 2’-FL under the brand ‘Aequival® 2′-FL’ in accordance with the  Australia New Zealand Food Standards Code.

  • FSANZ will carry out a five-year review (by March 2026) for the evidence of the substantiated beneficial role of 2′-FL in the normal growth and development of infants.

Up to now, at least 37 overseas countries have allowed the use of 2′-FL produced by microbial fermentation or chemical synthesis in infant formula products and many other foods (read ChemLinked analysis for more information about 2’-FL). In April this year, China consulted on the use of 2’-FL in children milk powder, infant formula, follow-up infant and young children formula, and infant formula for special medical purpose. Check China Proposes Three New Food Additives, Involving 2’-FL for Infant Formula for more details. 

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