Taiwan FDA proposes regulations on the use and labeling of 2'-fucosyllactose and difucosyllactose mixtures

Taiwan has released a draft regulation establishing use restrictions, specifications, and labeling requirements for the food ingredient 2?-Fucosyllactose (2?-FL) and Difucosyllactose (DFL) mixture produced through fermentation using genetically modified Escherichia coli K-12 DH1 MDO MAP1001d strains.

The draft is issued under the Food Safety and Sanitation Management Act and provides a legal framework for regulating this ingredient when used in food products.

Manufacturing Process

Under the proposed rules, the ingredient is produced by fermenting genetically modified E. coli strains, followed by ultrafiltration and dialysis to remove production microorganisms and biomass. The filtrate then undergoes concentration, deionization, decolorization, drying, and other purification steps. The final product does not contain genetically modified microorganisms or their recombinant DNA fragments.

Permitted Food Uses

The draft limits the use of the 2?-FL and DFL mixture to:

Infant formula and follow-on formula

Milk powders or similar products intended exclusively for children under seven years of age

Maximum Use Levels

Use limits are calculated based on the ready-to-consume product or product prepared according to label instructions:

Infant and follow-on formula: up to 1.6 g/L

Milk powder or similar products for children under seven: up to 1.2 g/L

Labeling Requirements

Products containing this ingredient must include production source information stating either:

“Produced using genetically modified microorganisms,” or

“Produced using genetically modified microorganisms, but the final product does not contain genetically modified microorganisms or their recombinant genes.”

Finished foods that undergo further manufacturing, processing, or formulation may be exempt from this labeling requirement.

Product Specifications

The draft sets detailed quality and compositional criteria, including:

Total specified sugar purity: ?92.0% (dry weight)

Combined 2?-FL and DFL content: ?85.0%

2?-Fucosyllactose: ?75.0%

Difucosyllactose: ?5.0%

Moisture: ?6.0%

Residual proteins: ?0.01%

Genetically modified microorganism detection: negative by real-time qPCR

pH (5% solution, 20°C): 4.0–6.0

The proposed regulation aims to ensure product safety, quality consistency, and transparent labeling, particularly for foods intended for infants and young children. Public consultation is expected before the draft is finalized.