On March 21, 2025, the National Center for Food Safety Risk Assessment (CFSA) issued a public consultation on four new food ingredients: Lutein esters, D-Psicose/D-Allulose, Bifidobacteriumanimalis subsp.lactis BLa80, and Bifidobacterium longum subsp. infantis LMG1158. The consultation period will end on April 20, 2025.
D-Allulose is a six-carbon ketose sugar that occurs naturally in small amounts in foods such as figs, kiwifruits, and wheat. The product under consideration, D-Allulose, is produced through two methods: microbial fermentation and enzymatic conversion.
Microbial fermentation: Glucose or sucrose is fermented by Escherichiacoli AS10, followed by purification, drying, and other processing steps.
Enzymatic conversion: Fructose is used as the raw material and is catalyzed by D-Allulose-3-epimerase, followed by decolorization, separation, purification, and crystallization.
The recommended daily intake of D-Allulose is ≤ 20 grams per day. It is not recommended for infants, pregnant women, or breastfeeding mothers.
D-Allulose is recognized as a "Generally Recognized As Safe" (GRAS) substance in the United States; approved as a natural health product ingredient in Canada; and authorized as a novel food ingredient in Australia and New Zealand.
This strain is isolated from breast milk and belongs to the Bifidobacterium genus, specifically Bifidobacterium animalis subsp. lactis.
The strain is included in both China's List of Bacterial Cultures Available for Food Use and the European Food Safety Authority's (EFSA) Qualified Presumption of Safety (QPS) list.
Food safety standards must comply with the GB 31639-2023 National Food Safety Standard Bacteria Preparations for Food Processing, with no detection of Cronobacter species (/100g).
This strain is isolated from the intestines of healthy infants and belongs to the Bifidobacterium genus, specifically Bifidobacterium longum subsp. infantis.
The strain is listed in both List of Bacterial Cultures Available for Food Use (containing 21 strains) and the EFSA's QPS list. In the U.S., it is managed as a "Generally Recognized As Safe" (GRAS) substance.
Food safety standards must comply with the GB 31639-2023 National Food Safety Standard Bacteria Preparations for Food Processing, with no detection of Cronobacter species (/100g).
In 2022, the National Health Commission of China updated the List of Bacterial Cultures Available in Infants and Young Children Food, which now includes 14 strains. Among them, Bifidobacterium animalis subsp. lactis accounts for 3 strains, and Bifidobacterium longum subsp. infantis includes 2 strains.
Lutein esters are derived from Tagetes erecta L. through processes including dehydration, grinding, solvent extraction, low molecular weight alcohol purification, and vacuum concentration. In the United States, lutein esters are managed as a "Generally Recognized As Safe" (GRAS) substance. In China, the former Ministry of Health approved lutein esters as a novel food ingredient in 2008, with applications in baked goods, dairy products, beverages, instant cereals, frozen desserts, seasonings, and candies, excluding infant foods.
Compared to the 2008 approval, the recommended daily usage has been increased from 12mg to 36mg per day (based on lutein dipalmitate). Additionally, comprehensive quality standards and specific testing methods have been introduced.
D-Allulose, a highly promising new low-calorie sweetener, is gaining traction in the food industry. It has already been adopted in food production processes in the United States, Australia, New Zealand, and other regions, with rapid advancements in technology development and commercialization. In China, as D-Allulose is set to be approved as a novel food ingredient, the food industry is poised for new growth opportunities.
If you require assistance with global D-Allulose compliance, feel free to reach out to us at info@zmuni.com. ZMUni Compliance Centre has extensive experience in novel food applications, particularly in markets such as the United States, the European Union, Brazil, and Thailand.
