1. Global regulatory panorama: Differentiated regulation of the three major camps

The United States: Relaxed innovation orientation

GRAS certification path: In 2012, it was approved by the company's self-declaration (such as Tate & Lyle). In 2019, the FDA explicitly exempted its "added sugar" label and allowed its use in dietary supplements (maximum dose 15g/serving).

Latest developments: In 2023, the FDA updated the Q&A guidelines to allow allulose to be labeled "net carbon water is 0" in keto foods.

Asia: Japan and South Korea lead commercialization

Japan: In 2013, it was included in FOSHU (foods for specific health use), and the function of "inhibiting blood sugar rise" was allowed to be labeled. The market size reached 12,000 tons in 2022.

South Korea: In 2020, the "Health Functional Food Code" was revised to list the combination of allulose and resistant dextrin as "blood sugar management" category.

EU: Under evaluation

EFSA's scientific opinion: The new food application (NPF) submitted in 2022 requires additional long-term human tolerance data, focusing on the effect of high doses (>0.5g/kg body weight/day) on intestinal permeability.

Transition plan: Some companies enter the market through "imported food", and a certain brand sells it under the name of "solid beverage concentrate". The end product's allulose content must be <10%. (Its applicability is assumed).

2. China's policy breakthroughs and application practices

Temporary solution: Use it in compliance with existing categories such as "solid beverages" and "candies", but avoid functional claims. (Its applicability is assumed).

Application path prediction:

Schedule: Refer to the approval cycle of erythritol (about 28 months). If it enters the formal review in 2024, it is expected to be approved in 2026.

Material preparation points:

Safety data: It must include a 90-day subchronic toxicity test (reference GB 15193) and a tolerance study of the Chinese population.

Process documents: It is clear that strains produced by enzymatic methods (such as engineered Bacillus subtilis) must pass genetic biosafety assessment.

3. Enterprise response strategies: Three major actions to plan ahead

Raw material reserves: Sign long-term agreements with compliant suppliers to lock in prices.

Formula pre-research: Develop the golden ratio of "allulose + mogroside" for beverages, baking and other scenarios (recommended sweetness ratio of 7:3).

Consumer education: Deliver the concept of "metabolic inertia" through popular science content to avoid confusion with artificial sweeteners (such as aspartame).