On August 1, 2025, the National Health Commission issued the National Food Safety Standard Standard for the Use of Nutritional Fortification Substances in Foods (Draft for Comments) (hereinafter referred to as the Draft). The deadline for comments is September 26, 2025. In order to facilitate a better understanding of the Draft by enterprises within the industry, Antion interpreted the main changes in the Draft for your reference.

PART.1 Newly added "mass food fortification" and "voluntary food fortification"

Compared with the current standard, the Draft deleted the definition of "foods for special dietary uses" to facilitate alignment with GB 13432 National Food Safety Standard the Labeling of Prepackaged Foods for Special Dietary Uses; Added the definitions of "mass food fortification" and "voluntary food fortification", and also added two appendices that specify the food categories, types of nutritional fortification substances and their usage for these two types of fortification.

PART.2 Regulations on the use of nutritional fortification substances in mass food fortification

The Draft divides mass food fortification into two categories: priority fortification and optional fortification. In the list of nutrient types and usage for priority fortification, compared with the second draft for comments, in terms of food categories, "pasteurized milk, sterilized milk" are deleted, and "nutritionally fortified milk" is added, with a clear definition of "modified milk made from raw milk with only food nutritional fortification substances added". In terms of fortified nutrients, the priority fortified nutrient for nutritionally fortified milk is vitamin D, with the usage of 10~40μg/kg; Optional fortified nutrients include vitamin A (600~1000μg/kg), γ-linolenic acid (2.5~6.3g/kg) and casein phosphopeptides (≤1.6g/kg). Additionally, taurine (0.1~0.5g/kg), L-carnitine (37.5~50mg/kg), lactoferrin (≤1.0g/kg) and isomerized lactose (≤1.9g/kg) are newly added.

PART.3 Regulations on the use of nutritional fortification substances in voluntary food fortification

(1) A new regulation clarifies that when both raw materials and the final product are allowed to use a certain nutritional fortification substance, the type and usage should comply with the fortification requirements of the final product.

(2) Compared with the current standard, some food categories that can be fortified and the types of nutrients that can be fortified in related categories are expanded, which includes deleting "modified milk", adding food categories such as "other modified milk" and "instant rice and flour products", and newly allowing the use of other nutritional components such as galactooligosaccharides in accordance with the announcement on "three new" foods.

(3) Adjusted the fortification levels of nutrients in some food categories. For example, the fortifications with vitamin B₁, vitamin B₂, vitamin B₆ and vitamin B₁₂ are newly added in "04.01.02 Processed Fruits".

PART.4 List of allowed compound sources of nutritional fortification substances

(1) Removed compound sources such as ferrous fumarate and zinc carbonate.

(2) Added new compound sources such as vitamin K₂ and 2'-fucosyllactose.

(3) Unified and standardized the names of compound sources of some nutritional fortification substances. For example, "phytonadione" has been standardized as "vitamin K₁ (phytonadione)", and "arachidonic acid (AA or ARA)" has been standardized as "eicosatetraenoic acid (AA or ARA)".

(4) Added raw material sources of nutritional fortification substances such as fructooligosaccharides and galactooligosaccharides.

PART.5 Adjustments to nutritional fortification substances related to foods for special dietary uses

Compared with the current standard, the Draft made several adjustments: In the list of nutritional fortification substances and their compound sources allowed for use in foods for special dietary uses, new varieties such as (6S)-5-methyltetrahydrofolate calcium and selenium-enriched yeast have been added, along with additional notes for some varieties; In the list of other nutritional components allowed only for some foods for special dietary uses and their usage, new varieties such as 2'-fucosyllactose have been added, raw material sources of varieties such as galactooligosaccharides have been supplemented, the names of some compounds have been unified and standardized, a lower limit for lactoferrin in infant and young children formula food has been added, and the scope of application of nutrition fortification substances such as 2'-fucosyllactose has been expanded to include food for special medical purpose.

PART.6 Newly added Appendix E Amino Acids and their Compound Sources Allowed for Use in Foods for Special Dietary Uses

To align with relevant announcements from the National Health Commission and the State Administration for Market Regulation, Table E.1 specifies the amino acids and their compound sources allowed for use in foods for special dietary uses.

PART.7 Adjustments to the description of food categories (names)

To maintain coordination between standards, the Draft has appropriately adjusted the names of food categories. For example, "01.01.03 Modified Milk" has been refined into "01.01.03.01 Nutritionally Fortified Milk" and "01.01.03.02 Other Modified Milk"; "01.04 Condensed Milk and its Modified Products" has been adjusted to "01.04 Concentrated Dairy Products"; and "04.02.02.01 Canned Fruits" and "04.02.02.02 Fruit Puree" under "04.02.02 Processed Vegetables" have been deleted.

PART.8 Summary

Through revisions such as refining the classification of nutritional fortification substances, improving clauses related to nutrition fortification substances in foods for special dietary uses and adjusting food categories (names), the Draft aligns with relevant standards, enhances the rigor and applicability of the standard and provides clearer guidance for the food industry. All relevant parties can provide feedback based on actual conditions to help the standard better meet industry development and food safety needs.

Source: Antion

Note: This article is compiled by Antion. Please indicate the source for reprint.