Detailed Rules for the Examination of Food Additive Production Licenses (2025 Edition) Issuance by SAMR

Announcement of the State Administration for Market Regulation on the Issuance of the Detailed Rules for the Examination of Food Additive Production Licenses (2025 Edition)

State Administration for Market Regulation
Announcement No. 55 of 2025

In order to standardize the work of food additive production licensing and strengthen the supervision and administration of food additive manufacturers, in accordance with the Food Safety Law of the People’s Republic of China, the Regulations for the Implementation of the Food Safety Law of the People’s Republic of China, the Measures for the Administration of Food Production Licensing (Order No. 24 of the State Administration for Market Regulation), and other laws, regulations, departmental rules, and national food safety standards, the State Administration for Market Regulation has organized the formulation of the Detailed Rules for the Examination of Food Additive Production Licenses (2025 Edition), which are hereby announced and shall come into force as of the date of issuance.

State Administration for Market Regulation
23 December 2025

Main Text
Detailed Rules for the Examination of Food Additive Production Licenses (2025 Edition)

Chapter I General Provisions

Article 1
For the purpose of strengthening the examination of food additive production licenses, these Detailed Rules for the Examination of Food Additive Production Licenses (2025 Edition) (hereinafter referred to as the “Detailed Rules”) are formulated in accordance with the Food Safety Law of the People’s Republic of China, the Regulations for the Implementation of the Food Safety Law of the People’s Republic of China, the Measures for the Administration of Food Production Licensing, and relevant national food safety standards.

Article 2
These Detailed Rules apply to the examination of food additive production licenses and shall be used in conjunction with the General Rules for the Examination of Food Production Licenses.

Article 3
The term “food additives” as used in these Detailed Rules refers to artificially synthesized or natural substances added to foods for the purpose of improving food quality, color, aroma, and taste, as well as for preservation, freshness retention, and processing technology needs. They include single-variety food additives, food flavorings, compound food additives, food nutritional fortifiers, base substances in chewing gum, and enzyme preparations.

Article 4
Single-variety food additives refer to single food additive varieties approved by national food safety standards or by announcements of the health administrative department of the State Council. The production license category code for single-variety food additives is 3201, including: acidity regulators, anti-caking agents, defoamers, antioxidants, bleaching agents, leavening agents, colorants, color retention agents, emulsifiers, flavor enhancers, flour treatment agents, coating agents, humectants, preservatives, stabilizers and coagulants, sweeteners, thickeners, food flavoring substances, food industrial processing aids, and others.

Acidity regulators refer to substances used to maintain or change the acidity or alkalinity of foods.
Anti-caking agents refer to substances used to prevent granular or powdered foods from aggregating and caking, maintaining their looseness or free-flowing properties.
Defoamers refer to substances that reduce surface tension and eliminate foam during food processing.
Antioxidants refer to substances that can prevent or delay the oxidative decomposition and deterioration of oils or food components, thereby improving food stability.
Bleaching agents refer to substances that can destroy or inhibit color-forming factors in foods, causing discoloration or preventing browning.
Leavening agents refer to substances added during food processing that enable products to expand and form a dense porous structure, thereby imparting a fluffy, soft, or crispy texture.
Colorants refer to substances that impart color to foods or improve food color.
Color retention agents refer to substances that interact with color-forming substances in meat and meat products so that they are not decomposed or damaged during food processing, storage, and other processes, thereby presenting a good color.
Emulsifiers refer to substances that improve surface tension between various constituent phases in an emulsion, forming a uniform dispersion or emulsion.
Flavor enhancers refer to substances that supplement or enhance the original flavor of foods.
Flour treatment agents refer to substances that promote flour maturation and improve product quality.
Coating agents refer to substances applied to the surface of foods to provide functions such as quality preservation, freshness retention, glazing, and prevention of moisture evaporation.
Humectants refer to substances added to help retain moisture in foods.
Preservatives refer to substances that prevent food spoilage and deterioration and extend food shelf life.
Stabilizers and coagulants refer to substances that stabilize food structure or maintain food tissue structure and enhance the viscosity of solid components.
Sweeteners refer to substances that impart sweetness to foods.
Thickeners refer to substances that can increase the viscosity of foods or form gels, thereby changing the physical properties of foods, imparting a smooth and appropriate mouthfeel, and also having emulsifying, stabilizing, or suspending functions.
Food flavoring substances refer to substances added to food products to produce aroma, modify aroma, or enhance aroma, including edible natural flavoring substances, edible natural flavoring complexes, synthetic food flavoring substances, thermally processed food flavoring substances, and smoked edible flavoring substances. They are generally formulated into food flavorings before being used for food flavoring, and some may also be used directly for food flavoring.
Food industrial processing aids refer to various substances that help food processing proceed smoothly and are unrelated to the food itself, such as filtration aids, clarifying agents, adsorbents, mold release agents, decolorizing agents, peeling agents, extraction solvents, etc.
Others refer to single-variety food additives that perform other functions not covered by the above functional categories.

Article 5
Food flavorings refer to concentrated blended mixtures composed of food flavoring substances and food flavoring auxiliaries that function to impart aroma (excluding preparations that only produce salty, sweet, or sour tastes, and also excluding flavor enhancers). Food flavorings may contain or not contain food flavoring auxiliaries; they are usually not used directly for consumption but are used in food processing. The production license category code for food flavorings is 3202.

Article 6
Compound food additives refer to food additives formed by physically mixing two or more single-variety food additives, with or without auxiliaries, in order to improve food quality or facilitate food processing. The production license category code for compound food additives is 3203.

Article 7
Food nutritional fortifiers refer to natural or artificially synthesized nutrients and other nutritional components added to foods for the purpose of increasing their nutritional content (value). The production license category code for food nutritional fortifiers is 3204.

Article 8
Base substances in chewing gum, also known as gum base, refer to base substances prepared from rubber and/or resin and other gum base ingredients through compounding, which are used in the production of chewing gum to provide chewability and/or foaming properties, and are not intended for nutritional purposes. The production license category code for base substances in chewing gum is 3205.

Article 9
Enzyme preparations refer to preparation products (which may contain one or more active enzyme components) obtained by direct extraction from edible or non-edible parts of animals or plants, or produced through fermentation and extraction of microorganisms obtained by traditional selection or genetic recombination technology (including but not limited to bacteria, actinomycetes, and fungal strains), or further processed through purification, formulation, and other processes, which are used in the food industry and possess specific catalytic activities. The production license category code for enzyme preparations is 3206.

Article 10
The following food additives are permitted to be repackaged:
(1) Sodium carbonate and sodium bicarbonate;
(2) Enterprises that have obtained production licenses for food flavoring substances or food flavorings may apply to repackage food flavoring substances that are not classified as hazardous chemicals, precursor chemicals for drug manufacture, or psychotropic drugs;
(3) Other food additives that are permitted to be repackaged as announced by the State Administration for Market Regulation.

Article 11
The standards and documents referenced in these Detailed Rules shall be the currently valid versions (including amendments to standards).

The following content (omitted)

Chapter II Production Premises
Chapter III Equipment and Facilities
Chapter IV Equipment Layout and Process Flow
Chapter V Personnel Management
Chapter VI Management Systems
Chapter VII Trial Product Inspection
Chapter VIII Additional Examination Requirements for the Production of Compound Food Additives
Chapter IX Additional Examination Requirements for the Production of Food Flavorings
Chapter X Supplementary Provisions

Appendix 1 On-site Inspection Scoring Record Form for Production Licensing of Single-Variety Food Additives
Appendix 2 On-site Inspection Scoring Record Form for Production Licensing of Compound Food Additives
Appendix 3 On-site Inspection Scoring Record Form for Production Licensing of Food Flavorings

Issued by the General Office of the State Administration for Market Regulation on 23 December 2025

 

Reference

https://www.samr.gov.cn/zw/zfxxgk/fdzdgknr/spscs/art/2025/art_ecd665d4860a4d21a45c521c27d363ef.html