Hygienic Management of Food Additives

作者：admin  点击次数：113  发布时间：2025-05-21

In order to strengthen the hygienic management of food additives, prevent food contamination, and protect the health of consumers, the production, operation and use of food additives must comply with national health standards and health requirements. The Ministry of Health of the People's Republic of China issued the "Food Additive Hygiene Management Measures" in Order No. 26, which came into effect on July 1, 2002. The management measures made clear provisions on the approval, production, operation, labeling, etc. of food additives.
(I) Approval of food additives
1. Scope of approval of food additives
The "Food Additive Hygiene Management Measures" stipulates that the following food additives must be approved by the Ministry of Health before they can be produced, operated or used:
(1) New varieties of food additives not listed in the "Food Additive Use Hygiene Standards" or the list of announcements of the Ministry of Health: (2) Varieties listed in the "Food Additive Use Hygiene Standards" or the list of announcements of the Ministry of Health that need to expand the scope of use or the amount of use.
When applying to produce or use a new type of food additive, the following materials shall be submitted:
(1) Application form;
(2) Name of raw material and its source;
(3) Chemical structure and physicochemical properties;
(4) Production process;
(5) Toxicological safety evaluation report issued by an inspection agency recognized by the provincial health administrative department or above, and hygienic inspection reports for three consecutive batches of products;
(6) When using microorganisms to produce food additives, a strain identification report and safety evaluation materials issued by an agency recognized by the Ministry of Health must be provided;
(7) Scope of use and usage;
(8) Experimental use effect report;
(9) Inspection method for the food additive in food;
(10) Product quality standards or specifications;
(11) Product samples;
(12) Labels (including instructions);
(13) Domestic and foreign safety information and other certification documents or materials allowed for use in other countries;
(14) Other information specified by the Ministry of Health. When applying to expand the scope or amount of food additives, the following materials shall be submitted:
(1) Application form:
(2) Type of food to be added, amount and production process;
(3) Report on experimental use effect;
(4) Test method of the food additive in food;
(5) Product sample;
(6) Label (including instructions);
(7) Domestic and foreign safety information and other certification documents or materials allowed for use in other countries;
(8) Other information specified by the Ministry of Health.
2. Approval procedure for food additives
The approval procedure for food additives is as follows:
(1) Applicants shall submit applications to the provincial health administrative department where they are located and provide materials in accordance with the provisions of Article 6 or Article 7;
(2) Provincial health administrative departments shall complete the preliminary review of the completeness, legality and standardization of the application materials within 30 days, and submit the preliminary review opinions to the Ministry of Health for approval;
(3) The Ministry of Health shall hold expert review meetings regularly to conduct technical reviews of the application materials and make decisions on whether to approve them based on the technical review opinions of the expert review meetings.
For the import of new types of food additives and food additives with expanded scope of use or usage, manufacturers or import agents shall apply directly to the Ministry of Health. When applying, in addition to the information required for normal domestic food additive approval, the following information shall also be provided:
(1) Documents of approval for production and sale issued by the government of the country (region) of production or its recognized agency. (2) Documents of review or certification of the producer issued by the relevant agency or organization of the country (region) where the manufacturer is located;
Food additives in imported food must comply with the "Sanitary Standards for the Use of Food Additives". If they do not comply, they must be approved by the Ministry of Health in accordance with the provisions of the "Food Additive Sanitation Management Measures" before they can be imported.
(II) Manufacturers that produce, operate and use food additives must obtain a sanitation license issued by the provincial health administrative department before they can engage in food additive production. When applying for a food additive sanitation license, a manufacturer shall submit the following materials to the provincial health administrative department:
(1) Application form;
(2) List of food additives produced;
(3) Production conditions, equipment and quality assurance system;
(4) Production process;
(5) Quality standards or specifications;
(6) Hygienic inspection reports for three consecutive batches of products;
(7) Labels (including instructions).

Food additive manufacturers shall have factories, equipment and facilities that are appropriate to the type and quantity of products, organize production in accordance with product quality standards, and establish enterprise production records and product sample retention systems.
Food additive manufacturers shall strengthen the sanitation management of the production process to prevent food additives from being contaminated and mixing between different varieties.
When producing compound food additives, the scope of use and amount of each single variety of additives shall comply with the varieties and their scope of use and amount specified in the "Sanitary Standards for the Use of Food Additives" or the list of announcements of the Ministry of Health. Single variety additives that do not have the same scope of use shall not be used in the production of compound food additives, and non-food substances that exceed the "Sanitary Standards for the Use of Food Additives" shall not be used to produce compound food additives. When enterprises produce food additives, they shall conduct quality inspections on their products. If the inspection is qualified, a product inspection certificate shall be issued; if there is no product inspection certificate, it shall not be sold.
Food additive operators must have storage and business premises that are suitable for the types and quantities of products they operate. When selling and storing food additives, they must be stored in special counters and shelves, and must not be mixed with non-edible products or toxic and harmful items. When purchasing food additives, food additive operators shall request a copy of the health license and a product inspection certificate.
It is prohibited to operate food additives without a health license and a product inspection certificate
The use of food additives must comply with the varieties, scope of use, and amount specified in the "Sanitary Standards for the Use of Food Additives" or the list of announcements of the Ministry of Health.
It is prohibited to use food additives for the purpose of covering up food spoilage or adulteration, adulteration, or counterfeiting.
(III) Labels and instructions for food additives Food additives must have packaging labels and product instructions. The labeling content includes: product name, origin, factory name, health license number, specifications, formula or main ingredients, production date, batch number or code, shelf life, scope of use and dosage, usage method, etc. The words "food additives" must be clearly marked on the label. For compound food additives, the names of each single variety should also be marked, and the content should be calculated according to the content.