Order of the Ministry of Health of the People’s Republic of China
sequence 26 number
The revision of the "Measures for Hygienic Management of Food Additives" was adopted at the ministerial meeting on December 11th, 2001, and is hereby promulgated and shall come into force as of July 1st, 2002. The Measures for Hygienic Management of Food Additives promulgated on March 15, 1993 shall be abolished at the same time.
Minister Zhang Wenkang
March 28th, 2002
Measures for hygienic management of food additives
Chapter I General Principles
the first In order to strengthen the hygiene management of food additives, prevent food pollution and protect the health of consumers, these measures are formulated in accordance with the Food Hygiene Law of People’s Republic of China (PRC).
the second These Measures shall apply to the production, operation and use of food additives.
Article Food additives must meet the national hygiene standards and hygiene requirements.
Article 4 The Ministry of Health is in charge of the health supervision and management of food additives throughout the country.
Chapter II Examination and Approval
Article 5 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 that are not listed in the Hygienic Standard for the Use of Food Additives or the list announced by the Ministry of Health;
(two) the varieties listed in the Hygienic Standard for the Use of Food Additives or the list announced by the Ministry of Health need to expand the scope or amount of use.
Article 6 To apply for the production or use of new varieties of food additives, the following materials shall be submitted:
(1) An application form;
(2) Names of raw materials and their sources;
(3) Chemical structure and physical and chemical characteristics;
(4) production technology;
(5) Toxicological safety evaluation reports issued by inspection agencies recognized by health administrative departments at or above the provincial level, and hygienic inspection reports of three consecutive batches of products;
(six) when using microorganisms to produce food additives, it is necessary to provide the strain identification report and safety evaluation data issued by the recognized institution of the Ministry of Health;
(seven) the scope of use and usage;
(eight) report on the effect of the trial use;
(nine) the inspection method of this food additive in food;
(ten) product quality standards or specifications;
(eleven) product samples;
(12) Labels (including instructions);
(thirteen) the relevant safety information at home and abroad and the certification documents or materials allowed by other countries;
(14) Other materials as stipulated by the Ministry of Health.
Article 7 To apply for expanding the scope or amount of use of food additives, the following materials shall be submitted:
(1) An application form;
(two) the types, usage and production technology of the food to be added;
(3) Report on the effect of trial use;
(4) the inspection method of the food additive in food;
(5) product samples;
(6) Labels (including instructions);
(seven) the relevant safety information at home and abroad and the certification documents or materials allowed by other countries;
(8) Other materials as stipulated by the Ministry of Health.
Article 8 Examination and approval procedures for food additives:
(a) the applicant shall apply to the local provincial health administrative department and provide information according to the provisions of Article 6 or Article 7;
(two) the provincial health administrative department shall complete the preliminary examination of the completeness, legality and standardization of the application materials within 30 days, and submit the preliminary examination opinions to the Ministry of Health for approval;
(3) The Ministry of Health regularly holds expert review meetings to conduct technical review of the application materials, and make a decision on whether or not to approve according to the technical review opinions of the expert review meetings.
Article 9 To import new varieties of food additives and expand the scope or amount of food additives, production enterprises or import agents shall directly apply to the Ministry of Health. At the time of application, in addition to the materials specified in Articles 6 and 7 of these Measures, the following materials shall also be provided:
(1) A certificate issued by the government of the producing country (region) or an institution recognized by it that allows production and sales;
(two) the certification materials issued by the relevant institutions or organizations of the country (region) where the production enterprise is located.
Food additives in imported food must conform to the Hygienic Standard for the Use of Food Additives. Do not meet, according to the relevant provisions of these measures to obtain the approval of the Ministry of health before import.
Chapter III Production, Operation and Use
Article 10 Food additive production enterprises must obtain the health license issued by the provincial health administrative department before they can engage in food additive production.
Article 11 When applying for a hygiene license for food additives, a production enterprise shall submit the following materials to the provincial health administrative department:
(1) An application form;
(2) List of varieties producing food additives;
(three) the production conditions, equipment and quality assurance system;
(4) production technology;
(5) Quality standards or specifications;
(6) Hygienic inspection reports of three consecutive batches of products;
(7) Labels (including instructions).
Article 12 A food additive production enterprise shall have workshops, equipment and facilities suitable for the product type and quantity, organize production according to product quality standards, and establish enterprise production records and product sample retention system.
Food additive production enterprises should strengthen the hygiene management in the production process to prevent food additives from being polluted and mixed among different varieties.
Article 13 In the production of compound food additives, the use scope and dosage of each single variety of additives shall conform to the varieties specified in the Hygienic Standard for the Use of Food Additives or the announcement list of the Ministry of Health and their use scope and dosage.
It is not allowed to use single varieties of additives without the same scope of use in the production of compound food additives, and it is not allowed to use non-edible substances beyond the Hygienic Standard for the Use of Food Additives to produce compound food additives.
Article 14 When producing food additives, enterprises shall conduct quality inspection on the products. If it passes the inspection, it shall issue a product inspection certificate; Without the product inspection certificate, it shall not be sold.
Article 15 Operators of food additives must have storage and business premises suitable for the variety and quantity of business. When selling and storing food additives, special counters and shelves must be set up, and they must not be mixed with non-edible products or toxic and harmful substances.
Article 16 When purchasing food additives, food additive operators shall obtain a copy of the hygiene license and a product inspection certificate.
It is forbidden to operate food additives without hygiene license and product inspection certificate.
Article 17 The use of food additives must conform to the "Hygienic Standard for the Use of Food Additives" or the varieties specified in the announcement list of the Ministry of Health, as well as their scope and dosage.
It is forbidden to use food additives for the purpose of covering up food spoilage or doping, adulteration or forgery.
Chapter IV Labels and Instructions
Article 18 Food additives must have packaging labels and product specifications, which include: product name, place of origin, factory name, hygiene license number, specifications, formula or main components, production date, batch number or code, shelf life, scope and dosage of use, usage method, etc., and the words "food additives" are clearly marked on the labels.
If there are applicable taboos and safety precautions for food additives, warning signs shall be given on the labels.
Article 19 Compound food additives, in addition to being marked according to the provisions of Article 18 of these Measures, shall also be marked with the name of each single variety, and arranged according to the content from large to small; Each single variety must use a name consistent with the Hygienic Standard for the Use of Food Additives.
Article 20 The packaging labels and product descriptions of food additives shall not have propaganda contents that expand the scope of use or exaggerate the use effect.
Chapter V Health Supervision
Article 21 The Ministry of Health may re-evaluate the safety of food additives that may have safety and hygiene problems, revise the scope and dosage of use or make a decision to ban the use, and make it public.
Article 22 The health administrative department of the local people’s government at or above the county level shall organize supervision and spot checks on the production, operation and use of food additives, and announce the results of supervision and spot checks to the public.
Article 23 The food hygiene inspection unit shall inspect the food additives according to the standards, norms and requirements formulated by the Ministry of Health, and the inspection and evaluation reports made shall be objective and true, and conform to the relevant standards, norms and requirements.
Article 24 The general hygiene supervision and management of the production and operation of food additives shall be implemented in accordance with the Food Hygiene Law and relevant regulations.
Chapter VI Penalty Rules
Article 25 Production, operation or use of food additives that do not meet the hygiene standards for the use of food additives or the relevant provisions of these Measures shall be punished in accordance with the provisions of Article 44 of the Food Hygiene Law.
Article 26 If the packaging label or product description of food additives does not indicate or falsely indicate the production date, shelf life and other specified matters, or does not indicate the Chinese label, it shall be punished in accordance with the provisions of Article 46 of the Food Sanitation Law.
Article 27 Violation of the Food Hygiene Law or other relevant hygiene requirements shall be punished in accordance with the corresponding provisions.
Chapter VII Supplementary Provisions
Article 28 The meanings of the following terms in these Measures:
Food additives refer to chemical synthetic or natural substances added to food to improve the quality, color, aroma and taste of food, as well as to meet the needs of preservation and processing technology.
A compound food additive refers to a food additive which is formed by physically mixing more than two kinds of single food additives.
Article 29 The Ministry of Health shall be responsible for the interpretation of these Measures.
Article 30 These Measures shall come into force as of July 1, 2002. On March 15, 1993, the Measures for Hygienic Management of Food Additives issued by the Ministry of Health were abolished at the same time.