The Measures for the Administration of New Varieties of Food Additives were reviewed and approved by the Ministry of Health at the Ministry of Health on March 15, 2010. They are hereby promulgated and will be implemented as of the date of promulgation.

 

Minister Chen Hao

March 30, 2010

 

Article 1 In order to strengthen the management of new varieties of food additives, these Measures are formulated in accordance with the relevant provisions of the Food Safety Law and the Implementation Regulations of the Food Safety Law.

Article 2 The new variety of food additives means:

(1) Food additive varieties not listed in the national food safety standards;

(2) Not included in the food additive varieties permitted by the Ministry of Health;

(3) Expanding the range of use or amount of food additives.

Article 3 Food additives should be technically necessary and proved to be safe and reliable through risk assessment.

Article 4 The use of food additives shall meet the following requirements:

(1) Food corruption should not be concealed;

(2) It should not cover up the food itself or the quality defects in the processing;

(3) not using food additives for the purpose of doping, adulteration or forgery;

(4) The nutritional value of the food itself should not be lowered;

(5) Minimizing the amount of food used in foods when the expected effect is achieved;

(6) Processing aids for the food industry shall be removed prior to the final product, unless otherwise specified.

Article 5 The Ministry of Health is responsible for the examination and approval of new varieties of food additives, and organizes the formulation of technical evaluation and review specifications for new varieties of food additives.

Article 6 Units or individuals (hereinafter referred to as applicants) who apply for the production, operation, use or import of new varieties of food additives shall submit an application for a new variety of food additive licenses and submit the following materials:

(1) The general name, functional classification, dosage and scope of use of the additive;

(2) Proving materials or documents that are technically necessary and effective;

(3) The quality specification requirements, production process and inspection methods of food additives, the inspection methods or related descriptions of the additives in food;

(4) Safety assessment materials, including production raw materials or sources, chemical structure and physical properties, production processes, toxicological safety evaluation materials or inspection reports, quality specification inspection reports;

(5) Labels, instructions and samples of food additive products;

(6) Other countries (regions) and international organizations that allow production and use of materials that contribute to safety assessment.

If the application for food additive varieties is extended to the scope of use or dosage, it may be exempted from submitting the fourth item of the preceding paragraph, except for those provided for in the technical review.

Article 7 In applying for the first import of new food additive varieties, in addition to the materials specified in Article 6, the following materials shall also be submitted:

(1) Proof materials issued by relevant departments or agencies of the exporting country (region) to allow the additive to be produced or sold in the country (region);

(2) Proof materials for the examination or certification of the production enterprise issued by the relevant institution or organization of the country (region) where the production enterprise is located.

Article 8 The applicant shall truthfully submit the relevant materials, reflect the actual situation, and be responsible for the authenticity of the contents of the application materials, and bear the legal consequences.

Article 9 The applicant shall indicate in the first item, the second item and the third item of the first paragraph of Article 6 of these Measures that it does not involve trade secrets and that it can be disclosed to the public.

The new varieties of food additives are technically necessary and useful, and should be open to the public for comments. At the same time, they should seek quality supervision, industrial and commercial administration, food and drug supervision and management, industry and information, business and other relevant departments and related industry organizations. opinion.

If there are major differences of opinion or involve major interests, a hearing may be held to hear opinions.

The relevant opinions reflected are used as reference for technical review.

Article 10 The Ministry of Health shall, within 60 days after acceptance, organize experts in medicine, agriculture, food, nutrition, and technology to conduct technical review on the technical necessity and safety assessment of new varieties of food additives, and make technical review conclusions. . Where it is necessary to supplement relevant materials in the technical review, the applicant shall be notified in a timely manner, and the applicant shall promptly supplement the relevant materials as required.

When necessary, experts can be organized to verify and evaluate new food additive development and production sites.

Where it is necessary to carry out verification and inspection on relevant data and inspection results, the applicant shall be informed of the requirements for inspection items, inspection batches and inspection methods. The safety verification inspection shall be carried out at the inspection agency that has obtained the qualification certification. Where there is no national food safety inspection method standard, the inspection method should be verified first.

Article 11 The specific procedures for the administrative licensing of new varieties of food additives shall be implemented in accordance with the relevant provisions of the Administrative Licensing Law and the Administrative Measures for Health Administrative Licensing.

Article 12 According to the conclusions of the technical review, the Ministry of Health has decided to grant a list of new food additives that are technically necessary and meet food safety requirements and to be included in the list of permitted food additives.

For lack of technical necessity and non-compliance with food safety requirements, no permission shall be given and the reasons shall be stated in writing.

Non-food chemicals or other substances that are harmful to human health that may be added to foods shall be implemented in accordance with Article 49 of the Implementing Regulations of the Food Safety Law.

Article 13 The Ministry of Health shall, based on the technical necessity and the results of food safety risk assessment, formulate and promulgate the national standards for food safety according to the procedures for the use, scope and amount of food additives permitted to be used in accordance with the national food safety standards.

Article 14 In any of the following circumstances, the Ministry of Health shall promptly organize a reassessment of food additives:

(1) Scientific research results or evidence that there may be problems with the safety of food additives;

(2) It is no longer technically necessary.

If the re-examination considers that it does not meet the food safety requirements, the Ministry of Health may revoke the approved food additive varieties or revise their scope of use and dosage.

Article 15 These Measures shall be implemented as of the date of promulgation. The Measures for the Administration of Food Additives Health, promulgated by the Ministry of Health on March 28, 2002, shall be abolished at the same time.