New varieties of food additive management approach
(March 30, 2010 the Ministry of Health announced come into force on the date of promulgation, 73rd), first for strengthening the management of 2 new varieties of food additives, in accordance with the food safety law and the relevant provisions of the regulations for the implementation of the food safety law, these measures are formulated.
New varieties of food additive in article refers to:
(A) food additives not included in food safety standards;
(B) not included in the Ministry of food additives are allowed;
(C) expand the scope of use or consumption of food additives.
Article of food additives should be technically necessary and safe and reliable through risk assessment.
Article fourth use of food additives shall comply with the following requirements:
(A) should not cover up the food spoilage;
(B) should not cover up the food itself or in the process of quality defects;
(C) no impurities or adulteration, forgery for the purpose of use of food additives;
(D) shall not reduce the nutritional value of the food itself;
(E) achieved the desired effect of reducing as much as possible in food consumption;
(Vi) processing aid used in food industry should be made before final removal, except with the permission of residues is provided.
Fifth Ministry of health is responsible for the review of food additive varieties permission to work, making new varieties of food additive specification for technical evaluation and review.
Sixth application for new varieties of food additive production, trade, use or import unit or individual (hereinafter the applicant), should come up with new varieties of food additive license application, and submit the following materials:
(A) additives common name, function classification, dosage and application scope;
(B) prove to be technically necessary and the use of information or documents;
(C) the quality of the food additive specifications, manufacturing processes and test methods, method or testing of the additive in food-related information;
(D) security assessments, including production or origin, chemical structure and physical properties of raw materials, production process, toxicological safety evaluation information on quality specifications or test reports, inspection reports;
(V) labels, brochures and product samples of food additives;
(Vi) other countries (regions), allow the production and use of international organizations, contribute to security assessment information.
Applications for varieties expand the scope of uses or amount of food additives, the fourth material can be submitted from the preceding paragraph, but requested additional technical review except as provided.
Article seventh imported new varieties of food additives, except as provided in article sixth of the materials, shall also submit the following materials:
(A) the exporting country (region) issued by the relevant departments or agencies allows the additives in the national (regional) production or sale of documents;
(B) the State in which the manufacturer (area) issued by relevant agencies or organizations of production enterprises review or certification of documents.
Article the applicant shall submit the relevant materials and reflect the true situation, and responsible for the authenticity of the content of the application materials, bear the legal consequences.
Article the applicant shall submit it to the first paragraph of this article sixth of the first item, second item, third item indicated in the material do not involve trade secrets, content that can be offered to the public.
New varieties of food additive technically necessary and use effects and so on, should be open to the public for comments and to obtain quality supervision, industrial and commercial administration management and food and drug supervision and management, industry and information technology, business and other related industry organizations.
There are major differences of opinion, or involve significant benefit, held a hearing to listen to views.
Reflect views as reference of the technical review. Tenth Ministry of health should be accepted within 60 days after the Organization of medicine, agriculture, food, nutrition, technology experts in the field of food additives, such as a new variety of technically need technical review and safety assessment information and technical review and conclusion.
The need to supplement the information in the technical review, shall promptly notify the applicant, the applicant shall supplement the materials in a timely manner as and when required.
If necessary, may appoint an expert to new varieties of food additive development and production site for verification, assessment. Need the verification test data and test results, test items, test batches, testing methods should be required to inform the applicant. Safety verification test should be achieved qualification inspection agencies.
There is no State test method standards of food safety should be first to validate the test.
11th new varieties of food additives, specific procedures for the administrative license in accordance with the administrative licensing law, such as management of health administrative license and relevant regulations.
12th according to the technical assessment conclusions, the Ministry of health decided to technically necessary and meet the food safety requirements of food additive varieties granted the license and included in the list of the food additives allowed to be published.
The lack of technical necessity and does not meet the food safety requirements, grant licenses, and state the reason in writing.
Found that may be added to foods in the non-food chemicals or other substances harmful to human health, in accordance with the regulations for the implementation of the food safety law article 49th.
13th Department of health according to technical necessities and food safety risk assessment, notice allows the use of food additives, scope of use, in accordance with national standards for food safety procedures, designed and published for food safety standards.
14th under any of the following circumstances, the Ministry of health shall organize a re-evaluation of food additives:
(A) scientific findings or evidence that food additive safety there may be a problem;
(B) ceased to hold a technical necessity.
To review that does not meet the food safety requirements, the Ministry of health may notice for cancellation of approved food additives or amend the scope of their use and dosage. 15th these measures come into force on the date of promulgation. Released on March 28, 2002, the Ministry of Health's food additives hygiene control abolished at the same time.