New varieties of food additive on regulating the license management announcement

(health ministry announcement no. 29 in 2011)

2011 no. 29

        According to the food safety law and its implementing regulations, the new varieties of food additive measures on the management of food additives and accept new declaration set "requirement, in order to regulate the new varieties of food additive license management, we notice the following:

        A, about the technology necessity materials

        Apply for new varieties of food additives, it shall submit the following technologies necessity proof materials:

        (1) food additive functional category and mechanism;

        (2) in plan to add to the food additives or not effect contrast;

        (3) and the same functional category of food additives use effect contrast material;

        (4) other relevant technology is necessary on the material.

        Application in food of new kinds of spices, from the first submit (2) and item (3) of material.

        Second, about the food additive quality specification

        The application of new varieties of food additives, such as no current effective food additives products standards, it shall submit the following quality specifications material:

        (1) food additives products standard text (including identification, the technical indexes requirements and the corresponding inspection method);

        (2) formulation explanations;

        (3) and international organizations and other countries (regions) of relative standard comparison;

        (4) the methods validation testing.

        Three, about the food additives on site audit

        The new varieties of food additives for safety evaluation of the organizations select 2-three experts, research and development of new varieties of food additive production site on the site to verify, evaluation:

        (1) developed the basic situation of the unit;

        (2) the production of the raw materials used by the source, and release records;

        (3) according to declare the process flow diagram check sample data of production processes and records;

        (4) if you need to test results were verified the inspection and verification test samples.

        (5) to expand the scope of application for use of food additives and dosage of, can according to the specific circumstances organization on site audit work.

        Four, about the validation of new varieties of food additives products standard

        There is no corresponding product standards of food additive of new varieties, take food additive new safety review of the institution shall submit the applicants based on information, the organization of product standards (including identification, the technical indexes requirements and the corresponding inspection method) verification, verify the results as the basis for the food safety risk assessment.

        Five, about the new varieties of food additives announcement content

Health food additive technology according to the necessity and the food safety risk assessment results, to meet the requirements of the food safety, shall decide on whether to grant permission and published by the new varieties of food additive, range and dosage, also release the new varieties of food additive quality specifications, as the basis for the production enterprise organization. In the corresponding the national food safety standards after coming on stage, food additive quality specification instant invalid.

        Six, on the encouragement of new varieties of food additives are proposed

        Apply for new varieties of food additives after accepting it, sanitation department through the health ministry web site (www.moh.gov.cn), food safety comprehensive information nets (www.nfsiw.gov.cn) and the national food safety standards nets (www.chinafoodsafety.net) announced relevant information, the public to solicit the social from all walks of life and all relevant departments and related industry organization advice welcome new varieties of food additive management Suggestions and opinions.

        Hereby public announcement.

, 25 November 2011