Decree No. 1 of the National Health and Family Planning Commission
The Administrative Measures for the Safety Review of New Food Raw Materials, which was reviewed and adopted by the former Ministry of Health on February 5, 2013, are hereby promulgated and shall come into force as of October 1, 2013.
Director Li Bin
May 31, 2013
Administrative Measures for Safety Review of New Food Raw Materials
*Article These Measures are formulated in accordance with the Food Safety Law of the People's Republic of China and its implementing regulations in order to standardize the review of safety assessment materials for new food raw materials.
Article 2 New food raw materials refer to the following items that have no traditional eating habits in China:
（1） Animals, plants and microorganisms;
（2） Ingredients isolated from animals, plants and microorganisms;
（3） Food ingredients whose original structure has changed;
（4） Other newly developed food raw materials.
Article 3 New food raw materials shall have the characteristics of food raw materials, meet the proper nutritional requirements, be non-toxic and harmless, and do not cause any acute, subacute, chronic or other potential harm to human health.
Article 4 New food raw materials shall be used for food production and operation only after the safety review of the National Health and Family Planning Commission.
Article 5 The National Health and Family Planning Commission shall be responsible for the examination and approval of safety assessment materials for new food ingredients.
The Health Supervision Department under the National Health and Family Planning Commission is responsible for the application and acceptance of safety assessment materials for new food raw materials, organizing the review of safety assessment materials and other specific work.
Article 6 The unit or individual (hereinafter referred to as the applicant) that intends to engage in the production, use or import of new food raw materials shall file an application and submit the following materials:
（1） Application form;
（2） New food raw material development report;
（3） Safety assessment report;
（4） Production process;
（5） Relevant standards implemented (including safety requirements, quality specifications, inspection methods, etc.);
（6） Labels and instructions;
（7） Domestic and foreign research utilization and relevant safety assessment data;
（8） Other data helpful to the review.
One unopened product sample or 30g of raw materials shall be attached.
Article 7 Those who apply for the import of new food raw materials shall submit the following materials in addition to the materials specified in Article 6:
（1） The certification materials issued by the relevant departments or institutions of the exporting country (region) that allow the product to be produced or sold in the country (region);
（2） Certification materials issued by relevant institutions or organizations of the country (region) where the manufacturer is located for the examination or certification of the manufacturer.
Article 8 An applicant shall truthfully submit relevant materials, reflect the true situation, be responsible for the authenticity of the contents of the application materials, and bear legal responsibility.
Article 9 When submitting the materials in Items 2 to 6 of Paragraph * of Article 6 of these Measures, the applicant shall indicate the contents that do not involve trade secrets and can be disclosed to the public.
Article 10 The National Health and Family Planning Commission shall solicit public opinions after accepting the application for new food ingredients.
Article 11 The National Health and Family Planning Commission shall, within 60 days from the date of accepting the application for new food raw materials, organize experts to review the safety evaluation materials for new food raw materials and draw a conclusion.
Article 12 If supplementary materials are needed in the process of examination, the applicant shall be informed in writing in a timely manner, and the applicant shall supplement relevant materials in a timely manner as required.
According to the needs of the examination, the applicant may be required to answer relevant technical questions on the spot, and the applicant shall cooperate.
Article 13 If it is necessary to conduct on-site inspection on the production process during the review process, experts can be organized to inspect the development and production site of new food raw materials, and issue on-site inspection opinions. The experts are responsible for the on-site inspection opinions issued. The provincial health supervision institutions shall cooperate.
Experts participating in the on-site inspection will not participate in the review and voting of the product safety assessment materials.
Article 14 The specific procedures for the review and licensing of safety assessment materials for new food raw materials shall be implemented in accordance with the Administrative Licensing Law, Administrative Measures for Health Licensing and other relevant laws and regulations.
Article 15 The National Health and Family Planning Commission shall, according to the conclusion of the safety review of new food raw materials, grant permission and make an announcement for those meeting the food safety requirements; If the food safety requirements are not met, no permission shall be granted and reasons shall be given in writing.
If it is substantially equivalent to the food or the announced new food raw materials, it shall make a decision to terminate the examination and notify the applicant in writing.
Article 16 According to the different characteristics of new food raw materials, the announcement can include the following contents:
（1） Name;
（2） Source;
（3） Production process;
（4） Main components;
（5） Quality specification requirements;
（6） Label identification requirements;
（7） Other contents to be announced.
Article 17 Under any of the following circumstances, the National Health and Family Planning Commission shall organize the reexamination of the announced new food raw materials in a timely manner:
（1） With the development of science and technology, the safety of new food raw materials is questioned;
（2） There is evidence that the safety of new food raw materials may be problematic;
（3） Other situations requiring re examination.
The National Health and Family Planning Commission may revoke the license for new food raw materials that fail to meet the food safety requirements after re examination.
Article 18 The production unit of new food raw materials shall conduct production in accordance with the requirements of the announcement of new food raw materials to ensure the food safety of new food raw materials.
Article 19 If the food contains new food ingredients, the product labels and identifications shall comply with the national laws, regulations, food safety standards and the requirements of the announcement of the National Health and Family Planning Commission.
Article 20 Those who produce or use new food raw materials without safety assessment in violation of the provisions of these Measures shall be dealt with in accordance with the relevant provisions of the Food Safety Law.
Article 21 Where an applicant conceals the relevant information or provides false materials to apply for a new food raw material license, the National Health and Family Planning Commission will not accept the application or refuse the license, and will give a warning, and the applicant shall not apply for a new food raw material license again within one year.
The National Health and Family Planning Commission will revoke the license if it passes the review of the safety assessment materials of new food raw materials and obtains the license by cheating, bribery and other improper means.
Article 22 The meanings of the following terms in these Measures:
Substantial equivalence means that if a newly declared food raw material is the same as a food or a published new food raw material in terms of species, source, biological characteristics, main ingredients, eating parts, usage, scope of use and application population, and the process and quality requirements are basically the same, they can be regarded as equally safe and substantially equivalent.
Traditional eating habits refer to the fact that a certain kind of food has a history of more than 30 years of production and operation as stereotyped or non stereotyped packaged food in the area under the jurisdiction of the province, and has not been included in the Pharmacopoeia of the People's Republic of China.
Article 23 The new food raw materials mentioned in these Measures do not include genetically modified food, health food and new varieties of food additives. The management of genetically modified food, health food and new varieties of food additives shall be implemented in accordance with relevant national laws and regulations.
Article 24 These Measures shall come into force as of October 1, 2013. The Administrative Measures for New Resource Food promulgated by the former Ministry of Health on December 1, 2007 shall be repealed at the same time.
