(July 2, 2007 Decree promulgated as of December 1, 2007, 56th) Chapter I General provisions article to strengthen the supervision and administration of new resources of food, safeguard the health of consumers, in accordance with the People's Republic of China food hygiene law (hereinafter referred to as the food sanitation Act), these measures are formulated.
Second article this approach provides of new resources food including: (a) in China no edible habits of animal, and plant and microbial; (ii) from animal, and plant, and microbial in the separation of in China no edible habits of food raw materials; (three) in food processing process in the using of microbial new varieties; (four) for used new process production led to original components or structure occurred change of food raw materials.
Third novel foods shall comply with the food hygiene law and the provisions of the relevant laws, regulations, standards, and to the human body may not have any acute, subacute, chronic, or other potential health hazards.
Fourth the State encourages scientific research and development of new resources of food.
Fifth Ministry in charge of the nation new resources of food hygiene supervision management.
Health administrative departments under local people's Governments at or above the county level are responsible for novel foods health supervision and management work within their respective administrative areas.
Chapter II application for novel foods sixth production operation or use of novel foods unit or individual, shall be reported to the Ministry of health for approval before the product listed for the first time.
Seventh article application new resources food of, should to Ministry of health submitted following material: (a) new resources food health administrative license application table; (ii) development report and security research report; (three) production process briefly and flowchart; (four) products quality standard; (five) both at home and abroad of research using situation and related of security information; (six) products label and the manual; (seven) helps review of other information.
Not unsealed by the attached sample 1 or 30 grams of raw materials.
Apply for new resources of food, should also be submitted to producer countries (areas) issued by relevant departments or agencies allows the national (regional) production (or sale) certificate or the food-producing countries (regions) of traditional edible history information. Chapter III security evaluation and approval article eighth Ministry of Health established system of safety evaluation of novel foods.
Safety evaluation of novel foods, such as risk assessment, substantial equivalence principle.
Ministry of health has formulated and promulgated the new resources food safety evaluation procedures, technical specifications and standards. Nineth Department of health new resources of food expert appraisal Committee (hereinafter referred to as assessment Board) is responsible for the safety evaluation of novel foods.
Assessment Committee is made up of food hygiene, toxicology, nutrition, microbiology, process and chemical experts.
Tenth Article assessments safety evaluation Committee according to the following information and data: sources of new resources of food, traditional food history, production process, quality standards, main components and content, estimated intakes, purpose and scope, and Toxicology; biological characteristics of microbial products, genetic stability, pathogenicity or toxicity data and other scientific data.
11th after the Health Ministry accepts applications for new resources of food, need correct information in the technical review, the applicant shall cooperate with. To validate the needs test, assessment Committee to identify new resources food safety certification testing, inspection lot, inspection method and inspection agencies, as well as on-site examinations and sampling samples, and inform the applicant.
Safety verification test is generally recognized by the Ministry of health inspection agencies.
Need for on-site reviewing and sampling samples, carried out by the provincial health administrative departments.
12th Ministry of health assessed the Committee's technical review conclusion, on-site review for administrative review, make a decision approved as new resources foods.
In the review process, such as audit to determine the reporting products for the ordinary food, it shall notify the applicant, and to terminate the approval decision.
13th novel foods approval procedures in accordance with the health administration regulation of administrative licensing procedures of health and health-related products and other related regulations. 14th novel foods approved by the Department of health notice in the form of lists.
According to different characteristics of novel foods, bulletin content generally includes the name (including the Latin name), species, origin, biological characteristics, use of technology, main ingredient, cooking area, scope of use, use, eat people, consumption and quality standards; the microorganisms and notice its strains.
15th according to the use of new resources of food, the Ministry of health released new resources to the list of ordinary foods at the right time.
16th article has following case one of of, Ministry of health can Organization Assessment Committee on has approved of new resources food for again evaluation: (a) with science and technology of development, on has approved of new resources food in edible security and nutrition awareness Shang occurred change of; (ii) on new resources food of edible security and nutrition quality produced questioned of; (three) new resources food supervision and monitoring work need.
Failed to pass the examination by the evaluation, the Ministry of health can notice to prohibit the production, marketing and use.
Fourth chapter management article 17th food production enterprises shall ensure the production and use of new resources food safety.
Meet the requirements of section II of this law, without the approval of the Ministry of health and published as a novel foods shall not be used as food or food ingredients production and use.
18th production of new resources of food businesses must comply with the relevant laws, regulations, technical specifications and requirements.
New resources of food production enterprises shall apply to the provincial health administration health permits, obtain a health permit before production.
19th food production enterprises in production or use before the novel foods shall be to verify the contents of the notice with the Ministry of health to ensure the products are new resources for the Ministry of food or new resources of food with the Ministry has substantial equivalence. 20th production of new resources of food businesses or use the new resources of food production and other food companies, should establish new resources food safety reporting system for collecting information, annual report to local health administrative departments to the new resources food safety information.
Discover new resources of food safety issues, and shall promptly report to the local administrative Department of public health.
21st new resources of food and food products containing the new resources of food, its product labels shall conform to the relevant regulations of the State, name label identifying new resources of food shall be consistent with the content of the Ministry.
22nd production new resources of food may not claim or imply that its efficacy and specific health functions.
23rd fifth chapter of health supervision Department of the people's Governments above the county level health shall be in accordance with the food hygiene law and relevant regulations, for new resources of food production and use of supervision and routine health supervision and management. 24th health administrative departments under local people's Governments at or above the county level should be regularly collected reports of new resources food safety information check, shall promptly report to the superior administrative departments of public health within the jurisdiction of the new resources food safety information. The provincial health administrative departments on reporting food security information survey report to the Ministry of health, confirmed and treated in time.
Health research and analysis of new resources food safety information in a timely manner, and to the public.
Production or use of new resources of food enterprises of public health Administrative Department shall cooperate with the investigation and handling of food safety issues, food safety information undeclared health administrative departments may give notice of criticism.
25th the new resources of food production and business operation without the approval of the Ministry of health, or without the approval of the Ministry of health of new resources as raw materials production and processing of food, by the health Administrative Department under local people's Governments at or above the county level in accordance with the provisions of the food sanitation law article 42nd will be punished.
Sixth chapter supplementary articles article 26th this way the meaning of the following terms: risk assessment refers to the human intake of foods containing hazardous substances the scientific evaluation of the possibility of adverse health effects, including hazard identification, hazard characteristic description, exposure assessment, risk characteristics of four steps.
Substantial equivalence refers to a new resources of food and traditional food or food ingredients or approved new resources of food species, origin, biological characteristics, main ingredient, cooking sites, use, scope of application and the crowd of largely the same, consistent technology and quality standards used by, the Visual is as safe for them, with substantial equivalence.
27th management of genetically modified food and food additives in accordance with relevant State regulations.
28th article of the rules take effect on December 1, 2007, on July 28, 1990 by the Ministry of health has issued the new food hygiene regulations and April 8, 2002, promulgated by the Ministry of health of the transgenic food safety control measures be repealed simultaneously.