People’s Republic of China Ministry of health
New varieties of food additive regulations on March 15, 2010 by the Ministry of health ministerial meeting are published, from the date of promulgation.
Minister Chen Zhu
March 30, 2010
First to strengthen the new varieties of food additive management, according to 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 III food additive risk assessment should be technically necessary and proven safe, reliable.
The 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 quality defects of processing;
(C) not intended to impurities or adulteration, forgery and use of food additives;
(Iv) should not reduce the nutritional value of the food itself;
(E) in achieving expected results as much as possible to reduce dosage in food;
(F) the food industry made with processing AIDS should be removed before final product, except that there are provisions allowing the residue.
Article fifth work of the Ministry of health is responsible for the review of the new varieties of food additives licensing, evaluations and reviews of organizations to develop new varieties of food additives technology specifications.
Sixth application of food additive production, distribution, use, or import new varieties of unit or individual (hereinafter the applicant), and new varieties of food additive license shall be filed, and submit the following materials:
(A) the generic names of additives, functional classification, dosage and application scope;
(B) proved to be technically necessary and use of results information or documents;
(C) the quality of food additive specifications, manufacturing processes and test methods, method for testing of the additive in food or related information note;
(D) the safety assessment materials, including production or origin, chemical structure and physical properties of raw materials, production process, toxicological safety evaluation or inspection reports, quality specifications and inspection reports;
(V) labels, brochures and product samples of food additives;
(Vi) other countries (regions), international organizations allows for the production and use of resources for safety assessment.
Applications expand the scope of uses or amount of food additive varieties, from prior to the submission of the fourth material, but except for the technical requirements to be submitted to a review.
Seventh at the first new varieties of imported food additives, except as provided in article sixth of the materials, shall also submit the following materials:
(A) the exporting country (region) issued by relevant departments or agencies of the additive is permitted in one’s country (region) the evidence of production or sales;
(B) the State in which the manufacturer (regions) the institution or organization to the manufacturer for examination or certification issued by the documentation.
Section VIII applicant shall truthfully submit the relevant materials and reflect the true situation, and be responsible for the authenticity of the application materials and bear the legal consequences.
Article submitted by the applicant in its sixth paragraph in these measures first, second or third item indicated in the material do not involve trade secrets, can be made public.
New varieties of food additive technically necessary and use effects and so on, should be made public for comment and to obtain quality supervision, industrial and commercial administration management and food and drug administration, industry and information technology, business, and other relevant departments and organizations in related industries.
There are major differences of opinion, or major interests are involved, can hold hearings to hear your opinion.
Reflect the views of the technical review of the references.
Tenth shall be accepted within 60 days after the Organization of the Ministry of health, medicine, agriculture, food, nutrition, technology experts in the field of food additives such as technically a new necessity and safety assessment for technical examination, technical assessment and conclusions. The need to supplement the information in the technical review, shall promptly notify the applicant, the applicant shall supplement the material in a timely manner, as required.
If necessary, can organize experts to verify new varieties of food additive research and production sites, respectively.
Need to verify the relevant information and test results test, test items, test batches, testing methods should be required to inform the applicant. Safety verification test should achieve qualification inspection agencies. There is no State test method standards of food safety should be first to validate testing methods.
11th new varieties of food additives, specific procedures for the administrative license in accordance with the administrative licensing law and the regulation on administrative authorization and other 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 permission be published and included in the list of permitted food additives.
The lack of technical necessity and does not meet the food safety requirements of no permission and to state the reason in writing.
To find possible non-food chemicals that are added to foods or other substances harmful to human health, according to the 49th article of the regulations for the implementation of the food safety law implementation.
On 13th Ministry of health according to the technical necessities and food safety risk assessment, allows the use of the variety and scope of use of food additives and dosage in accordance with national standards for food safety procedures, designed and published for the national food safety standards.
14th under any of the following circumstances, the Ministry of health shall organize a re-assessment of the food additive:
(A) scientific findings or evidence that food additive safety there may be a problem;
(B) no longer meets the technical necessity.
Review it does not meet the food safety requirements, approved by the Ministry of health announcement to withdraw or amend the scope of use of food additives 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.