Laws and regulations

 

(Order of the Ministry of Health No. 73)

 

(1) In order to strengthen the management of new varieties of food additives, these measures are formulated in accordance with the relevant provisions of the Food Safety Law and the Implementation Regulations of the Food Safety Law.

 

Article 2 New varieties of food additives refer to:

 

一 (1) Varieties of food additives not listed in national food safety standards

 

(2) Not included in the list of food additives permitted by the Ministry of Health

 

(3) Expanding the range or amount of food additive varieties.

 

Article 3 Food additives shall be technically necessary and proven safe and reliable after risk assessment.

 

Article 4 The use of food additives shall meet the following requirements:

 

一 (1) should not cover food spoilage

 

二 (2) Quality defects in the food itself or during processing should not be covered up

 

三 (3) Do not use food additives for the purpose of adulteration, falsification, or forgery

 

(4) The nutritional value of the food itself should not be reduced

 

五 (5) Reduce the amount in food as much as possible to achieve the expected effect

 

(6) Processing aids for the food industry should be removed before the final product is made, except where there are prescribed allowable residues.

 

Article 5 The Ministry of Health is responsible for the examination and approval of new varieties of food additives, and organizes the formulation of specifications for the technical evaluation and examination of new varieties of food additives.

 

Article 6 An entity or individual (hereinafter referred to as the applicant) that applies for the production, operation, use, or import of new varieties of food additives shall submit an application for a license for new varieties of food additives and submit the following materials:

 

一 (I) General name, functional classification, dosage and scope of use of additives

 

二 (II) Materials or documents that prove that it is technically necessary and effective

 

三 (3) Quality specifications, production processes and inspection methods of food additives, inspection methods of the additives in food or description of relevant conditions

 

(4) Safety evaluation materials, including production raw materials or sources, chemical structure and physical characteristics, production processes, toxicological safety evaluation data or inspection reports, quality specification inspection reports

 

(5) Samples of labels, instructions and food additive products

 

(6) Materials that are allowed to be produced and used by other countries (regions) and international organizations to help with safety assessment.

 

Applications for the expansion of the scope or amount of food additive varieties may be exempted from submitting the fourth item of the preceding paragraph, except for those required to be supplemented during the technical review.

 

Article 7 In applying for the first import of new varieties of food additives, in addition to the materials specified in Article 6, the following materials shall be submitted:

 

一 (I) Certificate issued by the relevant department or institution of the exporting country (region) that allows the additive to be produced or sold in the country (region)

 

二 (2) Certification materials issued by relevant agencies or organizations in the country (region) where the manufacturing enterprise is located to examine or certify the manufacturing enterprise.

 

Article 8 The applicant shall truthfully submit relevant materials, reflect the real situation, be responsible for the authenticity of the contents of the application materials, and bear the legal consequences.

 

Article 9 The applicant shall indicate in the materials submitted in Article 6, paragraph 1, paragraph 1, paragraph 2, and paragraph 3 of the present Measures, that it does not involve commercial secrets and can be disclosed to the public.

 

If the new food additive variety is technically necessary and effective, it should be solicited from the public. At the same time, quality supervision, industrial and commercial administration, food and drug supervision, industry and information technology, commerce and other relevant departments and relevant industry organizations should be consulted. opinion.

 

的 If there are major differences of opinion, or major interests are involved, a hearing may be held to hear opinions.

 

Relevant opinions reflected as reference basis for technical review.

 

Article 10 The Ministry of Health shall organize experts in the fields of medicine, agriculture, food, nutrition, and technology to conduct a technical review of the technical necessity and safety assessment data of new varieties of food additives within 60 days after acceptance, and draw conclusions of technical review . If it is necessary to supplement relevant information during the technical review, the applicant shall be notified in a timely manner, and the applicant shall be supplemented with relevant materials in a timely manner as required.

 

When necessary, experts can be organized to verify and evaluate the development and production of new varieties of food additives.

 

验证 If verification and inspection of relevant materials and inspection results are required, the applicant shall be informed of the inspection items, inspection batches, inspection methods and other requirements. The safety verification and inspection shall be carried out at an inspection institution that has obtained qualification certification. If there is no national food safety inspection method standard, the inspection method should be verified first.

 

Article 11 The specific procedures for the administrative license of new varieties of food additives shall be implemented in accordance with the relevant provisions of the Administrative License Law and the Administrative Measures for Sanitary Administrative Licenses.

 

Article 12 According to the conclusion of the technical review, the Ministry of Health has decided to approve new food additive varieties that are technically necessary and meet food safety requirements, and publish them on the list of permitted food additives.

 

缺乏 For lack of technical necessity and non-compliance with food safety requirements, no permission will be granted and reasons will be given in writing.

 

发现 The discovery of non-edible chemical substances or other substances that endanger human health may be added to food in accordance with Article 49 of the Implementation Regulations of the Food Safety Law.

 

十三 Article 13 Based on the technical necessity and the results of food safety risk assessment, the Ministry of Health will formulate and publish the types, scope of use, and dosages of permitted food additives in accordance with the procedures of national food safety standards and formulate and publish them as national food safety standards.

 

条 Article 14 In any of the following cases, the Ministry of Health shall promptly organize a re-evaluation of food additives:

 

一 (1) The results of scientific research or evidence that there may be problems with the safety of food additives

 

(Ii) It is no longer technically necessary.

 

If the re-examination considers that it does not meet the food safety requirements, the Ministry of Health may announce the withdrawal of the approved food additive variety or modify its scope and amount of use.

 

Article 15 These Measures shall be implemented as of the date of promulgation. The "Administrative Measures for the Hygiene of Food Additives" issued by the Ministry of Health on March 28, 2002 shall be repealed at the same time.

 

  Latest News

 

部 Ministry of Health intends to study the revocation of whitening agents in flour

 

9 On September 12, 2011, the National Food Safety Standard for Food Additive Use Standards ended soliciting opinions. As of the end of August, the Secretariat had received about 100 public suggestions.

 

Public suggestions are mainly divided into three categories, including suggestions to modify certain food classification systems in the standard, changes to specific indicators of the scope and amount of certain additives, and suggestions to modify the names of food additives. The relevant person in charge of the Ministry of Health stated that the opinions and suggestions collected will be classified, and experts will be organized to hold special meetings to study the opinions and suggestions one by one.

 

In the "National Food Safety Standard for Food Additives" (Consultation Draft), benzoyl peroxide, commonly known as "flour whitening agent", is still included in flour treatment agents, which once again attracted industry attention and discuss. Earlier, the grain sector and many manufacturers suggested that benzoyl peroxide be discontinued in flour.

 

In this regard, the relevant person in charge of the Ministry of Health told this newspaper that the Ministry of Health is coordinating relevant departments to study the withdrawal of benzoyl peroxide as a flour treatment agent and its related supporting policies.