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Relevant Policies for the Food Additives Industry
Release Date:
2019-12-13
Laws and Regulations (Order No. 73 of the Ministry of Health) Article 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 Implementing Regulations of the Food Safety Law. Article 2 New varieties of food additives refer to: (1) food additive varieties that have not been included in the National Food Safety Standards; (2) food additive varieties that have not been listed in the announcements issued by the Ministry of Health as being permitted for use; (3) food additive varieties for which the scope of use or the dosage has been expanded. Article 3 Food additives shall be technically necessary and, following risk assessment, proven to be safe and reliable.
Laws and Regulations
(Ministry of Health Order No. 73)
Article 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 Implementing Regulations of the Food Safety Law.
Article 2: New varieties of food additives refer to:
(1) Food additive varieties not included in the National Food Safety Standards
(2) Food additives not listed in the Ministry of Health’s announcement as being permitted for use
(3) Food additive varieties whose scope of use or usage levels are expanded.
Article 3: Food additives shall be technically necessary and proven safe and reliable through risk assessment.
Article 4: The use of food additives shall comply with the following requirements:
(1) Food spoilage and deterioration shall not be concealed.
(2) Quality defects in the food itself or during the processing should not be concealed.
(3) The use of food additives shall not be for the purpose of adulteration, falsification, or counterfeiting.
(4) The nutritional value of the food itself should not be reduced.
(5) Minimize the usage level in food as much as possible while achieving the intended effect.
(6) Processing aids used in the food industry shall be removed prior to the production of the final finished product, unless specific regulations permit residual amounts.
Article 5 The Ministry of Health shall be responsible for the review and approval of new varieties of food additives and shall organize the formulation of technical evaluation and review standards for such new varieties.
Article 6 Units or individuals applying for the production, operation, use, or import of a new food additive variety (hereinafter referred to as the “applicant”) shall submit an application for approval of the new food additive variety and provide the following materials:
(1) Common names, functional classification, usage levels, and scope of application of food additives
(2) Materials or documents demonstrating the technical necessity and effectiveness of use
(3) Quality specifications, production processes, and testing methods for food additives; as well as the testing methods for such additives in food or relevant explanatory information.
(4) Safety assessment materials, including information on manufacturing raw materials or their sources, chemical structure and physical properties, manufacturing processes, toxicological safety evaluation data or test reports, and quality specification test reports.
(5) Labels, instruction manuals, and samples of food additive products
(6) Information, such as that pertaining to the production and use authorized by other countries (regions) or international organizations, that is conducive to safety assessment.
Applications for expanding the scope of use or the permitted levels of food additives may be exempt from submitting the fourth item of the preceding paragraph, unless additional information is required during the technical review.
Article 7: For applications for the first-time import of a new variety of food additive, in addition to the materials specified in Article 6, the following materials shall also be submitted:
(1) Certificates issued by the relevant authorities or institutions of the exporting country (or region) attesting that the additive is permitted for production or sale in that country (or region).
(2) Certification or accreditation documents issued by the relevant authorities or organizations in the country (or region) where the manufacturing enterprise is located.
Article 8: Applicants shall truthfully submit the relevant materials, accurately reflect the actual situation, and be responsible for the authenticity of the content of such materials, bearing the corresponding legal consequences.
Article 9: The applicant shall indicate in the materials submitted pursuant to Items 1, 2, and 3 of Paragraph 1 of Article 6 of these Measures whether such materials do not involve trade secrets and may be made public.
Where new varieties of food additives are technically necessary and demonstrate effective performance, public consultation shall be conducted, and opinions shall also be sought from relevant departments such as quality supervision, industry and commerce administration, food and drug administration, industry and information technology, and commerce, as well as from pertinent industry organizations.
Hearings may be held to solicit opinions on matters involving significant disagreements or substantial interests.
The relevant comments received shall serve as reference material for the technical review.
Article 10 The Ministry of Health shall, within 60 days after receipt of an application, organize experts in medicine, agriculture, food science, nutrition, processing technology, and other relevant fields to conduct a technical review of the documentation on the technical necessity and safety assessment of the new food additive variety, and shall issue a conclusion on the technical review. Where additional information is required during the technical review, the applicant shall be promptly notified, and the applicant shall, in accordance with such notification, promptly submit the supplementary materials.
When necessary, experts may be convened to conduct on-site verification and evaluation of the research and development as well as the production facilities for new food additive varieties.
Where verification testing of relevant materials and test results is required, the applicant shall be informed of the requirements regarding the test items, test batches, test methods, and other relevant details. Safety verification testing shall be conducted by a testing institution that has obtained accreditation. Where no national standard for food safety testing methods yet exists, the testing method shall first be validated.
Article 11: The specific procedures for the administrative licensing of new varieties of food additives shall be implemented in accordance with the Administrative Licensing Law, the Measures for the Administration of Health Administrative Licensing, and other relevant provisions.
Article 12: Based on the conclusions of the technical review, the Ministry of Health shall decide to grant approval for new food additive varieties that are technically necessary and comply with food safety requirements, and shall publish such approvals by including the additives in the List of Permitted Food Additives.
Applications that lack technical necessity or fail to meet food safety requirements shall not be approved, and the reasons shall be provided in writing.
Where non-food-grade chemical substances or other substances harmful to human health are found to have been potentially added to food, the provisions of Article 49 of the Implementing Regulations of the Food Safety Law shall apply.
Article 13: The Ministry of Health shall, on the basis of technical necessity and the results of food safety risk assessments, formulate and promulgate as national food safety standards the varieties, scope of use, and maximum usage levels of food additives that have been approved for use in public announcements, in accordance with the procedures for establishing national food safety standards.
Article 14: Where any of the following circumstances exists, the Ministry of Health shall promptly organize a re-evaluation of food additives:
(1) Scientific research findings or evidence indicating that the safety of a food additive may be questionable
(2) No longer technically necessary.
Where a re-examination determines that a food additive does not meet food safety requirements, the Ministry of Health may issue an announcement to revoke the approval of the additive or to revise its scope of use and permitted levels.
Article 15 This Measures shall come into force on the date of its promulgation. The “Administrative Measures for the Hygiene of Food Additives” issued by the Ministry of Health on March 28, 2002, shall be repealed simultaneously.
Latest Updates
The Ministry of Health Plans to Study the Repeal of the Regulation Allowing the Addition of Flour Whitening Agents
On September 12, 2011, the public consultation on the National Food Safety Standard for the Use of Food Additives was concluded. By the end of August, the Secretariat had received approximately 100 public comments.
Public suggestions fall into three main categories: proposals to revise certain food classification systems in the standards; proposals to amend specific limits on the scope of use and maximum levels for certain food additives; and proposals to revise the names of food additives. A responsible official from the Ministry of Health stated that the collected suggestions will be categorized, and expert panels will be convened to conduct a detailed, item-by-item review of each proposal.
In the “National Food Safety Standard for the Use of Food Additives” (draft for public comment), benzoyl peroxide—commonly known as “flour whitening agent”—is still listed as a flour treatment agent, once again drawing attention and sparking debate within the industry. Previously, grain authorities and numerous food manufacturers had recommended phasing out the use of benzoyl peroxide in flour.
In response, a responsible official from the Ministry of Health told this newspaper that the ministry is coordinating with relevant departments to study the removal of benzoyl peroxide as a flour treatment agent and the related supporting policies.
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