Declaration of new varieties of food additives
Legal overview
The declaration and examination of new varieties of food additives shall be carried out in accordance with the requirements of the Measures for the Administration of New Varieties of Food Additives, the Provisions on the Declaration and acceptance of New Varieties of Food Additives, and the Announcement on Regulating the licensing Administration of New Varieties of Food Additives.
Among them, the "Measures for the Management of New varieties of Food Additives" put forward the overall requirements for the management of new varieties of food additives, and the measures stipulate the categories of new varieties of food additives, the basic requirements of food additives, the principles of use, the applicants, the main responsible agencies, the required information for declaration, the licensing procedures, and the requirements for announcements.
The "Provisions on the Declaration and acceptance of New varieties of Food Additives" mainly provides detailed provisions on the general requirements of application materials, the preparation requirements of materials, the review and acceptance of materials.
"Announcement on Regulating the Licensing Management of New Varieties of Food Additives" is to further standardize some specific matters of the administrative licensing management of new varieties of food additives. Provisions are made on the technical necessity materials, the quality specification requirements of food additives, the on-site audit of food additives, the product standards for verifying new varieties of food additives, the contents of the announcement of new varieties of food additives, and the encouragement of suggestions on new varieties of food additives.
Competent authority
National Health Commission (NHC)
Relevant regulations
Administrative Measures for New Varieties of Food Additives
Provisions on the Declaration and Acceptance of New Food Additives
"Food Safety National Standard Food additives Standards"
"Food Safety National Standard Food Nutrition agent use Standard"
What situations need to declare new food additives?
New varieties of food additives not included in the national food safety standards (GB2760 and GB14880);
New varieties of food additives that are not included in the announcement of the Health Commission;
Food additives that expand the scope or amount of use;
Information required for the registration and application of new varieties of food additives:
(1) The application form;
(2) general name, functional classification, dosage and scope of use;
(3) Materials or documents proving the technical necessity and effect of use;
(4) quality specification requirements, production and use processes and inspection methods, inspection methods of the additive in food or descriptions of relevant information;
(5) safety assessment data, including raw materials or sources of production, chemical structure and physical characteristics, production technology, toxicological safety assessment data or inspection reports, quality specification inspection reports;
(6) sample labels or instructions;
(7) Other countries (regions) and international organizations allow the production and use of materials conducive to safety assessment.
Apply for the expansion of the amount and scope of use of food additives, can be exempted from submitting the fifth information (safety assessment information).
Applying for the first import of new varieties of food additives, in addition to submitting the above specified information, should also submit the following information:
(1) A certificate issued by the relevant department or institution of the exporting country (region) allowing the production or sale of the additive in the country (region);
(2) Certification documents for examination or certification of the production enterprise issued by the relevant institution or organization of the country (region) where the production enterprise is located;
The services we provide
- Review of New Food additives
- Consultation and training for product customization
- Declaration of New Food additives
COC REACH LIMITED specializes in product registration and compliance consulting services. Leveraging its professional expertise, diverse resources, and global network, it is committed to providing regulatory consulting and environmental compliance services to pharmaceutical and chemical companies, consumer goods manufacturers, and large multinational corporations. It addresses issues related to environmental health and safety laws, product quality standards, and other challenges faced by enterprises during production, sales, and global trade processes.
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