Article 37 of the Food Safety Law of the People's Republic of China stipulates that the use of new food raw materials for the production of food, or the production of new varieties of food additives or new varieties of food-related products shall submit safety assessment materials of related products to the administrative department of health under The State Council. Article 93 The import of food produced using new food raw materials or new varieties of food additives or new varieties of food-related products shall be handled in accordance with the provisions of Article 37 of this Law.
New varieties of additives and resins for food contact materials, as the most important new varieties of food related products, need to be registered and declared in accordance with the relevant laws and regulations of new varieties of food related products.
The relevant laws and regulations for the declaration of new varieties of food related products are as follows:
Food Safety Law of the People's Republic of China, Provisions on Administrative Licensing of New Varieties of Food Related Products, Provisions on Application and Acceptance of New Varieties of Food Related Products
What situations need to declare new additives and resins for food contact materials?
If the substance has not been included in the following national standards or the Ministry of Health announcement allowed for use, and the scope of use is food contact materials and products, it belongs to food contact materials additives, new varieties of resins, need to be declared new varieties of food related products:
GB 9685-2016 "Food Safety National Standard for Food Contact materials and additives used in products Standard";
Product standards (e.g. GB 4806.6-2016 "Food Safety National Standard for food contact plastic resin");
New substances of food contact materials approved by the Ministry of Health;
Food contact resins, additives to expand the scope of use, the amount of use also need to be declared for new varieties of food related products.
1) Application form; 2) Physical and chemical properties; 3) Technical necessity, use and conditions of use; 4) Scope of use, usage; 5) Production process; 6) Quality specification requirements, testing methods and testing reports; 7) Toxicological safety assessment data; 8) Migratory and/or residual amounts, estimated dietary exposures and their assessment methods; 9) Information or supporting documents of permitted use at home and abroad; 10) Other information useful for assessment; 11) Power of attorney (if the application for authorization, need to provide).
Certification materials issued by the relevant department or institution of the exporting country (region) allowing the production or sale of the product in the country (region);
Certification materials issued by relevant institutions or organizations in the country (region) where the production enterprise is located for examination or certification of the production enterprise.
1, quality specification test
2, migration or residual test
3, toxicology test (toxicology test items are determined by the migration amount of the substance to be declared, please see the table below for specific requirements)
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