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Product categories: Health food, formula food for infants and young children, new food additive varieties, new food raw materials and formula food for special medical use

Service items: Provide technical support and review support work, including the technical evolution, guiding and rectification on preparation conditions of customer materials, assist in making the registration document, organize the expert to conduct pre-review and agent the declaration, etc., guide and help enterprises to complete the registration/declaration successfully within a certain time.

Registration service process for formula food for infants and young children

• China has strengthened the supervision on food for infants and young children and detailed the supervision and control measures in the aspects of production, circulation, import and other aspects after the “Sanlu milk powder incident” in 2008.

• At present, China has nearly 100 standards, laws and regulations and announcements directly related to formula food for infants and young children and nearly 400 general standards, laws and regulations and announcement.

• Since January 1, 2018, the overseas production enterprises can only export the formula food for infants and young children to China after realizing double registration of formula registration certificate& registration of Certification and Accreditation Administration of the People ’ s Republic of China.

Registration service process for health food

• It is estimated that the income of China nutrition and health food industry revenue will reach 307.4 billion yuan in 2017, the compound annual growth rate in the next five years (2017-2021) is about 16.12%, and income of China nutrition and health food industry will 559 billion yuan in 2021.

• The “Food Hygiene Law of the People's Republic of China” (1995) stipulated the special provisions on management system for food for specific health function. The “Food Safety Law of the People's Republic of China” (1995) added the special provisions on health food. The revised edition of Food Safety Law of the People's Republic of China detailed the management system for health food, and added specific system as the raw materials and function catalogue, registration or filing management and advertisement review, etc.

• In the approval letter of health food issued by China Food and Drug Administration, the Chinese products accounted for 95.5%, imported food accounted for only about 4.5%.Under the two-track system management of China health food, the imported health food enjoys limited benefit because of strict supervision.

Registration service process for new food raw materials

• New food raw materials refer to the following items in China without traditional eating habits: (I) animals, plants and microorganisms; (II) components separated from animals, plants and microorganisms; (III) food components that have changed in their original structure; (D) other newly developed food raw materials.

• For new food raw materials exported to China, “Administrative measures for safety review of new food raw materials” requires that except submitting the specified general materials, the evidentiary materials for allowing the products to be produced or sold in local country (area) issued by relevant departments and institutions of exporting country (area), evidentiary materials for production enterprises review or certification issued by relevant institutions and organizations in the country (area) where the production enterprise located shall be submitted.

• With the continuous development of technology, more and more innovative raw materials flow into the Chinese market.
 
Registration service process for new food additive varieties

• China current laws and regulations for food additives: “Food Safety Law for the People's Republic of China” (Presidential Decree No. 21), “Administrative License Law of the People's Republic of China (Presidential Decree No. 7), “Administrative measures for new food additive varieties” (No.73 of Ministry of Health), “Declaration and acceptance provisions for new food additive varieties” (No.49, 2010 of Ministry of Health) and “Standards for use of food additives” (GB2760-2014), etc.

• According to the Food Safety Law, the enterprises shall submit safety assessment materials of new food additive varieties to the Health Administrative Department of China State Council, and new food additive varieties will be approved and published after review of complying with the food safety.

Registration service process for formula food for special medical use

• Formula food for special medical use refers to the foods which are produced for meeting the specific needs of population under specific disease state, and the security requirement of it is high and shall be used under the doctor's guidance.

• China current laws and regulations for formula food for special medical use: “Food Safety Law for the People's Republic of China” (Presidential Decree No. 21), “Administrative License Law of the People's Republic of China” (Presidential Decree No. 7), “Administrative measures for registration of formula food for special medical use” (No.24 of Food and Drug Administration), General rules for formula food for special medical use (GB 29922-2013), “Good manufacturing practice for formula food for special medical use” (GB 29923-2013), General rules for formula food for special medical use for infants and young children (GB 25596-2010), etc.
 
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