ZMUni Compliance Centre

Our Services:

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• Application feasibility analysis

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• Application for new food additive varieties

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• Testing services (safety assessment reports)

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• Other customized consulting and compliance services

Scope of New Food Additive Varieties in China

New food additive varieties that are not listed in the national food safety standards "Standard for the Use of Food Additives" (GB 2760) and "Standard for the Use of Food Nutritional Enhancers" (GB 14880);
New food additive varieties not included in the list of permitted use by the National Health Commission (NHC);
Expansion of use or dosage of food additives ("expansion items")

Regulatory Requirements for New Food Additive Varieties in China

According to the "Food Safety Law of the People's Republic of China," new food additive varieties need to undergo evaluation and approval by the National Health Commission before they can be used in food.

Documents Required for New Food Additive Variety Application in China

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• Application form

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• Common name, functional classification, dosage, and scope of use

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• Supporting materials or documents demonstrating the technical necessity and effectiveness

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• Quality specifications, production and usage processes, and testing methods for the additive, as well as relevant information on the additive in the food

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• Safety assessment materials, including information on production materials or sources, chemical structure and physical characteristics, production processes, toxicological safety evaluation data or test reports, and quality specification test reports

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• Draft labels or instructions

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• Other materials from other countries (regions) or international organizations that contribute to the safety assessment

For the declaration of expanded use or dosage of food additives, the submission of Item 5 (safety assessment materials) may be exempted.

For the first-time import of new food additive varieties, in addition to the above-mentioned documents, the following should also be submitted:

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• Proof of permission for the additive to be produced or sold in the exporting country (region) issued by relevant departments or organizations

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• Proof of examination or certification of the production enterprise by relevant institutions or organizations in the country (region) where the imported new food additive manufacturer is located

Testing Items for New Food Additive Variety Application in China

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• Quality specification test report: Three batches of the food additive should be tested according to the quality specifications and testing methods provided in the application materials.

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• Toxicological safety evaluation data or test reports: Toxicological tests should be conducted according to the relevant requirements in GB 15193.1-2014 "National Food Safety Standard - Procedures for Toxicological Evaluation of Food Safety."

Related Regulations and Supporting Documents for New Food Additive Varieties in China:

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• Food Safety Law of the People's Republic of China

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• GB 2760 National Food Safety Standard - Standard for the Use of Food Additives and its supplements

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• GB 14880 National Food Safety Standard - Standard for the Use of Food Nutritional Enhancers and its supplements

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• Measures for the Management of New Food Additive Varieties

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• Regulations on the Declaration and Acceptance of New Food Additive Varieties

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• Announcement on Standardizing the Management of New Food Additive Varieties