On May 22, 2023, the Center for Food Evaluation of State Administration for Market Regulation released answers to 11 common questions about food supplement compliance. ZMUni has compiled this to assist you to navigate compliantly in the Chinese market.
01 Question: What are the requirements for the qualification documents for imported food supplements filing?
Answer: According to the relevant requirements of the Food Supplements Registration and Filing Management Measures and the Food Supplements Filing Guide (Trial):
Issuing Organization: Qualification documents involving overseas institutions should be issued by the government authority or legal service institution of the product's manufacturing country (region). The original qualification document should be stamped or signed by the issuing unit or institution's legal representative (or authorized person).
Contents of the Document: Contents should be listed item by item in accordance with the specific requirements in sections 6.1, 6.2, and 6.3 of the the Food Supplements Filing Guide (Trial). No items should be missing.
Notarization: Qualification documents issued by overseas institutions should be notarized by the notary office of the manufacturing country (region) and confirmed by the Chinese Embassy in that country. They should also be notarized by notary offices in China. If the qualification document has a validity period, it should be used within that period.
Language: The qualification documents for imported food supplements should be written in the official language of the product's manufacturing country (region). If the official language is not English, an English translation should be provided. This translation should also be notarized by the notary office of the manufacturing country (region) and confirmed by the Chinese Embassy in that country.
Question 02: What are the requirements for a power of attorney for the contact person when applying for a login account for imported food supplements?
Answer: The content of the authorization letter should be the foreign manufacturer's authorization to the contact person to handle the login account of the Food Supplements Filing Management Information System (it should contain the contact person's ID number, contact phone number, etc.), and should provide relevant information in accordance with the requirements of items 6.7 and 6.8 in the Food Supplements Filing Guide (Trial).
Question 03: What requirements should the filing person for imported food supplements meet?
Answer: According to the Food Supplements Registration and Filing Management Measures and the Food Supplements Filing Guide (Trial), the filing person for imported food supplements should be a listed overseas manufacturer. The overseas manufacturer (filer) refers to a legal person or other organization that meets the listing requirements of its country (region).
Question 04: What are the quality requirements for the raw materials such as Coenzyme Q10, fish oil, broken ganoderma lucidum spore powder, spirulina, and melatonin, which have been registered?
Answer: For such products, when declaring new product registration, a continuation of registration, change of registration, technology transfer, and reissue of certificates, the quality requirements of raw materials such as Coenzyme Q10, fish oil, broken ganoderma lucidum spore powder, spirulina, and melatonin should be formulated in accordance with the technical requirements for raw materials used in food supplements.
Question 05: What should be noted when declaring food supplements with donkey-hide gelatin (Ejiao) as the final product?
Answer: According to the Notice on the Declaration and Review of Food Supplements Products Using Red Yeast and Other Raw Materials (National Food and Drug Administration License [2010] No. 2), "For food supplements products with Ejiao as the final product, its product quality standards should comply with the relevant provisions of the Chinese Pharmacopoeia", that is, the characteristic components should include indicators such as L-hydroxyproline, glycine, alanine, L-proline, and characteristic peptides (calculated as donkey-derived peptides A1, donkey-derived peptides A2). When declaring the registration of new products with Ejiao as the final product, these characteristic components should be established according to the above requirements.
The characteristic peptide (calculated as donkey-derived peptides A1, donkey-derived peptides A2) is a new food added in the Chinese Pharmacopoeia (2020 Edition). Thus, for the previously approved products with Ejiao as the final product, when declaring continuation of registration, change of registration, technology transfer, and reissue of certificates, this peptide should be added as a characteristic component, and the stability test report of three batches of products with this indicator should be submitted.
Question 06: When the tests need to be redone or supplemented for characteristic components, hygiene, and stability tests, must the test samples used be the same batch as the original test samples?
Answer: In principle, the tests should be performed using samples from the same batch as the original test samples. If the original samples have exceeded the shelf life of the product, samples from another batch can be used for testing, but the reasons should be explained.
Question 07: For approved food supplements, what changes require change in the registration application, and how should the materials be submitted?
Answer: The changes in food supplements should be limited to the content specified in the approval certificate and its attachments, and should not result in substantial changes in product safety, health function, and quality controllability. For example, changes in product name, registrant name, and address, suitable population scope, unsuitable population scope, health functions, dosage and method of use, specifications, storage methods, shelf life, precautions, types of excipients, production process (main procedures and key process parameters), sensory description, identification, quality requirements for raw and auxiliary materials, type of hard capsule shell, physical and chemical, microbiological, characteristic component indicators and testing methods, type, name and standard of direct contact product packaging materials, etc.. For these changes, applicants should provide relevant materials in accordance with the "8. Change Registration Application Material and Requirements" in the Food Supplements Registration Application Service Guide (2016 Edition) when applying for change registration.
For adjustments to non-main processes and non-key process parameters that are not specified in the attachment of the approval certificate, there is no need to submit a change registration application.
Question 08: The Technical Guidelines for the Inspection and Evaluation of Physical and Chemical and Hygiene Indicators of food supplements (2020 Edition) has been implemented. For approved products whose characteristic component testing methods that adopted the Technical Specifications for the Inspection and Evaluation of food supplements (2003 Edition), is it necessary to apply for a change in registration, and how to submit materials?
Answer: For approved products whose characteristic component testing methods adopted the Technical Specifications for the Inspection and Evaluation of Food Supplements (2003 Edition), if the methods of the 2003 version are still applicable to this product, there is no need to apply for a change in registration.
If it is indeed necessary to apply for a change in registration, relevant materials should be provided in accordance with the "8. Change Registration Application Material and Requirements" in the Food Supplements Registration Application Service Guide (2016 Edition).
If there are no changes in the principles and operation steps of the proposed change method compared with the original testing method, the comparison results of the new and old methods should be provided for three batches of products.
If the method principle or operation steps have changed, methodological research should be conducted, referring to GB/T 5009.1 "General Rules for Physical and Chemical Parts of Food Hygiene Inspection Methods", investigating the precision, accuracy, and linear range of the proposed change method, and providing research materials.
Question 09: Can non-finial samples be used in safety evaluation tests?
Answer: According to the provisions of 3.4.2.3.2 (2) in the Rules for the Review and Approval of Food Supplements Registration (2016 Edition), in principle, the test should use fully packaged samples.
If non-finial samples need to be used for testing, the production and processing process of non-finial samples should be provided, along with the specific requirements and explanations for the necessity and rationality of sample processing issued by the food inspection agency.
Question 10: Do all probiotic ingredients have to undergo safety evaluation in accordance with the Technical Guidelines for the Safety Testing and Evaluation of Probiotic Ingredients for Food Supplements (2020 Edition)?
Answer: Yes, food supplements ingredients need to be tested and evaluated for safety and toxicology according to the Technical Guidelines for the Safety and Toxicology Testing and Evaluation of Food Supplements and Their Ingredients (2020 Edition) and the Technical Guidelines for the Safety Testing and Evaluation of Probiotic Ingredients for Food Supplements (2020 Edition).
The latter provides the test and evaluation procedures and methods for the pathogenicity (virulence) in the safety evaluation of bacteria, filamentous fungi (excluding fruiting bodies), and yeasts used in food supplement ingredients. It is also applicable to the pathogenicity testing and evaluation of probiotic strains used in food supplements ingredients (including those used in food supplement formulas and those used in ingredient production).
Question 11: What are the requirements for the alcohol content in food supplements liquors?
Answer: According to the Regulations on Application and Review of Amino Acid Chelates and Other Food Supplements (Trial), for applications to register food supplements that use alcohol as a carrier, the alcohol content of the product must not exceed 38 degrees.
References:
Center for Food Evaluation of State Administration for Market Regulation
National Committee on the Assessment of the Protected Traditional Chinese Medicinal Products
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