Q&As on the Key Points and Considerations in Health Food Development

On July 2, 2024, we hosted a free webinar on the key points and considerations in health food development. Many questions were raised during the webinar.

We have collected the questions and made a Q&A summary as follows:

Q1: It’s required to supplement additional identification research materials for re-registration, what steps should be taken?

A1: You may refer to sources such as the Pharmacopoeia of the People’s Republic of China, standards for traditional Chinese medicinal materials, and research papers to establish identification methods.

Q2: Is stimulant testing still required for the function of losing weight and alleviating physical fatigue according to the latest requirements?

A2: No. Only prohibited substances testing is required according to the latest regulations.

Q3: How to distinguish the primary and secondary raw materials of health food?

A3: It can be determined based on the product formulation, the primary and secondary functions of each ingredient, and the use levels.

Q4: If multiple new ingredients are used in health food products, is it necessary to apply for new food raw materials first?

A4: If you intend to use new ingredients lacking sufficient evidence in health food products, there are two approaches:

(1) Apply first for the new food raw material. Once approved, use it in health food products and then apply for health food registration.

(2) Alternatively, directly apply for registration of health food products containing the new ingredients. At the same time, submit the safety assessment materials for the new ingredients.

According to approach (2), the number of new ingredients in health food products should not exceed one. Therefore, when dealing with multiple new ingredients, it is advisable to first apply for new food raw materials.

Q5: Do two traditional Chinese medicine compound formulations require identification?

A5: Yes, it is typically required. If specific identification methods are not yet established, there should be sufficient evidence to justify this.

Q6: For health food products using Ginseng radix et rhizoma and Ganoderma as single ingredients, how long is the entire filing process?

A6: Currently, only domestic products are eligible for filing, and it generally takes about six months to obtain the filing certificate.

Q7: Can stability samples be tested internally, or must they be entrusted?

A7: They can be tested internally or entrusted to a legally qualified testing agency.

Q8: Are there specific standards or requirements for packaging materials that come into direct contact with the product?

A8: For health foods, packaging materials that are directly contact with products must comply with food contact material standards or the pharmaceutical packaging material standards.

Q9: Are the physicochemical parameters in the product technical requirements research reports the same as what the entrusted agency refers to as hygiene testing items?

A9: Hygiene testing refers to the full-item testing of all product technical requirements for the samples submitted. This includes sensory, identification (if applicable), physicochemical parameters, microbiological parameters, functional components or characteristic components parameters, packaging quantity or weight differences/net content, and allowable negative deviation parameters.

Q10: Can common food and health food be manufactured on the same production line?

A10: There are currently no prohibitive regulations against co-producing health food and common food. It is crucial to strictly enforce clearance management systems during the co-production to prevent cross-contamination and errors.

Q11: For filing products: 1) Is microbial testing required for warehouse-in inspection of raw and auxiliary materials? 2) Can the manufacturer’s report be used directly for the inspection, or is internal control testing necessary?

A11: Microbial testing is necessary if the quality requirements for raw and auxiliary materials include microbial parameter and the manufacturer cannot provide a valid certificate of compliance. You may use the manufacturer’s report directly, provided that it includes all required items and meets the relevant quality standards.

Above are the minimum requirements. If a company’s management system for raw and auxiliary materials sets stricter regulations, those internal requirements must be followed.

If you are interested in global hot topics of food compliance, our webinars will be unmissable to you. We have made a list of all the free webinars scheduled for 2024 for your reference: CIRS Food – Upcoming Free Webinars in 2024.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.