On May 17, 2024, the Taiwan Food and Drug Administration issued the revised Regulations for the Application of Health Food Permit (hereafter referred to as the Regulations), consistent with the proposed draft. The Regulations came into effect immediately.
In addition, as the Regulations covers provisions on extension, alteration, transference and reissuance of health food permits, the existing Guidelines on Registration for Extension, Alteration, Transference and Reissuance of Health Food Permits was abolished.
Major Proposed Revisions
Incorporating registration review rules
In accordance with the current practice of health food registration review, the proposed Regulations adds and revises certain review rules. Some examples are as follows:
1. The documents and data for product registration, if not originally written in English, must be accompanied by a Chinese or English translation provided by a registered translation agency.
2. The product stability test report, nutrients analysis report, sanitation test report, and identification report of the ingredients with health functions shall each cover at least three batches of products produced by the factory production line and within the validity period before issuing the report. Additionally, for each report, at least two of the batches tested were completed within the last three years. In comparison, the current Regulations only specifies that the product stability test report, nutrients analysis report and sanitation test report shall each cover at least three batches of samples.
3. For health foods manufactured by different manufacturing plants in different stages, the supporting documents showing that the manufacturing conforms to the good manufacturing practice standards shall be provided separately. If different plant buildings of the same manufacturing plant are involved in the manufacturing, a floor plan of the plant area shall also be submitted.
4. For health foods manufactured by a contractor, a certificate of entrusted manufacturing shall be provided. For health food authorized for sale, an authorization certificate shall be submitted.
5. For product that has already obtained a health food permit, if additional health functions are to be claimed, the business operator must submit new applications for additional functions one by one. This should not be done through modification of the existing health food permit.
Adding registration contents for health food permit
The draft clarifies the registration contents for the health food permit, aiming to provide clearer information to the public. The proposed registration items of the permit are as follows:
l Product names in Chinese and English
l Name, address and responsible person of the applicant company
l Name and address of the manufacturing plant
l Raw material ingredients as well as product appearance and form
l Ingredients with health functions (i.e., quality indicators) and their contents
l Product health function items and descriptions
l Packaging specifications and materials
l Product shelf life, storage methods and conditions
l Contents published on the Chinese product label, container or packaging, and instructions
l Issue date, month, year and permit number of the health permit
l Other registration items designated by the central competent authority
Updating regulations for extending, modifying, transferring, and reissuing health food permits
The draft Regulations incorporates the Guidelines on Registration for Extension, Alteration, Transference and Reissuance of Health Food Permits and adds requirements for these situations. Take the extension of health food permits as an example, applicants shall, within three months prior to the expiration date, complete an application form and submit the relevant documents, along with the required fees to the central regulatory authority. After the permit has expired, a new registration application must be submitted.
However, applicants who submit new registration application within six months after the expiration date are exempt from the re-review process and the submission of certain documents, such as product and its health functions ingredients stability testing plan and result report.
Specifying the use of online platforms
The Regulations clearly states that health food business operators can go to the online application platform set up by TFDA for product registration, to upload the scanned copy of relevant documents. However, for permit extension, changes in registration contents, as well as registration transfer and reissuance, the original permit shall be mailed to the central competent authority for stamping or destruction, after the applicant completes the procedures stipulated in the Regulations.
Source: Chemlinked
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