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Chapter Law Content

Title: Health Food Control Act CH
Category: Ministry of Health and Welfare(衛生福利部)
Chapter II Health Food Permit
Article 6
No food shall be labeled or advertised as health food unless it is registered as such in accordance with this Act.
This Act shall govern any food that is labeled or advertised as food furnishing specific nutrient or specific health care effects.
Article 7
No health food shall be manufactured or imported unless and until an application for review and testing registration supported by information on its ingredients, specifications, functions and effects, a summary of the manufacturing process, specifications and methods of analysis, other relevant data and documentation, as well as label and sample are submitted along with permit fee, review and testing fees to, and a product registration permit is issued by, the central competent authority or the organization commissioned thereby.
The permit fee referred to in the preceding paragraph means the fee for the issuance, replacement, or supplementary issuance of the health food permit against the application for review and testing registration. The review and testing fees mean the fees for the review and testing. The relevant fee amount shall be prescribed by the competent authority.
An application for change of the registered items of the health food after permit is issused must be filed with the relevant review fee to the central competent authority.
The central competent authority may, where necessary, commission relevant organization (institution), school or group to deal with the review and testing referred to in the first paragraph. The relevant regulations shall be prescribed by the central competent authority.
Regulations of the application for permit referred to in the first paragraph shall be prescribed by the central competent authority.
Article 8
A health food manufacture or import permit is valid for five years. Application for renewal shall be filed within three months prior to the expiration of the term with the central competent authority if continued manufacture or importation after the expiration is desired. The term of each renewal shall not exceed five years. Such permit shall automatically become null and void if the above application for renewal is not filed within the prescribed period or renewal is not granted.
If the above permit is stained, damaged or lost, an application shall be filed, with reasons stated, with the original issuing authority for a replacement or new permit, and the original permit shall at the same time be surrendered for cancellation or canceled by the issuing authority by public notice.
Article 9
The central competent authority may re-evaluate approved health food during the validity of the health food permit for any of the following reasons:
1. where scientific research raises doubts about the effects of the product;
2. where the ingredients, formula, or method of production of the product is subject to doubt ; or
3. where the re-evaluation is considered necessary by the competent food sanitation authority.
Where the health food does not pass re-evaluation, the central competent authority shall request the company concerned to make improvement within a prescribed period, and may revoke the permit if the improvement is not made within such period.