Regulations for Application of Health Food Permit

Regulations for Application of Health Food Permit DOH Food No. 88027973, Promulgated, May 21, 1999 DOH Food No. 0950408514, Amended, October 30, 2006 DOH Food No. 1011302400, Amended, August 29, 2012 Article 1 These Regulations are set forth pursuant to the paragraph 5 of Article 7 of the Health Food Control Act (hereinafter referred to as "Act"). Article 2 The application by the subparagraph 1, paragraph 1 of Article 3 of this Act shall submit the following documents and information for product registration: (1) Application form (2) Specifications of the raw materials and quantity of ingredients of the product (3) Safety assessment report (4) Health care effect assessment report (5) Identification report on ingredients with health care effect, and method of examination (6) Health care effect stability test report http://law.moj.gov.tw/Eng/LawClass/LawContent.aspx?PCODE=L0040030 (7) Summary of manufacturing process (8) Documentary evidence of good manufacturing practices (9) Sanitary specifications and its test report (10) General nutrients analysis report (11) Relevant research reports and literature (12) Package, label and product instruction sheet (13) Certificate of the applicant's corporation or business registration (14) Intact product samples and review fee Article 2-1 The application by the subparagraph 2, paragraph 1 of Article 3 of this Act shall submit the following documents and information for product registration: (1) Application form (2) Specifications of the raw materials and quantity of ingredients of the product (3) Ingredients specification test report (4) Health care effect stability test report (5) Summary of manufacturing process (6) Documentary evidence of good manufacturing practices (7) Sanitary specifications and its test report (8) General nutrients analysis report (9) Package, label and product instruction sheet (10) Certificate of the applicant's corporation or business registration (11) Intact product samples and review fee Article 2-2 The application by the subparagraph 1 or 2, paragraph 1 of Article 3 of this Act to the central competent health authority for product registration, the authority just accept one product for one health care effect or one specification per case. It will be issued one license after permitting. The products had have health food license could be added health care effect items; they should be applied as the change license registration to the central competent health authority. Article 3 The above application shall be subject to the preliminary review by the central competent health authority in terms of the completeness of the documents and information submitted, particulars of the applicant, package, label and instruction sheet of the product, general consumption safety of the raw materials and ingredients of the product etc. If the information submitted for preliminary review is incomplete, the necessary documents and information shall be submitted within the period prescribed in the notice of the central competent health authority, otherwise the case will be closed. If an application by the subparagraph 1, paragraph 1 of Article 3 of this Act is accepted after preliminary review, 20 copies each of the application documents and information described in subparagraphs 1 to 12 of the above article shall be submitted to the central competent health authority within the period prescribed in the notice of said authority. Article 4 If an application by the subparagraph 1, paragraph 1 of Article 3 of this Act is deemed to have met all requirements after preliminary review, the health food review committee of the central competent health authority shall review the application documents and information in terms of the safety, health care effect, package, label and instruction sheet of the product, and provide its review opinion on the application to the central competent health authority. If an application by the subparagraph 2, paragraph 1 of Article 3 of this Act is deemed to have met all requirements after preliminary review, it would not be submitted to the health food review committee of the central competent health authority for secondary review, but this authority could ask for product verification. Article 5 Upon completing review of an application in accordance with the above opinion and applicable laws and regulations, the central competent health authority shall notify the applicant that the application is rejected or accepted, or request the applicant to submit further necessary information or samples for verification, as the case may be. Article 6 If an applicant is requested to submit further necessary information after review of its application, the information being requested shall be submitted within the period prescribed in the notice of the central competent health authority, otherwise the case will be closed. Article 7 If an applicant is requested to submit samples for verification after review of its application, sufficient original, intact samples for examination shall be submitted along with an examination fee to an analysis institution designated by the central competent health authority in accordance with the contents of the notice of said authority within one month of such notice. Results of the examination shall serve as reference for the above authority to rely on in granting approval. If such samples are not submitted within the prescribed period, the central competent health authority will reject the application without giving any notice. Article 8 If an application is accepted, the central competent health authority shall issue an approval in writing upon payment of a permit fee by the applicant. The approval shall be valid for five years and extendable within three months prior to expiration. The original approval shall automatically be cancelled if no application for extension is filed within the prescribed period or such application is not accepted. Article 9 The specifications of the raw materials and quantity of ingredients shall be reviewed mainly in terms of the following aspects: (1) Such ingredients shall be harmless to human health and safety without including any of those described in Article 12 of the Act. (2) Information on such specifications and quantity shall consist of the detailed name and contents of all raw materials and food additives. (3) The scope and application of food additives shall conform to regulations promulgated by the central competent health authority. Article 10 The safety assessment report shall be reviewed mainly in terms of the following aspects: (1) Safety assessment tests shall be conducted in accordance with the Guidelines of Health Food Safety Assessment promulgated by the central competent health authority. The assessment report shall be accomplished by information as required by the Guidelines. (2) Information on toxicity test may be exempted under any of the following circumstances: a. The raw materials of the product are conventionally consumed and the product is in the form of commonly processed food; or b. There are complete academic literature and reports on the toxicology and safety, as well as records of consumption, of the product; and the raw materials, components and manufacturing process of the product are consistent in every aspect with those mentioned in the above academic literature and reports. Article 11 The health care effect assessment report shall be reviewed mainly in terms of the following aspects: (1) Pursuant to subparagraph 2 of the first paragraph of Article 3 of the Act, health care effect shall be harmless, definite and steady as duly supported by scientific assessment and test or by academic principles. (2) Pursuant to subparagraph 3 of the first paragraph of Article 3 of the Act, the reasonable intake of the product shall be supported by scientific evidences. (3) Health care effect assessment and test shall be conducted in accordance with the Guidelines of Health Food Health Care Effect Assessment promulgated by the central competent health authority, otherwise, supporting scientific evidence of the test adopted shall be submitted for verification of the accuracy of such test. The certificate of ingredients specification shall be reviewed mainly in if conform the specification for health food by the central competent health authority or not. Article 12 The identification report on ingredients with health care effect and method of examination shall be reviewed mainly in terms of the following aspects: (1) The product shall contain ingredients with definite health care effect pursuant to the subparagraph 1, paragraph 1 of Article 3 of the Act. (2) The identification report shall include results of qualitative and quantitative tests on the above ingredients. (3) The method of examination shall be generally recognized as scientifically reliable and accurate. (4) With respect to ingredients with health care effect which cannot be identified by existing technology, information on the ingredients carrying such effect or the relevant supporting literature shall be submitted. The ingredients specification test report shall be reviewed mainly in if conform the specification for health food by the central competent health authority or not. Article 13 The health care effect stability test report shall be reviewed mainly in terms of the following aspects: (1) Such report shall serve as the basis to review the shelf life of the health care effect. (2) Such report shall consist of the testing method, data and results with respect to at least three lots of samples. (3) The application by the subparagraph 1, paragraph 1 of Article 3 of this Act, the representative characteristics of the efficacy ingredient shall be adopted as the testing criteria in the stability test. Where existing technology cannot identify ingredients with health care effect, items listed in the Guidelines of Health Food Health Care Effect Assessment shall serve as such criteria. (4) The application by the subparagraph 2, paragraph 1 of Article 3 of this Act, the representative characteristics of the efficacy ingredient shall conform the specification for health food in the stability test. Article 14 The summary of manufacturing process shall be reviewed mainly in terms of the following aspects: (1) The summary shall include the preparation and processing procedures of the raw materials, and conditions of processing. (2) In case of extraction, the method of extraction and name of the solvent shall be provided; in case of concentration, the multiples shall be provided. Article 15 The supporting document of good manufacturing practices shall be reviewed in terms of mainly in the following aspects: (1) In case of domestic products, information on control of the manufacturing process shall be submitted in accordance with the good manufacturing practices regulations enacted by the central competent health authority. Where necessary, the central competent health authority may perform the on-side inspection of the manufacturer's premises. (2) In case of imported products, the full text of the good manufacturing practices regulations of the country of origin, quality control plan, and official certificate of compliance with such regulations shall be submitted. Article 16 The sanitary specifications and its test report shall be reviewed mainly in terms of the following aspects: (1) Such specifications shall conform to Articles 11 and 12 of the Act. (2) At least three lots of samples shall be examined. Article 17 The review of the general nutrients analysis report shall be focused as follows: (1) The nutrients analysis shall include at least the requirements for health food and product nutrients labeling regulations. (2) At least three lots of samples shall be examined. Article 18 The relevant research reports and literature shall be reviewed mainly in terms of the following aspects: Literature and information that are submitted on research and application of similar products at home and abroad shall be generally recognized as scientifically reliable and accurate. Article 19 The package, label and product instruction sheet shall be reviewed mainly in terms of the following aspects: (1) The container, package and instruction sheet of the product shall contain material facts as specified in Articles 13 and 14 of the Act. (2) The descriptions of health care effect being submitted for review shall correspond with the assessment results; the contents thereof shall be true and not be misleading. Article 20 The Regulation shall be enforced as of the enforcement of the Act. The amendatory clauses of the Regulation shall be enforced as of the enforcement of the Act.