Act Governing Food Safety and Sanitation Article 21
None of the foods, food additives, food utensils, food containers or packaging and food cleansers which are designated by the central competent authority in a public announcement shall be manufactured, processed, prepared, repacked, imported or exported without filing product registration with and procuring a permit document from the central competent authority. Any change in the registered matters shall be subject to the prior approval of the central competent authority.None of the genetically modified food raw materials shall be used as the food raw materials without being reviewed by the central competent authority in the health risk assessment, filing product registration with and procuring a permit document.Importers of genetically modified food raw materials, that have filed product registration with and procured a permit document from the central competent authority, shall establish a traceability system for tracing the source and tracking the flow of the genetically modified food raw materials in accordance with Paragraph 5 of Article 9.The permits mentioned in the preceding Paragraphs 1 and 2 shall be valid for a term of one year to five years subject to the decisions by the central competent authority. Application for extension shall be filed within three months prior to the expiration of the term with the central competent authority if continued manufacture, processing, preparation, repacking, importation or exportation is desired after the expiration. The term of each extension shall not exceed five years.The regulations governing the revocation of the permits mentioned in Paragraphs 1 and 2, and issuance, replacement, re-issuance, extension, transfer, de-registration, and change in the registered matters of the permit document, etc. shall be prescribed by the central competent authority.The product registration under Paragraphs 1 and 2 may be commissioned to another institution in accordance with regulations which are prescribed by the central competent authority.For the unregistered genetically modified food raw materials mentioned in Paragraph 2 prior to the amendment of this Act on January 28, 2014, shall complete the review and registration within two years after promulgation of this Act.
中文原文 食品安全衛生管理法第21條
經中央主管機關公告之食品、食品添加物、食品器具、食品容器或包裝及食品用洗潔劑，其製造、加工、調配、改裝、輸入或輸出，非經中央主管機關查驗登記並發給許可文件，不得為之；其登記事項有變更者，應事先向中央主管機關申請審查核准。
食品所含之基因改造食品原料非經中央主管機關健康風險評估審查，並查驗登記發給許可文件，不得供作食品原料。
經中央主管機關查驗登記並發給許可文件之基因改造食品原料，其輸入業者應依第九條第五項所定辦法，建立基因改造食品原料供應來源及流向之追溯或追蹤系統。
第一項及第二項許可文件，其有效期間為一年至五年，由中央主管機關核定之；期滿仍需繼續製造、加工、調配、改裝、輸入或輸出者，應於期滿前三個月內，申請中央主管機關核准展延。
但每次展延，不得超過五年。
第一項及第二項許可之廢止、許可文件之發給、換發、補發、展延、移轉、註銷及登記事項變更等管理事項之辦法，由中央主管機關定之。
第一項及第二項之查驗登記，得委託其他機構辦理；其委託辦法，由中央主管機關定之。
本法中華民國一百零三年一月二十八日修正前，第二項未辦理查驗登記之基因改造食品原料，應於公布後二年內完成辦理。
食品所含之基因改造食品原料非經中央主管機關健康風險評估審查，並查驗登記發給許可文件，不得供作食品原料。
經中央主管機關查驗登記並發給許可文件之基因改造食品原料，其輸入業者應依第九條第五項所定辦法，建立基因改造食品原料供應來源及流向之追溯或追蹤系統。
第一項及第二項許可文件，其有效期間為一年至五年，由中央主管機關核定之；期滿仍需繼續製造、加工、調配、改裝、輸入或輸出者，應於期滿前三個月內，申請中央主管機關核准展延。
但每次展延，不得超過五年。
第一項及第二項許可之廢止、許可文件之發給、換發、補發、展延、移轉、註銷及登記事項變更等管理事項之辦法，由中央主管機關定之。
第一項及第二項之查驗登記，得委託其他機構辦理；其委託辦法，由中央主管機關定之。
本法中華民國一百零三年一月二十八日修正前，第二項未辦理查驗登記之基因改造食品原料，應於公布後二年內完成辦理。