Act Governing Food Safety and Sanitation｜第 48 條｜Food and Drug Administration｜Act｜In Force
第 九 章｜衛生福利部 / 食品藥物管理署｜v108.06.12
Last Amended: 2019-06-12
Anyone committing any of the following and failing to correct the violation within the time limit prescribed shall be fined between NT$30,000 and NT$3,000,000. In severe circumstances, the enterprise may be ordered to terminate business, suspend business for a certain period of time, revoke all or part of the items listed in the company registration, business registration or factory registration, or the registration of the food business operators. If registration of the food business operators is revoked, re-application for new registration within one (1) year shall be prohibited : 1. .violating Paragraph 1 of Article 7 for failing to establish a food safety monitoring plan, or Paragraph 2 or Paragraph 3 for failing to be equipped with the laboratory; 2. violating Paragraph 3 of Article 8, failing to file registration; or violating Paragraph 5 of Article 8, failing to obtain certification; 3. violating Paragraph 1 of Article 9, failing to retain documents or meet the required retention period; 4. violating Paragraph 2 of Article 9, failing to establish tracing or tracking system; 5. violating Paragraph 3 of Article 9, failing to issue electronic uniform invoices, resulting in the inability to trace or track food ; 6. violating Paragraph 4 of Article 9, failing to declare in the electronic method or to declare according to the method and specification prescribed by the central competent authority; 7. violating Paragraph 3 of Article 10; 8. violating any of the standards prescribed by the central competent authority in accordance with Article 17 or Article 19; 9. the products sold by food business operators that violate the specifications, scope of use, or limitations of food additives prescribed by the central competent authority pursuant to Article 18; 10. violating Paragraph 4 of Article 22 or Paragraph 3 of Article 24, failing to report to the competent authority within the jurisdiction; 11. violating Paragraph 4 of Article 35, failing to attach product ingredients report and official sanitation certificate issued by the export country ; or 12. violating the restrictions prescribed by the central competent authority in a public announcement pursuant to Paragraph 2 of Article 15-1.
有下列行為之一者，經命限期改正，屆期不改正者，處新臺幣三萬元以上三百萬元以下罰鍰；情節重大者，並得命其歇業、停業一定期間、廢止其公司、商業、工廠之全部或部分登記事項，或食品業者之登錄；經廢止登錄者，一年內不得再申請重新登錄： 一、違反第七條第一項規定未訂定食品安全監測計畫、第二項或第三項規定未設置實驗室。 二、違反第八條第三項規定，未辦理登錄，或違反第八條第五項規定，未取得驗證。 三、違反第九條第一項規定，未保存文件或保存未達規定期限。 四、違反第九條第二項規定，未建立追溯或追蹤系統。 五、違反第九條第三項規定，未開立電子發票致無法為食品之追溯或追蹤。 六、違反第九條第四項規定，未以電子方式申報或未依中央主管機關所定之方式及規格申報。 七、違反第十條第三項規定。 八、違反中央主管機關依第十七條或第十九條所定標準之規定。 九、食品業者販賣之產品違反中央主管機關依第十八條所定食品添加物規格及其使用範圍、限量之規定。 十、違反第二十二條第四項或第二十四條第三項規定，未通報轄區主管機關。 十一、違反第三十五條第四項規定，未出具產品成分報告及輸出國之官方衛生證明。 十二、違反中央主管機關依第十五條之一第二項公告之限制事項。