Regulations for Cosmetics Recall Article 2
Operational procedure of cosmetics recall shall be classified in three classes according to the risks to health as follows:1. Class 1(1) Violation of Paragraph 1 of Article 6 of the Act, which cosmetics contain mercury, lead, or other ingredients banned for use as per the public announcement of the central competent authority.(2) Violation of Paragraph 3 of Article 6 of the Act, which cosmetics use ingredients that pose a hazard to human health or impact the hygiene and safety.(3) Violation of Paragraph 1 of Article 8 of the Act, which cosmetics are manufactured by non-registered factories.(4) According to Subparagraph 8 of Paragraph 1 of Article 17 of the Act, the product notification or license was revoked or rescinded by the central competent authority.(5) According to Paragraph 2 of Article 17 of the Act, cosmetics that are of the unclear source; or pose hazards to hygiene and safety as per the public announcement of the central competent authority.2. Class 2(1) Violation of Paragraph 1 of Article 4 of the Act in failing to complete product notification or failing to establish the product information file that are made in accordance with Subparagraph 1 of Paragraph 1 of Article 17 of the Act in failing to make corrections within the time limit specified by the competent authority.(2) Violation of the regulations prescribed pursuant to Paragraph 2 or Paragraph 3 of Article 4 of the Act, pertaining to the provisions of items, contents, modifications, or methods for establishment and maintenance, retention period, and location of product notification or information file that are made in accordance with Subparagraph 1 of Paragraph 1 of Article 17 of the Act in failing to make corrections within the time limit specified by the competent authority.(3) Violation of Paragraph 1 or Paragraph 2 of Article 5 of the Act in failing to apply for a specific purpose cosmetics license or modifying the originally registered particulars without authorization that are made in accordance with Subparagraph 2 of Paragraph 1 of Article 17 of the Act in failing to make corrections within the time limit specified by the competent authority.(4) Violation of Paragraph 3 of Article 5 of the Act on supplying, selling, publicly displaying, offering consumer trial, or altering the uses of said cosmetics that are made in accordance with Subparagraph 2 of Paragraph 1 of Article 17 of the Act in failing to make corrections within the time limit specified by the competent authority.(5) Sellers of cosmetics violate Paragraph 5 of Article 7 of the Act, alter or modify the labels, leaflets, outer packaging, or containers of cosmetics for sale.(6) Violation of the Establishment Standards for Cosmetics Manufactory specified in Paragraph 1 of Article 8 of the Act or the Good Manufacturing Practice Regulations specified in Paragraph 2, and said violation could possibly pose a hazard to hygiene and safety as determined by the competent authority.(7) Violation Paragraph 1 or Paragraph 2 of Article 10 of the Act, the labels of cosmetics are deceptive, exaggerated or having medical efficacy.3. Class 3: The outer packaging or containers of cosmetics violate Paragraph 1, Paragraph 2 or Paragraph 3 of Article 7 of the Act or public announcement of labeling regulations prescribed pursuant to Paragraph 4 of Article 7 of the Act.
中文原文 化粧品回收處理辦法第2條
化粧品回收作業，依回收化粧品對人體健康之風險程度，分為下列三級：
一、第一級：
（一）違反本法第六條第一項規定，含有汞、鉛或其他經中央主管機關公告禁止使用之成分。
（二）違反本法第六條第三項規定，使用對人體健康有害之成分或有其他影響衛生安全情事。
（三）違反本法第八條第一項規定，由未辦理工廠登記場所製造。
（四）本法第十七條第一項第八款所定經中央主管機關撤銷或廢止產品登錄或許可證。
（五）本法第十七條第二項所定來源不明或經中央主管機關公告有害衛生安全。
二、第二級：
（一）違反本法第四條第一項規定，未完成產品登錄或未建立產品資訊檔案，經主管機關依本法第十七條第一項第一款命其限期改正而屆期不改正。
（二）違反依本法第四條第二項或第三項所定辦法有關登錄或檔案之項目、內容、變更或建立與保存方式、期限及地點之規定，經主管機關依本法第十七條第一項第一款命其限期改正而屆期不改正。
（三）違反本法第五條第一項或第二項規定，未申請特定用途化粧品許可證或擅自變更原登記事項，經主管機關依本法第十七條第一項第二款命其限期改正而屆期不改正。
（四）違反本法第五條第三項規定，供應、販賣、公開陳列、提供消費者試用或轉供他用，經主管機關依本法第十七條第一項第二款命其限期改正而屆期不改正。
（五）違反本法第七條第五項規定，販賣業者將標籤、仿單、外包裝或容器等改變出售。
（六）違反本法第八條第一項化粧品製造工廠設廠標準或第二項化粧品優良製造準則規定，經主管機關認定有害衛生安全之虞。
（七）違反本法第十條第一項或第二項規定，化粧品標示有虛偽、誇大或醫療效能之情事。
三、第三級：化粧品之外包裝或容器，違反本法第七條第一項、第二項、第三項或依第四項公告事項之標示規定。
一、第一級：
（一）違反本法第六條第一項規定，含有汞、鉛或其他經中央主管機關公告禁止使用之成分。
（二）違反本法第六條第三項規定，使用對人體健康有害之成分或有其他影響衛生安全情事。
（三）違反本法第八條第一項規定，由未辦理工廠登記場所製造。
（四）本法第十七條第一項第八款所定經中央主管機關撤銷或廢止產品登錄或許可證。
（五）本法第十七條第二項所定來源不明或經中央主管機關公告有害衛生安全。
二、第二級：
（一）違反本法第四條第一項規定，未完成產品登錄或未建立產品資訊檔案，經主管機關依本法第十七條第一項第一款命其限期改正而屆期不改正。
（二）違反依本法第四條第二項或第三項所定辦法有關登錄或檔案之項目、內容、變更或建立與保存方式、期限及地點之規定，經主管機關依本法第十七條第一項第一款命其限期改正而屆期不改正。
（三）違反本法第五條第一項或第二項規定，未申請特定用途化粧品許可證或擅自變更原登記事項，經主管機關依本法第十七條第一項第二款命其限期改正而屆期不改正。
（四）違反本法第五條第三項規定，供應、販賣、公開陳列、提供消費者試用或轉供他用，經主管機關依本法第十七條第一項第二款命其限期改正而屆期不改正。
（五）違反本法第七條第五項規定，販賣業者將標籤、仿單、外包裝或容器等改變出售。
（六）違反本法第八條第一項化粧品製造工廠設廠標準或第二項化粧品優良製造準則規定，經主管機關認定有害衛生安全之虞。
（七）違反本法第十條第一項或第二項規定，化粧品標示有虛偽、誇大或醫療效能之情事。
三、第三級：化粧品之外包裝或容器，違反本法第七條第一項、第二項、第三項或依第四項公告事項之標示規定。