Cosmetics Hygiene and Safety Management Act
Articles and Penalties for Violations of Product Information Files (PIFs)
Article 4
1. Cosmetics manufacturers or importers of a certain scale and those whose cosmetics are listed in the announcement by the central competent authority shall complete product registration and establish product information files before supplying, selling, giving away, publicly displaying, or providing cosmetics to consumers for trial; the same applies to any changes.
2. The procedures for the items, contents, procedures, changes, validity periods, repeals and revocations, and other matters to be followed regarding the registration of products of a certain scale and those mentioned in the preceding paragraph shall be determined by the central competent authority.
3. The procedures for the items, contents, changes, establishment and retention methods, duration, location, qualifications of personnel signing safety data, and other matters to be followed regarding the product information files of a certain scale and those mentioned in the first paragraph shall be determined by the central competent authority. Article 13
1. The competent authority may send personnel to the premises of cosmetic businesses to conduct random inspections of their facilities, product information files, product supply sources and flow data, related records and documents, etc., or to sample and test cosmetics or the raw materials used therein. Cosmetic businesses shall cooperate and shall not evade, obstruct, or refuse such inspections.
Article 16
1. If a cosmetic business falls under any of the following circumstances, the non-compliant cosmetics shall not be supplied, sold, given away, publicly displayed, or provided to consumers for trial:
**I.** Violation of Article 4, Paragraph 1.
**II.** Violation of the provisions concerning the items, contents, changes, establishment and retention methods, duration, and location of registration or files as stipulated in Article 4, Paragraph 2 or 3, which the competent authority deems to pose a risk to public health and safety. Article 17
1. Cosmetic manufacturers or importers shall immediately notify retailers and recall non-compliant products sold on the market within the time limit set by the competent authority if any of the following circumstances apply:
**I.** Violating the provisions of Article 4, Paragraph 1, or the regulations stipulated in Paragraph 2 or 3 regarding the items, content, changes, establishment, and retention methods, duration, and location of registration or files, and failing to rectify the situation within the time limit ordered by the competent authority.
Article 18
1. Cosmetic businesses shall have their non-compliant cosmetics confiscated and destroyed if any of the following circumstances apply:
**I.** Violating the provisions of Article 4, Paragraph 1, or the regulations stipulated in Paragraph 2 or 3 regarding the items, content, changes, establishment, and retention methods, duration, and location of registration or files, and being deemed harmful to health and safety by the competent authority. Article 23
1. Any cosmetics business operator who commits any of the following acts shall be fined between NT$10,000 and NT$1,000,000, and may be subject to repeated penalties; in serious cases, the operator may be suspended from business for one month to one year, or ordered to cease operations, have all or part of its company, business, or factory registrations revoked, or have its cosmetics registration or license revoked:
**I. Violating Article 4, Paragraph 1.**
**II. Providing false information in the registration or file established in accordance with Article 4, Paragraph 1.**
**III. Violating the provisions of Article 4, Paragraph 2 or the regulations stipulated in Paragraph 3 regarding the items, content, changes, establishment, and retention methods, duration, and location of registration or files, and failing to rectify the situation within the specified period after being ordered to do so.**
**X. Violating Article 13, Paragraph 1.** **Article 24**
**1. If a cosmetics business operator commits any of the following acts, and fails to rectify the situation within a specified period, a fine of NT$10,000 to NT$1,000,000 may be imposed, and penalties may be imposed for each recurrence. In serious cases, the operator may be suspended from business for one month to one year, or ordered to cease operations, have all or part of its company, business, or factory registrations revoked, or have the cosmetics’ registration or license revoked:**
**3.** Violating Article 17, Paragraphs 1 and 2 by failing to notify the retailer or failing to recall products within the specified period, or violating Paragraph 3 or the provisions of Paragraph 4 regarding disposal methods, recall implementation methods, completion deadlines, contents of plans and reports, or record keeping.