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Title: Cosmetic Hygiene and Safety Act CH
Category: Ministry of Health and Welfare(衛生福利部)
Chapter 4 Sampling Check, Test, and Control
Article 13
Competent authorities may dispatch personnel to enter the premises of cosmetics businesses to conduct sampling checks of their facilities, product information files, data on product supply sources and destinations, relevant records and documents, or sampling tests of cosmetics or their raw materials used. Cosmetics businesses shall give their cooperation, and shall not evade, obstruct, or refuse.
In conducting sampling tests referred to in the preceding paragraph, the competent authorities shall sample amounts not to exceed quantities sufficient for conducting sampling tests and shall provide dockets to the cosmetics business.
In carrying out their official duties for conducting sampling checks or sampling tests, the personnel shall present evidentiary documents in relation to the performance of their duties.
Article 14
In order to enhance border control for cosmetics imports, the central competent authority may make public announcement about certain cosmetics categories or items that could possibly pose a hazard to hygiene and safety and may only be imported after sampling checks and sampling tests show compliance.
Regulations governing the methods, techniques, items, scope of sampling checks and sampling tests, and other matters to be observed with regard to the preceding paragraph shall be prescribed by the central competent authority.
Article 15
Competent authorities shall immediately initiate investigations and may order cosmetics businesses to suspend the manufacture, import, or sale, or order their products to be withdrawn from the market or to be sealed and stored if the cosmetics businesses are suspected to have violated the provisions of this Act or the cosmetics have one of the following conditions:
1.Expiration date exceeded;
2.Source unclear;
3.Other conditions sufficiently harmful to human health.
When competent authorities conduct investigations as specified in the preceding paragraph or other sampling checks or sampling tests referred to in this Act, they may order cosmetics businesses to provide testing specifications, testing methods, and testing reports of original manufacturers, as well as information, samples, reference standards, and relevant data necessary for testing. Cosmetics businesses shall give their cooperation, and shall not evade, obstruct, or refuse.
Penalties shall be rescinded and products shall be unsealed in the absence of any conditions specified in Paragraph 1 after investigations.
Article 16
Cosmetics businesses shall not supply, sell, give away, publicly display, or offer consumer trial cosmetics that are in violation of the provisions if one of the following conditions applies:
1.Violation of Paragraph 1 of Article 4;
2.Violation of the regulations prescribed pursuant to Paragraph 2 or Paragraph 3 of Article 4, 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 could possibly pose a hazard to hygiene and safety as determined by competent authorities;
3.Violation of Paragraph 1 or Paragraph 2 of Article 5;
4.Violation of Paragraph 1 or the public announcement made pursuant to Paragraph 3 of Article 6;
5.Violation of Paragraph 1, Paragraph 2, Paragraph 3, or Paragraph 5, or the public announcement made pursuant to Paragraph 4 of Article 7;
6.Violation of Paragraph 1 of Article 8 in failing to apply for factory registration;
7.Violation of the Establishment Standards for Cosmetics Manufactory specified in Paragraph 1 or the Good Manufacturing Practice Regulations specified in Paragraph 2 of Article 8, and said violation could possibly pose a hazard to hygiene and safety as determined by competent authorities;
8.Violation of the labeling provisions specified in Paragraph 1 or Paragraph 2 of Article 10;
9.Product notification or product license revoked or rescinded by the central competent authority.
The same shall apply to cosmetics that have exceeded expiration date, are of unclear source, or pose other hazards to hygiene and safety as per public announcement of the central competent authority.
Article 17
Cosmetics manufacturers or importers shall immediately notify sellers and recall violating products from the market within a time period specified by competent authorities if one of the following conditions applies:
1.Violation of Paragraph 1 or the regulations prescribed pursuant to Paragraph 2 or Paragraph 3 of Article 4, pertaining to the provisions of items, contents, modifications, or methods for establishment and maintenance, retention period, and location of product notification or information file, and failure to make corrections within the time limit specified by competent authorities;
2.Violation of Paragraph 1, Paragraph 2, or Paragraph 3 of Article 5, and failure to make corrections within the time limit specified by competent authorities;
3.Violation of Paragraph 1 or the public announcement made pursuant to Paragraph 3 of Article 6;
4.Violation of Paragraph 1, Paragraph 2, Paragraph 3, or Paragraph 5, or the public announcement made pursuant to Paragraph 4 of Article 7;
5.Violation of Paragraph 1 of Article 8 in failing to apply for factory registration;
6.Violation of the Establishment Standards for Cosmetics Manufactory specified in Paragraph 1 of Article 8 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 competent authorities;
7.Violation of the labeling provisions specified in Paragraph 1 or Paragraph 2 of Article 10;
8.Product notification or product license revoked or rescinded by the central competent authority.
The same shall apply to cosmetics that are of unclear source or pose other hazards to hygiene and safety as per public announcement of the central competent authority.
Sellers shall cooperate with manufacturers and importers in the recall of cosmetics with regard to the preceding two paragraphs.
Regulations for cosmetics that shall be recalled, their classification, handling methods, implementation methods for recall operations, deadlines for completion, contents of protocol and report, record retention, and other matters to be observed with regard to Paragraph 1 and Paragraph 2 shall be prescribed by the central competent authority.
Article 18
Violating cosmetics shall be confiscated and destroyed if one of the following conditions applies:
1.Violation of Paragraph 1 or the regulations prescribed pursuant to Paragraph 2 or Paragraph 3 of Article 4, pertaining to the provisions of items, contents, modifications, or methods for establishment and maintenance, retention period, and location of product notification or information file, and said violation poses a hazard to hygiene and safety as determined by competent authorities;
2.Violation of Paragraph 1, Paragraph 2, or Paragraph 3 of Article 5, and said violation poses a hazard to hygiene and safety as determined by competent authorities;
3.Violation of Paragraph 1 or the public announcement made pursuant to Paragraph 3 of Article 6;
4.Violation of Paragraph 1, Paragraph 2, Paragraph 3, and Paragraph 5, or the public announcement made pursuant to Paragraph 4 of Article 7, and said violation poses a hazard to hygiene and safety as determined by competent authorities;
5.Violation of Paragraph 1 or Paragraph 2 of Article 8, and said violation poses a hazard to hygiene and safety as determined by competent authorities;
6.Violation of Paragraph 1 of Article 9, and said violation poses a hazard to hygiene and safety as determined by competent authorities;
7.Violation of Paragraph 1 or Paragraph 2 of Article 10, and said violation poses a hazard to hygiene and safety as determined by competent authorities;
8.Product notification or product license revoked or rescinded by the central competent authority.
The same shall apply to cosmetics that have exceeded expiration date, are of unclear source, or pose other hazards to hygiene and safety as per public announcement of the central competent authority.
Article 19
The competent authority shall keep strictly confidential the particulars of, and may at its discretion grant reward to, anyone informing against cosmetics, labels, promotional materials, advertisements, or cosmetics businesses that are found to have violated the provisions of this Act.
Regulations for the reward of informing with regard to the preceding paragraph shall be prescribed by the central competent authority.