化粧品證明書核發及管理辦法

The Regulations are enacted under Paragraph 2 of Article 29 of the Cosmetics Hygiene and Safety Act (the “Act”).

1The certificates stipulated under the Regulations are classified into the following five categories:

21. Type A Cosmetics Manufacturing and Sale Certificate: the certificate could prove that domestic cosmetics may be produced and sold domestically.

32. Type B Cosmetics Manufacturing and Sale Certificate: the certificate could prove that domestic cosmetics have been produced and sold domestically.

43. Cosmetics Manufacturing Certificate: the certificate could prove that domestic cosmetics produced at a domestic manufacturing facility.

54. Imported Cosmetics Sale Certificate: the certificate could prove that imported cosmetics sold domestically.

65. Cosmetic Good Manufacturing Practice Certificate: the certificate could prove that cosmetics manufacturing facility complies with Cosmetic Good Manufacturing Practice.

1Applying for the Type A Cosmetics Manufacturing and Sale Certificate, the applicant shall file an application and attach the following documents and information:

21. The certificate of completed product notification or the copy of the license.

32. The copy of the company or business registration.

43. Except for the factory exempt from the registration, the copy of the factory registration.

54. For the contract manufacturer, the OEM agreement.

65. Necessary documents and information required by the central competent authority.

1Applying for the Type B Cosmetics Manufacturing and Sale Certificate, the applicant shall file an application and attach the following documents and information:

21. The certificate of completed product notification or the copy of the license.

32. The copy of the company or business registration.

43. Except for the factory exempt from the registration, the copy of the factory registration.

54. For the contract manufacturer, the OEM agreement.

65. The proof could prove that cosmetics have been sold.

76. Necessary documents and information required by the central competent authority.

1Applying for the Cosmetics Manufacturing Certificate, the applicant shall file an application and attach the following documents and information:

21. The certificate of completed product notification or the copy of the license.

32. The copy of the company or business registration.

43. Except for the factory exempt from the registration, the copy of the factory registration.

54. For the contract manufacturer, the OEM agreement.

65. Necessary documents and information required by the central competent authority.

1Applying for the Imported Cosmetics Sale Certificate, the applicant shall file an application and attach the following documents and information:

21. The certificate of completed product notification or the copy of the license.

32. The copy of the company or business registration.

43. The authorization document of the original manufacturer.

54. Necessary documents and information required by the central competent authority.

1Cosmetics business apply for Cosmetic Good Manufacturing Practice Certificate shall file an application and attach the following documents and information:

21. The copy of the company or business registration of the applicant.

32. The copy of the factory registration.

4The central competent authority shall execute an on-site inspection after receiving the application of the preceding Paragraph. It issues document and certificate of conformity after determining the cosmetics business comply with the Cosmetic Good Manufacturing Practice Regulations.

5Cosmetics business may apply mutatis mutandis the preceding two Paragraph and apply for the inspection of Cosmetic Good Manufacturing Practice Regulations compliance to the central competent authority. After determining the compliance, the authority issues the document of conformity.

6Cosmetics business may attach the document of conformity and apply the certificate per Paragraph 1 of this Article. The validity term of the certificate is determined by the validity term of the document of conformity.

7Cosmetics business shall apply to the Ministry of Economic Affairs for the inspection of Paragraph 2 and Paragraph 3 before January 1, 2021. After determining the compliance, the Ministry of Economic Affairs issues the document of conformity.

If the attached document or information of the application per the Regulations is incomplete, the central competent authority shall request for the correction within the time limit. Fail to correct within the time limit, and the application shall be refused.

1The application of the certificate stipulated under the Regulations shall not be granted if the attached document or information meets one of the following conditions:

21. Attached document or information is inconsistent with the content of the application.

32. Attached document or information is deceptive or false.

1The certificate stipulated under the Regulations may be rescinded if one of the following conditions met:

21. The certificate of cosmetics notification or the license has been revoked or rescinded.

32. The registration of the company, business, or factory has been revoked or rescinded.

4The cosmetics manufacturing facility is inspected under Paragraph 2 of Article 8 of the Act and the result is non-conformance, after the request of correction within the time limit per Sub-paragraph 3 of Paragraph 1 of Article 22 of the Act, the cosmetic Good Manufacturing Practice certificate shall be rescinded if the failure of correction within the time limit.

If the certificate stipulated under the Regulations has been revoked or rescinded, the central competent authority shall request cosmetics business return the certificate within the time limit. Fail to return the certificate within the time limit, and it shall be canceled.

The Regulations shall take effect on July 1, 2019.