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Title: Cosmetic Hygiene and Safety Act CH
Category: Ministry of Health and Welfare(衛生福利部)
Chapter 2 Manufacturing, Import, and Management of Factories
Article 4
Cosmetics categories and cosmetics manufacturers or importers of a certain scale that are specified by the central competent authority as per public announcement shall complete product notification and establish product information file prior to the supply, sale, giveaway, public display, or consumer trial offer of cosmetics. The same shall apply to modifications.
Regulations governing the certain scale, the items, contents, procedures, modifications, validity term, revocation, and rescission of product notification, and other matters to be observed with regard to the preceding paragraph shall be prescribed by the central competent authority.
Regulations governing the certain scale, the items, contents, modifications, methods for establishment and maintenance, retention period, location, qualification of signatory for the safety report of product information file, and other matters to be observed with regard to Paragraph 1 shall be prescribed by the central competent authority.
Article 5
For the manufacturing or import of specific purpose cosmetics designated by the public announcement of central competent authority, an application for registration shall be filed with the central competent authority. No manufacturing or import shall be allowed until a license is approved and issued.
Licensed cosmetics of the preceding paragraph shall not modify any of the originally registered particulars without approval of the central competent authority. However, this restriction does not apply to particulars that may be voluntarily modified per public announcement by the central competent authority.
The import of specific purpose cosmetics shall be exempted from application for registration of Paragraph 1 if one of the following conditions applies. Furthermore, the supply, sale, public display, consumer trial offer, or transfer to other uses of said cosmetics shall be forbidden:
1.Import for personal use, the quantity of which complies with public announcement of the central competent authority;
2.Import for the application for registration of Paragraph 1 or for use in research and trial, through special permission of the central competent authority.
For the import of specific purpose cosmetics for personal use of the preceding Subparagraph 1 that exceed the quantity specified in public announcement, their excess portion shall be ordered a return or destruction within a specified time limit by the customs.
Prior to the enforcement of this Act as amended on April 10, 2018, for the manufacturing or import with a license of cosmetics containing medical or poisonous drugs whose license validity term expires within five years following the enforcement of this Act as amended on April 10, 2018, and where it is necessary to continue the manufacturing or import, an application for extension may be filed within three months before the expiration of validity term and an application for registration in accordance with Paragraph 1 may be exempted.
Regulations governing the issuance, modifications, revocation, and rescission of licenses with regard to Paragraph 1 and Paragraph 2, the application procedure for special permission with regard to Subparagraph 2 of Paragraph 3, the license extension with regard to Paragraph 5, and other matters to be observed shall be prescribed by the central competent authority.
The provisions of Paragraph 1 and Paragraph 2 shall cease to apply starting five years after the date of enforcement of this Act as amended on April 10, 2018.
Article 6
Cosmetics shall not contain mercury, lead, or other ingredients banned for use as per public announcement of the central competent authority. However, this restriction does not apply to residual traces contained therein that are inevitable due to contemporary technical or professional standards, provided that such traces pose no hazard to human health.
The central competent authority may restrict the use of cosmetics ingredients to prevent and avoid causing allergies, irritations, depigmentation, and conditions that pose a hazard to human health.
For the banned use and residual traces in Paragraph 1, and the restriction for use of ingredients or other conditions that pose an impact to the hygiene and safety of the preceding paragraph, their composition, content, applied body part, usage method, and other matters to be observed shall be publicly announced by the central competent authority.
Cosmetics businesses shall not subject animals to testing when conducting safety evaluation of cosmetics or cosmetic ingredients, unless one of the following conditions applies and has been approved by the central competent authority:
1. The ingredient is widely used, and its function cannot be replaced by other ingredients;
2. Those that require animal testing to be conducted, having evaluation data that demonstrate the potential for harming human health.
Cosmetics in violation of the provisions in the preceding Paragraph shall not be provided for sale.
Regulations governing the application procedure for using animals as test subjects and other matters to be observed with regard to Paragraph 4 shall be prescribed by the central competent authority.
Article 7
The outer packaging or containers of cosmetics shall conspicuously label the following information:
1.Product name;
2.Function;
3.Usage and storage instructions;
4.Net weight, volume, or amount;
5.Full ingredient names. For specific purpose cosmetics, the content of specific purpose ingredients contained therein shall be labeled separately;
6.Precautions for use;
7.Name, address, and telephone number of manufacturer or importer; country of origin of imported product;
8.Manufacturing date and shelf life, or manufacturing date and expiration date, or shelf life and expiration date;
9.Lot number;
10.Other information required to be labeled as per public announcement of the central competent authority.
The information to be labeled as specified in the preceding paragraph shall be provided in Chinese or internationally common symbols. However, the information of Subparagraph 5 may be labeled in English.
For the information of each subparagraph in Paragraph 1, if it cannot be labeled due to the surface area of outer packaging or container being too small or other special circumstances, said information shall be stated on the label, in the leaflet, or by other means.
The format and method of labeling and other matters to be observed with regard to the preceding three paragraphs shall be publicly announced by the central competent authority.
Sellers of cosmetics shall not alter or modify the labels, leaflets, outer packaging, or containers of cosmetics for sale.
Article 8
Manufacturing facilities for cosmetics shall comply with the Establishment Standards for Cosmetics Manufactory. Except those specified jointly by the central competent authority and central competent industry authority as per public announcement, factory registration shall be completed.
For cosmetics categories that are specified by the central competent authority as per public announcement, their manufacturing facilities for cosmetics shall comply with cosmetic Good Manufacturing Practice Regulations. The facilities are subject to on-site inspection by the central competent authority.
The provisions of the preceding paragraph may be applied mutatis mutandis to foreign manufacturing facilities.
The standards referred to in Paragraph 1 shall be formulated jointly by the central competent authority and central competent industry authority. The regulations referred to in Paragraph 2 shall be formulated by the central competent authority.
Article 9
Licensed pharmacists or personnel with professional skills in the field of cosmetics shall be hired and stationed at the factory to supervise the dispensation and manufacturing of cosmetics.
The qualifications, training, responsibilities of personnel with professional skills in the field of cosmetics, and other matters to be observed with regard to the preceding paragraph shall be prescribed by the central competent authority.