Taiwan Releases Amendments to Statute for Control of Cosmetic Hygiene

Takehome：

"Taiwan Legislative Yuan" previously approved the amendments to "Statute for Control of Cosmetic Hygiene" which is now renamed as “Cosmetic Hygiene Safety Administration Act” (See CL news). On May 2, 2018 Taiwan FDA released the new Act.

Except for Item 4 to Item 6, Article 6 and Paragraph 6, Item 1, Article 23 will be effective on Nov 9, 2019, the implementation date of this new Act shall be stipulated by "Taiwan Executive Yuan".

Compared with the previous version, the detailed amendments in the new Act are listed in the following table:

Summary of changes to Taiwan overarching cosmetic regulation (contrast with the previous version)
Entry No.	Type of change	Before revision	After revision	Description of changes
Article 3	Amendment	The term "cosmetic(s)" as used in this Statute shall refer to the substance(s) for external use on human body in order to freshen the hair or skin, to stimulate the sense of smell, to cover body odor, or to improve facial appearance. The scope and categories of cosmetics shall be defined as per public notice(s) to be published by the central competent health authorities.	The term "cosmetic(s)" as used in this Act shall refer to the substance(s) for external use on human body, teeth or oral mucosa in order to freshen the hair or skin, to stimulate the sense of smell, to cover body odor, to improve facial appearance, or to clean the body, except for those cosmetics are defined as drugs according to other regulations.	The scope of cosmetics is extended to oral products. Non-medicated toothpastes and mouthwashes are classified as cosmetics.
Article 3	New entry	/	The term “cosmetic enterprise” as used in this Act shall refer to the cosmetic manufacturer, importer and distributor. The term “Product Information File” as used in this Act shall refer to the files related to cosmetics quality, safety and functions. The term “cosmetic ingredient” as used in this Act shall refer to the single chemical substance or compounds containing in cosmetics.	Add three new terms’ definitions.
Article 4	New entry	/	Cosmetics manufacturers of certain types announced by the central competent authority and importers of a certain scale shall complete product notification and establish product information files prior to supply, sales, gifts, public displays or trials for consumers.	Establish product notification system and product information file system.
Article 5	Amendment	For importation of any cosmetic containing medical, poisonous or potent drug(s), an application stating therein the name and content of raw materials, the name of colorant used, and the usage of the cosmetic, accompanied by the label, leaflet, samples, package, container, certificate of analysis and relevant supporting documents, together with the payment of license/certification fee and examination fees shall be submitted to the central competent health authorities for its examination and testing. The cosmetic shall be imported only after an import license is issued by the central competent authorities.	For importation of special use cosmetics, except for those cosmetics for personal use and research, an application shall be submitted to the central competent authorities for its examination and testing. The cosmetic shall be manufactured or imported only after a license is issued by the central competent authorities.	Cosmetics containing medicated, poisonous ingredients or potent drugs (medicated cosmetics) are renamed as special use cosmetics.
Article 6	New entry	/	Cosmetics shall not contain mercury, lead or other ingredients that are prohibited by the central competent authority. Except for unavoidable minimal residue that is not harmful to humans	Tighten the control of cosmetics ingredient usage.
Article 8	New entry	/	Cosmetics manufacturing sites shall comply with Standards for Cosmetics Manufactories. Except for those being announced by the central competent authority, other manufacturing sites shall complete factory registration. For cosmetic products announced by the central competent authority, manufacturing sites shall comply with Good Manufacturing Practice of cosmetics, and the central competent authority shall conduct on-site inspections. The provision shall also apply to foreign cosmetics manufacturing sites.	Implement GMP for the production of cosmetics. Manufacturers are required to build excellent quality control systems to stabilize product quality.
Article 10	Amendment and abolishment	No obscene, immoral, false or exaggerate advertisement may be published or publicized in newspapers, publications, advertising leaflets, or on broadcasting, slides, motion pictures, television and other mass communication media for promoting the sale of cosmetics. Before publicizing or advertising any cosmetic product, the manufacturer or dealer thereof shall first submit to the central, municipal or county/city competent health authorities for its approval all the text, pictures and/or oral statements contained therein; and shall subsequently present the approval letter or certificate to the mass communication institutions concerned for their examination.	The labels, claims and advertisements of cosmetics shall not be false or exaggerated. Cosmetics shall not be labeled, or advertised using medical efficacy claims. Advertising companies shall, within six months from the date of publication, preserve the name, the ID number, or the registration document number for the establishment of the company, trade name, legal person or group, residence or address, telephone number of the person who commissioned the advertisement, shall not avoid, obstruct or reject when requested by the competent authority.	Abolish pre-market approval of advertisements. Cosmetics shall not be labeled or advertised for medical efficacy. Advertising companies shall preserve and provide information of the person who commissioned the advertisement.
Article 11	New entry	/	Cosmetic enterprise shall establish and maintain the information of product direct supply and flow, except for those cosmetics sell to consumers directly.	Cosmetic enterprise shall establish and maintain product supply and flow information.
Article 12	New entry	/	Cosmetic enterprises shall notify the competent authority when severe adverse event happens or adverse physiological effects are found. Severe adverse event refers to one of the following situations: Death; Life threatening; Temporary or permanent disability; Congenital malformations of infants; Cause the user to be hospitalized.	Specify cosmetic enterprises' obligations. Voluntary disclosure of product safety information.
Article 14	New entry	/	To strengthen the border control of imported cosmetics, the central competent authority may announce certain kinds of cosmetics that are harmful to human body health and safety, and these products can be imported only after passing the random inspection or sampling inspection.	Strengthen supervision on cosmetic production and take steps to tighten border control for possible sampling inspections.
Article 17	New entry	/	Manufacturer or importer who violates any of the prohibitive provisions set forth in Article 4; Article 5; Article 6; Article 7; Article 8; Article 10 of this Act, manufacture or import products from unknown supply, products being announced to be hazardous by the central competent authority or product license was revoked shall notify distributor at once and recall unqualified products within stipulated time.	Manufacturer who violates the regulations is required to recall or destroy unqualified products within stipulated time.
Article 19	New entry	/	The competent authority shall not only strictly guard the secret information of any individual who reports cosmetic enterprises violating the provision of this Act, but also reward them.	Establish a report system for unqualified cosmetics.
The original Article 8，11, 13，17, 18	Abolishment	For importation of cosmetic colorant(s), an application stating therein the name of such colorant(s), accompanied by the label, leaflet, sample, package, container of, the certificate of analysis and other relevant supporting documents for the cosmetic involved; together with the payment of license/certification fee and examination fees shall be submitted to the central competent health authorities for its examination and testing. The cosmetic pigment(s) may be imported only after an import license is issued by the central competent health authorities. ~~Import or sale of any cosmetic containing cosmetic colorant not conforming to the statutory standards is prohibited.~~ A seller of cosmetic colorants may commence the business operation only after obtaining a business license from the competent health authorities under the appropriate municipal or county(city) government. For manufacturing cosmetic colorants, an application stating therein the name of such colorants, accompanied by the labels, samples, packages and/or containers, and certificate of analysis, together with the payment of license/certification fee and examination fees shall be submitted to the central competent health authorities for its examination, testing and registration. Manufacture of such cosmetic colorant may start only after having obtained the license required. No colorant other than the cosmetic colorants lawfully designated by the competent health authorities may be used in manufacturing cosmetics, unless otherwise approved by the central competent health authorities.	/	There is no provision for colorants in the new Act. Colorants registration system may be abolished.
The original Article 27	Abolishment	Any offender of any of the prohibitive provisions set forth in Paragraph One, Article 7; Paragraph One, Article 8; Article 11; Paragraph One, Article 15; Paragraph One, Article 16; Paragraph One, Article 17; Paragraph One, Article 18; or Paragraph One, Article 23 of this Statute shall be sentenced to imprisonment for a period of less than one year, detention, or in lieu thereof or in addition thereto shall be imposed with a fine in an amount no more than One Hundred and Fifty Thousand New Taiwan Dollar (NT$ 150,000).	/	Abolish criminal liability and increase fines.

ChemLinked uploaded the original document of “Cosmetic Hygiene Safety Administration Act” to the database, stakeholders wanting to know details can refer to it.