The Cosmetic Hygiene and Safety Act Reshapes Taiwan’s Cosmetic Regulation

The Act for Control of Cosmetic Hygiene, enacted since 1972, was overhauled and renamed as Cosmetic Hygiene and Safety Act on May 2, 2018.  To allow the local players to adapt to the changes, some of which are quite drastic, the Government had the majority part of the new law implemented on July 1, 2019, while deferring the implementation of the more crucial amendments to later dates. 

What follows are highlights of some of the most noteworthy changes introduced in the new law. 

“Cosmetic” Redefined

In the new law, the definition of “cosmetic” is extended to cover any “products applied externally to the human body, teeth, or oral cavity mucous membranes, and used to moisturize hair and skin, stimulate the sense of smell, improve body odors, change appearance, or cleanse the body (italics added by the author to show the extension).” That is, while shampoo, shower gel and soaps have already been deemed as cosmetics per the old law, the new law moves further to place products like “tooth paste for non-medical use” and “mouthwash for non-medical use” under its regulation. However, a transition period is attached to this amendment: it will not be implemented until July 1, 2020.

The Product Information File (PIF) System

The PIF system employed in the new law was modeled after the EU counterpart.  Under the local PIF system, which has been implemented since July 1, 2019, manufacturers or importers of a certain scale (to be specified by the Ministry of Health and Welfare (MOHW)) shall submit a Product Notification (PN) along with a PIF to a public online database operated by MOHW to disclose the complete quality, safety, and function data of a cosmetic product, before supplying, selling, or publicly displaying the product, or offering it as a gift or offering a trial of the same to consumers.  On the other hand, whoever conducts any of said actions shall likewise complete the PN and PIF procedures if the cosmetic product of concern falls within a list of special types of cosmetics also to be specified by the MOHW.  According to a news release issued by the MOHW, a PIF shall contain data on safety evaluation, manufacturing processes and function test results of the cosmetic product, along with a statement declaring compliance with the country’s Good Manufacturing Practice (GMP) Regulations, plus the basic information of the product.

Deepening Governance on Manufacturing

On top of a pre-existing bylaw that provides the compliance standards on premises for cosmetic manufacturing, the new law, with reference of other jurisdictions’ regulations and the international trend, expressly stipulates that premises for cosmetic manufacturing shall be operated in line with said standards and the term “manufacturing” shall cover packaging, processing, retail packaging, and package changing.  In addition, the new law mandates the MOHW to compile a list for cosmetics which shall be produced in line with the country’s GMP Regulations.  On the other hand, the new law requires that premises for cosmetic manufacturing shall be equipped with licensed pharmacists or personnel with professional skills in the field of cosmetics to supervise the dispensation and manufacturing of cosmetics.

Phasing-out of the Pre-Market Registration System

To tie in with the aforesaid PIF system and regulations on cosmetic manufacturing, the current pre-market registration system will be abolished on July 1, 2024, reflecting an international paradigm shift in regulating cosmetics from pre-market control to post-market surveillance.  Although there will be almost five years before the transition period expires, the applicable scope of the registration system has been much reduced since July 1, 2019.  In the transition period, only “specific purpose cosmetics” designated by the MOHW have to be registered before they are produced in Taiwan or imported into Taiwan, whereas this pre-market control system used to apply to all cosmetics with pharmaceutical or toxic ingredients (a.k.a. medicated cosmetics, e.g. hair dyes and perms) under the old law.

Smarter Regulation for Mandatory Labeling

The new law requires mandatory labeling of “the name, address, and telephone number of manufacturer or importer, and country of origin of imported product,” in contrast with the old law which only demanded labeling of names and addresses of manufacturers and importers.  The new labeling rule, which will not be implemented until July 1, 2021, is further buttressed by the PIF system, as a cosmetic manufacturer’s name and address need be included and disclosed in the PIF database.

On the other hand, the new law lifts the “Chinese language only” requirement for cosmetic labeling of ingredients. Cosmetic ingredient labeling in English will be as good as in Chinese, although the implementation of this friendly rule is also deferred to July 1, 2021.

Ex Post Control of Cosmetic Advertising

This new change was brought forth due to an Interpretation rendered by Taiwan’s Constitutional Court in 2017 (Interpretation No. 744) which declared the old law’s ex ante review rules for cosmetic advertising are unconstitutional. A statistical analysis showing the ineffectiveness of the ex ante review system in curbing unlawful cosmetic advertising in Taiwan also provided impetus to the conversion to the ex post control system now employed in the new law.  As for content control of cosmetic advertising, the new law provides that “cosmetics shall not be so labeled, promoted, or advertised as having medical efficacy,” on top of a pre-existing rule that proscribes deceptive or exaggerated cosmetic advertising conduct.  Meanwhile, the upper limits of relevant fines for unlawful cosmetic advertising are significantly increased under the new law, a sort of compensation for the abolishment of the penal punishments provided in the old law.  A cosmetic advertisement asserting medical efficacy shall incur a fine ranging from NT$600,000 to NT$5 million.