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 take effect 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…