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The Cosmetic Hygiene and Safety Act Creates a New Era of Cosmetics Management 【Date:2019-02-26】 unit:醫療器材及化粧品組

The amendment of the Statute for Control of Cosmetic Hygiene was promulgated by the President on May 2nd, 2018, and renamed as "Cosmetic Hygiene and Safety Act". The Act was referred to international regulations which will include non-therapeutic toothpaste and mouthwash into cosmetics management to ensure the safety of consumer use. After the new Act takes effect, for cosmetic categories specified by the Ministry of Health and Welfare, businesses shall complete product notification, establish product information files (PIF), and comply with cosmetic good manufacturing practice (GMP) before their products are introduced into the market in order to replace the current registration system for medicated cosmetics, which can accelerate the products entering the market. Meanwhile, consumers are provided with more product selection and online product information. The new Act can also enhance the safety management of cosmetics and to ensure stable production of high-quality cosmetics, to further maintain the hygiene and safety of cosmetics.

Moreover, new systems such as the establishment of product sources & flow data and serious adverse effects & hazards reporting are included, and the amount of administrative fines is greatly increased. The penalties for violating cosmetic advertising are also increased, for those who have severe violations will be required to publish corrective advertisements and withdraw their products so that the consumer rights will be protected with more sound regulations.

Since the presidential promulgation of the new Act, Taiwan Food and Drug Administration (TFDA) has announced a number of draft subordinate laws, announcements and supporting measures, including Enforcement Rules of the Cosmetic Hygiene and Safety Act, Regulations Governing Notification of Cosmetic Products, Regulations for Cosmetic Product Information File Management, and Regulations for Labeling of Label, Leaflet and Packaging of Cosmetics, etc. TFDA will collect public comments and announce relevant regulations in accordance with legal procedure.

According to TFDA, the implementation of Cosmetic Hygiene and Safety Act will create a new era for cosmetic management system which is in line with international regulatory trend. It is TFDA’s intent to elevate the safety, stability and quality of cosmetics and to help enhance the international competitiveness of local cosmetic industry.