Page 86 - 2018食藥署年報(英文版)

of the revision, industrial impacts forum, external briefing sessions, cross-ministerial/cross-
departmental meetings, and notice to the WTO for comments from its member states were
completed and opinions from all parties concerned were extensively collected to render the
amended draft of the Statute for Control of Cosmetic Hygiene. It was reviewed and approved
by the Executive Yuan on September 8, 2016, and the title was changed to Cosmetic Hygiene
and Safety Act. There are a total of 32 articles.
2. This amended draft was reviewed and approved by the Social Welfare and Environmental

Hygiene Committee of the Legislative Yuan on December 20, 2017, and it was decided by
the Legislative Yuan on December 29 of the same year to be submitted for negotiation among
party caucuses. (Note: The amended draft passed the third reading in the 7th meeting of the
Legislative Yuan on April 10, 2018. The President promulgated it through the Hua-Zong(I)-
Yi-Zi No. 10700045851 order on May 2, 2018, with the date of enforcement to be determined
separately by the Executive Yuan.)
3. The Administration has also called for more than a hundred rounds of training and briefing
sessions since 2013 and planned the implementation of GMP and product information file
systems in phases according to the risk associated with respective products in order to minimize

the impacts of the new system on the industry.

Outcomes and Benefits

1. The current amendment takes international regulations into consideration by including non-
pharmaceutical toothpaste and mouthwashes in the management of cosmetics. Once the
new Act is enforced, for cosmetics categories specified by the central competent authority,
businesses must complete product notification and establish the product information file (PIF)
before their products are introduced to the market and their manufacturing site must fulfill the

Good Manufacturing Practice (GMP). This measure helps not only shorten the time to market
and provide consumers with more diversified options and the possibility of searching for
product information online but also reinforce the safety management of cosmetics and ensure
steady production of qualified cosmetics to maintain the hygiene and safety of cosmetics.
2. In addition, data on the sources and flows of products and systems such as spontaneous reporting
obligations of businesses were added this time. The value of the fine involved was significantly
increased, too. Penalties for non-compliant cosmetic advertisements were also increased. For
violations involving falsified or exaggerated claims, the fine increased from current NTD 50,000
to NTD 40,000-NTD 200,000. For those involving medical efficacy, the fine is reinforced to

NTD 600,000-NTD 5 million. The competent authority may demand posting of correction
advertisements and products be removed from shelves when violations in advertising are severe.
The even more normalized regulations are meant to protect the rights of consumers.
3. The current amendment is a major systematic reform that helps streamline the administrative
efficiency of the government and reinforce source and circulation management to protect the

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