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54
2014 Annual Report
Section 1 Cosmetics Regulations and Product Review
Status
In accordance with the provision of the current statute for the control of cosmetics
hygiene, pre-market approval & registration are required for medicated cosmetic and pre-
authorization is required for cosmetics advertisement. However in recent years the global
cosmetic market continues to gain increasingly active circulation. In order to harmonize
our cosmetic regulations with the rest of the world and promote the development of the
cosmetic industry in our country, we have referred relevant cosmetic regulations from
various countries. In the future, we will aim to abolish the medicated cosmetics pre-market
registration system and cosmetics advertisement pre-authorization system.
Policy and Outcome
1. Create a Regulatory Environment in Compliance with International Norms
(1) Draft of amendment to the statute for the control of cosmetics hygiene
a. Referring to international norms, we are planning to amend the definition of
cosmetics and abolish the pre-market registration system for medicated cosmetics
and color additives. Instead, we will ask to establish a Product Information File (PIF),
and adopt the pre-market notification system. To enhance source management, we
have implemented sample testing system at the border and determine the feasibility
of full implementation of the cosmetic GMP system. Furthermore, we plan to remove
the penalty system and replace it with administrative fines, add to the lower limit
and raise the upper limit of the fines. Moreover, we have added the rules for adverse
reactions reporting from cosmetic use, and product removal from the retailer
shelves.
b. For the Draft Amendment to the Statute for the Control of Cosmetics Hygiene in
2013, we held three seminars and one hearing. Additionally, three seminars for
Cosmetics Product Notification portal and PIF, and three seminars for the GMP
regulations for cosmetics were held, for the purposes of achieving policy advocacy,
strengthening communication and collecting public opinions.
(2) Revision of administrative regulations and health standards
To harmonize our cosmetics regulations with the rest of the world, we revised the
administrative regulations and health standards, as shown in Table 5-1