Page 62 - Taiwan Food and Drug Administration 2016 Annual Report

Taiwan Food and Drug Adminstration

Policies and Outcomes

1. Creating the Legal Environment and Harmonization with International Standards
(1) Drafting the Revised Statute for Control of Cosmetic Hygiene
a. TFDA drafted amendment of the Statute for Control of Cosmetic Hygiene. Key revisions included
the use of Product Noti?cation system and Product Information File (PIF) to replace the medicated
cosmetic manufacturers system, the removal of preliminary review requirement of cosmetic
advertisements, and the addition of requirements on Good Manufacturing Practice (GMP) that
cosmetic companies must comply with, as well as furnishing of information on direct sources
of supply and distribution. The revision also required companies to actively withdraw cosmetic
products from market, initiate other disposal actions, and inform the competent authority if the
products were found to cause severe adverse reactions or were suspected of causing hygiene or
health hazards, in order to safeguard the cosmetic hygiene and safety (Figure 2-5-2).
b. The amendment of the Statute for Control of Cosmetic Hygiene was notified to the World Trade
Organization (WTO) on January 16, 2015. The draft was then submitted to the Executive Yuan for
review on June 29, 2015 and handled according to legal procedures of the Executive Yuan.
c. To achieve the objectives of effective public communication and advocate awareness for
relevant policies, TFDA hosted one relevant regulation seminar, three training sessions on
cosmetic product noti?cation system and system operations, one experience sharing seminar for
overseas GMP assessment processes, and one seminar on GMP and PIF systems for cosmetics
with respect to the Amendment of the Statute for Control of Cosmetic Hygiene.

Amended
Act for Control of De?nition
Cosmetic Hygiene of
cosmetics
Added
Added
PAE reporting
Product registration
Border inspections
Requirements on PIF registration
Elevating cosmetic Comprehensive GMP
product withdrawal Emphasized
management regulations and recalls management implementation
responsibility
from Statute to Act. of business owner
Imposed
Temporarily heavy penalties Abolished
retained for willful
violators
Preliminary
Inspection and examination of
registration of
Statute for Control of speci?c purpose advertisements
Cosmetic Hygiene cosmetics Abolished Inspection and
(transition period) Criminal registration of
sentencing colorants
Increased ?nes
Added
Whistleblower
clauses
Figure 2-5-2 Key revisions of the Amendment of the Statute for Control of Cosmetic Hygiene
(2) Adding and RevisingVarious Regulations and Hygiene Standards
In 2015, TFDA adjusted the Fee-Charging Standards for the Registration of Cosmetic Products and
Cosmetic Colorants and Fee-Charging Standards for the Review of Medicament and Cosmetic
Advertisements to better reflect service costs and user payment principles. Regulations used in
other countries were also referenced to formulate Guidelines for Safety Assessments of Cosmetics
Using Nanomaterials as Ingredients and revise the List of Legally Permitted Cosmetic Colorants
for the purpose of regulatory harmonization. Table 16 in Annex I lists details on the additions and
60 revisions to regulations and hygiene standards related to cosmetics that were made in 2015.