Page 65 - Taiwan Food and Drug Administration 2016 Annual Report

2016 ANNUAL
REPORT

while achieving effective management of marketed products. To familiarize businesses with the
use and operations of the noti?cation portal, TFDA organized three training courses in 2015. A
total of 903 businesses and 1,694 cosmetic products were successfully registered online.

Section 3. Cosmetics Quality Chain Monitoring

Current Status Part II - Key Administrative Results Cosmetics Management
Every year, TFDA employs risk assessment mechanisms to select speci?c items for conducting
national medicament and cosmetic quality monitoring programs. Joint audit programs for cosmetics
were also carried out regularly every year in order to strengthen post-market safety management.
Policies and Outcomes

1. Quality Monitoring of Cosmetics Sold on the Market
In 2015, ?ve quality monitoring programs were carried out to sample 251 items, of which 244
were compliant with quality monitoring standards (conformity rate of 97.2%) and 212 were
compliant with product labeling requirements (conformity rate of 84.5%). The seven cases
failed quality monitoring standards as well as the 39 cases whose packaging and labeling failed
to display ingredients required as publicly announced by the TFDA were transferred to the
respective local health bureaus and dealt with in accordance with the law. Table 2-5-2 shows
the results of various monitoring projects.
2. Joint Audit of Marketed Cosmetics
In 2015, a total of ?ve cosmetics were subject to joint audits that covered 2,200 items, of which
82 were found to be nonconforming for a violation rate of 3.7%. Cases of suspected product
violations were transferred to the respective local health bureaus and dealt with in accordance
with relevant regulations (Table 2-5-3).

Table2-5-2
表 2-5-2 Results of quality monitoring and testing of cosmetics in 2015
?唑?酮 Total Item inspected
Project title Quality testing Package labeling
cases
Pass Nonconforming Pass Nonconforming
Survey on Methanol, Benzene and Phthalate Esters in
Marketed Nail Polishes in Taiwan 59 57 2 58 1

Survey on Hydroquinone, Mercury, Tretinoin and Steroids
in Marketed cosmetics from hospitals in Taiwan 60 60 0 33 27

Survey on the contents of Methylisothiazolinone and
Methylchloroisothiazolinone in Cosmetics Products 71 70 1 62 9
Marketed in Taiwan

Survey on the Qualities of Commercial Hair Dyes in Taiwan 30 27 3 28 2

Survey on the Qualities of Commercial Sunscreens in Taiwan 31 30 1 31 0
251 244 7 212 39
Total item (Conformity rate %)
(100) (97.2) (2.8) (84.5) (15.5)

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