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2015 Annual Report
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Risk Assessment
Management and
Research Outcomes
Cosmetics
Management
Appendix
National
Laboratory and
Testing Network
Risk Communication
and Consumer
Protection
International
Cooperation and
Cross-Strait Exchange
Food
Management
Medicinal
Products
Management
Policy and
Organization
Controlled
Drugs
Management
Medical
Devices
Management
4. Cosmetic Safety and Risk Assessments
(1) Risk Identification and Data Collection
a. Evaluation of Cosmetic Adverse Reaction/Defective Product Reports
Since the establishment of the Cosmetic Products Adverse Events Reporting System in 2008,
TFDA has continuously analyzed and evaluated adverse events of cosmetics that are released to
the market every year. A total of 105 adverse events were received in 2014, of which 89 (about
85%) involved labeling issues (including incomplete labeling, untruthful labeling, and lack of labeling)
followed by illegal ingredients or other active ingredients, abnormal appearance, packaging defects,
expiration, and other issues.
b. Monitoring of Cosmetic Alerts
TFDA continues to actively collect global news on cosmetic recalls and safety-related information
while monitoring information on domestic online purchases and webpages on medical hygiene,
beauty and health, and medical news. In 2014, a total of 407 domestic and global alerts were
monitored while 62 consumer Red and Green Light alerts were issued.
c. Post-market Surveillance of Cosmetic Products
TFDA has carried out post-market surveillance that includes quality inspections and joint audits
of commercially available cosmetics (whitening, cleansing, nail polish, and lipstick). A total of 520
items were randomly sampled to undergo quality testing (conforming rate of 93%) while 697
items underwent labeling checks (conforming rate of 93.8%). Nonconforming products have been
transferred to the responsible local health bureau and handled according to the relevant laws.
(2) Risk Assessment Mechanism and Control
a. Cosmetic Hygiene Management Consultation Committee
Since 1996, TFDA has held annual meetings of the Cosmetic Hygiene Management Consultation
Committee to discuss cosmetic management policies, quality, safety, and safe technologies, to serve
as reference for policy development in addition to scientific literature and international management
regulations.
b. Stipulating Quality and Safety Related Regulations for Cosmetics
Based on scientific evidence, specialized literature, international cosmetics management
specifications as well as recommendations from Cosmetic Hygiene Management Consultation
Committee members, TFDA publicly announced a total of 182 standards for medicated cosmetics,
300 types of illegal ingredients, and 100 types of restricted ingredients such as preservatives,
bacteriostatic agents, astringents, and whitening agents by the end of 2014. Targeted demographics
and applicable body parts are also referenced when formulating maximum microbial contents within
the cosmetics. Both medicated cosmetics and general cosmetics must satisfy all pertinent hygiene
standards.
c. Advocating Cosmetic PAE Reports
In 2014, a total of three promotion meetings was held for the Cosmetic Products Adverse Events
Reporting System. Awareness-raising meetings were held and reporting system instruction manuals
were disseminated to strengthen public understanding of the Cosmetic PAE Reporting System and
improve reporting rates.