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2015 Annual Report


Risk Assessment

Management and

Research Outcomes





Laboratory and

Testing Network

Risk Communication

and Consumer



Cooperation and

Cross-Strait Exchange






Policy and








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


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


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.