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Food and Drug Administration


Section 4 Cosmetics Safety Management

Current Status

TFDA established the Cosmetic Product Defect Reporting System in 2008, which was renamed

Cosmetic Products Adverse Events Reporting System in 2014. Significant promotional efforts

have been made since 2009 to help increase cosmetics safety awareness among consumers,

leading to annually increasing numbers of defective product reports. Public announcements,

hygiene standards, and relevant information are released every year. Key administrative focuses

also include improvements to risk communication and interaction with cosmetic companies as

well as accelerating transmission of cosmetics safety information.

Policies and Outcomes

1. Cosmetic Products Adverse Events (PAE) Reporting System (originally

Cosmetic Product Defect Reporting System)

(1) The number of cosmetic PAEs reported has risen from six cases in 2009 to 105 cases in 2014 (Figure

6-6). According to statistics of PAE categories (partial defects or adverse reaction that include

two or more defect types) of 2014, 89 items associated with labeling issues, 18 with appearance

abnormalities, eight with defective packaging, and one with an expiration problem. The remaining

15 items were categorized as


(Figure 6-7).

(2) In 2014, a total of three awareness-raising meetings for the Cosmetic Products Adverse Events

Reporting System have been held. Documentation and operation manuals for the Reporting

System were also created and distributed as part of the promotion program to improve public

understanding and encourage the public to report cosmetic PAEs.

(3) TFDA also constantly collects the latest news on cosmetic recalls and safety-related information

around the world, and monitors information on domestic online shopping reports, webpages

on medical hygiene, beauty and health, and medical news. In 2014, a total of 407 domestic

and global alerts were monitored and 62 consumer Red and Green Light alerts were issued.

2. Promoting Cosmetics Safety

TFDA has attended 2 seminars regarding cosmetic research and development and quality

surveillance, which were held by Taiwan Testing and Quality Assurance Association (TTQAA)

and The Beauty Business Trade Association of Taipei to introduce current management

specifications for cosmetics and trends of future legal revisions so that cosmetic businesses are

provided with the correct concepts of cosmetic selection and purchases.