Page 69 - Taiwan Food and Drug Administration 2016 Annual Report

2016 ANNUAL
REPORT

Chapter 6. Risk Assessment and Management

To ensure the safety and quality of food, drugs, medical devices, and cosmetics and
achieve preventive measures or early detection of potential product risks, TFDA continued to
promote risk management systems, using risk assessment as the basis to stipulate policies and
corresponding management practices. Risk management and crisis handling were incorporated
into administrative operations to effectively minimize the impact of an actual crisis.

Section 1. Risk Assessment

Current Status Part II - Key Administrative Results Risk Assessment and Management
Risk assessment plays a key role in managing safety risks of food, drugs, medical devices,
and cosmetics. To gather risk-related information, TFDA continued to implement routine surveys
(such as total diet study and medicinal Product Quality Inspections), establish reporting systems
(such as reporting of unintended reactions of food products as well as adverse reactions for
drugs, medical devices, and cosmetics) to acquire feedback information, and monitoring of alerts
in Taiwan and other countries. TFDA also organized expert or advisory meetings to conduct risk
assessments and provide a reference for formulating or revising risk management measures, while
post-marketing surveillance was carried out to achieve better understanding of product quality
and safety. The principles of scienti?c evidence, preventive action, and information transparency
were employed to build a food and drugs safety management system.
Policies and Outcomes
To accurately assess risk levels, manage specific as well as potential risk factors, identify
risks, and collect information, various channels were employed to acquire risk-related data of
food, drugs, medical devices, and cosmetics. Information related to potential product risks was
collected as well. Inquiry meetings, risk-related data analysis, and risk assessment courses were
also provided to train risk assessment professionals.
1. Food Safety Risk Assessments
(1) Risk Identi?cation and Data Compilation
a. Establishing the National Food Consumption Database and Risk Assessment Data
The establishment of the National Food Consumption Database in 2015 was a continuation of the
research findings of 2014. An additional food category was added to give a total of four major
categories (primary, secondary, minor, and items) while making continuous updates and revisions
to national dietary information. Results of food consumption calculations were then publicized in the
National Food Consumption Database which can then be downloaded or used in other calculations.
b. Study of Background Risk Factors in Food and Risk Assessments in Total Diet Study.

(a) Investigations and Risk Assessments for Dioxins in Food
Risk assessment and investigations of food-borne dioxins were carried out in 2015. Content analysis
and exposure risk assessments of dioxins (including 17 types of polychlorinated dibenzodioxins
/ dibenzofurans and 12 types of dioxin-type polychlorinated biphenyls) in 126 food items were
completed in central Taiwan. The estimated life-time average daily dose (LADD) was 0.422 pg
WHO-TEQ /kg BW/day, which was lower than the recommended tolerable daily intake (TDI) of the
WHO that ranged from 1 to 4 pg WHO-TEQ /kgBW/day and the tolerable weekly intake (TWI) of 14
pg WHO-TEQ /kg BW/week recommended by the European Scienti?c Committee on Food (SCF).
Note : Toxic equivalent quotient for dioxin and dioxin like compounds calculated with toxic
equivalency factor established by WHO (2005).
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