Page 27 - Taiwan Food and Drug Administration 2016 Annual Report

2016 ANNUAL
REPORT

critical point controls, and principles of risk management of the food industry in order to
independently assess the scale and equipment needed for internal laboratories, and have
the said laboratories carry out all or part of food self-testing required. All food businesses that
are Exchange-Listed, OTC-Listed required by law to establish their own laboratories since
December 10, 2015. Additionally, all companies with a capital sum over NT$ 100 million and
factory registration for the production, processing, or mixing of 10 food industry categories that
include edible oils, processed meat products, processed dairy product, processed aquatic
products, ?our, starch, salts, sugar, soy sauce, and prepackaged tea drinks are required to Part II - Key Administrative Results Food Management
establish their own laboratories as well.
(2) The Second Tier : Implementing third-party veri?cation systems

a.According to the Act Governing Food Safety and Sanitation, food businesses of a certain
scale and category must have their sanitation and safety management systems verified by
a certification body (CB) accredited by the central competent authority; Health and Safety
Management System means that the food business needs to be comply with Act Governing
Food Safety 8 (5) gudelines (GHP、HACCP).

b.Oil and fat manufacturers were inspected in 2014. In 2015, inspections announcements were
released for canned food products, special nutrient foods, dairy products, and food additive
industries. By the end of 2015, 308 verification audits were carried out for the sanitation and
safety management systems of ?ve types of food manufacturers. Details are listed in Table 2-1-5.

Table2-1-5 Number of businesses that underwent third-party verification as of 2015

Type of business Number verified Date implemented
Oil and fat manufacturer with a capital sum above NT$ 30 million 32 103.12.05

Canned food manufacturers 149 104.01.01
Special nutrient food manufacturers 9 104.06.04

Dairy product manufacturers 37 104.06.04
Food additive manufacturers 81 104.06.04

Total 308

(3) The Third Tier : Enhancing inspection capacity and post-marketing surveillance
a.Work with local governments, health bureaus and departments to carry out programs for
the inspection, sampling and testing, as well as post-marketing surveillance of food products:
Increased inspection, sampling, and monitoring of key administrative targets, high risk food
items, and issues with high levels of public concern, and work with health bureaus and
departments to carry out various projects. In 2015, 47 project inspection and sampling tests
were carried out in addition to four post-marketing surveillance programs for heavy metals,
mycotoxins, veterinary drugs, and residual agricultural chemicals. 4,940 items were inspected in
2015. Nonconformities were handled according to law by the local health bureaus. Root cause
analysis and improvements were also carried out by an inter-departmental coordination system.
Table 2-1-6 shows the results of these TFDA surveillance efforts. Refer to Table 4 in Annex I for
detailed statistics on testing for residual pesticides and veterinary drugs in food products.

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