Page 84 - 2017食品藥物管理署年報(英文版)

2017 Taiwan Food and Drug Administration Annual Report

4. The second tier (Third party certification systems)

(1) According to the Act Governing Food Safety and Sanitation Article 5, paragraph 5
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and 6, 3 party certification system (2 tier quality control) refers to food businesses
of a certain scale and category must have their sanitation and safety management
systems certified by a certification body (CB) accredited by the central competent
authority; Health and Safety Management System means that the food business needs
to comply with Good Hygiene Practice for Food (GHP) and Food Safety Control
System(HACCP).

(2) TFDA promulgated “Act governing food businesses safety and sanitation management
as well as the management of commissioned validations” on November 7, 2014
that food businesses categories and scales within the scope of central competent
authorities announcement must receive mandatory on-site inspections conducted by
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3 party certification body. TFDA promulgated “Accreditation of Certification Body
and Sanitation and Safety Control of Food Businesses of Certification Regulations”,
“SOPs of food safety and sanitation management accreditation system” and “SOPs of
food safety and sanitation management certification body system” on May 13, 2016
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to complete 2 tier quality control system.

(3) Starting from 2014, TFDA required food businesses with announced capital over NT$
30,000,000 dollars, including edible oil manufacturers, canned food, special nutrients,
dairy, food additives businesses and 10 food categories (including sugar, salt, flour,
starch, soy sauce) with capital more than NT$ 30,000,000 dollars for certifications. A
total of 519 businesses completed certifications by the end of 2016.

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