1 
 Draft Certification of Sanitation and Safety Control of Food Businesses and 
Commission of Certification Regulations 
 
Provisions 
 
Chapter 1 General Principles  
 
Article 1  These regulations are promulgated pursuant to Paragraph 6 of Article 8 of the 
Act Governing Food Safety and Sanitation (hereinafter referred to as the Act). 
 Article 2  The sanitation and safety certific ation of food businesses conducted pursuant 
to Paragraph 5 of Article 8 of the Act and the certification nature and procedures shall be subject to the pe rtinent announcement of the central 
competent authority.   
 The term, certification, provided in  the preceding paragraph refers to the 
procedures implemented on the sanitation and safety management systems of food businesses in examination and subs tantiation of their compliance with 
the Act and other related laws and regulations. 
 
Chapter 2 Certification Procedures and Approaches 
 
Article 3  Food businesses as referred in the announcement provided pursuant to 
Paragraph 1 of the preceding article are required to prepare the following documents and information for examin ation when the central competent 
authority conducts the on-site certific ation procedures; where circumstances 
require, the central competent authority may take samples of the products: 
1. Official business establishment certificate; 
2. Basic information of food businesses; 3. Information pertaining to the manufacturing process management, 
standard operating procedures, quali ty control, and other sanitation and 
safety management system; 
4. Other documents required by the central competent authority. 
Food businesses shall not be entitled to  any payment or compensation for the 
sampling provided for the purpose referred in the preceding paragraph. 
 Article 4  Food businesses undergoing the ce rtification procedure shall be obliged to 
submit true and accurate documents and information.   2 
  
Article 5 Where a food business undergoing  the examination or sampling inspection 
referred in Article 3 is found to have violated the Act, the competent municipal or county (city) authority shal l be entitled to impose the penalties 
defined in the Act.   
 
Chapter 3 Commission and Management of the Certification Procedures 
 
Article 6 Should the central competent auth ority commission a certification procedure 
pursuant to Paragraph 5 of Article 8 of th e Act, the certification body to which 
procedure is entrusted (hereafter referre d as the certification service provider) 
shall be selected through an open selection process.     
 Article 7  The certification service provider sh all be a government agency (institution), a 
university, or a non-profit corporate body possessing the following qualifications:  
1. Substantiating documents certifying the required previous experience in 
implementing food sanitation and safety management audit and certification; 
2. Employment of professional personnel carrying the following 
qualifications: 
(1) At least one licensed food tec hnologist, livestock technologist, 
aquaculture technologist, dietician, or veterinarian; 
(2) Personnel certified by a domestic un iversity to have completed at least 
15 credits of academic subjects in criminal law, civil law, code of 
criminal procedures, code of civil procedures, and administrative law. 
3. Other qualifications required by th e central competent authority pursuant 
to the nature of a particular food industry. 
 Article 8  The certification service provider implementing a certification procedure shall 
have established a pertinent management system complete with printed procedure manual(s), and contents of which shall include information on the 
organization structure, document control, records control, management review, complaints handling, internal audit, and preventive and corrective actions. 
The manual referred in the preceding paragraph shall be reviewed regularly 3 
 to ensure applicability and shall be upda ted or revised from time to time to 
suit the actual operating conditions . The internal audit and management 
review procedures mentioned shall be conducted at least once a year.  
Article 9 The certification service prov ider shall ensure that the personnel 
implementing the certification proc edure possess the necessary audit 
technique and the knowledge of food sa fety and sanitation and related laws 
and regulations; moreover, the certification service provider shall keep a record of the initial and regular pers onnel assessments conducted on said 
personnel. 
The personnel referred in the preceding pa ragraph shall have attended at least 
eight hours of continued education an d training course conducted by an 
institution (body) or civilian institutio n or group recognized by the central 
competent authority. Education or t raining curriculum shall include the 
examination techniques and related laws.  
Article 10 The certification service provider shall define a certification implementation 
plan and submit the plan to the cent ral competent authority for approval; 
implementation shall follow approbatio n. The audit and sampling inspection 
should be conducted pursuant to the Food Inspection Measure Regulation. 
 
Article 11 Upon conclusion of the contract rela tionship, the certification service provider 
is obliged to ensure proper preservati on of the information produced in the 
course of the certification procedure, certification information received from the commissioned  party, and the manuals and other certification related 
documents and information regulated in Article 8.  
 Upon conclusion of contract relationship, the certification service provider 
shall turn over the aforementioned do cuments and information to the central 
competent authority. 
 Article 12 The certification service provider is under an obligation to ensure the 
confidentiality of all information acquir ed in the course of the certification 
procedure, and shall desist from  disclosing said information. 
 Article 13 When implementing an audit proced ure pursuant to Paragraph 1 of Article 3, 
the certification service provider shall submit the prepared schedule to the central competent authority one week pr ior to the audit date. The central 
competent authority may appoint a representative to attend the audit 4 
 procedure. The certification service provider shall not evade, obstruct, or 
refuse such attendance. 
 Article 14 The certification service provider is obliged to inform the central competent 
authority of the certification results;  moreover, related documents and data 
shall be attached to said information. 
 
Article 15 The central competent authority sha ll notify the certification service provider 
of its requirement to submit operatio n-related documents and data and shall 
conduct unscheduled on-site audit proced ure on the venue of operations of 
the certification service provider. 
The certification service provider shall not evade, obstruct, or refuse the 
foregoing notice, requirement or examination. 
 
Article 16 All documents and information provided to the central competent authority 
by the certification service provider pursuant to the provisions of the 
Regulations shall be true and accurate.   
 
Article 17 A certification service provider and its personnel entrusted with the 
processing of certification work sha ll observe the “conflict of interest” 
regulations as dictated in the Administrative Procedure Act.  
 A certification service provider shall de sist from institutin g any violent acts, 
threats, demands or post factum bribery, from accepting bribes or other improper benefits, from forging and alte ring documents, or from making false 
reports or statements. Any such violat ion shall be subject to legal action. 
 
Article 18 The central competen t authority shall sign a work  consignment contract with 
the certification service provider. Cont ract shall clearly define matters and 
other details, related rights and obligations, breach of contract penalty and reasons, dispute processing, and factors for the revocation or temporary suspension of the consigned work covered in the contract.  
 Article 19 Where a certification service provider  violates the provisions herein stipulated, 
the central competent authority shall resort  to the actions stipulated in Article 
48-1 of the Act.  
 
Chapter 4  Supplementary Provisions
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Article 20 These regulations shall be effe ctive as of the date of promulgation.