1 
 Draft of Regulations Governing Traceability of Food s and 
Relevant Products  
 
Article 1  This regulation is prescribed in accordance with the provision of 
Paragraph 4 of Article 9 of the Act Governing Food  Safety and  
Sanitation (hereinafter referred to as “th is Act”) . 
 
Article 2  “Food s and relevant products ” referred to  in th is regulation  shall mean  
foods, special dietary food s, food additives, food utensils, food 
containers or packa ging, and food cleansers prescribed  under 
Subparagraphs 1 to 6, Paragraphs 1 , Article 3 of th is Act. 
 
Article 3  “Traceability ” referred to in this regulation  shall mean  food businesses 
establish ed the information and management  to trace the source and 
track the flow of foods  and relevant product s at all stage of supply chain . 
 
Article 4  Food businesses that engage in the manufacture, processing, preparation 
of the foods and relevant products shall establish traceability system 
including at least the following management items : 
 
1. Raw material source  information : 
(1) name,  food business  registration number , address, contact perso n 
and contact telephone number  of raw material supplier ; 
(2) raw material  name ; 
(3) net weight, volume, quantity or measurement ; 
(4) lot/batch number ; 
(5) expiry date , manufactu re date or other recognizable date or 
information about the source of the raw material;  
(6) receivi ng date; and  
(7) country of origin of raw material.  
 
2. Product i nformation:  
(1)product  manufacture r; 
                (2)name, food business registration number, address, contact person 
and contact phone number  of the product  responsible domestic  
company ; 
(3) product name ; 
(4) main and minor raw materials ; 2 
 (5) food additives ; 
(6) packaging containers ; 
(7) storage conditions ; 
(8) net weight, volume, quantity or measurement;  
(9) expiry date and manufacture date ; and  
(10)labelling  information of food containing ingr edients of 
genetically modified organisms . 
3. Identification: including any unique mark, lot/batch number, text or 
picture that is identifiable on raw materials, semi - products or e nd 
products . 
 
4. Product  flow information  
(1)name, food business registration num ber, address, contact person 
and contact telephone number of the product transporting 
distributor;  
(2) name, address, contact person and contact telephone number of 
the product recipient besides natural person; in the case of that is 
food business, the foo d business registration number shall be 
included;  
(3) product name;  
(4) net weight, volume, quantity or measurement;  
(5) lot/batch number;  
(6) expiry date or manufacture date;  
(7) delivery dat e; 
(8)name, weight or volume, lot/batch number, expiry date, re call 
reason and  follow -up measures of recall products; name and 
address of product -return ing businesses ; 
(9)name, weight or volume, lot/batch number, expiry date, sales 
returned  reason and record s of follow -up measures of  sales 
returned  products; name and address of product -return ing 
businesses ;and 
(10)name, weight or volume, lot/batch number, expiry date, inferior  
(including discard) reason and follow -up measures of inferior 
products  (including discard items) . 
 
5. name, wei ght or volume, lot/batch number  and expiry date of 
inventory material s and products . 
6. name, weight or volume, lot/batch number,  expiry date , follow -up 3 
 measures  and the cause  of material s and products  that passed their 
expir y date . 
7. Other necessary information or record for internal traceabili ty system 
management with effective connection for tracing the source and 
tracking the flow.  
 
The information of food business registration number mentioned in the 
Item 1 of Subparagraph 1, Item 2 of Subparagraph 2, and Item 1 and 2 of 
Subparagraph 4 of th e preceding paragraph, shall mean that the food 
business registration number information for those food businesses 
designated by the central competent authority in a public announcement 
shall be retained.  
 
The information of country of origin of raw materi al mentioned in the 
Item 7 of Subparagraph 1 of the Paragraph 1 shall mean that the country 
of origin information for those raw materials required to be labeled 
designated by the central competent authority in a public announcement 
shall be retained.  
 
If the manufacturer and the responsible domestic company in the Item 6 
and 7 of Subparagraph 2 of the Paragraph 1 are the same, either of them 
may be chosen to be recorded.  
 
Labelling  information of food containing ingredients of genet ically 
modified organisms  mentioned in the Item 10 of Subparagraph 2 of the 
Paragraph 1  shall mean that labelling requirements for food containing 
ingredients of genetically modified organisms (GMOs)  by the central 
competent authority in a public announcement shall be retained.  
 
Article 5  Food businesses that engage in the import  of the foods and relevant 
products shall establish  traceability system  includ ing at least the 
following  management items s: 
 
1. Product Information:  
(1) Chinese and English (foreign) product name ; 
(2) main and minor  raw materi als; 
(3) food additives ; 
(4) packaging containers ; 4 
 (5) storage conditions ; 
(6) employer identification number and  food business  registration 
number;  
(7) name or factory code,address, contact person and contact phone  
number of the exporter and manufacturer (slaughter or 
respon sible company of the export country) ;  
(8) net weight, volume, quantity or  measurement ; 
(9) lot/batch  number;  
(10) expiry date , manufactu re date or other recognizable date or 
information about the source of the p roduct ; 
(11) date of customs release ; 
(12) application number for i mport food and relevant products 
inspection ;  
(13)co untry of origin of raw material ; and 
(14)labelling requirements for food containing ingredients of 
genetically modified organisms . 
 
2. Identification: including any unique mark, lot/batch number, text or 
picture that is identifiable on products  
 
3. Product  flow information : 
(1) name, food business registration number, address, contact person 
and contact telephone number of the product transporting 
distributor;  
(2) name, address, contact person and contact telephone numb er of the 
product recipient besides natural person; in the case of that is food 
business, the food business registration number shall be included;  
(3) product name;  
(4) net weight, volume, quantity or measurement;  
(5) lot/batch number;  
(6) expiry date or manufacture date or other recognizable date or 
information about the source of the raw materials;  
(7) delivery date ; 
(8) name, weight or volume, lot/batch number, expiry date, recall 
reason and record s of follow -up measures of recall products; name 
and address of product -returnin g businesses ; 
(9) name, weight or volume, lot/batch number, expiry date, sales 
returned reason and record s of follow -up measures of  sales 5 
 returned  products; name and address of product -return ing 
businesses ; and  
(10) name, weight or volume, lot/batch number, expiry date, inferior  
(including discard) reason and follow -up measures of inferior 
products  (including discard items)  
 
4. name, weight or volume, lot/batch number  and expiry date of 
inventory material s and products . 
5. name, weight or volume, lot/batch number,  expiry  date, follow -up 
measures  and the cause  of material s and products  that passed their 
expir y date.  
6. Other necessary information or record for internal traceability system 
management with effective connection for tracing the source and 
tracking the flow.  
 
The information of food business  registration number mentioned in the 
Item 6 of Sub paragraph  1, Item 1 and 2 of Sub paragraph  3 of the 
preceding paragraph,  shall mean that the food business  registration 
number information for those food businesses  designated by  the central 
competent authority  in a public announcement shall be retained.  
 
The information of country of origin of raw material  mentioned in  the 
Item 13 of S ubparagraph 1 of the Paragraph 1 shall mean that the 
country of origin information for those raw  material s in food products 
required to be labeled designated  by the central competent authority in a 
public announcement  shall be retained.  
 
Labelling  information of food containing ingredients of genet ically 
modified organisms  mentioned in the Item 14 of Subparagraph 1 of the 
Paragraph 1 shall mean that labelling requirements for food containing 
ingredients of genetically modified organisms (GMOs)  by the central 
competent authority in a public announcement shall be retained.  
 
 
Article 6  Food businesses that engage in the sale and export of the foods and 
relevant products shall establish  traceability system  includ ing at least the 
following  management items : 
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 1. Product Information:  
(1) name, food business registration number, address, contact person 
and contact telephone  number of product supplier;  
(2) product name;  
(3) net weight, volume, quantity or measurement;  
(4) lot/batch number;  
(5) expiry date or manufacture date or other recognizable date or 
information about the source of the raw material;  
(6) receiving date; and  
(7) country of origin of raw material ; and  
(8) labelling requirements for food containing ingredients of 
geneti cally modified organisms . 
 
2. Identification: including any unique mark, lot/batch number, text or 
picture that is identifiable on products . 
 
3. Product flow information:  
(1) name,  food business  registration number , address, contact person 
and contact telephone number  of the product transporting 
distributor ; 
(2) name , address, contact person and contact telephone number  of the 
product recipient besides natural person ; in the case o f that is food 
business , the food business  registration number shall be included;  
(3) product name ; 
(4) net weight,  volume, quantity or measurement ; 
(5) lot/batch number ; 
(6) expiry date or manufacture  date or other recognizable date or 
information about the source of the  raw material;  
(7) delivery date; 
(8) name, weight or volume, lot/batch number, expiry date, recall 
reason and records of follow -up measures of recall products; name 
and address of  product -return ing businesses ; 
(9) name, weight or volume, lot/batch number, expiry dat e, sales 
returned reason and records of follow -up measures of sales returned 
products; name and address of product -returning businesses ; and 
(10) name, weight or volume, lot/batch number, expiry date, inferior  
(including discard) reason and follow -up measures of inferior 
products  (including discard items) . 7 
 4. name, weight or volume, lot/batch number  and expiry date of 
inventory material s and products . 
5. name, weight or volume, lot/batch number,  expiry date , follow -up 
measures  and the cause  of material s and products  that passed their 
expir y date.  
6. Other necessary information or record for internal traceability system 
management with effective connection for tracing the source and 
tracking the flow.  
 
The information of food business  registration number mentioned in the 
Item 1 of Sub paragraph  1, Item 1 and 2 of Sub paragraph  3 of the 
preceding paragraph,  shall mean that the food business  registration 
number information for those food business es designated by the central 
competent authority  in a public announcement shall be  retained.  
 
The information of  country of origin of raw material  information 
mentioned in  the Item 7 of S ubparagraph 1 of the P aragraph 1  shall 
mean that the country of origin information for those raw material s in 
food products required to be labeled designated  by the central competent 
authority in a public announcement  shall be retained.  
 
Labelling  information of food containing ingredients of  genetically 
modified organisms  mentioned in the Item 8 of Subparagraph 1 of the 
Paragraph 1 shall mean that label ling requirements for food containing 
ingredients of genetically modified organisms (GMOs)  by the central 
competent authority in a public announcement shall be retained.  
 
Article 7  Food businesses that engage in the packaging of the foods  and relevant 
products shall comply with the provisions of Article 4 . If the original 
packaging has not been changed after combining the various raw 
materials, the provisions of the previous articles shall be complied with.  
 
Article 8  Food businesses shall record detailed information of manage ment items 
referred to Articles 4 to 6.  
Food businesses shall retain records such as complete proof and shall 
also keep documents regarding food traceability in written or electronic 
form for at least 5 years.  
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 Article 9  The municipal or county/city competent author ity may enter  the place of 
food business es to perform  on-site examination and ensure that food 
businesses  are in compliance with the provisions of  food traceability 
relevant documents , and businesses shall not  evade, impede or refuse . 
 
Article 10  This regulation  shall be implemented as of its being promulgated.