1 Draft Amendment to the Food Business Shall Establish Traceability 
System of Food Products 
MOHW Food No. 105 1301941, October 4 2016. 
The competent authority: Ministry of Health and Welfare (MOHW) 
Basis for the enactment: The stipulations in Article 9  of the Act Governing Food 
Safety and Sanitation. 
I. The food businesses for which shall establish their own traceability system of 
food products are as follows: 
(1) Food importers and  manufacturers of edible oils and fats. 
(2) Food importers and  manufacture rs of meat products,  the food manufacturers 
refer to thoses who shall meet the regulations on food safety control system 
of meat products.  
(3) Food importers and  manufacturers of dairy products (exclude prepackaged 
milk powders and modified milk powders produc ts), the food manufacturers 
refer to thoses who shall meet the regulations on food safety control system 
of dairy products.  
(4) Food importers and  manufacturers of seafood products,  the food 
manufacturers refer to thoses who shall meet the regulations on food safety 
control system of seafood product s. 
(5)  Food manufacturers of lunch box. 
(6)  Food importers and  manufacturers of food additives. 
(7) Food importers of raw materials of genetically modified foods. 
(8) Food importers and manufacturers of soybeans. 
(9) Food importers and manufacturers of wheat. 
(10) Food importers and  manufacturers of maize (corn). 
(11) Food importers and  manufacturers of wheat flour. 
(12) Food importers and  manufacturers of starches. 2 
 (13) Food importers  and manufacturers  of food grade salts, the food  
manufacturers  refer to the NaCl containing more than 95% of food grade 
salts. 
(14) Food importers  and manufacturers  of sugars . 
(15) Food importers of tea leaves.  
(16) Food manufacturers of prepackaged tea drinks.  
(17) Food importers  and manufacturers  of soybean products.  
(18) Food retailers, importers and manufacturers of infant and follow -up formula.  
(19) Food retailers, importers and manufacturers of prepackaged milk powders 
and modified milk powders products.  
(20) Food manufacturers  of egg products . 
(21) Food manufacturers  of edible vinegar s. 
(22) Food importers  of infant food s. 
II. The scale of the food businesses designated in the preceding section shall be as 
follows:  
(1) Food manufac turers provided in Subparagraph  1, Paragraph  I: Food 
manufacturers applying for factory registration  will enter  into force on 
October  31, 2014 . 
(2) Food importers  provided in Subpar agraph  1, Paragraph  I: Food importers 
applying for  business registration , company registration or  factor y 
registration  will enter  into force on October  31, 2014 . 
(3) Food manufacturers provided in Subparagraphs 2 to 5 and 19 , Paragraph  I: 
Food manufacturers applying for factory registration  will enter  into force on 
February  5, 2015 . 
(4) Food importe rs provided in Subparagraphs 2, 3, 4, 6 , 7 and 19 , Paragraph  I, 
and food manufac turers provided in Subparagraph  6, Paragraph  I: Food 3 
 importers  and manufacturers  applying for  business registration , company 
registration  or factory registration  will enter  into force on February  5, 2015.  
(5) Food manufacturers provided in Subparagraphs  8 to 1 4, 16 and 17 , 
Paragraph  I: Food manufacturers whose a mount of capital  are at least  
NT$30,000,000 and applying for factory reg istration  will ent er into force on 
July 31, 2015.  
(6) Food importers  provided in Subparagraphs  8 to 15 and 17,  Paragraph  I: Food 
importers  applying for  business registration , company registration or  factory 
registration  will enter  into force on July 31, 2015.  
(7) Food manufac turers provided in Subparagraph  18, Paragraph  I: Food 
manufacturers whose a mount of capital  are at least  NT$30,000,000 and 
applying for factory registration  will enter  into force on January 1, 201 6. 
Food manu facturers whose a mount of capital  are below NT$30,000,000 and 
applying for factory registration  will enter  into force on July  1, 2016.  
(8) Food importers  provided in Subparagraphs  18, Paragraph  I: Food importers 
applying for  business registrat ion, company registration or  factory 
registration  will enter  into force on January 1, 201 6. 
(9) Food ret ailers provided in Subparagraph  18 and 19, Paragraph  I: Food 
retailers whose a mount of capital  are at least  NT$30,000,000  and applying 
for business registration, company registration or factory registration wil l 
enter  into force on January  1, 201 7. 
(10) Food manufacturers  provided  in Subparagraphs 20 and 21, Paragraph I : Food 
manufacturers whose a mount of capital  are at least  NT$30,000,000 and 
applying for factory registration  will enter  into force on January  1, 2017；
Food manufacturers whose a mount of capital  are below  NT$30,000,000 and 
applying for factory registration  will enter  into force on January  1, 2018.  4 
 (11) Food import ers provided in Subparagr aph 22, Paragraph I : Food importers 
applying for  business registration , company registration or  factory 
registration  will enter  into force on January 1, 2017.  
III. Food importers  and manufacturers  provided  in Paragraph  I shall  upload  
Traceabili ty Information  of last month  to the website ( http://ftracebook.fda.gov.tw ) 
before  10th of each month . The scale of the food businesses designated : 
(1) Food manufac turers provided in Subparagraph  1, Paragraph  I: Food 
manufacturers  whose a mount of capital  are at least NT$30,000,000 and  
applying for factory registration  will enter  into force on October  31, 2014. 
Food manufacturers whose a mount of capital  are below NT$30,000,000 and 
applying for factory registration  will enter  into force on January  1, 201 7. 
(2) Food importers  provided in Subparagraph  1, Paragraph  I: Food importers 
applying for  business registration , company registration or  factory 
registration  will enter  into force on October  31, 2014.  
(3) Food manufacturers provided in Subparagraphs 2, 3 and 5, Paragraph  I: Food 
manufacturers  whose a mount of capital  are at least  NT$30,000,000 and  
applying for factory registration  will enter  into force on January 1, 2016. 
Food man ufacturers whose a mount of capital  are below NT$30,000,000 and 
applying for factory registration  will enter  into force on January 1, 2017.  
(4) Food importers provided in Subparagraphs 2, 3, 7 to 15, 1 8 and 19, 
Paragraph  I: Food importers apply ing for business registration, company 
registration or factory registration will enter  into force on January  1, 201 6. 
(5) Food manufac turers provided in Subparagraph  4, Paragraph  I: Food 
manufacturers  whose a mount of capital  are at least NT$30 ,000,000 and  
applying for factory registration  will enter  into force on March 1, 2016. Food 5 
 manufacturers whose a mount of capital  are below NT$30,000,000 and 
applying for factory registration  will enter  into force on January 1, 2017.  
(6) Food imp orters provide d in Subparagraph  4, Paragraph  I: Food importers  
applying for  business registration , company registration or  factory 
registration  will enter  into force on January 1, 2017.  
(7) Food importers and food manufac turers provided in Subparagraph  6, 
Paragraph  I: Food importers  and manufacturers applying for  business 
registration , company registration or  factory registration  will enter  into force 
on January 1, 2017 . 
(8) Food manufacturers provided in Subparagraphs  8 to 14 and 16, Paragraph  I: 
Food manufacturers whose a mount of capital  are at least  NT$30,000,000 and 
applying for factory registration  will enter  into force on January 1, 2016.  
(9) Food manufac turers provided in Subparagraph  17, Paragraph  I: Food 
manufacturers whose a mount of capital  are at least  NT$30,000,000 and 
applying for factory registration  will enter  into force on March  1, 2016.  
(10) Food imp orters provided in Subparagraph  17, Paragraph  I: Food importers 
applying for business regis tration, company registration or  factory 
registration will ent er into force on March  1, 201 6. 
(11) Food manufacturers provided in Subparagraphs 18 and 19, Paragraph  I: Food 
manufacturers  whose a mount of capital  are at least  NT$30,000,000 and  
applying for factory registration  will enter  into force on January 1, 2016. 
Food manufacturers whose a mount of capital  are below NT$30,000,000 and 
applying for factory registration  will enter  into force on July 1, 2016.  
(12) Food retailers provided in Subparagrap hs 18 and 19, Paragraph  I: Food 
retailers whose amount of capital are at least  NT$30,000,000  and applying 6 
 for business registration, company registration or  factory registration will 
enter into force on January 1 , 201 7. 
(13) Food manufacturers  provided  in Subparagraphs 20 and 21, Paragraph I : Food 
manufacturers  whose a mount of capital  are at least  NT$30,000,000 and  
applying for factory registration  will enter  into force on January  1, 2018 . 
Food manufacturers whose amount of capital are below NT $30,000,000 and 
applying for  factory registration will enter  into force on January  1, 201 9. 
(14) Food import ers provided in Subparagraph  22, Paragraph I : Food importers 
applying for business registration, company registration or factory 
registration will ent er into force on January 1, 201 8. 
IV. Food importers  and manufacturers  provided  in Paragraph  I shall use electric 
uniform invoices  if food importers  and manufacturers  have to use uniform 
invoices  referred  to “Value -added and Non -value -added Busin ess Tax Act ”. The 
scale of the food businesses designated : 
(1) Food manufactur ers provided in Subparagraph  1, Paragraph  I: Food 
manufacturers  whose a mount of capital  are at least  NT$30,000,000 and  
applying for factory registration  will enter  into force on December  31, 2014. 
Food manufacturers whose a mount of capital  are below NT$30,000,000 and 
applying for factory registration  will enter  into force on January 1, 201 8. 
(2) Food importers  provided in Subparagraph  1, Paragraph  I: Food  importers 
applying for  business registration , company registration or  factory registration  
will enter  into force on December  31, 2014.  
(3) Food manufacturers provided in Subparagraphs 2, 3 and 5, Paragraph  I: Food 
manufacturers  whose a mount o f capital  are at least  NT$30,000,000 and  
applying for factory registration  will enter  into force on January 1, 2017. 7 
 Food manufacturers whose a mount of capital  are below NT$30,000,000 and 
applying for factory registration  will enter  into force on January 1 , 2018.  
(4) Food importers provided in Subparagraphs 2, 3, 7 to 15, and 17, Paragraph  I: 
Food importers applying for business registration, company registration or  
factory registration will ent er into force on January 1, 201 7. 
(5) Food manufac turers provided in Subparagraph  4, Paragraph  I: Food 
manufacturers  whose applying for factory registration  will enter  into force on 
January 1, 2018.  
(6) Food imp orters provided in Subparagraph  4, Paragraph  I: Food importers  
applyi ng for  business registration , company registration or  factory registration  
will enter  into force on January 1, 2018.  
(7) Food  manufacturers prov ided in Subparagraph  6, Paragraph  I: Food 
manufacturers whose a mount of capital  are at least  NT$30, 000,000 and 
applying for  business registration , company registration or  factory registration  
will enter  into force on January 1, 201 8. Food manufacturers whose a mount 
of capital  are below NT$30,000,000 and applying for factory registration  will 
enter  into force on January 1, 2019.  
(8) Food imp orters provided in Subparagraph  6, Paragraph  I:: Food importers   
applying for  business registration , company registration or  factory registration  
will enter  into force on January 1, 2018 . 
(9) Food manufac turer s provided in Subparagraph s 8 to 14, 16 and 17, Paragraph  
I: Food manufacturers whose a mount of  capital  are at least  NT$30,000,000 
and applying for factory registration  will enter  into force on January 1, 2017.  
(10) Food  retailers, importers an d manufacturers  provided in Subparagraphs  18 
and 19, P aragraph  I: Food businesses provided in Paragraphs II will enter  into 
force on September  1, 201 5. 8 
 (11) Food manufacturers provided in Subparagraphs  20 and 21, Paragraph  I: Food 
manufacturers  whose a mount of capital  are at least  NT$30,000,000 and 
applying for factory registration  will enter into force on January 1, 2020. Food 
manufacturers whose a mount of capital  are below NT$30,000,000 and 
applying for factory registration  will ent er into forc e on January 1, 2021 . 
(12) Food importers provided in Subparagraph 22, Paragraph  I: Food importers 
applying for business registration, company registration or  factory registration 
will ent er into force on January 1, 20 20.