Regulations of Inspection of Imported Foods and Related 
Product s 
DOH Food No. 09000 74645 Promulg ated, Decembe r 14, 2001. 
DOH Food No. 09604 03095 Amende d and prom ulgated o n 
June 22, 2007; these re gulation s are effective as on July 1,  
2007. 
DOH Food No. 0991 304411 Amen ded and pro mulgated on  
Decemb er 30 , 2010 and the title was amende d to “Reg ulation s 
of Inspe ction of Imported F oods and Related Prod ucts”. 
DOH Food No. 10213 00813 Partial am ende d and p romulgate d 
on April 1, 20 13. 
MOHW Food  No. 102205 1463  Amen ded and pro mulgated on  
January 27, 2 014. 
 
Chapter 1 General Principles 
 
Article 1 The regulations are duly enact ed in accordance wit h Paragraph 3 of 
Article 33 of the Act Governing F ood Sanit ation (hereinaf ter “the Act”). 
 
Article 2  The terms herein are defined as follows: 
1. Obligatory Inspection Applicant: Business who import s food, food 
additives, food utensils, food p ackaging, or food cleans ers, and other 
related product s (hereinaf ter "product s"). 
2. Inspection Authority: The central competent au thority or it s 
commissioned organization, institut ion, corporation or group. 
3. V erification: The inspecti on authority check product name, 
specification and p ackage of product s applied for inspection. And 
exam it s appearance, shape, pr operties, indication and other 
examination in accordance with laws and regulations. 
4. Analysis: The inspection aut hority t ake samples and send to 
laboratories to conduct sensory , chemical, biologic al, or physical 
examination and experiment. 
 
Chapter 2 Application for Inspection  
 
Article 3 The Obligatory Inspection Applicant or Represent ative shall file an 
application for inspection to the inspec tion authority at the port of entry  
within fif teen (15) days pr ior to the entry date. 
If the application be filed by repres entative, an identification doc ument 
for the represent ative sha ll be provided. If the represent ative is an 
individual, he/she shall s ubmit his/her certifi cate of identification. If any 
entity , who undert akes application and declaration agent as business, 
shall submit it s broker licens e, busines s license and identification  
document s to the inspection author ity for  future referen ce. 
 
Article 4 Obligatory Inspection Applicant s shall submit the following docum ents to 
the inspection authority for inspection: 
1. An application form for inspection. 
2. A declaration form of product i nformation. 
 13. A photocopy of application for import declaration. 
4. Necessary certificates required by  the Food and Drug Administration,  
Ministry of Health and W elfare (hereinaf ter as“TFDA”). 
In accordance with Article 32 of the Act, the inspection authority may 
require Obligatory Inspection Applic ants to provide other necessary 
certificates and dat a. The Obligator y Inspection Applicant s shall not  
evade, obstruct or refuse. 
 
Article 5 The Obligatory Inspection App licant s can apply for pre-declaration of 
product information to the inspection authorities.  Document s referred to in 
subp aragraph 2 of p aragraph 1 of the preceding article for those who 
acquired approval of document s from  inspection authorities, shall be 
exempt from submitti ng the declara tion form of product information on 
application of inspection.  
Term of validity for the preceding approv al document is two (2) years. 
If product s applied for inspection are not conformant wi th the 
pre-declaration of product informati on, the inspection agencies  shall 
abolish all approval document s iss ued to Obligatory Inspection 
Applicant s, and suspend their applications  for pre-declaration of product 
information within one (1) year . 
 
Article 6 Product s for inspection applicat ion in the same shipment shall have the  
same import declaration eCCC c odeeproduct name eingredient sebrande
producer and country of origin. 
If the import product s were live, fresh or chilled fish, prawn, crab, 
shellfis h, or belong to the same cla ss from four classes of mollusk, the 
inspection authority may permit the applic ant to apply dif ferent product s 
in one inspection application. 
 
Article 7 For any Obligatory Inspection Applic ant belong to one of the following 
situations, the competent  authority shall dismiss his/her applic ation for 
inspection: 
1. Applicant s fail to apply an ins pection application pursuant to Article 4 
or the preceding article of this regulation. 
2. Incomplete inspection application form eproduct information  
declaration form e or other related form, an d fail to  make corre ction 
within a limited period.  
 
Chapter 3 Inspection Procedures  
 
Article 8 The inspec tion authority may proc eed produc t inspection with the fol lowing 
measures: 
1. Batch-by-batch inspection: Ins pect each submitted batch of product  
by on-site verification and sampling analysis basis. 
2. Randomly-selected batch inspection: Randomly select eac h 
submitted batch of product by follo wing inspection rate, and inspect  
the chosen product by on-site ve rification an d sampling analys is. 
(1)Regular  randomly-selected batch inspection: The inspection is  
performed based on a 2-10% inspection rate. 
(2)Reinforced randomly-selected batch  inspection: The inspection is  
 2performed based on a 20-50% inspection rate. 
3. Batch-by-batch verification: On-s ite inspect each submitted batch of 
product. 
4. Certification insp ection: Certif icate Document inspection for an 
excellent industry whic h is registered by an entente or agreement 
between the health and safety com petent authority of  Taiwan and the 
exporting country . 
5. Oversee inspection: For specific  product s, each submitted batch of 
product shall be ins pected by  on-site verification and sampling  
analys is. And the inspection rate is not changed by  the inspection 
result. 
For those product s not be select ed in randomly-selected batch 
inspection, the inspection authoriz e may exam extra by on-site 
verification and sampling analysis;  For product s be designat ed for 
batch-by-batch verification, the ins pection authorize may exam extra by 
sampling analysis. 
 
Article 9 Product s applied for inspecti on that bel ong to one of the following 
situations shall be inspect ed on a batch-by-batch basis: 
1. Product s proved to cause harm to humans according to domestic and 
foreign product safety information or scientific evidence.  
2. Product s designated for batch-by- batch inspection are listed in the  
TFDA  annual inspection plan (hereinaf ter as “inspection plan” ) for 
imported product s. 
3. Product s with the same origin and com modity clas sification c ode of 
the Republic of China (hereaf ter referred to as ‘C CC Code’) as 
preceding batches of product s belonging to reinforced 
randomly-selected batch inspections of  the same obligatory inspectio n 
applicant, and whose inspection result s do not conform to regulations.  
4. For product s applied to oversee inspection and fail the inspection two 
batches in a row .    
5. The inspection aut hority determines t hat it is necessary to carry out 
the inspection on a batch-by-batch basis. 
Prior to the completion of the batch- by-batch inspectio n procedures for 
the preceding batch, the batches  re-app lied for inspection to such batch 
of product s shall be subject to inspection on a batch-by-batch basis . 
 
Article 10 Product s applied for inspecti on that bel ong to one of the following 
situations shall be inspected on a reinforced randomly-selected batch 
basis: 
1. Product s designated for rein forced randomly-selected batch  
inspection are listed in the ins pection plan for imported product s. 
2. Product s applied f or inspection or iginally belong to batch-by-batch 
inspection, and the same obligat ory inspection applicant has imported 
five consec utive batches of such product s from the same origin and 
CCC Code , and who se laborat ory exam ination res ults conform to 
regulations . However , if the pr eceding batch before these five 
consecutiv e batches of the same obligator y inspection applicant failed 
to conform to regulations, then the quantity  of these fi ve consec utive 
batches of such product s shall be three times greater than the 
 3preceding batch of unqualified product s. 
3. Product s with the same origin a nd CCC Code as pr eceding batches of 
product s belonging to r egular randomly-selected batch inspection of  
the same obligatory inspection applicant, and whose inspection 
result s do not conform to regulations. 
4. The inspection aut hority determines t hat it is necessary to carry out 
the inspection on a reinforced r andomly-selected batch basis. 
For product s applied t o inspection orig inally  belongs to  batch-by-batch 
inspection , the inspection aut hority  may not be restricted by the 
restrictions stipulated in the preceding p aragraph based on it s 
considerations of health and safety .
 
Article 11 Product s applied for inspecti on that bel ong to one of the following 
situations shall be inspected on a r egular randomly-selected batch basis: 
1. Product s do not apply to batch-b y-batch inspection, reinforced  
randomly-selected batch inspection,  certification inspection or 
oversee ins pection. 
2. Product s applied to inspection or iginally belongs to reinforced 
randomly-selected b atch inspec tion, and the same obligatory 
inspection applicant has imported five consecutive batches of such 
product s from the same origin  and CCC Code, and whose labor atory 
examination result s conform to regul ations. However , if the precedin g 
batch before those five consec utive batches of the same obligatory 
inspection applicant fail to conform to regulations, then the quantity of 
these five consecutiv e batches of such product s shall be three times 
greater than the preceding batch of unqualified product s. 
For product s applied to inspection or iginally belongs to reinforced 
randomly-selected batch inspection, the inspection authority  may not be 
restricted by the restrictions sti pulated in the subp aragraph 2 of 
preceding p aragraph based on it s considerations of health and safety .
 
Article 12 If an obligatory inspection applic ant import s product s after failing on-site  
verification for product s belong to  the same origin cou ntry and CCC Code, 
those product s shall be inspected on a batch-by-batch verification basis. 
If three consecutive batches of pr oduct s designated for batch-by-batch 
verification in preceding p aragraph c onform to regulations, and the tot al 
amount reach two ti mes as the pr evious unqualified product s, then the 
same product s for future import c an be exempt from  batch-b y-batch 
verification. 
 
Article 13 The inspection authority may adopt oversee inspection on specific  
product s based on considerations of health and safety . 
 
Chapter 4 Preferential Meas ure for Excellent Industry 
 
Article 14 Import product s belong to following si tuations may apply to the minimum 
inspection rate of normal randomly-selected batch inspection. 
1. Obligatory Inspection Applicant s apply an import s product quality  
assurance project to inspection  authority , and been approved and 
registered by inspection authority , and hav e ten cons ecutive bat ches 
 4of product s pass the randomly-s elected batch inspection within one  
year. 
2. T wenty consecutive batches  of import product s pass the 
randomly-selected batch in spection within one year . 
3. Thirty consecutive batches of i mport product s pass the 
randomly-selected batch inspection within two year . 
Any product applied to minimum ins pection rate in accordance with 
preceding p aragraph failed a border inspec tion or market 
randomly-selected inspection, sha ll ceas e to apply to preferential 
measure in preceding p aragraph.  
 
Article 15 Obligatory Inspection Applicant s import product s in preceding article an d 
all the ins pected product s conform to t he regulations within two (2) years, 
then their future import product s may be inspected on certi fication 
inspection basis in ac cordance with Article 4. 
If necessary , the inspection authority may inspect product s in preceding 
paragraph by on-site verification or sa mpling analysis. If the result is not 
qualified, future import product s of the obligatory ins pection applicant 
cease to apply to the preferential m easures in preceding p aragraph. 
 
Chapter 5 Inspection Operation 
 
Article 16 The samples required for inspec tion may be t aken free-of-charge from the 
Obligatory Inspection Applicant s by the inspection authority , but the 
amount of sampling s hall be lim ited to the requirement of  examination and 
sample retention purposes. 
After collecting the samples, the authority shall iss ue a receipt for  
sampling to the Obligatory Inspection Applicant s. 
 
Article 17 Verifying and sampling of ins pection shall c onduct in the place where the 
product s were stored. If the product s were shipped in full cont ainer load, 
the inspec tion authority may conduct verifying and sampling in the 
centralized inspection area of port. T he Obligatory Inspection Applicant s 
shall cooperate with the inspection authority’ s verifying and sampling 
operation.  
During the sampling in preceding paragraph, Obligatory Inspection 
Applicant s shall not appoint any specific sample. 
 
Article 18 Examination shall be conducted in the order of  sampling. Howev er, the 
inspection authority shall fir st inspect product s that applied for 
re-examination according to these regulations. 
 
Chapter 6 Prior Release 
 
Article 19 Due to requiring five or more days for examination, or sampling of such 
product s is dif ficult in a cont ainer ya rd, or the product i s perishable, af ter 
the obligatory inspection applicant sign an af fidavit of custodial 
responsibility , the inspection authority may issue a Notic e of Prior Release  
for import for customs clearance. Ho wever , for product s designated for 
batch-by-batch inspec tion shall be ret ained at border temporarily . 
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Article 20 Product s that belong to one of the following situatio ns, the inspection 
authority may issue a prior release not ice af ter the obligatory inspection  
applicant p aying a guarantee bond j
1. Product s were belongs to Reinforced randomly-selected batch 
inspection. 
2. Product s were belongs to Oversee inspection and the result is not  
qualified. 
The amount of the guarantee bond in the preceding p aragraph shall be 
twice as the product s DDP  (Delivered Duty Paid) price. 
 
Article 21 Paying the guarantee bond in a ccordance with preceding article by an 
obligatory inspection applic ant shall be  by financial-institutions-issued  
cashier's check or check, or post al order . 
After the product s applied for inspecti on conform to the regulations, and 
no violation of Subp aragr aph 3 of Article 51 of the A ct, the obligatory  
inspection applicant may request the in spection authority to refund the 
guarantee bond. 
 
Chapter 7 Issuance of Certifications 
 
Article 22 After the product s applied for in spection c onform to the regulations, the 
inspection authority shall iss ue a permission notice to the obligatory  
inspection applicant. Obligatory inspec tion applicant may also apply to the 
inspection authority for a written permission notice. 
The obligatory inspection applic ant can cl aim remai ning samples by 
presenting the sampling receipt within 15 days af ter receipt of the notice 
of inspection result s. However , for samples with short shelf life, the 
inspection authority shall dispos e of the samples direc tly. 
 
Article 23 Product s that fail to confor m to the regulations, a notification of  
noncompliance for import food and re levant product s shall be iss ued. 
The obligat ory inspection applicant c an apply for re-examination to the 
original ins pection authority within 15 day s after receipt of the notifi cation 
of result s. Application for re-exami nation is  limited to one time only , and  
shall be performed by t he original ins pection authority using rem aining 
samples for the re-ex amination. 
Remaining samples of product s that do not conform to regulations  shall 
be destroyed at the end of the period of application for re-examin ation. 
 
Article 24 Imported product s that do not co nform to regulations upon inspection shall 
be disposed of in one of the following ways by the obligatory inspection  
applicant: 
1. Return o r destroy . 
2. For product s do not conform to Articl e 22 or Article 18 of this Act, or  
violate Par agraph 1 of Article 21 of th is Act, the obligatory inspection 
applicant may apply to TFDA  for disinf ection, reconditioning or t aking 
the enforcement of appropr iate safety meas ures. 
3. For product s violate Article 22, Article 24, Article 26, Article 27 or  
Paragraph 1 of Article 28 of  this  Act, the obligatory inspection 
 6applicant may apply to TFDA  for relabeling. 
When the obligatory ins pection applicant t akes appr opriate action in 
accordanc e with the Subp aragraph 2 or  3 of the preceding Par agraph, 
the TFDA  may issue a prior release not ice to the obligatory inspection 
applicant for prior release. 
If imported product s that have been releas ed via a prior release notice 
fail an inspection, the inspection authority shall orde r the obligatory 
inspection applicant  to retrieve and t ake appropriate action in 
accordanc e with the provisions of Paragraph 1 of this Article. 
 
Chapter 8 Other Regulations of Inspection 
 
Article 25 If an obligatory inspection appli cant import product s belong to the same 
origin cou ntry and CCC Code, an d its inspec tion result s do not conform to 
regulations  for two ti mes within si x months, the TFDA  may require the  
obligatory inspection applicant to prov ide written document  before a given 
date, to explain the reasons fo r non-conformance, and a pr oposed  
improvement plan with prevent ative measures. 
If product s belong to the same orig in coun try and CCC Code, and it s 
inspection result s do not conform to regulations for three times within six 
months, the TFDA  may require the gov ernment of the exporting country 
to provide written docum ent before a given date, to explain the reasons  
for non-conformance, and a propos ed improvement plan with 
prevent ative measures. 
 
Article 26 If the obligatory inspection ap plicant or government of the exporting 
country/area fails to provide writt en docum ent before the given date or 
after receiving the notification ment ioned in the preceding article and 
following imported product s applied for re-examin ation still do not conform 
to regulations, the TFDA  may tem porarily suspend the inspection 
application of related industry , country of origin and product s. 
 
Chapter 9 Supplement ary Provisions 
 
Article 27 When conducting on-site inspec tions according to the regulations , 
inspectors shall carry their identification document s with them. 
 
Article 28 Except for Article 20 and 21 that were amended in January 27 2014 come 
into enforcement from June 19 2014, the other provisions shall c ome into 
enforcement from the date of promulgation.  
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