1 Regulations of Imported Inspection for Foods and 
Related Products 
 
Chapter 1 General Principles 
Article 1 The regulations are d uly enacted in accordance with P aragraph 3 of 
Article 33 of the Act Governing Food Sanitation (hereinafter “t he Act”). 
Article 2 The inspec tion and declaration o f imported food, food  additives, food 
utensils, food containers, food pa ckaging or food cleansers, an d other 
related products (hereinafter "p roducts"), or consignment of su ch 
inspection and declaration, preferential measures of inspection  and 
declaration for registered exce llent industry, prior release qu alification, 
inspection, margin collecting , and other compulsory rules, shal l be 
performed accordance wit h the regulations. 
Article 3  The terms herein are defined as follows: 
1. Obligatory Inspection Applic ant: Business who imports food p roducts.  
2. Inspection Authority: The cent ral competent authority or its  
commissioned organization or institution. 
3. On-site Inspection: On-site check product name, specificatio n and 
package of products applied for inspection. 
4. Sampling and Analysis: The ins pection authority take samples  and 
send to laboratories to conduct sensory, chemical, biological, or 
physical examination. 
 Chapter 2 Application for Inspection 
Article 4 The Obligatory Inspec tion Applicant or Representative  shall file an 
application for inspection to the inspection authority at the p ort of entry 
within fifteen days prio r to the entry date. 
If the representative files the application, an identification document for 
the representative shall be provided. 
Article 5 Any entity, who underta kes application and declaratio n agent as 2 business, shall submit its broker license, business license and  
identification documents to the inspection authority for future  reference.  
If the inspection authority disco vers any failure to declare fu ll and 
accurate product information, the inspection authority may temp orarily 
suspend the agent's application a nd declaration agent business for six 
months period. 
Article 6 Obligatory Inspection Applicants shall submit the fol lowing documents to 
the inspection authorit y for inspection: 
1. An application form for inspection. 
2. A declaration form o f product information. 
3. A photocopy of application for import declaration. 4. Necessary certificates requi red by the inspection authority.  
The inspection authority may requi re Obligatory Inspection Appl icants to 
provide other necessary certifi cates for its inspection needs. The 
Obligatory Inspection Applicants shall not evade, obstruct or r efuse. 
Article 7 Products for inspection  application in the same shipm ent shall have the 
same import declaration 、 CCC code 、 p roduct name 、 ingredients 、 brand 、
producer and country of origin. H owever, the inspection authori ty may 
permit the applicant to apply different products in one inspect ion 
application. 
Article 8 For any Obligatory Ins pection Applicant belong to one  of the following 
situations, the competent authorit y shall dismiss his/her appli cation for 
inspection: 1. Applicants fail to apply an inspection application pursuant to Article 6 
of this regulation. 
2. Incorrect inspection applicat ion form、product information de claration 
form、 or other related form， or fail to fill in information req uired by 
relevant provisions. 
 Chapter 3 Inspection Procedures 3 Article 9 In addition to review documents as prescribed in Arti cle 6, the inspection 
authority may proceed product ins pection with the following mea sures: 
1. Batch-by-batch inspection: In spect each submitted batch of p roduct 
by on-site inspection a nd sampling analysis basis. 
2. Randomly-selected batch inspe ction: Randomly select each 
submitted batch of product by fo llowing inspection rate, and in spect 
the chosen product by on-site ins pection and sampling analysis.  
(1)Regular randomly-selected batch  inspection: The inspection i s 
performed based on a 2-10% inspection rate. 
(2)Reinforced randomly-selected batch inspection: The inspectio n is 
performed based on a 20-50% inspection rate. 
3. Batch-by-batch verification : On-site inspect each submitted batch of 
product. 
4. Certification inspection: Doc ument inspection for products t hat 
produced by the compet ent-authority-regist ered excellent indust ry 
and foreign manufacturer. 
5. Oversee inspection: For specif ic products, each submitted ba tch of 
product shall be inspected by in-site inspection and 
randomly-selected batch inspecti on basis. For those products no t be 
selected in randomly-selected bat ch inspection, the inspection 
authorize may exam extra by in-s ite inspection and in-site insp ection 
basis; For products be designated for batch-by-batch inspection , the 
inspection authorize may exam e xtra by randomly-selected batch 
inspection basis. 
For the abovementioned inspections, verification, and certifica tion, if 
necessary, the inspection authorit y shall take samples of an ap propriate 
amount to conduct sensory, chemical, biological, or physical la boratory 
examination. 
Article 10 Products applied for inspection that belong to one o f the following 
situations shall be inspect ed on a batch-by-batch basis: 4 1. Products proved to cause harm to humans according to domesti c and 
foreign product safety informa tion or scientific evidence. 
2. Products designated for batch -by-batch inspection are listed  in the 
annual inspection plan fo r imported products. 
3. Products with the same origi n and commodity classification c ode of 
the Republic of China (hereafter referred to as ‘CCC Code’) as 
preceding batches of products  belonging to reinforced 
randomly-selected batch inspec tions of the same obligatory 
inspection applicant, and whose inspection results do not confo rm to 
regulations. 
4. The inspection authority in c onsideration of health and safe ty, 
determine that it is necessary to  carry out the inspection on a  
batch-by-batch basis. 
Prior to the completion of the batch-by-batch inspection proced ures for 
the preceding batch, the batches r e-applied for inspection to s uch batch 
of products shall be subject to i nspection on a batch-by-batch basis. 
Article 11 Products applied for inspection that belong to one o f the following 
situations shall be inspected on a reinforced randomly-selected  batch 
basis: 
1. Products designated for rein forced randomly-selected batch 
inspection are listed in the annual inspection plan for importe d 
products. 
2. Products applied for inspecti on originally belongs to batch- by-batch 
inspection, and the same obligat ory inspection applicant has 
imported five consecutive batc hes of such products from the sam e 
origin and CCC Code, and whose l aboratory examination results 
conform to regulations. However,  if the preceding batch before these 
five consecutive batches of the sa me obligatory inspection appl icant 
failed to conform to regulatio ns, then the quantity of these fi ve 
consecutive batches of such products shall be three times great er 5 than the preceding batch  of unqualified products. 
3. Products with the same ori gin and CCC Code as preceding batc hes 
of products belonging to regular  randomly-selected batch inspec tion 
of the same obligatory inspecti on applicant, and whose inspecti on 
results do not conform to regulations. 
4. The inspection authority, out o f considerations of health an d safety, 
determine that it is necessary to  carry out the inspection on a  
reinforced randomly-selected batch basis. 
For products applied for inspecti on originally belongs to batch -by-batch 
inspection, the inspection authorit y may not be restricted by t he 
restrictions stipulated in t he preceding paragraph based on its  
considerations of health and safety. 
Article 12 Products applied for inspection that belong to one o f the following 
situations shall be inspected on a regular randomly-selected ba tch 
basis: 
1. Cases not as described in Art icle 10 and preceding article. 
2. Products applied for inspecti on originally belongs to reinfo rced 
randomly-selected batch inspecti on, and the same obligatory 
inspection applicant has imported five consecutive batches of s uch 
products from the same origin and CCC Code, and whose laborator y 
examination results c onform to regulations. 
However, if the preceding batch before those five consecutive b atches 
of the same obligatory inspecti on applicant fail to conform to regulations, 
then the quantity of these five c onsecutive batches of such pro ducts 
shall be three times greater t han the preceding batch of unqual ified 
products. For products applied for inspec tion originally belongs to reinf orced 
randomly-selected batch inspecti on, the inspection authority ma y not be 
restricted by the restrictions  stipulated in the subparagraph 2  of 
preceding paragraph based on its c onsiderations of health and s afety. 6 Article 13 If an obligatory in spection applicant imports produc ts after failing on-site 
inspection for products belong to t he same origin country and C CC 
Code, those products shall be inspected on a batch-by-batch ver ification 
basis: 
If three consecutive batches  of products designated for batch-by-batch 
verification in preceding par agraph conform to  regulations, and  the total 
amount reach two times as the pr evious unqualified products, th en the 
same products for future import can be exempt from batch-by-bat ch 
verification. 
Article 14 The inspection authorit y may adopt oversee inspectio n on specific 
products based on considerat ions of health and safety. 
 
Chapter 4 Excellent Industry and Preferential Measure 
Article 15 The Obligatory Inspec tion Applicants shall apply for  pre-declaration of 
product information to the inspec tion authorities. Documents re ferred to 
in subparagraph 2 of paragraph 1 o f the preceding article for t hose who 
acquired approval of documents fr om inspection authorities, sha ll be 
exempt from being submitted on application of inspection. 
Term of validity for the precedi ng approval document is two yea rs. 
If products applied for inspection  are not conformant with the 
pre-declaration of product informa tion, the inspection agencies  shall 
abolish all approval doc uments issued to Obligatory Inspection 
Applicants, and suspend their app lications for pre-declaration of product 
information within one year. 
Article 16 Import products bel ong to following situations may a pply to the minimum 
inspection rate of normal random ly-selected batch inspection. 
1. Obligatory Inspection Applic ants apply an imports product qu ality 
assurance project to inspection au thority, and been approved an d 
registered by inspection authorit y, and have ten consecutive ba tches 
of products pass the randomly-sel ected batch inspection within one 7 year. 
2. Obligatory Inspection Applic ants import products belong to t he same 
origin country and CCC Code, and have twenty consecutive batche s 
of products pass the randomly-sel ected batch inspection within one 
year. 
3. Obligatory Inspection Applic ants import products belong to t he same 
origin country and CCC Code, and have thirty consecutive batche s 
of products pass the randomly-sel ected batch inspection within two 
year. 
Article 17 Obligatory Inspecti on Applicants import products in proceeding article, 
and all the inspected products c onform to the regulations, then  their 
future import products may be in spected on certification inspec tion 
basis. 
The inspection authority may in spect products in preceding para graph 
by on-site inspection or randomly -selected batch inspection bas is. If the 
result is not qualified, futur e import products of the obligato ry inspection 
applicant cease to apply to the pr eferential measures in preced ing 
paragraph. 
 
Chapter 5 Inspection Operation Article 18 The samples required  for inspection may be taken fre e-of-charge from 
the Obligatory Inspection Applicants by the inspection authorit y, but the 
amount of sampling shall be limi ted to the requirement of exami nation 
and sample retention purposes. Afte r collecting the samples, th e 
authority shall issue a receipt for sampling to the Obligatory Inspection 
Applicants. 
Article 19 Checking and samplin g of inspection shall conduct in  the centralized 
inspection area of port and t he storehouse, Obligatory Inspecti on 
Applicants shall cooperate with th e inspection authority’s chec king and 
sampling operation. 8 During the sampling in precedi ng paragraph, Obligatory Inspecti on 
Applicants shall not appoi nt any specific sample. 
Article 20 Examination shall be conducted in the order of sampl ing. However, the 
inspection authority shall fi rst inspect products that applied for 
re-examination according to these regulations. 
 
Chapter 6 Prior Release 
Article 21 Due to requiring five o r more days for examination, or sampling of such 
products is difficult in a container yard, or the product is pe rishable, after 
the obligatory inspection applic ant sign an affidavit of custod ial 
responsibility, the inspection aut hority may issue a Notice of Prior 
Release for import for custom s clearance. However, for products  
designated for batch-by-batch i nspection shall be retained at b order 
temporarily. 
Article 22 In the case of pr oducts belongs to Reinforced random ly-selected batch 
inspection, if the obligatory inspection applicant apply to ins pection 
authority for prior release in  accordance with preceding articl e, the 
obligatory inspection applican t shall pay a guarantee bond at t he same 
time with application. And t he amount of the guarantee bond sha ll be 
twice as the products CIF price. 
Article 23 Paying the guarant ee bond in accordance with precedi ng article by an 
obligatory inspection applican t shall be by promissory notes, c hecks 
issued by financial institutions  deposits or postal orders. 
After the products applied for in spection conform to the regula tions, and 
no violation of Paragraph 2 of A rticle 33 of the Act, the oblig atory 
inspection applicant may request the inspection authority to re fund the 
guarantee bond. 
Chapter 7 Issuance of Certifications 
Article 24 After the products appl ied for inspection conform to  the regulations, the 
inspection authority shall iss ue a permission notice to the obl igatory 9 inspection applicant. Obligatory inspection applicant may also apply to 
the inspection authority for a written permission notice. 
The obligatory inspection applican t can claim remaining samples  by 
presenting the sampling receipt within 15 days after receipt of  the notice 
of inspection results. However, fo r samples with short shelf li fe, the 
inspection authority shall dis pose of the samples directly. 
Article 25 Products that fail to  conform to the regulations, a notification of 
noncompliance for import food an d relevant products shall be is sued. 
The obligatory inspection applic ant can apply for re-examinatio n to the 
original inspection authority wit hin 15 days after receipt of t he 
notification of results. Applicat ion for re-examination is limi ted to one 
time only, and shall be performed by the original inspection au thority 
using remaining samples for t he re-examination. If the remainin g 
samples of food utensils, food co ntainers, food or packaging ar e 
insufficient for re- examination,  the inspection authority may re-sampling 
in accordance with Article 18. 
Remaining samples of products th at do not confo rm to regulation s shall 
be destroyed at the end of the pe riod of application for re-exa mination. 
Article 26 Imported products that  do not conform to regulations  upon inspection 
shall be disposed of in one of t he following ways by the obliga tory 
inspection applicant: 
1. Returned or destroyed. 
2. Reconditioning, disinfection or  taking the enforcement of ap propriate 
safety measures approved by t he inspection authority. 
3. Relabeling approved by t he inspection authority. 
When the obligatory inspection applicant takes appropriate acti on in 
accordance with the Subparagraph 2 or 3 of the preceding Paragr aph, 
the inspection authority may issue a prior release notice to th e obligatory 
inspection applicant. If imported products that have been released via a prior releas e notice 10 do not conform to regulations m entioned in the paragraph 1, the  
inspection authority shall or der the obligatory inspection appl icant to 
retrieve and take appropriate act ion in accordance with the pro visions of 
Paragraph 1 of this Article. 
 Chapter 8 Other Regulati ons of Imported Food Product 
Article 27 Products applied for inspection that belong to one o f the following 
situations, the competent author ity may require the obligatory inspection 
applicant or government of the ex porting country to provide wri tten 
document before a given date, t o explain the reasons for 
non-conformance, and a proposed im provement plan with preventat ive 
measures: 
1. Obligatory inspection applican t import products belong to th e same 
origin country and CCC Code, and its inspection results do not conform to regulations for tw o times within six months. 
2. Products, and whose inspection  results do not conform to reg ulations 
for three times within six months. 
Article 28 Imported products that  do not conform to regulations  upon inspection 
shall be disposed of in one of t he following ways by the obliga tory 
inspection applicant: 
1. Return or destroy. 
2. Disinfection, reconditioning or taking the enforcement of ap propriate 
safety measures approved by the inspection authority within a l imited 
time period. 
3. Relabeling approved by the in spection authorit y within a lim ited time 
period. 
When the obligatory inspection ap plicant takes appropriate acti on in 
accordance with the Subparagraph 2 or 3 of the preceding Paragr aph, 
the inspection authority may issue a prior release notice to th e obligatory 
inspection applicant for prior release. 11 If imported products that have been released via a prior releas e notice 
do not conform to regulations m entioned in the paragraph 1, the  
inspection authority shall or der the obligatory inspection appl icant to 
retrieve and take appropriate act ion in accordance with the pro visions of 
Paragraph 1 of this Article. 
 
Chapter 9 Supplementary Provisions 
Article 29 When conducting on-site  inspections according to the  regulations, 
inspectors shall carry their i dentification doc uments with them . 
Article 30  Except for Article 22 and 23 come into enforcement from June 21 2014, 
the other provisions shall come  into enforcement from the date of 
promulgation.