1 
 Regulations of the Health Risk Assessment Review  of Designated 
Tobacco Products  
Tobacco Hazards Prevention Act  (hereinafter referred to as “this Act ”) has been  
promulgat ed and amended  under Presidential Order  No. 11200010211  on February 15 , 2023 . 
Paragraph 1 of A rticle 7 of this Act stipulate s that tobacco products  designat ed by the central 
competent authority  (hereinafter referred to as “the products ”) shall be submitted by the 
manufacturers and/or importers to the central competent authority for  application for the  
health risk assessment  review and granted by the central competent authority  before 
manufacturing or importing  the products . Paragraph  2 of Article  7 of this Act  stipulates that 
if new health risk (s) related to  the tobacco products that have been declared to the central 
competent authority  is/are discovered , the central competent authority may designate the 
tobacco products as the products  that shall be submitted for  application for the  health risk 
assessment  review  within a specified period of time and order the recall  of the products  and 
suspension from  manufacturing or importing the products within a  specified period of time. 
If the  products are not granted by the central competent authority under the  health risk 
assessment  review , the ce ntral competent authority shall  order the recall or destruction  of the 
products within a period of time  and prohibit  the manufac ture and/or importation o f the 
products . To provide legitimate grounds for the application  and review, the  regulations of 
the health risk assessment review are stipulated  in pursu ant to the authorization under 
Paragraph 3  of Article  7 of this Act, and the main points are as follows :  
1) The source of law for these regulations  (Article 1).  
2) The obligor and time limit  of and exemption from  the submission of  the products  for 
application for  the health risk assessment  review  (Article 2 ).  
3) The application form, documents and data that shall be submitted by the  manufac-
turer s or importer s of the product s (Article 3).  
4) The methods by which the central competent authority conducts health risk assess-
ment  review  (Article 4).  
5) The circumstance s in which the applica tion for  the health risk assessment  review 
shall be deni ed (Article 5).  
6) The central competent authority may require the manufacturer s and/or importer s of 
the product s which have been granted by the central competent authority under the 
health risk assessment review  to submit post -market monitoring and control mecha-
nisms (Article 6).  
7) The amount of the fee for applying  for the health risk assessment  review  is deter-
mined by the central competent authority ( Article 7).  
8) The products that are denied under the health risk assessment review shall not be 
submitt ed by the same applicant for  application for the health risk assessment review 
within one year  (Article 8).    
 
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 9) The application form required in these Regulations shall b e promulgated by the cen-
tral competent authority  (Article 9 ).  
10) The central competent authority may authorize related professional institutions, 
agencies, legal persons or groups to execute the tasks in these Regulations  (Article 
10).  
11) The effective  date of these regulations  (Article 11).  
   
 
3 
 Regulation s of the  Health Risk Assessment s Review  of 
Designated Tobacco Products  
Article 1  
These Regulation s are stipulated  in accordance with the provisions of Paragraph 3  of 
Article 7 of Tobacco Hazards Prevention Act ( hereinafter referred to as “this Act ”). 
Article 2  
Designated  tobacco products ( hereinafter referred to as “the p roducts ”) shall be submitted 
by the manufacturer s and/or importer s (hereinafter referred to as “the applicants ”) to the 
central  competent authority for  application for  the health risk assessment  review  before 
manufacturing and/or importing the products or within the time limit specified by the 
central competent authority under Paragraph 2  of Article 7 of th is Act. The products  with 
research or test plan s, not in commercial ized packaging , not for sale,  and their volume  not 
exceed ing the required volume for research or test  are not subject to these regulations .  
The application  in the preceding P aragraph  shall be submitted by the imp orter s if the 
products are manufactured abroad .  
Article 3  
The application  in the preceding A rticle shall be submitted with the application  form  
promulgated  by the central competent authority and the following documents and data of 
the products :  
(1) Health risk research data which have been  published or known to , or which should 
reasonably be known to,  the applicants  and health risk compar ison results  with other 
tobacco products;  
(2) Data on raw materials, additives, and other relevant ingredients;  
(3) Data on emissions;  
(4) Data on the methods for testing the substances  in Subparagraph 2 and 3 of this Para-
graph ; 
(5) Processing methods;  
(6) Research  data on addiction  of the users ; 
(7) Research  data on that people younger than  20 years  of age  and first -time smokers  are 
induced to use the products ; 
(8) Nicotine and tar  yields  in emissions of the minimum  usage unit ; 
(9) Sample s of the products and  essential  components  and safety statement s for use;  
(10) Safety certification documents and /or data issued by certified laboratories  in accord-
ance with relevant national standard s; 
(11) Documents and/or data on the countries, the dates and the volumes that the products 
are granted for sale;  
(12) Specific measures , implementation methods and the commitments  for the monitoring 
and control  mechanism s of tobacco hazards ; and  
(13) Other documents and /or data  designated by t he central competent authority.  
The documents and /or data in the preceding Paragraph , except for figures, shall be 
submitted in Traditional Chinese, and annota ted in English whe re necessary.  
Where the documents and /or data required in Paragraph 1 are incomplete, the central 
competent authority shall order the  applicants  to supplement the  documents and/or   
 
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 data once and for all . If the documents and/or data are not  supplemented within the 
specified  time limit, the application shall be rejected.  
International standards approved by the central competent authority may substitute 
for the national standards in Subparagraph 10 of Paragraph 1 before the national 
standards are promulgated .  
Article 4  
The central competent authority shall invite  and assemble  experts and scholars in public 
health, health policy , toxicology, and other relevant fields to conduct the health risk 
assessment  review .  
The review in the preceding Paragr aph may refer  to the relevant health risk assessment  
reviews and post -market  monitoring  and control mechanisms for the p roducts in other 
countries, as w ell as other relevant regulatory  measures.  
Article 5  
The application of the  health risk assessment  review of the products  shall  be deni ed if any 
one of the following circumstances occur:  
(1) Insufficient  data to prov e that the health risks of the p roducts are no t higher than the 
cigarettes present in the domestic market;   
(2) Any circumstance prohibited by th is Act;   
(3) Any emerging eviden ce which prove s the obvious  health impact ; and 
(4) Any circumstance in conflict with the  announcement s of the central competent author-
ity.  
Article 6  
The c entral competent authority may  require the applicant to implement  and submit  
information of  the following post -market monitoring and control mechanism s for the 
products that have been granted under  the health risk assessment  review :  
(1) Ongoing or completed research es on the use of the p roducts by consumers and the 
findings;  
(2) Information on sales of the p roducts and consumer complaints;  
(3) Information on  the use of the products  of current and first -time smokers;  
(4) Any change in  manufacture  process or composition of  the p roducts;  
(5) Adverse event reporting, analysis, and response mec hanisms;  
(6) Newly discovered data on addiction;  
(7) Information on adverse events  of health  occurring abroad; and  
(8) Other necessary monitoring and control mechanisms.  
If the applicants  fail to comply with the provisions  in the preceding Paragraph , the central 
competent authority shall order the applicants  to take rectification  within a  specified pe-
riod of time . If no rectification is taken within the  time limit , the authorization for the 
products under the health risk assessment review shall be ab olished .  
Article 7.  
The applicants of the  health risk assessment  review  shall pay  the fee ; the amount  of the 
fee shall be determin ed by the central competent authority.  
Article 8  
The p roducts  that are deni ed under the  health risk assessment  review shall not be submitted   
 
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 by the same applicant for  application for the health risk assessment review  within one year 
since the arrival of the denial order .  
Article 9  
The application form  required in these Regulations shall be promulgated  by the central 
competent authority.  
Article 10  
The central competent authority may authorize related professional institutions, agencies, 
legal persons or groups to execute the tasks in these Regulations .  
Article 11  
The effective  date of these Regulations shall be determin ed by the central competent 
authority.