1 
 Proposal for Legal Inspection of  Masks Claiming Protection against PM 2.5  
 
By the Bureau of Standards, Metrology and Inspection (BSMI), Ministry of Economic Affairs  
 
Background:  
In response to the requests from consumers for regulating masks claiming prote ction against PM 
2.5 to ensure effective protection of consumer health from exposure to particles in air pollution, 
the Bureau of Standards, Metrology and Inspection (BSMI) proposes to require that masks, both 
domestically produced and imported, claiming p rotection against PM 2.5 be subject to mandatory 
inspection before they are placed on the market. The conformity assessment procedure will be 
Declaration of Conformity.  
 
Proposed date of implementation:  1 March  2019 
 
Products (HS/CCCN codes) covered and th eir applicable inspection standard s: 
HS/CCC Code  English Name  Inspection standard  Inspection Scheme  
6307.90.50.10.6  PM 2.5 M asks CNS 15980  Declaration of 
Conformity  
6307.90.50.20.4  
Remarks :  
1. The obligatory inspection applicant should keep the declara tion of conformity and technical file for at least five 
years after the commodity is no longer produced or imported.  
2. The obligatory inspection applicant should keep  the declaration in his business place and present it in 24 hours 
upon request by the BSMI d uring market check s. The technical file shall be provided  in ten work ing days.  
3. The fee for applying for identification number under the Declaration of Conformity procedure is charged in 
accordance with the Regulations Governing Fees for Commodity Inspectio n. 
4. The inspection  standards can be accessed  at the CNS online service  website : www.cnsonline.com.tw . You can 
preview the content of these standards for free. If you need  to download  and print  the standards , plea se contact 
our Information Center.  
Tel: +886 -2-23414772 or +886 -2-23431994  
Fax: +886 -2-8192 -6746  
E-mail: cnsonline@hibox.hinet.net   
 
Inspection standards:  
CNS 15 980 
 
Declaration of Conformity  (DoC ): 
The D oC announced by the BSMI to be applicable to certain products allows the manufacturer to have the 
testing done by laboratories on his choice from laboratories designated by the BSMI, to prepare the 
technical documents on his own, and to draw up the declara tion declaring the conformity of his products 
with relevant standards. These products are placed under market surveillance conducted by the BSMI.  
 
Locations to apply for Type Testing:  
The test for the commodities listed in the table should be conducted by the Bureau of Standards, Metrology 
and Inspection, Ministry of Economic Affairs , or its designated  laboratories.  
 
Related requirements : 
The technical file shall include the followings :   
(1) Description of the commodity . 
a. commodity configuration, materials a nd the rank of particle protective performance . 
b. commodity catalogue and color photos with 4*6 inches and above.    
c. summary of specifications.  
(2) One original copy of the test report . 
(3) A classification  table of product types.  2 
 (4) Summary of manufacturing proce ss. 
(5) The control me asures of manufacturing process  or other certifying documents.  
(6) Specimen of labelling in Chinese . 
(7) A test report and instruction manual, if the product is to be labelled as sterilized by ethylene oxide.  
(8) Other technical documents required . 
(9) Documents mentioned above, such as the description of commodity, summary of manufacturing, 
control measures of manufacturing processes and other technical documents required by be provided in 
electronic format.