Working Standards for Environmental Agent Permit 
Application and Issuance Draft Amendment Table of 
Comparison  
Amended  Current  
Article 1  These Standards are determined 
pursuant to Article 10, Paragraph 1 
of the Environmental Agents 
Control Act (hereinafter  referred to 
as the “Act”).  Article1  These Standards are determined 
pursuant to Article 10, Paragraph 1 
of the Environmental Agents Control 
Act (herein referred to as this Act).  
Article 2  Manufacturers, processors, or 
importers of environmental agents 
shall apply for permits and permit 
documents in accordance with these 
standards.   
Article 3 Manufacturers, processors, or 
importers of environmental agents  
shall submit application forms and 
documentary proof and data as 
specified in Attachment 1  to apply 
for a permi t from the central 
competent authority.  
Applicants using natural insect 
repelling substances as 
environmental agents shall submit 
application forms and documentary 
proof and data as specified in 
Attachment 2 to apply for a permit 
from the central competent  
authority. However, natural 
substances with natural pyrethrum 
extracts must be processed pursuant 
to the previous paragraph.  Article6  Applications for environmental 
agent licenses, including extensions, 
modifications, replacements, and 
renewals should be made to the central 
competent authority and should include 
application forms and supporting 
documentation and materials 
(Attachment 3). Such applications should 
be made online as prescribed by the 
central competent authority. This 
restriction shall not app ly, however, if the 
central competent authority agrees to 
permit written applications. This 
restriction shall not apply, however, when 
the central competent authority has 
granted its consent.  
Article 4  The application specified in the 
previous article sha ll be  submitted 
through the Internet. This restriction 
shall not apply, however, if the 
central competent authority agrees 
to permit written applications.  Article6  Applications for environmental 
agent licenses, including extensions, 
modifications, replacem ents, and 
renewals should be made to the central 
competent authority and should include 
application forms and supporting 
documentation and materials 
(Attachment 3). Such applications should 
be made online as prescribed by the 
central competent authority. T his 
restriction shall not apply, however, if the 
central competent authority agrees to 
permit written applications. This 
restriction shall not apply, however, when 
the central competent authority has 
granted its consent.  
Article 5 Full Chinese translation s shall be 
provided if the documentary proof 
submitted according to Articles 3, Article6 If the documentation referred to in 
the foregoing paragraph is in a language 
other than Chinese, the complete Chinese 16, and 17  are foreign language 
documentary proof; if the submitted 
data is in a foreign language, 
applicants must complete the 
application in Chinese in according 
to the forma t and contents of the 
application form, and attach 
relevant information on the original 
manufacturer.  translation of said documen tation must 
be attached; applications shall be filled 
out in Chinese, and information about the 
original manufacturer attached.  
Article 6 Applications for environmental 
agent permits and permit documents  
handled by the central competent 
authority shall be  reviewed in 
accordance with the following rules:  
I. In the event  the submitted 
document ary proof or data is 
incomplete or does not comply 
with regulations, if the 
applicant has failed to properly 
submit or correct the materials 
by the deadline after being 
notified to do so, or if the 
applicant has performed more 
than three rounds of correction, 
the application shall be 
rejected. Each correction 
period shall be limited to 60 
days.  
II. The application shall be 
summarily rejected in the event  
the review fee has not been 
paid in accordance with 
regulations.  
III. Applications with documents 
or data that contain false or 
misleading information shall be 
rejected.  
IV. Applications regarding 
chemical repellent agents for 
human use shall be jointly 
reviewed in consultation with 
the MOHW.  Article18 Applications for environmental 
agent permits handled by the central 
competent authority shall perform checks 
according to the following rules:  
I. When the submitted verifying documents 
or information is incomplete or does not 
comply with re gulations, if the applicant 
has failed to properly submit or correct 
the materials by the deadline after being 
notified to do so, or if the applicant has 
performed more than three rounds of 
correction, the application shall be 
rejected. Each correction per iod shall be 
limited to 60 days.  
II. The application shall be summarily 
rejected when the review fee has not 
been paid in accordance with 
regulations.  
Article 7 Environmental agents that fulfill 
any of the following criteria shall be 
considered special en vironmental 
agents:  
I. Agents that require specialized 
safety precautions for their use.  
II. Agents that require sprayers, 
fumigators, foggers, sterilizers, 
ultra-low volume (ULV) 
sprayers, or other application 
equipment for their use.  Article2  Environmental agents that me et 
any of the following criteria shall be 
considered special environmental 
agents:  
I. Agents requiring specialized 
safety precautions for their use.  
II. Agents that require sprayer, 
fumigators, foggers, sterilizers, 
ultra-low volume (ULV) 
sprayers, or other appli cation 
equipment for their use.  III. Environmental germicides wi th 
active ingredient 
concentrations exceeding the 
limits listed in Attachment 3. 
IV. Dosage forms of germicides 
used for environmental 
sanitation not listed in 
Attachment 3 and with active 
ingredient concentrations of 
5% and above.  III. Environmental germicides with 
active ingredient concentrations 
exceeding the limits listed in 
Attachment 2.  
IV. Application types of germicides 
used for environmental 
sanitation not listed in 
Attachment 2 and that have 
active in gredient concentrations 
above 5%.  
Article 8 Environmental agents with 
particular characteristics may be 
restricted with respect to category, 
product type, name, content volume, 
dosage form, component and 
content, performance, and 
applicable scope or meth od of use.  
Bitterant additives must be added to 
general environmental agents and 
rodenticideds. This does not apply, 
however, to agents with particular 
characteristics.  Article5  Environmental agents with 
special qualitites may be limited with 
respect to ca tegory, product type, name, 
volume of content, type of application, 
components and component content, 
performance, and scope and method of 
use, 
General use rodenticides shall use a 
bitterant additive. However, specialized 
rodenticides are not subject to th is 
restriction.  
Article 9 The first time an active component 
of an environmental agent or 
microbial preparation used as an 
environmental agent is registered as 
an environmental agent in Taiwan, 
licensing or registration materials 
from the competent author ity of any 
developed country shall be 
provided. Chemical agents 
developed in Taiwan are not subject 
to this restriction.  Article7  The first time an active 
component of an environmental agent or 
microbial preparation used as an 
environmental agent is regist ered as an 
environmental agent in Taiwan, licensing 
or registration materials from the 
competent authority of any developed 
country shall be provided. Chemical 
agents developed in Taiwan are not 
subject to this restriction.  
Article 10 Applicants seeking t o import 
environmental agents shall submit 
the following signed 
documentation from the Republic 
of China representative authority 
stationed overseas:  
I. Proof of permission to 
manufacture and sell said 
environmental agent from the 
competent authority in the 
country of origin.  
II. Authorization to act as a sales 
agent.  
If the competent authority in the country 
of origin has issued manufacture 
documents for export only in 
Subparagraph 1 of the foregoing 
paragraph, production registration or 
permit issued by any deve loped country 
shall be provided. If there is no system Article8  Applicants seeking to 
import environmental agents shall submit 
signed documentation from the Republic 
of China repr esentative authority 
stationed overseas:  
I. Proof of permission to manufacture 
and sell said environmental agent from 
the competent authority in the country of 
origin.  
II. Authorization to act as a sales agent.  
If the competent authority in the country 
of origin has issued manufacture 
documents for export only in 
Subparagraph 1 of the foregoing 
paragraph, production registration or 
permit issued by any developed country 
shall be provided. If there is no system 
for such permits in the country of origin 
as re quired, the proof of permission to 
manufacture may be used instead as for such permits in the country of origin 
as required, the proof of permission to 
manufacture may be used instead as 
proof that said environmental agent is 
not listed for control by the competent 
autho rity in the country of origin.  
In the event  there is no system for such 
permits in the country of origin nor any 
verification documents provided by the 
relevant competent authority, applicants 
shall provide verification documents for 
the manufacture and sa le of said 
environmental agent from the relevant 
product management agency or 
institution, or verification documents that 
the product is already being sold and 
used as a commercial environmental 
agent in the country of origin or in 
countries outside the co untry of origin. 
Said documents need not be submitted to 
Republic of China overseas 
representative offices for signed 
verification.  proof that said environmental agent is 
not listed for control by the competent 
authority in the country of origin.  
When there is no system for such permits 
in the country of origin nor a ny 
verification documents provided by the 
relevant competent authority, applicants 
shall provide verification documents for 
the manufacture and sale of said 
environmental agent from the relevant 
product management agency or 
institution, or verification doc uments that 
the product  is already being sold and 
used as a commercial environmental 
agent in the country of origin or in 
countries outside the country of origin. 
Said documents need not be submitted to 
Republic of China overseas 
representative offices fo r signed 
verification.  
Article 11 The following documents from 
Mainland China region shall first 
be notarized by Mainland China 
notary authorities, and then 
authenticated by the organization 
or civic group established or 
designated by the Mainland 
Affairs  Council, Executive Yuan.  
I. Proof of permission to 
manufacture and sell said 
environmental agent from the 
competent authority in the 
Mainland China region.  
II. Authorization to act as a sales 
agent.  
III. Photocopy of formal 
registration document issued 
by Mainland Ch ina region 
competent authority  
IV. Toxicity testing report  
V. Efficacy (potency) testing 
report  
VI. For environmental agents not 
regulated in the Mainland 
China region, verification 
documents from the relevant 
product management agency or 
institution, or verification  
documents that the product is 
already being sold and used as Article9  The following documents 
from Mainland China region should first 
be notarized by Mainland China notar y 
authorities, and then authenticated by the 
organization or civic group established or 
designated by the Mainland Affairs 
Council, Executive Yuan.  
I. Proof of permission to manufacture 
and sell said environmental agent from 
the competent authority in the Mainland 
China region.  
II. Authorization to act as a sales agent  
III. Photocopy of formal registration 
document issued by Mainland China 
region competent authority  
IV. Toxicity testing report  
V. Efficacy (potency) testing report  
VI. For environmental agent s not 
regulated in the Mainland China region, 
verification documents from the relevant 
product management agency or 
institution, or verification documents that 
the product is already being sold and 
used as a commercial environmental 
agent in the Mainland C hina region or in 
other countries.  a commercial environmental 
agent in the Mainland China 
region or in other countries.  
Article 12 Environmental agent permits shall 
specify the following items:  
I. Permit number.  
II. Name, address and statutory 
responsible person of 
company.  
III. Name and address of 
manufacturing plant.  
IV. Types and categories of 
environ mental agents.  
V. Product names.  
VI. Product validity period.  
VII. Performance data.  
VIII. Dosage form and package 
volume.  
IX. Composition and contents.  
X. Permit date and validity 
period.  
XI. Other items designated by the 
central competent authority.  
Barring the aforementioned specif ied 
registrations, the permit document 
shall also document the source 
location of raw materials.  Article17  Environmental agent permit 
documents shall include the following 
items:  
I. Permit document number  
II. Name, address and statutory 
responsible person of company  
III. Name and address of factory of 
manufacturer  
IV. Types and categories of environmental 
agents  
V. Product names  
VI. Product validity period  
VII. Performance data  
VIII.  Application amount and package 
volume  
IX. Composition and contents  
X. Date  of permit issuance and validity 
period  
XI. Other items designated by the 
central competent authority  
Article 13 Environmental agents of the 
following substances  are exempted  
from applications for 
environmental agent permits and 
permit documents:  
I. Single c omponent solutions of 
hypochlorous acid and its salts, 
sodium chlorite with 
concentrations of less than 6%.  
II. Bleaching agents with chlorine 
concentrations of 40% or less.  
III. Hypochlorous acid and its 
salts, sodium chlorite,  chlorine 
dioxide, sodium borate (bor ic 
acid) raw materials.  
IV. Natural substance 
environmental sanitation raw 
agent materials.  Article3  An environmental agent permit is 
not required for the following 
environmental agents:  
I. Single component solutions of 
hypochlorous acid and its salts, sodium 
chlorite with concentrations of less than 
6%; or solutions of greater than 6% 
concentration when not for use as 
germicides.  
II. Bleaching agents with chlorine 
concentrations of 40% or less; or 
concentrations of 40% or greater when 
not for use as germicides . 
III. Hypochlorous acid and its salts, 
chlorine dioxide, sodium borate (boric 
acid) raw materials. However, general or 
special environmental agents using 
sodium borate (boric acid) or chlorine 
dioxide as a component are not subject to 
this restriction.  
IV. Natural substances used as pest 
repellants and not as pesticides, provided 
with certification of biological effects 
and components. However, natural 
substances with natural pyrethrum 
extracts are not subject to this restriction.  In Subparagraph 3 of the foregoing 
paragraph, general or restricted -use 
environmental sanitation agents 
containing chlorine dioxide as an active 
component are regulated to apply for 
Environmental Agents Permit and will 
take effect on July 1, 2014.  
Efficacy and components of natura l 
materials shall be provided and are 
regulated in Subparagraph 4 of 
Paragraph 1 and will take effect on 
January 1, 2014.  
Article 14 Pursuant to Article 10, Paragraph 1 
of this Act regarding 
environmental agent permit 
applications, a permit shall not be 
issued in the event of  any one of 
the following circumstances:  
I. The toxicity of the 
environmental agent is 
categorized as highly toxic or 
extremely toxic according to 
the WHO Pesticide Oral and 
Dermal Toxicity Classification 
(Attachment 4). However, 
rodentic ides and pollution 
control agents are not subject 
to this restriction.  
II. The applicant already has a 
permit covering the same 
components and said 
components are sourced from 
the same manufacturer.  
III. The environmental agent 
includes two or more 
components with the same 
efficacy. However, germicides 
and components that are 
proven to add functionality are 
not subject to this restriction.  
IV. The environmental agent 
product name already exists or 
the Chinese name of the active 
component in the 
environmental agent is th e 
product name. However, those 
manufacturing or importing 
technical grade agents using 
the Chinese name of the active 
ingredient as the product name 
are not subject to this 
restriction.  
V. The competent authority has Article2  Pursuant to Article 10, Paragraph 
1 of this Act regarding environmental  
agent permit applications, a permit shall 
not be issued when any one of the 
following circumst ances applies:  
I. The toxicity of the environmental agent 
is categorized as highly toxic or 
extremely toxic according to the WHO 
Pesticide Oral and Dermal Toxicity 
Classification (Attachment 1). However, 
rodenticides and pollution control agents 
are not su bject to this restriction.  
II. The applicant already has a permit 
covering the same components and said 
components are sourced from the same 
manufacturer.  
III. The environmental agent includes two 
or more components with the same 
efficacy. However, germici des and 
components that are proven to add 
functionality are not subject to this 
restriction.  
IV. The environmental agent product 
name already exists or the Chinese name 
of the active component in the 
environmental agent is the product name. 
However, those manufacturing or 
importing technical grade agents using 
the Chinese name of the active ingredient 
as the product name are not subject to 
this restriction.  
V. The competent authority has determined 
that there is cause for concern that an 
environmental agent  may be hazardous 
to humans or to the environment.  
VI. Information on documents or 
application forms is false or misleading.  
The permit will not be extended in 
the case of Paragraph 5 or Paragraph 6 of 
the aforesaid.  determined that there is cause 
for concern  that an 
environmental agent may be 
hazardous to humans or to the 
environment.  
 
Article 15  Environmental agent permits  are 
valid for a 5 -year effective period. 
Each extension may not exceed 5 
years. Environmental agent permit 
documents are valid for a 3 -year 
effective period. Each extension 
may not exceed 3 years. Extension 
shall be applied for within 3 to 6 
months prior to permit expiration 
from the central competent 
authority to continue using the 
environmental agents after the 
expiration date.  
If an extension is applied for within 
the specified period but the central 
competent authority fails to review and 
complete the approval or rejection of 
the extension, the applicant may 
continue usage according to the 
contents specified in the original 
permit.  
If an extension is not applied for 
within the specified period and an 
approval or rejection has yet to be 
issued by the cen tral competent 
authority, the original permit and 
permit documents become invalid 
following the date of expiration.   
Article 16  Applicants of environmental agent 
permit extensions shall submit 
application forms and 
documentary proof and data as 
specified in Attachment 5 to apply 
for a permit extension from the 
central competent authority.  
Applicants of environmental agent 
permit document extensions shall 
submit application forms and 
documentary proof and data as 
specified in Attachment 5 to apply for 
a per mit document extension from the 
central competent authority.   
Article 17  Applicants of environmental agent 
permit modification, replacement, 
or renewal shall submit application 
forms and documentary proof and 
data as specified in Attachment 7  to apply for  permit modification, 
replacement, or renewal from the 
central competent authority.  
Applicants of environmental agent 
permit document modification, 
replacement, or renewal shall submit 
application form and documentary and 
data as specified in Attachment 8 to 
apply for a permit modification, 
replacement, or renewal from the 
central competent authority.  
Applications for modifying 
manufacturer name, address, and 
domestic manufacturer name and 
address for permits and permit 
documents as specified in 
Subparagrap hs 1 and 2 shall be 
submitted within 30 days following the 
approval date of the last acquired 
relevant proof document from the 
competent authority of the relevant 
industry.  
Article 18  The methods of applying for 
permit or permit document 
extensions or mo difications shall 
be processed pursuant to Article 4.   
Article 19  Review processes for permit or 
permit document extensions or 
modifications shall be processed 
pursuant to Article 6.   
Article 20 Environmental agent efficacy, 
effective content analysis, o r 
physicochemical property  tests 
shall be performed sequentially  by 
the following testing agencies 
(institutions):  
I. Environmental  testing 
organizations with permits 
approved  by the central 
competent authority.  
II. Testing organizations 
designated by the central  
competent authority, or public 
or private academic and 
research institutions.  
III. Testing organizations that 
conform to the principles of 
Good Laboratory Practice 
(GLP) of the OECD; relevant 
documentary proof shall be 
provided.  Article11  The environmental age nt testing 
in the foregoing article shall be 
conducted by the following testing 
organizations:  
I. Testing and analysis organizations by the 
central competent authority or certified 
testing and analysis organizations.  
II. Testing and analysis organizations 
designated by the central competent 
authority testing and analysis 
organizations, or public or private 
academic and research institutions.  
III. An inspection and test organization 
that conforms to principles of Good 
Laboratory Practice (GLP) of the OECD, 
and related documents of proof shall be 
provided.  
The composition analysis and testing of 
environmental agents should be 
performed as prescribed in the first 
subparagraph of the foregoing paragraph.  
Subparagraph 2 of Paragraph 1 will 
take effect on January 1, 2014.  Article 21 An environmental agent toxicity 
testing organization must be a 
professional toxicological testing 
organization, and must comply 
with superior laboratory operating 
regulations or testing regulations 
of Taiwan, the United States, 
Europea n Union, Japan, or the 
Organization for Economic 
Cooperation and Development 
(OECD).  Article12  An environmental agent toxicity 
testing organization must be a 
professional toxicological testing 
organization, and must comply with 
superior laboratory operatin g regulations 
or testing regulations of Taiwan, the 
United States, European Union, Japan, or 
the Organization for Economic 
Cooperation and Development (OECD).  
Article 22 Environmental agent toxicity 
testing items are as follows:  
I. For first -time application s to 
register an active component as 
an environmental agent, see 
Attachment 9. 
II. For technical grade 
environmental agents and 
general and special 
environmental agents, see 
Attachment 10. 
III. For microbial preparations 
used as environmental agents 
and pollution c ontrol agents, 
see Attachment 11. 
IV. Toxicity tests for chemical 
repellent agents for human use 
are specified in Attachments 12 
and 13.  
For the general and special 
environmental agents in the foregoing 
Subparagraph 2, synergists representing 
less than 1% of t he total volume shall not 
be deemed active components.  Article13  Environmental agent toxicity 
testing items are as follows:  
I. For first -time applications to register an 
active component as an environmental 
agent, see Attachment 4.  
II. For technical grade environmental 
agents and general and special 
environmental agents, see Attachment 5.  
III. For microbial preparations used as 
environmental agents and pollution 
control agents, see Attachment 6.  
For the general and special 
environmental agents in the forego ing 
second item, synergists representing less 
than 1% of the total volume shall not be 
deemed active components.  
Article 23 Testing methodologies adopted for 
environmental agent efficacy 
(potency) testing, active 
component content analysis or 
physical and  chemical properties 
reports shall be conducted in 
accordance with Chinese National 
Standards as a priority, or with 
testing methodologies 
promulgated by the central 
competent authority.  
If the standard tests or methodologies 
specified above have not been 
promulgated in Taiwan, test standards 
approved by the Organization for 
Economic Cooperation and 
Development (OECD) and 
organizations validated by it or the Article10  Testing methodologies adopted 
for the environmental agent efficacy 
(potency) testing, active component 
content analysis or physical and chemical 
properties reports shall be conducted in 
accordance with Chinese National  
Standards or central competent authority 
testing methodologies; if standard testing 
methodologies for certain items have not 
been officially announced, then the 
applicant shall provide the testing 
methodology.  
For the foregoing paragraph standard tests 
or methods that are not promulgated in 
Taiwan, test standards approved by the 
Organization for Economic Cooperation 
and Development (OECD) and 
organizations validated by it or the competent authority of any country 
such as the U.S. or Japan shall be 
adopted, or the applicant shal l provide 
the test method.  
 competent authority of any country such 
as the U.S. or Japan shall be adopted or 
the applicant shall provide the test 
method.  
Regulations on standard tests 
adopted by test reports of physical and 
chemical properties of environmental 
agents in Paragraph 1 will be in effect on 
July 1, 2014.  
Article 24 Environmental agent efficacy 
(potency) testing reports shall 
comply with the following rules:  
I. For the biological species and 
conditions to be used in 
environmental agent efficacy 
testing, see Attachment 14. 
II. Efficacy (potency) testing 
reports must be submitted for 
application and registra tion of 
control performance. However, 
for agents that control 
centipedes, millipedes, and 
spiders, the examiner may 
indicate recommended dosage 
amounts and methods of 
application based on previous 
studies, which can then be 
submitted by the applicant.  
III. Efficacy (potency) testing 
reports for special 
environmental agents and 
microbial preparations used as 
environmental agents shall 
include the dilution factor of its 
control performance (including 
the highest dilution factor to 
achieve control results that 
meet  efficacy auditing 
standards).  
IV. Applications related to 
mosquito repellent incense, 
electrically -activated mosquito 
repellent incense, and 
electrically -activated liquid 
mosquito repellent incense 
indicating usage period of over 
8 hours must submit a 
time-correlated testing and 
analysis evidence report.  
V. For dichlorobenzenes, 
naphthalene, or synthetic 
camphor products with the 
same active component as the Article14  Environmental agent efficacy 
(potency) testing reports shall comply 
with the following rules:  
I. For the biological species and conditions 
to be used in environmental agent 
efficacy testing, see Attachment 7.  
II. Control performa nce data included in 
the registration application must include 
an efficacy (potency) testing report; 
however, for agents that control 
centipedes, millipedes, and spiders, the 
examiner may indicate recommended 
application amount and method of 
application ba sed on documentation, 
which can then be submitted by the 
applicant.  
III. Efficacy (potency) testing reports for 
special environmental agents and 
microbial preparations used as 
environmental agents shall include the 
dilution factor of its control performanc e 
(including the highest dilution factor to 
achieve control results that meet efficacy 
auditing standards).  
IV. Applications related to mosquito 
repellent incense, electrically -activated 
mosquito repellent incense, and 
electrically -activated liquid mosquit o 
repellent incense indicating usage period 
of over 8 hours must submit a 
time-correlated testing and analysis 
evidence report.  
V. For dichlorobenzenes, naphthalene, 
or synthetic camphor products with 
the same active component as the 
technical grade agent,  the enterprise 
shall carry out efficacy testing on 
either the technical grade agent or 
the product.  technical grade agent, the 
enterprise shall carry out 
efficacy testing on either the 
technical grade agent  or the 
product.  
Article 25 The performance data of 
environmental agents in Item 1, 
Article 9 of this Act shall be 
determined pursuant to efficacy 
testing results standard s 
(Attachment 15). Article15  The performance data of 
environmental agents in Article 9, 
Paragraph 1 of this Act shall be 
determined pursuant to efficacy testing 
results standards (Attachment 8).  
Article 26 For applications regarding 
approval or modificati on of 
general, special, or environmental 
or microbial raw agent materials  
with validity periods of more than 
two years, products with the same 
manufacture date and batch 
number shall be submitted along 
with efficacy (potency) testing 
reports and active com ponent 
analysis reports conducted at the 
time of manufacturing and those 
conducted two years or more 
following manufacture. However, 
the validity period for 
environmental agents shall be no 
longer than a maximum of five 
years.  
The effective period of envir onmental 
sanitation raw agent material products 
is 5 years . Article16  Applications for approval or 
modification of general and special 
environmental agents with validity 
periods of more than two years shall 
submit products with the same 
manufacture date an d batch number, 
along with efficacy (potency) testing 
reports and active component analysis 
reports conducted at the time of 
manufacturing and when conducted two 
years or more following manufacture.  
Applications for approval or modification 
of technical gr ade environmental agents 
with validity periods of more than three 
years shall submit products with the 
same manufacture date and batch 
number, along with active component 
analysis reports conducted at the time of 
manufacturing and when conducted three 
years or more following manufacture.  
The validity period for 
environmental agents shall be no longer 
than a maximum of five years.  
Article 27 Under any one of the following 
circumstances, the central 
competent authority may revoke or 
void the environmental ag ent 
permit or permit document : 
I. Information on documents or 
application forms is false or 
misleading.  
II. False items that are knowingly 
recorded on the record form for 
environmental agents on the 
basis of the obligation 
stipulated in Article 24, 
Paragraph 1 of  the Act.  
If the environmental technical grade 
agents import permit acquired for the 
manufacture and processing of 
environmental agents for export is not 
used on the manufacture and processing Article19  The central competent authority 
has the right to revoke Environmental 
Agents Permit in any of the following 
cases:  
I. False contents of documents or 
information.  
II. False items that are recorded on the 
record for m for environmental agents on 
the basis of the obligation recorded in 
Paragraph 1, Article 24 of the Act  
If environmental technical grade 
agents import permit acquired for the 
manufacture and processing of 
environmental agents for export is not 
used on the  manufacture and processing 
of the abovementioned agents, the 
central competent authority shall 
withdraw the import permit.  of the abovementioned agents, the 
central competent authority s hall 
withdraw the import permit.  
Article 28 These Standards shall be 
implemented following the date of 
promulgation.  Article20  The standards shall take effect 
from the date of promulgation unless an 
enforcements date is specified.  
 
 
 
 Article 3 Attachment 1  
Amended  Current  
Attachment 1  
I.  Documents and Information to Be Submitted with Environmental Agent Permit Applications  
Manufacture Permit  Import Permit  
Documentation  
1. Photocopy of document verifying 
company registration (not required in 
the case of non -companies)  
2. Photocopy of document verifying 
commercial registration  (not required in 
the case of companies ) 
3. Photocopy of the personal identification 
document of the statutory responsible 
person  
4. Photocopy of factory registration  
5. Photocopy of verification letter of 
professional technician at site  
6. Photocopy of technical grade 
environmental agents transfer approval 
or technical grade environmenta l agent 
permit use authorization  
7. Photocopy of environmental agent 
licensing application sample approval 
document  
  1.Photocopy of document verifying 
company registration (not required 
in the case of non -companies)  
2. Photocopy of document verifying 
commercial registration  (not 
required in the case of companies ) 
3. Photocopy of the personal 
identification document of the 
statutory responsible person  
4. Photocopy of environmental agent 
sales vendor permit  
5. Signed original copy of 
manufacturing and sales  permits 
from regulatory authorities in 
country of origin  
6. Signed original copy of foreign 
enterprise authorization document  
7. Information on overseas product 
commercialization (labels)  
8. Photocopy of environmental agent 
licensing application sample 
approval document  
Materials  
1. Physical and chemical properties data 
for technical grade and finished product 
agents (microbial preparations must 
submit biological properties data) ( Note 
5 and Note 6 ) 
2. Methodology of physical, chemical, and 
biological analyses  
3. Active component content analysis 
report ( Note 4 ,Note 7 ,Note 9 andNote 
13.1 ) 
4. Toxicity texting report ( Note 4 ,Note 9 , 
Note 10  and Note 11 ) 
5. Efficacy testing (for environmental 
agents and microbial preparations used 
for environmental sani tation) or 
potency testing (for microbial 
preparations used for pollution control 
and pollution control agents ( Note 
4,Note 7  and Note 9 )  1. Physical and chemical properties 
data for technical grade and 
finished product agents (and attach 
data concerning original 
manufacturing plant; attach 
biological data in the case of 
microbial preparations) ( Note 5  and 
Note 6 ) 
2. Methodology of physical, chemical, 
and biological analyses  
3. Active component content analy sis 
report ( Note 4 ,Note 7 ,Note 
9andNote 13.1 ,) 
4. Toxicity texting report ( Note 4 ,Note 
8, Note 9 , Note 10  and Note 11 ) 
5. Efficacy testing (for environmental 
agents and microbial preparations 
used for environmental sanitation) 
or effectiveness testing (for Attachment 3  
I.  Documents and Information to Be Submitted with Environmental Agent Permit Applications  
Manufacture Permi t  Import Permit  
Documentation  
1. Photocopy of document verifying 
company registration (not required in 
the case of non -companies)  
2. Photocopy of document verifying 
commercial registration  
3. Photocopy of the personal identification 
document of the sta tutory responsible 
person  
4. Photocopy of factory registration (Note 
1) 
5. Photocopy of verification letter of 
professional technician at site  
6. Photocopy of technical grade 
envi ronmental agents transfer approval 
or technical grade environmental agent 
permit use authorization  
7. Photocopy of environmental agent 
licensing application sample approval 
document (Note 4 ) 
  1.Photocopy of document verifying 
company registration (not required 
in the case of non -companies)  
2. Photocopy of document verifying 
commercial registration  
3. Photocopy of the personal 
identification document of the 
statutory responsible p erson  
4. Photocopy of environmental agent 
sales vendor permit  
5. Signed original copy of 
manufacturing and sales permits 
from regulatory authorities in 
country of origin (Note 2 )  
6. Signed original copy of foreign 
enterprise authorization document 
(Note 3 ) 
7. Information on overseas product 
commercialization (labels)  
8. Photocopy of environmental agent 
licensing application sample 
approval document (Note 4 ) 
Materials  
1. Physical and chemical properties data 
for technical grade and finished product 
agents (microbial preparations must 
submit biological properties data) (Note 
5 and Note 6 ) 
2. Methodology of physical, chemical, and 
biological analyses  
3. Active component content analysis 
report (Note 4 ,Note 7 ,Note 9 andNote 
13.1 ) 
4. Toxicity texting report (Note 4 ,Note 9 , 
Note 10  and Note 11 ) 
5. Efficacy testing (for environmental 
agents and microbial preparations used 
for environmental sanitation) or 
potency testing (for microbial 
preparations used for pollution control 
and pollution control agents (Note 
4,Note 7  and Note 9 )  1. Physical and chemical properties 
data for technical grade and 
finished product agents (and attach 
data conc erning original 
manufacturing plant; attach 
biological data in the case of 
microbial preparations) (Note 5  and 
Note 6 ) 
2. Methodology of physical, chemical, 
and biological analyses  
3. Active component content analysis 
report (Note 4 ,Note 7 ,Note 
9andNote 13.1 ,) 
4. Toxicity texting report (Note 4 ,Note 
8, Note 9 , Note 10  and Note 11 ) 
5. Efficacy testing (for environmental 
agents and microbial preparations 
used for environmental san itation) 
or effectiveness testing (for 6. Overview of production method 
(explanation of production process)  
7. Product safety and quality testing, usage 
and storage description  
8. Pollution control manual  
9. Labels  microbial preparations used for 
pollution control and pollution 
control a gents ( Note 7  and Note 9 ) 
6. Overview of production method 
(explanation of production process, 
and att ach data concerning original 
manufacturing plant)  
7. Product safety and quality testing, 
usage and storage description  
8. Labels  
 
 
II.  Documents of Proof and Information for Application for Import Permit of Technical Grade 
Agents Required by Export of Ge neral or Restricted -Use Environmental Agents  
Documentation  
1.Photocopy of document verifying company registration (not required in the case 
of non -companies)  
2. Photocopy of document verifying commercial registration  (not required in the 
case of companie s) 
3. Photocopy of the personal identification document of the statutory responsible 
person  
4. Photocopy of environmental agent sales vendor permit  
5. Photocopy of factory registration  
6. Photocopy of manufacturing and sales permits from regulatory authori ties in country of 
origin  
7. Signed original copy of foreign enterprise authorization document  
8. Information on overseas product commercialization (labels)  
Materials  
1. Physical and chemical properties data for technical grade agents  
2. Methodology of physical, chemical analyses  
3. Toxicity texting report summary  (Chinese and English summaries)  
4. Efficacy testing  summary (Chinese and English summaries)  
5. Overview of production method (explanation of production process)  
6. Product safety and quality te sting, usage and storage description  
7. Labels  
 
 
 6. Overview of production meth od 
(explanation of production process)  
7. Product safety and quality testing, usage 
and storage description  
8. Pollution control manual  
9. Labels  microbial preparations used for 
pollution control and pollution 
control agents (Note 7  and Note 9 ) 
6. Overview of production method 
(explanation of production process, 
and attach data concerning original 
manufacturing plant)  
7. Product safety and quality testing, 
usage and storage description  
8. Labels  
 
 
II.  Documen ts of Proof and Information for Application for Import Permit of Technical Grade Agents 
Required by Export of General or Restricted -Use Environmental Agents  
Documentation  
1.Photocopy of document verifying company registration (not required in the case of 
non-companies)  
2. Photocopy of document verifying commercial registration  
3. Photocopy of the personal identification document of the statutory responsible person  
4. Photocopy of environmental agent sales vendor permit  
5. Photocopy of factory registration  (Note 1 ) 
6. Photocopy of manufacturing and sales permits from regulatory authorities in country of origin (Note 
2 (1)~(4))   
7. Signed original copy of foreign enterprise authoriz ation document  
8. Information on overseas product commercialization (labels)  
Materials  
1. Physical and chemical properties data for technical grade agents  
2. Methodology of physical, chemical analyses  
3. Toxicity texting report summary  (Chinese and Engl ish summaries)  
4. Efficacy testing  summary (Chinese and English summaries)  
5. Overview of production method (explanation of production process)  
6. Product safety and quality testing, usage and storage description  
7. Labels  
 
Note 1: If the photocopy of doc ument verifying factory registration does not list the dosage form of the 
environmental agent for which the application has been made, the applicant must submit a photocopy 
of the letter of approval stating the chief product from the competent authority in  charge of factory 
registration.   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 Note 2: Verification documents of manufacturing and sales permits from the competent authority in the 
country of origin shall include:  
A. Date of issuance and date of signing  
B. Permit number  
C. Name of environmental agent  
D. Type of active component and contained amount  
E. Company name and address  
F. Manufacturer name and address  
G. Seal of competent authority or signature of responsible person in country of origin  
The content of documents shall be sufficient to judge whet her the authorization documents are for the same 
environmental agent. When such content is not clearly indicated, explanations and documents with 
such content must be submitted and authenticated. If manufacturing and sales verification documents 
are from d ifferent competent authorities in the country of origin, then verification documents from each 
competent authority in the country of origin shall be submitted  
Note 3: Foreign manufacturers authorization and verification documents shall include  
A. Company n ame and address  
B. Manufacturer name and address  
C. Name of authorized domestic agent or distributor  
D. Product name  
E. Manufacturer name and address  
F. Name of authorized domestic agent or distributor  
G. Product name  
If foreign companies have licensed dom estic manufacturers to manufacture the environmental agent, 
then proof of authorization to manufacture shall be attached.  
Note 4: When manufacturing or importing samples needed for testing, an application must be made to the 
central competent authority for  approval pursuant to Article 23, Paragraph 1 of this Act, and samples 
must be provided to relevant units for testing within one year after receipt of approval.  
Note 5: Test reports shall be submitted with physical and chemical information. When applying f or a 
environmental agent new dosage form or new use method (where no domestic registration has been 
made to manufacture the environmental agent with that dosage form or use method), technical data for 
the technical grade manufacturing plant and relevant ex planation should be provided. When a new 
dosage form or new use method has been developed domestically, a comparative table showing the 
doses of relevant current dosage forms (powder, liquid, gas) used must be provided.  
Note 6: When applying for a technica l grade environmental agent permit, five component analysis reports 
shall be provided and all impurities accounting for more than 0.1% of the technical grade 
environmental agent must be listed and related toxicity information must be supplied by the 
manufa cturer of said technical grade environmental agent. If technical grade agents are isomers, then 
cis-trans isomer ratio analysis data shall be submitted along with related explanations. The central 
competent authority will determine the method for isomer or  impurity testing to be used by the 
applicant. Apart from food -grade substances, materials safety data sheets for other secondary 
components added to general or special environmental agents must be attached.  
Note 7: Environmental agent manufacturing permit  applications must submit efficacy (potency) testing 
results for all batches manufactured on the same date as the testing sample. If applicants for import 
permits are conducting testing in Taiwan, samples for environmental agent testing must be taken from 
the same batch and same manufacturing date as the active component samples. When a synergist is  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 added to a finished product, an analytical report concerning the synergist's active components must be 
provided regardless of whether the synergist content exce eds 1%, and synergist test values must be 
included. When importing an environmental agent whose active component is p -dichlorobenzene or 
manufacturing technical grade environmental agent p -dichlorobenzene, test must also be performed to 
determine whether t he substance contains o -dichlorobenzene, which is prohibited in environmental 
agents. The composition test report should list the test method numbers.  
Note 8: Toxicity testing and efficacy (potency) testing for environmental agent import permit application s 
must submit testing reports from the original manufacturer of the product. Efficacy testing may not be 
conducted by the original manufacturer. However, the independent institutions established pursuant to 
relevant laws are not subject to this restriction . Efficacy (potency) testing must be done by testing 
institutions authorized by the central competent authority.  
Note 9: Active component analysis testing, toxicity testing and efficacy (potency) testing reports must be 
signed by tester and statutory respo nsible person and must display the seal of the testing body or 
institution. If submitted toxicity report and materials are photocopies, such photocopies shall be signed 
by the certified toxicity expert, director of the toxicity testing lab, or the original  manufacturer related 
to the testing. If a toxicology test report or data is photocopied, one of the concerned parties must sign 
the test report; the signer may be a toxicologist who has passed an examination, the statutory 
responsible person of the origin al toxicological analysis and testing organization or unit, or the 
responsible person of the original manufacturing plant.  
Note 10: Toxicity testing reports:  
A. For active components registered in Taiwan for the first time as environmental sanitation agent s, 
toxicity testing reports for the technical grade agent must be submitted as per items in Attachment 
4. 
B. For applications for general or special environmental agent import permits, written explanation of 
the source of the technical grade agent of the f inished product and the toxicity testing report of the 
finished product as per items in Attachment 5 shall be submitted. If the source of the technical 
grade agents has not been registered domestically, then a toxicity testing report of the technical 
grade  agent shall be submitted as well, as per items in Attachment 5.  
C. For applications for general or special environmental agent manufacturing permits, a toxicity 
testing report for the finished product shall be submitted as per items in Attachment 5. In th e case 
of a general or special environmental agent, if a registered manufacturer's registration of the same 
components and composition has been authorized, and documents verifying the registered 
manufacturer's authorized registration file are provided, a t oxicity test report is not needed. 
However, an application for change of components or composition may not be made when a 
product's registration has been authorized.  
D. For applications for me -too component technical grade environmental agent manufacture o r import 
permits, a toxicity testing report shall be submitted as per items in Attachment 5.When, in the case 
of a technical grade environmental agent, a registered manufacturer has been authorized to use 
toxicity test data or authorized to manufacture the  environmental agent, the applicant must submit 
composition analysis reports for five lots of the environmental agent produced by the authorized 
manufacturer and the original manufacturing plant's original composition analysis report for 
comparison and exp lanation, and must also provide a detailed explanation of the original 
manufacturing process from the registered manufacturer and an explanation of the manufacturing 
process from the company authorized to use toxicity test data or manufacturer authorized t o 
manufacture the environmental agent; if the technical grade environmental agents have the same composition, and documents verifying the registered manufacturer's authorized registration file are 
provided, a toxicity test report is not needed.  
E. For envi ronmental agent microbial preparations and pollution control agents, toxicity testing items 
shall be submitted per Attachment 6.  
Note 11: Applications for active components hypochlorous acid and its salts, chlorine dioxide, sodium 
chlorite, bleach powder, sodium borate (boric acid), dichlorobenzenes and naphthalene shall submit 
toxicity data but need only to cover acute oral toxicity and acute dermal toxicity. Hazardous Substances 
Data Base (HSDB), Registry of Toxic Effects of Chemical Substances (RTECS), o r other research 
documentation regarding toxicity must also be submitted. If in a foreign language, then Chinese 
summary translation shall be attached translated sections clearly indicated.  
Note 12: The registered content quantities on an environmental age nt permit are limited to ten. The registered 
content quantity packaging of general environmental agents in a liquid state is limited to 5 liters.   
 
III. Documentation  and Materials Required for the Extension of Environmental Agent Permits  
Note13: For extensions to permits for technical grade environmental agent, p -dichlorobenzene, naphthalene, 
and synthetic camphor, no efficacy (potency) testing is required.  
Note13.1
 When new permit and permit renewal applications are made for mosquito incense agents, a test 
report concerning dioxin content of the mosquito incense agent from within the most recent year 
must be attached.  
 
 Manufacture permi t Import permit  
Documents of proof  
1. Photocopy of document verifying company 
registration (not required in the case of 
non-companies)  
2. Photocopy of document verifying commercial 
registration  
3. Photocopy of the personal identification document 
of the statutory  responsible person  
4. Photocopy of factory registration ( Note 1 ) 
5. The original permit  
6. Photocopy of document of approval for transfer 
of technical grade environmental agent or 
docum ent of authorization of use for technical 
grade agent  
 
 1. Photocopy of document verifying company 
registration (not required in the case of 
non-companies)  
2. Photocopy of document verifying commercial 
registration  
3. Photocopy of the personal identification 
docume nt of the statutory responsible person  
4. Photocopy of environmental agent sales vendor 
permit  
5. The original permit  
6. Official copy of document of authorization 
issued by a foreign firm in the last 2 years (note 
3)  
7. Information of proof that the original permits  
for manufacture and marketing are still 
effective (such as information from official 
website or other official documents)  
Information  
1. Analysis report of the content of active ingredients 
in the last year (note 7 and note 13 .1)  
2. Efficacy(potency) test report in the last year (note 
7 and note 13)  
3. Labels  1. Report of the content of active components 
analysis conducted domestically in the last year 
(note 7 and note 13 .1)  
2. Report of Efficacy(potency) test conducted 
domestically in the last year (no te 7 and note 
13) 
3. Labels   
IV. Verification Documents and Materials Required for Environmental Agent Permit Modification 
Applications  
Permit  
document  
 
Required  
 
Modification  Manufacture permit  Import permit  
Company 
name  1. Photocopy of company license 
or document of proof for 
company registration (not 
required if not a company)  
2. Photocopy of business 
registration certif icate   
3. Photocopy of factory 
registration  
4. The original permit  
5. Labels  
6. Photocopy of certificate for 
employment of professional 
technicians   
(Note 14)  1. Photocopy of company license or 
document of proof for company 
registration (not required if n ot a 
company)  
2. Photocopy of business 
registration certificate  
3. Photocopy of environmental agent 
vendors permission license  
4. Official copy of verified document 
of proof for approval of manufacture 
and marketing by the last 2 years  
competent authority  of country of 
origin (note 2)  
5. Statement for legal liability of the 
product (required for permit holders 
for change of information)  
6. The original permit  
7. Labels  
Company 
address  1. Photocopy of company license 
or document of proof for 
company regi stration (not 
required if not a company)  
2. Photocopy of business 
registration certificate  
3. Photocopy of factory 
registration  
4. The original permit  
5. Labels  1. Photocopy of environmental agents 
vendors permission license  
2. The original permit  
3. Label s 
Responsible 
person  1. Photocopy of company license 
or document of proof for 
company registration (not 
required if not a company)  
2. Photocopy of business 
registration certificate  
3. Photocopy of factory 
registration  
4. Photocopy of person 
identification  
5 The original permit  1. Photocopy of environmental agent 
vendors permission license  
2. Photocopy of person identification  
3. The original permit  Manufacturer 
name  1. Photocopy of company license 
or document of proof for 
company registration (not 
require d if not a company)  
2. Photocopy of business 
registration certificate  
3. Photocopy of factory 
registration  
4. The original permit  
5. Labels  
note 15
  1. Official copy of verified document 
of proof for approval of manufacture 
and marketing by the competent 
authority of country of origin in the 
last 2 years (note 2)  
2. Official copy of document of 
authorization issued by a foreign 
firm in the last 2 years
 note 3
  
3. The original permit  
4. Labels  
 note 15  and note 16
  
Manufacturer  
address  1. Photocopy of co mpany license 
or document of proof for 
company registration (not 
required if not a company)  
2. Photocopy of business 
registration certificate  
3. Photocopy of factory 
registration  
4. The original permit  
5. Labels  
note 17
  1. Official copy of verified docum ent 
of proof for approval of manufacture 
and marketing by the competent 
authority of country of origin in the 
last 2 years
 note 2
  
2. The original permit  
3. Labels  
note 16
  
Product name  
 1. The original permit  
2. The last date of manufacture, lot 
number  and quantity of 
environmental agent  
3. Labels  
4. Document of proof issued by a 
firm of exported country ( note 
18-1) 1. Official copy of verified document 
of proof for approval of manufacture 
and marketing by the competent 
authority of country of origin i n the 
last 2 years
 note 2
  
2. The original permit  
3. The last date of manufacture, lot 
number and quantity of 
environmental agent  
4. Labels  
note 18
  
5. Document of proof issued by a firm 
of exported country ( note 18 -1) 
Packing  The original permit  1. Document of approval i ssued by the 
original foreign manufacturer  
2. The original permit  
Performance  1. Report of the content of active 
ingredients analysis conducted 
domestically in the last year
 note 
7
 
2. Report of efficacy(potency) test 
conduct domestically in the last 
year
 note 7
  
3. The original permit  
4. Labels  1. Mill certificate issued by the 
manufacturer  
2. Report of the content of active 
components analysis conducted 
domestically in the last year
 note 7
  
3. Performance (effectiveness) test 
report in the last year
 note 7
 
4. The original permit  
5. Labels  
Addictives  1. Information about physical and 1. Mill certificate issued by the Note 14:
 The change of name of the permit -holding manufacturer is limite d to that the name of firm is to be 
changed due to merging or returning to business.  
Note 15:  The change of name of the manufacture or import permit -holding manufacturer is limited to that the 
name of firm is to be changed due to merging or returning to b usiness.  
Note 16:  For the change of manufacturer commissioned by the foreign firm that has the permit for 
manufacture, a certified document of commission to manufacture shall be provided.  New 
application is required for a manufacturer of a different coun try.   
Note 17:  The change of address of manufacturer stated in the manufacture permit is limited to rearrangement 
of address.   
Note 18:  For the change of the product name in foreign language on the permit of import, the document of 
proof for the name of product in foreign language issued by the original foreign firm and the 
document of proof for the name of product in foreign language issued by the highest competent 
authority of the country of origin shall be provided.   
Note 18 -1: The foreign name of an environmental agent is for export and import only. The environmental 
agent shall be registered with a foreign name according to the request of firms in import 
countries.  
Note 19:  the change of addictives is limited to the change of type or packing of addic tives providing the same 
performance.   
Note 20:  In case of multiple changes in a single permit which require the same documents, the repeated ones 
can be omitted.   
Note 21:  Review fees are required for changes of information.  However, the change of comp any address 
and responsible person or the rearrangement of manufacturer’s address shall be subject to this 
restriction.   
Note 22: When applying for the manufacturing and processing of environmental agents for exports for which 
the technical grade agents a re not from the R.O.C., documents and information for the application 
for import permit of technical grade agents are required as on Attachment 3 ( II). 
 (note 19)  chemical properties  
2. Material Safety Data 
Sheet(MSDS)  
3. The original permit  manufacturer  
2. Information about physical and 
chemical properties  
3. Material Safety Data Sheet(MSDS)  
4. The original permit  
Shelf life 
active of 
product  1. Report for measurement of active 
ingredient content decay (the 
active ingredient content analysis 
reports before and after the 
expiration date)  
2. Test report for the performance 
(effectiveness) test of the said 
agent from the same manufacture 
date and lot number of the agent 
containing the identical active 
components (cross -reference)  
3. The original permit  
4. Labels  1. Mill certificate issued by t he 
manufacturer  
2. Report for measurement of active 
component content decay (the active 
component content analysis reports 
before and after the expiration date)  
3. Test report for the performance 
(effectiveness) test of the said agent 
from the same manufac ture date and 
lot number of the agent containing 
the identical active components 
cross -reference
 ; test reports not 
required for technical grade products  
4. The original permit  
5. Labels  
Others  Relevant documents or information  Relevant documents or information   Article 3 Attachment 2
 
Attachment 2 Documents and Information to Be Submitted wi th Environmental 
Agent Permit Document of Natural Insect Repelling Substances 
Applications  
 
Manufacture Permit Document  Import Permit Document  
Documentation  
1. Photocopy of document 
verifying company 
registration (not required in 
the case of non -companie s) 
2. Photocopy of document 
verifying commercial 
registration  (not required in 
the case of companies)  
3. Photocopy of the personal 
identification document of 
the statutory responsible 
person  
4. Photocopy of factory 
registration  
5. Certificate to origin of 
natural substances  1.Photocopy of document 
verifying company 
registration (not required in 
the case of non -companies)  
2. Photocopy of document 
verifying commercial 
registration  (not required in 
the case of companies)  
3. Photocopy of the personal 
identific ation document of 
the statutory responsible 
person  
4. Certificate to origin of 
natural substances  
5. Signed original copy of 
foreign enterprise 
authorization document  
6. Information on overseas 
product commercialization 
(labels)  
Materials  
1. Active comp onent content 
analysis report  (including 
raw materials and product)  
2. Efficacy testing report  
3. Explanation of production 
process for natural 
substances   
4. Labels  (Note)  1. Active component content 
analysis report  (including 
raw materials and product)  
2. Efficacy testing report  
3. Explanation of production 
process for natural 
substances   
4. Labels  (Note)  
 
Note: The Items of the Label:  
1. Permit number of Insect Repelling Products.  
2. Product names.  
3. The contents of the products:  
(1) Active ingredient and concentration  
(2) Net content . 
(3) Performance.  
(4) Applicable range and method .  
(5) Toxicosis symptom, first aid and detoxification method  4. The method to recycle and clean waste containers  
5. Manufacturer's name , telephone number and address and or igin country  of 
the product. ( Importer's name , telephone number and address shall be 
labeled for import products)  
6. Manufacturing date .  
 
 Article 7 Attachment 3
Attachment 3 Concentrations  of Ge rmicides for General Environmental Sani tation Use  
Active Component Chinese/English Name  Application Type  Concent
ration  
Name of Active ingredient    
Alky1 dimethy1 benzy1 ammonium saccharinate  Liquid, aerosol spray  4.80 %  
Benzalkonium chloride  Liquid, aerosol spray  4.80 %  
Didecyldimethyl ammo nium chloride  Liquid, aerosol spray  1.68 %  
Glutaraldehyde  Liquid, aerosol spray  2.68 %  
n-Alkyldimethylbenzyl ammonium chloride  Liquid, aerosol spray  4.80 %  
Obanol -516 Liquid, aerosol spray  5.00 %  
o-Benzyl -p-chlorophenol  Liquid, aerosol spray  5.00 %  
o-Phenylphenol  Liquid, aerosol spray  5.00 %  
p-Chlorophenol  Liquid, aerosol spray  5.00 %  
p-Dichlorobenzene  Liquid, aerosol spray  5.00 %  
Polyalkyl polyamino ethylglycine  Liquid, aerosol spray  5.00 %  
p-ter-Amylphenol  Liquid, aerosol spray  5.00 %  
Calcium hy pochlorite, Ca(ClO) 2 Pellet, tablet, powder, 
liquid  90 %  
Chlorine dioxide, ClO 2 Liquid, powder,  tablet  50 %  
Sodium chlorite, NaClO 2 Liquid, powder, tablet  50 %  
Sodium hypochlorite, NaClO  Powder  50 %  
Bleach  Powder  80 %  
 Attachment 2  
 Concentrations of Germicides for General Environmental Sanitation Use  
Active Component Chinese/English Name  Application Type  Concent
ration  
Name of Active ingredient    
Alky1 dimethy1 benzy1 ammonium saccharinate  Liquid, aerosol spray  4.80 %  
Benzalkonium chloride  Liquid, a erosol spray  4.80 %  
Didecyldimethyl ammonium chloride  Liquid, aerosol spray  1.68 %  
Glutaraldehyde  Liquid, aerosol spray  2.68 %  
n-Alkyldimethylbenzyl ammonium chloride  Liquid, aerosol spray  4.80 %  
Obanol -516 Liquid, aerosol spray  5.00 %  
o-Benzyl -p-chlorophenol  Liquid, aerosol spray  5.00 %  
o-Phenylphenol  Liquid, aerosol spray  5.00 %  
p-Chlorophenol  Liquid, aerosol spray  5.00 %  
p-Dichlorobenzene  Liquid, aerosol spray  5.00 %  
Polyalkyl polyamino ethylglycine  Liquid, aerosol spray  5.00 %  
p-ter-Amylphenol  Liquid, aerosol spray  5.00 %  
Calcium hypochlorite, Ca(ClO) 2 Pellet, tablet, powder, liquid  90 %  
Chlorine dioxide, ClO 2 Liquid, powder,  tablet  50 %  
Sodium chlorite, NaClO 2 Liquid, powder, tablet  50 %  
Sodium hypochlorite, NaClO  Powder  50 %  
Bleach  Powde r 80 %  Article 14 Attachment 4
Amended  Current  
Attachment  4  Toxicity Classification for Pesticides by WHO in 2009  
 
 LD 50 for Rat (mg/kg)  
 Oral Dermal  
Extremely Toxic  <5 <50 
Highly Toxic  5-50 50-200 
Moderately Toxic  50-2000  200-2000  
Lightly Toxi c >2000  >2000  
Slightly Toxic  >=5000  
 
 Attachment 1  
Toxicity Classification for Pesticides by WHO in 2009  
 LD 50 for Rat (mg/kg)  
 Oral Dermal  
Extremely Toxic  <5 <50 
Highly Toxic  5-50 50-200 
Moderately Toxic  50-2000  200-2000  
Lightly Toxic  >2000  >2000  
Slightly Toxic  >=5000  
  Article 16 Attachment 5
Amended  Current  
 
Attachment 5  Documentation and Information Required for the Extension of Environmental Agent Permits  
 
 
 Manufacture permit  Import permit  
Documents of proof  
1. Photocopy of document veri fying company 
registration (not required in the case of 
non-companies)  
2. Photocopy of document verifying commercial 
registration (not required in the case of companies)  
3. Photocopy of the personal identification document 
of the statutory responsible pers on 
4. Photocopy of factory registration  
5. The original permit  
6. Photocopy  of document of approval for transfer of 
technical grade environmental agent or document 
of authorization of use for technical grade agent  
 1. Photocopy of document verifying compan y 
registration (not required in the case of 
non-companies)  
2. Photocopy of document verifying commercial 
registration  (not required in the case of 
companies)  
3. Photocopy of the personal identification 
document of the statutory responsible person  
4. Photoc opy of environmental agent sales vendor 
permit  
5. The original permit  
6. Official copy of document of authorization 
issued by a foreign firm in the last 2 years  
7. Information of proof that the original permits for 
manufacture and marketing are still effec tive 
(such as information from official website or 
other official documents)  
Information  
1. Analysis report of the content of active ingredients 
in the last year  
2. Efficacy(potency) test report in the last year  
3. Labels  1. Report of the content of act ive components 
analysis conducted domestically in the last year  
2. Report of Efficacy(potency) test conducted 
domestically in the last year  
3. Labels   Article 16 Attachment 6
Attachment 6  Documentation  and Information Required fo r the Extension of 
Environmental Agent Permit Document of Natural Insect Repelling 
Substances Applications  
 
Manufacture Permit Document  Import Permit Document  
Documents of proof  
1. Photocopy of document 
verifying company registration 
(not required in the  case of 
non-companies)  
2. Photocopy of document 
verifying commercial 
registration  (not required in the 
case of companies)  
3. Photocopy of the personal 
identification document of the 
statutory responsible person  
4. Photocopy of factory 
registration  
5. The original permit document  
6. Certificate to origin of natural 
substances  1.Photocopy of document 
verifying company registration 
(not required in the case of 
non-companies)  
2. Photocopy of document 
verifying commercial 
registration  (not required in the 
case  of companies)  
3. Photocopy of the personal 
identification document of the 
statutory responsible person  
4. The original permit document  
5. Signed original copy of foreign 
enterprise authorization 
document  
Information  
1. Active component content 
analysis  report  (including raw 
materials and product)  
2. Efficacy testing report  
3. Labels  1. Active component content 
analysis report  (including raw 
materials and product)  
2. Efficacy testing report  
3. Labels  
 
 
 Article 17 Attachment 7
Amended  Current  
 
Attachment 7 Verification Documents and Materials Required for Environmental Agent Permit 
Modification Applications  
 
Permit  
document  
 
Required  
 
Modification  Manufacture permit  Import permit  
Company 
name  1. Photocopy of company license 
or document of proof f or 
company registration (not 
required if not a company)  
2. Photocopy of business 
registration certificate  (not 
required if a company)  
3. Photocopy of factory 
registration  
4. The original permit  
5. Labels  
6. Photocopy of certificate for 
employment of profe ssional 
technicians   1. Photocopy of company license or 
document of proof for company 
registration (not required if not a 
company)  
2. Photocopy of business 
registration certificate  (not 
required if a company)  
3. Photocopy of environmental agent 
vendors per mission license  
4. Official copy of verified document 
of proof for approval of manufacture 
and marketing by the last 2 years  
competent authority of country of 
origin  
5. Statement for legal liability of the 
product (required for permit holders 
for change o f information)  
6. The original permit  
7. Labels  
Company 
address  1. Photocopy of company license 
or document of proof for 
company registration (not 
required if not a company)  
2. Photocopy of business 
registration certificate  (not 
required if a company)  
3. Photocopy of factory 
registration  
4. The original permit  
5. Labels  1. Photocopy of environmental agents 
vendors permission license  
2. The original permit  
3. Labels  
Responsible 
person  1. Photocopy of company license 
or document of proof for 
company regist ration (not 
required if not a company)  
2. Photocopy of business 1. Photocopy of environmental agent 
vendor s permission license  
2. Photocopy of person identification  
3. The original permit   registration certificate  (not 
required if a company)  
3. Photocopy of factory 
registration  
4. Photocopy of person 
identification  
5 The original permit  
Manufacturer 
name  1. Photocopy of company license 
or document of proof for 
company registration (not 
required if not a company)  
2. Photocopy of business 
registration certifi cate (not 
required if a company)  
3. Photocopy of factory 
registration  
4. The original permit  
5. Labels  1. Official copy of verified document 
of proof for approval of manufacture 
and marketing by the competent 
authority of country of origin in the 
last 2 ye ars 
2. Official copy of document of 
authorization issued by a foreign 
firm in the last 2 years
 note 3
  
3. The original permit  
4. Labels  
Manufacturer  
address  1. Photocopy of company license 
or document of proof for 
company registration (not 
required if not a company)  
2. Photocopy of business 
registration certificate  (not 
required if a company)  
3. Photocopy of factory 
registration  
4. The original permit  
5. Labels  1. Official copy of verified document 
of proof for approval of manufacture 
and marketing by the competent 
authority of country of origin in the 
last 2 years  
2. The original permit  
3. Labels  
Product name  
 1. The original permit  
2. The last date of manufacture, lot 
number and quantity of 
environmental agent  
3. Labels  
4. Document of proof issued by a 
firm of exported country  1. Official copy of verified document 
of proof for approval of manu facture 
and marketing by the competent 
authority of country of origin in the 
last 2 years  
2. The original permit  
3. The last date of manufacture, lot 
number and quantity of 
environmental agent  
4. Labels  
5. Document of proof issued by a firm 
of exported cou ntry 
Packing  The original permit  1. Document of approval issued by the 
original foreign manufacturer  
2. The original permit  
Performance  1. Report of the content of active 
ingredients analysis conducted 
domestically in the last year  
2. Report of efficacy( potency) test 
conduct domestically in the last 1. Mill certificate issued by the 
manufacturer  
2. Report of the content of active 
components analysis conducted 
domestically in the last year   
 
 year 
3. The original permit  
4. Labels  3. Performance (effectiveness ) test 
report in the last year  
4. The original permit  
5. Labels  
Addictives  
 1. Information about physical and 
chemical properties  
2. Material Safety Data 
Sheet(MSDS)  
3. The original permit  1. Mill certificate issued by the 
manufacturer  
2. Information abou t physical and 
chemical properties  
3. Material Safety Data Sheet(MSDS)  
4. The original permit  
Shelf life 
active of 
product  1. Report for measurement of active 
ingredient content decay (the 
active ingredient content analysis 
reports before and after the 
expiration date)  
2. Test report for the performance 
(effectiveness) test of the said 
agent from the same manufacture 
date and lot number of the agent 
containing the identical active 
components (cross -reference)  
3. The original permit  
4. Labels  1. Mill certi ficate issued by the 
manufacturer  
2. Report for measurement of active 
component content decay (the active 
component content analysis reports 
before and after the expiration date)  
3. Test report for the performance 
(effectiveness) test of the said agent 
from the same manufacture date and 
lot number of the agent containing 
the identical active components 
cross -reference
 ; test reports not 
required for technical grade products  
4. The original permit  
5. Labels  
Others  Relevant documents or information  Relevant documents or information  Article 17 Attachment 8
Attachment 8  Verificati on Documents and Materials Required for Environmental Agent 
Permit Document of Natural Insect Repelling Substances Modification 
Applications  
 
 Manufacture Permit Document  Import Permit Document  
Company 
name  or 
address  1. Photocopy of company license or 
document of proof for company 
registration (not required if not a 
company)  
2. Photocopy of business 
registration certificate (not 
required if a company)  
3. The original permit document  
4. Labels  (note)  1. Photocopy of company license or 
document of proof for  company 
registration (not required if not a 
company)  
2. Photocopy of business 
registration certificate (not 
required if a company)  
3. The original permit document  
4. Labels  (note)  
Responsible 
person  1. Photocopy of person 
identification  
2. The original p ermit document  1. Photocopy of person 
identification  
2. The original permit document  
Product 
name  1. The original permit document  
2. The last date of manufacture, lot 
number and quantity of 
environmental agent  
3. Labels  1. The original permit document  
2. The last date of manufacture, lot 
number and quantity of 
environmental agent  
3. Labels  
4. Do cument of proof issued by a 
firm of exported country  
 
 
 Article 22 Attachment 9
Attachment  9 
Toxicity Testing Items for Registering Environmen tal Agent Active Components in Taiwan for the first 
Time  
Testing Items  Mandatory  Optional  
Acute toxicity testing    
Acute oral toxicity  ○  
Acute dermal toxicity  ○  
Acute inhalation toxicity  ○  
Acute eye irritation  ○  
Acute dermal irritation  ○  
Dermal sensitization  ○  
Acute neurotoxicity   △ 
Subchronic  toxicity  testing    
90-day feeding toxicity  ○  
21-day dermal toxicity   △ 
90-day i nhalation  toxicity   △ 
90-day neurotoxicity   △ 
Chronic  toxicity  testing    
Chronic feeding  toxicity  ○  
Oncogenicity  ○  
Two-Generations  Reproduction Toxicity  ○  
Teratogenicity  ○  
Mutagenicity  testing    
In vitro  mammalian cell assay  ○  
Bacterial rever se gene mutation assay  ○  
In vivo  cytogenetics  ○  
Metabolism    
Metabolism in animal  ○  
Metabolism in plant   △ 
Environmental fate studies    
Hydrolysis  ○  
Photodegradation  ○  
Metabolism in soil  ○  
Metabolism in Aquatic   △ 
Accumulation studies   △ 
Non-target organism toxicity    
Aquatic organism toxicity  ○  
Avian toxicity   △ 
Honey bee acute contact toxicity   △ 
△Optional items: original manufacturers in possession of toxicity test data shall submit such data.Attachment  4  
Toxicity Testing Items fo r Registering Environmental Agent Active Components in 
Taiwan for the first Time  
Testing Items  Mandatory  Optional  
Acute toxicity testing    
Acute oral toxicity  ○  
Acute dermal toxicity  ○  
Acute inhalation toxicity  ○  
Primary eye irritation  ○  
Primary  dermal irritation  ○  
Dermal sensitization  ○  
Acute delayed neurotoxicity   △ 
Subchronic testing    
90-day feeding studies  ○  
21-day dermal studies   △ 
90-day inhalation   △ 
90-day neurotoxicity   △ 
Chronic testing    
Chronic feeding  ○  
Oncogenicity study ○  
Reproduction -2 generations at least  ○  
Teratogenicity  ○  
Mutagenicity    
Chromosomal aberration  ○  
Gene mutation  ○  
Other genotoxic effects  ○  
Metabolism    
Metabolism in animal  ○  
Metabolism in plant   △ 
Environmental fate studies    
Hydroly sis ○  
Photodegradation  ○  
Metabolism in soil  ○  
Metabolism in Aquatic   △ 
Accumulation studies   △ 
Non-target organism toxicity    
Aquatic organism toxicity  ○  
Avian toxicity   △ 
Honey bee acute contact toxicity   △ 
△Optional items: original manufactu rers in possession of toxicity test data shall submit such data.Article 22 Attachment 10
Attachment 10 
Toxicity Testing Items for Technical Grade Environmental Agents and General and Special Environmental Agents  
                  Test Items  
 
 
          Types  
 
Classifications  Active 
Components  Acute 
Oral 
Toxicity  Acute 
Dermal 
Toxicit
y Acute 
Inhalation 
Toxicity  Acute 
eye 
irritation  
Acute 
dermal 
irritation  Mutagenicity  Dermal 
Sensitiz
-ation  Aquatic 
Organis
m 
Toxicity  
Technical 
Grade 
Envi ronmental 
Agent  Previously  
registered 
component 
(me-too 
comp.)  1 ○ ○ ○ ○ ○  ○ 
General Use 
Environmental 
Agents  Pesticid es,  
Miticide s 
(aerosol)  1       
 1 
2–3 ○ ○     
 1 
4 or more  ○ ○ ○ ○ ○ ○ 
 1 
Pesticid es, 
Miticide s 
(mosquito -repe
llent incense, 
electrically -act
ivated 
mosquito 
repellent 
incense, liquid 
electrically -act
ivated 
mosquito 
repellent 
incense, smoke 
generator, 
fumigant)  1       
 1 
2–3 ○ ○ 
 3    
 1 
4 or more  ○ ○ ○ ○ ○ ○ 
 1 
Pesticid es, 
Miticide s
bait, 
powder, 
granules, 
flakes, 
pieces/chunks, 
liquid, oil, 
paste)  1       
 1 
2–3 ○ ○  
 2   
 1 
4 or more  ○ ○ ○ ○ ○ ○ 
 1 
Rodenticide  1       
 1 
Bactericides  
/Fungicides  1       
 1 
2–3 ○ ○  
 2   
 1 
4 or more  ○ ○ ○ ○ ○ ○ 
 1 
Special 
environmental 
agents  Insecticide 
(liquid, 
suspensions, 
oils, wettable 
powders, 
ultra-low 
capacity 
agents, 
hydrates, 
emulsions, or 
other 
preparations), 
Germicides  1    
 2   
 1 
2–3 ○ ○  
 2   
 1 
4 or more  ○ ○ ○ ○ ○ ○ 
 1 
Explanation:  
I. ○: Mandatory  
II. 
 1: Fin ished products made with technical grade environmental agents that are toxic to aquatic organisms and labeled as being toxic to aquatic organisms are 
not required to submit aquatic organism toxicity data.  
III. 
 2: Finished products made with technical grad e environmental agents that can cause dermal sensitization and that have been labeled as causing dermal 
sensitization are not required to submit dermal sensitization data.  
IV. 
 3: Agents labeled to indicate that the windows should be temporarily closed whe n used in an indoor environment and that people and domestic animals Attachment 5 
Toxicity Testing Items for Technical Grade Environmental Agents and General and Special Environmental 
Agents  
                  Test It ems 
 
 
          Types  
 
Classifications  Active 
Components  Acute 
Oral 
Toxicity  Acute 
Dermal 
Toxicity  Acute 
Inhalation 
Toxicity  Acute 
eye 
irritation  
Acute 
dermal 
irritation  Mutageni
-city Dermal 
Sensitiz
-ation  Aquatic 
Organism 
Toxicity  
Technical 
Grade 
Environ mental 
Agent  Previously  
registered 
component 
(me-too comp.)  1 ○ ○ ○ ○ ○  ○ 
General Use 
Environmental 
Agents  Pesticid es,  
Miticide s 
(aerosol)  1       
 1 
2–3 ○ ○     
 1 
4 or more  ○ ○ ○ ○ ○ ○ 
 1 
Pesticid es, 
Miticide s 
(mosquito -repell
ent incense, 
electrically -activ
ated mosquito 
repellent 
incense, liquid 
electrically -activ
ated mosquito 
repellent 
incense, smok e 
generator, 
fumigant)  1       
 1 
2–3 ○ ○ 
 3    
 1 
4 or more  ○ ○ ○ ○ ○ ○ 
 1 
Pesticid es, 
Miticides
bait, 
powder, 
granules, flakes, 
pieces/chunks, 
liquid, oil, 
paste)  1       
 1 
2–3 ○ ○  
 2   
 1 
4 or more  ○ ○ ○ ○ ○ ○ 
 1 
Rodenticide  1       
 1 
Bactericides  
/Fungicides  1       
 1 
2–3 ○ ○  
 2   
 1 
4 or more  ○ ○ ○ ○ ○ ○ 
 1 
Special 
environmental 
agents  Insecticide 
(liquid, 
suspensions, 
oils, wettable 
powders, 
ultra-low 
capacity agents, 
hydrates, 
emulsions, or 
other 
preparations), 
Germicides  1    
 2   
 1 
2–3 ○ ○  
 2   
 1 
4 or more  ○ ○ ○ ○ ○ ○ 
 1 
Explanation:  
I. ○: Mandatory  
II. 
 1: Finished products made with technical grade environmental agents that are toxic to aquatic organisms and labeled as being toxic to 
aquatic organi sms are not required to submit aquatic organism toxicity data.  
III. 
 2: Finished products made with technical grade environmental agents that can cause dermal sensitization and that have been la beled as 
causing dermal sensitization are not required to subm it dermal sensitization data.  
IV. 
 3: Agents labeled to indicate that the windows should be temporarily closed when used in an indoor environment and that peopl e and 
domestic animals should vacate the space are exempt from having to submit acute inhalation  toxicity testing data of the finished product, 
whereas those without such labeling must submit said data.  should vacate the space are exempt from having to submit acute inhalation toxicity testing data of the finished product, wher eas those without such labeling 
must submit said data.  
V.  If an active component of an environmental sanitation germicide is being registered for environmental use for the first time, bu t the same active component 
has already been registered for agricultural, pharmaceutical, or veterinary use, technical grade enviro nmental agent toxicity testing items shall be submitted.  
VI. Mutagenicity testing items including In vitro  mammalian cell assay, Bacterial reverse gene mutation assay, and In vivo  cytogenetics . 
VII. Registering pheromone for environmental agent active comp onents in Taiwan for the first Time, toxicity testing items are the same as the items of me -too 
comp.  
 
 
 V.  If an active component of an environmental sanitation germicide is being registered for environmental use for the first t ime, but the same 
active  component has already been registered for agricultural, pharmaceutical, or veterinary use, technical grade environmental agen t 
toxicity testing items shall be submitted.  
VI. Mutagenicity testing items including In vitro  mammalian cell assay, Bacterial rev erse gene mutation assay, and In vivo  cytogenetics . 
VII. Registering pheromone for environmental agent active components in Taiwan for the first Time, toxicity testing items are the same as the 
items of me -too comp.  Article 22 Attachment 11
Attachment  11 
Toxicity Testing Items for Registering Environmental Agent Active Components of chemical repellent 
agents for human use in Taiwan for the first Time  
 
I. Toxicity (Pathogenicity) Testing for Microbial Preparations Used as environmental A gents:  
Test Items  Mandatory  Optional  
1. Biological 
toxicity  
testing  (1) Acute oral toxicity (pathogenicity testing)  
(2) Acute dermal toxicity  
(3) Acute pulmonary or inhalation toxicity 
(pathogenicity testing)  
(4) Eye irritation (contagion testing)  
(5) De rmal sensitization  
(6) Intravenous injection acute toxicity 
(pathogenicity testing)  
(7) Cell culture testing  
(8) Other  ○ 
○ 
○ 
 
○ 
△ 
△ 
 
△ 
△  
 
 
 
△1 
 
 
 
△2 
2. Ecological 
Toxicity Data  
△3 (1) Aquatic organism acute toxicity  
(2) Avian acute toxicity  
(3) Non -target plant pathogeny  
(4) Non -target insect pa thogeny  
(5) Honey bee pathogeny/acute toxicity  ○ 
△ 
△ 
△ 
△ △4 
△4 
 
△4 
 
 
II. Toxicity (Pathogenicity) Testing of Pollution Control Agents and Pollution Control Microbial 
Preparations:  
Test Items  Mandatory  Optional  
1. Biological 
toxicity 
testing  (1) Acute ora l toxicity  (pathogeny test)  
(2) Acute dermal toxicity test  
(3) Acute lung or inhalation toxicity 
(pathogeny test)  
(4) Eye irritation (infection test)  
(5) Allergic reaction  ○ 
△ 
△ 
 
△ 
△  
2. Ecological 
Toxicity Data  
△3 
 (1) Residue in the environment from 
microbial preparation production   
(2) Impact on nutrient cycling  
(3) Acute aquatic organism toxicity  
(4) Aquatic organism acute toxicity  
(5) Other  △ 
 
△ 
○(aquatic)  
○(soil)  
△  
 
△5 
△5 
 
Explanation:  
I. ○: Mandatory  
II. 
 : Further testing dependant on results.  
III. 
 1: For opportunistic pathogens, injection pathology test results (intravenous, intracerebral, or 
intraperitoneal) shall be submitted.  
IV. 
 2: This data must be submitted for viral environmental agent microbial preparations.  
V . 
 3: For pollution contro l agents and environmental agent microbial preparations consisting of microbes 
for which no literature or reports exist for whether they are pathogenic to the human body or other 
beneficial biological life, if used in physical or chemical isolation process ing equipment, or if the 
quantity of microbes from the preparation occurring in the discharge from this processing (total Attachment  6  
Testing Items for Microbi al Preparations Used ad Environmental Agents and Pollution 
Control Agents  
 
I. Toxicity (Pathogenicity) Testing for Microbial Preparations Used as environmental 
Agents:  
Test Items  Mandatory  Optional  
1. Biological 
toxicity  
testing  (1) Acute oral toxicity (pathogenicity testing)  
(2) Acute dermal toxicity  
(3) Acute pulmonary or inhalation toxicity 
(pathogenicity testing)  
(4) Eye irritation (contagion testing)  
(5) Dermal sensitization  
(6) Intravenous injection acute toxicity 
(pathogenicity testing)  
(7) Cell c ulture testing  
(8) Other  ○ 
○ 
○ 
 
○ 
△ 
△ 
 
△ 
△  
 
 
 
△1 
 
 
 
△2 
2. Ecological 
Toxicity Data  
△3 (1) Aquatic organism acute toxicity  
(2) Avian acute toxicity  
(3) Non -target plant pathogeny  
(4) Non -target insect pathogeny  
(5) Honey bee pathogeny/acute toxicity  ○ 
△ 
△ 
△ 
△ △4 
△4 
 
△4 
 
II. Toxicity (Pathogenicity) Testing of Pollution Control Agents and Pollution Control Microbial 
Preparations:  
Test Items  Mandatory  Optional  
1. Biological 
toxici ty 
testing  (1) Acute oral toxicity  (pathogeny test)  
(2) Acute dermal toxicity test  
(3) Acute lung or inhalation toxicity 
(pathogeny test)  
(4) Eye irritation (infection test)  
(5) Allergic reaction  ○ 
△ 
△ 
 
△ 
△  
2. Ecological 
Toxicity Data  
△3 
 (1) Residue in  the environment from 
microbial preparation production   
(2) Impact on nutrient cycling  
(3) Acute aquatic organism toxicity  
(4) Aquatic organism acute toxicity  
(5) Other  △ 
 
△ 
○(aquatic)  
○(soil)  
△  
 
△5 
△5 
 
Explanation:  
I. ○: Mandatory  
II. △: Further testing depend ant on results.  
III. △1: For opportunistic pathogens, injection pathology test results (intravenous, intracerebral, or 
intraperitoneal) shall be submitted.  
IV. △2: This data must be submitted for viral environmental agent microbial preparations.  
V. △3: For pollution c ontrol agents and environmental agent microbial preparations consisting of 
microbes for which no literature or reports exist for whether they are pathogenic to the human body or 
other beneficial biological life, if used in physical or chemical isolation pr ocessing equipment, or if the 
quantity of microbes from the preparation occurring in the discharge from this processing (total microbes per milliliter) is lower than the quantity of the same microbe in the carrier substance (water or 
soil), data on residue in t he environment from microbial preparation production may be submitted, and 
the data listed in the sub -items of this main testing item do not need to be submitted. However, projects 
involving genetic engineering absolutely must perform this testingitem.  
VI. 
4: Not required if agent is to be used indoors.  
VII. 
 5: Mandatory for genetically engineered microbial preparations; other importers or local operators 
shall be required to conduct such testing as deemed necessary.  microbes per milliliter) is lower than the quantity of the same microbe in the carrier substance (water or 
soil), data on residue  in the environment from microbial preparation production may be submitted, and 
the data listed in the sub -items of this main testing item do not need to be submitted. However, projects 
involving genetic engineering absolutely must perform this testingitem . 
 △4: Not required if agent is to be used indoors.
 △5: Mandatory for genetically engineered microbial preparations; other importers or local 
operators shall be required to conduct such testing as deemed necessary.
 Article 22 Attachment 12
Attachment 12  
Toxicity Testing Items for New Active Components of chemical repellent agents for human use  
 
Testing Items  Mandatory  Optional  
Acute toxicity testing    
Acute oral toxicity  ○  
Acute dermal toxicity  ○  
Acute inhalation toxicity  ○  
Acute eye irritation  ○  
Acute dermal irritation  ○  
Dermal sensitization  ○  
Acute neurotoxicity   △ 
Subchronic  toxicity  testing    
90-day feeding toxicity  ○  
21-day dermal toxicity   △ 
90-day inhalation  toxicity   △ 
90-day neurotoxicity   △ 
Chronic  toxicity  testing    
Chronic feeding  toxicity  ○  
Oncogenicity  ○  
Two-Generations  Reproduction Toxicity  ○  
Teratogenicity  ○  
Mutagenicity  testing    
In vitro  mammalian cell assay  ○  
Bacterial reverse gene mutation assay  ○  
In vivo  cytogenetics  ○  
Metabolism    
Metabolism in animal  ○  
Metabolism in plant   △ 
Environmental fate studies    
Hydrolysis  ○  
Photodegradation  ○  
Metabolism in soil  ○  
Metabolism in Aquatic   △ 
Accumulation studies   △ 
Nontarget organism toxicity    
Aquatic organism toxicity  ○  
Avian toxicity   △ 
Honey bee acute contact toxicity   △ 
 
 Article 22 Attachment 13
Attachment 13  
Toxicity Testing Items for Technical Grade and General Environmental Agents for chemical repellent agents for human use  
 
             Test Items  
 
 
Classifications  Active 
Components  Acute 
Oral 
Toxicity  Acute 
Dermal 
Toxicity  Acute 
Inhalation 
Toxicity  Acute eye 
irritation 
Acute 
dermal 
irritation  Mutagenicity  Dermal 
Sensitization  Acute 
neurotoxicity  
Technical 
Grade 
Environmental 
Agent  Previously 
registered 
component 
(me-too 
comp.)  1 
  
  
  
  
  
  
  
General Use 
Environmental 
Agents  Chemical 
repellent 
agents for 
human use  1 
  
 2 
 1 
 3  
   
2-3 
  
  
 1 
 3  
   
4 
  
  
  
  
  
   
 
Explanation:  
I. It shall be required if foreign original manufacturer has the toxicity testing information.  
II. It shall be required if finished product type is aerosol.  
III. It shall be required if acute oral LD 50 < 2000  mg/kg bw.  
IV. It shall be required if finished product cause dermal sensitization.  
V . Mutagenicity testing items including In vitro mammalian ce ll assay, Bacterial reverse gene mutation assay, and In vivo 
cytogenetics.  
 
 Article 24 Attachment 14
Attachment  14  
Type of Organisms and Conditions for Environmental Agent Performance tests  
Test Organisms  Type Scientific 
Name  Sex Strain No. of 
Genera
tion Age Test 
Condition  
Mosquitoes, 
adults  Aedes albopictus  ○ Female  ○ <10 3-7 days of 
eclosion  Have not 
sucked 
blood  
 Aedes aegypti  ○ Female  ○ <10 3-7 days of 
eclosion  Have not 
sucked 
blood  
and Culex  
quinquefasciatus   
culex pipiens  
molestus  ○ 
 
 
○ 
 Female  
 
 
Female  ○ 
 
 
○ <10 
 
 
<10 3-7 days of 
eclosion  
 
3-7 days of 
eclosion  Have not 
sucked 
blood  
Have not 
sucked 
blood  
Mosquitoes, 
larvae  Aedes albopictus  ○  ○ <10 3-4 days   
 Aedes aegypti   ○  ○ <10 3-4 days   
and Culex  
quinquefas
ciatus 
culex 
pipiens  
molestus  ○ 
 
○ 
  ○ 
 
○ 
 <10 
 
<10 3 days early ~ 
4 days end  
 
3 days early ~ 
4 days end   
Flies, adults  Musca domestica  ○ Female  ○ <10 3-7 days of 
eclosion   
Flies, larvae  Musca domestica  ○  ○ <10 3-5 days   
Cockroaches  Periplaneta 
americana  ○ Female
/male ○  Adult △  
 Blattella ○ Female ○  Adult △  Attachment  7 
Type of Organisms and Conditions for Environmental Agent Performance tests  
Test Organisms  Type Scientific 
Name  Sex Strain  No. of 
Genera
tion Age Test 
Condition  
Mosquitoes, 
adults  Aedes albopictus  ○ Female  ○ <10 3-7 days of 
eclosion  Have not 
sucked 
blood  
 Aedes aegypti  ○ Female  ○ <10 3-7 days of 
eclosion  Have not 
sucked 
blood  
and Culex  
quinquefasciatus   
culex pipiens  
molestus  ○ 
 
 
○ 
 Female  
 
 
Female  ○ 
 
 
○ <10 
 
 
<10 3-7 days of 
eclosion  
 
3-7 days of 
eclosion  Have not 
sucked 
blood  
Have not 
sucked 
blood  
Mosquitoes, 
larvae  Aedes albopictus  ○  ○ <10 3-4 days   
 Aedes aegypti   ○  ○ <10 3-4 days   
and Culex  
quinquefas
ciatus  
culex 
pipiens  
molestus  ○ 
 
○ 
  ○ 
 
○ 
 <10 
 
<10 3-4 days  
 
3-4 days   
Flies, adul ts Musca domestica  ○ Female  ○ <10 3-7 days of 
eclosion   
Flies, larvae  Musca domestica  ○  ○ <10 3-5 days   
Cockroaches  Periplaneta 
americana  ○ Female
/male ○  Adult △  
 Blattella ○ Female ○  Adult △  or 
or or 
or or 
or or 
or germanica  /male 
Fleas Ctenocephalides 
felis ○  ○  Adult  Have not 
sucked 
blood  
 Xenopsylla 
cheopis  ○  ○  Adult  Have not 
sucked 
blood  
Flea larvae  Ctenocephalides 
felis ○  ○  2-3 days   
 Xenopsyl la 
cheopis  ○  ○  2-3 days   
Termites (indoor)  Coptotermes 
flaviceps  ○  ○  Workers   
 Odontotermes 
formosanus   ○  ○  Workers   
Ants No limit for types 
or strains  No limit 
for types 
or strains   ○  Workers   
Fire ants △ No limit for 
strains  No limit 
for 
strains      
Rats Rattus 
norvegicus  ○ ○ ○ <10 Adult (>200g)   
 Rattus rattus   ○ ○ ○ <10 Adult (>100g)   
Forcipomyia 
taiwana   ○ Female  ○    
Forcipomyia 
taiwana, larvae  
Dust mites  
 
and 
 
Drosophila , adults  
  
 
Dermatophagoid
es farina  
Dermatophagoid
es pteronyss inus 
Drosophila  
albomicans  
 ○ 
 
○ 
 
○ 
 
○ 
 
  ○ 
 
 
 
 
 
○ 
 
  
 
 
 
 
 
<10  
 
 
 
 
 
1-3 days  
  germanica  /male 
Fleas Ctenocephalides 
felis ○  ○  Adul t Have not 
sucked 
blood  
 Xenopsylla 
cheopis  ○  ○  Adult  Have not 
sucked 
blood  
Flea larvae  Ctenocephalides 
felis ○  ○  2-3 days   
 Xenopsylla 
cheopis  ○  ○  2-3 days   
Termites (indoor)  Coptotermes 
flaviceps  ○  ○  Workers   
 Odontotermes 
formosanus   ○  ○  Workers   
Ants No limit for types 
or strains  No limit 
for types 
or strains   ○  Workers   
Fire ants △ No limit for 
strains  No limit 
for 
strains       
Rats Rattus 
norvegicus  ○ ○ ○ <10 Adult (>200g)   
 Rattus rattus   ○ ○ ○ <10 Adult (>100g)   
Forcipomyia 
taiwana  ○ ○ Female  ○    
Forcipomyia 
taiwana, larvae  
Dust mites  
 
and 
 
Drosophila , adults  
 
Mothfly  
 
 
Dermatophagoid
es farina  
Dermatophagoid
es pteronyssinus  
Drosophila  
albomicans  
 ○ 
 
○ 
 
○ 
 
○ 
 
○  ○ 
 
 
 
 
 
○ 
 
○  
 
 
 
 
 
<10  
 
 
 
 
 
1-3 days  
  
Explanation:   or or 
or 
or 
or or 
or 
or Mothfly  
Cimicidae  
Silverfish  
Booklice  
case-bearing clothes moth  
Carpet beetles  
spider  
springtail  Cimex lectularius  
Cimex hemipterus  
Ctenoletisma villosa  
Lepisma saccharin a 
Liposcdis entomophila  
L ipo cel is bostricho phil us  
 
 
Crossopriza lyoni  
Lycosidae  
Entomobryidae
male/female  
male/female
male/female
male/female
male/female
male/female
male/female
male/female
male/female
male/female
male/female
Adult or  larvae 
Adult or nymphs  
Adult or nymphs  
Adult or nymphs  
Adult  
Adult  
Adult  
larvae  
end stage of  larvae 
Adult  
Adult  
Adult or nymphs   
Explanation:   
I. ○: Mandatory  
II. It shall use larvae or nymphs if it is insect growth regulators (IGR)  III. ○: Mand atory  
IV. △: If fire ant testing uses insect growth regulators (IGR, then workers or queens 
must be used; Cockroach mortality testing or bait efficacy testing employing IGR 
must use 3rd instar or older larvae.  Article 25 Attachment 15
Attachment  15  
Control Efficacy Testing Results Evaluation Standards for Environmental Agent Permit 
Registrations  
Efficacy Evaluation standards  Required efficacy testing report data  
Pesticid es 
efficacy 
Miticide s 
efficacy  
Repellent  
efficary  For residue cont rol, mortality rate greater than 70 
%. 
 
 1. 24 hour mortality.  
2. For those testing reptiles with residue method and 
suitable for indoor uses, test report on residue 
period (2 weeks at least) is required.  
1. Mortality rate greater than 80 %.  
2. Those a dded with knockdown agent shall 
comply with review criteria: KT 50 less than 6 
minutes for mosquitoes, KT 50 less than 8 
minutes for flies and KT 50 less than 11 
minutes for cockroaches are considered 
effective for knockdown.  1. 24 hour mortality.  
2. The add ed knockdown agent shall have a 50% 
knockdown time ( KT 50). 
For long release formulations (such as baits), 
mortality greater than 80 %.  There shall be mortality and the number of average 
days of mortality.  Maximum observation period is 
14 days.  
Flush -out time: FT50 less than or equal to 7 
minutes is considered effective for flush -out.  Flush -out agent shall have 50% flush -out time.  
Growth 
inhibition 
efficacy  Growth retarding rate (or mortality) greater than 
or equal to 70 % is considered effective fo r 
growth retarding.  Growth retarding rate for control of cockroaches, ants, 
fire ants and other insects.   
Pupal or eclosion retarding rate greater than or 
equal to 50 % is considered effective for growth 
regulation.  Those for control of larvae of mosq uitoes, flies and 
fleas shall have pupal rate and eclosion rate.  
Knockdown 
efficacy(mo
squito coil, 
mosquito 
mat, 
mosquito 
liquid)  1. KT 50 less than 6 minutes for mosquitoes, 
KT 50 less than 8 minutes for flies and KT 50 
less than 11 minutes for cockroaches  are 
considered effective for knockdown.  
2. Knockdown agent with a mortality of 80% is 
considered effective for pest control.  1. Knockdown agent shall have 50% knockdown 
time KT 50). 
2. The knockdown agent looking for not only 
knockdown effect but also con trol effect shall have 
24 hour mortality.   
Rat mortality  Greater than 80 %  Rodenticides shall have mortality and the number of 
average days of mortality.  
Sterilization 
effect  Sterilization rate greater than 99.9 %.  Bactericides/fungicides shall be mar ked with 
disinfection rate (note 1).  
Repelling  Repelling rate greater than 75 %.  Insect repellents shall have repelling effect of 24 Attachment  8  
Control Efficacy Testin g Results Evaluation Standards for Environmental Agent Permit 
Registrations  
Efficacy Evaluation standards  Required efficacy testing report data  
Pesticid es 
efficacy 
Miticide s 
efficacy  For residue control, mortality rate greater than 70 
%. 
 
 1. 24 hour mor tality.  
2. For those testing reptiles with residue method and 
suitable for indoor uses, test report on residue 
period (2 weeks at least) is required.  
1. Mortality rate greater than 80 %.  
2. Those added with knockdown agent shall 
comply with review crit eria: KT 50 less than 6 
minutes for mosquitoes, KT 50 less than 8 
minutes for flies and KT 50 less than 11 
minutes for cockroaches are considered 
effective for knockdown.  1. 24 hour mortality.  
2. The added knockdown agent shall have a 50% 
knockdown time ( KT 50). 
For long release formulations (such as baits), 
mortality greater than 80 %.  There shall be mortality and the number of average 
days of mortality.  Maximum observation period is 
14 days.  
Flush -out time: FT50 less than or equal to 7 
minutes is consi dered effective for flush -out.  Flush -out agent shall have 50% flush -out time.  
Growth 
inhibition 
efficacy  Growth retarding rate (or mortality) greater than 
or equal to 70 % is considered effective for 
growth retarding.  Growth retarding rate for control of cockroaches, ants, 
fire ants and other insects.   
Pupal or eclosion retarding rate greater than or 
equal to 50 % is considered effective for growth 
regulation.  Those for control of larvae of mosquitoes, flies and 
fleas shall have pupal rate and eclos ion rate.  
Knockdown 
efficacy(mo
squito coil, 
mosquito 
mat, 
mosquito 
liquid)  1. KT 50 less than 6 minutes for mosquitoes, 
KT 50 less than 8 minutes for flies and KT 50 
less than 11 minutes for cockroaches are 
considered effective for knockdown.  
2. Knockdown a gent with a mortality of 80% is 
considered effective for pest control.  1. Knockdown agent shall have 50% knockdown 
time KT 50). 
2. The knockdown agent looking for not only 
knockdown effect but also control effect shall have 
24 hour mortality.   
Rat mortal ity  Greater than 80 %  Rodenticides shall have mortality and the number of 
average days of mortality.  
Sterilization 
effect  Sterilization rate greater than 99.9 %.  Bactericides/fungicides shall be marked with 
disinfection rate (note 1).  
Repelling  Repel ling rate greater than 75 %.  Insect repellents shall have repelling effect of 24 hours.  
Note 1: The following bacteria should be included in Environmental Sanitation Germicide testing..  
Bacillus cere us Bacillus cereus  BCRC 10603  
Escherichia coli  Escherichia coli  BCRC 10675  
Pseudomonas aeruginosa  Pseudomonas aeruginosa  BCRC 10944  
Salmonella choleraesuis  Salmonella choleraesuis  BCRC 10744  
Staphlococcus aureus 
subsp. aureus  Staphlococcus aureus subsp . aureus  BCRC12657  
Aspergillus niger  (note 2)  Aspergillus niger  BCRC 30130  
Note 2: For germicidal preparations used as environmental sanitation agents not targeting fungi, Aspergillus niger  
testing is not required.  
 hours.  
Note 1: The following bacteria should be included in Environmental Sanitation Germicide testing..  
Bacillus cereus  Bacillus cereus  BCRC 10603  
Escherichia coli  Escheri chia coli  BCRC 10675  
Pseudomonas aeruginosa  Pseudomonas aeruginosa  BCRC 10944  
Salmonella choleraesuis  Salmonella choleraesuis  BCRC 10744  
Staphlococcus aureus 
subsp. aureus  Staphlococcus aureus subsp. aureus  BCRC12657  
Aspergillus niger  (note 2)  Aspergil lus niger  BCRC 30130  
Note 2: For germicidal preparations used as environmental sanitation agents not targeting fungi, Aspergillus niger  
testing is not required.