1 Regulations of New and Existing Chemical Substances 
Registration  
The original 33 articles  were  promulgated by  Order of  the Environmental Protection Administration , Executive 
Yuan  on December 4 , 2014  and took into force  from December 11, 2014 . 
The f ull 33 articles  were  amended and  promulgated by  Order of  the Environmental Protection Administration, 
Executive Yuan on  March 11 , 201 9. 
The f ull 32 articles  were  amended and  promulgated by Order of the Environmental Protection Administration, 
Executive Yuan on  November 23 , 2021 . 
Table of Contents  
Chapter 1 General Principles  
Chapter 2 New Chemical Substances Registration  
Chapter 3 Existing Chemical Substances Registration  
Chapter 4 Information Dissemination and Protection of Business Secrets  
Chapter 5 Supplementary Provisions  
Appendix 1  
Appendix 2  
Appendix 3  
Appendix 4  
Appendix 5  
Appendix 6 
Appendix 7  
Appendix 8  
Appendix 9  
Appendix 1 0 
 Chapter 1 General Principles  
Article 1 These Regulations are stipulated pursuant to Article 30, paragraph 5 of 
the Toxic and Concerned Chemical Substances Control Act (hereinafter “this 
Act”). 
Article 2  The term “registrant ” as used herein means a natural person, a juristic 
person, an uninco rporated body having a representative or manager, an 
administrative authority, or a body, who may be the subject of rights and 
obligations under other laws, that is subject to chemical substances 
registration pursuant to Article 30 of this Act.  
A registrant may appoint a representative to process the application 
and/or reporting affairs covered in the Regulations. The representative 
should be a natural person possessing the nationality of the Republic of 
China (R.O.C.), or a juristic person, an ins titute or an organization that is 
constituted or registered by law.  2 When applying for chemical substances registration according to the 
Regulations, a registrant shall attach a copy of a National Identification Card, 
a copy of company registration, busines s registration, factory registration, or 
other documents verifying the registrant ’s establishment. A representative 
shall provide a notarized or certified appointment letter.  
Article 3  The terms used in the Regulations are defined as follows:  
I. “Chemical Su bstance ” refers to a chemical element and its 
compounds in the natural state or obtained by any manufacturing 
process, including any additives necessary to preserve its stability 
and any unintended constituents deriving from the processes 
used, but excludi ng any solvent which may be separated without 
affecting the stability of the substance or changing its 
composition.  
II. “Substance which Occurs in Nature ” refers to a naturally 
occurring substance as such, unprocessed or processed only by 
manual, mechanical or  gravitational means, by dissolution in 
water, by flotation, by extraction with water, by steam distillation 
or by heating solely to remove water, or which is extracted from 
air by any means without any chemical changes, or a large 
molecule from living org anisms or natural polymer obtained 
without chemical processing.  
III. “Mixture ” refers to a mix or solution composed of two or more  
substances which do not react.  
IV. “Article ” refers to an object which during production is given a 
specific shape or design.  
V. “Polymer ” refers to a chemical substance that fits the following 
criteria:  
A. A macro -molecular chemical substance consisting of 
molecules characterized by the sequence of one or more 
types of monomer units;  
B. A molecule containing at least three monomer units that 
are covalently bound to at least one other monomer unit; 
such molecules account for over 50% of the weight of that 
substance, and the amount of the said molecules presenting 
the same molecular weight must be less than 50% of the 
weight of that substance; and  
C. Differences in the molecular weight are primarily 
attributable to differences in the number of monomer units.  
VI. “Polymer to which the 2% Rule is applicable ” refers to 
monomers or reactants of polymer that are not regarded as part 
of the polymer when the weig ht percentage of the monomers or 
reactants is less than 2%; if the naming of the polymer is a 3 monomer -based representation, it may or may not include 
monomers and other reactants used at less than 2% weight. A 
monomer -based representation means the naming of polymer is 
based on constituent monomers.  
VII. “Polymer of Low Concern ” (PLC) refers to a chemical substance 
that is evaluated by the central competent authority and fulfills 
any one of the following conditions:  
A. Polymer with an average molecular weight in a range of 
1,000 to 10,000 Daltons, containing oligomers of 
molecular weights below 500 Daltons in an amount less 
than 10% and oligomers of molecular weights below 1,000 
Daltons in an amount less than 25%;  
B. Polymer with an average molecular weight over 10,000  
Daltons, containing oligomers of molecular weights below 
500 Daltons in an amount less than 2% and oligomers of 
molecular weights below 1,000 Daltons in an amount less 
than 5%;  
C. Polyester; or  
D. Insoluble polymer.  
VIII. “Intermediate ” refers to a chemical substance  produced and 
consumed in the course of the manufacturing process of another 
chemical substance.  
IX. “On-site Isolated Intermediate ” refers to an intermediate that is 
produced and consumed on the same site.  
X. “Incidental Reaction Product ” refers to a chemical su bstance 
resulting from a chemical reaction induced by any change in 
environmental condition during the use and the storage of the 
original chemical substance.  
XI. “Impurity ” refers to an unintended constituent present in a 
substance as manufactured. It origina tes from the starting 
materials or is the result of secondary or incomplete reactions 
during the production process. While it is present in the final 
substance, it was not intentionally added, nor does it enhance the 
commercial value of that substance. An individual impurity shall 
be no more than 10% (w/w) of the final substance. The total of 
all impurities present shall be no more than 20% (w/w) of the 
substance.  
XII. “Scientific Research and Development ” (SRD) refers to any 
scientific experimentation, educatio n, analysis, or chemical 
research carried out under strictly controlled conditions for 
scientific or academic research.  
XIII. “Product and Process Orientated Research and Development ” 4 (PPORD) refers to any scientific development related to product 
development or  the further development of a substance, in the 
course of which pilot plants or production trials are used to 
develop the production process or to test the fields of application 
of the substance.  
XIV. “Substance classified as  Carcinogenic, Mutagenic or Toxic for 
Reproduction (CMR) ” refers to a substance that is classified as 
carcinogenicity category 1, mutagenicity category 1, or 
reproductive toxicity category 1, based on the R.O.C. National 
Standards (CNS) 15030.  
XV. “Chemical Su bstance under Customs Supervision ” refers to a 
chemical substance under customs supervision, which is 
temporarily stored or placed in a harbor ’s designated area, 
warehouse, container freight station, bonded warehouse, logistics 
center, or free trade zone, with a provision for re -exportation or 
transit.  
Article 4  The Regulations shall not apply to any of the following substances or 
items: 
I. Substances which occur in nature  
II. Chemical substances in machines or equipment for test run 
purposes  
III. Inseparable intermediates from chemical reactions in the reaction 
vessel or production process  
IV. Chemical substances for national security or national defense 
purposes  
V. Chemical substances under customs supervision  
VI. Chemical waste produced or released from industrial proc esses  
VII. Incidental reaction products or impurities that are of no 
commercial application  
VIII. Mixtures, but individual constituents of mixtures shall not be 
applied to this Article  
IX. Articles  
X. Polymer to which the 2% Rule is Applicable and is listed on the 
inventory  of existing chemical substances  
The Regulations shall not apply to the substances or items  regulated 
under the following Acts promulgated by the government authorities:  
I. Agro -pesticides, as defined by the Agro -pesticides Management 
Act 
II. Feeds and feed additives, as defined by the Feed Control Act  
III. Fertilizers, as defined by the Fertilizer Management Act  
IV. Veterinary drugs, as defined by the Veterinary Drugs Control Act  
V. Medicaments, as defined by the Pharmaceutical Affairs Act  5 VI. Controlled drugs, as defined by the Controlled Drugs Act  
VII. Cosmetics, as defined by the Cosmetic Hygiene and Safety Act  
VIII. Foods, food additives, food utensils, food containers or 
packaging, and food cleansers, as defined by the Act Governing 
Food Safety and Sanitation  
IX. Tobacco products, as  defined by the Tobacco Hazards Prevention 
Act 
X. Tobacco and alcohol, as defined by the Tobacco and Alcohol 
Administration Act  
XI. Radioactive materials, as defined by the Atomic Energy Act and 
the Ionizing Radiation Protection Act  
XII. Industrial use explosive mater ials, as defined by the Industrial 
Explosives Administrative Act  
XIII. Controlled chemicals as prescribed in the Occupational Safety 
and Health Act  
XIV. Chemical substances regulated by the Montreal Protocol under 
the Air Pollution Control Act  
XV. Environmental agents, a s defined by the Environmental Agents 
Control Act  
XVI. Toxic and concerned chemical substances, as defined by this Act  
For a chemical substance manufactured or imported as a raw material in 
the preceding paragraph, the chemical substance shall be subject to the  
provisions of the Regulations.  
 Chapter 2 New Chemical Substances Registration  
Article 5  To apply for new chemical substances registration approval, 
manufacturers or importers shall refer to the following registration types 
based on estimated annual manufactured or imported quantity:  
I. Standard registration: at 1 ton or more  
II. Simplified registration: at 100 kilograms or more, but less than 1 
ton 
III. Small quantity registration: less than 100 kilograms  
If the uses or properties of a new chemical substance to be manufactured 
or imported meets any of the following circumstances, its registration type 
shall be selected by referring to the estimated annual manufactured or 
imported quantity, as specified in Appendix 1.  
I. A substance used for the purpose of SRD  
II. A subs tance used for the purpose of PPORD  
III. An On -site Isolated Intermediate  
IV. Polymer  
V. Prior verified Polymer of Low Concern, PLC  
Article 6  The quantity thresholds for standard registration are specified in 6 Appendix 2.  
The registration information items of each registration type are specified 
as follows:  
I. Standard registration: as specified in Appendixes 3 and 4  
II. Simplified registration: as specified in Appendix 5  
III. Small quantity registration: as specified in Appendix 6  
Article 7  For a manufactured or imported new chemical substance undergoing 
application for simplified registration or small quantity registr ation pursuant 
to the previous two  Articles, the central competent authority may demand the 
registrant to register data in accordance with the requirements of st andard 
registration if the new chemical substance  is identified as a  CMR  substance . 
Article 8  For a new chemical substance meeting the circumstances of being a 
substance used for the purposes of SRD or PPORD; or having other special 
forms, in addition to registering the new chemical substance in accordance 
with the required information items of the Regulations, the registrant shall fill 
in and submit the following documents to the central competent authority:  
I. Registration form for SRD and PPORD  
II. Registratio n form for nanoscale chemical substances  
Article 9  Upon reviewing  information  of a new chemical substance  submitted by 
a registrant, the central competent authority shall approve the registration 
along with an incidental provision  to prohibit or restrict handling, and shall 
require the registrant to regularly report handling conditions, update  
registration report data, or submit chemical substances hazard information, if 
the central competent authority determines that there is a c oncern over the 
toxicological characteristics of a new chemical substance conforming to the 
definitions of Class 1, Class 2, or Class 3 toxic chemical substances.  
Upon reviewing  information  of a new chemical substance  submitted by 
a registrant, the central  competent authority shall approve the registration 
along with an incidental provision  to restrict handling, and shall require the 
registrant to submit information on exposure assessment and risk assessment, 
update registration report data, or submit chemi cal substances hazard 
information, if the central competent authority determines that there is a 
concern of environmental pollution or any threat to human health.  
Article 10  When different registrants apply to register the same new chemical 
substance join tly or sequentially, they may use common data needed for the 
registration through consultation.  
The new chemical substance, subjected to the joint registration pursuant 
to the preceding paragraph, is to be registered according to the Regulations, 
for which  the overall quantity of the joint registration shall be the sum of the 
individual quantities from each co -registrant.  
By taking into account the overall manufactured or imported quantity of 
the new chemical substances registered and approved, the central competent 7 authority may require registrants to apply for the new registration under the 
designated regist ration type or to apply for joint registration.  
For a joint registration that is agreed upon by co -registrants, but for 
which no agreement has been rea ched on the cost sharing of the registration 
data, the central competent authority may determine an average 
apportionment at the request of the application ’s registrants. The registration 
data can be used after the registrants have paid their respective sh ares of 
expenses according to the decision made by the central competent authority.  
Article 11  The central competent authority issues the registration number for a new 
chemical substance that is registered and approved.  
Article 12  The valid period of the  new chemical substances registration approval is 
5 years.  
Upon agreements for the joint registration for early and late registrants, 
the valid periods of such joint registration for the late registrants shall be 
consistent with those periods for the early  registrants.  
Article 13  A registrant, to extend the valid period of the registration approval, shall 
make an application to the central competent authority three to six months 
prior to its expiration. Information on estimated quantity of new chemical 
substances manufactured or imported for the following year shall be 
submitted to the central competent authority at the same time. Upon approval 
of the central competent authority, the extension shall be granted pursuant to 
the previous Article.  
If the centra l competent authority is unable to make the 
rejection/approval decision for the extensions before the original approval 
registration expires, those who file the extension application pursuant to the 
preceding paragraph may continue to manufacture or import  the new chemical 
substances, in compliance with the situation specified in the originally 
approved registration, until the review is completed.  
If the central competent authority is unable to make the 
rejection/approval decision for the extensions before the original approval 
registration expires, those who fail to file the extension application pursuant 
to paragraph 1 shall stop manufacturing or importing the new chemical 
substances after the original approval registration expires. If a registrant does 
not apply for an extension before the original approval registration expires, 
the original approval registration becomes ineffective exactly on the 
following day of t he expiration day specified in  the original approval 
registration. A new application for reg istration shall be made in order to 
continue manufacturing or importing such chemical substances.  
If the registration type intended for extension is inconsistent with the 
original approval registration, a new application for registration shall be 
made.  
Article 14  A new chemical substance registered and approved under any one of 8 following circumstances may be included in the inventory of existing 
chemical substances by the central competent authority:  
I. It shall be at least 5 years after the standard registration is filed 
and completed;  
II. It shall be at least 5 years after the PLC registration is filed and 
completed in accordance with the small quantity registration; or  
III. A new chemical substance becomes a toxic or concerned 
chemical substance announced by  the central competent 
authority.  
A registrant may apply for inclusion in the inventory of existing 
chemical substances, when a new chemical substance has been registered and 
approved for any of the following registrations:  
I. Standard registration filed and completed through submission of 
information on hazard assessment and exposure assessment, or  
II. PLC registration in accordance with the small quantity 
registration.  
A new chemical substance registered and approved, which has been 
included in the inventory of existing chemical substances pursuant to the 
provisions o f the preceding two  paragraphs, is subject to the related rules of 
registered and approved existing chemical substances.  
 Chapter 3 Existing Chemical Substances Registration  
Article 15  For an existing chemical substance first manufactured or imported in 
annual quantity of 100 kilograms or more, a registrant shall, within 6 months 
from the date of occurrence of the fact, apply for the phase 1 registration and 
attach information, as specified in Appendix 7. No existing chemical 
substance shall be manufactured or imported, unless the registration approval 
is obtained within the specified period.  
The central competent authority is to issue a phase 1 registration number 
to a registrant whose registra tion application is approved, pursuant to the 
preceding paragraph.  
Registration for existing chemical substances, manufactured or imported 
in annual quantity less than 100 kilograms, may be made in accordance with 
paragraph 1. After the registration applic ation is approved, the 
abovementioned existing chemical substances are subject to the Regulations.  
Article 16  The central competent authority may, by stages, designate the lists of 
existing chemical substances subject to standard registration, including t he 
names of the chemical substances, quantity thresholds and deadlines for 
registration, based on the circumstances of the phase 1 registration of existing 
chemical substances.  
The quantity thresholds subject to the standard registration of existing 
chemic al substances designated by stages pursuant to the previous paragraph 9 are specified in Appendix 8, whereas the designated lists and deadlines are 
specified in Appendix 9.  
Registrants manufacturing or importing any existing chemical 
substances listed in App endix 9 shall apply for the standard registration of 
such existing chemical substances and attach information, as specified in 
Appendixes 3 and 4.  
On-site isolated intermediates may be exempted from needing an 
application for the standard registration of existing chemical substances 
pursuant to the provisions of the pr eceding three  paragraphs.  
Registrants manufacturing or importing existing chemical substances, 
which are not any of the chemical substances listed in Appendix 9 or do not 
meet the quantity th resholds in Appendix 8, may apply for the registration of 
chemical substances pursuant to paragraph 3.  
Article 17  When different registrants, pursuant to Article 16, paragraphs 2 or 5, 
apply to register the same existing chemical substance jointly or sequ entially, 
they may use common data needed for the registration through consultation.  
The existing chemical substance, subjected to the joint registration 
pursuant to the preceding paragraph, is to be registered according to Article 
16, paragraph 3.  
For a j oint registration that is agreed upon by co -registrants, but for 
which no agreement has been reached on the cost sharing of the registration 
data, the central competent authority may determine an average 
apportionment at the request of the application ’s registrants. The registration 
data can be used after the share of expenses has been paid.  
Article 18  The central competent authority issues the completion number for the 
standard registration of an existing chemical substance to those who apply 
and complete  information registration specified in Appendix 3 pursuant to the 
provisions of the previous two  Articles.  
Upon acquisition of the completion number as described in the previous 
paragraph, the registrant shall complete information registration specified in  
Appendix 4 proactively or before the due date decided  by the central 
competent authority.  
 Chapter 4 Information Dissemination and Protection of 
Business Secrets  
Article 19  Information  on chemical substances  registered and approved by the 
central competent authority shall be disseminated to the public. The 
information items which shall be disseminated are as follows:  
I. Registrant information  
II. Names of chemical substances  
III. Manufacture or import conditions  
IV. Classification and labelling  10 V. Guidance on safe use  
VI. Physical and chemical properties  
VII. Toxicological and ecotoxicological information  
VIII. Hazard assessment  
IX. Exposure assessment  
The content pursuant to the previous paragraph shall be publicly 
disseminated through the Internet by the central competent authority.  
Article 20  Information on chemical substances  that is registered, which involves 
confidential matters on national defense or business secrets, shall be kept 
confidential.  
The aforementioned business secrets  shall conform to the following 
conditions:  
I. They are  not known to persons generally involved in information 
of this type;  
II. They have  economic value,  actual or potential, due to their  
secretive nature; and  
III. The owner s have  taken rea sonable measures to maintai n their  
secrecy.  
For registered information determined to be business secrets pursuant to 
paragraph 1, the following shall be protected and kept confidential:  
I. Registrant information  
II. Substance identification  
III. Information on manufacturing and importing  
IV. Life c ycle description  
A registrant may apply for protection of  confidential information  with 
supporting documentation  conforming to paragraph 2, on any of the following 
occasions:  
I. Application for the registration of a new chemical substance,  
II. Application for the  phase 1 registration of an existing chemical 
substance,  
III. Application for the standard registration of an existing chemical 
substance, or  
IV. Application for the inclusion in the inventory of existing 
chemical substances pursuant to Article 14.  
A registrant who  does not apply for  protection of  confidential 
information regarding  a chemical substance  that is  registered and approved 
pursuant to the previous paragraph  may state the reasons  for confidentiality, 
provide supporting documentation  conforming to paragraph  2, and apply to 
the central competent authority for protection  of confidential information  
when filing an extension application for a registered new chemical substance , 
or after the registration is approved for an existing chemical substance.  
Article 21  The confidential period of  the information  on chemical substances 11 approved by the central competent authority is valid for 5 years.  
Except for the existing chemical substances, the confidential period 
pursuant to Article 20, paragraph 5 expires as the valid period for the 
corresponding registration expires.  
A registrant may apply for extension of a confidential period  specified 
in paragraph 1 three to six months prior to expiry of the period.  
The maximum confidential period for a new chemical substance is 15 
years; for an existing chemical substance, the maximum confidential period 
is 10 years. For a new chemical substance that has been included in the 
inventory of existing chemical substances, the maximum confidential period 
is 15 years.  
Article 22  The central competent authority shall notify the registrants when 
information  on chemical substances is publicly disseminated in accordance 
with Article 69, paragraph 2 of this Act.  
 Chapter 5 Supplementary Provisions  
Article 23  The central competent authority may provide the information of the 
registered new and existing chemical substances to the industry competent 
authorities to manage chemical substances used in the subject industry.  
A registrant selling or transferring new or existing chemical sub stances 
shall provide the guidance on safe use and other identifiable labels as 
permitted under the Registrations.  
Article 24  For registered new and existing chemical substances, the registrant shall, 
starting from the following year after the registratio n is approved, submit a 
report annually on the manufactured or imported quantity in the previous year 
for the new or existing chemical substances, in accordance with Appendix 10 , 
between April 1 and September 30.  
Where the information reported by the registrant is incomplete  as 
determined by the central competent authority, the central competent 
authority shall notify the registrant to make a correction within a prescribed 
period. Where the registrant fails to do so or the correction fails to meet the 
requirements, the central competent authority shall impose an administrative 
penalty in accordance with this Act.  
The report and correc tion, pursuant to the previous two  paragraphs, shall 
be submitted via the Internet transmission system designated by the central 
competent authority. However, a report or correction in writing may be 
submitted with the consent of the central competent authority.  
Article 25  The review periods of all the applications accepted by the central 
competent authority in the Regulations are as follows:  
I. New chemical substances small quantity registration, PLC prior 
verification, PLC small quantity registration, existing chemical 
substances phase 1 registration, protection of confidential 12 information , and corresponding extension : 7 working days from 
the date of receipt of the application  
II. New chemical substances simplified registration and the 
inclusion in the inventory of existing chemical substances: 14 
working days from the date of receipt of the application  
III. New chemical substa nces standard registration: 45 working days 
from the date of receipt of the application  
IV. Existing chemical substances standard registration: 90 working 
days from the date of receipt of the application  
The review periods for small quantity registration and s implified 
registration may be extended to 45 working days when the registration 
applications satisfy the conditions in Article 9.  
The central competent authority shall notify the registrants if the review 
periods of the p revious two  paragraphs are extended . The number of 
extensions is limited to one.  
Article 26  The central competent authority shall review application documents for 
all applications accepted under the Regulations. Should the review procedure 
find documents inadequate, mistaken, or unspecific, the central competent 
authority shall require the registrant to provide a correction within 30 working 
days from the date of receiving the notification from the central competent 
authority. The said corrections shall be given only twice. Howeve r, if the 
failure to provide a correction within this limited period is caused by scientific 
or technical factors, this requirement shall not apply to registrants who report 
to the central competent authority and obtain its consent.  
The review periods, pur suant to any of the subparagraphs in the previous 
Article, shall be calculated anew from the date that the central competent 
authority receives the correction submitted by the registrant pursuant to the 
previous paragraph.  
The application shall be rejected  if the registrant fails to make the 
correction within the limited period or fails to make the correction within a 
given period more than two times.  
Article 27  A registrant shall apply for changes to the registered information on 
chemical substances proac tively or within 30 working days from the date of 
receiving the notification from the central competent authority.  
If the change pursuant to the  previous paragraph involves  basic 
information related to a registrant, an application for change shall be made 
within 30 working days from receiving approval for change of company 
registration, business registration, factory registration, as well as other 
documentary proof issued by the industry competent authorities. An 
application for change of a designated respo nsible person  to the registered 
information  shall be made within 60 working days after the change in the 
designated responsible person  approved by the industry competent 13 authorities . 
If the registration type for which a change is applied differs from the 
original registration type that has been approved, a new registration 
application shall be submitted.  
Under any of the following circumstances, the registrant may file an 
application to the central competent authority for a revocation of an approval 
registration and a cancellation of the corresponding registration number:  
I. A new registration has been submitted and approved pursuant to 
the preceding paragraph ; or 
II. A chemical substance with registration approval is no longer 
being manufactured or imported.  
Article 28  If registrants who obtained chemical substances registration approval are 
found with any of the following circumstances, the central competent 
authority may withdraw or revoke approval of the registration and cancel their 
registration  numbers:  
I. False registration information;  
II. Obtaining approval of chemical substances registration by fraud, 
coercion, or other improper means;  
III. Manufacturing or importing chemical substances by using or 
forging registration numbers that belong to others;  
IV. Improper use of chemical substances reported by the industry 
competent authorities;  
V. Documentary proof of company registration, business 
registration, factory registration, or other equivalent permission 
of business establishment that has been withdrawn or revoked by 
the industry competent authorities; or  
VI. Dissolution or termination of business.  
Article 29  For chemical substances registered and approved under  any of the 
following circumstances, the registrant shall provide supplementary 
information proactive ly or before the due date decided  by the central 
competent authority:  
I. New scientific evidence on chemical substances,  
II. New information on the uses of chemical substances,  
III. New information on toxicology or ecotoxicology of chemical 
substances,  
IV. New information  on hazard assessment or exposure assessment 
of chemical substances, or  
V. Other information designated by the central competent authority.  
Article 30  If a registrant has any concerns regarding the result of registration 
review, written appeal with stated reasons may be submitted within 30 
working days from receiving the notification of the review result.  
The number of appeals pursuant to the previous paragraph shall be only 14 one. 
Article 31  Registrants submitting all of the applications pursuant to the Reg ulations 
shall pay a corresponding fee according to the fee -charging standards set for 
this Act; the registrants shall submit the  information  on chemical substances 
via the Internet transmission system designated by the central competent 
authority.  
The information as prescribed in the previous paragraph shall be written 
in Chinese. All foreign materials shall be written in English or in other foreign 
languages with a Chinese or English edition attached.  
The central competent authority shall not accept an y application if 
registrants fail to process their registrat ion pursuant to the previous two  
paragraphs. However, this requirement shall not apply to registrants who 
report to the central competent authority and obtain its consent.  
Article 32 The Regulati ons take into force upon the date of promulgation.  15 Appendix 1  
Registration Types for New Chemical Substances by Estimated Annual Manufactured or 
Imported Quantity and Uses or Properties  
Uses or  
Properties  
 
 
 
Annual  
Manufactured  or 
Imported Quantity  For Scientific 
Research and 
Development, 
SRD  For Product 
and Process 
Orientated 
Research and 
Development, 
PPORD  On-site 
Isolated 
Intermediates  Polymer  Prior verified 
Polymer of 
Low 
Concern, 
PLC 
Less than 1 ton  Exemption  Small 
Quantity 
Registration  Small 
Quantity 
Registration  Small 
Quantity 
Registration  Exemption  
1 ton or more, but 
less than 10 tons  Simplified 
Registration  Simplified 
Registration  Simplified 
Registration  Simplified 
Registration  Small 
Quantity 
Registration  
10 tons or more  Standard 
Registration  Standard 
Registration  Standard 
Registration  Standard 
Registration  Small 
Quantity 
Registration  
Note:  Academic organizations are not required to submit documentation to the central 
competent authority for record and reference, if the new chemical substance is less 
than 1 ton and is used for scientific research and development. However, as a new 
chemical substance used in business premises, for the purpose of research and 
deve lopment (including for research, analysis, sampling, or testing, etc.), submission 
of documentation to the central competent authority must be made for record and 
reference.  16 Appendix 2  
Quantity Thresholds for New Chemical Substances Subject to Standard Reg istration  
Annual 
Manufactured or 
Imported Quantity  Substances 
classified as  
Carcinogenic, 
Mutagenic or Toxic 
for Reproduction 
(CMR)  On-site Isolated 
Intermediates, 
Polymer, or 
substances for 
Scientific Research 
and Development 
(SRD) or for 
Product and 
Process Orientated 
Research and 
Development 
(PPORD)  Other Chemical 
Substances  
Less than 1 ton  Level 1  - - 
1 ton or more, but 
less than 10 tons  Level 2  - Level 1  
10 tons or more, but 
less than 100 tons  Level 3  Level 1 Level 2  
100 tons or more, 
but less than  1,000 
tons Level 4  Level 1 Level 3  
1,000 tons or more  Level 4  Level 1  Level 4  
Notes:  
I. For 10  metric  tons or more of a new chemical substance which meets the definition 
of being a CMR substance and concurrently meets the definition of on -site isolated 
intermediates, polymer, or substances for SRD or PPORD, the quantity threshold 
thereof shall be consider ed that for CMR substances.  
II. According to Article 29, after registration applications have been approved, the 
registrant s shall proactively provide  supplementary  information based on the 
quantity thresholds when the actual manufactured or imported  quantity increase 
leads  to an increase  in levels . 17 Appendix 3  
Information Items, Regarding Registrants and Substances, of New and Existing Chemical 
Substances Subject to Standard Registration  
Sections  Items  Level 1  Level 2  Level 3  Level 4  
1. General Information  1.1 Registrant information  V V V V 
1.2 Substance identification  V V V V 
2. Manufacture, Use and 
Exposure  2.1 Information on manufacturing 
and importing  V V V V 
2.2 Life cycle description  V V V V 
2.3 Exposure information  V V V V 
3. Classification and 
Labelling  3.1 Physical hazards  V V V V 
3.2 Health hazards  V V V V 
3.3 Environmental hazards  V V V V 
3.4 Labelling elements  V V V V 
4. Guidance on Safe Use  4.1 First-aid measures  V V V V 
4.2 Fire-fighting measures  V V V V 
4.3 Accidental release measures  V V V V 
4.4 Handling and storage  V V V V 
4.5 Transport information  V V V V 
4.6 Exposure controls/personal 
protection  V V V V 
4.7 Stability and reactivity  V V V V 
4.8 Disposal considerations  V V V V 18 5. Physical and 
Chemical Properties  5.1 State of the substance  V V V V 
5.2 Melting point/freezing point  V V V V 
5.3 Boiling point  V V V V 
5.4 Density  V V V V 
5.5 Partition coefficient:  
n-octanol/water  V V V V 
5.6 Water solubility  V V V V 
5.7 Vapor pressure  V V V V 
5.8 Flash point  V V V V 
5.9 Flammability  V V V V 
5.10 Explosive properties  V V V V 
5.11 Oxidizing properties  V V V V 
5.12 pH V V V V 
5.13 Auto -ignition temperature  V V V V 
5.14 Viscosity    V V 
5.15 Corrosive to metals    V V 
6. Toxicological 
Information  6.1 Acute toxicity by oral, dermal, or 
inhalation route  V V V V 
6.2 Skin irritation/corrosion  V V V V 
6.3 Serious eye damage/irritation  V V V V 
6.4 Skin sensitization  V V V V 
6.5 Genotoxicity  V V V V 
6.6 Basic toxicokinetics   V V V 
6.7 Repeated dose toxicity by oral, 
dermal, or inhalation route   V V V 19 6.8 Reproductive/developmental 
toxicity   V V V 
6.9 Carcinogenicity     V 
7. Ecotoxicological 
Information  7.1 Short -term toxicity to aquatic 
invertebrates  V V V V 
7.2 Toxicity to aquatic algae and 
cyanobacteria  V V V V 
7.3 Biodegradation in water: 
screening tests  V V V V 
7.4 Short -term toxicity to fish   V V V 
7.5 Hydrolysis   V V V 
7.6 Toxicity to microorganisms   V V V 
7.7 Adsorption/desorption   V V V 
7.8 Long -term toxicity to aquatic 
invertebrates    V V 
7.9 Long -term toxicity to fish    V V 
7.10 Toxicity to soil macroorganisms 
except arthropods     V 
7.11 Toxicity to terrestrial plants     V 
7.12 Toxicity to soil microorganisms     V 
7.13 Biodegradation in water and 
sediment: simulation tests     V 
7.14 Biodegradation in soil     V 
7.15 Bioaccumulation: 
aquatic/sediment     V 
7.16 Sediment toxicity     V 
Note: In each level of the standard registration, items marked with “V” should be submitted.  20 Appendix 4 
Information Items, Regarding Hazard and Exposure Assessment, of New and Existing 
Chemical Substances Subject to Standard Registration  
Sections  Items  Level 1  Level 2  Level 3  Level 4  
1. Hazard Assessment  1.1 Human health hazard assessment 
of physicochemical properties   V V V 
1.2 Human health hazard assessment   V V V 
1.3 Environmental hazard assessment   V V V 
1.4 PBT ( persistent, bioaccumulative 
and t oxic) and vPvB ( very 
persistent and very 
bioaccumulative ) assessment   V V V 
2. Exposure Assessment  2.1 Exposure scenario(s)   V V V 
2.2 Exposure estimation   V V V 
2.3 Risk characterization   V V V 
Notes:  
I. In each level of the standard registration, items marked with “V” should be submitted.  
II. Chemical substances annually manufactured or imported in quantity of 10  metric  
tons or more which do not meet any of following conditions may be exempted from 
submitting  exposure assessment s: 
A. Physicochemical properties hazardous to human health  
B. Human health hazard  
C. Environmental hazard  
D. Being persistent, bioaccumulative and toxic (PBT)  
E. Being very persistent and very bioaccumulative (vPvB)  
  21 Appendix 5 
Information Items of New Chemical Substances Subject to Simplified Registration  
Sections  Items  
1. General information  1.1 Registrant information  
1.2 Substance identification  
2. Manufacture,  Use and 
Exposure  2.1 Information on manufacturing and importing  
2.2 Life cycle description  
2.3 Exposure information  
3. Classification and 
Labelling  3.1 Physical hazards  
3.2 Health hazards  
3.3 Environmental hazards  
3.4 Labelling elements  
4. Guidance on Safe Use  4.1 First-aid measures  
4.2 Fire-fighting measures  
4.3 Accidental release measures  
4.4 Handling and storage  
4.5 Transport information  
4.6 Exposure controls/personal protection  
4.7 Stability and reactivity  
4.8 Disposal considerations  
5. Physical and Chemical 
Properties  5.1 State of the substance  
5.2 Melting point/freezing point  
5.3 Boiling point  
5.4 Density  
5.5 Partition coefficient : n-octanol/water  
5.6 Water solubility  
 
  22 Appendix 6 
Information Items of New Chemical Substances Subject to Small Quantity Registration  
Sections  Items  
1. General information  1.1 Registrant information  
1.2 Substance identification  
2. Manufacture and Use  2.1 Information on manufacturing and importing  
2.2 Life cycle description  
 
  23 Appendix 7 
Information Items of Existing Chemical Substances Subject to Phase 1 Registration  
Sections  Items  
1. General information  1.1 Registrant  information  
1.2 Chemical Abstracts Service (CAS) Registry Number 
or serial number  
2. Manufacture and Use  2.1 Manufactured and imported quantity  
2.2 Life cycle description  
Note: A serial number shall refer to a code assigned for an existing chemical substance 
listed in  the national inventory of existing chemical substances established by the 
Ministry of Labor, where  an information confidentiality request has been approved, 
or for chemical substances with no CAS Registry Number.  
  24 Appendix 8 
Quantity Thresholds for Exist ing Chemical Substances Subject to Standard Registration  
Annual Manufactured 
or Imported Quantity  Substances classified as  
Carcinogenic, Mutagenic or 
Toxic for Reproduction 
(CMR)  Other Chemical Substances  
1 ton or more, but less 
than 10 tons  Level 2  Level  1 
10 tons or more, but 
less than 100 tons  Level 3  Level 2  
100 tons or more, but 
less than 1,000 tons  Level 4  Level 3  
1,000 tons or more  Level 4  Level 4  
Note: According to Article 29, after the standard registration has been completed, the 
registrants shall proactively provide supplementary  information based on the 
quantity thresholds when the actual manufactured or im ported quantity increase  
leads to an increase in levels.  
  25 Appendix 9 
Designated List of Existing Chemical Substances Subject to Standard  Registration and 
Deadlines for Standard Registration  
Stage  Serial 
No. CAS 
Registry No.  Name  
1 1 79-10-7 Acrylic acid  
1 2 10043 -01-3 Aluminium sulfate  
1 3 7664 -41-7 Ammonia, anhydrous  
1 4 1336 -21-6 Ammonium hydroxide  
1 5 123-77-3 1,1'-Azobis(formamide)  
1 6 100-52-7 Benzaldehyde  
1 7 552-30-7 Benzene -1,2,4 -tricarboxylic acid 1,2 -anhydride  
1 8 119-61-9 Benzophenone  
1 9 25973 -55-1 2-(2H-Benzotriazol -2-yl)-4,6-ditertpentylphenol  
1 10 90-43-7 2-Biphenylol  
1 11 103-23-1 Bis(2 -ethylhexyl) adipate  
1 12 106-94-5 1-Bromopropane  
1 13 111-76-2 2-Butoxyethanol  
1 14 25013 -16-5 Butylated hydroxyanisole  
1 15 128-37-0 Butylated hydroxytoluene  
1 16 57693 -14-8 C.I. Acid black 172  
1 17 105-60-2 ε-Caprolactam  
1 18 1333 -86-4 Carbon black  
1 19 95-48-7 o-Cresol  
1 20 108-77-0 Cyanuric chloride  
1 21 108-94-1 Cyclohexanone  
1 22 95-33-0 N-Cyclohexyl -2-benzothiazolesulfenamide  
1 23 108-91-8 Cyclohexylamine  26 1 24 1309 -64-4 Diantimony trioxide  
1 25 1303 -86-2 Diboron trioxide  
1 26 80-43-3 Dicumyl peroxide  
1 27 7173 -51-5 Didecyldimethylammonium chloride  
1 28 127-19-5 N,N-Dimethylacetamide  
1 29 80-15-9 α,α-Dimethylbenzyl hydroperoxide  
1 30 793-24-8 N-1,3-Dimethylbutyl -n'-phenyl -1,4-
phenylenediamine  
1 31 64742 -54-7 Distillates (petroleum), hydrotreated heavy paraffinic  
1 32 64742 -55-8 Distillates (petroleum), hydrotreated light paraffinic  
1 33 64742 -65-0 Distillates (petroleum), solvent -dewaxed heavy 
paraffinic  
1 34 96-76-4 2,4-Di-tert-butylphenol  
1 35 75-56-9 1,2-Epoxypropane  
1 36 106-91-2 2,3-Epoxypropyl methacrylate  
1 37 141-43-5 Ethanolamine  
1 38 111-15-9 2-Ethoxyethyl acetate  
1 39 140-88-5 Ethyl acrylate  
1 40 2687 -91-4 1-Ethyl -2-pyrrolidinone  
1 41 107-21-1 Ethylene glycol  
1 42 107-15-3 Ethylenediamine  
1 43 149-57-5 2-Ethylhexanoic acid  
1 44 15571 -58-1 2-Ethylhexyl  10-ethyl -4,4-dioctyl -7-oxo-8-oxa-3,5-
dithia -4-stannatetradecanoate  
1 45 110-00-9 Furan  
1 46 98-00-0 Furfuryl alcohol  
1 47 107-22-2 Glyoxal  
1 48 142-82-5 Heptane  
1 49 100-97-0 Hexamethylenetetramine  
1 50 110-54-3 Hexane  27 1 51 10035 -10-6 Hydrogen bromide  
1 52 7722 -84-1 Hydrogen peroxide  
1 53 99-96-7 4-Hydroxybenzoic acid  
1 54 5873 -54-1 1-Isocyanato -2-(4-isocyanatobenzyl)benzene  
1 55 4098 -71-9 3-Isocyanatomethyl -3,5,5 -trimethylcyclohexyl 
isocyanate  
1 56 9016 -87-9 Isocyanic acid, polymethylenepolyphenylene ester  
1 57 78-79-5 Isoprene  
1 58 25068 -38-6 4,4'-Isopropylidenediphenol, oligomeric reaction 
products with 1 -Chloro -2,3-epoxypropane  
1 59 108-67-8 Mesitylene  
1 60 79-41-4 Methacrylic acid  
1 61 111-77-3 2-(2-Methoxyethoxy)ethanol  
1 62 108-87-2 Methylcyclohexane  
1 63 101-68-8 4,4'-Methylenediphenyl diisocyanate  
1 64 872-50-4 N-Methylpyrrolidinone  
1 65 8030 -30-6 Naphtha  
1 66 91-20-3 Naphthalene  
1 67 1313 -99-1 Nickel(II) oxide  
1 68 13770 -89-3 Nickel(II) sulfamate  
1 69 7786 -81-4 Nickel(II) sulfate  
1 70 556-67-2 Octamethylcyclotetrasiloxane  
1 71 111-65-9 Octane  
1 72 6197 -30-4 Octocrilene  
1 73 144-62-7 Oxalic acid  
1 74 101-80-4 4,4'-Oxydianiline  
1 75 111-46-6 2,2'-Oxydiethanol  
1 76 108-95-2 Phenol  
1 77 98-83-9 2-Phenylpropene  28 1 78 10025 -87-3 Phosphoryl trichloride  
1 79 7757 -79-1 Potassium nitrate  
1 80 71-23-8 1-Propanol  
1 81 409-21-2 Silicon carbide  
1 82 7775 -09-9 Sodium chlorate  
1 83 7758 -19-2 Sodium chlorite  
1 84 7681 -49-4 Sodium fluoride  
1 85 7631 -90-5 Sodium hydrogensulfite  
1 86 100-42-5 Styrene  
1 87 7664 -93-9 Sulfuric acid  
1 88 100-21-0 Terephthalic acid  
1 89 75-91-2 Tert-butyl hydroperoxide  
1 90 98-54-4 4-Tert-butylphenol  
1 91 4067 -16-7 3,6,9,12 -Tetraazatetradecamethylenediamine  
1 92 79-94-7 2,2',6,6' -Tetrabromo -4,4'-isopropylidenediphenol  
1 93 75-59-2 Tetramethylammonium hydroxide  
1 94 140-66-9 4-(1,1,3,3 -Tetramethylbutyl)phenol  
1 95 7550 -45-0 Titanium tetrachloride  
1 96 108-88-3 Toluene  
1 97 2451 -62-9 Triglycidyl isocyanurate  
1 98 95-63-6 1,2,4 -Trimethylbenzene  
1 99 115-86-6 Triphenyl phosphate  
1 100 101-02-0 Triphenyl phosphite  
1 101 597-82-0 O,O,O -Triphenyl phosphorothioate  
1 102 42978 -66-5 Tripropylene glycol diacrylate  
1 103 26523 -78-4 Tris(nonylphenyl) phosphite  
1 104 100-40-3 4-Vinylcyclohexene  29 1 105 7646 -85-7 Zinc chloride  
1 106 1314 -13-2 Zinc oxide  
Notes:  
I. A registrant shall, after obtaining a phase 1 registration number of the existing 
chemical substance listed in this Appendix, complete the information items specified 
in Appendix 3 by the following prescribed deadlines:  
A. For a phase 1 registration number first obtained  before December 31, 2019, the 
registrant shall comple te the information items specified in Appendix 3 before 
December 31, 2024, if the registered annual manufactured or imported quantity 
is 1 metric  ton or more.  
B. For a phase 1 registration number first obtained after January 1, 2020, the 
registrant shall, cou nting from January 1 of the following year upon obtaining 
the number, complete the information items specified in Appendix 3 within 5 
years, if the registered annual manufactured or imported quantity is 1  metric  ton 
or more.  
C. For an existing chemical substa nce with an  annual manufactured or imported 
quantity  that is  less than 1  metric  ton at the time of  first obtaining the phase 1 
registration number, if the substance ’s actual annual manufactured or imported 
quantity reaches 1  metric  ton or more  on or  before  December 31, 2019 , the 
registrant shall complete the information items specified in Appe ndix 3 before 
December 31, 2024 . For a n existing chemical substance with an  annual 
manufactured or imported quantity  that is  less than 1  metric  ton at the time of  
first obtaining the phase 1 registration number , if the substance ’s actual annual 
manufactured or imported quantity reaches 1  metric  ton or more  on or  after 
January 1, 2020 , the registrant shall complete the information items specified in 
Appendix 3 withi n 5 years, counting from January 1 of the following year.  
D. For reapplication for a phase 1 registration due to cancellation of a phase 1 
registration number, the registrant, if subject to the standard registration pursuant 
to the previous three  subparagraph s, shall complete the information items 
specified in Appendix 3 by the deadl ines specified in the previous three  
subparagraphs after obtaining a phase 1 registration number again; or complete 
the information items specified in Appendix 3 at the time of rea pplication for 
the phase 1 registration if the deadl ines specified in the previous three  
subparagraphs are due.  
II. The existing chemical substances listed in this Appendix shall be identified 
according to the CAS Registry Numbers. The names presented are for reference only.  
  30 Appendix 10 
Reporting Items of New and Existing Chemical Substances  
Sections  Items  
1. Registrant and 
Registration Number  1.1 Registrant information  
1.2 Registration number  
2. Manufactured and 
Imported Quantity  2.1 Manufactured quantity  
2.2 Imported quantity