1  
Regulation s of New and Existing 
Chemical Substances Registration  
 
Full text of 33 articles determined and promulgated by  the Environmental Protection Administration, 
Executive Yuan Order Huan -Shu-Tu-Tzu No. 1030101706 on December 4, 2014.  
Full text of 33 articles amended and proclaimed by  the Environmental Protection Administration, Executive 
Yuan Order Huan- Shu-Hua-Tzu No. 1088000098 on March 11, 2019. The Regulations  shall come into force 
upon the date of promulgation. 
 
Table of Contents  
Chapter 1 General Provisions   
Chapter 2 New Chemical Registration  
Chapter 3 Existing Chemical 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 
 
Chapter 1 General Provisions  
 
Article 1  
The Regulations  are stipulated according to Article 7 -1 Paragraph 6 of the Toxic Chemical 
Substances Control Act (hereinafter “the Act”).  
 
Article 2  
The term “registrant” as used herein means a natural person, a juristic person, an 
unincorporated body having a representative  or manager, an administrative authority, or a 
person, who may be the subject of rights and obligations under other laws, that is subject to  2 chemical substances registration pursuant to Article 7 -1 of the Act.  
A registrant may appoint a representative to p rocess the application and/or reporting 
affairs covered in the Regulation s. The representative should be a natural person possessing the 
nationality of the Republic of China, or a juristic person, an institute or an organization that is 
constituted or regi stered by law.  
When applying for chemical substance registration according to the Regulations , a 
registrant shall attach a copy of a National Identification Card, a copy of company registration, 
business 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 Substance ” 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 constituent s deriving from the processes used, but 
excluding any s olvent which may be separated without affecting the stability of the 
substance or changing its composition.  
II. “Substance which Occur s in Nature ” refers to a substance that is: unprocessed; processed 
only by manual, gravitational, or mechanical means; by diss olution in water; by water 
extraction; by vapor distillation; by flotation; by heating solely to remove water; by 
extraction from air by any means, without chemical change in the substance; or, large 
molecules from organisms, or polymers occurring in natur e and not chemically processed.  
III. “Mixture ” refers to a mixture or a solution composed of two or more substances in which 
they do not react.  
IV. “Article ” refers to a manufactured item formed to a specific shape or design during 
manufacture.  
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 contains at least three monomer units covalently bound; such  molecules 
take 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.  
C. Differences in the molecular weight are primarily attributable to dif ferences in the 
number of monomer units. 
VI. “Polymers that the 2% Rule is Applicable ” refers to a polymer when its monomers or 
reactants may not be regarded as part of the polymer when the weight percentage of the 
monomers or reactants is less than two percen t; if the naming of the polymer is a 
monomer -based representation, it may or may not include monomers and other reactants 
used at two  percent weight or less. A monomer -based representation means  the naming of  3 polymers is  based on constituent monomers. 
VII. “Polymer of Low Concern ” (PLC) refers to a substance that is evaluated by the central 
competent authority, and fulfil ls any one of the following conditions:  
A. A polymer with an average molecular weight in a range of 1,000 to 10,000 Daltons, 
contains oligomers of  molecular weights below 500 Daltons in an amount of less 
than 10%; oligomers below 1,000 Daltons in an amount of less than 25%. 
B. A polymer with an average molecular weight over 10,000 Daltons, contains 
oligomers of molecular weights below 500 Daltons in an  amount of less than 2%; 
oligomers below 1,000 Daltons in amount of less than 5%.  
C. Polyester polymers.  
D. Insoluble polymers.  
VIII. “Intermediate”  refers to a chemical substance produced and consumed in the course of the 
manufacture of another chemical substance.  
IX. “On-site Isolated Intermediates ” refers to intermediates that are produced and consumed 
on the same site.  
X. “Incidental Reaction Products ” refers to chemical substances produced when a substance 
undergoes a chemical reaction that is consequent to the use of the substance, the result of 
storage or the change of environmental factors.  
XI. “Impurity ” refers to an unintended constituent present in a  substance as produced. It 
originates from the starting materials or is the result of secondary or incomplete reactions 
during the production process. While it is present along with the final substance , it was 
not intentionally added, nor does it enhance t he commercial value of that substance. The 
concentration of an individual impurity is no more than 10% (w/w). All impurities 
presented are no more than 20% (w/w).  
XII. “Scientific Research and Development ” (SRD) refers to any scientific experimentation, 
educati on, analysis, or chemical research carried out under strictly controlled conditions 
for scientific or academic research.  
XIII. “Product and Process Orientated Research and Development ” (PPORD) refers to any 
scientific development related to product development or the further development of a 
substance, in the course of which a pilot plant or production trials are used to develop the 
production process or to test the fields of application of the substance.  
XIV. “Substance of Carcinogenic, Mutagenic or Toxic for Reproduction ” (CMR) refers to a 
substance that meets any criteria of carcinogenicity category 1; mutagenicity category 1; 
reproductive toxicity category 1, based on the R.O.C. National Standards (CNS) 15030. 
XV. “Substances under Customs Supervision”  refers to chemic al substances under customs 
supervision, which are in temporary storage or placed in a harbour’s designated area or 
warehouse, container freight station, bonded warehouse, logistics center or free trade zone, 
with a provision for re -exportation or transit. 
 
Article 4   4 The Regulations  shall not apply to any of the following substances or articles:  
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 wastes produced or released from industrial process . 
VII. By-products or impurities that are o f no commercial application . 
VIII. Mixtures; but individual constituents of mixtures shall not be applied to the Article . 
IX. Articles . 
X. Polymers that the 2% Rule is Applicable and listed on the inventory of existing chemical 
substances . 
The Regulation s shall not apply to the substances or articles 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 . 
VI. Controlled drugs, as defined by the Controlled Drugs Act . 
VII. Cosmetic(s), as defined by the Statute for Control of Cosmetic Hygiene . 
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 materials, as defined by the Industrial Explosive s Administrative 
Act. 
XIII. Chemicals regulated by the Montreal Protocol under the Air Pollution Control Act . 
XIV. Environmental agents, as defined by the Environmental Agents Control Act . 
XV. Toxic chemical substances, as defined by the Act . 
For a chemical substance man ufactured or imported as a raw material of the preceding 
Paragraph, the chemical substance shall be subject to the provisions of the Regulations . 
 
Chapter 2 New Chemical Registration  
 
Article 5   5 To apply for new chemical 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 regis tration: less than 100 kilograms. 
If 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 specif ied in Appendix 1. 
I. A substance used for the purpose of SRD . 
II. A substance used for the purpose of PPORD. 
III. On-site Isolated Intermediates.  
IV. Polymers.  
V. Polymer of Low Concern, PLC. 
To apply for the registration of Polymer of Low Concern pursuant to S ubparagraph 5 of 
the preceding Paragraph, a registrant shall first submit a prior verification application to the 
central competent authority. Once the application is reviewed and verified, the registrant may 
select the registration type in accordance with the precedin g Paragraph.  
 
Article 6  
The registration types and the corresponding registration information items are specified 
as follows:  
I. Standard registration: as specified in Appendix 2. 
II. Simplified registration: as specified in Appendix 3.  
III. Small quantity registratio n: as specified in Appendix 4.  
 
Article 7  
For a manufactured or imported new chemical substance that applies for simplified 
registration or small quantity registration pursuant to the previous two Articles, the central 
competent authority may demand the registrant to register data in accordance with the 
requirements of standard registration if the new chemical substance is identified as a substance 
of CMR.  
 
Article 8  
For a new chemical substance meeting the criteria of the substances used for the purposes  
of scientific research and development, or for product and process orientated research and 
development; 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 submit the following documents to the central competent authority:  
I. Registration form for SRD and PPORD. 
II. Nanoscale chemical substances registration form.   6  
Article 9  
Upon reviewing new chemical substance information submitted by a registrant, the 
central competent authority shall approve the registration by attaching conditions to prohibit or 
restrict handling, and require submission of periodic report s of handling status, updates of 
relevant registration reports, or hazard communic ation, if the central competent authority 
determines that there is a concern over the toxicological characteristics of new chemical 
substances conforming to definitions of Class 1, Class 2, or Class 3 of toxic chemical 
substances.  
Upon reviewing new chemic al substance information submitted by a registrant, the 
central competent authority shall approve the registration along with conditions to restrict its 
handling, and require submission of information on exposure assessment and risk assessment, 
updates of relevant registration reports, or hazard communication, if the central competent 
authority determines that there is a concern of environmental pollution or endangerment to 
human health.  
 
Article 10  
Co-registrants, or the early and late registrants for the same new chemical substance, may 
apply for joint use of the substance information required for registration under agreement.  
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 register ed and approved, the central competent authority may require registrants to 
apply for the new registration under the designated registration type, or apply for the joint 
registration.  
For a joint registration that is agreed upon by co -registrants, but for which no agreement 
has been reached on the cost sharing of the registration information, the co- registrants may 
submit an equal -cost-sharing request application to the central competent authority. The 
registered chemical substance information can be used after the shared cost has been paid 
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 v alid periods of the new chemical substance registration approval are as follows:  
I. The standard registration is valid for 5 years.  
II. The simplified registration and small quantity registration are valid for 2 years.   7 III. The PLC small quantity registration in accordance with Article 5 Paragraph 2 is valid for 
5 years.  
The valid periods of joint registrations for the new chemical substance pursuant to Article 
10, are specified in the preceding Paragraph. However, upon agreements for joint registrations 
for early  and late registrants, the valid periods of such joint registrations 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. The 
aforementioned extension application requires approval by the competent authority and the 
valid period is pursuant to the previous Article.  
If the central 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 substance, in compliance with the situation specified in the or iginally 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 the  preceding  Paragraph 1 shall stop manufacturing or importing the 
new chemical substance after the valid period of the original approved registration expires. If a 
registrant does not apply for an extension before the valid period expires, the original approved 
registration is revoked exactly on the following day of the expiration day specified with the 
original approved registration. A new application of registration shall be made in order to 
continue manufacturing or importing suc h chemical substance.  
If the registration type intended for extension is inconsistent with the originally approved 
registration, a new application of registration shall be made.  
 
Article 14  
A new chemical substance registered and approved in any one of following circumstances 
may be included in the inventory of existing chemical substances by the central competent 
authority:  
I. It shall be at least five years after the registration is filed and completed in accordance 
with the standard registration as speci fied in Appendix 1.  
II. It shall be at least five years after the PLC registration process is filed and completed in 
accordance with the small quantity registration.  
III. Toxic chemical substances announced by the central competent authority.  
A registrant may apply  for inclusion in the inventory of existing chemical substances,  8 when a new chemical substance, registered and approved, meets any of the following 
situations:  
I. Standard registration that has been filed and completed through submission of information 
on haz ard assessment and exposure assessment.  
II. PLC registration in accordance with the small quantity registration that has been filed and 
completed.  
A new chemical substance registered and approved, which has been included in the 
inventory of existing chemical s ubstances pursuant to the provisions of the preceding two  
Paragraphs, is subject to the related rules of registered and approved existing chemical 
substances.  
 
Chapter 3 Existing Chemical Registration  
 
Article 15  
For an existing chemical substance first manufactured or imported in annual volume 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 chemical information, as specified in 
Appendix 6. No existing che mical substance shall be manufactured or imported, unless the 
registration approval is obtained within the specified time period.  
The central competent authority is to issue a phase 1 registration number to a registrant 
whose registration application is ap proved, pursuant to the preceding Paragraph.  
Registration for existing chemical substances, manufactured or imported in annual 
volume less than 100 kilograms, may be made in accordance with the preceding Paragraph 1. 
After the registration application is a pproved, the above mentioned existing chemical 
substances are subject to the Regulation s. 
 
Article 16  
The central competent authority may, by stages, designate the lists of existing chemical 
substances subject to standard registration, including the names of the chemical substances, 
quantity thresholds and the deadlines for registration, based on the circumstances of the phase 
1 registration of existing chemical substances.  
The said designated lists, by stages, subject to the existing chemical substances standard 
registration, the quantity thresholds, and the deadlines for registration pursuant to the previous 
Paragraph are specified in Appendix 6. 
Registrants manufacturing or importing any existing chemical substances listed in 
Appendix 6, shall, starting f rom January 1st, 2020, apply for the standard registration of such 
existing chemical substances and attach information, as specified in Appendix 7.  
Registrants manufacturing or importing existing chemical substances, which are not any 
of the chemical subst ances listed or do not meet the quantity thresholds in Appendix 6, may  9 apply for registration of chemical substances pursuant to the  previous Paragraph.  
 
Article 17  
The registrants, pursuant to Paragraph 2 or 4 of the previous Article, who intend to 
regist er the same existing chemical substance concurrently, earl ier or late r to each other, may 
apply for using the required registration information jointly under agreement. 
The registrant, to apply for the joint registration pursuant to the previous Paragraph shall 
register  relevant  information on the chemical substance, according to Paragraph 3 of the 
previous Article.  
For joint registration that is agreed by co -registrants, but for which no agreement is 
reached on the cost sharing of registration information, the central competent authority may 
determine the cost to be equally shared at the request of co- registrants. Then the registered 
information can be used after the shared cost has been paid.  
 
Article 18  
The central competent authority issues a completion number for the standard registration 
of an existing chemical substance to those who apply and complete chemical substance 
information registration pursuant to the provisions of the previous two Articles. 
 
Chapter 4 Information Dissemination and  Protection  
of Business Secret s 
 
Article 19  
Chemical substance information registered and approved by the central competent 
authority shall be made public. The information items  which shall be disclosed are as follows:  
I. Identification of Registrant. 
II. Chemical substance name. 
III. Manufacture or import conditions . 
IV. Hazard classification and labelling . 
V. Safe use information . 
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 disclosed through the 
Internet by the central competent authority.  
 
Article 20   10 Chemical information registered, which concerns confidential matters on national defense 
or business secrets, shall be kept confidential.  
The aforementioned business secrets shall conform to the following conditions:  
I. It is not known to persons generally involved in information of this type . 
II. It has actual or potential economic value, due to its secretive nature.  
III. Its owner has taken reasonable measures to maintain its confidentiality.  
For registered information determined to be business secrets pursuant to Paragraph 1, the 
following shall be protected and kept confidential:  
I. Identification of registrant. 
II. Identification of chemical substance . 
III. Information on manufacture or import . 
IV. Use of chemical substance. 
A registrant may apply for confidential information protection with proof documents 
conforming to Paragraph 2 of this Article, in 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.  
IV. Three to six months prior to the inclusion in the inventory of existing c hemical substances 
pursuant to Article 14.  
A registrant, who does not apply for confidential information protection for a chemical 
substance registered and approved pursuant to the previous Paragraph, may state the reasons, 
with proof documents conforming to Paragraph 2, and apply to the central competent authority 
for information protection, at the time of filing an extension application for a registered new 
chemical substance, or after the registration is approved for an existing chemical substance.  
 
Article 21  
The confidentiality periods of the chemical substance information approved by the central 
competent authority are specified as follows:  
I. Standard registration of a new chemical substance or PLC small quantity registration: 
confidentiality is to be valid for 5 years.  
II. Simplified registration or small quantity registration of a new chemical substance: 
confidentiality is to be valid for 2 years.  
III. Registration of an existing chemical substance: confidentiality is to be valid for 5 years.  
Except for the ex isting chemical substance registered pursuant to the S ubparagraph 3 of 
the above Paragraph, the confidentiality period pursuant to P aragraph 5 of the previous Article 
expires as the valid period for the corresponding registration expires. 
A registrant may apply for the extension of the confidentiality periods specified in 
Paragraph 1 three to six months prior to the expiry of the confidentiality period. 
The maximum confidentiality period for a new chemical substance is 15 years; for an 
existing chemical sub stance, the maximum confidentiality period is 10 years.  11  
Article 22  
The central competent authority shall notify the registrant when chemical substance 
information is publicly disseminated in accordance with Article 41 Paragraph 2 of the Act. 
 
Chapter 5 Supplementary Provisions  
 
Article 23  
The central competent authority may provide the information of the registered new 
chemical substances and existing chemical substances to the government authorities in charge 
of the subject industry to manage chemical substances used in the subject industry.  
A registrant selling or transferring new or existing chemical substances shall provide the 
information on safe use, and other identifiable labels as permitted under the Registration. 
 
Article 24  
For registered new and existing chemical substances, the registrant shall, starting from 
April 1st 2020, during the period from April 1st to September 30th of each year, submit a 
report on the manufactured or imported quantity in the previous year for the new chemical 
substance, or the existing chemical substance, in accordance with Appendix 8.  
The report, pursuant to the previous Paragraph, shall be submitted via the Internet 
transmission system designated by the central competent authority. However, a re port 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 Regulation s are as follows:  
I. New chemical substances small quanti ty registration, PCL prior verification, PCL small 
quantity registration, existing chemical substance phase 1 registration, chemical 
information protection 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 substances 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 simplified registration may be 
extended to 45 working days when the re gistration applications satisfy the conditions in Article 
9.  12 The central competent authority shall notify the registrant if the review period of the 
previous two P aragraphs  is extended. The number of extensions is limited to one time. 
 
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 
supplementation or correction within 30 working days of receiving the notification from the 
central competent authority. The said notification of supplementation and correction shall be 
given only twice. However, if the failure to provide suppl ementation or 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, pursuant to any of t he Subparagraphs in the previous Article, shall be 
calculated anew from the date that the central competent authority receives the 
supplementation or correction submitted by the registrant pursuant to the previous Paragraph.  
The application shall be reject ed if the registrant fails to make supplementation or 
correction within the limited time, or fails to make the supplementation or correction within a 
given time period more than two times.  
 
Article 27  
A registrant shall apply for modification when changing  the application information for 
chemical substance registration within 30 working days since changes to the information have 
been made.  
If the modification pursuant to the previous Paragraph involves the basic information 
related to a registrant, a modification application shall be made within 30 working days of 
changes upon receipt of documentary proof of company registration, business registration, 
factory registration, as well as other documentary proof issued by government authorities in 
charge of the subject industry. The modification of owner information shall be made within 60 
working days since changes to the information have been made.  
If the registration type for which modification is applied differs from the original 
registration type that has be en 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 withdrawal of an approval registration and cancel the 
corresponding regi stration number:  
I. A new registration has been submitted and approved, pursuant to the preceding Paragraph.  
II. A chemical substance with registration approval is no longer being manufactured or 
imported. 
 
Article 28   13 If registrants who obtained chemical substanc e registration approval are found with  any of 
the following circumstances, the central competent authority may void or revoke approval of 
the registration, and cancel their registration numbers : 
I. Providing incorrect chemical substance registration information. 
II. Obtaining approval of chemical substance 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 report ed by government authorities in charge of 
subject industry.  
V. Documentary proof of company registration, business registration, factory registration or 
other equivalent permission of business establishment that has been voided or revoked by 
their competent a uthorities. 
VI. Dissolution or suspension of business. 
 
Article 29  
For chemical substances registered and approved with any of the following circumstances, 
the registrant shall provide supplementary information proactively or as prescribed by the 
central competent authority by an appointed due date : 
I. New scientific evidence on chemical substances . 
II. New information on the uses of chemical substances . 
III. New information on toxicology and ecotoxicology of chemical substances . 
IV. New information on hazard assessment of chemical substances . 
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 of receiving the notice of the 
review result.  
The number of appeals pursuant to the previous Paragraph shall be made once only.  
 
Article 31  
Registrants submitting all of the application material pursuant to the Regulations  shall pay 
a corresponding fee according to the fee standard set in the Regulations ; the registrant shall 
submit the chemical substance information through Internet transmission systems, registration 
tools, or forms designated by the central competent authority.  
Information submitted through Internet transmission systems, registration tools, or forms 
pursuant to previous Paragraphs shall be written in Chinese. All foreign material shall have a 
Chinese translation  attached . 
The central competent authority shall not accept any application if reg istrants fail to  14 process their registration 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  
Registrants shall keep copies of  all the submitted information and relevant verification 
documents in written or electronic form for 5 years, for recordkeeping and reference.  
Information, where business secrets are involved and information protection is applied for 
and approved by the c entral competent authority, shall be kept in written or electronic form for 
15 years, for record and reference.  
 
Article 33  
The Regulations  shall come into force upon the date of promulgation.  
   15 Appendix 1  
Registration Application Types for Chemical Substances by Estimated Annual Manufactured 
or Imported Tonnage and Uses or Properties  
Uses or  
Properties  
 
 
 
 
Manufactured  
or Imported Volume  Scientific 
Research and 
Development  Process 
Orientated 
Research and 
Development, 
PPORD  On-site 
Isolated 
Intermedi ates Polymer  Polymer of 
Low Concern  
(Prior 
Verification 
needed)  
Less than 1 ton  Exemption*a 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  
Note:  
a. Academic organizations are not required to submit documentation to the central competent 
authority for record and reference, if the new substance is used for scientific experimentation, 
education, analysis, or chemical research carried out under strictly controlled conditions. 
However, as a chemical used in business premises, for the purpose of research and 
development, (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 
Standard Registration of New Chemical Substances - Information Items  *1, 2, 3, 4, 5 
Section  Items  
1. Information of the registrant and 
basic identification of the 
substance  1.1 Information of the registrant  
1.2 Substance identification  
2. Information on m anufacture , use 
and exposure of the substance  2.1 Manufacture and importation  
2.2 Use information  
2.3 Exposure information  
3. Hazards classification and 
labelling  3.1 Physical hazards  
3.2 Health hazards  
3.3 Environmental hazards  
3.4 Labelling  
4. Safe use information  4.1 First aid measures  
4.2 Firefighting 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 Physical state  
5.2 Melting / freezing point  
5.3 Boiling point  
5.4 Density  
5.5 Octanol  / water partition coefficient  
5.6 Water solubility  
5.7 Vapor pressure  
5.8 Flash point  
5.9 Flammability  
5.10  Explosive properties  
5.11  Oxidation properties  
5.12  pH value  
5.13  Auto -ignition temperature  
5.14  Viscosity  
5.15  Corrosive to metals  
6. Toxicological information  6.1 Acute toxicity: oral, dermal, inhalation  
6.2 Skin corrosion /  irritation   17 6.3 Eye irritation  
6.4 Skin sensitization  
6.5 Genetic toxicity  
6.6 Basic toxicokinetics  
6.7 Repeat dose toxicity: oral, inhalation, dermal  
6.8 Reproductive  / Developmental toxicity  
6.9 Carcinogenicity  
7. Ecotoxicological in formation  7.1 Short -term toxicity testing on invertebrates 
(daphnia)  
7.2 Toxicity to aquatic algae and cyanobacteria  
7.3 Biodegradation in water: screening tests  
7.4 Short -term toxicity testing on fish  
7.5 Hydrolysis  
7.6 Toxicity to microorganisms  
7.7 Adsorption / desorption 
7.8 Long -term toxicity testing on invertebrates 
(daphnia)  
7.9 Long -term toxicity testing on fish  
7.10 Toxicity to soil macroorganisms except 
arthropods  
7.11  Toxicity to terrestrial organisms  
7.12  Toxicity to soil microorganisms  
7.13 Biodegradation in water and sediment: 
simulation test  
7.14  Biodegradation in soil  
7.15  Bioaccumulation: aquatic / sediment 
7.16  Toxicity to sediment  
8. Hazard assessment  8.1 Summary of human health hazard assessment of 
physicochemical properties  
8.2 Summary of health hazard assessment  
8.3 Summary of environmental hazard assessment  
8.4 Summary of PBT and vPvB assessment  
9. Exposure assessment  9.1 Exposure scenarios  
9.2 Exposure estimation  
9.3 Risk characterization  
Note:  
1. Detailed information requirements shall refer to the content of the registration tool released by 
the central competent authority.  
2. Chemical substances annually manufactured or imported in volume of 1 ton or more, but less  18 than 10 tons, which do not meet the definition of substance of carcinogenic, mutagenic or toxic 
for reproduction (CMR) Category 1, may be exempted from submission of Section 8- -Hazard 
assessment and Section 9 --Exposure assessment.  
3. Chemical substances annually manufactured or imported in volume of  10 tons or more which 
do not meet any of following conditions, may be exempted from submission of Section 
9--Exposure assessment . 
(1) Physicochemical properties hazardous to human health. 
(2) Health hazard . 
(3) Environmental hazard.  
(4) Persistent, bioaccumulative and toxic (PBT) . 
(5) Very persistent and very bioaccumulative (vPvB) . 
4. Chemical substances falling within definition of on- site isolated intermediates, polymers, 
scientific research and development, or p roduct and process orientated research and 
development  (PPORD) may be exempted from submission of Section 8 --Hazard assessment 
and Section 9- -Exposure assessment.  
5. Submissio n of the aforesaid Section 5 to Section 9, including physical and chemical properties, 
toxicological, ecotoxicological, hazard assessment, and exposure assessment information shall 
refer to respective registration information requirements of four levels, w hich is described in 
the supplementary appendix below. In each level of registration information requirements, 
items marked with “V” should be submitted. 
Supplementary Appendix * a, b, c, d, e 
Section 5  
Physical and chemical properties  I II III IV 
Physical state  V V V V 
Melting / freezing point  V V V V 
Boiling point  V V V V 
Density  V V V V 
Octanol / water partition coefficient  V V V V 
Water solubility  V V V V 
Vapor pressure  V V V V 
Flash point  V V V V 
Flammability  V V V V 
Explosive properties  V V V V 
Oxidation properties  V V V V 
pH value  V V V V 
Auto -ignition temperature  V V V V  19 Viscosity    V V 
Corrosive to metals    V V 
Section 6  
Toxicological i nformation  I II III IV 
Acute toxicity: oral, dermal, inhalation  V V V V 
Skin corrosion / irritation  V V V V 
Eye irritation  V V V V 
Skin sensitization  V V V V 
Genetic toxicity  V V V V 
Basic toxicokinetics   V V V 
Repeat dose toxicity: oral, inhalation, dermal   V V V 
Reproductive / Developmental toxicity   V V V 
Carcinogenicity     V 
Section 7  
Ecotoxicological i nformation  I II III IV 
Short -term toxicity testing on invertebrates (daphnia)  V V V V 
Toxicity to aquatic algae and cyanobacteria  V V V V 
Biodegradation in water: screening tests  V V V V 
Short -term toxicity testing on  fish  V V V 
Hydrolysis   V V V 
Toxicity to microorganisms   V V V 
Adsorption / desorption  V V V 
Long -term toxicity testing on invertebrates (daphnia)    V V 
Long -term toxicity testing on fish    V V 
Toxicity to soil macroorganisms except arthropods     V 
Toxicity to terrestrial organisms     V 
Toxicity to soil microorganisms     V 
Biodegradation in water and sediment: simulation test    V 
Biodegradation in soil     V 
Bioaccumulation: aquatic / sediment    V 
Toxicity to sediment     V 
Section 8  
Hazard  assessment  I II III IV 
Summary of human health hazard assessment of 
physicochemical properties   V V V  20 Summary of health hazard assessment   V V V 
Summary of environmental hazard assessment   V V V 
Summary of PBT and vPvB assessment   V V V 
Section 9  
Exposure assessment  I II III IV 
Exposure scenarios   V V V 
Exposure estimation   V V V 
Risk characterization   V V V 
Note:  
a. Minimum information on physical and chemical properties, toxicology, and ecotoxicology shall 
be submitted for new chemical substances manufactured or imported annually  based on annual  
tonnage manufactured/imported:  
i. Level I testing data shall be submitted for substances at tonnages of 1 ton or more, but less 
than 10 tons per year;  
ii. Level II testing data shall be submitted for substances at tonnages of 10 tons or more, but 
less than 100 tons per year;  
iii. Level III testing data shall be submitted for substances at tonnages of 100 tons or more , but 
less than 1,000 tons per year;  
iv. Level IV testing data shall be submitted for substances at tonnages of 1,000 tons or more.  
b. For new chemical substances which meet the definition of on- site isolated intermediates, 
polymers, substances used for scientif ic research, or for product and process orientated research 
and development (PPORD) and in annual manufactured or imported volume of 10 tons or more, 
the minimum information on physical/chemical properties and toxicological information may 
be requested referr ing to Level I testing data.  
c. For new chemical substances that meet definition of carcinogenic, mutagenic or toxic to 
reproduction (CMR) Category 1, minimum information on physical and chemical properties, 
toxicological, and ecotoxicological shall be s ubmitted: 
i. Level I testing data shall be submitted for substances in annual manufactured or imported 
volume of less than 1 ton;  
ii. Level II testing data along with Section 8 --Hazard assessment and Section 9 --Exposure 
assessment shall be submitted for substance s in annual manufactured or imported volume of 
1 ton or more, but less than 10 tons;  
iii. Level III testing data along with Section 8 --Hazard assessment and Section 9 --Exposure 
assessment shall be submitted for substances in annual manufactured or imported vol ume of 
10 tons or more, but less than 100 tons;  
iv. Level IV testing data along with Section 8 --Hazard assessment and Section 9 --Exposure  21 assessment shall be submitted for substances in annual manufactured or impor ted volume of 
100 tons or more.  
d. Testing items  in level I, II, III, IV testing data sets  of physical/chemical p roperties toxicological 
and eco toxicological information shall be conducted according to registration tools and forms 
issued by the central competent authority.  
e. According to Article 29, after  registration application has been approved, the registrants should 
proactively provide the supplemental information when the actual manufactured or imported 
tonnage increases  which  leads to an increase in the required minimum information . 
   22 Appendix 3 
Simplified Registration of New Chemical Substances - Information Items  
Section  Items  
1. Information of the registrant and 
basic identification of the 
substance  1.1 Information of the registrant  
1.2 Substance identification  
2. Information on manufacture , use  
and exposure  of the substance  2.1 Manufacture and importation  
2.2 Use information  
2.3 Exposure information 
3. Hazards classification and 
labelling  3.1 Physical hazards  
3.2 Health hazards  
3.3 Environmental hazards  
3.4 Labelling  
4. Safe use information  4.1 First aid measures  
4.2 Firefighting 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 Physical state  
5.2 Melting / freezing point  
5.3 Boiling point  
5.4 Density  
5.5 Octanol / water partition coefficient  
5.6 Water solubility  
Note:  
Detailed information requirements shall refer to the content of the registration tool released by the 
central competent authority.  
   23 Appendix 4 
Small Quantity Registration of New Chemical Substances - Information Items  
Section  Items  
1. Information of the registrant and 
basic identification of the 
substance  1.1 Information of the registrant  
1.2 Substance identification  
2. Information on manufacture and 
use of the substance  2.1 Manufacture and importation  
2.2 Use information  
Note:  
Detailed information requirements shall refer to the content of the registration tool released by the 
central competent authority.  
   24 Appendix 5 
Phase 1 Registration of the Existing Chemical Substances - Information Items *5 
Section  Items  
1. Basic information of the registrant  1.1 Type of the registrant  
1.2 Full name of the company / organization 
1.3 Company address  
1.4 Telephone number, extension 
1.5 Fax number  
1.6 Industrial / commercial registration  
1.7 Business Administration Number (BAN)  
1.8 Name of the person responsible  
1.9 Name of contact person  
1.10 Telephone number of contact person  
1.11 Email address of contact person  
1.12 Consignor company*1 
1.13 EMS administration number*2 
2. Basic identification of the 
substance  2.1 CAS NO. or serial numbers*3 
3. Information on manufacture and 
use of the substance  3.1 Manufactured and imported quantities*4 
3.2 Use information  
Note:  
1. If the registrant is an appointed notarized representative, company full name, country and 
address of the consignor company shall be provided. 
2. If there is the EMS (Environmental Management System) administration number, it should be 
provided. 
3. 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 Mi nistry of Labor, where 
information confidentiality request has been approved, or the chemical substance has no CAS 
number.  
4. The annual manufactured and imported volume at the time of application.  
5. Detailed information requirements shall refer to the content of the registration tool released by 
the central competent authority.  
   25 Appendix 6 
Designated List of Existing Chemical Substances Subject to Standard Registration, the 
Quantity Thresholds and the Deadlines for Registration*1 
Stage  Serial 
No. CAS No.*2 Nam e 
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  
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   26 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-stannatetradecanoat
e 
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 
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   27 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  
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  
1 105 7646- 85-7 Zinc chloride  
1 106 1314- 13-2 Zinc oxide  
Note:   28 1. A registrant shall, after obtaining a phase 1 registration number of the existing chemical 
substance listed in  this Appendix, complete the standard registration for the existing chemical 
substances within the deadlines specified below based on the following quantity thr esholds:  
(1) For a phase 1 registration number first obtained before December 31st, 2019, the regist rant 
shall: 
A. complete the standard registration before December 31st, 2022, for substances 
tonnages at tonnages of 1 ton or more but less than 100 tons, based on the registered 
annual manufactured or imported volume at the time of obtaining the phase 1 
registration number;  
B. complete the standard registration before December 31st, 2021, for substances at 
tonnages of 100 tons or more, based on the registered annual manufactured or imported 
volume at the time of obtaining the phase 1 registration number.  
(2) For a phase 1 registration number first obtained after January 1st, 2020, the registrant shall, 
counting from January 1st of  the following  year upon obtaining the number,  
A. complete the standard registration within three years, for substances at tonnages of 1 
ton or more but less than 100 tons, based on the registered annual manufactured or 
imported volume at the time of obtaining the phase 1 registration number;  
B. complete the standard registration within two years, for substances at tonnages of 100 
tons or m ore, based on the registered annual manufactured or imported volume at the 
time of obtaining the phase 1 registration number.  
(3) For an existing chemical substance at annual tonnages of less than 1 ton  when  first 
obtaining the phase 1 registration number, t he registrant shall:  
A. complete the standard registration before December 31st, 2022, for the substance ’s 
actual manufactured or imported annual volume reaches  1 ton or more  before 
December 31st, 20 19; 
B. complete the standard registration within three  years, cou nting from January 1st of the 
following year, for the substance ’s actual manufactured or imported annual volume 
reaches 1 ton or more after January 1st, 2020. 
(4) Registrants pursuant to (1) and (2) with annual manufactured or imported tonnage of 100 
tons or m ore who fail to complete the following standard registration information items, 
can apply for a n extension 6 months prior to the specified deadline with consent from the 
central competent authority:  
a. 6.7 Repeat dose toxicity: oral, inhalation, dermal  
b. 6.8 R eproductive / Developmental toxicity  
c. Any item under Section 8--H azard assessment  
d. Any item under Section 9--Exposure assessment  
The extension shall be no longer than 1 year.  
(5) For reapplication for a phase 1 registration due to cancellation of a phase 1 registration  29 number, the registrant, if subject to the standard registration pursuant to the previous four  
paragraphs , shall  
A. complete the standard registration within the deadlines specified in  the previous 
paragraphs after obtaining a phase 1 registration number;  
B. complete the standard registration at the time of reapplication of phase 1 registration if 
the deadlines specified in the previous paragraphs are due.  
2. The existing chemical substances listed in  this Appendix shall be identified according to the 
CAS Number. The names presented are for reference only.  
   30 Appendix 7 
Standard Registration for t he Existing Chemical Substances - Information Items  *1, 2, 3, 4, 5, 6 
Section  Items  
1. Information of the registrant and 
basic identification of the 
substance  1.1 Information of the registrant  
1.2 Substance identification  
2. Information on m anufacture, use 
and exposure of the substance  2.1 Manufacture and importation 
2.2 Use information  
2.3 Exposure information 
3. Hazards classification and 
labelling  3.1 Physical hazards  
3.2 Health hazards  
3.3 Environmental hazards  
3.4 Labelling  
4. Safe use information  4.1 First aid measures  
4.2 Firefighting 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 Physical state  
5.2 Melting / freezing point  
5.3 Boiling point  
5.4 Density  
5.5 Octanol / water partition coefficient  
5.6 Water solubility  
5.7 Vapor pressure  
5.8 Flash point  
5.9 Flammability  
5.10 Explosive properties  
5.11 Oxidation properties  
5.12 pH value  
5.13 Auto -ignition temperature  
5.14 Viscosity  
5.15 Corrosive to metals  
6. Toxicological information  6.1 Acute toxicity: oral, dermal, inhalation  
6.2 Skin corrosion /  irritation   31 6.3 Eye irritation  
6.4 Skin sensitization  
6.5 Genetic toxicity  
6.6 Basic toxicokinetics  
6.7 Repeat dose toxicity: oral, inhalation, dermal  
6.8 Reproductive  / Developmental toxicity  
6.9 Carcinogenicity  
7. Ecotoxicological information  7.1 Short -term toxicity testing on invertebrates 
(daphnia)  
7.2 Toxicity to aquatic algae and cyanobacteria  
7.3 Biodegradation in water: screening tests  
7.4 Short -term toxicity testing on fish  
7.5 Hydrolysis  
7.6 Toxicity to microorganisms  
7.7 Adsorption / desorption 
7.8 Long -term toxicity testing on invertebrates 
(daphnia)  
7.9 Long -term toxicity testing on fish  
7.10 Toxicity to soil macroorgani sms except 
arthropods  
7.11 Toxicity to terrestrial organisms  
7.12 Toxicity to soil microorganisms  
7.13 Biodegradation in water and sediment: 
simulation test  
7.14 Biodegradation in soil  
7.15 Bioaccumulation: aquatic / sediment 
7.16 Toxicity to sediment  
8. Hazard assessment  8.1 Summary of human health hazard assessment of 
physicochemical properties  
8.2 Summary of h ealth hazard assessment  
8.3 Summary of environmental hazard assessment  
8.4 Summary of PBT and vPvB assessment  
9 Exposure assessment  9.1 Exposure scenarios  
9.2 Exposure estimation  
9.3 Risk characterization  
Note:  
1. Detailed information requirements shall refer to the content of the registration tool released by 
the central competent authority.  
2. Chemical substances that do not meet definition of carcinogenic, mutagenic or toxic to  32 reproduction (CMR) Category 1 and in annual manufactured or imported volume of 1 ton or 
more, but less than 10 tons, may be exempted from submission of Section 8- -Hazard 
assessment and Section 9 --Exposure assessment.  
3. Chemical substances annually manufactured or imported in volume of 10 tons or more, which 
do not meet any of the following conditions, may be exempted from submission of  Section 
9--Exposure assessment.  
(1) Human health hazar dous physicochemical properties . 
(2) Health hazardous . 
(3) Environmental hazardous . 
(4) Persistent, bioaccumulative,  and toxic (PBT) . 
(5) Very persistent and very bioaccumulative (vPvB) . 
4. Submission of the aforesaid Section 5 to Section 9, physical and chemical  properties, 
toxicological, eco toxicological, hazard assessment, and exposure assessment information shall 
refer to respective registration information requirements of four levels, which is tabulated in 
the supplementary appendix below. In each level of the registration information requirements, 
items marked with “V” should be submitted. 
5. The central competent authority may designate registration information to be submitted based 
on information collected from Phase 1 registration of existing chemical substances and 
international information on chemical substances. Other requirements to be met shall refer to 
the registration tools released by t he central competent authority.  
6. All of the co -registrants among joint registration pursuant to Article 17 of the Regulation s shall 
submit information according to the registration tools and forms released by t he central 
competent auth ority.  
Supplementary Appendix  *a, b, c, d, e 
Section 5  
Physical and chemical properties  I II III IV 
Physical state  V V V V 
Melting / freezing point  V V V V 
Boiling point  V V V V 
Density  V V V V 
Octanol / water partition coefficient  V V V V 
Water solubility  V V V V 
Vapor pressure  V V V V 
Flash point  V V V V 
Flammability  V V V V 
Explosive properties  V V V V  33 Oxidation properties  V V V V 
pH value  V V V V 
Auto -ignition temperature  V V V V 
Viscosity    V V 
Corrosive to metals    V V 
Section 6  
Toxicological i nformation  I II III IV 
Acute toxicity: oral, dermal, inhalation  V V V V 
Skin corrosion /  irritation  V V V V 
Eye irritation  V V V V 
Skin sensitization  V V V V 
Genetic toxicity  V V V V 
Basic toxicokinetics   V V V 
Repeat dose toxicity: oral, inhalation, dermal   V V V 
Reproductive / Developmental toxicity   V V V 
Carcinogenicity     V 
Section 7  
Ecotoxicological i nformation  I II III IV 
Short -term toxicity testing on invertebrates (daphnia)  V V V V 
Toxicity to aquatic algae and cyanobacteria  V V V V 
Biodegradation in water: screening tests  V V V V 
Short -term toxicity testing on fish   V V V 
Hydrolysis   V V V 
Toxicity to microorganisms   V V V 
Adsorption / desorption  V V V 
Long -term toxicity testing on invertebrates (daphnia)    V V 
Long -term toxicity testing on fish    V V 
Toxicity to soil macroorganisms except arthropods     V 
Toxicity to terrestrial organisms     V 
Toxicity to soil microorganisms     V 
Biodegradation in water and sediment: simulation test    V 
Biodegradation in soil     V 
Bioaccumulation: aquatic / sediment    V 
Toxicity to sediment     V 
Section 8   34 Hazard assessment  I II III IV 
Summary of human health hazard assessment of 
physicochemical properties   V V V 
Summary of human health hazard assessment   V V V 
Summary of environmental hazard assessment   V V V 
Summary of PBT and vPvB asses sment   V V V 
Section 9  
Exposure assessment  I II III IV 
Exposure scenarios   V V V 
Exposure estimation   V V V 
Risk characterization   V V V 
Note:  
a. For existing chemical substances manufactured or imported, pursuant to Article 16, minimum 
information on physical and chemical properties, toxicology, and ecotoxicology of the existing 
chemical substances  shall be submitted as follows:  
i. Level I testing data sh all be submitted for substances in annual manufactured or imported 
volume of 1 ton or more, but less than 10 tons;  
ii. Level II testing data shall be submitted for substances in annual manufactured or imported 
volume of 10 tons or more, but less than 100 tons ; 
iii. Level III testing data shall be submitted for substances in annual manufactured or imported 
volume of 100 tons or more, but less than 1,000 tons;  
iv. Level IV testing data shall be submitted for substances in annual manufactured or imported 
volume of 1,000 t ons or more. 
b. For existing chemical substances manufactured or imported that meet the definition of 
carcinogenic, mutagenic or toxic to reproduction (CMR) Category 1, pursuant to Article 16, 
minimum information on physical and chemical pro perties, toxicolog ical, and eco toxicological 
of the existing chemical substances shall be submitted as follows:  
i. Level II testing data along with Section 8 --Hazard assessment and Section 9 --Exposure 
assessment shall be submitted for substances in annual manufactured or imported volume of 
1 ton or more, but less than 10 tons;  
ii. Level III testing data along with Section 8 --Hazard assessment and Section 9 --Exposure 
assessment shall be submitted for substances in annual manufactured or imported volume of 
10 tons or more, but less than 100 tons;  
iii. Level IV testing data along with Section 8 --Hazard assessment and Section 9 --Exposure 
assessment shall be submitted  for substances in annual manufactured or imported volume of 
100 tons or more.   35 c. For existing chemical substances that do not meet the criteria listed in Appendix 6 under Article 
16, or with manufactured or imported tonnage  of less than 1 ton, the registrant s can voluntarily 
submit  the registration information with any level requirement.  
d. Testing and information items required for existing chemical substances in levels  I, II, III, IV 
testing data set of physical/chemical pr operties, toxicological and eco toxico logical information 
shall be conducted according to registration tools and forms released by the central competent 
authority.  
e. After the standard registration has been completed, according to Article 29, the registrants 
should proactively provide the supple mental information if the actual annual manufactured or 
imported tonnage increases lead to the required minimum information increase.  
   36 Appendix 8 
New Chemical Substances and Existing Chemical Substances Reporting Requirement  
Section  Items  
1. Registrant and registration number  1.1 Information of the registrant  
1.2 Approved registration number  
2. Quantity of substances manufactured 
and imported 1.1 Quantity of manufactured substances  
1.2 Quantity of imported substances  
Note:  
Detailed information requirements shall refer to the  content of the reporting tool released by the 
central competent authority.