1 Amendments to Regulations of New and Existing Chemical Substances Registration ( Draft)  
 
Chapter 1 General Provisions  
Article 1  
These Regulations (hereinafter “ 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 chemical substances 
registration pursuant to Article 7- 1 of the Act.  
A registrant may appoint a repre sentative to apply for chemical substances registration. 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 registered by laws.  
Whe n 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 verifyin g the r egistrant’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 additive s necessary to preserve its 
stability and any unintended constituent deriving from the process es used, but excluding any 
solvent which may be separated without affecting the stability of  the substance or changing its 
composition.  
II. Substance which Occur ed in Nature refers to a substance that is : unprocessed ; processed only 
by manual, gravitational, or mechanical means ; by dissolution in water ; by water extraction ; 
by vapor distillation ; by flotation ; by heating solely to remove water ; by extract ion from air 
by any means, without chemical change in the substance; or , large molecules from organisms, 
or polymers occurring in nature 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 criter ia: 
A. A macro -molecular chemical substance consisting of molecules characterized by the 2 sequence of one or more types of monomer units.  
B. The molecule s that  contain at least three monomer units covalently bound;  such molecules 
must be over 50% of the wei ght 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 differences in the number 
of monome r units.  
VI. Polymers for which the 2% Rule is Applicable refers to the monomer -based representation of 
polymers which may or may not include monomers and other reactants used at 2 percent  
weight  or less. A monomer -based representation means naming of poly mers is based on 
constituent monomers.  
VII. Polymer of Low Concern (PLC) refers to a substance that is evaluated by the central 
competent authority, and fulfills 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 amount of less than 10%; 
oligomers below 1,000 Daltons in amount of less than 25%.  
B. A polymer with an average molecular weight over 10,000 Daltons, contains oligomer s of 
molecular weights below 500 Daltons in 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 the 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 refers to any scientific experimentation, education, 
analysis, or chemical research carried out under strictl y controlled conditions for scientific 
or academic research.  
XIII. Product and Process Orientated Research and Development (PPORD) refers to any 3 scientific development related to product development or the further development of a 
substance, in the course of which 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 R.O.C. National Standards (CNS) 15030.  
XV. Substances under Customs Supervision refers to chemical substances under customs 
supervision, which are in tem porary storage or placed in a harbor’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  
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 su bstances for national security or national defense purposes  
V. Chemical substances under customs supervision  
VI. Chemical waste produced or re leased from industrial process  
VII. By -product or impurity that is of no commercial application  
VIII. Mixtures; however,  the Regulations apply to constituents in mixture.  
IX. Articles  
X. A polymer for which the 2% rule is applicable and listed on the inventory of existing chemical 
substances  
The Regulations 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 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  4 XI. Radioactiv e Materials, as defined by the Atomic Energy Act and the Ionizing Radiation Protection Act  
XII. Chemicals regulated by the Montreal Protocol under the Air Pollution Control Act  
XIII. Environmental agents, as defined by the Environmental Agents Control Act  
XIV. Toxic chemical substances, as defined by the Act  
A chemical substance manufactured or imported is a raw material accord ing to the preceding 
Paragraph ; the Regulations shall apply to such  chemical substances . 
Chapter 2 New Chemical Registration  
Article 5  
To apply for new chemical registration approval, manufacturers or importers  shall refer to the 
following registration type s based on estimated annual manufactured or imported amount:  
1. Standard registration: 1 ton or more.  
2. Simplified registration: 100 kilograms or  more, but less than 1 ton. 
3. Small quantity registration: less than 100 kilograms.  
If a new chemical substance to be manufactured or imported, fits any of the following 
circumstances, its registration type shall be selected by referring to the estimated ann ual 
manufactured or imported quantity , as specified in Appendix 1. 
1. A substance used for Scientific Research and Development.  
2. A substance used for Product and Process Orientated Research and Development, PPORD.  
3. On-site Isolated Intermediates.  
4. Polymers.  
5. Polymer of Low Concern (PLC).  
To apply for the registration of Polymer of Low Concern pursuant to subparagraph 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:  
1. Standard registration as specified in Appendix 2. 
2. Simplified registration as specified in Appendix 3.  
3. Small quantity registration as specified in Appendix 4. 
Article 7  
The central competent authority may demand a manufactured or imported new chemical 
substan ce undergo the standard registration if it is identified as a substance of carcinogenic, 
mutagenic, or toxic to reproduction; regardless if it is entitled to the simplified registration or the 
small quantity pursuant to the preceding 2 articles.  5 Article 8  
For a new chemical substance fulfilling 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, a registrant shall register  this new chemical 
substance by submitting the information items in accordance with the Regulations. The following 
documents shall be submitted to the central competent authority:  
1. Registration form for scientific research and development (SRD), product and process orientated 
research and development (PPORD).  
2. Nanoscale chemical substances registration form.  
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 to require submission of periodic report s of handling status, updates of relevant 
registration reports, or hazard communication, if the central competent authority determines that 
there is possibility that toxicological characteristics of the new chemical substances conform to 
the definitions of Class 1, Class 2, or Class 3 of toxic chemical substances, according to the Act.  
Upon reviewing the new chemical substance information submitted by a regi strant, the central 
competent authority shall approve the registration along with conditions to restrict its handling, 
and to 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 registration under agreement and use the substance information required for the 
registration.  
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 importe d quantity of the new chemical 
substances registered and approved, the c entral 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 h as been paid according to the 
decision made by the central competent authority.  6 Article 11   
The central competent authority issues the registration number for a new chemical subs tance that 
is registered and approved.  
Article 12  
The valid 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.  
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 reg istrants, 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 im ported for the following  year 
shall be submitted to the central competent authority. The aforementioned extension application 
requires approval by the competent authority and the valid period is pursuant to the previous 
Article.  
If the central competent au thority is unable to make the rejection/approval decision for the 
extensions before the original approval registration expires, those who file an extension 
application pursuant to the preceding Paragraph may continue to manufacture or import the new 
chemic al substance, 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 app roval registration expires, those who fail to file an extension 
application pursuant to the preceding Paragraph shall pause 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 from the expiration day of the original approved registration. A 
new application of registration shall be made in order to continu e manufactur ing or import ing 
such a 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 regis tered and approved in any one of following circumstances may 7 be included in the inventory of existing chemical substances by the central competent authority.  
I. It shall be at least five years after the standard registration process is filed and completed.  
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, 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 hazard 
assessment and exp osure 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 substances pursuant to the provisions of the preceding two Paragraphs, is 
subject to the related rules of registered and approved existing chemical substance s. 
Chapter 3 Existing Chemical Registration  
Article 15  
An existing chemical substance manufactured or imported shall  undergo  phase  1 registration by 
attaching chemical information, as specified in Appendix 5, from September 1, 2015, to March 
31, 2016, if its annual average volume over the past three consecutive years prior to the 
registration application exceeds 100 kilo grams, or at least one highest annual volume during the 
three consecutive year period prior to registration application exceeds 100 kilograms.  
The central competent authority is to issue the phase 1 registration number to a registrant whose 
regist ration ap plication is approved.  
Article 16  
After April 1 , 2016, 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 5. No existing chemical substance shall be manufactured or imported, unless the 
registration approval is obtained within the specified time period.  
The central competent authori ty is to issue a phase 1 registration number to a registrant whose 
registration application is approved, pursuant to the preceding Paragraph.  
A registration may be made for existing chemical substances, which are manufactured or 
imported in annual volume l ess than 100 kilograms, in accordance with the preceding Paragraph 
1. After the registration application is approved, the above mentioned existing chemical 
substances are subject to the Regulations.  
Article 17  
The central competent authority may, by stag es, designate the lists of existing chemical 
substances subject to standard registration, including the names of the chemical substances, 8 quantity thresholds and the deadlines for registration, based on the circumstances of the phase 1 
registration of exis ting chemical substances.  
The said designated lists, by stages, subject to the existing chemical substances standard 
registration, the quantity thresholds, and the deadlines for registration are specified in Appendix 
6. 
For manufacturing or importing any e xisting chemical substances listed in Appendix  6, the 
registrants shall, starting from January 1 , 2019, apply for the standard registration of such 
existing chemical substances and attach information, as specified in Appendix 7 . 
Article 18  
Different regis trants for the same existing ch emical substance pursuant to Paragraph 1 of the 
previous article, may apply for the joint registration under agreement. 
The registrant, to apply for the joint registration pursuant to the previous Paragraph shall register 
the chemical substance by submitting information according to  Paragraph 2 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 comp etent 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 19  
The central competent authority issues a registration number to those  who apply and complete 
chemical substance registration pursuant to the provisions  of the previous two articles.  
Chapter 4 Information Dissemination and Business Secret Protection  
Article 20  
Chemical substance information registered and approved by the central competent authority shall 
be made public. The information contents disclosed is as follows:  
I. Identification of r egistrant  
II. Chemical substance name  
III. Manufacture or import conditions  
IV. Hazard classification and labelling  
V. Safe use inform ation  
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 i nternet 
by the authority . 9 Article 21  
Chemical information registered, which concerns confidential matters on national defense or 
business secrets, shall be kept secret.  
The aforementioned business secret s shall conform to the following conditions:  
I. It is not known to persons generally involved in information of this type;  
II. It has economic value, actual or potential, due to its secretive nature;  
III. Its owner has taken reasonable measures to maintain its secrecy.  
For registered information determined to be business secret s pursuant to Paragraph 1, the 
following shall be protected and kept secret:  
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 secret i nformation 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 an existing chemical substance pursuant 
to Article 14.  
A registrant, who does not apply for secret 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 competen t authority for 
information protection after the registration and before the application for the extension.  
Article 22  
The confidentiality periods of the chemical substance information approved by the central 
competent authority are specified as follows:  
I. Standard registration of an existing chemical substance or a 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 existing chemical substance registered pursuant to Subparagraph 3 of the above 
Paragraph, the confidentiality period pursuant to Paragraph  5 of the previous Article expires as 
the valid period for the corresponding registration expires.  
A registrant may apply for an extension of the confidentiality period in  Paragraph 1 three to six 10 months prior to the expiry  of the confidentiality period.  
The maximum confidentiality period for a new chemical substance registered, pursuant to the 
previous Paragraph, is 15 years; for an existing chemical substance, the maximum confidentiality 
perio d is 10 years.  
Article 23  
The central competent authority sha ll 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 24  
The central competent authority may provide the information of the r egistered 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 sub stances shall provide the 
information on safe use, and other identifiable labels as granted under the Registrations.  
Article 25  
For registered new and existing chemical substances, the registrant shall, starting from January 
1, 2019, during the period from April 1 to September 30 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 P aragraph, shall be submitted via internet transmission 
systems designated by the central competent authority. However, a report in writing may be 
submitted with the consent of the central competent authority.  
Article 26  
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, 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: 14 working days from the date of receipt of the 
application. 
III. New chemical substances s tandard 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. 
Where appropriate, the review periods pursuant to the previo us Paragraph may be extended. 
Registrants shall be notified of the extension. Extension is limited to one time only.  11 Article 27  
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 a uthority. The said notification of supplementation and correction shall be 
given only twice. However, if the failure to provide supplementation or correction within this 
limited period is caused by scientific or technical factors, this requirement shall no t apply to 
registrants who report to the central competent authority and obtain  its consent.  
The review periods, pursuant to any of the subparagraphs in the previous Article, shall be 
calculated anew from the date that the central competent authority recei ves the supplementation 
or correction submitted by the registrant pursuant to the previous Paragraph.  
The application pursuant to the previous Paragraph shall be rejected if the registrant fails to 
make supplementation or correction within the limited  time , or fails to make the supplementation 
or correction within a given t ime period more than two times.  
Article 28  
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 docum entary proof of company registration, business registration, factory registration, 
as well as other documentary proof issued by government authorities in charge of the subject 
industry . 
If the registration type for which modification is applied differs fro m 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 withdrawal  of an approval re gistration and cancel the corresponding 
registration number:  
I. A newer 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 29 
If registrants who obtained chemical substance registration approval are found to have  any of the 
following circumstances, the central competent authority may void or revoke approval of the 
registration, and cancel their registration numbers.  
I. Furnishing  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 12 to others. 
IV. Improper use of chemical substances reported 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 
authorities.  
VI. Dissolution or suspension of business. 
Article 30  
For chemical substances registered and approved with  any of the following circumstances, the 
registrant shall provide supplementary informati on proactively or as prescribed 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 and ecotoxicology of chemical substances  
IV. New information hazard assessment of chemical substances  
V. Other information designated by the central competent authority  
Article 31  
If a registrant has any concerns regarding the result of registration review, a written appeal with 
stated reasons may be submitted within 30 working days of receiving the notice of the review 
result.  
The number of appeal s pursuant to the previous Paragraph shall be made once only.  
Article 32  
Registrants submitting all of the application pursuant to the Regulations shall pay a 
corresponding fee according to the fee standard set in the Act; the registrant shall submit the 
chemical substance information through i nternet transmission systems, registration tools, or 
forms designated by the central competent authority.  
Information submitted through i nternet transmission systems, registration tools, or forms 
pursuant to previous Paragraphs shall be written in Chinese. All foreign material shall ha ve 
attached along with it a Chinese translation.  
The central competent authority shall not accept any application if registrants fail to process 
registration pursuant to the previous 2 Paragraphs. However, this requirement shall not apply to 
registrants wh o report to the central competent authority and obtain  its consent.  
Article 33  
Registrants shall keep copies of all the submitted information and relevant verifying 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 central competent authority, shall be kept in written or electronic form for 15 13 years , for record and reference.  
Article 34  
The Regulations shall c ome into force upon the date of promulgation. 14 Amendments Appendi ces of Regulations for  New and Existing Chemical Substances Registration 
(Draft)  
 
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 
Intermediate
s 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:  
Academic organization s 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 document ation to the 
central competent authority must be made for record and reference.  
Appendix 2 - Standard Registration of New Chemical Substances - Information Items *1, 2, 3, 4, 5 
Section  Items  
1. Basic identification of 
the registrant and 
substances  1.1 Information of the registrant  
1.2 Substance identification  
2. Substances 
manufacture, use and 
exposure information  2.1 Manufacture and importation  
2.2 Use information  
2.3 Exposure information  
3. Hazards classification 3.1 Physical hazards  15 and labelling  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 
6.3 Eye irritation  
6.4 Skin sensitization  
6.5 Genetic toxicity  
6.6 Basic toxicokinetics  
6.7 Repeat dose toxicity: oral, inhalation, dermal  16 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 o n 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 Physicochemical -property -to-human -health 
hazard assessment  
8.2 Health hazard assessment  
8.3 Environmental hazard assessment  
8.4 PBT and vPvB assessment  
9. Exposure assessment  9.1 Exposure scenarios description  
9.2 Exposure estimation  
9.3 Risk characterization  
Note:  
1. Detailed information requirements shall refer to the content of the registration tool announced 
by the central competent authority.  
2. Chemical substances annually manufactured or imported in volume of 1 ton or more, but less 
than 10 tons, which  do not meet definition of substance of carcinogenic, mutagenic or toxic 17 for reproduction (CMR) Category 1 , may be exempted from submission of Sec tion 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 asses sment.  
(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 intermedi ates, polymers, 
scientific research and development, or product and process orientated research and 
development  (PPORD) may be exempted from submission of Section 8 -Hazard assessment and 
Section 9 -Exposure assessment.  
5. 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 supplementar y appendix below. In each level of registration information 
requirements, items marked with “V” should be submitted.  
Supplementary Appendix * a, b, c, d 
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 18 pH value  V V V V 
Auto -ignition temperature  V V V V 
Viscosity    V V 
Corrosive to metals    V V 
Section 6  
Toxicological Information  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 Information  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 19 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 
Physicochemical -property -to-human -health hazard 
assessment   V V V 
Health hazard assessment   V V V 
Environmental hazard assessment   V V V 
PBT and vPvB assessment   V V V 
Section 9  
Exposure Assessment  I II III IV 
Exposure scenarios description   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 annually manufactured or imported 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, 20 polymers, substances used for scientific 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 inform ation on physical/chemical properties and toxicological 
information may be requested referred 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 eco -toxicological shall be submitted:  
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 substances 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 -Exposur e 
assessment shall be submitted for substances in annual manufactured or imported volume 
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 
assessment shall be submitted for subs tances in annual manufactured or imported volume 
of 100 tons or more.  
d. Testing items in level I, II, III, IV testing data set of physical/chemical properties toxicological 
and eco -toxicological information shall be conducted according to registration tools  and forms 
issued by the central competent authority.  
Appendix 3 - Simplified Registra tion of New Chemical Substances - Information Items  
Section  Items  
1. Basic identification of the 
registrant and substances  1.1 Information of the registrant  
1.2 Substance identification  
2. Substances’ manufacture, use 
and exposure information  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 hazard s 
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  21 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 announced by 
the central competent authority.  
Appendix  4- Small Quantity Registration of New Chemical Substances - Information Items  
Section  Items  
1. Basic identification of the 
registrant and substances  1.1 Information of the registrant  
1.2 Substance identification  
2. Manufacture and use 
information  2.1 Manufacture and importation  
2.2 Use information  
Note:  
Detailed information requirements shall refer to the content of the registration tool announced by 
the central competent authority.  
Appendix 5 - Phase 1 Registration of t he Existing Chemical Substances - Information Items *6  
Section  Items  
1. Basic identification 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  22 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 s 2.1 CAS NO. or serial number*3 
3. Manufacture and use 
information  of the substances  3.1 Manufactured and imported quantities*4-5 
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 Ministry of Labor, where 
information confidentiality request has been approved, or the chemical substance has no CAS 
number.  
4. For a substance refers to Article 15 of the Regulations, the said quantity indicates t he average 
annual volume in past 3 years right before an application, or the highest annual quantity right 
before an application (for manufacture or importation has been interrupted before an 
application).  
5. For a substance refers to Article 16 of the Regulations, the said quantity indicates the annual 
manufactured or imported volume when the application is filed  
6. Detailed information requirements shall refer to the content of the registration tool announced 
by the central competent authority.  
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 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  23 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  
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  24 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  
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  25 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:  
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 followin g quantity thresholds:  
(1) For a phase 1 registration number first obtained before December 31, 2018, the registrant shall:  
A. complete the standard registration before December 31, 2021, 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 numbe r;  
B. complete the standard registration before December 31, 2020, 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 1, 2019, the registrant shall, 
counting from the next 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 26 more, based on the registered annual manufact ured or imported volume at the time of 
obtaining the phase 1 registration number.  
(3) For an existing chemical substance at annual tonnages less than 1 ton while first obtaining the 
phase 1 registration number, the registrant shall, counting from the next year  of the actual 
manufactured or imported annual volume at 1 ton or more, complete the standard registration 
within three years.  
(4) For reapplication for phase 1 registration due to cancellation of a phase 1 registration number, the 
registrant, if subject to th e standard registration pursuant to the previous three Paragraphs, shall  
A. complete the standard registration within the deadlines specified in 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 previous Paragraphs are due.  
2. The existing chemical substances listed in this Appendix shall be identified according to the 
CAS No. The names presented are for reference only.  
Appendix  7- Standard Registration for the Existing Chemical Substances - Information 
Items*1, 2, 3, 4, 5 
Section  Items  
1. Basic identification of the 
registrant and substances  1.1 Information of the registrant  
1.2 Substance identification  
2. Substances manufacture, use 
and exposure information  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 1.1 Physical state  27 properties  1.2 Melting / freezing point  
1.3 Boiling point  
1.4 Density  
1.5 Octanol / water partition coefficient  
1.6 Water solubility  
1.7 Vapor pressure  
1.8 Flash point  
1.9 Flammability  
1.10 Explosive properties  
1.11 Oxidation properties  
1.12 pH value  
1.13 Auto -ignition temperature  
1.14 Viscosity  
1.15 Corrosive to metals  
6. Toxicological information  6.1 Acute toxicity: oral, dermal, inhalation Skin 
corrosion/irritation  
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  28 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 Physicochemical -property -to-human -health hazard 
assessment summary  
8.2 Health hazard assessment summary  
8.3 Environmental hazard assessment summary 
8.4 PBT and vPvB assessment  
9. Exposure assessment  9.1 Exposure scenarios description  
9.2 Exposure estimation  
9.3 Risk characterization  
Note:  
1. Detailed information requirements shall refer to the content of the registration tool announced 
by the central competent authority.  
2. Chemical substances that do not meet definition of carcinogenic, mutagenic or toxic to 
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 hazardous 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 chemic al 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  registration information 
requirements, items marked with “V” should be submitted.  29 5. The central competent authority may designate registration information to be submitted based 
on information collected from Phase 1 registration of existing chemical substanc es and 
international chemicals registration. Other requirements to be met shall refer to the 
registration tools announced by the central competent authority.  
6. All of the co -registrants among joint registration pursuant to Article 18 of the Regulations 
shall submit information according to the registration tools announced by the central 
competent authority.  
Supplementary Appendix*a, b, c 
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 
Viscosity    V V 
Corrosive to metals    V V 
Section 6  
Toxicological Information  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 30 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 Information  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  31 Hazard assessment  I II III IV 
Physicochemical -property -to-human -health 
hazard assessment   V V V 
Health hazard assessment   V V V 
Environmental hazard assessment   V V V 
PBT and vPvB assessment   V V V 
Section 9  
Exposure Assessment  I II III IV 
Exposure scenarios description   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 17, minimum 
information on physical and chemical properties, toxicology, and ecotoxicology of the existing 
chemical substances shall be submitted as follow s: 
i. Level I testing data shall 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 sub mitted for substances in annual manufactured or 
imported volume of 1,000 tons or more.  
b. For existing chemical substances manufactured or imported that meet definition of 
carcinogenic, mutagenic or toxic to reproduction (CMR) Category 1, pursuant to Article 17, 
minimum information on physical and chemical properties, toxicological, 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 
assessm ent 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 an nual manufactured or imported volume 
of 10 tons o r 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 impor ted volume 32 of 100 tons or more.  
c. Testing items in level I, II, III, IV testing data set of physical/chemical properties, 
toxicological and eco -toxicological information shall be conducted according to registration 
tools and forms issued by t he central competent authority.  
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  2.1 Manufactured quantity  
2.2 Imported quantity  
Note:  
Detailed information requirements shall refer to the content of the reporting tool announced by 
the central competent authority.