1 
 Amendments of Regulation of New and Existing Chemical Substances Registration (draft)  
 
Chapter 1 General Provision  
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 representative 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.  
Applying for che mical 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 its establishment. A re presentative 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 manufa cturing process, including any additive necessary to preserve its stability and any unintended 
constituent deriving from the process used, but excluding any solvent which may be separated without 
affecting the stability of the substance or changing its com position.  
II. Substance which Occur s 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, or is  extracted from air by any means, without chemical 
change in the substance; or  for large molecules from organisms, or polymers occurring in nature and not 
chemically processed.  
III. Mixture refers to a mixture or a solution composed of t wo 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 s ubstance consisting of molecules characterized by the sequence of one 
or more types of monomer units.  
B. A molecule that 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 differences in the number of 
monomer units.  
VI. Polymers for which the 2% R ule is Applicable refers to the monomer -based representation of 
polymers which may include or may not include monomers and other reactants used at 2 percent  weight  or 
less. A monomer -based means  of naming polymers is based on constituent monomers.  
VII. Pol ymer 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 2 
 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 oligomers of molecular 
weights below 500 Daltons in amo unt 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 or consumed in the course of the manufacture 
of another chemical substance.  
IX. On -site Isolated Intermediates refers to intermediates that are produced or 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 ou t 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 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 temporary 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 substances for national defense purposes  
V. Chemical substances under customs supervision  
VI. Waste  
VII. By -product or impurity that is of no commercial application  
VIII. Mixtures; but constituent s of mixture s shall be subject  to the Regulations . 
IX. Articles  
X. A polymer for which the 2% rule is applicable and listed on the inventory of existing chemical 
substances, or that is a new chemical substance meeting the 2% rule  
XI. Agro -pesticides, as defined by the Agro -pesticides Managemen t Act  
XII. Feeds and feed additives, as defined by the Feed Control Act  3 
 XIII. Fertilizers, as defined by the Fertilizer Management Act  
XIIII. Veterinary drugs, as defined by the Veterinary Drugs Control Act  
XV. Medicaments, as defined by the Pharmaceutical  Affairs Act  
XVI.  Controlled drugs, as defined by the Controlled Drugs Act  
XVII. Cosmetic(s), as defined by the Statute for Control of Cosmetic Hygiene  
XVIII. Foods and food additives, as defined by the Act Governing Food Safety and Sanitation  
XIX. Tobacco  products, as defined by the Tobacco Hazards Prevention Act  
XX. Tobacco and alcohol, as defined by the Tobacco and Alcohol Administration Act  
XXI. Radioactive Materials, as defined by the Atomic Energy Act and the Ionizing Radiation Protection 
Act 
XXII. Ch emicals regulated by the Montreal Protocol under the Air Pollution Control Act  
XXIII. Environmental agents, as defined by the Environmental Agents Control Act  
Raw materials as substances manufactured or imported in accordance with item XI to item XXIII as the 
above list sh all be subject to  in the Regulations . 
Chapter 2 New Chemical Registration  
Article 5  
Manufacturers or importers, to apply for the new chemical registration approval, shall refer to the 
following registration type based on estimated annual  manufactured or imported amount:  
1. Small quantity registration: less than 100 kilograms.  
2. Simplified registration: 100 kilograms or more, but less than 1 ton.  
3. Standard registration: 1 ton or more.  
If a new chemical substance to be manufactured or imported, falls under any of the following 
circumstances, its registration type shall be selected by referring to the estimated annual manufactured or 
imported quantity as specified in Appendix 1.  
1.  A substance used for Scientific Research and Development.  
2.  A s ubstance used for Product and Process Orientated Research and Development, PPORD.  
3.  On -site Isolated Intermediates.  
4.  Polymers.  
5.  Polymer of Low Concern(PLC).  
A registrant, to apply for the registration of Polymer of Low Concern pursuant to subparagr aph 5 of the 
preceding paragraph, 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 preceding paragr aph. 
Article 6  
The registration types and the corresponding registration information items, specified as follows:  
1. Standard registration as specified in Appendix 2.  
2. Simplified registration as specified in Appendix 3.  
3. Small quantity registration a s specified in Appendix 4.  
Article 7  
The central competent authority may demand a manufactured or imported new chemical substance be 
subject to the standard registration if it is identified as a substance that is  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.  4 
 Article 8  
For a new chemical substance fulfilling the criteria of the substances us ed 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 accord ance 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 s ubstances 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 su bmission of periodic report 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 con form 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 registrant, the central competent 
authority shall approve the registration alon g 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 of the same new chemical substance, may apply for joint 
registration under agreement and use the substance information requi red 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, which the overall quantity of the joint registration shall be the 
summation of the individual quantities from each co -registrant.  
By taking into account the overall manufactured or imported quantity of the new chemical substances 
registered and approved, the central competent authority may require registrants to apply for the new 
registration under the designated registration type, or apply for the joint registration.  
For the joint registration that is agreed by co -registrants, but 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 approves and issues the registration number for a new chemical substance 
registered.  
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.  
Article 13  
A registrant, to extend the valid period of the registration approval, shall make an application three months 
before its expiration. Information on estimated quantity of new chemical substances manufactured or 
imported for next year shall be submitted to the central competent authority. Th e aforementioned 5 
 extension application requires approval by the competent authority.  
If the registration type intended for extension is inconsistent with the originally approved registration, a 
new application of registration shall be made according to the  Regulations.  
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 registration process is filed and completed in accordance with the 
standard registration as specified in Appendix 1.  
II. It shall be at least five years after PLC registration process is filed and completed in accordance with 
the small quantity registration as  specified in Appendix 5.  
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 completed and filed through submission of information on hazard 
assessment and exposure assessment.  
II. PLC registration that has been completed and filed . 
A new chemical substance registered and appro ved, 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.  
Chapter 3 Existing Chemical Registration  
Article 15  
An existing chemical substance manufactured or imported shall be applied for the phase 1 registration by 
attaching chemical information, as specified in Appendix 5, from September 1st, 2015, to March 31st, 
2016, if its annual avera ge volume over the past three consecutive years prior to the registration 
application exceeds 100 kilograms, 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 
registration application is approved.  
Article 16  
After April 1st, 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 6. No existing 
chemical 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 approved, pursuant to the preceding paragraph.  
A re gistration may be made for existing chemical substances, which are manufactured or imported in 
annual volume less 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 
Regulation.  
Article 17  
The central competent authority may, by stages, announce the designated lists of existing chemical 
substances subject to standard registration, including the quantity threshold and the deadli ne for 
registration, based on the circumstances of the phase 1 registration of existing chemical substances.  
For existing chemical substances listed on the said lists pursuant to the previous paragraph, the registrant 
shall file for standard registration o f existing chemical substances and submit content items as specified in 6 
 Appendix 7 within the deadline announced.  
Article 18  
Different registrants for the same existing chemical 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 registra tion 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 19  
The central competent authority issues 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. Identificatio n 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 that shall be disclosed pursuant to the previous paragraph shall be made public through the 
internet.  
Article 21  
Chemical information registered, which concerns confidential matters on national security or b usiness 
secrets, shall be kept secret. The aforementioned business secret shall conform to the following conditions:  
I. It is not known to persons generally involved in the information of this type;  
II. It has economic value, actual or potential, due to it s secretive nature; and  
III. Its owner has taken reasonable measures to maintain its secrecy.  
For those registered information determined to be business secret, the following shall be protected and 
kept secret.  
I. Identification of registrant  
II. Identific ation of chemical substance  
III. Information on manufacture or import  
IV. Use of chemical substance  
A registrant may apply for secret information protection with proof documents conforming to Paragraph 2 
of this article, in any of the following conditions :  
I. Application of  the new chemical substance registration.  7 
 II. Application of the e xisting chemical substance phase 1 registration.  
III. Application of the e xisting chemical substance standard registration.  
IV. Three to six months prior to the application of inclusion in inventory of existing chemical substances 
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 d ocuments conforming to 
Paragraph 2, and apply to the central competent authority for information protection after submitting the 
registration application.  
Article 22  
A chemical substance  that has been  registered and approved  has the confidentiality perio ds specified as 
follows:  
I. Existing chemical substance phase 1 registration, standard registration, and PLC small quantity 
registration: confidentiality is to be valid for 5 years from the date of registration approval.  
II. Simplified registration or small quant ity registration: confidentiality is to be valid for 2 years from 
the date of registration approval.  
III. New chemical substances, which are included in the inventory of existing chemical substances in 
accordance with Article 14: confidentiality is to be valid for 5 years from the date of registration 
approval.  
Except for the existing chemical substance registered under the phase 1 registration, pursuant to 
subparagraph 1 of the previous paragraph, the duration of confidentiality is the same as the validity peri od 
for the corresponding registration types.  
A registrant may apply for an extension when it is three months prior to the expiry of the confidentiality 
period.  
A maximum duration of information protection for a chemical substance registered, pursuant to t he 
previous paragraph, is 15 years; but for the new chemical substances, which are included in the inventory 
of existing chemical substances pursuant to Article 14, the maximum duration of the protection on the 
chemical identification is 10 years.  
Article 23  
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 24  
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 sellin g or transferring new or existing chemical substances shall provide the information on 
safe use and other identifiable labels as granted under the Registrations.  
Article 25  
For the registered new and existing chemical substances, the registrant shall, sta rting from 201 9 January 
1st, during the period from March 1st to June 31st of each year, submit a report on the manufactured or 
imported quantity of the previous year for the new chemical substance, or the existing chemical substance, 
in accordance with Ap pendix 8.  
The report, pursuant to the previous paragraph, shall be submitted via the internet transmission systems, 
designated by the central competent authority. However, a report in writing may be submitted with the 
consent of the central competent auth ority.  8 
 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, exist ing 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 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.  
Where appropria te, the review periods pursuant to the previous paragraph may be extended. Registrants 
shall be notified of the extension. Extension is limited to one time only.   
Article 27  
The central competent authority shall review application documents for all applic ations 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 commencing f rom the next day after receipt of the notice. 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 technica l factors, this 
requirement shall not apply to registrants who report to the central competent authority for its consent.  
The review periods, pursuant to any of the subparagraphs in the previous Article, shall be calculated anew 
from the date that the cent ral competent authority accepts the supplementation or correction provided 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 correct ion within the time limited, or fails to make the supplementation or correction 
within a given time period more than two times.  
Article 28  
A registrant shall apply for modification when adding additional information to the application for 
chemical substance registration within 30 working days of changes to the information.  
If the additional information 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 
document ary proof issued by government authorities in charge of the subject industry.  
If the registration type for which modification is applied differs from the original registration approved, a 
new registration application shall be submitted pursuant to the Reg ulations.  
Article 29  
If registrants who obtained chemical substance 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 num bers.  
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 
belongs to others.  
IV. Improper use of chemical substances reported by government authorities in charge of subject 9 
 industry.  
V. Documentary proof of company registration, business registration, factory registration or other 
equivalent permission of b usiness establishment has been voided or revoked by their competent 
authorities.  
VI. Dissolution or suspension of business.  
Article 30  
For chemical substances registered and approved having any of the following circumstances, the registrant 
shall provide supp lementary information proactively or as prescribed by the central competent authority.  
I. New scientific evidence on chemical substances  
II. New information on toxicology and ecotoxicology of chemical substances  
III. New information hazard assessment of ch emical substances  
IV. 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 fro m the next day the notice of the review result is 
received.  
The appeal 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 the Internet transmission systems, registration tools, or forms designated by the central competent 
authority.  
Information submitted throug h Internet transmission systems, registration tools, or forms pursuant to 
previous paragraphs shall be written in Chinese. All foreign material shall have attached along with it a 
Chinese translation.  
The central competent authority shall not accept any ap plication if registrants fail to process registration 
pursuant to the previous 2 paragraphs. However, this requirement shall not apply to registrants who report 
to the central competent authority for its consent.  
Article 33  
Registrants shall keep copies o f all the information submitted 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 centr al competent authority, shall be kept in written or electronic form for 15 years for record and 
reference.  
Article 34  
The Regulations shall come into force  upon the date of promulgation.  10 
 Amendments Appendixes of Regulation of New and Existing Chemical Substances Registration (draft)  
 
Appendix 1 -Registration Application Type for Chemical Substance by Estimated Annual Manufactured or 
Imported Quantity and Chemical  Characteristics  
Annual 
Manufactured 
or Imported 
Volume  Scientific 
Research and 
Development  Process 
Orientated 
Research and 
Development, 
PPORD  On-site Isolated 
Intermediates  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:  
An academic organization is not required to submit documentation to the central competent authority for record 
and reference, if the new substance is used for any 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 refere nce. 
Appendix 2 - Standard Registration of New Chemical Substances —Information Item s *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 
properties  5.1 Physical state  
5.2 Melting / freezing point  
5.3 Boiling point  11 
 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  
6.8 Reproductive/Developmental toxicity  
6.9 Carcinogenicity  
7. Ecoto xicological 
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 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  12 
 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 volumes of 1 ton or more, but less than 10 tons, 
and do not meet 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 volumes of  10 tons or more and do not meet any 
of 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. Chemical substances falling within definition of on -site isolated intermediates, polymers, scientific research 
and development, or p roduct and process orientated re search 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 supplementary appendix below. In each 
level of registration information requirements, items marked wi th “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 
pH value  V V V V 
Auto -ignition temperature  V V V V 
Viscosity    V V 
Corrosive to metals    V V 
Section 6  13 
 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 
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 14 
 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 mor e, 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 scienti fic 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 re ferred 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 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 volum e 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 substances 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 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. Substances’ manufacture, use and 
exposure information  2.1  Manufacture and importation  15 
 2.2  Use information  
2.3  Exposure information  
3. Hazards classification and labelling  3.1  Physical hazards  
3.2  Health hazard  
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 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 the Existing Chemical Substances -Information Items *5 -1 
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  16 
 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. Substances manufacture and use 
information  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 Ministry of Labor, where information confidentiality request 
has been approved, or the chemical substance has no CAS number.  
4. The average annual volume in past 3 years right before a n application, or the highest annual quantity right 
before an application (for manufacture or importation has been interrupted before an application).  
5. Detailed information requirements shall refer to the content of the registration tool announced by the central 
competent authority.  
Appendix 6 - Phase 1 Registration of the Existing Chemical Substances -Information Items *5 -2 
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  
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. Substances manufacture and use 
information  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 exi sting 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.  17 
 4. The manufacture and im port volume at the time of application.  
5. Detailed information requirements shall refer to the content of the registration tool announced by the central 
competent authority.  
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 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  18 
 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 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 volumes 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 volumes of  10 tons or more , and do not meet any 
of 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.  
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. 19 
 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 shal l submit 
information according to the registration tools announced by the central competent authority.  
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 
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  20 
 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  
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 21 
 Note:  
a. Minimum information on physical  and chemical properties, toxicology, and ecotoxicology shall be 
submitted for existing chemical substances manufactured or imported per year 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 ten 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 o r 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 existing 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 as follows:  
i. Level I testing data shall be submitted for substances in annual manufactured or imported volume of less 
than 1 ton;  
ii. Level II t esting 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 as sessment 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;  
iv. Level IV testing data along with Section 8 -Hazard assessment and Section 9 -Exposure assessme nt shall 
be submitted for substances in annual manufactured or imported volume 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 a ccording to registration tools and forms issued by the 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.