1 Draft Amendment s to Regulations for New and Existing Chemical Substances Registration  
Chapter 1 General Principles  
Article 1  
These Regulations are stipulated pursuant to Article 30, paragraph 5 of the Toxic and Concerned 
Chemical Substances Control Act (hereinafter “this Act”).  
Article 2  
The term “registrant” as used herein means a natural person, a juristic person, an unincorporated 
body having a representative or manager, an administrative authority, or a body, who may be the 
subject of rights and obligations under other laws, that is subject to chemical substances 
registration pursuant to Article 30 of this Act.  
A registrant may appoint a representative to process the applica tion and/or reporting affairs 
covered in the Regulations. 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 law.  
Whe n applying for chemical substances registration according to the Regulations, a registrant 
shall attach a copy of a National Identification Card, a copy of company registration, business 
registration, factory registration, or other documents verifying the registrant’s establishment. A 
representative shall provide a notarized or certified appointment letter.  
Article 3  
The terms used in the Regulations are defined as follows:  
I. “Chemical Substance ” refers to a chemical element and its compounds in the natural state or obtained 
by any manufacturing process, including any additives necessary to preserve its stability and any 
unintended constituents deriving from the processes used, but excluding any solvent which may be 
separated without affecting the stability o f the substance or changing its composition.  
II. “Substance which Occurs in Nature ” refers to a naturally occurring substance as such, unprocessed or 
processed only by manual, gravitational or mechanical means, by dissolution in water, by extraction 
with water , by steam distillation, by flotation or by heating solely to remove water, or which is 
extracted from air by any means without any chemical changes, or a large molecule from living 
organisms or a natural polymer obtained without chemical processing.  
III. “Mixt ure” refers to a mix or solution composed of two or more substances which do not react.  
IV. “Article ” refers to an object which during production is given a specific shape or design . 
V. “Polymer ” refers to a chemical substance that fits the following criteria:  
A. A macro -molecular chemical substance consisting of molecules characterized by the sequence of 
one or more types of monomer units  
B. A molecule containing at least three monomer units that are covalently bound to at least one other 
monomer unit; such molecules  account  for over 50% of the weight of that substance, and the 2 amount of the said molecules presenting the same molecular weight must be less than 50% of the 
weight of that substance. A molecule containing at least three monomer units that are covalently 
bound to at least one other monomer unit; such molecules account  for over 50% of the weight of 
that substance, and the amount of the said molecules presenting the same molecular weight must 
be less than 50% of the weight of that substance  
C. Differences in the m olecular weight are primarily attributable to differences in the number of 
monomer units  
VI. “Polymer for which the 2% Rule is applicable ” refers to monomers or reactants of polymer  that are 
not regarded as part of the polymer when the weight percentage of the  monomers or reactants is less 
than 2%; if the naming of the polymer is a monomer -based representation, it may or may not include 
monomers and other reactants used at less than 2% weight. A monomer -based representation means 
the naming of polymer is based on constituent monomers.  
VII. “Polymer of Low Concern ” (PLC) refers to a chemical substance that is evaluated by the central 
competent authority, and fulfills any one of the following conditions:  
A. Polymer with an average molecular weight in a range of 1,000 to 1 0,000 Daltons, containing 
oligomers of molecular weights below 500 Daltons in an amount less than 10% and oligomers of 
molecular weights below 1,000 Daltons in an amount less than 25%  
B. Polymer with an average molecular weight over 10,000 Daltons, containing  oligomers of 
molecular weights below 500 Daltons in an amount less than 2% and oligomers of molecular 
weights below 1,000 Daltons in an amount less than 5%  
C. Polyester  
D. Insoluble polymer  
VIII. “Intermediate ” refers to a chemical substance produced and consumed in the course of the 
manufacturing process of another chemical substance.  
IX. “On-site Isolated Intermediate ” refers to an intermediate that is produced and consumed on the same 
site. 
X. “Incidental Reaction Product ” refers to a chemical substance resulting from a c hemical reaction 
induced by any change in environmental condition during the use and the storage of the original 
chemical substance.  
XI. “Impurity ” refers to an unintended constituent present in a substance as manufactured. It originates 
from the starting mate rials or is the result of secondary or incomplete reactions during the production 
process. While it is present in the final substance, it was not intentionally added, nor does it enhance 
the commercial value of that substance. An individu al impurity shall be no more than 10% (w/w)  of 
the final substance . The total of a ll impurities present shall be no more than 20% (w/w)  of the 
substance.  
XII. “Scientific Research and Development ” (SRD) refers to any scientific experimentation, education, 
analysis, or chemical research carried out under strictly controlled conditions for scientific or 
academic research.  3 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 plants 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 su bstance that 
is classified as carcinogenicity category 1, mutagenicity category 1, or reproductive toxicity category 
1, based on the R.O.C. National Standards (CNS) 15030.  
XV. “Chemical Substance under Customs Supervision ” refers to a chemical substance under customs 
supervision, which is temporarily stored or placed in a harbor ’s designated area, warehouse, container 
freight station, bonded warehouse, logistics center, or free trade zone, with a provision for re -
exportation or transit.  
Article 4  
The Regulations shall not apply to any of the following substances or 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 prod uction process  
IV. Chemical substances for national security or national defense purposes  
V. Chemical substances under customs supervision  
VI. Chemical waste produced or released from industrial processes  
VII. Incidental reaction products or impurities that are of no comm ercial application  
VIII. Mixtures, but individual constituents of mixtures shall not be appli ed to th is Article  
IX. Articles  
X. Polymer to which  the 2% Rule is Applicable and is listed on the inventory of existing chemical 
substances  
The Regulations shall not apply to the substances or objects 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. Cosmetics, as defined by the Cosmetic Hygie ne and Safety Act  
VIII. Foods, food additives, food utensils, food containers or packaging, and food cleansers, as defined by 
the Act Governing Food Safety and Sanitation  
IX. Tobacco products, as defined by the Tobacco Hazards Prevention Act  4 X. Tobacco and alcohol, as defined by the Tobacco and Alcohol Administration Act  
XI. Radioactive materials, as defined by the Atomic Energy Act and the Ionizing Radiation Protection Act  
XII. Industrial -use explosive materials, as defined by the Industrial Explosives Administrative Act  
XIII. Contro lled chemicals as prescribed in the Occupational Safety and Health Act  
XIV. Chemical substances regulated by the Montreal Protocol under the Air Pollution Control Act  
XV. Environmental agents, as defined by the Environmental Agents Control Act  
XVI. Toxic and concerned c hemical substances, as defined by this Act  
For a chemical substance manufactured or imported as a raw material in the preceding paragraph, 
the chemical substance shall be subject to the provisions of the Regulations.  
Chapter 2 New Chemical Substances Registration  
Article 5  
To apply for new chemical substances registration approval, manufacturers or importers shall refer 
to the following registration types based on estimated annual manufactured or imported quantity:  
I. Standard registration: at 1 ton or m ore 
II. Simplified registration: at 100 kilograms or more, but less than 1 ton  
III. Small quantity registration: less than 100 kilograms  
If the uses or properties of a new chemical substance to be manufactured or imported meets any 
of the following circumstances , its registration type shall be selected by referring to the estimated 
annual manufactured or imported quantity, as specified in Appendix 1.  
I. A substance used for the purpose of SRD  
II. A substance used for the purpose of PPORD  
III. An On -site Isolated Intermediate  
IV. Polymer  
V. Prior verified Polymer of Low Concern, PLC  
Article 6  
The quantity thresholds for standard registration are as specified in Appendix 2.  
The registration information items of each registration type are specified as follows:  
I. Standard registration: as specified in Appendixes 3 and 4  
II. Simplified registration: as specified in Appendix 5  
III. Small quantity registration: as specified in Appendix 6  
Article 7  
For a manufactured or imported new chemical substa nce undergoing  appli cation for simplified 
registration or small quantity registration pur suant to the previous two Articles, the central 
competent authority may demand the registrant to register data in accordance with the 5 requirements of standard registration if the new chemical substance is identified as a s ubstance of 
CMR.  
Article 8  
For a new chemical substance meeting the circumstances of being a substance used for the 
purposes of scientific research and development ; or for product and process orient ed research and 
development; or having other special form s, in addition to registering the new chemical substance 
in accordance with t he required information items of the Regulations, the registrant shall submit 
the following documents to the central competent authority:  
I. Registration form for SRD and PPORD  
II. Nanos cale chemical substances registration form  
Article 9  
Upon reviewing new chemical substances information submitted by a registrant, the central 
competent authority shall approve the registration along with an additional clause to prohibit or 
restrict handl ing, and shall  require registrants to regular ly report  hand ling conditions, update  
registratio n report data, or submi t chemical substances hazard information, if the central 
competent authority determines that there is a concern over the toxicological characteristics of a 
new chemical substance conforming to the definitions of Class 1, Class 2, or Class 3 toxic 
chemical s ubstances.  
Upon reviewing new chemical substances information submitted by a registrant, the central 
competent authority shall approve the registration along with an additional clause to restrict 
handling, and shall require registrants to  submi t informatio n on exposure assessment and risk 
assessment, update registration report data, or submi t chemical substances hazard information, if 
the central competent authority determines that there is a concern of environmental pollution or 
any threat to human health.  
Article 10  
When different registrants apply to register the same new chemical substance jointly or 
sequentially, they may use common data needed for  the registration through consultation.  
The new chemical substance, subjected to the joint registration pursuant to the preceding 
paragraph, is to be registered according to the Regulations, for which the overall quantity of the 
joint registration shall be the sum of the individual quantities from each co -registrant.  
By taking into account the overall manufa ctured 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 to 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 data, the central competent authority may determine 
an average apportionment at the request of the application ’s registrant s. The registration data can 6 be used after the registrants have paid their respective shares of expenses according to the decision 
made by the central competent authority.  
Article 11   
The central competent authority issues the registration nu mber for a new chemical substance that 
is registered and approved.  
Article 12  
The valid period of the new chemical substances registration approval is 5 years.  
Upon agreements for the joint registration for early and late registrants, the valid periods of  such 
joint registration for the late registrants shall be consistent with those periods for the early 
registrants.  
Article 13  
A registrant, to extend the valid period of the registration approval, shall make an application to 
the central competent author ity three to six months prior to its expiration. Information on 
estimated quantity of new chemical substances manufactured or imported for the following year 
shall be submitted to the central competent authority at the same time. Upon approval of the 
centr al competent authority, the extension shall be granted pursuant to the previous Article.  
If the central competent authority is unable to make the rejection/approval decision for the 
extensions before the original approval registration expires, those who fi le the extension 
application pursuant to the preceding paragraph may continue to manufacture or import the new 
chemical substances, in compliance with the situation specified in the originally approved 
registration, until the review is completed.  
If the central competent authority is unable to make the rejection/approval decision for the 
extensions before the original approval registration expires, those who fail to file the extension 
application pursuant to Paragraph 1 shall stop manufacturing or importi ng the new chemical 
substances after the valid period of the original approved registration expires. If a registrant does 
not apply for an extension before the valid period expires, the original approved registration is 
revoked exactly on the following day  of the expiration day specified with the original approved 
registration. A new application of registration shall be made in order to continue manufacturing 
or importing such chemical substances.  
If the registration type intended for extension is inconsist ent with the originally approved 
registration, a new application for registration shall be made.  
Article 14  
A new chemical substance registered and approved under  any one of following circumstances may 
be included in the inventory of existing chemical substances by the central competent authority:  
I. It shall be at least five years after the standard registration 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 qua ntity registration  7 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 has been registered and approved for any of the f ollowing registration s: 
I. Standard registration filed and completed through submission of information on hazard assessment 
and exposure assessment  
II. PLC registration in accordance with the small quantity registration  
A new chemical substance registered and app roved, 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 substances.  
Chapter 3 Existing Chemica l Substances Registration  
Article 15  
For an existing chemical substance first manufactured or imported in annual quantity of 100 
kilograms or more, a registrant shall, within 6 months from the date of occurrence of the fact, 
apply for the phase 1 registration and attach chemical information, as specified in Appendix 7. No 
existing chemical substance shall be manufactured or imported, unless the registration approval 
is obtained within the specified period.  
The central competent authority is to issu e a phase 1 registration number to a registrant whose 
registration application is approved, pursuant to the preceding paragraph.  
Registration for existing chemical substances, manufactured or imported in annual quantity less 
than 100 kilograms, may be made  in accordance with Article 15 , paragraph 1. After the registration 
application is approved, the above mentioned existing chemical substances are subject to the 
Regulations.  
Article 16  
The central competent authority may, by stages, designate the lists of existing chemical substances 
subject to standard registration, including the names of the chemical substances, quantity 
thresholds and deadlines for registration, based on the circumstances of the phase 1 registration 
of existing chemical substances.  
The q uantity thresholds subject to the standard registration of existing chemical substances by 
stage as designated pursuant to the previous paragraph are specified in Appendix 8, whereas the 
designated lists and deadlines are specified in Appendix 9.  
Registran ts manufacturing or importing any existing chemical substances listed in Appendix 9, 
shall apply for the standard registration of such existing chemical substances and attach 
information, as specified in Appendixes 3 and 4.  
On-site isolated intermediates m ay be exempted from needing an appl ication for the standard 
registration of existing chemical substances pursuant to the provisions of the preceding three 
paragraphs.  8 Registrants manufacturing or importing existing chemical substances, which are not any of  the 
chemical substances listed in Appendix 9 or do not meet the quantity thresholds in Appendix 8, 
may apply for the registration of chemical substances pursuant to Article 16 , paragraph 3.  
Article 17  
When different registrants, pursuant to Article 16 , paragraphs 2 or 5, apply to register the same 
existing chemical substance jointly or sequentially, they may use common data needed for 
registration through consultation.  
The existing chemical substance, subjected to the joint registration pursuant to the pr eceding 
paragraph, is to be registered according to Article 16 , paragraph 3.  
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 data, the central competent authority may determine 
an average apportionment at the request of the applicati on’s registrants. The registration data can 
be used after the share of expenses has been paid.  
Article 18  
The central competent authority issues a completion number for the standard registration of an 
existing chemical substance to those who apply and com plete information registration specified 
in Appendix 3 pursuant to the provisions of the previous two Articles.  
Upon acquisition of the completion number as described in the previous paragraph, the registrant 
shall complete information registration specifi ed in Appendix 4 proactively or before the due date 
appointed by the central competent authority.  
Chapter 4 Information Dissemination and Protection of Business Secrets  
Article 19  
Chemical substances information registered and approved by the central competent authority shall 
be disseminated to the public. The information items which shall be disseminated are as follows:  
I. Registrant information  
II. Chemical substance names  
III. Manufacture or import conditions  
IV. Classification and labelling  
V. Guidance on safe use  
VI. Physical and chemical properties  
VII. Toxicological and ecotoxicological information  
VIII. Hazard assessment  
IX. Exposure assessment  
The content pursuant to the previous paragraph shall be publicly disseminated through the Internet 
by the central competent authority.  9 Article 20  
Chemical substances information that is registered, which involves confidential matters on 
national defense or business secrets, shall be kept confidential.  
The aforementioned business secrets shall conform to the following conditions:  
I. It is not  known to persons generally involved with information of this type  
II. It has actual or potential economic value due to its secretive nature  
III. Its owner has taken reasonable measures to maintain its confidentiality  
For registered information determined to be bus iness secrets pursuant to Article 20 , paragraph 1, 
the following shall be protected and kept confidential:  
I. Registrant information  
II. Substance identification  
III. Information on manufacturing and importing  
IV. Life cycle description  
A registrant may apply for confidential information protection with proof documents conforming 
to Article 20 , paragraph 2, in any of the following occasions:  
I. Application for the registration of a new chemical substance  
II. Application for the phase 1 registrat ion of an existing chemical substance  
III. Application for the standard registration of an existing chemical substance  
IV. Application for the inclusion in the inventory of existing chemical substances pursuant to Article 14  
A registrant, who does not apply for con fidential information protection for a chemical substance 
registered and approved pursuant to the previous paragraph, may state the reasons, with proof 
documents conforming to Article 20 , paragraph 2, and apply to the central competent authority 
for inform ation protection, at the time of filing an extension application for a registered new 
chemical substance or after the registration is approved for an existing chemical substance.  
Article 21  
The confidential period of the chemical substance information approved by the central competent 
authority is 5 years.  
Except for the existing chemical substances, the confidential period pursuant to Article 20 , 
paragraph 5 expires as the valid period for the corresponding registration expires.  
A registrant may apply for the extension of the confidential periods specified in Article 21 , 
paragraph 1 three to six months prior to the expiry of the confidential period.  
The maximum confidential period for a new chemical substance is 15 years; for an existing 
chemical substance, the maximum confidential period is 10 years. For a new chemical substance 
that has been included in the inventory of existing chemical substances, the maximum confidential 
period is 15 years.  
Article 22   10 The central competent authority shall no tify the registrant when chemical substances information 
is publicly disseminated in accordance with  Article 69, paragraph 2  of this Act.  
Chapter 5 Supplementary Provisions  
Article 23  
The central competent authority may provide the information of the reg istered new and existing 
chemical substances to the industry competent authorities to manage chemical substances used in 
the subject industry.  
A registrant selling or transferring new or existing chemical substances shall provide the 
information on safe us e and other identifiable labels as permitted under the Registrations.  
Article 24  
For registered new and existing chemical substances, the registrant shall, starting from the 
following year after the registration is approved, submit a report annually on the manufactured or 
imported quantity in the previous year for the new or the existing chemical substances, in 
accordance with Appendix 10 between April 1 and September 30.  
Where the information reported by the registrant does not comply with the relevant regulations as 
determined by the competent authority, the competent authority shall notify the registrant to make 
a correction within a prescribed period. Where the registrant fails to do so or the correction fails 
to meet the requirements, the competent a uthority shall impose an administrative penalty in 
accordance with Article 56, paragraph 4 of this Act and notify the registrant to make another 
correction within a prescribed period. If the registrant fails to do so or the made correction fails 
to meet th e requirements again, an administrative penalty shall be imposed for each violation.  
The report and correction, pursuant to the previous two paragraphs, shall be submitted via the 
Internet transmission system designated by the central competent authority. However, a report or 
correction in writing may be submitted with the consent of the central competent authority.  
Article 25  
The review periods of all the applications accepted by the central competent authority in the 
Regulations are as follows:  
I. New chemi cal substances small quantity registration, PLC prior verification, PLC small quantity 
registration, existing chemical substances phase 1 registration, confidential business information 
protection and corresponding extension: 10 working days from the date of receipt of the application  
II. New chemical substances simplified registration and the inclusion in the inventory of existing 
chemical substances: 20 working days from the date of receipt of the application  
III. New chemical substances standard registration: 60 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  11 The review periods for small quantity registration and simplified registration may be e xtended to 
60 working days when the registration applications satisfy the conditions in Article 9.  
The central competent authority shall notify the registrant if the review period of the previous two 
paragraphs is extended. The number of extensions is limi ted to one.  
Article 26  
The central competent authority shall review application documents for all applications accepted 
under the Regulations . Should the review procedure find documents inadequate, mistaken, or 
unspecific, the central competent authority shall require the registrant to provide a correction 
within 30 working days from the date of receiving the notification from the central competent 
authority. The said notification of corrections shall be given only three times. However, if the 
failure to p rovide supplementation or correction within this limited period is caused by scientific 
or technical factors, this requirement shall not apply to registrants who report to the central 
competent authority and obtain its consent.  
The review periods and the n umber of extensions of review periods, pursuant to any of the 
subparagraphs in the previous Article, shall be calculated anew from the date that the central 
competent authority receives the correction submitted by the registrant pursuant to the previous 
paragraph.  
The application shall be rejected if the registrant fails to make the correction within the limited 
time, or fails to make the correction within a given period more than three times.  
Article 27  
A registrant shall apply for changes to the register ed information for chemical substances 
proactively or within 30 working days from the date of receiving the notification from the central 
competent authority.  
If the change pursuant to the previous paragraph involves basic information related to a registra nt, 
an application  for change  shall be made within 30 working days from recei ving approval for 
change of company registration, business registration, factory registration, as well as other 
documentary proof issu ed by the industry competent au thorities. An application  for change  of a 
designated responsible  person  shall be made within 60 working days after  the change in  the 
designated responsible person . 
If the registration type for which a cha nge is applied differs from the original registration type 
that ha s been approved, a new registration application shall be submitted.  
Under any of the following circumstances , the registrant may file an application to the central 
competent authority for a revocation of an approval registration and a cancellation of the 
corresponding registration number:  
I. A new registration has been submitted and approved pursuant to the preceding paragraph  
II. A chemical substance with registration approval is no longer being manufactured or imported  
Article  28 12 If registrants who obtained chemical substances registration approval are found with any of the 
following circumstances , the central competent authority may withdraw or revoke approval of the 
registration, and cancel their registration numbers:  
I. False regis tration information  
II. Obtaining approval of chemical substances registration by fraud, coercion, or other improper means  
III. Manufacturing or importing chemical substances by using or forging registration numbers that belong 
to others  
IV. Improper use of chemical su bstances reported by the industry competent authorities  
V. Documentary proof of company registration, business registration, factory registration, or other 
equivalent permission of business establishment that has been ordered a dissolution, withdrawn, or 
revoked by the industry competent authorities  
VI. Dissolution or termination of business  
Article 29  
For chemical substances registered and approved with any of the following circumstances, the 
registrant shall provide supplementary information proactively or as prescribed by the central 
competent authority by an appointed due date:  
I. New scientific evidence on chemical substances  
II. New information on the uses of chemical substances  
III. New information on toxicology and ecotoxicology of chemical substances  
IV. New information  on hazard assessment or exposure assessment of chemical substances  
V. Other information designated by the central competent authority  
Article 30  
If a registrant has any concerns regarding the result of registration review, written appeal with 
stated reasons  may be submitted within 30 working days from receiving the notice of the review 
result.  
The number of appeals pursuant to the previous paragraph shall be only one.  
Article 31  
Registrants submitting all of the application pursuant to the Regulations shall  pay a corresponding 
fee according to the fee -charging standards set for this Act; the registrant shall submit the chemical 
substances information through Internet transmission systems designated by the central competent 
authority.  
The information as presc ribed in previous paragraphs shall be written in Chinese. All foreign 
materials shall have a Chinese edition attached.  
The central competent authority shall not accept any application if registrants fail to process their 
registration pursuant to the previo us two paragraphs. However, this requirement shall not apply 
to registrants who report to the central competent authority and obtain its consent.  13 Article 32  
The Regulations take force upon the date of promulgation.  14 Draft Amendment s to the Appendixes of Regulations for New and Existing Chemical Substances 
Registration  
Appendix 1  
Registration Types for New Chemical Substances by Estimated Annual Manufactured or Imported 
Quantity and Uses or Properties  
Uses or  
Properties  
 
 
Annual  
Manufactured  
or Imported Quantity  For Scientific 
Research and 
Development, 
SRD  For Product 
and Process 
Orientated 
Research and 
Development, 
PPORD  On-site 
Isolated 
Intermediates  Polymer  Polymer of 
Low 
Concern, 
PLC  
(Prior 
Verification 
required)  
Less than 1 ton  Exemption  Small 
Quantity 
Registration  Small 
Quantity 
Registration  Small 
Quantity 
Registration  Exemption  
1 ton or more, but less 
than 10 tons  Simplified 
Registration  Simplified 
Registration  Simplified 
Registration  Simplified 
Registration  Small 
Quantity 
Registration  
10 tons or more  Standard 
Registration  Standard 
Registration  Standard 
Registration  Standard 
Registration  Small 
Quantity 
Registration  
Note: Academic organizations are not required to submit documentation to the central competent authority 
for record and reference, if the new chemical substance is less than 1 ton and is used for scientific 
research and development. However, as a chemical used in business premises, for the purpose of 
research a nd development, (including for research, analysis, sampling, or testing, etc.), submission of 
documentation to the central competent authority must be made for record and reference.  
Appendix 2  
Quantity Thresholds for New Chemical Substances Subject to Standard Registration  
Annual Manufactured 
or Imported Quantity  Substances of 
Carcinogenic, 
Mutagenic or Toxic 
for Reproduction 
(CMR)  On-site Isolated 
Intermediates, 
Polymer, for 
Scientific Research 
and Development 
(SRD), or for Product 
and Process 
Orientat ed Research 
and Development 
(PPORD)  Other Chemical 
Substances  
Less than 1 ton  Level 1  - - 
1 ton or more, but 
less than 10 tons  Level 2  - Level 1  
10 tons or more, but 
less than 100 tons  Level 3  Level 1 Level 2  
100 tons or more, but 
less than 1,000 tons  Level 4  Level 1 Level 3  15 1,000 tons or more  Level 4  Level 1  Level 4  
Notes:  
1. For 10  metric tons or more  of a new chemical substance  which meets the definition of being a CMR 
substance and concurrently meets the definition of on -site isolated intermediates, polymer, and 
substances for SRD or PPORD, the quantity threshold thereof shall be considered that for CMR 
substances.  
2. According to Article 29, after registration applications have been approved, the registrants should 
proactively provide the supplemental information based on the new quantity threshold when the 
actual manufactured or imported quantity increases which leads to an increase in the quantity 
threshold.  
Appendix 3  
Information Items, Regardi ng Registrants and Substances, of New and Existing Chemical 
Substances Subject to Standard Registration  
Sections  Items  Level  1 Level 2  Level 3  Level 4  
1. General Information  1.1 Registrant information  V V V V 
1.2 Substance identification  V V V V 
2. Manufacture, Use and 
Exposure  2.1 Information on manufacturing and 
importing  V V V V 
2.2 Life cycle description  V V V V 
2.3 Exposure information  V V V V 
3. Classification and 
Labelling  3.1 Physical hazards  V V V V 
3.2 Health hazards  V V V V 
3.3 Environmental hazards  V V V V 
3.4 Labelling elements  V V V V 
4. Guidance on Safe Use  4.1 First -aid measures  V V V V 
4.2 Fire-fighting measures  V V V V 
4.3 Accidental release measures  V V V V 
4.4 Handling and storage  V V V V 
4.5 Transport information  V V V V 
4.6 Exposure controls/personal protection  V V V V 
4.7 Stability and reactivity  V V V V 
4.8 Disposal considerations  V V V V 
5. Physical and Chemical 
Properties  5.1 State of the substance  V V V V 
5.2 Melting point/Freezing point  V V V V 
5.3 Boiling point  V V V V 
5.4 Density  V V V V 16 5.5 Partition coefficient: n -octanol/water  V V V V 
5.6 Water solubility  V V V V 
5.7 Vapor pressure  V V V V 
5.8 Flash point  V V V V 
5.9 Flammability  V V V V 
5.10 Explosive properties  V V V V 
5.11 Oxidizing properties  V V V V 
5.12 pH V V V V 
5.13 Auto -ignition temperature  V V V V 
5.14 Viscosity    V V 
5.15 Corrosive to metals    V V 
6. Toxicological 
Information  6.1 Acute toxicity by oral, dermal, or 
inhalation route  V V V V 
6.2 Skin irritation/corrosion  V V V V 
6.3 Serious eye damage/irritation  V V V V 
6.4 Skin sensitization  V V V V 
6.5 Genotoxicity  V V V V 
6.6 Basic toxicokinetics   V V V 
6.7 Repeated dose toxicity by oral, 
dermal, or inhalation  route   V V V 
6.8 Reproductive/developmental toxicity   V V V 
6.9 Carcinogenicity     V 
7. Ecotoxicological 
Information  7.1 Short -term toxicity to  aquatic 
invertebrates  V V V V 
7.2 Toxicity to aquatic algae and 
cyanobacteria  V V V V 
7.3 Biodegradation in water: screening 
tests  V V V V 
7.4 Short -term toxicity to fish   V V V 
7.5 Hydrolysis   V V V 
7.6 Toxicity to microorganisms   V V V 
7.7 Adsorption/desorption   V V V 
7.8 Long -term toxicity to  aquatic 
invertebrates    V V 
7.9 Long -term toxicity to fish    V V 
7.10 Toxicity to soil macroorganisms 
except arthropods     V 
7.11 Toxicity to terrestrial plants     V 
7.12 Toxicity to soil microorganisms     V 
7.13 Biodegradation in water and 
sediment: simulation tests     V 17 7.14 Biodegradation in soil     V 
7.15 Bioaccumulation: aquatic/sediment     V 
7.16 Sediment toxicity     V 
Note:  In each level of the standard registration, items marked with “V” should be submitted.  
Appendix 4  
Information Items, Regarding Hazard and Exposure Assessment, of New and Existing Chemical 
Substances Subject to Standard Registration  
Sections  Items  Level 1  Level 2  Level 3  Level 4  
1. Hazard Assessment  1.1 Human health hazard assessment of 
physicochemical properties   V V V 
1.2 Human health hazard assessment   V V V 
1.3 Environmental hazard assessment   V V V 
1.4 PBT (persistent, bioaccumulative and 
toxic) and vPvB (very persistent and 
very bioaccumulative) assessment   V V V 
2. Exposure Assessment  2.1 Exposure scenario(s)   V V V 
2.2 Exposure estimation   V V V 
2.3 Risk characterization   V V V 
Note:  
1. In each level of the standard registration, items marked with “V” should be submitted.  
2. Chemical substances annually manufactured or imported in quantity of 10 tons or more which do not 
meet any of following conditions, may be exempted from submission of expos ure assessment:  
(1) Physicochemical properties hazardous to human health  
(2) Health hazard  
(3) Environmental hazard  
(4) Being persistent, bioaccumulative and toxic (PBT)  
(5) Being very persistent and very bioaccumulative (vPvB)  
Appendix 5  
Information Items of New Chemical Substances Subject to Simplified Registration  
Sections  Items  
1. General information  1.1 Registrant information  
1.2 Substance identification  
2. Manufacture, Use and 
Exposure  2.1 Information on manufacturing and importing  
2.2 Life cycle description  
2.3 Exposure information  18 3. Classification and 
Labelling  3.1 Physical hazards  
3.2 Health hazards  
3.3 Environmental hazards  
3.4 Labelling elements  
4. Guidance on Safe Use  4.1 First -aid measures  
4.2 Fire-fighting measures  
4.3 Accidental release measures  
4.4 Handling and storage  
4.5 Transport information  
4.6 Exposure controls/personal protection  
4.7 Stability and reactivity  
4.8 Disposal considerations  
5. Physical and Chemical 
Properties  5.1 State of the substance  
5.2 Melting point/Freezing point  
5.3 Boiling point  
5.4 Density  
5.5 Partition coefficient : n-octanol/water  
5.6 Water solubility  
 
 
Appendix 6  
Information Items of New Chemical Substances Subject to Small Quantity Registration  
Sections  Items  
1. General information  1.1 Registrant information  
1.2 Substance identification  
2. Manufacture and Use  2.1 Information on manufacturing and importing  
2.2 Life cycle description  
 
 
Appendix 7 
Information Items of Existing Chemical Substances Subject to Phase 1 Registration  
Sections  Items  
1. General information  1.1 Registrant information  
1.2 Chemical Abstracts Service (CAS) Registry Number or serial 
number  
2. Manufacture and Use  2.1 Manufactured and imported quantity  
2.2 Life cycle description  
Note:  A serial number shall refer to a code assigned for an existing chemical substance listed in the national 
inventory of existing chemical substances established by the Ministry of Labor, where information 19 confidentiality request has been approved, or the chemical substance has no CAS Registry Number.  
Appendix 8 
Quantity Thresholds for Existing Chemical Substances Subject to Standard Registration  
Annual Manufactured or 
Imported Quantity  Substances of Carcinogenic, 
Mutagenic or Toxic for 
Reproduction (CMR)  Other Chemical Substances  
1 ton or more, but less than 
10 tons  Level 2  Level 1  
10 tons or more, but less than 
100 tons  Level 3  Level 2  
100 tons or more, but less 
than 1,000 tons  Level 4  Level 3  
1,000 tons or more  Level 4  Level 4  
Note:  According to Article 29, after the standard registration has been completed, the registrants should 
proactively provide the supplemental information based on the new quantity threshold when the 
actual manufactured or imported quantity increases which leads to an increase in the quantity 
threshold.  
Appendix  9 
Designated List of Existing Chemical Substances Subject to Standard Registration and Deadlines 
for Standard Registration 
Stage  Serial 
No. CAS  
Registry  
No. Name  
1 1 79-10-7 Acrylic acid  
1 2 10043 -01-3 Aluminium sulfate  
1 3 7664 -41-7 Ammonia, anhydrous  
1 4 1336 -21-6 Ammonium hydroxide  
1 5 123-77-3 1,1'-Azobis(formamide)  
1 6 100-52-7 Benzaldehyde  
1 7 552-30-7 Benzene -1,2,4 -tricarboxylic acid 1,2 -anhydride  
1 8 119-61-9 Benzophenone  
1 9 25973 -55-1 2-(2H-Benzotriazol -2-yl)-4,6-ditertpentylphenol  
1 10 90-43-7 2-Biphenylol  
1 11 103-23-1 Bis(2 -ethylhexyl) adipate  
1 12 106-94-5 1-Bromopropane  
1 13 111-76-2 2-Butoxyethanol  
1 14 25013 -16-5 Butylated hydroxyanisole  
1 15 128-37-0 Butylated hydroxytoluene  
1 16 57693 -14-8 C.I. Acid black 172  20 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  
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  21 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  
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  22 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 information items specified in Appendix 3 within the following 
prescribed deadlines:  
(1) For a phase 1 registration number first obtained before December 31, 2019, the registrant shall 
complete the information items specified in Ap pendix 3 before December 31, 2023, if the 
registered annual manufactured or imported quantity is 1 ton or more.  
(2) For a phase 1 registration number first obtained after January 1, 2020, the registrant shall, 
counting from January 1 of the following year upon  obtaining the number, complete the 
information items specified in Appendix 3 within four years, if the registered annual 
manufactured or imported quantity is 1 ton or more.  
(3) For an existing chemical substance at annual manufactured or imported quantity of less than 1 
ton when first obtaining the phase 1 registration number, the registrant shall complete the 
information items specified in Appendix 3 within four years, counting from January 1 of the 
following year, if the substance ’s actual annual manufacture d or imported quantity reaches 1 
ton or more after January 1, 2020.  
(4) For reapplication for a phase 1 registration due to cancellation of a phase 1 registration number, 
the registrant, if subject to the standard registration pursuant to the previous three pa ragraphs, 
shall complete the information items specified in Appendix 3 within the deadlines specified in 
the previous three paragraphs after obtaining a phase 1 registration number again; or complete 
the information items specified in Appendix 3 at the tim e of reapplication of the phase 1 
registration if the deadlines specified in the previous three paragraphs are due.  
(5) Registrants who complete information items specified in Appendix 3 will be issued with a 
completion number in accordance with Article 18, paragraph 1. The said registrants shall, as 
prescribed in Article 18, paragraph 2, submit information items specified in Appendix 4 
proactively or as prescribed by the central competent authority by an appointed due date.  
2. The existing chemical substances li sted in this Appendix shall be identified according to the CAS 
Registry Numbers. The names presented are for reference only.  
Appendix  10 
Reporting Items of New and Existing Chemical Substances  
Sections  Items  
1. Registrant and 
Registration Number  1.1 Registrant information  
1.2 Registration number  
2. Manufactured and 
Imported Quantity  2.1 Manufactured quantity  
2.2 Imported quantity