Regulation of New and Existing Chemi cal Substances Registration (Draft) 
 
 11. Definition z The term “registrant” as used herein means a natural person, a juristic person, an unincorporat ed body having a representative or manager, an administrativ e authority, or a person who 
may be subjects of rights and obligations unde r other laws, that is subject  to chemical subs tances registration pursuant to Art icle 7-1 of Toxic Chemical Substances Control Act. 
A registrant may appoint a representative to apply for chemical substances registration. 
Applying for chemical substance registration, a registra nt shall attach company registrati on, business registration or factory registration, or other verify ing documents; a representative 
shall supply notarized appointment letter.  
z The term “Chemical Substanc e” as used herein means a chemical element and its compounds in the natural state or obtained by any  manufacturing process, including any additive 
necessary to preserve its stability and any unintended constitu ent deriving from the process used, but excluding any solvent wh ich may be separated without af fecting the stability of the 
substance or changi ng its composition.  
z The term “Substances which Occurred in Natu re” as used herein means s ubstances that are unprocessed,  processed only by manual, gravitational, or mechanical means, or by 
dissolution in water, or by water extraction, or by flotation, or by heating solely to remove water, or are extracted from air by any means, without  chemical change in  the substance; or 
large molecules from organisms, or polymers occurring in nature and not chemically processed. 
z The term “Mixture” as used herein means a mixture or a solution composed of two or more substa nces in which they do not react. 
z The term “Article” as used herein means a manufactured item formed to a specific shape or design during the manufacturing proce ss. 
z The term “Polymer” as used herein means a chemical  substance with the following characteristics:  
A. A macro-molecular chemical s ubstance consisting of molecules characterized by the sequence of one or more types of monomer u nits. 
B. A molecule contains at leas t three monomer units covalently bound; such molecu les take over 50 percent of the weight for tha t substance ,and the amount of the said molecules 
presenting the same molecular weight must be le ss than 50 weight percent of the substance. 
C. Differences in the molecular weight  are primarily attributable to differe nces in the number of monomer units. 
z The term “Polymers for which the 2% Rule is  Applicable” as used  herein means the m onomer-based representation of polymers which  may include or may not  include monomers and 
other reactants used at 2% weight or less.  A monomer-based repr esentation means naming of polymers  is based on constituent mono mers 
z The term “Polymer of Low Concern” as used herein means a subs tance that complies with other re levant provisions and guidance is sued by the central competent authority, and any 
one of the following conditions: 
A. A polymer with a number average molecula r weight in a range of 1,000 to 10,000 Da ltons, contains oligomers of molecular weig hts below 500 Daltons in amount of less than 10%; 
oligomers below 1,000 Daltons in amount of less than 25%. The sa id polymer shall not contain high  concern or high activity func tional groups designated by  the central competent 
authority.  
B. A polymer with a number average molecula r weight over 10,000 Daltons, contains oli gomers of molecular weights below 500 Dalt ons in amount of less than 2%; oligomers below 
1,000 Daltons in amount of less than 5%.  
C. Polyester polymers containing monomers a nd other reactants listed in relevant guida nce determined by the central competent a uthority.  
z The term “Intermediate” as used herein means a chemical substance produced and consumed in the course of the manufacturing of a nother chemical substance.  
z The term “On-site Isolated Intermediates” as used herein means intermediates that are produced and consumed on the same site. 
z The term “Incidental Reac tion Products” as used herein mean s substances produced when a subs tance undergoes a chemical reaction  that is consequent to the use to which the 
substance is put or that results from storage or fr om environmental factors. 
z The term “Impurity” as used herein mean s an unintended constituent present in a su bstance as produced. It may originate from th e starting materials or be th e result of secondary or 
incomplete reactions during the production proc ess. While it is present along with the final substance, it was not intentionall y added, nor does it enhance the commercial value of that 
substance. The concentration of an indivi dual impurity is no more than 10% (w/w). All impurities present comprise no more than 20% (w/w). 
z The term “Scientific Research and Development” as used herein m eans any scientific experimentation, education, analysis, or che mical research carried out under strictly controlled 
conditions. 
z The term “Product and Process Orientated Rese arch and Development, PPORD” as used herein means any sc ientific development relat ed 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 a pplication of th e substance. 
z The term “Substance of Carcinogenic, Mutage nic or Toxic for Reproduction, CMR” as used  herein means a subs tance that meets any criteria of carcinogenicity  category 1, category 2; 
mutagenicity category 1,  category 2; productive toxicity  category 1, category 2, based on National Standards CNS 15030.  
z The term “Substances under Custom s Supervision” as used herein means chemical s ubstances under customs s upervision, which are i n temporary storage or placed in a harbor’s 
designated area or warehouse, co ntainer freight station, bonded warehouse, logist ics center or free trade zone, with a provisio n to re-exportation or  in transit. Regulation of New and Existing Chemi cal Substances Registration (Draft) 
 
 22. Exemption z A substance or a polymer occurring in nature without physical and chemical processing.  
z Chemical substances accompanied in machines and equipment for test ­run purposes. 
z Intermediates inseparable from chemical reactions  in reaction vessels or production process.  
z Chemical substances for national defense purposes 
z Chemical substan ces under customs supervision.  
z Waste 
z Mixtures. Exemption is not applicable to the i ndividual chemical constituents of the mixtures. 
z Articles. If new chemical substances contained in articles are released under normal use, exemption is not applicable to the co nstituent substance. 
z Polymers for which the 2% Rule is applicable and are listed on the chemical substances inventory. 
z Other categories that are publicly announced  by the central competent authority. Regulation of New and Existing Chemi cal Substances Registration (Draft) 
 
 33. Regulation on New Chemical Substances 
Requirements Type of 
Registration  Information 
Requirements Working Days of 
Review Procedure Valid periods of 
registration document 
A new chemical substance manufactur ed or imported in annual quantities of 1 ton or more; or for 
a new chemical substance manufactured or imported for the purposes of scientific research and 
development, and product- and process-orientated research and development, in annual quantities 
of 100 tons or more. Standard 
Registration Appendix 1 Within 45 working 
days. 5 years 
A new chemical substance manuf actured or imported in annual quantities of 100 kilograms or 
more, but less than 1 ton; or for a new chemic al substance manufactured or imported for the 
purposes of scientific research and development, and product- a nd process-orientated research 
and development, in annual quantities of 1 ton or more, but less than 100 tons. Simplified 
Registration Appendix 2 Within 14 working 
days. 2 year New chemical 
substance 
A new chemical substance manufact ured or imported in annual quantities of less than 100 
kilograms; or a new chemical substance manufactured or importe d for the purposes of product- 
and process-orientated research  and development, in annual qua ntities of less than 1 ton. Small Quantity 
Registration Appendix 3 Within 7 working 
days. 2 year 
A new chemical substance in compliance with the definition of an on-site isolated intermediate 
or polymer, with annually manufactured or imported quantities of 100 tons or more. Standard 
Registration Appendix 1 Within 45 working 
days. 5 years New chemical 
substance in 
compliance with 
the definition of 
an on-site 
isolated 
intermediate or 
polymer A new chemical substance in compliance with the definition of an on-site isolated intermediate 
or polymer, with annually manufactured or impor ted quantities of 1 ton or more, but less than 
100 tons. Simplified 
Registration Appendix 2 Within 14 working 
days. 2 year Regulation of New and Existing Chemi cal Substances Registration (Draft) 
 
 4 A new chemical substance in compliance with the definition of an on-site isolated intermediate 
or polymer, with annually manufactured or imported quantities of less than 1 ton. 
 Small Quantity 
Registration Appendix 3 Within 7 working 
days. 2 year 
Substance of 
Carcinogenic, 
Mutagenic or 
Toxic for 
Reproduction, 
CMR New chemical substances identified as CMR substances may be filed for standard registration designated by the central competent  authority. 
 
Substances previously reviewed and verified by the central competent authority, as polymers of 
low concern in annual quantities of less than 1 ton. No requirement No requirement - - Polymer of Low 
Concern , PLC 
Substances previously reviewed and verified by the central competent authority, as polymers of 
low concern in annual quantities of 1 ton or more. Small Quantity 
Registration Appendix 3 within 7 working days 5 years 
Additional 
Information 
Requested for 
chemicals used 
for special 
purpose or 
having special 
forms For a new chemical substance fulfilling the cr iteria of the substances for the purpose of scientific research and development, or for product and process oriented research and development; or 
having other special forms,  chemical substance information shall be supplied in accordance with the regulations, as well as ad ditional forms and information designated by the central 
competent authority. 
4. Joint 
Registration Co-registrants, or the early and late regi strants of the same new chemical substanc e, may apply for joint registration under th e agreement. 
For joint registration that is agreed by the co-registrants, but no agreement is reached upon th e cost sharing of registration information, the central competent authority may determine the cost 
to be equally shared at the request of the later co-registrant.  The use of registration information is approved after the share d cost has been paid. Regulation of New and Existing Chemi cal Substances Registration (Draft) 
 
 55. Inclusion in 
the 
inventory of 
existing 
chemical 
substance  The new chemical substances that are granted under registration in any one of the following circumstances shall be included in the inventory of existing chemic al substances by the central 
competent authority.  
1. It has been at least 5 years that registration process is filed and completed in accordance with the standard registration a s specified in Appendix 1.  
2. It has been at least 5 years that PLC registration process is filed and completed in accordance with the small quantity regi stration as specified in Appendix 3. 
3. It has been at least 5 years that the first registration process is filed and completed in accordance with the standard regi stration as specified in Appendix 1, where the chemical substance 
has been successively a pplied for registration. 
4. Toxic chemical substances announced by the central competent authority.  
For new chemical substances that are granted under registration, the registrant may apply for inclusion in the inventory of exi sting chemical substances, where standard registration has been 
made and completed through submission of information on hazard assessment and exposure assessment,  as specified in Appendix 1. 
6. Transitional 
measures New chemical substances manufactured or imported during the period from the effective date to December 31, 2015, shall be appli ed for small quantity regist ration through submission of 
chemical information as specified in Appe ndix 3. With permission and registration doc ument granted by the central competent aut hority, The aforementioned regi stration document is valid 
for 2 years, which shall not be extended upon expiration. 
7. The regulation includes review procedur e, post registration extension, modificati on, revocation, cancellation and keeping of  registration documents. 
8. A manufacturer or importer to sale or tr ansfer new chemical substances shall take  the initiative to present registration doc ument or identifiable labels as 
granted under registration, as we ll as information of safe use. 
9. Chemical substance information granted under registration by the central competent au thority shall be made public on the Int ernet. The information 
disclosed is as follows: 
A. Chemical substance’s name B. Manufacturing or import conditions C. Hazard classification and labelling  D. Safe use information E. Physical and chemical properties F. Toxicological and ecot oxicological information 
G. Hazard assessment H. Exposure assessment 
10. Chemical information registered, which is  involved in confidential matters on national security and business secrets, shall  be kept confidential. The 
aforementioned confidential business information  shall conform with the following conditions: 
A. It is not known to persons generally involved in the information of this type; 
B. It has economic value, actual or pote ntial, due to its secretive nature; and 
C. Its owner has taken reasonable m easures to maintain its secrecy. 
For those information determined to be business secret, the following information shall be kept confidential.  Regulation of New and Existing Chemi cal Substances Registration (Draft) 
 
 6A. Identification of chemical substance 
B. Information on manufacture or import  C. Use of chemical substance 
11. A registrant may make application of in formation protection with proof documents during the registration process of new che mical substance, existing 
chemical substance registration or 3-6 months prior to inclusi on in inventory of existing chemi cal substances. Confidentiality is valid for 5 years. Extension 
may be applied 3 months prior to the expiry of the confidentiality period. 
 
 
5. Regulation on Existi ng Chemical Substances 
Requirements Type of Registration Information 
Requirements 
An existing chemical substance manufactured  or imported in annual quantities over 100 kilograms or more during the period 
specified by the central competent authority. Phase 1 registration Appendix 5  
An existing chemical substance manufactured  or imported, for the first time, in a nnual quantities over 100 kilograms, after 
March 31st , 2016. Post Phase 1 Registration Appendix 5  Existing 
chemical 
substance 
Phase in existing chemical substance listed in a public notice announced by the central competent authority 
 Standard Registration for Existing 
Chemical Substance Appendix 6 
Joint Registration Different registrants of phase in existing ch emical substance, which is liste d in public notice and subjecte d to standard registration, may apply for joint registration under the agreement. 
For joint registration that is agreed by the co-registrants, but no agreement is reached upon th e cost sharing of registration information, the central competent authority may determine the cost to 
be equally shared at the request of the later co-registrant. The use of registration information is approved after the shared c ost has been paid. 
6. The regulation includes review procedur e, extension, modification, revocation, cance llation and keeping of registration docu ments 
7. A manufacturer or importer to sale or transfer existing chemical substances shall take the initiative to present registratio n number, registration document or 
other identifiable labels as  granted under registration. 
8. Chemical substance information granted under registration by th e central competent authority shall be made public on the Int ernet. The information 
disclosed is as follows: 
A. Chemical substance’s name 
B. Manufacture or import conditions C. Hazard classification and labelling D. Safe use information E. Physical and chemical properties F. Toxicological and ecot oxicological information 
G. Hazard assessment 
H. Exposure assessment 
9. Chemical information re
gistered, which is involved in confidential matters on national securit y and business secrets, shall be ke pt secret. The Regulation of New and Existing Chemi cal Substances Registration (Draft) 
 
 7aforementioned business secret  shall conform with the following conditions: 
A. It is not known to persons generally involved in the information of this type; 
B. It has economic value, actual or pote ntial, due to its secretive nature; and 
C. Its owner has taken reasonable m easures to maintain its secrecy. 
For those information determined to be business secret , the following information shall be kept secret.  
D. Identification of chemical substance. E. Information on manufacture or import.  F. Use of chemical substance. 
10. A registrant may make application of in formation protection with proof documents during the registration process of new che mical substance, existing 
chemical substance registration or 3-6 mont hs prior to inclusion in inventory of ex isting chemical substances. Confidentiality is valid for 5 years. Extension 
may be applied 3 months prior to the expiry of the confidentiality period. 
 G/TBT/N/TPKM 
 
- 8 - 
Regulation of New and Existing Chemical Substances Registration (Draft) 
 
 
Appendix 1--Standard Registrati on of New Chemical Substan ces-- Information Requirements 
 
Section Items 
1. Basic identificati on 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 Regulation of New and Existing Chemi cal Substances Registration (Draft) 
 
 96 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/Devel opmental toxicity 
6.9 Carcinogenicity 
7 Ecotoxicological Information 7.1 Short-term to xicity 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  
9.3 Risk characterization  
Note:  
For detailed information requirements refe r to the content of the registration method announced by the central competent author ity. 
Supplementary Appendix 
Section 5 
Physical and chemical properties I II III IV 
Physical state V V V V 
Melting / freezing point V V V V Regulation of New and Existing Chemi cal Substances Registration (Draft) 
 
 10Boiling 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, de rmal, 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/Developmenta l 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 macroor ganisms except    V Regulation of New and Existing Chemi cal Substances Registration (Draft) 
 
 11arthropods 
Toxicity to terrestri al organisms    V 
Toxicity to soil mi croorganisms    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  
Health hazard assessment     V 
Environmental hazard assessment     V 
PBT and vPvB assessment     V 
Section 9  
Exposure Assessment  I II III IV 
Exposure scenarios description    V 
Exposure estimation    V 
Risk characterization    V 
 Regulation of New and Existing Chemi cal Substances Registration (Draft) 
 
 12Appendix 2--Simplified Registration of New Chemical Substances-- Information Requirements 
 
Section Items 
1. Basic identificati on of the registrant 
and substances  1.1  Information of the registrant  
1.2  Substance Identification  
2. Substances’ manufacture, use and 
exposure information 2.1  Manufacture and importation  
2.2  Use information 
2.3  Exposure information 
3. Hazards Classification and Labelling 3.1  Physical hazards 
3.2  Health hazard 
3.3  Environmental hazards 
3.4  Labelling 
4. Safe use information 4.1 First aid measures 
4.2 Firefighting measures 
4.3 Accidental re lease 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:  
For detailed information requirements refe r to the content of the registration method announced by the central competent author ity. 
 Regulation of New and Existing Chemi cal Substances Registration (Draft) 
 
 13Appendix 3--Small Quantity Registration of Ne w Chemical Substances-- Information Requirements 
 
Section Items 
1. Basic identificati on 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: 
For detailed information requirements refe r to the content of the registration method announced by the central competent author ity. 
 Regulation of New and Existing Chemi cal Substances Registration (Draft) 
 
 14Appendix 4–-Information Requirements of Phase 1 Re gistration of Existing Chemical Substances 
 
Section Items 
1. Basic identification of the regi strant 1.1 Type of 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 responsible person 
1.9 Name of contact person 
1.10 Telephone number of contact person 
1.11 Email address of contact person 
1.12 Original manufacturer of substances* 
1.13 EMS administration number 
2. Basic identification of the substa nce 2.1 CAS NO. or serial numbers 
3. Substances manufacture and use 
information 3.1 Manufactured and imported quantities 
3.2 Use information 
Note:  For detailed information requirements re fer to the content of the registration method announced by the central competent autho rity. Regulation of New and Existing Chemi cal Substances Registration (Draft) 
 
 15Appendix 5 –- Phase-in of Designated Standard Registra tion for Existing Chemical Substances - Information 
Requirements  
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 Regulation of New and Existing Chemi cal Substances Registration (Draft) 
 
 165.13 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 Ecotoxicological Information 7.1 Short-te rm 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 micro-organisms 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 macro-organisms except 
arthropods 
7.11 Toxicity to terrestrial organisms 
7.12 Toxicity to soil micro-organisms 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 Physicoch emical-property-to-human-health 
hazard assessment  Regulation of New and Existing Chemi cal Substances Registration (Draft) 
 
 178.2 Health hazard assessment  
8.3 Environmental hazard assessment 
8.4  PBT and vPvB assessment  
9 Exposure Assessment 9.4  Ex posure Scenarios Description 
9.5  Exposure Estimation 
9.6 Risk Characterization  
Note: 
For detailed information requirements refe r to the content of the registration method announced by the central competent author ity. 
 
Supplementary Appendix 
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 , de rmal, 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 Regulation of New and Existing Chemi cal Substances Registration (Draft) 
 
 18Reproductive/ 
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 m acro-organisms except 
arthropods    V  
Toxicity to terrestri al organisms    V 
Toxicity to soil mi croorganisms    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  
Health hazard assessment     V 
Environmental hazard assessment     V 
PBT and vPvB assessment     V 
Section 9  
Exposure Assessment  I II III IV 
Exposure scenarios description    V 
Exposure estimation    V 
Risk characterization    V