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Regulation of New Chemical Substances Registration (Draft) 
 
1. Definition z These Regulations are promulgated according to Article  13 of the Occupational Safety and Health Act. 
z Manufactures or importers shall submit a chemical safety assessment report  (hereinafter referred to as "assessment report") ac cording to the related guidance issued by the central 
competent authority, with respect to the registration type, cat egory, and annual quantity bands of new chemical  substances. 
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 “the Inventory of Chemical Substa nces” as used herein means the chemical substa nces that are publicly announced to be in the chemical substance database designated by the 
central competent authority after consulting with the centr al authorities in charge of the relevant industries. 
z The term “New Chemical Substance” as used herein means the chem ical substances which are not in the inventory of chemical subst ances.   
z The term “Registrant” as used herein mean s a firm or institute which imports or dome stically manufactures new chemical substanc es, or an appointed third party notary.   The 
firm/institute or third party notary shall obtain documentary pr oofs of domestic commercial and industrial registrations or aca demic institute, as well as notarized appointment letters. 
z The term “Registration Tool” as used herein means a program system for new chemical substa nce registration and approval. 
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 “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 “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 “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 “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. 
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 “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 said polymer shall not contain hi gh concern or hi gh activit y functional groupsa sd e s i gnatedin related guidelines  
 
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Regulation of New Chemical Substances Registration (Draft) 
 
issued 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 “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.  
 
2. Exemption z A substance or a polymer occurred in nature  without physical and chemical process.  
z Chemical substances accompanied in the machines and equipments for test ­run purpose. 
z Inseparable intermediates from the chemical reaction in the reaction vessel or production process.  
z Chemical substances fo r national defence purpose 
z Incidental reaction products or impurities without intended commercial purpose 
z Chemical substan ces under customs supervision.  
z Waste 
z A polymer that is listed in the inventory of chem ical substances and applicable to the 2 % Rule. 
z Mixtures. However exemption is not applicable to mixtures which constituent chemicals are new chemical substances. 
z Articles. If the new chemical substances  contained in articles re lease under formal use, exemption is  not applicable. 
z Other chemical substance category, as designated to be exempted by the central competent authority.    
 
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Regulation of New Chemical Substances Registration (Draft) 
 
3. Registration Approval and Safety Assessment Report 
Types of Registration Information 
requirement Valid 
Period 
Standard Registration  Appendix 1 5 years 
Simplified Registration  Appendix 2 1 year Manufacturers or importers shall not manufacture or import chemicals containing a new chemical substance prior to submitting an assessment report to the central competent authority a nd receiving registration appr oval for the new substance. 
 
New chemical substance registrations are divided into three types with respective information requirement for approval.  
 
Three months before the expiration of regi stration document, of simplified registratio n and small quantity, a registrant may ap ply 
to the central competent authority for an extension. New registration document shall be issued after review.   
Registration document approved under small quantity registration is valid fo r 1 year. However Polymer of Low Concern 
approved under small quantity regist ration is valid for 5 years.  Small Quantity 
Registration  Appendix 3 1 year Types of 
registration 
New chemical substance registration type is determined depe nding on annual manufactured or imported quantity of the new 
chemical substance with re ference to Appendix 4. Appendix 4 
 
 
Registration for chemicals with 
special forms or 
purposes.  For a new chemical substance subjected to registration conforming to the following conditions, its registration type is to be 
determined regarding its annual manufactured or im ported quantity with reference to Appendix 5.  
 
1. A substance used for Scient ific Research and Development 
2. A substance used for Product and Process Or ientated Research and Development, PPORD 
3. On-site Isolated Intermediates 
4. Polymers or Polymers of Low Concern 
 
A registrant applying for registration of Polymer of Low Concern shall submit prior verification application to the central 
competent authority and obtain confirmation document.  Appendix 5 
Joint registration Two or more manufactures or importers appl ying for registration for the same new chemic al substance may jointly or successively  submit application for registration approval. Quantities 
shall be aggregated for all substances  approved under joint submission.  
The central competent authority may subject a new chemical subs tance to registration type modification or joint submission wher e its national annual manufactured or imported quantity 
reaches certain amount.  
CMR substances The central competent authority may subject a new chemical substance to the standard registration if it is identified as a subs tance of carcinogenic, mutagenic, or toxic to reproduction; 
regardless if it is entitled to simplified registration or small quantity registration. 
4. Registration 
approval 
document The following items shall be specified in the a registration approval document: 
1. Registrant basic information 
2. New chemical substance serial number  
3. Approved registered use 
4. Approved registration type 
5. Document issue date and valid period   
 
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Regulation of New Chemical Substances Registration (Draft) 
 
5. Information 
dissemination  The central competent authority shall disseminate the following necessary information related to chemical substances in order t o maintain worker right of hazard recognition.  
1. New chemical substance serial number  
2. Hazard classification and labelling 
3. Physical and chemical properties 
4. Toxicological information 
5. Safe use information 
6. Other information that is determined to be disclosed to pe rsonnel specially appointed by the central competent authority for  workers safeguarding and health or necessary emergency 
measures.  
6. Inclusion in 
the inventory 
of chemical 
substances The central competent authority may include new chemical substa nces conforming to the following requirement in the inventory of  chemical s ubstances through period public 
announcement.   
1. It’s over 5 years after the date standa rd registration process was completed.  
2. It’s over 5 years after the date small quantity registration process of  new chemical substances verified as PLC was complete d.  
3. Early inclusion application is submitted by a registrant of ne w chemical substance, where level 2 or further level of inform ation required by standard regist ration as specified in Appendix 
1, has been met and hazard assessment and exposure assessment have  been submitted.  
4. Early inclusion application is submitted by a registrant of ne w chemical substance verified as PLC, where small quantity reg istration process has been completed; or polymers, where 
standard registration has been completed.    
5. It’s over 5 years after the date of first joint registration process for a new chemical substance successively registered wa s completed.   
6. Other substances designated to  be listed in the inventory of chemical substa nces in consultation with other central competen t authorities.  
7. Confidentiality 
of chemical 
names For a chemical substance to be listed in the inventory of chem ical substances conforming to th e following three provisions, the  registrant shall apply for confidentiality of chemical names 6 
months before the subs tance is to be listed in the inventory.  
1. The substance name subjected for protectio n contains business secret of a registrant. 
2. A registrant has taken actions and will re main the confidentiality of substance name.  
3. The substance name has not been accessed by the third part y through reasonable and legitimate approach unless otherwise auth orized by the registrant.  
Valid period of approved confidentiality  of chemical names is 5 years.  
Six months before the expiration of confid entiality of chemical names, the applicant may request to extend confidentiality for once time. New registra tion document shall be issued to those 
request reviewed and approved.  
8. Others The regulations include provisions governing re view procedure, correction/s upplementation, written appe al, record keeping, as w ell as commission juridical associations funded by the 
central competent authority, administra tive corporations and professional groups. 
9. Effective date These regulations shall take effect on January 1st, 2015. 
 
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Regulation of New Chemical Substances Registration 
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Appendix 1 
 
Standard Registration- Information It ems and Content of Chemical Safety 
Assessment Report 
1. Basic identification of the registrant and substances 
Information of the registrant; Substance Identification 
2. Substances manufacture, use and exposure information 
Manufacture and importation; Use information; Exposure information 
3. Hazards Classification and Labelling 
Physical hazards; Health hazard s; Environmental hazards; Labelling 
4. Safe use information 
First aid measures; Firefighting measures; Accidental  release measures; Handlin g and storage; Transport 
information; Exposure controls / personal protection 
5. Physical and chemical properties 
Physical state; Melting / freezing point; Boiling point; Density; Octanol/water partition coefficient; Water 
solubility; Vapor pressure; Flash point; Flammability; Explosive properties;  Oxidation properties; pH value; 
Auto-ignition temperature; Viscosity; Corrosive to metals 
6. Toxicological Information 
Acute toxicity: oral, dermal, inhalation; Skin corrosion /irritation; Eye irritation; Skin sensitization; Genetic 
toxicity; Basic toxicokinetics; Repeat Dose Toxicity: oral, inhalation, dermal; Reproductive/Developmental 
toxicity; Carcinogenicity 
7. Hazard assessment  
Physicochemical-property-to-human-health hazard assessment ; Health hazard assessment  
8. Exposure Assessment  
Exposure scenarios description; Exposur e estimation; Risk characterization  
 
Note:  
 
1. For detailed information requirements, please refer to the content of the registration tool announced by the central 
competent authority. 
2. Substances in volume of 1 ton or more, and less than 10 tons, or substances which do not fall within definition of 
CMR substance are exempted fro m submission of haza rd assessment and e xposure Assessment.  
3. Chemical substances whic h do not possess health hazards or environm ental hazard, in annual manufactured or 
imported volume of 10 tons or more, and which physical and chemical properties are not hazardous to human health 
shall be exempted from submissi on of exposure assessment.   
4. Chemical substance fall within defi nition of On-site Isolated Intermediate s, Polymers, Scientific Research and 
Development, or PPORD, shall be exempted from subm ission of hazard assessment and exposure assessment. 
5. Submission of the aforesaid informati on, physical and chemical properties and toxicological information shall refer to 
respective registration information require ments of four levels, which is tabula ted as supplementary appendix below. 
In each level of registration information requirem ents, items marked with “V” should be submitted. 
 
 
 
 
 
 
 
  
 
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Supplementary Appendix 
 
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 
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 
Note 
1. For new chemical substances in annual manufactured or imported volume reaching 1 ton or more, but less 
than 10 tons; 10 tons or more, but less than 100 tons; 100 tons or more, but less than 1,000 tons; 1,000 tons 
or more, the registrant shall respectively provide minimum information on phys ical/chemical properties 
and toxicological test data with referenc e to level I, II, III,  IV data set.  
2. For new chemical substances which fit the defini tion of on-site isolated intermediates, polymers, 
substances used for scientific research, or for product and process orientated research and development, 
PPORD, in annual manufactured or imported volume of 10 tons or more, the minimum information on 
physical/chemical properties and t oxicological information referred to level I testing data shall be 
submitted.  
3. For new chemical substances that  fall within definition of  carcinogenic, mutagenic or toxic to reproduction 
(CMRs) substances, in annual manufactured or imported volume of less than 1 ton; 1 ton or more, but less 
than 10 tons; 10 tons or more, but less than 100 tons; 100 tons or more, the minimum information 
submitted on physical/chemical properties and toxicological information shall respectively refer level I, II, 
III, IV testing data.  
4. Testing items in level I, II, III, IV testing data set of  physical/chemical properties and toxicological 
information shall be conducted  according to relevant guidance issued  by the central competent authority.  
  
 
 
 
  
 
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Regulation of New Chemical Substances Registration 
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Appendix2 
 Simplified Registration-Information It ems and Content of Chemical Safety 
Assessment Report 
 
1. Basic identification of the registrant and substances 
Information of the registrant; Substance Identification 
2. Substances manufacture, use and exposure information 
Manufacture and importation; Use information; Exposure information 
3. Hazards Classification and Labelling 
Physical hazards; Health hazard s; Environmental hazards; Labelling 
4. Safe use information 
First aid measures; Firefighting measures; Accidental  release measures; Handlin g and storage; Transport 
information; Exposure controls / personal protection 
5. Physical and chemical properties  
Physical state; Melting / freezing point; Boiling poin t; Density; Octanol/water partition coefficient; Water 
solubility 
Note 
 
1. For detailed information requirements, please refer to the content of the registration tool announced by the central 
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Regulation of New Chemical Substances Registration 
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Appendix3 
 Small Quantity Registration-Informat ion Items and Content of Chemical 
Safety Assessment Report 
 
1. Basic identification of the registrant and substances 
Information of the registrant; Substance Identification 
2. Substances manufacture, use and exposure information  
Manufacture and importation; Use information  
Note 
 
1. For detailed information requirements, please refer to the content of the registration tool announced by the central 
competent authority.  
 
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Regulation of New Chemical Substances Registration 
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Appendix 4 
 
Annual Manufactured or Imported Vo lume and Registration Types -1 
 
Annual Manufactured or 
Imported Volume Registration Type 
Ö100 kg Small Quantity Registration 
Ú100kg, Ö1ton Simplified Registration 
Ú1ton Standard Registration 
  
 
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Appendix 5 
 
Annual Manufactured or Imported Vo lume and Registration Types -2 
 
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) 
Ö1ton 
Exemption Small Quantity 
Registration Small Quantity 
Registration Small 
Quantity 
Registration Exemption 
Ú1ton~Ö10ton Simplified 
Registration Simplified 
Registration Simplified 
Registration Simplified 
Registration 
Ú10ton Standard 
Registration Standard RegistrationStandard 
Registration Standard 
Registration Small Quantity 
Registration