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 application and/or reporting affairs covered in the Regulations. The representative should be a natural person possessing the nationality of the Republic of China (R.O.C.), or a juristic person, an institute or an organization that is constituted or registered by law.
When 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 of 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, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation 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 natural polymer obtained without chemical processing.
III.“Mixture” 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 amount of the said molecules presenting the same molecular weight must be less than 50% of the weight of that substance; and
C.Differences in the molecular weight are primarily attributable to differences in the number of monomer units.
VI.“Polymer to 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 10,000 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; or
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 chemical 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 materials 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 individual impurity shall be no more than 10% (w/w) of the final substance. The total of all 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.
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 classified as Carcinogenic, Mutagenic or Toxic for Reproduction (CMR)” refers to a substance 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 items:
I.Substances which occur in nature
II.Chemical substances in machines or equipment for test run purposes
III.Inseparable intermediates from chemical reactions in the reaction vessel or production process
IV.Chemical substances for national 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 commercial application
VIII.Mixtures, but individual constituents of mixtures shall not be applied to this 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 items 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 Hygiene 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
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.Controlled 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 chemical 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.
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 more
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 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