These Regulations are promulgated according to Article 13, Paragraph 3 of the Occupational Safety and Health Act.

The terms used in these Regulations are defined as follows:
1. Chemical Substance refers to 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 constituent deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.
2. Registrant as used herein means a firm or an institute which obtains approval from the central competent authority to import, or domestically manufacture new chemical substances, and completes registration procedure.
3. Substance which Occur in Nature refers to a substance that is unprocessed, processed only by manual, gravitational, or mechanical means, by dissolution in water, by water extraction, by vapor distillation, by flotation, by heating solely to remove water, are extracted from air by any means, without producing chemical change in the substance; or large molecules from organisms, or polymers occurring in nature and not chemically processed.
4. Mixture refers to a mixture or a solution composed of two or more substances in which they do not react.
5. Article refers to a manufactured item formed to a specific shape or design during manufacture.
6. 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 contains at least three monomer units covalently bound; such molecules take over 50% of the weight of that substance, and the amount of the said molecules presenting the same molecular weight must be less than 50% of the weight of that substance.
C. Differences in the molecular weight are primarily attributable to differences in the number of monomer units.
7. Polymer for which the 2% Rule is Applicable refers to the monomer-based representation of polymers which may include or may not include monomers and other reactants used at 2 weight percent or less. A monomer-based representation means naming of polymers is based on constituent monomers.
8. Intermediate refers to a chemical substance produced and consumed in the course of the manufacture of another chemical substance.
9. On-site Isolated Intermediate refers to an intermediate that is produced and consumed on the same site.
10.Impurity refers to an unintended constituent present in a substance as produced. It originates from the starting materials or is the result of secondary or incomplete reactions during the production process. While it is present along with the final substance it was not intentionally added, nor does it enhance the commercial value of that substance. The concentration of an individual impurity is no more than 10% (w/w). All impurities presented are no more than 20% (w/w).
11.Incidental Reaction Products refer to chemical substances produced when a substance undergoes a chemical reaction that is consequent to the use of the substance, the result of storage or the change of environmental factors
12.Substance under Customs Supervision refers to a chemical substance under customs supervision, which is in temporary storage or placed in a harbor's designated area or warehouse, container freight station, bonded warehouse, logistics center or free trade zone, with a provision for re-exportation or transit
13.Scientific Research and Development refers to any scientific experimentation, education, analysis, or chemical research carried out under strictly controlled conditions.
14.Product and Process Orientated Research and Development (PPORD) refers to any scientific development related to product development or the further development of a substance, in the course of which pilot plant or production trials are used to develop the production process or to test the fields of application of the substance.
15.Polymer of Low Concern (PLC) refers to a substance that is evaluated by the central competent authority, and fulfills any one of the following conditions:
A. A polymer with an average molecular weight in a range of 1,000 to 10,000 Daltons, contains oligomers of molecular weights below 500 Daltons in amount of less than 10%; oligomers below 1,000 Daltons in amount of less than 25%.
B. A polymer with an average molecular weight over 10,000 Daltons, contains oligomers of molecular weights below 500 Daltons in amount of less than 2%; oligomers below 1,000 Daltons in amount of less than 5%.
C. Polyester polymers.
A. D. Insoluble polymers.
16. "Substance of Carcinogenic, Mutagenic or Toxic for Reproduction, CMR, Category 1" (hereinafter "CMR substance, Category 1") refers to a substance that meets any criteria of carcinogenicity category 1; mutagenicity category 1; reproductive toxicity category 1, based on R.O.C. National Standards CNS 15030.

These Regulations shall not apply to a new chemical substance, which is excluded from the inventory of chemical substances announced on an information web site by the central competent authority(hereinafter "the announced inventory") and meets any of the following conditions:
1. Substances which occurred in nature.
2. Chemical substances accompanied in the machines or equipment for test-run purpose.
3. Inseparable intermediates from the chemical reaction in the reaction vessel or production process.
4. Chemical substances for national defense purpose
5. By-product or impurity that is of no commercial application.
6. Chemical substances under customs supervision.
7. Waste
8. A polymer that the 2% rule is applicable and is listed on the announced inventory
9. Mixtures. Exemption is not applicable to a mixture composed of new chemical substances. .
10.Articles
11.Others that have been designated and officially announced by the central competent authority

These regulations shall not apply to a new chemical substance, which according to its use is subjected to permit and control regulations promulgated by other government authorities in charge of subject industry.