Regulations of New and Existing Chemical Substances Registration｜第 3 條｜化學物質管理｜Regulation｜In Force
第 一 章｜環境部｜v1.0
Last Amended: 2021-11-23
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.