Regulations of New and Existing Chemical Substances Registration 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; andC.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; orD.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.
中文原文 新化學物質及既有化學物質資料登錄辦法第3條
本辦法用詞，定義如下：
一、化學物質：指自然狀態或經過製造過程得到之化學元素或化合物。
包括維持產品穩定所需之任何添加劑或製程衍生而非預期存在於化學物質中之成分，但不包括可以分離而不影響物質穩定性，或改變其組成結構之任何溶劑。
二、天然物質：指未經加工或只經人力、重力、機械等作用，溶解於水、以水萃取、蒸氣蒸餾、浮力、加熱移除水分，或用任何方法從空氣中分離出且未產生任何化學變化之物質，或來自於生物體之大分子，或未經化學加工之天然聚合物。
三、混合物：指含二種以上不會互相反應之物質、溶液或配方。
四、成品：指製造過程中，已形成特定形狀之物品或依特定設計之物品。
五、聚合物：指符合下列條件之化學物質：
（一）由一種或多種類型之單體單元按序列聚合成大分子之化學物質。
（二）由三個以上之單體單元以共價鍵形式相連而成之分子，其在化學物質中之總重量百分比須大於百分之五十，而且分子量相同者之重量百分比須小於百分之五十。
（三）分子量分布差異是由於其單體單元數目之差異而造成。
六、百分之二規則之聚合物：指聚合物之單體或反應體之重量百分比未滿百分之二，則該單體或反應體可不視為該聚合物之化學本體。
若聚合物名稱以單體基礎式命名時可選擇包括或不包括未滿重量百分之二之單體及反應體。
單體基礎式命名指聚合物名稱以其組成單體為基礎來加以命名者。
七、低關注聚合物：指經中央主管機關審核並符合下列條件之一者：
（一）聚合物之數目平均分子量介於一千至一萬道爾頓之間者，其分子量小於五百道爾頓之寡聚合物含量少於百分之十，分子量小於一千道爾頓之寡聚合物含量少於百分之二十五。
（二）聚合物之數目平均分子量大於一萬道爾頓者，其分子量小於五百道爾頓之寡聚合物含量少於百分之二，且分子量小於一千道爾頓之寡聚合物含量少於百分之五。
（三）聚酯聚合物。
（四）不可溶性聚合物。
八、中間產物：指在一連串化學反應程序中，部分化學反應程序之產物做為後續反應原料之化學物質。
九、限定場址中間產物：指在單一場所製造並消耗之中間產物。
十、副產物：指在使用或儲存過程中，因環境變化發生化學反應而生成之化學物質。
十一、雜質：指非預期而存在於化學物質中之成分，源自化學物質原料、反應過程中次要反應或不完全反應；化學物質中之不純物亦屬雜質。
在最終化學物質中出現之雜質，其為非刻意加入，亦不會增加該化學物質之商業價值。
單一雜質成分含量不得超過該化學物質之重量百分之十；多重雜質成分總量不得超過該化學物質之重量百分之二十。
十二、科學研發用途：指在科學或學術環境與控制條件下執行之科學性實驗、教育、分析或研究等用途。
十三、產品與製程研發用途：指在工廠產製試驗用於發展生產程序或測試物質應用領域之過程，與產品開發或製程物質發展直接相關之研發過程。
十四、致癌、生殖細胞致突變性或生殖毒性物質：指物質危害分類符合中華民國國家標準CNS15030所列之致癌物質第一級；生殖細胞致突變性物質第一級；生殖毒性物質第一級之危害分類者。
十五、海關監管化學物質：指儲存於海關監管之碼頭專區、貨棧、貨櫃集散站、保稅倉庫、物流中心或自由貿易港區等，待出口之化學物質。
一、化學物質：指自然狀態或經過製造過程得到之化學元素或化合物。
包括維持產品穩定所需之任何添加劑或製程衍生而非預期存在於化學物質中之成分，但不包括可以分離而不影響物質穩定性，或改變其組成結構之任何溶劑。
二、天然物質：指未經加工或只經人力、重力、機械等作用，溶解於水、以水萃取、蒸氣蒸餾、浮力、加熱移除水分，或用任何方法從空氣中分離出且未產生任何化學變化之物質，或來自於生物體之大分子，或未經化學加工之天然聚合物。
三、混合物：指含二種以上不會互相反應之物質、溶液或配方。
四、成品：指製造過程中，已形成特定形狀之物品或依特定設計之物品。
五、聚合物：指符合下列條件之化學物質：
（一）由一種或多種類型之單體單元按序列聚合成大分子之化學物質。
（二）由三個以上之單體單元以共價鍵形式相連而成之分子，其在化學物質中之總重量百分比須大於百分之五十，而且分子量相同者之重量百分比須小於百分之五十。
（三）分子量分布差異是由於其單體單元數目之差異而造成。
六、百分之二規則之聚合物：指聚合物之單體或反應體之重量百分比未滿百分之二，則該單體或反應體可不視為該聚合物之化學本體。
若聚合物名稱以單體基礎式命名時可選擇包括或不包括未滿重量百分之二之單體及反應體。
單體基礎式命名指聚合物名稱以其組成單體為基礎來加以命名者。
七、低關注聚合物：指經中央主管機關審核並符合下列條件之一者：
（一）聚合物之數目平均分子量介於一千至一萬道爾頓之間者，其分子量小於五百道爾頓之寡聚合物含量少於百分之十，分子量小於一千道爾頓之寡聚合物含量少於百分之二十五。
（二）聚合物之數目平均分子量大於一萬道爾頓者，其分子量小於五百道爾頓之寡聚合物含量少於百分之二，且分子量小於一千道爾頓之寡聚合物含量少於百分之五。
（三）聚酯聚合物。
（四）不可溶性聚合物。
八、中間產物：指在一連串化學反應程序中，部分化學反應程序之產物做為後續反應原料之化學物質。
九、限定場址中間產物：指在單一場所製造並消耗之中間產物。
十、副產物：指在使用或儲存過程中，因環境變化發生化學反應而生成之化學物質。
十一、雜質：指非預期而存在於化學物質中之成分，源自化學物質原料、反應過程中次要反應或不完全反應；化學物質中之不純物亦屬雜質。
在最終化學物質中出現之雜質，其為非刻意加入，亦不會增加該化學物質之商業價值。
單一雜質成分含量不得超過該化學物質之重量百分之十；多重雜質成分總量不得超過該化學物質之重量百分之二十。
十二、科學研發用途：指在科學或學術環境與控制條件下執行之科學性實驗、教育、分析或研究等用途。
十三、產品與製程研發用途：指在工廠產製試驗用於發展生產程序或測試物質應用領域之過程，與產品開發或製程物質發展直接相關之研發過程。
十四、致癌、生殖細胞致突變性或生殖毒性物質：指物質危害分類符合中華民國國家標準CNS15030所列之致癌物質第一級；生殖細胞致突變性物質第一級；生殖毒性物質第一級之危害分類者。
十五、海關監管化學物質：指儲存於海關監管之碼頭專區、貨棧、貨櫃集散站、保稅倉庫、物流中心或自由貿易港區等，待出口之化學物質。