一、毒性化學物質:指人為產製或於產製過程中衍生之化學物質,經中央主管機關公告者。其分類如下:
Toxic chemical substances means those chemical substances that are produced by human activity or derived from production processes and that have been officially announced by the central competent authority.
Toxic chemical substances shall be classified as follows.
(一)第一類毒性化學物質:化學物質在環境中不易分解或因生物蓄積、生物濃縮、生物轉化等作用,致污染環境或危害人體健康者。
Class Ⅰ toxic chemical substances: those chemical substances that are not prone to decompose in the environment or that pollute the environment or endanger human health due to bioaccumulation, bioconcentration or biotransformation
(二)第二類毒性化學物質:化學物質有致腫瘤、生育能力受損、畸胎、遺傳因子突變或其他慢性疾病等作用者。
Class Ⅱ toxic chemical substances: those chemical substances that cause tumors, infertility, teratogenesis, genetic mutations or other chronic diseases
(三)第三類毒性化學物質:化學物質經暴露,將立即危害人體健康或生物生命者。
Class Ⅲ toxic chemical substances: those chemical substances that endanger human health or the lives of biological organisms immediately upon exposure
(四)第四類毒性化學物質:化學物質有污染環境或危害人體健康之虞者。
Class Ⅳ toxic chemical substances: those chemical substances for which there is concern of pollution of the environment or the endangerment of human health
二、運作:對化學物質進行製造、輸入、輸出、販賣、運送、使用、貯存或廢棄等行為。
Handling means such activities as the manufacture, import, export, sale, transport, use, storage or discarding of chemical substances.
三、污染環境:因化學物質之運作而改變空氣、水或土壤品質,致影響其正常用途,破壞自然生態或損害財物。
Pollution of the environment means an alteration of the quality of air, water or soil due to the handling of chemical substances such that it causes an impact on the normal use of the air, water or soil, destruction of the natural ecology or damage to property.
四、釋放量:化學物質因運作而流布於空氣、水或土壤中之總量。
Release quantity means the total quantity of a chemical substance that is dispersed into the air, water or soil due to handling.
第三條 本法所稱主管機關︰在中央為行政院環境保護署;在直轄市為直轄市政府;在縣(市)為縣(市)政府。
Article 3 The competent authority referred to in this Act means the Environmental Protection Administration, Executive Yuan, at the central government level, the municipal government in special municipalities and the county or city government in counties or cities.
第四條 主管機關得指定或委託專責機關,辦理毒性化學物質管理之研究、人員訓練、危害評估及預防有關事宜。
Article 4 The competent authority may designate or commission dedicated organizations to perform research, personnel training, risk assessment and risk prevention work related to the management of toxic chemical substances.
第五條 中央主管機關得依化學物質之毒理特性,公告為第一類、第二類、第三類或第四類毒性化學物質。
Article 5 The central competent authority may officially announce chemical substances as Class Ⅰ, Class Ⅱ, Class Ⅲ or Class Ⅳ toxic chemical substances based on the toxicity characteristics of chemical substances.
第一類、第二類及第三類毒性化學物質,中央主管機關得限制或禁止其有關之運作。
The central competent authority may restrict or prohibit the handing of Class Ⅰ, Class Ⅱ and Class Ⅲ toxic chemical substances.
第四類毒性化學物質之運作,除應依本法及中央主管機關規定申報運作紀錄、釋放量紀錄、該毒性化學物質之毒理相關資料及適用第二十三條、第二十九條、第三十三條及第三十四條規定外,不受本法其他規定之限制。
With the exception of requirements for the reporting of handling records, release quantity records and toxicity information related to the toxic chemical substances at issue pursuant to this Act and the regulations of central competent authority and being subject to Article 23, Article 29, Article 33 and Article 34, the handling of Class Ⅳ toxic chemical substances shall not be subject to the restrictions of other regulations of this Act.
第六條 毒性化學物質之運作及其釋放量,運作人應依中央主管機關之規定作成紀錄,妥善保存備查;主管機關得令其定期申報紀錄。
Article 6 For the handling of toxic chemical substances and their release quantities, the handler shall maintain records and preserve them properly for future reference pursuant to the regulations of the central competent authority; the competent authority may order the handler to report records at regular intervals.
第七條 第一類及第二類毒性化學物質之運作,中央主管機關得會商目的事業主管機關以釋放總量管制方式管制之。
Article 7 The central competent authority in consultation with the industry competent authority may control the handling of Class Ⅰ and Class Ⅱ toxic chemical substances by means of total release quantity control methods.
第八條 第三類毒性化學物質之運作人,應依中央主管機關規定,檢送該毒性化學物質之毒理相關資料、危害預防及應變計畫,送請當地主管機關備查,並公開供民眾查閱。
Article 8 The handler of Class Ⅲ toxic chemical substances shall, pursuant to central competent authority regulations, submit toxicity information, risk prevention methods and a response plan related to the toxic chemical substances at issue to the local competent authority to be filed for future reference and shall provide this information to the public for reference.
第九條 毒性化學物質之運作,除法律另有規定外,應依照中央主管機關公告或審定之方法行之。
Article 9 Unless other regulations apply, the handling of toxic chemical substances shall be conducted in accordance with methods officially announced or approved by the central competent authority.
前項公告,由中央主管機關會商有關機關後為之。
The central competent authority shall issue the official announcements in the foregoing paragraph after consultation with the relevant agencies.
第十條 毒性化學物質經科學技術或實地調查研究,證實原公告之管理事項已不合需要時,中央主管機關應即公告變更或註銷之。
Article 10 When there is verification through scientific techniques or field testing and research of a toxic chemical substance that original officially announced management items fail to meet requirements, the central competent authority shall promptly issue an official announcement of modification or cancellation.
第十一條 中央主管機關得指定應申請核發許可證或登記備查之毒性化學物質運作行為。
Article 11 The central competent authority may designate toxic chemical substance handling activities for which permits or registration shall be required.
經指定應申請核發許可證之運作行為,運作人應提出該物質之成分、性能、管理方法及有關資料,向主管機關申請審查,核發許可證後,始得運作。
For handling activities that have been designated as requiring permits, the handler shall submit information concerning composition, properties, management methods and relevant information for the substance at issue to the competent authority for the application for a review, and may only begin handling after the issuance a permit.
經指定應登記備查之運作行為,運作人應依中央主管機關規定提送相關資料,報請主管機關登記備查後,始得運作。
For handling activities that have been designated as requiring registration, the handler shall send relevant information to the competent authority pursuant to central competent authority regulations, and may only begin handling after registration.
第十二條 中央主管機關應公告指定運作人對其運作風險投保第三人責任險,其保險契約項目及內容由中央主管機關會商相關機關後定之。
Article 12 The central competent authority shall officially announce and designate that handlers purchase third person liability insurance to cover handling risks; the central competent authority shall determine the items and contents of the insurance policy after consultation with the relevant agencies.
第十三條 許可證之有效期間為五年,期滿六個月前,得向原發證機關申請核准展延,每次展延不得超過五年。
Article 13 The validity period for permits shall be five years; applications for the approval of extensions may be submitted to the original permit issuing agency six months prior to expiration; each extension may not exceed 5 years.