第 一 章 總則

Chapter 1 General Provisions

第 1 條

本辦法依職業安全衛生法（以下簡稱本法）第十四條第三項規定訂定之。

Article 1

These Regulations are prescribed in accordance with paragraph 3, Article 14 of the Occupational Safety and Health Act (hereinafter referred to as the "Act")

第 2 條

本辦法所定管制性化學品，指本法施行細則第十九條規定之化學品，如附表一。

Article 2

The Controlled Chemicals prescribed by these Regulations shall refer to the chemicals as defined in Article 19 of the Enforcement Rules of the Occupational Safety and Health Act and are specified in Appendix 1.

第 3 條

本辦法所稱運作，指對於管制性化學品之製造、輸入、供應或供工作者處置、使用之行為。

本辦法所稱運作者，指從事前項行為之製造者、輸入者、供應者或雇主。

Article 3

The term "handling" referred to in these Regulations means the act of manufacturing, importing, supplying of priority management chemicals, or providing such for workers to use or handle.

The term "handlers" referred to in these Regulations mean the manufacturers, importers, suppliers or employers who engage in the aforementioned acts.

第 4 條

下列物品不適用本辦法：

一、有害事業廢棄物。

二、菸草或菸草製品。

三、食品、飲料、藥物、化粧品。

四、製成品。

五、非工業用途之一般民生消費商品。

六、滅火器。

七、在反應槽或製程中正進行化學反應之中間產物。

八、其他經中央主管機關指定者。

Article 4

The provisions of these Regulations do not apply to the following items:

1.  Hazardous industrial wastes;

2.  Tobacco or tobacco products;

3.  Food, beverages, drugs, cosmetics;

4.  Manufactured articles;

5.  General domestic consumer products not for industrial uses;

6.  Fire extinguishers;

7.  Intermediate products undergoing chemical reactions in reactors or processes;

8.  Others designated by the central competent authority.

第 5 條

中央主管機關得邀請專家學者組成技術諮議會，辦理下列事項之諮詢或建議：

一、管制性化學品之篩選及指定。

二、管制性化學品申請許可之審查。

三、其他管制性化學品管理事項之研議。

Article 5

The central competent authority may invite experts and scholars to establish an advisory committee to give advice or suggestions for the following matters:

1.  Selection and designation of the Controlled Chemicals;

2.  Review of the Controlled Chemicals permit applications;

3.  Review of other matters related to management of the Controlled Chemicals.

第 二 章 申請許可條件及程序

Chapter 2 Permission Requirements and Procedures

第 6 條

運作者於運作管制性化學品前，應向中央主管機關申請許可，非經許可者，不得運作。

本辦法施行前，已於國內運作第二條之管制性化學品者，運作者應於本辦法施行後一年內取得許可文件，附表一有變更者，亦同。

Article 6

Before handling the Controlled Chemicals, a handler shall apply to the central competent authority for permission. No handling shall be commenced without permission.

Those who, before the implementation of these Regulations, have domestically handled the Controlled Chemicals as defined in Article 2, shall within one year of these Regulations coming into force obtain a permit. The same applies in the event of any change to Appendix 1.

第 7 條

運作者申請前條管制性化學品運作許可，應檢附下列資料：

一、運作者基本資料，如附表二。

二、管制性化學品運作資料，如附表三。

前項之申請，應依中央主管機關公告之方法，登錄於指定之資訊網站，並依中央主管機關公告之收費標準繳納費用。

第一項申請之管制性化學品為混合物者，其成分相同而濃度不同，但用途、危害分類及暴露控制措施相同時，得合併申請。

Article 7

To apply for handling permission of the Controlled Chemicals, a handler shall submit the following information items:

1.  Basic information of a handler, as specified in Appendix 2;

2.  Handling information of the Controlled Chemicals, as specified in Appendix 3.

The application information of the preceding paragraph shall be registered on the designated information website in accordance with the methods published by the central competent authority. Fees shall be charged in accordance with the fee standards issued by the central competent authority.

If the Controlled Chemicals under the applications of the first paragraph are mixtures, containing the same ingredients in different concentrations, but with the same use, hazard classifications, and exposure control measures, the permission may be jointly applied for.

第 8 條

中央主管機關受理前條申請案之審查，必要時得至運作場所進行現場查核。

Article 8

When the central competent authority accepts the application pursuant to the preceding article, to review the application, the central competent authority may visit handling sites and execute on-site inspection, if necessary.

第 9 條

中央主管機關處理前條申請案，應自受理日起三十個工作日內，將申請許可結果通知運作者，必要時得延長三十個工作日。但因可歸責於運作者之事由，而未能於期限內處理完成者，不在此限。

Article 9

Processing the application pursuant to the preceding article, the central competent authority shall notify the applicant of the permission result within 30 working days upon acceptance of the application. The period may, if necessary, be extended for 30 working days. However, the limit does not cover cases where the cause for not being able to complete the application within the given time is attributable to the handler.

第 10 條

運作者申請許可案件，有下列情形之一者，中央主管機關得不予受理：

一、未依第七條規定登錄資料。

二、未依申請收費標準繳費。

三、經通知限期補正資料，屆期未補正。

Article 10

If one of the following circumstances occurs to a handler applying for permission, the central competent authority may not accept the application:

1.  Failing to register information pursuant to Article 7.

2.  Failing to pay the fee in accordance with the application fee standard.

3.  After receiving a timely supplementation or correction notice, but failing to do so within the period of time prescribed.

第 11 條

運作者申請許可案件，有下列情形之一者，中央主管機關得不予許可：

一、經技術諮議會認有重大風險。

二、二年內曾因違反本法或本辦法，而由中央主管機關撤銷或廢止同一管制性化學品許可。

Article 11

If one of the following circumstances occurs to a handler applying for permission, the central competent authority may not grant permission:

1.  The advisory committee determines there is a significant risk.

2.  The permit for the Controlled Chemical has been revoked or cancelled by the central competent authority due to violation of the Act or these Regulations within two years.

第 三 章 許可期間及查核管理

Chapter 3 Permit Validity Period and Inspection Management

第 12 條

管制性化學品之許可文件，應記載下列事項：

一、許可編號、核發日期及有效期限。

二、運作者名稱及登記地址。

三、運作場所名稱及地址。

四、許可運作事項：

（一）管制性化學品名稱。

（二）運作行為及用途。

五、其他備註事項。

Article 12

The permit for the Controlled Chemical shall specify the following items:

1.  The permit number, issue date and expiration date.

2.  The name of the handler and registered address.

3.  The name of the handling site and address.

4.  The permitted handling conditions

(1)  The name of the Controlled Chemical

(2)  The handling activity and use

5.  Other notes.

第 13 條

前條許可文件之有效期限為五年，中央主管機關認有必要時，得依化學品之危害性或運作行為，縮短有效期限為三年。

運作者於前項期限屆滿仍有運作需要者，應於期滿前三個月至六個月期間，依第七條規定，重新提出申請。

Article 13

The permit pursuant to the preceding article is valid for five years. The central competent authority may, when deemed necessary, shorten the validity period to three years depending on the hazardous properties or the handling activity of the Controlled Chemicals.

If a handler will still have the need for handling by the end of validity period pursuant to the preceding paragraph, the handler shall apply for a new permit in accordance with Article 7 three to six months before the end of the validity period.

第 14 條

運作者取得許可文件後，應依下列規定辦理：

一、每年四月至九月期間，定期更新附表三之實際運作資料，並登錄於第

    七條規定之資訊網站。

二、依前條核發之許可文件與相關申請資料，至少留存五年備查。

三、就下列事項建立工作者之暴露資料，至少留存十年備查：

（一）工作者姓名。

（二）從事之作業概況及作業期間。

（三）工作者暴露情形。

（四）其他經中央主管機關指定之事項。

Article 14

A handler who has obtained the permit shall comply with the following provisions:

1.  From April to September each year, the actual handling information as specified in Appendix 3 shall be periodically updated and registered on the designated information website pursuant to Article 7.

2.  The permit issued pursuant to the preceding article and relevant application information shall be retained for future reference for at least five years.

3.  The work’s exposure information as developed based on the following provisions shall be retained for future reference for at least ten years:

(1)  The workers’ names.

(2)  The general operation information and operating period.

(3)  The workers’ exposure conditions.

(4)  Other matters as designated by the central competent authority.

第 15 條

運作者於許可有效期限內，有下列異動情形之一者，應於異動後三十日內，依附表四於指定之資訊網站申請變更：

一、運作者名稱或負責人。

二、運作場所名稱或地址。

運作者於許可有效期限內，有下列情形之一者，應依第七條規定重新提出申請：

一、運作行為或用途變更。

二、前項第一款之異動涉及運作者主體變更。

三、前項第二款之地址異動，經技術諮議會認有風險。

Article 15

Within the permit validity period, if there is a change to any of the following items, a handler shall file the change on the designated information website pursuant to Appendix 4 within 30 days from the date the change occurs:

1.  The name of the handler or the responsible person.

2.  The name of the handling site or address.

Within the permit validity period, a handler under any of the following circumstances, shall apply for a new permit pursuant to Article 7:

1.  There is a change to the handling activity or the use.

2.  The change of the first subparagraph of the preceding paragraph is related to the change of the entity of the handler.

3.  The advisory committee determines that the change to the address of the second subparagraph of the preceding paragraph carries a risk.

第 16 條

許可文件遺失或毀損者，得依附表五於指定之資訊網站提出補發之申請。

Article 16

Where a permit is lost or damaged, an application may be made for reissuance pursuant to Appendix 5 on the designated information website.

第 17 條

中央主管機關及勞動檢查機構得就運作者之運作及管理情形實施查核，有下列情形之一者，經限期令其改正，屆期未改正或情節重大者，得撤銷或廢止其許可，並得限期停止其運作行為之全部或一部：

一、違反第十四條或第十五條之規定。

二、運作事項與許可文件不符。

三、規避、妨礙或拒絕中央主管機關或勞動檢查機構之查核。

Article 17

The central competent authority and labor inspection agencies may conduct inspection according to a handler’s handling and management status. When engaging in any of the following violations, the handler who has been ordered to undertake timely correction actions, but fails to do so, or where the circumstances constitute a serious offense, the central competent authority may revoke or cancel its permits and suspend its handling activities in whole or in part within a prescribed time.

1.  Violating Article 14 or Article 15.

2.  Failing to have the handling conditions consistent with the permit.

3.  Evading, obstructing, or refusing the inspection by the central competent authority or labor inspection agencies.

第 18 條

運作者歇業，或經目的事業主管機關撤銷、廢止其工商登記等證明文件時，應通報中央主管機關。

中央主管機關於知悉前項情形時，應廢止其許可。

Article 18

When a handler suspends the business, or the documents certifying industrial/commercial registration have been voided or revoked, the handler shall report to the central competent authority.

The central competent authority after having learned of the situation of preceding paragraph, shall cancel the permit.

第 四 章 附則

Chapter 4 Supplementary Provisions

第 19 條

本辦法自中華民國一百零四年一月一日施行。

Article 19

These Regulations shall enter into force on January 1, 2015.