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Regulations for the Labeling and Hazard Communication of Hazardous Chemicals

  • Last Modify Date:2020-01-21

危害性化學品標示及通識規則(民國 107 11 09 日修正)

Regulations for the Labeling and Hazard Communication of Hazardous Chemicals (2018.11.09 Modified)

第 一 章 總則

Chapter Ⅰ General Regulations

1

本規則依職業安全衛生法(以下簡稱本法)第十條第三項規定訂定之。

Article 1

These Regulations have been enacted in accordance with the provisions of Article 10, Paragraph 3 of the Occupational Safety and Health Act (hereinafter referred to as the "Act").

2

本法第十條所稱具有危害性之化學品(以下簡稱危害性化學品),指下列

危險物或有害物:

一、危險物:符合國家標準 CNS15030 分類,具有物理性危害者。

二、有害物:符合國家標準 CNS15030 分類,具有健康危害者。

Article 2

Hazardous chemicals referred to in Article 10, Paragraph 1 of the Act (hereinafter referred to as "hazardous chemicals") mean the following dangerous substances or harmful substances:

1.Dangerous substances: Substances with physical hazards that satisfy CNS15030 classification;

2.Harmful substances: Substances with health hazards that satisfy CNS15030 classification.

3

本規則用詞,定義如下:

一、製成品:指在製造過程中,已形成特定形狀或依特定設計,而其最終

    用途全部或部分決定於該特定形狀或設計,且在正常使用狀況下不會

    釋放出危害性化學品之物品。

二、容器:指任何袋、筒、瓶、箱、罐、桶、反應器、儲槽、管路及其他

    可盛裝危害性化學品者。但不包含交通工具內之引擎、燃料槽或其他

    操作系統。

三、製造者:指製造危害性化學品供批發、零售、處置或使用之廠商。

四、輸入者:指從國外進口危害性化學品之廠商。

五、供應者:指批發或零售危害性化學品之廠商。

Article 3

Terminologies in these Regulations are defined as followed:

1.Manufactured article: Means a manufactured item formed to a specific shape or design during manufacturing process, and the final use of which is entirely or partially determined by the specified shape or design, and during normal usage, will not release substances of hazardous chemicals.

2.Container: Means any bag, cartridge, bottle, box, can, barrel, reactor, storage tank, piping system or any other container that can hold hazardous chemicals, but it does not include engines, fuel tanks or other operation system in a transportation vehicle.

3.Manufacturer: Refers to the firm that manufactures hazardous chemicals for wholesale, retail, process, or use.

4.Importer: Refers to the firm that imports hazardous chemicals from abroad.

5.Supplier: Refers to the firm that provides wholesales or retails with hazardous chemicals.

4

下列物品不適用本規則:

一、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.Industrial waste;

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 二 章 標示

Chapter Ⅱ Labeling

5

雇主對裝有危害性化學品之容器,應依附表一規定之分類及標示要項,參

照附表二之格式明顯標示下列事項,所用文字以中文為主,必要時並輔以

作業勞工所能瞭解之外文:

一、危害圖式。

二、內容:

(一)名稱。

(二)危害成分。

(三)警示語。

(四)危害警告訊息。

(五)危害防範措施。

(六)製造者、輸入者或供應者之名稱、地址及電話。

前項容器內之危害性化學品為混合物者,其應標示之危害成分指混合物之

危害性中符合國家標準 CNS15030 分類,具有物理性危害或健康危害之所

有危害物質成分。

第一項容器之容積在一百毫升以下者,得僅標示名稱、危害圖式及警示語

Article 5

Employers shall conspicuously label the following items on containers containing hazardous chemicals in accordance with the classification and label elements prescribed in Attachment 1. and the format of Attachment 2. The text for the labels in Chinese shall be primary, and if necessary, supplement with foreign languages that workers understand:

1.Hazard pictograms

2.Contents:

(1)Name;

(2)Hazardous ingredients;

(3)Signal Words;

(4)Hazard statements;

(5)Precautionary statements;

(6)Name, address, and telephone number of manufacturer, importer or supplier.

If the contained hazardous chemicals prescribed in the preceding Paragraph are mixtures, their hazardous ingredients that should be labeled refer to all hazardous ingredients that contain hazardous properties of physical and health hazards that satisfy CNS15030 classification within the mixture.

If the volume of the container prescribed in Paragraph 1 is under 100ml, it may label only the names, hazard pictograms, and signal words.

6

雇主對前條第二項之混合物,應依其混合後之危害性予以標示。前項危害性之認定方式如下:一、混合物已作整體測試者,依整體測試結果。二、混合物未作整體測試者,其健康危害性,除有科學資料佐證外,應依    國家標準 CNS15030 分類之混合物分類標準,對於燃燒、爆炸及反應    性等物理性危害,使用有科學根據之資料評估。

Article 6

For mixtures as prescribed in Paragraph 2 of the preceding Article, the employer shall label them based on the hazardous properties after mixing.

The hazardous properties of the preceding Paragraph are determined as follows:

1.If a mixture has been tested as a whole, the results shall be used;

2.If a mixture has not been tested as a whole, in addition to having scientific proofs to its health hazards, the physical hazards of its flammable, explosive, and reactive properties shall be assessed using scientifically valid data in accordance with the standards for classifying mixtures set by CNS 15030 Classification.

7

第五條標示之危害圖式形狀為直立四十五度角之正方形,其大小需能辨識

清楚。圖式符號應使用黑色,背景為白色,圖式之紅框有足夠警示作用之

寬度。

Article 7

The shape of the labeled hazard pictograms prescribed in Article 5 is a 45 degrees vertical square, and must be sized so that it can be clearly recognized. The symbols should be in black with white background, and the red frame of the symbol shall be wide enough to have sufficient warning effect.

8

雇主對裝有危害性化學品之容器屬下列情形之一者,得免標示:

一、外部容器已標示,僅供內襯且不再取出之內部容器。

二、內部容器已標示,由外部可見到標示之外部容器。

三、勞工使用之可攜帶容器,其危害性化學品取自有標示之容器,且僅供

    裝入之勞工當班立即使用。

四、危害性化學品取自有標示之容器,並供實驗室自行作實驗、研究之用

    。

Article 8

Employers may be exempted from labeling if one of the following conditions apply to the containers containing hazardous chemicals:

1.Inner container inside a labeled external one and is served as internal lining that will not be taken out;

2.External container with a labeled inner container and the label is visible from the outside;

3.Portable container with its hazardous chemicals transferred from labeled containers by a worker and only used immediately by the same worker during the shift;

4.Hazardous chemicals transferred from labeled containers only for laboratory to use in experiments or research.

9

雇主對裝有危害性化學品之容器有下列情形之一者,得於明顯之處,設置

標示有第五條第一項規定事項之公告板,以代替容器標示。但屬於管系者

,得掛使用牌或漆有規定識別顏色及記號替代之:

一、裝同一種危害性化學品之數個容器,置放於同一處所。

二、導管或配管系統。

三、反應器、蒸餾塔、吸收塔、析出器、混合器、沈澱分離器、熱交換器

    、計量槽或儲槽等化學設備。

四、冷卻裝置、攪拌裝置或壓縮裝置等設備。

五、輸送裝置。

前項第二款至第五款之容器有公告板者,其內容之製造者、輸入者或供應

者之名稱、地址及電話經常變更,但備有安全資料表者,得免標示第五條

第一項第二款第六目之事項。

Article 9

If one of the following conditions applies to the containers containing hazardous chemicals, the employer may install a placard labeling items specified in Paragraph 1 of Article 5 in an obvious location instead of labeling the containers. For a piping system, however, labeling may be substituted by hanging an application plate or by painting the pipelines with specified identification color or symbols:

1.Several containers which contain the same type of hazardous chemicals and are stored in the same location;

2.Ducting or piping systems;

3.Chemical equipment such as reactor, distillation tower, absorption tower, extractor, blender, precipitator, heat exchanger, measuring tank, or storage tank;

4.Equipment such as cooling devices, stirring devices, or compression devices;

5.Conveying apparatus.

Containers with placards prescribed in subparagraphs 2 to 5 of the preceding Paragraph may be exempted from labeling the information required by subparagraph 2(6), Paragraph 1 of Article 5 if the name, address, and telephone number of the manufacturer, importer, or supplier change frequently but the Safety Data Sheet (SDS) is available.

10

雇主對裝有危害性化學品之容器,於運輸時已依交通法規有關運輸之規定

設置標示者,該容器於工作場所內運輸時,得免再依附表一標示。

勞工從事卸放、搬運、處置或使用危害性化學品作業時,雇主應依本規則

辦理。

Article 10

When transporting containers containing hazardous chemicals within the workplace, the employer may be exempted from relabeling as prescribed in Attachment 1 if the containers have already been labeled in accordance with related transportation laws and regulations.

Employers must label containers in accordance with these Regulations when workers engage in operations involving loading and unloading, transporting, handling, or utilization of hazardous chemicals.

11

製造者、輸入者或供應者提供危害性化學品與事業單位或自營作業者前,

應於容器上予以標示。

前項標示,準用第五條至第九條之規定。

Article 11

Manufacturers, importers, or suppliers shall label the containers prior to providing business entities or self-employed workers with hazardous chemicals.

Article 5 to 9 shall apply, mutatis mutandis, to the previous Paragraph.

第 三 章 安全資料表、清單、揭示及通識措施

Chapter Ⅲ Safety Data Sheet, Inventory, Disclosure, and Communication Measures

12

雇主對含有危害性化學品或符合附表三規定之每一化學品,應依附表四提

供勞工安全資料表。

前項安全資料表所用文字以中文為主,必要時並輔以作業勞工所能瞭解之

外文。

Article 12

For every chemical that contains hazardous chemicals or meet the regulations specified in Attachment 3, the employer shall provide to workers a Safety Data Sheet (SDS) in accordance with Attachment 4.

The text for the Safety Data Sheet (SDS) referred to in the previous Paragraph shall be primarily in Chinese characters, and if necessary, in foreign languages that workers understand as supplement.

13

製造者、輸入者或供應者提供前條之化學品與事業單位或自營作業者前,

應提供安全資料表,該化學品為含有二種以上危害成分之混合物時,應依

其混合後之危害性,製作安全資料表。

前項化學品,應列出其危害成分之化學名稱,其危害性之認定方式如下:

一、混合物已作整體測試者,依整體測試結果。

二、混合物未作整體測試者,其健康危害性,除有科學資料佐證外,依國

    家標準 CNS15030 分類之混合物分類標準;對於燃燒、爆炸及反應性

    等物理性危害,使用有科學根據之資料評估。

第一項所定安全資料表之內容項目、格式及所用文字,適用前條規定。

Article 13

Manufacturers, importers, or suppliers shall provide Safety Data Sheets prior to providing business entities or self-employed workers with hazardous chemicals prescribed in the preceding Article. If such chemicals are mixtures of two or more hazardous ingredients, the Safety Data Sheet (SDS) shall be prepared based on the hazardous properties after mixing.

For the chemicals prescribed in the previous Paragraph, hazardous ingredients shall be listed by their chemical names, and the methods of hazard classification of mixtures as follows:

1.If a mixture has been tested as a whole, the results shall be used;

2.If a mixture has not been tested as a whole, in addition to having scientific proofs to its health hazards, the physical hazards of its flammable, explosive, and reactive properties shall be assessed using scientifically valid data in accordance with the standards for classifying mixtures set by CNS 15030 Classification.

The content, template, and text for the Safety Data Sheet (SDS)described in the preceding Article shall apply to Paragraph 1.

14

前條所定混合物屬同一種類之化學品,其濃度不同而危害成分、用途及危

害性相同時,得使用同一份安全資料表,但應註明不同化學品名稱。

Article 14

When the mixtures prescribed in the preceding Article belong to the same group of chemicals with different concentrations but the same hazardous ingredients, usages, and hazardous properties, the same Safety Data Sheet (SDS) may be used, but the different names of the chemicals should be clearly noted.

15

製造者、輸入者、供應者或雇主,應依實際狀況檢討安全資料表內容之正

確性,適時更新,並至少每三年檢討一次。

前項安全資料表更新之內容、日期、版次等更新紀錄,應保存三年。

Article 15

Manufacturers, importers, suppliers, or employers shall check the accuracy of a Safety Data Sheet (SDS) based on the actual circumstances and update it as needed. A Safety Data Sheet shall be reviewed at least once every three years.

Records of revision, such as content, date, and version of the Safety Data Sheet updates in the preceding Paragraph shall be kept for three years.

16

雇主對於裝載危害性化學品之車輛進入工作場所後,應指定經相關訓練之

人員,確認已有本規則規定之標示及安全資料表,始得進行卸放、搬運、

處置或使用之作業。

前項相關訓練應包括製造、處置或使用危害性化學品之一般安全衛生教育

訓練及中央交通主管機關所定危險物品運送人員專業訓練之相關課程。

Article 16

After a vehicle carrying hazardous chemicals enters a workplace, the employer shall designate a personnel with related trainings to confirm that the chemicals are labeled and Safety Data Sheets (SDS) are available in accordance with these Regulations before loading and unloading, transporting, handling, or utilization of the chemicals.

Related trainings of the preceding Paragraph shall include general health and safety educational training for the manufacturing, handling, or utilization of hazardous chemicals, as well as related curricula for specialized training of dangerous goods transport personnel designated by the central competent authority for transportation and communications.

17

雇主為防止勞工未確實知悉危害性化學品之危害資訊,致引起之職業災害

,應採取下列必要措施:

一、依實際狀況訂定危害通識計畫,適時檢討更新,並依計畫確實執行,

    其執行紀錄保存三年。

二、製作危害性化學品清單,其內容、格式參照附表五。

三、將危害性化學品之安全資料表置於工作場所易取得之處。

四、使勞工接受製造、處置或使用危害性化學品之教育訓練,其課程內容

    及時數依職業安全衛生教育訓練規則之規定辦理。

五、其他使勞工確實知悉危害性化學品資訊之必要措施。

前項第一款危害通識計畫,應含危害性化學品清單、安全資料表、標示、

危害通識教育訓練等必要項目之擬訂、執行、紀錄及修正措施。

Article 17

In order to prevent workers from not having accurate information on hazardous chemicals that thereby would result in occupational accidents, the employer shall adopt the following mandatory measures:

1.Formulate a hazard communication plan based on actual circumstances; review and update promptly, and implement according to the plan. The record of implementation shall be kept for three years;

2.Prepare an inventory of hazardous chemicals. The content and format of such shall refer to Attachment 5;

3.Place the Safety Data Sheet(s) of hazardous chemicals at an easily accessible location at the workplace;

4.Provide educational training to workers on the manufacturing, handling, or utilization of hazardous chemicals. The curriculum content and hours of such training shall be administered in accordance with the Occupational Safety and Health Education and Training Regulations;

5.Any other necessary measures needed to ensure workers are well aware of the hazardous chemicals information.

The hazard communication plan in subparagraph 1 of the preceding Paragraph shall include the formulation, administration, recording, and correction measures of necessary items such as inventory of hazardous chemicals, Safety Data Sheet(s), labeling, and educational training on hazard communication.

18

製造者、輸入者或供應者為維護國家安全或商品營業秘密之必要,而保留

揭示安全資料表中之危害性化學品成分之名稱、化學文摘社登記號碼、含

量或製造者、輸入者或供應者名稱時,應檢附下列文件,向中央主管機關

申請核定:

一、認定為國家安全或商品營業秘密之證明。

二、為保護國家安全或商品營業秘密所採取之對策。

三、對申請者及其競爭者之經濟利益評估。

四、該商品中危害性化學品成分之危害性分類說明及證明。

前項申請檢附之文件不齊全者,申請者應於收受中央主管機關補正通知後

三十日內補正,補正次數以二次為限;逾期未補正者,不予受理。

中央主管機關辦理第一項事務,於核定前得聘學者專家提供意見。

申請者取得第一項安全資料表中之保留揭示核定後,經查核有資料不實或

未依核定事項辦理者,中央主管機關得撤銷或廢止其核定。

Article 18

Manufacturers, importers, or suppliers that withhold the disclosure of the name,Chemical Abstract Service number, concentration, or manufacturer, importer as well as supplier's name of hazardous chemical ingredients in Safety Data Sheet(s) for the necessity of national security or trade secret protection purposes, shall applyto the central competent authority for approval by offering the following written documentation:

1.Documents that prove such information have been identified as a national security or trade secret;

2.Countermeasures undertaken to protect information of national security or trade secrets;

3.Assessment of economic interests to the applicant and their competitors;

4.Explanations and proofs regarding hazard classification of hazardous chemical ingredients contained in the products.

If documents of the preceding Paragraph aredeficient, the applicant shall make corrections and supplements within 30 days afterreceiving the notification of corrections and supplements from the central competent authority.Corrections and supplements shall only be made no more than twice.In case corrections and supplements are not made in time, the application shall not be accepted.

When handling affairs of Paragraph 1, the central competent authority may employ scholars and experts for consultation prior to granting approval.

If an applicant who obtained a Safety Data Sheet withholding approval document of Paragraph 1 is found to submit documents containing false information or fail to perform handling in accordance with approved items, the central competent authority may void or revoke its approval.

18-1

危害性化學品成分屬於下列規定者,不得申請保留安全資料表內容之揭示:一、勞工作業場所容許暴露標準所列之化學物質。二、屬於國家標準CNS15030分類之下列級別者:(一)急毒性物質第一級、第二級或第三級。(二)腐蝕或刺激皮膚物質第一級。(三)嚴重損傷或刺激眼睛物質第一級。(四)呼吸道或皮膚過敏物質。(五)生殖細胞致突變性物質。(六)致癌物質。(七)生殖毒性物質。(八)特定標的器官系統毒性物質-單一暴露第一級。(九)特定標的器官系統毒性物質-重複暴露第一級。三、其他經中央主管機關指定公告者。前條及本條有關保留揭示申請範圍、核定後化學品標示、安全資料表之保留揭示,按中央主管機關所定之技術指引及申請工具辦理。

Article 18-1

Hazardous chemical ingredients possessing the following shall not apply for withholding the aforementioned Safety Data Sheet disclosure:

1.Hazardous substances listed in Standards of Permissible Exposure Limits at Job Site.

2.Substance classified as the following hazard categories in CNS15030 Classification:

(1)Acute toxicity category 1, category 2, or category 3;

(2)Skin corrosion or irritation category 1;

(3)Serious eye damage or eye irritation category 1;

(4)Respiratory or skin sensitization;

(5)Germ cells mutagenicity;

(6)Carcinogenicity;

(7)Reproductive toxicity;

(8)Specific target organ systemic toxicity - single exposure category 1

(9)Specific target organ systemic toxicity- repeated exposure category 1

3.Others designated and publishedby the central competent authority.

The scope of withholding application, approved labeling of hazardous chemicals, Safety Data Sheet withholding pursuant to preceding Article and this Article shall be in accordance with the guidance and application tools designated by the central competent authority.

19

主管機關、勞動檢查機構為執行業務或醫師、緊急應變人員為緊急醫療及

搶救之需要,得要求製造者、輸入者、供應者或事業單位提供安全資料表

及其保留揭示之資訊,製造者、輸入者、供應者或事業單位不得拒絕。

前項取得商品營業秘密者,有保密之義務。

Article 19

The competent authority, labor inspection agencies, or medical doctors, emergency response personnel in response to first aid and rescue need may request the manufacturer, importer, supplier, or business entity to provide Safety Data Sheets and information withheld from disclosure. The manufacturer, importer, supplier, or business entity shall not deny the request.

Those who acquired the trade secrets of the preceding Paragraph are obligated to keep the information confidential.

第 四 章 附則

Chapter Ⅳ Supplementary Provisions

20

對裝有危害性化學品之船舶、航空器或運送車輛之標示,應依交通法規有

關運輸之規定辦理。

Article 20

The labeling for ships, aircraft, or vehicles transporting hazardous chemicals are subject to related transportation laws and regulations.

21

對放射性物質、國家標準 CNS15030 分類之環境危害性化學品之標示,應

依游離輻射及環境保護相關法規規定辦理。

Article 21

The labeling of radioactive substances and hazardous chemicals possessing environmental hazards as specified in CNS 15030 Classification are subject to laws and regulations related to ionizing radiation and environmental protection.

22

對農藥及環境用藥等危害性化學品之標示,應依農藥及環境用藥相關法規

規定辦理。

Article 22

The labeling of hazardous chemicals such as agrochemicals and environmental chemicals shall be subject to the provisions of agro-pesticides, environmental agents and other related laws.

23

本規則自中華民國一百零三年七月三日施行。

本規則修正條文,自發布日施行。但第十二條附表四自中華民國一百零九

年一月一日施行。

Article 23

These Regulations shall come into force from July 3, 2014.

In addition to Attachment 4 of Article 12 of these Regulations amended taking effect on January 1, 2020, these amendments of Regulations shall be put in force on the date of promulgation.

  • Publish Date:2019-01-28
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