Laws Information

法規資訊
Title: Regulations for the Labeling and Hazard Communication of Hazardous Chemicals
Am Date: 2018-11-09
Legislative History: Amended on November 9, 2018.

Transaction

Amended

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.
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.

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.

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.

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.

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.

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.