These Regulations are formulated pursuant to Article 17, Paragraph 2, and Article 27, Paragraph 2 of the Toxic and Concerned Chemical Substances Control Act (herein referred to as this Act).
The terminologies in this Act are defined as follows:
I. Containers and packaging: These refer to any bags, drums, bottles, boxes, cans, barrels, and other equipment that can be used to contain toxic or concerned chemical substances, but should not include storage tanks, pipes, reactors, and other fixed facilities.
II. Operating sites and facilities: These refer to sites for the manufacture, import, export, sale, transport, use, and storage for toxic or concerned chemical substances, pipelines, and other fixed facilities, including storage tanks, reactors, and transport-related holding, loading, and unloading sites, but do not refer to facilities used to perform chemical reactions or the engines, fuel tanks, or other operating systems for transportation vehicles.
The containers or packaging of toxic and concerned chemical substances should comply with the classification and labeling key points that are determined by the National Standard CNS15030 and should clearly mark the following items in accordance with the format as the attached Table Labeling Format:
I. Pictograms: A square presented at a 45° angle to the vertical direction consisting of a red outline on a white background. The interior of the square should contain a suitable sized black symbol for identification.
B. Hazardous Ingredients: All toxic or concerned chemical substances exceeding the control concentration shall be labeled with the Chinese and English names announced by the central competent authority and the Chemical Abstracts Service Registration Number. The words "toxic or concerned chemical substances" and the weight percentages of the toxic chemical substances contained therein shall be stated (w/w).
C. Caution words or Warnings
D. Hazard Statements
E. Precautionary Statements
F. Name, address, and telephone number of the manufacturer, vendor, or supplier.
If, with regard to the labeling in the foregoing paragraph, the hazardous characteristics cannot be classified in accordance with the classification scheme in National standard CNS15030, only the items in Subparagraph 2 of the foregoing paragraph should be labeled.
Containers or packaging less than 100 milliliters specified in Paragraph 1 may be marked only with the name, hazard pictograms, and warning.
Due to the size, or shape, or material used of the container or packaging for toxic and concerned chemical substances, the labels may have difficulty to fit as prescribed by Article 3, in which case folding labels or hanging labels should be used instead and put on an obvious place.
Manufacturers and importers should mark clearly on each container or packaging the toxic and concerned chemical substances. Purchasers should keep the clarity and integrity of labeling content of each container or package.
The user should label the containers or packaging of toxic and concerned chemical substances that are individually packaged or mixed for self-use as prescribed in Article 3.
When, in the foregoing paragraph, the same toxic or concerned chemical substances are contained in several containers or packages in the same location, an announcement board may replace the individual labels as prescribed in Article 9.
When any one of the following situations is applied, the containers or packaging of toxic and concerned chemical substances may be exempted from the prescription in Article 3:
I. When the outer container or packaging is already labeled and the inner container or packaging is used only as lining and not subsequently removed.
II. When the inner container or packaging is already labeled clearly and also easily seen from the outer container or packaging.
III. Toxic and concerned chemical substances are taken from marked containers or packaging and immediately used solely by the team currently on duty.
IV. Toxic and concerned chemical substances are taken from marked containers or packaging and used by a laboratory for experiment or research on a self-use basis.
Export the containers or packaging of exported toxic or concerned chemical substances may comply with international customary practices or solely comply with relevant regulations of the destination country.
Operating sites and facilities of toxic and concerned chemical substances should install an obvious announcement board that contains the following items:
I. Toxic chemical substances and the hazardous concerned chemical substances announced by the central competent authority according to this Act: (herein referred to as hazardous concerned chemical substances) Pictograms, name, hazardous ingredients, caution words or warnings, hazard statements and precautionary statements prescribed in Action 3, Paragraph 1 of this Act.
II. Operating sites and facility of concerned chemical substance: Pictograms, name, hazardous ingredients or caution words or warnings prescribed in Action 3, Paragraph 1 of this Act.
When an operating site that handles various kinds of toxic and concerned chemical substances, all labeling and warning content may be announced on the same bulletin. If the hazard statements or precautionary statements in Subparagraphs 1 and 2 are the same, it can be combined together in the text.
If the caution and warning texts of an operating site and facility in Subparagraphs 1 and 2 are the same as assigned regulations by other government agencies, all of them may be combined together in the text.
When any one of the following situations is applied, the containers or packaging of toxic and concerned chemical substances are exempted from the description in Article 3:
I. A temporary storage site for toxic and concerned chemical substances when an application of disposal has been made pursuant to this Act.
II. A warehouse that is prepared for the temporary place of nonspecific toxic chemical substances before or after transportation by air or sea has been already marked with the words "Dangerous Goods Storage".
III. An operating site that is employed solely for experimentation, research, and education, and only handles less than the assigned quantity, with all of the entrances and exits of the site marked with the words "Operating Premises of Toxic and Concerned Chemicals".
The pipelines that carry the toxic and hazardous concerned chemical substances, the flow directions, Chinese names, English names or abbreviations of chemicals must be displayed clearly and obviously. If it is necessary, the marks can be replaced by tags.
A handler who is manufacturing or importing toxic and concerned chemical substances should prepare all of safety data sheets for each material in accordance with contents and formats assigned by the central competent authority.
Following up the operating situations, a handler should regularly review, correct and update the contents of materials safety data sheets. A review process must be examined at least once every 3 years. Records of updating of content, date, and version, etc. should also be preserved for three years for future reference.
The emergency contact telephone number on the materials safety data sheets should be accessible at all times and able to answer questions about accidents.
When toxic and concerned chemical substances are imported or purchased from a customs auction by a controlling agency, the labeling of the containers or packaging and materials safety data sheets should be completed within four days after gaining possession of the substances.
When a toxic and concerned chemical substance is a mixture, materials safety data sheets should be prepared and labeling performed in accordance with the mixture’s toxicological hazard.
The materials in a mixture should be judged for toxicological or relevant hazard of its main components in the foregoing paragraph and listed as follows:
I. If the overall testing has been performed and toxicological hazard is based on the results of overall testing.
II. If the overall testing has not been performed, apart from where corroborating scientific data is available, the health hazard and environmental hazard of such substances should comply with mixture classification standards in National Standard CNS15030. The physical hazard of substances such as combustion, explosion and reaction should be employed to assess the data with a scientific basis.
Toxic and concerned chemical substances with the same regulatory control number but with different components or concentrations should prepare the different Chinese and English names and separate materials safety data sheets. When the hazardous components, usages and classifications are equal, the same materials safety data sheet is applicable.
Sellers of toxic and concerned chemical substances should have the materials safety data sheets available for purchasers of those toxic and concerned chemical substances.
Handlers of toxic and concerned chemical substances should keep the materials’ safety data sheets in an easily accessible location in the operating site.
Container, packaging, operating site and facility, labeling and materials safety data sheet of toxic and concerned chemical substances must be written mainly in Chinese. English may be added when necessary.
The Regulations take effect on January 16, 2020, except for Acts 3 and 12, which take effect on January 16, 2021.