SDS Authoring and Confidential Business Information in Taiwan

1. Background

Under the promotion of GHS for hazard transfer and communication, and to protect human health and the environment, the requirement to disclose substance information and identify its hazard properties before trade activities are adopted by more and more countries and regions. In Taiwan, the chemical substances are regulated under both the Toxic and Concerned Chemical Substances Control Act (TCCSCA) and the Occupational Safety and Health Act (OSHA), both of which are now fully implemented.

According to Article 10 of the OSHA, the employers shall label, make inventories, and display safety data sheets (SDS) for hazardous chemicals, and adopt necessary hazard communication measures. And the manufacturers, importers, or suppliers, before providing the chemicals to business entities or self-employed workers, shall label them and provide SDSs. The detailed requirements for the manufacturers, importers, and suppliers to disclose the information of hazardous chemicals are stipulated in the Regulations for the Labeling and Hazard Communication of Hazardous Chemicals (hereinafter referred to “the Regulations”). 

2. Scope

The hazardous chemicals that are subject to the requirement to disclose substance information include dangerous substances and harmful substances; followings are the definitions of the two kinds of chemicals in the Regulations:

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

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

Although the Regulations request enterprises to provide detailed substance information in the SDS for risk reduction and elimination, enterprises can apply for withholding the disclosure of key information for the necessity of security or trade secret protection purposes. According to Article 18 of the Regulations, for the specific purposes, the manufacturers, importers, and suppliers could apply to the authority to withhold the disclosure the following information in SDS:

• Name, CAS Number, and concentration of the hazardous chemical ingredient, and/or

• The name of manufacture, importer, and supplier.

Not all substances are eligible for CBI protection. For hazardous chemicals which belong to any of the below three categories, enterprises shall not apply for CBI protection:

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

• A 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;

9. Specific target organ systemic toxicity- repeated exposure category 1.

• Others designated and published by the central competent authority.

3. Procedure

For each application for withholding the disclosure of SDS CBI, the following information shall be submitted:

• Basic information

1. Information of applicant, contact, or agent, and;

2. Information on the hazardous chemical ingredient, and;

3. The items that applied for withholding disclosure

Note: If the applicant is not an enterprise or institution in Taiwan, it should entrust a local enterprise or institution to apply and submit an authorization document.

• Supporting materials proving the necessity of cause

1. Documents that prove the information that has been identified as  security or a trade secret cause, and;

2. Countermeasures undertaken to protect security or trade secrets, and;

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

• Explanations and proofs regarding the hazard classification of hazardous chemical ingredients contained in the products：

1. Supporting materials including explanations and proof that this hazardous chemical ingredient does not belong to any hazard categories specified above.

Re-submission is limited within 30 days upon receiving the request for correction or supplementation in case of unqualified or incomplete document submission. Re-submission can be done a maximum of 2 times. After a CBI application is approved, the Taiwan competent authority should revoke or repeal CBI approval in cases where information submitted is falsified or does not comply with requirements.

A general application procedure is shown in Figure 1.

Figure 1. The SDS CBI Application Procedure

For the detailed guide to the operation of the application, you may refer to this webinar: How to Deal with SDS Confidentiality of Business Information in Taiwan.

4. FAQs

Here are the frequently asked questions provided by REACH24H, regarding Taiwan GHS and how to apply for SDS CBI protection.