Confidential Business Information (CBI) Application for SDS in Taiwan Region

 Legal Basis

Article 18 of the Regulation of Labelling and Hazard Communication of Hazardous Chemicals (hereinafter referred to as “the Regulation“) provides that manufacturers, importers or suppliers can apply  for Confidential Business Information (CBI) protection of specific items in their Safety Data Sheets (SDS) for national security or trade secret protection:

• Name of hazardous chemical ingredient
• CAS number of hazardous chemical ingredient
• Concentration of hazardous chemical ingredient
• Name of manufacturer, importer, or supplier

Hazardous Chemical Ingredients Excluded from Article 18 Information Protection Provision

In accordance with Article 18 of the Regulation, SDS Withholding Applications may not be submitted for hazardous chemical ingredients that fall under the following conditions:

1) Workplaces allowed to expose the chemical substances listed in the standard.

2) Substances under the national standard CNS15030 classification:

• Acute toxicity (category 1, category 2 or category 3)
• Skin corrosion or irritation (category 1)
• Serious eye damage/eye irritation (category 1)
• Respiratory and skin sensitization
• Germ cell mutagenicity
• Carcinogenicity
• Reproductive toxicity
• Specific target organ toxicity- Single exposure (category 1)
• Specific target organ toxicity- Repeated exposure (category 1)
• Other substances as may be determined and authorized by the competent authority.

Information to be Submitted for CBI Protection

To apply for CBI protection for each SDS in Taiwan, the following documents must be submitted:

1) Main information:

• Details of Applicant/contact person /representative
• Hazard chemical ingredient information
• The information that withhold the disclosure in SDS

Note: If the applicant is a non-Taiwan manufacturer or institution, the manufacturer or corresponding institution in Taiwan will have to be entrusted for the submission of the application and authorization documents.

2) National security or trade secrets certification information:

• Certification as a national security or trade secret
• Countermeasures to protect national security or trade secrets
• Evaluation of the economic benefits of applicants and their competitors

3) Hazard classification description and information of hazardous chemical ingredient:

This chemical ingredient cannot belong to any of the following categories： acute toxicity (category 1, category 2 or category 3), skin corrosive or irritation (category 1), severe eye injury or eye irritation (category 1), respiratory or skin sensitization, germ cell mutagenicity, carcinogenicity, reproductive toxicity, specific target organ toxicity -single exposure (category 1), specific target organ toxicity – repeated exposure (category 1).

Note: For those applying only to withhold “the name of the manufacturer, importer or supplier”, it will not be necessary to provide “information on the hazardous chemical ingredient” nor “hazard classification description and certification information of hazardous components”.

Our Services

• Technical analysis to determine if the chemical ingredient allows for the filing of CBI protection
• Collection of chemical information of hazardous ingredients
• Data gap analysis
• Information organizing and online submission
• Effective and regular communication with the local Taiwan team and official authorities