Taiwan Confidential Business Information (CBI) Application for SDS

Overview of the Chemical Control Act

Legal Basis for Information Protection

In the Taiwan region, the disclosure of chemical information is primarily governed by Article 18 of the Regulation of Labelling and Hazard Communication of Hazardous Chemicals. This regulation recognizes the need for enterprises to safeguard proprietary data and allows manufacturers, importers, or suppliers to apply for a withholding of specific sensitive information within the Safety Data Sheet (SDS).

Protection can be requested for several key identifiers if they are deemed necessary for trade secret protection or national security:

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

Proregulations offers expert guidance throughout the CBI application process, ensuring your confidential data remains protected without compromising regulatory standing in the Taiwan market.

Exclusions from Information Protection

While the regulation allows for confidentiality, certain hazardous ingredients are strictly excluded from withholding provisions to ensure public safety and worker health. According to Article 18, CBI applications may not be submitted if substances fall under specific hazard classifications based on the CNS 15030 standard:

• Acute toxicity (Category 1, 2, or 3).
• Skin corrosion or irritation (Category 1).
• Serious eye damage or eye irritation (Category 1).
• Respiratory and skin sensitization.
• Germ cell mutagenicity, carcinogenicity, or reproductive toxicity.
• Specific target organ toxicity—Single or Repeated exposure (Category 1).
• Any other substances determined and authorized by the competent authority.

Furthermore, withholding is prohibited for substances where workplaces are allowed to expose employees to the chemical substances listed in the national standard.

Information to be Submitted for Application

Enterprises seeking to withhold disclosure must prepare a comprehensive application dossier that satisfies the evidentiary requirements of the authorities.

Main Information Requirements

• Applicant details: Information regarding the applicant, contact person, or representative.
• Hazardous ingredient information: Detailed data on the specific chemical ingredient for which protection is sought.
• Withholding details: Specification of exactly what information is being withheld from the SDS.

Confidentiality and Security Evidence

Applicants must provide robust justification for the CBI status, including:

• Certification as a trade secret or national security matter.
• Countermeasures implemented to protect the security of the information.
• Economic evaluation: An analysis of the economic benefits of the information to the applicant and their competitors.

If the applicant is a non-Taiwan manufacturer or institution, they must entrust a manufacturer or corresponding institution within Taiwan to submit the application and authorization documents.

Application Scope and Special Provisions

The nature of the application depends on the specific classification of the hazardous chemical ingredient. It is important to note that the ingredient cannot belong to any of the high-risk categories listed in the exclusions (such as Category 1-3 acute toxicity or Category 1 CMRs).

For those applying only to withhold the name of the manufacturer, importer, or supplier, it is not necessary to provide "information on the hazardous chemical ingredient," "hazard classification," or "certification information of hazardous components". This simplified pathway is specifically designed for businesses protecting supply chain relationships rather than the chemical formulation itself.

Proregulations' CBI Application Services

Navigating the technical and legal requirements for CBI in Taiwan requires a detailed understanding of hazard classifications and administrative procedures. We provide comprehensive support to secure your trade secrets.

• Technical eligibility analysis
  We conduct a thorough review to determine if your specific chemical ingredients qualify for an SDS withholding application under current hazard standards.
• Hazardous ingredient data collection
  Our team assists in gathering and organizing the necessary chemical data required for a successful submission.
• Dossier preparation and online submission
  We manage the organization of all required information and handle the formal online submission to the Taiwan authorities.
• Regulatory communication and support
  Proregulations facilitates effective and regular communication with our local Taiwan team and official authorities to resolve queries.

If you need to protect your confidential business information while maintaining compliance with Taiwan's hazardous chemical regulations, please contact us.