Important Information
Canada has aligned the Workplace Hazardous Materials Information System (WHMIS) with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
This document discusses the WHMIS supplier requirements as regulated by the federal legislation – the Hazardous Products Act (HPA) and the Hazardous Products Regulations (HPR). This document reflects the Hazardous Products Regulations requirements as of December 15, 2022.
Health Canada is the government body responsible for the overall WHMIS supplier-related laws. WHMIS is also regulated in the workplace by the provinces, territories and federal governments (for federally regulated workplaces) under their occupational health and safety legislation. While these jurisdictions based their WHMIS regulations on a common model, small variations between jurisdictions may exist.
Suppliers and employers must use and follow the WHMIS requirements for labels and safety data sheets (SDSs) for hazardous products sold, distributed, or imported into Canada.
Please refer to the following OSH Answers documents for more information about WHMIS:
- context WHMIS – General
- context WHMIS – Pictograms
- context WHMIS – Labels
- context WHMIS – Hazard Classes and Categories
- context WHMIS – Safety Data Sheets (SDSs)
- context WHMIS – Education and Training
- context WHMIS – WHMIS Program
- context WHMIS – Glossary
- context WHMIS – Variances
- context WHMIS – Laboratories
- context WHMIS - Information for Suppliers and Importers
- context WHMIS - Legislation
What is the protection of confidential business information?
The protection of confidential business information (CBI) is a process that allows certain information, such as the chemical identity of one or more hazardous ingredients in a WHMIS-regulated product, not to be disclosed on the safety data sheet (SDS) or label for the hazardous product. To protect confidential business information, there are 2 mechanisms to exempt suppliers and/or employers from some of these requirements:
The confidential business information mechanism balances workers’ right-to-know with industry’s need to protect trade secrets.
- requirement Health Canada is responsible for administering one of these mechanisms through the review of claims for exemption (see next section for more information).
- requirement The Hazardous Products Regulations also provides suppliers the option of using prescribed concentration ranges to mask concentrations or concentration ranges that are confidential business information.
What information can be claimed for confidential business information protection?
The following information can be claimed for exemption by suppliers or employers:
Employers may also claim:
If a claim has been filed to protect the chemical identity or true concentration (or true concentration range) of an ingredient, this information must be replaced in the SDS, and if applicable, on the label by a reference to the Hazardous Materials Information Review Act (HMIRA) claim for exemption information (e.g., an asterisk linking to the HMIRA Registry Number (RN)). The chemical name of the trade secret ingredient must be replaced with a code name or code number (e.g., a generic chemical name). For example, methanol can be replaced by ‘alcohol’. Additionally, the Chemical Abstracts Service (CAS) No., and true concentration or concentration range may be replaced with a word such as "Proprietary", "CBI" or "Trade Secret". For example,
* HMIRA RN: 3333 – Decision Granted Date January 1, 2025
Concentration ranges
If the concentration or concentration range is claimed as a trade secret, suppliers are encouraged to provide a replacement concentration range that includes the true concentration or true concentration range.
Note that suppliers can protect the actual concentration or concentration range of an ingredient without submitting a confidential business information claim by providing one or a combination of two adjacent concentration ranges prescribed in the Hazardous Products Regulations. If suppliers use the prescribed concentration ranges to protect the trade secret, they must include a statement indicating that the actual concentration is withheld as a trade secret on the SDS, immediately following the concentration range.
*The actual concentration range has been withheld as a trade secret.
- requirement chemical identity of a hazardous ingredient, substance or material (including impurities and stabilizing solvents)
- requirement concentration or concentration range of a hazardous ingredient, substance or material (see note on concentration ranges below)
- requirement the name of any toxicological study that identifies the ingredient, substance or material
- requirement product identifier (for example, chemical name, trade name)
- requirement other means of identification information
- requirement information that could be used to identify the supplier
How do I know if a confidential business information claim is valid?
The supplier or employer that is claiming a trade secret must replace the specific confidential business information with the HMIRA registry number and the date of filing or the date the claim was granted, on the product SDS and, if applicable, on the label.
Health Canada provides a list of Active Claims for Exemptions that shows:
The registry number of the product in the table (on the Health Canada site) links to a more detailed record that includes the above information as well as the following:
To verify that the SDS or label has an active confidential business information claim, the HMIRA registry number and date shown on the SDS and label should match the information on the Health Canada web page, and the link to the registry number will provide confirmation that the claim was determined to be valid.
- context Registry number (RN or Reg #)
- context Case number
- context Claimant name
- context Product identifier (usually product name)
- context Claim/exemption status
- context Expiry date for the confidential business information exemption claim
- context Claim type (original or refiling)
- context Date of filing
- context Claim validity status (i.e., valid, partially valid, invalid)
- context Claim validity decision date
What is required in a complete application package?
When applying for confidential business information exemption, certain items and information must be provided, including but not limited to:
The information provided in the application must be consistent across all the documents submitted:
- context Copy of safety data sheet, label, or both – in both English and French
- context Relevant business information for the applicant (claimant)
- context Product identifier(s) and description
- context 100% composition of product, including all Chemical Abstracts Service (CAS) numbers, chemical identities and actual concentrations and/or concentration ranges.
- context Information to support the claim (e.g., Are there measures in place to protect the confidentiality of the information being claimed? What is the economic value and material financial loss to the claimant under different situations?)
- context French translation of generic chemical name(s).
- context All mandatory information is on the forms.
- context A declaration of confidentiality signed by the individual with signing authority for the claimant.
- context Payment information (credit card) or cheque/money order.
- context All ingredients disclosed on the SDS are also disclosed on the product’s 100% composition document.
- context The product identifier and generic chemical names are the same on the application form and the SDS, label, or both.
- context The subject of the claim for exemption is the same throughout the forms and the SDS.
What are the steps in the confidential business information exemption process?
For additional information, please visit Health Canada’s web page “Exemptions for confidential business information for workplace hazardous products”.
- context The claimant applies for the HMIRA Claim for Exemption, which involves completing an online application package and providing all the information specified to Health Canada.
- context Health Canada does a preliminary review of the claim package. If the package is incomplete, the claimant is notified and the claim is put on hold until the missing information is provided.
- context If the package is complete, Health Canada will review the information and register the claim if it meets the filing requirements, including receipt of payment. The claimant will receive a Hazardous Materials Information Review Act (HMIRA) Registry Number (RN). This HMIRA RN allows the supplier to sell or import, or the employer to use, the product with the confidential business information hidden.
- context The SDS and/or label must show the HMIRA RN and the date filed (date on which the HMIRA RN was assigned) or the date granted (date of the claim validity determination granting the 3-year exemption), as appropriate, with a direct link to the replacement information. Suppliers (or employers) who apply to withhold CBI must continue to meet label and SDS requirements. These requirements include the details of any safety precautions workers need to take when using the product and the first-aid treatment required in the case of exposure.
- context Health Canada will next assess the validity of the claim according to the criteria outlined in section 3 of the Hazardous Materials Information Review Regulations.
- context If the claim is determined to be valid or partially valid (in other words, some of the CBI requested in the claim meets the criteria), the supplier may continue selling or importing, or an employer may continue using, the product without disclosing the exempted information for which the claim is considered valid for a period of 3 years, after which the exemption expires.
- context Health Canada will subject all products with a 3-year exemption to a prioritization process. This process is based on criteria that rank products based on potential risk factors related to worker health and safety. The prioritization process helps Health Canada determine which products to select for an in-depth compliance review. Prioritization will be complemented by other reasons to select a product for review, including random sampling. Suppliers (or employers) are responsible for ensuring that their product's safety data sheet (SDS) (and label, if applicable) are compliant, whether it is prioritized for in-depth compliance review or not.
- context for the validity of the trade secret claim, and
- context whether the SDS or label are fully compliant, verifying the classification and that WHMIS regulatory requirements are met.
- context Health Canada proceeds with prioritizing the exemption, ranking products based on potential risk factors related to worker health and safety. Some exemption applications will be selected for an in-depth compliance review, including random sampling. The in-depth review includes checking:
- context Health Canada may provide a compliance decision to the claimant that outlines findings on claim validity and SDS and/or label compliance. The claimant has 30 days to respond to the compliance decision with any new information if they do not agree with Health Canada’s preliminary compliance decision. All new information the claimant provides will be considered and used to inform Health Canada’s final compliance decision. Health Canada reviews any claim amendments after the 30-day response period (if applicable) and issues their final compliance decision to the claimant. The compliance decision will include corrective measures (orders) required for any non-compliances found in the label and/or safety data sheet.
- context The claimant then has 30 days to comply with these corrective measures by providing a revised copy of the safety data sheet (and label, if applicable) containing all requested changes to Health Canada.
- context Once the claimant has met all requirements, Health Canada will notify the claimant by sending a confirmation letter.
- context If the claimant does not comply with the order, Health Canada will take further appropriate compliance and enforcement action, such as suspending or cancelling the confidential business information exemption. Health Canada publishes a notice of decision online.
- context For claims granted 3-year exemptions, the claim expires at the end of the 3 years. At that time, the supplier or employer must refile the claim if they wish to continue to protect the CBI, and a new HMIRA RN will be issued if the refiled claim meets filing requirements.