What is CBI?
WHMIS requires that suppliers provide employers with the necessary information to help make it possible to safely use hazardous products in Canadian workplaces. If a product is considered hazardous but certain information is considered confidential or a trade secret, then a claim may be filed to protect this Confidential Business Information (CBI) under the Hazardous Materials Information Review Act (HMIRA).
CBI protection in Canada remains largely the same under WHMIS 2015 as it was under WHMIS 1988. Health Canada is the government body responsible for CBI and WHMIS-related laws.
Please refer to the following OSH Answers documents for information about WHMIS 2015:
- WHMIS 2015 – General
- WHMIS 2015 – Pictograms
- WHMIS 2015 – Labels
- WHMIS 2015 – Hazard Classes and Categories
- WHMIS 2015 – Safety Data Sheets (SDSs)
- WHMIS 2015 – Education and Training
- WHMIS 2015 – WHMIS Program
- WHMIS 2015 – Glossary
- WHMIS 2015 – Variances
- WHMIS 2015 – Laboratories
What is Protection of CBI?
The protection of CBI is a process that allows certain information, such as the chemical identity of one or more trade secret hazardous ingredients in a WHMIS-regulated product, to not be disclosed on the safety data sheet (SDS) and/or label for the hazardous product. A supplier or employer who wants to protect CBI must file a claim for exemption with Health Canada. The CBI process includes a Health Canada review of the SDS and/or label to verify that the hazard and safe use information complies with WHMIS 2015 requirements.
This mechanism balances workers’ right-to-know with industry’s need to protect trade secrets.
What information can be claimed for CBI protection?
The following information can be claimed for exemption by suppliers or employers:
- chemical identity of an ingredient, substance or material (including impurities and stabilizing solvents)
- concentration or concentration range of an ingredient, substance or material
- the name of any toxicological study that identifies the ingredient, substance or material
Employers may also claim:
- product identifier (chemical name, trade name and/or other means of identification information)
- information that could be used to identify the supplier
If a claim has been filed to protect the chemical identity and/or true concentration (or true concentration range) of an ingredient, this information must be replaced in the SDS by a reference to the 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 generic chemical name, for example, ‘Alcohol’. Additionally, the Chemical Abstracts Service (CAS) No. may be replaced with a word such as ‘Proprietary’ and the true concentration (or true concentration range) may be replaced with a word such as ‘Proprietary’ and/or a replacement concentration range. Note that if a replacement concentration rangeis used it must include the true concentration or true concentration range.
|Substance||CAS No.||% (w/w)|
* HMIRA RN: 3333 – Decision Granted Date January 1, 2021
How do I know if a CBI claim is valid
The supplier or employer that is claiming a trade secret must replace the CBI with the HMIRA RN and the date of filing or the date the claim was granted, or a link to this information, on the product SDS and/or label.
Health Canada provides a list of Active Claims for Exemptions that shows:
- Claimant Name
- Registry Number (RN or Reg #)
- Product Name
- Notice of Filing (NoF) Date
- Notice of Decision (NoD) Date or a Decision Pending notation
- Expiry Date for the CBI claim
There are links to the official Canada Gazette publication notice regarding the filing of the claim and the decision made on the claim. The NoD date also links to any additional information about the CBI claim validity. To verify that the SDS and/or label has an active CBI claim, the HMIRA RN and date shown on the SDS/label should match the information on this web page, and the link to the NoD will provide confirmation that the claim was determined to be valid.
What is required in a complete application package?
When applying for CBI, certain items and information must be provided, including:
|Table 1 – Complete CBI Application Package Checklist*|
Copy of SDS and/or label.
100% composition of product, including all CAS numbers, chemical identities and actual concentrations and/or concentration ranges.
All ingredients disclosed on the SDS are also disclosed on the product’s 100% composition document.
|Payment information (credit card) or cheque/money order.|
|Consistent use of product identifier and generic chemical names between the application form and the SDS/label.|
|Consistent subject of the claim for exemption throughout the forms and the SDS.|
|French translation of generic chemical name(s).|
|Provision of all mandatory information on forms.|
|Declaration of confidentiality signed by the individual with signing authority for the claimant.|
* Using the Health Canada Application form is not a mandatory requirement of the HMIRA; however, the information communicated regarding a claim for exemption must clearly and consistently convey what is being claimed as CBI and address the requirements addressed in the HMIRA and the Hazardous Materials Information Review Regulations (HMIRR) (subsections 11(3)(4) of the HMIRA and sections 3, 4, 5, 6, 7 and 8 of the HMIRR).
Is there a transition to WHMIS 2015 for CBI claims?
As of June 1, 2016, all claims for exemption submitted by suppliers will be assessed according to WHMIS 2015 criteria. Employers have until December 1, 2017 to submit claims for exemption using either WHMIS 2015 SDSs and labels, or using WHMIS 1988 MSDSs and labels. After this date, all submissions will be processed according to WHMIS 2015 criteria.
What are the steps in the CBI process?
- The claimant applies for the HMIRA Claim for Exemption – which involves completing an application package and providing all the information specified to Health Canada (HC).
- HC does a preliminary review of the claim package. If the package is incomplete, the claimant is notified and it is put on hold until the missing information is provided.
- If the package is complete, HC issues a HMIRA RN and a Date of Filing to the claimant. The claimant can then sell, import, or use the product in Canada; and must cite the HMIRA RN and the Date of Filing on the SDS and/or label in place of the CBI. They must also meet other requirements of the Hazardous Products Regulations (HPR) section 5.7.
- HC proceeds with a full assessment of the claim to check:
- for the validity of the trade secret claim, and
- whether the SDS and/or label are fully compliant, verifying the classification and that WHMIS regulatory requirements are met.
- HC may provide a Consultation Document (CD) to the claimant that outlines findings on claim validity and SDS and/or label compliance.
- The claimant may respond to the CD with amendments to the claim and/or comments on findings of non-compliances, if appropriate.
- HC reviews any claim amendments (if applicable) and issues a decision to the claimant. If the claim is found not to be fully valid, HC may issue orders for corrective measures relating to the validity of the claim. See additional steps below for non-compliant SDS and/or label.
- Non-compliant SDS and/or label – Resolution:
- If HC finds the SDS and/or label to be non-compliant, a Statement of Decisions (SoD) will detail the corrective measures.
- Claimants receiving a SoD must resolve issues and submit a revised SDS and/or label with a signed compliance undertaking declaration.
- HC reviews the response and, if compliant, will issue a confirmation of compliance undertaking letter to the claimant.
- If voluntary compliance is not achieved within the allowed timeframe, HC will issue orders under the HMIRA.
- HC publishes a NoD in the Canada Gazette.
For additional information, please contact Health Canada.
Although every effort is made to ensure the accuracy, currency and completeness of the information, CCOHS does not guarantee, warrant, represent or undertake that the information provided is correct, accurate or current. CCOHS is not liable for any loss, claim, or demand arising directly or indirectly from any use or reliance upon the information.