Trade Secret Requirements. Are they the same or different internationally?
By: Kirsten Alcock, Manager of Product Safety, email
The Hazardous Products Regulations (HPR) in Canada dictates what information must be available on a SDS within each prescribed section. The SDS is required by law to disclose all hazardous ingredients within a product formulation, their weight percentage, the applicable CAS number, the toxicological properties such as Threshold Limit Values (TLVs), and any and all precautions that the worker must abide by when handling the product. It is important to note that different countries have different requirements.
Very often we receive SDSs from our clients that were created for countries other than Canada. Many of these SDSs claim Trade Secret for their CAS and chemical name. This is non-compliant for Canada. Our rules for claiming Trade Secret are different from other countries and this leads to difficulties for our clients trying to sell and provide compliant SDSs for their formulated products. If you intend to sell your products into Canada, ensure that your supplier SDSs for the components have all the information necessary if their ingredients are hazardous.
If a supplier or manufacturer wishes to withhold the chemical identity and CAS number of any hazardous ingredient(s) on the SDS as Confidential Business Information (CBI), a HMIRA Claim For Exemption Registration must be filed and approved by Health Canada. This is different from the US regulations so please ensure you are preparing your SDSs in accordance with the country you plan to sell your product to. Under a HMIRA Registration, chemical names may be replaced with a Generic Chemical Identity (GCI) and registrants may mask functional groups, location, and number of substitutions. However, broad and vague terms such as “surfactant” are not acceptable for your chemical name.
A HMIRA Registry Number is issued by Health Canada and, once granted, it is required to appear on the SDS in order to be sold to the Canadian industrial market. The HMIRA registration must be renewed every three years and a new HMIRA Registry number will be issued. Health Canada requires a full, complete registration package in order to review your claim for exemption. A full submission includes, but is not limited to, the product formula, SDSs associated with your claim, measures taken to protect information, the claim for exemption form, and payment authorization. The fee structure varies depending on whether the submission is an original claim or a refilled claim. When more than 15 claims are filed at the same time, the fees can be reduced. The HMIRA also offers small business fees for smaller companies wishing to claim.
Fees associated with HMIRA claims for exemption are subject to an annual fee adjustment in accordance with the Service Fees Act (SFA). Health Canada selected April 1st of every year as the anniversary date for the annual fee adjustments.
HOW DELL TECH CAN HELP:
- Develop Generic Chemical Identity (GCI) for the ingredient(s) you with to claim as CBI
- Prepare and submit a complete registration package to HMIRA on your behalf
- Provide guidance on the payment authorization and fee structure
- Prepare the SDS for the product submission
Contact:
Dell Tech
Kirsten Alcock, B.Sc. (Hons)
Manager, Product Safety Group
519-858-5074
kirsten@delltech.com
Dell Tech has provided professional, confidential consulting services to the chemical specialty
industry in Canada, the USA, Europe, and Asia for the last 40 years.
Contact us today for more information.
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