by Alexis Sumner, Hazard Communication Specialist.
The use of prescribed concentration ranges has officially been adopted to the Hazardous Products Regulations (HPR), as published in Part II of the Canada Gazette on April 18, 2018.
Health Canada had previously delayed the GHS implementation for manufacturers and importers until June 1, 2018, to provide time to review the disclosure requirements within the HPR regarding the safety data sheet (SDS). Proposed amendments were reported and summarized in our October 2017 news article.
Previously – under the Controlled Products Regulations (CPR) – prescribed ranges were available for use. Although the intent of these ranges was not to mask the exact concentration of a controlled substance for trade secrecy reasons, that is indeed how industry was using them.
With the use of these prescribed ranges, industry did not submit claims for trade secret protection under the Hazardous Materials Information Review Act (HMIRA). As the number of HMIRA claims grew drastically prior to the original June 1, 2017 HPR deadline, Health Canada postponed the deadline and evaluated the use of prescribed ranges.
What’s been amended in the HPR?
The published amendment replaces Section 4.5 of the HPR and officially adopts the use of the 13 listed ranges. Either the actual concentration of the hazardous substance can be listed or one of the prescribed concentration ranges is allowed on the SDS.
For actual concentrations between 0.1% and 30%, in certain situations (see full regulatory text for further information) up to two concentration ranges from the specified ranges can be combined. This is a change from the proposed amendments, as originally the combination of three ranges was proposed.
The amendment requires that if the prescribed ranges are used to cover the exact concentration for trade secrecy, a statement to the effect that the actual concentration range is withheld as a trade secret must be provided. This aligns with a similar requirement in the Hazard Communication Standard under OSHA in the US.
Health Canada has committed to review the additional concerns which were brought up through the comment period that fell outside of the scope of the HPR regulation. Primarily, concerns were raised over confidential business information (CBI) claims for carcinogens, mutagens, reproductive toxicants and respiratory sensitizers (CMRRs). Labour representatives have expressed concern over masking the identity of CMRRs and workers’ safety, and have recommended a similar approach to the EU.
Any proposed changes regarding this request to the HMIRA and/or HPR would need to be published for public comment within Part I of the Canada Gazette. If a company has already submitted a claim under HMIRA to mask the concentration of a hazardous substance, Health Canada is reviewing options.
Note: Two stakeholders requested clarity on the plan to address and/or refund products for which HMIRA claims have already been submitted to seek exemption from the HPR requirements for concentration disclosure. Health Canada is currently exploring options for addressing CBI claims for ingredient concentration submitted under WHMIS 2015.
HMIRA claims would still need to be filed for the use of ranges to protect CBI that are not one of the prescribed ranges. Additionally, HMIRA claims are needed anytime a company wishes not to disclose the CAS registry number of a hazardous substance that is required to be disclosed on the SDS based on the criteria in the HPR. HMIRA claims are not needed for non-hazardous substances as they are not required to be disclosed on the SDS.
As a reminder, Section 4.4 of the HPR requires that the classification and information on the SDS must reflect the most hazardous concentration listed for the hazardous substance(s) present in a product.
Recommended Action Items
- Review the published amendments (pages 733-754 of the Gazette).
- Institute the use of prescribed ranges, as applicable, on your company’s SDSs.
- Review if HMIRA claims are needed for CAS registry numbers or ranges not listed in the amendments.
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The full text of the Regulations Amending the Hazardous Products Regulations can be found in the Canada Gazette, Part II, April 18, 2018 edition
Canada, Hazardous Products Regulations (HPR), Concentration Ranges