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Health Canada issued a statement on 21 October 2017 to propose an amendment to the Hazardous Products Regulations (HPR), also known as the Workplace Hazardous Materials Information System (WHMIS 2015). The amendment to the regulations would provide industry members the possibility of utilizing prescribed concentration ranges in safety data sheets (SDSs) in lieu of confidential business information (CBI) applications as means of protecting their product formulations. The proposal identifies which concentration ranges may be utilized, and imposes a requirement upon suppliers to provide a statement of trade secret as justification for withholding the actual concentration or concentration range. The Ministry will welcome comments if submitted within 30 days after the date of the publication of the notice.
The proposed amendment would revise the text of section 4.5 of the HPR. The proposed revision would provide an option to utilize a prescribed concentration range, if the actual concentration of the material or substance in the hazardous product falls within one of the specified ranges. The concentration ranges being considered are as follows: 0.1 to 1%; 0.5 to 1.5%; 1 to 5%; 3 to 7%; 5 to 10%; 1 to 13%; 10 to 30%; 15 to 40%; 30 to 60%; 45 to 70%; 60 to 80%; 65 to 85%; and 80 to 100%.
The proposed revision to the regulations also mandates that the concentration range expression be immediately followed by a statement that reflects that the actual concentration is withheld as a trade secret.
Lastly, the proposal contemplates the scenario where a substance or material is not present at the same concentration and the actual concentration does not entirely fall within any of the prescribed concentration ranges. To this extent, the proposal reads as follows: “if the actual concentration range of the material or substance in the hazardous product is equal to or greater than 0.1% but less than or equal to 30%, and the actual concentration range does not fall entirely within any of the concentration ranges set out in subsection (3), a concentration range that is created by combining up to three consecutive ranges from those set out in paragraphs (3)(a) to (g), provided that the combined concentration range does not include any range that falls entirely outside the actual concentration range in which the material or substance is present in the hazardous product.”
Trade secret claims are mandated in Canada as means of benefiting from an exemption to the HPR requirement of disclosing the actual concentration of a hazardous substance in an SDS. Stakeholders have often echoed the monetary and administrative burdens of applying for a CBI exemption in Canada. Hence, the opportunity to use prescribed concentration ranges is viewed under a positive light.
The comment period will remain open until 20 November 2017. Stakeholders wishing to partake of the commentary period must identify their comments with a Canada Gazette, Part I citation and the date of the publication of the announcement. Please address comments and send to Ms. Julie Calendino, Workplace Hazardous Materials Bureau, Consumer Product Safety Directorate, Department of Health, Address Locator 4908B, 269 Laurier Ave. West, 8th Floor, Ottawa, Ontario K1A 0K9. Other ways to contact the Ministry include by phone at 1-855-407-2665; fax to 613-993-5016 or email at firstname.lastname@example.org.
The Ministry also reminds manufactures and importers that they have until 1 June 2018 to finalize their transition to the HPR.