Canada and prescribed concentration ranges
In a previous blog post (December 13, 2017), we noted that Canadian regulations permit a company to file a claim of confidential business information (CBI) for ingredients on a safety data sheet (SDS). When Health Canada notifies the company that it has received a complete claim filing, they issue a claim number and claim filing date under the Hazardous Materials Information Review Act (HMIRA). The number is sometimes called an HMIRA number or an HMIRA registration number.
The company can then state in Section 3 of the SDS that ingredient information has been withheld, and must include the HMIRA number. The company can substitute a generic name for the actual ingredient name, and/or replace the actual concentration/concentration range with a wider concentration range, or even no concentration at all. (Health Canada may later require modifications to the claim, however, including the use of a different generic name, prior to final approval.)
The HMIRA procedure came into effect with the release of the updated Workplace Hazardous Materials Information System (WHIMS 2015), which includes the globally harmonized (GHS) classification and labeling standards.
Prior to adoption of the GHS, the Canadian regulations (WHMIS 1988) included a provision for withholding exact ingredient concentrations/concentration ranges by using prescribed concentration ranges. Unlike the HMIRA process, the company did not need to file a claim with Health Canada prior to issuing the SDS.
When WHIMS 2015 came into effect, companies preparing SDSs expressed the concern that Health Canada would not be able to process the flood of CBI claims that might result from the HMIRA process. Accordingly, Canada modified the regulations to restore the ability of companies to use the prescribed concentration ranges.
Here are the prescribed ranges:
0.1 to 1 %
0.5 to 1.5 %
1 to 5 %
3 to 7 %
5 to 10 %
7 to 13 %
0 to 30 %
5 to 40 %
0 to 60 %
45 to 70 %
60 to 80 %
65 to 85 %
80 to 100 %
As long as the actual concentration/concentration range of an ingredient falls completely within one of these ranges, you can use the range on the SDS, rather than revealing the actual concentration/concentration range.
In addition, if an actual ingredient concentration/concentration range is between 0.1 and 30 percent, but does not fall entirely within a single prescribed range, you can combine two adjacent ranges, using the lower concentration from the lower range, and the upper concentration from the upper range, to define the new concentration range.
The prescribed concentration range approach does not allow you to substitute a generic name for the actual ingredient name, however. And you must include a trade secret statement, indicating that the actual concentration or concentration range is being withheld as a trade secret.