Health Canada Amendment to the HPR (Hazardous Product Regulations)
Health Canada published a proposed amendment to the HPR (Hazardous Product Regulations), which included an option to use specified concentration ranges for ingredients rather than the exact or actual chemical concentration on their SDSs (safety data sheets) (October 21, 2017).
That proposed amendment to allow ranges, would offer industry some Confidential Business Information (CBI) protection of formulations without having to go through a potentially costly CBI application claim under the Hazardous Materials Information Review Act (HMIRA).
After receiving comments and questions on the proposed amendment to allow the use of concentration ranges on SDSs, Health Canada has advised that the amendment has been approved and registered as of April 4, 2018. The approved amendment has yet to appear in the official Gazette II publication, but is expected to appear on April 18, 2018. Since it is officially registered, the amendment is effective, and can be applied, now.
Health Canada, through this new amendment, is giving the option to suppliers, to list prescribed concentration ranges for ingredients on SDSs, without having to apply for a potentially costly exemption, in accordance with the HMIRA.
Suppliers may use this option when they wish to protect exact concentrations, or ‘actual concentration ranges’, which they feel are trade secrets.
The following are the approved, prescribed, list of concentration ranges:
0.5 – 1.5%
1.0 – 5.0%
3.0 – 7.0%
5.0 – 10.0%
7.0 – 13.0%
10.0 – 30.0%
15.0 – 40.0%
30.0 – 60.0%
45.0 – 70.0%
60.0 – 80.0%
65.0 – 85.0%
80.0 – 100.0%
A supplier may choose to list any one of the above ranges on an SDS, for ingredients that require disclosure, and where the exact concentration or ‘actual concentration range’, falls within one of these ranges. Important here is any ‘one‘ range. Only one range can be selected, if the exact concentration or ‘actual concentration range’ falls inside one of the above prescribed ranges.
In cases where a supplier’s ingredients vary in concentration and aren’t always present at the same concentration, yet the supplier feels that the variable concentrations are trade secrets, the supplier can choose to combine up to 2 consecutive prescribed ranges, IF that variable concentration is < 30%.
As an example, perhaps a supplier has a key solvent in a mixture present in a variable concentration of 2.0 – 6.0%, the supplier would have the option under this new amendment, of combining the above 1.0 – 5.0% and 3.0 – 7.0% prescribed concentration ranges, into a single range listed on the SDS of 1.0 – 7.0%.
The same would not hold true if an ingredient’s concentration varied and was above 30%. A supplier would not, for example, be able to combine two of the above prescribed ranges, if an ingredient’s variable concentration was 28.0 – 45.0%. For ingredients like this, that are in variable concentrations, but are mostly > 30%, suppliers have the option of listing one of the above, appropriate, prescribed ranges; or listing the ‘actual concentration range’.
So with our example of 28.0 – 45.0% variable concentration, a supplier could list any one of three prescribed concentrations:
- 10 – 30%; 15-40%;
- or 30-60%… (although common sense would dictate that 10-30% is not appropriate for a variable concentration of 28-45%);
- or list the actual range of 28.0 – 45.0%.
ICC’s recommendation in this specific example, would be to list 30 – 60% since it covers almost all of the actual variable range, if a supplier didn’t want to specifically identify the actual variable range.
A couple of important points Suppliers must keep in mind when taking advantage of this new amendment, is that when choosing to list one of the prescribed ranges as a trade secret mechanism, there must be a qualifying statement added, immediately following the prescribed ranges on an SDS, that identifies the prescribed concentration range as a trade secret.
A statement such as “The exact concentrations of the above listed chemicals are being withheld as a trade secret” would be a reasonable statement to use at the bottom of Section 3, if a Supplier were using one prescribed range for every ingredient listed on an SDS.
Additionally, the new amendment allows the use of specific prescribed ranges. Period. A Supplier must list a ‘prescribed range’ as it appears in the HPR and not alter it, once it is chosen. For example, perhaps a Supplier has an alcohol present at exactly 4.5%, and the Supplier chose to take advantage of this new amendment, the concentration listed on the SDS must only be either 1.0 – 5.0% or 3.0 – 7.0%. That supplier could not combine those two ranges, since the exact concentration is known and fits inside a prescribed range, and they could not narrow one of the ranges (e.g. 3-6% instead of 3-7%).
All other parts of the HPR are not modified in this amendment. They all remain as is. Specifically, Section 4.4 of the HPR is still applicable.
Section 4.4 is stated as follows:
If ingredients in a mixture that is a hazardous product are present in a range of concentrations, the information provided on the safety data sheet must be based on data available that correspond to the most hazardous concentration of each ingredient in the mixture, whether those data pertain to an ingredient or the mixture as a whole.
In most cases, the ‘most hazardous concentration’ of an ingredient will be the high end of a concentration range. Suppliers need to keep this section in mind if they are choosing to list a prescribed range on the SDS. If a mixture classification was performed using an exact concentration for all ingredients, that mixture classification has to be reviewed to ensure that it reflects the most hazardous concentration of each ingredient present.
As an example, consider a mixture that has a Skin Irritant – Category 2 material present at 9.0%. A Supplier completed a mixture calculation and did not classify that mixture as a Skin Irritant – Category 2, since the ingredient with that classification is present at < 10.0%. However, the Supplier chooses to list the ingredient on the SDS with a prescribed range. In this case, the Supplier decided to choose the prescribed range of 7.0 – 13.0%. Although this would be an appropriate range to choose, it would cause a problem with the classification of the mixture. If that same Skin Irritant – Category 2 material was present at > 10% and up to 13%, then the mixture would require the Skin Irritant – Category 2 designation that the supplier earlier, had just dropped.
If the supplier still listed the 7-13% range on the SDS for the Skin Irritant – Category 2 material, but did not classify the mixture as such, and did not include the required harmonized label elements for that classification, then the SDS would end up being non-compliant.
For further information
For further information on WHMIS regulations, please consult the following website link: