The use of prescribed concentration ranges on an SDS – what you need to know as a Supplier and as a consumer.
By Cara Pembroke, Health & Safety Information Team Lead at Chemscape
Within WHMIS 1988 Controlled Products Regulations (CPR), Suppliers had the option to use prescribed concentration ranges within the ingredient section of their MSDS. This was used for products where the ingredient concentration could vary from batch to batch. It was also used by Suppliers (including Manufacturers and Importers) to protect trade secrets of one or more hazardous ingredients; rather than providing actual concentrations they were able to use a range.
In the initial transition from WHMIS 1988 to WHMIS 2015/GHS, the use of prescribed concentration ranges was not included in the Hazardous Product Regulations (HPR). However, an amendment was made to the HPR in April 2018 to bring back the use of prescribed concentration ranges.
Using a concentration range is an alternative to submitting a Confidential Business Information (CBI) claim through Health Canada. If confidentiality is a top concern, a CBI claim, once approved, allows your business to list an ingredient as proprietary on the SDS, along with the Hazardous Materials Information Review Act (HMIRA) number that Health Canada has assigned to your claim. This number ensures that information about hazardous ingredient(s) can be accessed in the case of an emergency or by medical professionals as needed, therefore this number must be included on the SDS. Submitting a CBI claim can be costly and time-consuming for both the Suppliers and Health Canada.
Prescribed Concentration Ranges can be used as follows:
(a) from 0.1 to 1%;
(b) from 0.5 to 1.5%;
(c) from 1 to 5%;
(d) from 3 to 7%;
(e) from 5 to 10%;
(f) from 7 to 13%;
(g) from 10 to 30%;
(h) from 15 to 40%;
(i) from 30 to 60%;
(j) from 45 to 70%;
(k) from 60 to 80%;
(l) from 65 to 85%; and
(m) from 80 to 100%.
What do I need to know as a Supplier?
As noted above, using prescribed ranges can be an alternative to submitting a CBI claim. If using a range:
- A statement that the actual concentration is withheld as a trade secret must be shown immediately following the prescribed range on an SDS.
- If your actual concentration range falls into more than one of the above prescribed ranges, you may combine two consecutive concentration ranges but only if the actual concentration is between 0.1%-30%. If it falls within one range, one prescribed range must be used.
- This amendment does not apply to disclosing the identity of your hazardous ingredient(s), including CAS registry number. A CBI claim must be approved before a business can list an ingredient identity as confidential.
- The GHS hazard classifications must still reflect the most hazardous concentration of each ingredient.
- Update SDSs that were previously authored without prescribed concentration ranges, so that revised SDSs are compliant with the HPR; showing the correct, prescribed ranges and corresponding GHS information.
What do I need to know as a consumer?
Prescribed ranges can only be used in cases where there is a trade secret requirement or where the material or substance is not always present at the same concentration.
The hazard information presented on the Supplier’s SDS and label must correspond to the most hazardous concentration possible for each ingredient, including those with a prescribed concentration range. The use of a prescribed range will not conceal or exempt a business from providing the correct hazard information of a product.