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:
Another SDS ‘Headache’
If you are supplying chemical products that require Safety Data Sheets (SDS’s) to multiple countries, you are also likely to know this headache well.
With the implementation of the Globally Harmonized System of Classification & Labeling (GHS) around the world progressing, issues are beginning to appear which emphasize points where…. Maybe requirements are not so ‘harmonized’. One such issue, is ingredient disclosure requirements on SDS’s for mixtures across different regions of the world.
The United Nation’s (UN’s) GHS system, does contain some standardized recommendations for SDS, including that SDS’s should be provided only for chemicals classified as ‘hazardous’, SDS’s should contain basic minimum information (e.g., 16 sections with specific headings), as well as more detailed recommended guidance on how to prepare each section of the SDS.
Ingredient disclosure recommendations, in particular, appear in Annex 4 of the GHS. In general, the GHS recommends that for a mixture classified as hazardous, the SDS should list all ‘hazardous’ ingredients, which are individually hazardous to health or the environment, when the ingredients are present above concentration cutoff levels. There’s several parts of that general requirement, which can be viewed as a ‘can of worms’.
Are the cutoff levels the same for each region of the world? How should one handle ingredient disclosure when you are in a region that doesn’t regulate environmental hazards on SDS’s? Are ‘non-hazardous’ chemical mixtures really not Continue Reading…
The Issues with Exclusions and Confidential Business Information (CBI) Keep Coming
Health Canada recently 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). The proposed amendment to allow these ranges, would offer industry some CBI protection of formulations without having to go through a potentially costly CBI application claim under the Hazardous Materials Information Review Act (HMIRA).
The “Why” of the Notice
After receiving comments and questions on the proposed amendment, Health Canada brought forward two additional bigger issues, the full exclusion of consumer products from the Hazardous Products Act (HPA) and HPR (or WHMIS 2015), and whether to allow CBI protections of substances with special health hazards (particularly carcinogens, mutagens, reproductive toxicants and respiratory sensitizers, or “CMRRs”).
The “What” of the Notice
With regard to the full exclusion of consumer products from the HPA and HPR, stakeholders felt that since the Consumer Chemicals and Containers Regulations 2001 (CCCR 2001) did not include hazard criteria for special health hazards like the CMRR’s, a worker that might purchase a consumer product from a retail store to use in their workplace, will not have the same full hazard information on the product (and will therefore not protect themselves appropriately) that they would have if the Continue Reading…
Do My Products Need a SDS?
Determining which of your consumer chemical products would require a GHS Safety Data Sheet (SDS), can sometimes be difficult and confusing. Which products actually do need to have compliant SDS, can differ depending on which country/region you are in, and how the product is being used.
In Canada, chemical products that are labeled, packaged, and sold at retail outlets as consumer products, are regulated by the Canadian Consumer Product Safety Act (CCPSA), and the Consumer Chemicals and Containers Regulations 2001 (CCCR 2001). Examples of ‘retail’ outlets are stores such as Canadian Tire, Home Depot, Rona, and corner gas stations that anyone off the street can walk into and buy chemical products in, etc.
Chemical products, which are intended for use in worksites and not sold at retail outlets, on the other hand, are regulated by the Hazardous Products Act (HPA) and Hazardous Products Regulations (HPR, or “WHMIS 2015“). It is the HPA and HPR (WHMIS 2015), where GHS SDS requirements are found, while the CCPSA and CCCR 2001 do not currently contain any SDS requirements at all.
In the HPA, in Part II, Section 12(j) and Schedule 1, CCPSA consumer products are actually excluded from the application of the HPA’s requirements.
What does this exclusion mean?
Keep in mind that the CCPSA and CCCR 2001 do not contain any SDS requirements, while the HPA and HPR Continue Reading…
Isn’t everyone using GHS for SDS’s and labels?
The answer to that is yes, and also no.
The European Union (EU)
In the EU, REACH [Regulation (EC) No. 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals] and GHS regulations [Regulation (EC) No. 1272/2008 on classification, labelling and packaging of substances and mixtures, or the ‘CLP’] have already been implemented for many years. Most phases of the EU’s implementation plan have already been completed. There is one last remaining date that has not yet passed, however, with respect to SDS’s and labels.
SDS’s and labels for pure substances are required to fully compliant with REACH and the CLP. The last transition date for pure substance SDS’s was completed on December 1, 2012. Any SDS and label for a pure substance after that date, had to be fully compliant with REACH and CLP regulations, and display only GHS information.
SDS’s and labels for mixtures, for products placed on the market in the EU for the first time after June 1, 2015, are also required to be fully compliant with REACH and the CLP, and display only GHS information.
Mixture SDS’s and labels, only for products already placed on the market in the EU for the first time before June 1, 2015, however, may still show old system EU information. These SDS’s and labels for mixtures, may still display the EU’s old system Continue Reading…
Frequently Asked SDS Symbols Questions
How many times have you thought you understood a requirement, only to second guess yourself about whether you got that right or not? It could be something relatively straight forward, or something a bit more complicated. Everyone has these moments occasionally, especially with the implementation of GHS around the world. At ICC, two of the questions that seem to pop up from time to time, revolve around symbols on SDSs.
Do GHS pictograms have to appear on an SDS?
The answer: No. The ‘pictogram,’ specifically, doesn’t have to appear. This answer, in part, boils down to terminology.
In both Canada, under WHMIS 2015 Hazardous Products Regulations (HPR) requirements, and in the United States, under Hazcom 2012 requirements, Section 2 of an SDS is required to list the label ‘information elements’ that are applicable to the product. Hazard ‘symbols’ being one of the required ‘information elements’.
In both the United States and in Canada, ‘pictogram’ is defined as a “symbol” along with other “elements, such as a border or background color”. So a complete GHS ‘pictogram’ is actually two part; a graphic symbol on the inside, and a frame surrounding it. Both countries include an allowance only to show a ‘symbol’ (ie. not a ‘pictogram’), or, just the name of the symbol, on the SDS [Hazcom 2012, Appendix D, Table D.1, Item 2(b); WHMIS 2015 Hazardous Continue Reading…
New Concentrations and Concentration Ranges Rules
If you’ve begun switching your MSDSs to SDSs under the new WHMIS 2015 regulations, you likely know this headache all too well.
With the publication and implementation of the Hazardous Products Regulations (HPR or WHMIS 2015), Health Canada removed the old Controlled Products Regulations’ (CPR or WHMIS 1988) list of prescribed concentration ranges that could be used in MSDSs. These concentrations were in place, in part, to allow some Confidential Business Information (CBI) protection when concentrations varied in a product. WHMIS 2015 now requires disclosure of exact concentrations of ingredients, or the actual concentration range of the ingredient. Actual concentration ranges can only be used if the concentration varies in the product due to issues such as batch to batch variability. You cannot list a range if you have an exact concentration, and simply wanted to “protect your formula”.
Suppliers would be required to file a CBI claim under WHMIS 2015 requirements, if even just to protect the exact concentration of one ingredient on a SDS. A whole host of difficulties may face the supplier in obtaining information that would be needed to complete this type of CBI submission, such as obtaining exact concentration information from suppliers outside the country, where CBI or trade secret requirements are different from those in Canada. In the United States, for example, there is no federal requirement Continue Reading…
FAQs Arising from My Attendance at the SCHC Conference
Last week I had the pleasure of attending a Q&A session at the fall session of the SCHC conference. The session included speakers from OSHA and Health Canada. There were a number of great questions, and here are some of those questions and answers that stood out to me.
Are any required pictograms being considered by OSHA for combustible dusts?
This topic is in discussion, but there is definitely an aversion to creating whole new pictograms (i.e., non-current GHS pictograms).
Will there be a Word template (like the old OSHA form 174) provided by OSHA?
Yes, but progress on it is very slow since it is not a priority.
Has there been any progress by OSHA on creating more pictogram precedence rules? Right now if you have an acute toxicity classification requiring a skull and crossbones, you would still have to include the exclamation if you had a STOT SE Category 3 material. The exclamation seems redundant.
There is “some” discussion on this but, more pressure from industry is needed for this discussion to progress further.
Is it okay with OSHA to continue using HMIS/NFPA in a US workplace?
Yes, but you need to make sure training and other information available on the GHS hazards of chemicals used in the workplace is readily available. Also, by 2016, HMIS/NFPA ratings are updated to reflect any “new” GHS Continue Reading…
WHMIS 2.0 Comment Period
It should be no surprise by now that Canada is moving ahead with GHS, or WHMIS 2.0 implementation, and that a comment period was available. The target is still to synchronize the WHMIS GHS implementation with the US OSHA date of June 2015.
During the comment period Health Canada formally received 67 submitted “comments” from industry on the WHMIS 2.0 proposal in Gazette I – mostly for support of the GHS initiative. One comment focused on aerosols and the fact that the proposal indicates it is in alignment with the 5th revised edition of the GHS purple book. But, manufacturers would currently still have to assign a compressed gas classification under the proposal as it stands now. The 5th edition, though, drops the compressed gas designation for aerosols. Health Canada is investigating this issue.
Comments are being reviewed and upon completion, subsequent steps include amendments to OSH legislation, developing guidance documents and training materials, and final publication in Gazette II.
Also, there are important variances to note in WHMIS 2.0 versus OSHA GHS. The phrase “Not applicable” MUST NOT be used in Section 11 of an SDS; and for STOT classifications, suppliers MUST NOT identify a specific organ and route of exposure unless they are 100% positive there are no other target organ effects. A general statement that does not specify an organ or a specific Continue Reading…
Most people have seen, at one time or another, ads for new children’s products or household/personal use products on the television, or online, with what appears to be an ‘amazing’ deal… those famous ‘limited time offers’ with the amazing deal to ‘purchase now and you’ll get two products for the price of one’.Shoppers need to keep in mind that it’s not always just about the ‘deal’.
When shopping online or via mail, shoppers need to keep in mind that some products may be prohibited in your home country and others still may have special safety requirements that are actually more strict than the safety requirements for the same product in other countries. The more you know about the health, environmental and user risks of the product you are about to purchase, the better you can protect the health and stability of both you and your family. If you do not practice responsible shopping, you can end up putting yourself and your family into some sticky situations.
One example of the consequences of not practicing responsible shopping is during the purchase of a children’s car seat in Canada. Perhaps you’ve seen an ad online for a really good deal on a car seat that is coming from the United States and you happen to live in Canada. Car seats for children are regulated by both Health Canada and Transport Canada, and must pass Continue Reading…