In a January 2024 regulatory and compliance webinar, Veronica Marrero, the Director of Professional Services in Regulatory Operations at TotalSDS, explored the latest regulatory requirements in four major jurisdictions: Canada, the EU, Brazil, and China.
Marrero and the key speaker, Senior Regulatory Compliance Specialist Rennee Karlik, covered the most pressing regulatory changes in hazard communication and labeling. Here’s a breakdown of the key points they discussed in the webinar.
Challenges and Goals of Regulatory Changes and New Jurisdictional Adoptions
For several years, regulatory and compliance entities across key jurisdictions have been working toward classification and labeling harmonization. However, there is still a long way to go before achieving true alignment across all jurisdictions.
Notably, in China, regulatory requirements have lagged behind EU frameworks, and in Brazil, health and safety regulations have done the same. Since the Canadian regulatory frameworks largely mirror those adopted in the U.S., these critical jurisdictions have experienced some disparity with the EU, Brazilian and Chinese markets.
A lack of consistency in labeling and classification requirements can complicate trade and lead to non-compliance. The upcoming changes seek to narrow this gap and rectify discrepancies in labeling requirements among critical trade jurisdictions.
Regulatory Updates: Deadlines Approaching in 2025 and 2026
In the webinar, Karlik largely focused on regulatory updates that have a 2025 or 2026 implementation deadline. Here’s a look at the first of the four jurisdictions discussed on the webinar: Canada.
Canada’s Regulatory Changes for Compliance
Canada has updated its hazardous product regulations to incorporate the Globally Harmonized System’s (GHS) revision seven, as well as a very limited portion of GHS revision eight, the Hazard Class “chemicals under pressure.” Canada has adopted all of the corresponding elements that apply to that class, including:
- Label elements
- Hazard statements
- Pictograms
- Signal words
It will continue using all other hazard classifications from revision seven.
What Can We Expect From the Regulatory Updates in Canada?
The updates will prompt the following changes:
Changes to Physical Hazard Classes Regulatory
The most notable change involves the adoption of the Chemicals Under Pressure hazard class, which has three separate categories. The standard categorizes chemicals under pressure based on the percentage of combustible components in the mixture, as well as the ignition point.
The new framework also updates the flammable gasses hazard class. Currently, there are two flammable gasses categories: Category 1 and 2. The updates add new subcategories under Category 1A and 1B.
After this change takes effect, the current “Flammable Aerosols” hazard class will simply be called “aerosols,” and it will include a third category.
Changes in Health Hazards for New Standard Regulatory
The rule changes will also alter the way acute toxicity is classified.
In addition to the current protocol, if a substance or mixture, not already classified as acutely toxic, releases toxic gas when in contact with water, it will now be classified as acutely toxic. The LC50 rating of the toxic gas that is released will dictate the category of the acute toxicity classification.
The updates will also add a new category, known as “Category 2,” that pertains to serious eye damage and irritation. Canadian regulators will continue using the two existing “2A” and “2B” categories.
Additionally, a new hazard statement has been added to the “combustible dust” grouping. The latest statement is as follows: “May form explosive dust-air mixture.” However, manufacturers don’t have to use both hazard statements. They can continue using the old one or switch to the new terminology.
Lastly, there has been a change to the format and content requirements on the SDS. Disclosure requirements in Section 3 have been updated, along with changes to the properties required in Section 9.
What Is Staying the Same for Canada Regulatory?
Despite making some major regulatory and compliance changes in 2024, Canada has still not adopted explosives as a classification. The nation will continue using its biohazardous infectious materials classification table as well, even though it differs from the GHS framework.
Canada has also declined to adopt environmental hazards, so all requirements related to those categories will remain the same. Biohazardous infectious materials will remain a special category in the Canadian regulatory and compliance framework, however. This is a classification unique to Canada that is not part of the GHS.
Canada’s Regulatory Changes: What It Means for Chemical Manufacturers, Suppliers, Distributors, or Importers
As an entity involved with the production, distribution, or importation of chemicals, you must update your SDSs and labels to align with these changes. The compliance deadline is December 14, 2025.
EU Updates Its Classification: Labeling and Packaging (CLP) Regulation to Adopt New Hazard Classes
In April 2023, the EU Commission published several revisions to its CLP regulatory and compliance framework. The updates added new hazard classes and prescribed criteria for the classification, labeling, and packaging of substances and mixtures within these classes. The new classes are as follows:
- Endocrine disruptors
- Persistent, bioaccumulative, and toxic
- Very persistent and bioaccumulative
- Mobile and toxic
- Very persistent and very mobile
Here’s a closer look at these additions:
Hazard Classes Unique to the EU
The aforementioned hazard classes are unique to the European Union. They are not part of GHS, nor are they derived from the GHS framework.
Still, it’s important to be cognizant of these additional hazard classes if you send or receive chemicals to an EU trading partner to ensure compliance with the EU standards..
Implications for Manufacturers, Suppliers, Distributors, and Importers in the EU
If you are a manufacturer, supplier, distributor, or other entity that sends chemicals to the European Union, you must incorporate the new hazard classifications into your labeling process. Evaluate your products and identify which items fall under one of these new hazard-class umbrellas.
During the updates, the EU established two separate compliance deadlines. Substances must comply with the new regulation by May 1, 2025, but mixtures have an extended deadline of May 1, 2026.
Brazil Adopts the GHS Revision 7 in New NBR
Brazil adopted GHS revision 7 as part of NBR 14725:2023. Under this framework, the country modified the Portuguese name for “SDS” to more accurately reflect global naming conventions and promote harmony with other nations. Brazil also incorporated two key hazard classes: “Desensitize explosives” and “Flammable gasses.”
As with Canada, this will be a subdivision of gasses, which now includes:
- Category 1
- Category 1A and 1B
- A category for unstable gasses, which will fall under 1A
Brazil did not add any new health hazards. However, it did adopt some changes to its environmental hazard regulatory and compliance framework to include substances that are hazardous to the ozone layer.
Additional Changes
NBR 14725:2023 mandates the creation of a 24/7 local phone number for emergencies. This resource is meant to help businesses and their employees in the event of a chemical exposure or accident.
The updates have also modified Section 9 of SDSs, adding some physical properties and removing others. Brazil is also changing some of the hazard and precautionary statements and standardizing labeling requirements.
Interestingly, another change Brazil has enacted is making it optional for manufacturers to indicate on the label where to find SDS for their products. Previously, this was a mandatory part of hazard labeling. Brazil is also allowing manufacturers to include an SDS QR code on the label of small packages.
One of the most notable changes involves merging NBR 14725 into a consolidated standard. Previously, it was divided into separate parts, which made compliance and safety optimization much more difficult for everyone.
What Are the Implications for Manufacturers, Suppliers, Distributors, and Importers in Brazil?
If you manufacture or supply chemicals to Brazil, you’ll need to conduct a comprehensive review of your SDS and labels. Make sure they are compliant by Brazil’s deadline of July 4, 2025. Pay particular attention to section 9, as this portion of SDS included the most substantial changes.
New Regulation Updates Expected This Year (2024)
The United States is much further behind the GHS standardization initiative than Canada, Brazil, and the EU. However, OSHA has been working to rectify this, recently issuing a final rule to update GHS to the seventh iteration.
OSHA’s Final Rule to amend its HCS to GHS revision seven was issued on May 20, 2024, and takes effect on July 19, 2024. Mandatory compliance with the updated standard begins January 19, 2026. While this leaves little time for chemical manufacturers to prepare, the change was originally proposed in early 2021. Therefore, most entities involved in chemical production were aware that this impending change was just over the horizon.
Like the U.S., China is behind in its GHS adoption. However, it’s expected that China will finalize and publish updates before the end of 2024. If your business imports chemical products to China, it’s vital that you stay apprised of these developments.
OSHA Updates: Changes to Aerosols
Under the OSHA Final Rule, there will be updates to the aerosol hazard class, much like the one Canada has adopted. Instead of just one blanket category of flammable aerosols, there will now be three distinct categories, each with unique labeling and hazard statement requirements.
OSHA Updates: Changes to Flammable Gasses
OSHA will also be updating the class on flammable gas hazards. Under the new rules, there will be categories 1, 1A, 1B, and 2. Like Canada, the U.S. Category 1A has several subcategories, including pyrophoric and chemically unstable gasses.
Other Changes for OSHA
The OSHA Final Rule was just published, so chemical manufacturers are still sorting through the changes and requisite deadlines. However, here are the SDS content requirement alterations that have been identified thus far:
- Addition of a desensitized explosives hazard class and corresponding label elements
- Addition of a non-mandatory exclamation mark (pictogram) for hazards not otherwise classified
- New rules regarding prescribed concentration ranges
- Inclusion of concentration ranges in Section 8 under control parameters
- Addition of some physical properties and the removal of others in Section 9
- Expansion of Section 11 to include interactive effects
- Renaming of Section 14 subsection to “transport in bulk”
Additionally, OSHA has clarified its language regarding the communication of hazards that result from a chemical reaction during the product’s normal conditions of use. OSHA has always accounted for the foreseeable conditions of use when classifying chemical products, a practice that sets it apart from other jurisdictions.
What Is the Expected Transition Period for Final Rulemaking Once Published?
OSHA’s Final Rule surprised many becoming mandatory just 18 months after being published. This prompt turnaround gives chemical manufacturers very little time to adopt the changes. However, it is likely that OSHA will issue further guidance.would be wrong to assume that OSHA will provide an extension or push back the deadline. Instead, your team must work swiftly to adapt to the new requirements and avoid regulatory and compliance headaches.
What Are the Regulatory Cooperation Efforts Between the U.S. and Canada?
For several years, Canada and the U.S. have proactively worked together to promote harmony and consistency in chemical hazard communication and labeling. The Regulatory Cooperation Council (RCC) has been extremely valuable during this process.
The recent changes adopted by Canada and the U.S. demonstrate an ongoing commitment to uniformity in labeling. While the two nations will never be perfectly aligned, there is a lot of consistency in these published changes.
China GHS Revision 8 and Expected to Finalize GB 30000
Currently, China is using GHS revision four but is expected to finalize GB 30000.1, which will adopt GHS revision 8. If approved, the rule change will also adopt the desensitized explosives classification from GHS revision 9.
However, the effective date has not been announced, as China has not officially adopted any final ruling yet. Therefore, it’s important to keep a close eye on the situation, as it is unknown when regulators will make a public announcement or how soon the effective date will be.
While we don’t anticipate an effective date this year, China may opt for a rapid implementation, much like OSHA did. Learn more about GHS classification lists in China and other areas.
Q&A: Regulatory and Compliance Changes
Can I Access the Webinar?
Absolutely. TotalSDS is committed to helping members of the chemical manufacturing industry promote safety and compliance. As such, we have created a comprehensive library of free educational and informational resources, including this webinar.
You can access a recording of the Regulatory and Compliance: What is Planned for 2024 and How to Stay Ahead of Changes? webinar via this link.
Will the Prescribed Concentration Ranges Be the Same for the U.S. and Canada?
Canada changed the prescribed concentration ranges for trade secret ingredients to allow for narrower concentration ranges that fall within the prescribed ranges.. OSHA’s final rule newly adopted prescribed concentrations ranges and fully aligned with Canada’s Hazardous Products Regulations.
Our Labels Are EU-compliant. Are There Any Major Differences We Need to Be Mindful of to Align With OSHA requirements?
While the EU leverages a later version of GHS, the United States has additional hazard classifications and subcategories that may be omitted from EU-compliant labels.
For example, the U.S. has different concentration limits than the EU for some hazard classifications and vice versa. Therefore, you must create an SDS for each unique jurisdiction to avoid discrepancies and compliance issues.
What Happens if My Shipment Gets Audited and Is Found to Be Non-Compliant With SDS Requirements?
Suppose that you are shipping chemicals from the U.S. to Canada, and an inspector determines that the transportation section doesn’t match the hazard classification. In this instance, customs can hold your product until the discrepancy is resolved.
The process can take weeks, and your customer’s shipment will be delayed. This has the potential to damage your reputation and lead to profit losses.
Do the EU’s New Hazards Introduce Any New Updates to the SDS Format?
Currently, there are no new subheader requirements for the EU’s additional hazard classes. While you must communicate endocrine disruptors, as well as any of the other new health and environmental hazards, there aren’t any subheaders for these categories. As long as the appropriate hazards are listed on your SDS, you should be in compliance with the EU’s rules.
Jurisdictional Differences With TotalSDS Authoring Software
TotalSDS authoring software was specifically designed to address jurisdictional differences in SDS and labeling requirements. During your authoring process, our setup wizard will ask what jurisdiction you are authoring for.
After you input your choice, the platform will automatically adjust concentration limit triggers based on the relevant set of regulatory and compliance guidelines for that jurisdiction. As soon as you select your jurisdiction, the template becomes highly customized.
Our team carefully modified the system to address each country’s concentration limits and other labeling requirements to give you peace of mind. For instance, if you select the United States as your jurisdiction, the software will automatically evaluate your products for additional hazards, including combustible dust.
At TotalSDS, we understand that no one knows your product better than you do. With that in mind, we’ve included an override feature so that you can ultimately decide the appropriate classification for your product. While our wizard does the calculations for you and gives you a recommendation based on the selected criteria, you are in control.
How TotalSDS Can Keep You Compliant
The TotalSDS platform provides user-friendly authoring and management tools to create compliant documents with ease. Our regulatory team offers personalized guidance every step of the way and can assist with translating complex requirements into compliant documents.
In addition to our software solutions, TotalSDS offers professional services to meet your labeling and hazard communication needs. Schedule a demo to learn more.
