How to place on the market in USA and Canada

Manufacturers and suppliers have a crucial role in ensuring the safe and sustainable use of chemicals in North America by following the ever-changing regulatory landscape for each respective country. The US and Canada currently operate under different regulations, which requires companies to follow separate regulatory requirements when placing their products and substances on the market. Whilst there are plans to try and harmonize the regulations there do remain large differences in the requirements.

Comparison of substance import requirements

United States

U.S. Customs and Border Protection (CBP) requires companies importing chemicals, mixtures, or articles containing chemical substances to comply with the Toxic Substances Control Act (TSCA), administered by the Environmental Protection Agency (EPA).

• Importers must certify to CBP whether the substance complies with the TSCA Inventory or is exempt.
• If a substance is not listed and not exempt, a Pre-Manufacture Notification (PMN) must be submitted at least 90 days before shipment. This involves providing data on toxicology, ecotoxicology, environmental fate, physicochemical properties, and intended use.
• Substances regulated under other frameworks (e.g., pesticides, foods, cosmetics) are exempt from TSCA but must meet their respective import requirements.
• Certain chemicals under TSCA Section 6 have additional import restrictions.

Canada

To import a substance into Canada, it must appear on the Domestic Substances List (DSL) or Non-Domestic Substances List (nDSL) or be exempt.

• Substances listed on the DSL generally do not require notification unless flagged for Significant New Activity (SNAc).
• If listed on the NDSL or not listed, a New Substance Notification (NSN) is required. Requirements vary by substance type, physical form, and annual quantity. Requirements are lighter for substances listed on the NDSL.
• Canada’s New Substances Notification Regulations (NSNR) outline different schedules for chemicals, polymers, and organisms, with thresholds ranging from 100 kg to 50,000 kg/year. Higher volumes or substances with health/environmental concerns require more comprehensive data, including physicochemical properties, toxicological profiles, and environmental fate.

Safety Data Sheet comparison

In the US, the Occupational Safety and Health Administration (OSHA) mandates that Safety Data Sheets (SDS) must meet the requirements of the Hazard Communication Standard (HCS) whereas in Canada, SDS must align with the Workplace Hazardous Materials Information System (WHMIS) and the Hazardous Products Regulations (HPR). This requires companies to prepare two unique SDS when placing on the market in the US and Canada due to the unique regulatory nuances between the regulations, such as language requirements and thresholds for disclosure.

In January 2023, Canada published the revisions to the Hazardous Products Regulations (HPR). The HPR amended and revised the previous standards for hazard classification, labelling, and SDS requirements for hazardous products in the workplace, bringing them into alignment with the 7th & some parts of the 8th Revised Editions of Globally Harmonised System (GHS).

Similarly, the US Occupational Safety and Health Administration (OSHA) is also updating its Hazard Communication Standard (HazCom). The final rule was published in May 2024.

However, the timing of the updates between the two countries is not synchronized, leading to potential misalignment in the classification and labeling of hazardous chemicals. This misalignment could pose challenges for companies operating in both countries, as they may need to comply with two different sets of regulations until the US finalizes its updates. The transition period in Canada ends on December 14, 2025, whilst in the US the transition runs until 19 July 2027.

Poison Centre Notification comparison

In the US, manufacturers and suppliers may voluntarily notify their hazardous products to the American Association of Poison Control Center ’s (AAPCC). This allows for the product information to become available to Poison Centers across all the States through the Poisindex® database. Once submitted, it is imperative to keep the product formulations and classifications up to date. Products registered within this database may include the US Poisons Center emergency phone number on their SDS and product labels.

Canada does not yet have a robust products database for Poison Centers nor is it a regulatory requirement to register products. However, ensuring proper documentation and labelling is crucial for market entry and safety, specifically in an emergency. Note that the Canadian Surveillance System for Poison Information (CSSPI) is looking to integrate these regulations soon.

Emergency response comparison

In the US there are regulatory requirements to include an emergency telephone number on SDS and on transportation documents. The Hazard Communication Standard states that an emergency number must be included in Section 1 of the SDS. If this number is not a local US number, the full number including international dialling codes should be given on the SDS. During transportation, shipping paperwork must also include an emergency number, accessible 24/7, which will provide access to expert support in the event of an accident during transportation.

In Canada it is also a requirement to include an emergency number on the SDS. The telephone number does not have to be in Canada, however if there are any restrictions to using the number e.g. only available during specific time periods, this should be indicated. Also, if a response is not available in English or French this should be stated. Again, during transportation an emergency number is required on the shipping document. The number must be available 24/7 and a response available in English or French.

Support for your organization

Ricardo’s expertise in global chemical regulations ensures proactive compliance and provides insight to the ever-changing regulatory landscape. Our chemical and sustainability experts support chemical manufacturers and distributors around the world, helping to reduce risk, deliver operational best practice and improve the long-term sustainability of operations, products, and services.

Tailoring our services to the needs of your organisation, we ensure compliance with all United States and Canadian legislation is maintained at all times and provide pro-active notifications of changes that may impact your organisation.

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