Team Nexreg

Exporting Chemical Products to the US: Compliance Guide

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Exporting chemical products to the United States opens the door to one of the largest markets in the world, but it is not without its challenges. The US regulatory environment is complex, and businesses need to be aware of key rules and requirements to ensure a smooth process. From understanding federal regulations to dealing with state-specific laws, there is a lot to consider. But with the right approach, navigating these hurdles becomes much more manageable.

 

Key US Regulatory Bodies Governing Chemical Exports

When it comes to chemical products, the US market is governed by several federal agencies. Two of the most critical include the:

  • Environmental Protection Agency (EPA): The EPA enforces the Toxic Substances Control Act (TSCA), which is designed to track and regulate chemicals that pose potential environmental and human health risks. If you’re exporting to the US, you need to make sure the chemicals in your product are all listed on the TSCA inventory or that your product qualifies for an exemption. Failure to comply with TSCA can lead to fines, product recalls, and even legal action.
  • Occupational Safety and Health Administration (OSHA): OSHA is responsible for ensuring the safety of workers who may handle or be exposed to chemical products. The agency mandates that chemical products used in the workplace follow the Hazard Communication Standard (HCS), which is aligned with the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). This means your product labels must clearly communicate hazards and safety precautions.
  • Food and Drug Administration (FDA): The FDA regulates a broad range of products, including foods, drugs, cosmetics, and natural health products. If you’re importing or manufacturing any product that falls under FDA jurisdiction, you must comply with their standards for safety, labeling, and approval processes. Failure to comply can result in product seizures, fines, and bans from the US market.
  • Consumer Product Safety Commission (CPSC): The CPSC regulates consumer product safety, ensuring that products, including chemical-based items like cleaners or Cosmetics fall under FDA not CPSC. Suggest changing to paints or glues or something like that. meet specific safety requirements to prevent harm to the public. Products falling under CPSC regulations must adhere to stringent safety standards and labeling requirements to protect consumers from potential hazards.

 

Labeling and Compliance: Workplace or Consumer?

One of the most important things to get right when exporting chemical products to the US is labeling. The regulation to consider for label compliance depends on if the product will be used in the workplace or sold to consumers.  Under OSHA’s HCS, chemical manufacturers and importers of hazardous materials used in the workplace are required to ensure that their products are labeled according to GHS guidelines. This includes detailed information about potential hazards, precautionary statements, and first-aid instructions. Getting your labeling wrong is not only a violation but can also harm your brand’s reputation in the market. Additionally, for new chemical products not listed on the TSCA inventory, you may need to submit a Pre-Manufacture Notice (PMN) to the EPA before they can be introduced into commerce. This process helps the EPA assess potential risks associated with the chemical before it enters the market. Other chemical types such as certain Per- and polyfluoroalkyl substances (PFAS) can be subject to Significant New Use Rules (SNUR), or Consent orders that provide specific conditions with which a company must comply for the manufacture, processing, distribution, or disposal of the substance.

For consumer products sold to the public, whether in stores or online, compliance with CPSC requirements is crucial. The CPSC ensures that consumer products, including those containing hazardous chemicals, are properly labeled and packaged to prevent risks such as poisoning, burns, or other injuries. Labels for consumer products must include specific safety information, such as hazard warnings, proper usage instructions, and details on how to avoid injury. Chemicals subject to the Poison Prevention Packaging Act (PPPA) must be sold in child-resistant packaging. Failure to meet CPSC requirements can lead to product recalls, fines, and damage to your company’s reputation.

 

State-Specific Compliance Challenges

Beyond federal regulations, companies exporting chemical products to the US also need to be aware of state-specific rules. A prime example is California’s Proposition 65, which requires businesses to provide clear warnings if their products contain any chemicals known to cause cancer, birth defects, or other reproductive harm.

Additionally, California has the Cleaning Products Right to Know Act, which mandates that manufacturers disclose ingredients in cleaning products sold to the public. This law requires both online disclosure and labeling for certain hazardous chemicals, ensuring consumers are aware of any harmful substances.

In Texas, the Texas Hazardous Substances Act requires manufacturers of hazardous substances whose products are distributed in Texas to file a registration statement with the Department of State Health Services (DSHS) before commencing business activities. This registration statement serves as a means of oversight and regulation to uphold safety standards and protect public health. Failure to comply with these labeling and registration requirements can lead to administrative fines and the withdrawal of products from the market.

Many states have also taken the initiative to adopt their own PFAS regulations to restrict uses and require notification to the state of products containing intentionally added PFAS. These regulations create a patchwork of differing requirements across states, making compliance a complex but critical task for businesses to manage. Compliance with state laws is crucial, as failure to adhere can result in steep penalties and restricted market access.

 

 

Key Challenges and Considerations

Navigating the regulatory landscape for exporting chemical products to the US requires a thorough understanding of both federal and state laws. Each state may impose additional regulations beyond those enforced by the EPA, FDA, CPSC, and OSHA, making it essential for businesses to remain up-to-date with varying requirements. It is critical that Safety Data Sheets (SDS), compliant labeling, and accurate chemical descriptions are prepared to ensure smooth customs clearance and avoid any potential delays. Proper preparation is essential to meet regulatory expectations and facilitate a smooth export process.

 

Practical Tips for Success in the US Market

To succeed in exporting chemical products to the US, preparation is key. Here are a few practical tips:

  • Determine the specific requirements for your product type: Different product categories, such as drugs or cosmetics may have specific obligations, such as registrations, that must be adhered to. Ensure you follow the compliance requirements associated with your product type. Additionally, products intended for the workplace will have different compliance requirements than those intended for the general public.
  • Start early with compliance checks: Make sure the chemicals in your product is listed on the TSCA inventory and that you understand whether any pre-manufacture approvals are needed.
  • Consult with experts: If you’re unsure about the specifics of US regulations, working with a compliance consultant can save you time and avoid costly mistakes.
  • Stay up-to-date on regulations: US laws are constantly evolving, especially when it comes to environmental safety and chemical hazards. Being proactive about regulatory updates ensures long-term success.

Ensuring compliance with the specific regulatory requirements for your product is crucial to avoid delays, penalties, or legal challenges. By thoroughly preparing and addressing potential issues in advance—such as accurate labeling, necessary approvals, and proper documentation—businesses can facilitate a smoother process and meet the standards set by US authorities. Staying informed and proactive about these regulations is key to maintaining compliance and minimizing risks in the US market.

 

How Nexreg Can Support Your Regulatory Compliance Needs

Expanding into the US market comes with complex regulatory requirements, and Nexreg is here to help. We offer a range of services designed to make the process easier:

  • Workplace SDS and label creation for industrial products.
  • Consumer label compliance for consumer-facing goods.
  • Transport consulting and label requirements for dangerous goods.
  • Product-specific compliance for categories like cosmetics and cleaning products, ensuring your products meet local regulations.

For companies looking to export to new regions, Nexreg also offers New Market Regulatory Analysis and Product Stewardship. This service provides a thorough review of your product’s formula against regional regulatory lists, highlighting any restrictions or actions needed for compliance. Whether it’s for industries such as manufacturing, cosmetics, or agriculture, Nexreg offers a detailed summary report to guide you through the process.

We can also assess the regulatory impact of changing raw materials or developing new formulations. Our team reviews full formulas, including CAS numbers and percentages, to ensure compliance with all regional standards. If your product uses multiple raw materials, we assist with building the final formula to ensure all chemicals meet regulatory requirements.

With Nexreg’s services, you can confidently navigate regulatory challenges and ensure compliance when entering new markets.

Ready to export your chemical products to the US?
Contact Nexreg today to ensure your products comply with every regulation seamlessly.

 

 

 

References

  1. United States Environmental Protection Agency (EPA). (2023). TSCA Overview. Retrieved from https://www.epa.gov/tsca.
  2. Occupational Safety and Health Administration (OSHA). (2023). Hazard Communication Standard (HCS) Overview. Retrieved from https://www.osha.gov/hazcom.
  3. OSHA. (2023). The Globally Harmonized System of Classification and Labeling of Chemicals (GHS). Retrieved from https://www.osha.gov/ghs.
  4. EPA. (2023). Pre-Manufacture Notices (PMN). Retrieved from https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
  5. California Office of Environmental Health Hazard Assessment (OEHHA). (2023). Proposition 65: Chemicals in Products. Retrieved from https://oehha.ca.gov/proposition-65.
  6. EPA. (2023). Chemical Testing and Assessments. Retrieved from https://www.epa.gov/assessing-and-managing-chemicals-under-tsca.
  7. OSHA. (2023). Safety Data Sheets (SDS) Requirements. Retrieved from https://www.osha.gov/sds.
  8. Consumer Product Safety Commission (CPSC). (2023). Overview of the Consumer Product Safety Act (CPSA). Retrieved from https://www.cpsc.gov/Regulations-Laws–Standards/Statutes/The-Consumer-Product-Safety-Act.
  9. Food and Drug Administration (FDA). (2023). Overview of Food Safety and Modernization Act (FSMA). Retrieved from https://www.fda.gov/food/food-safety-modernization-act-fsma.