CA Proposition 65 Requirements for Manufacturers of Complex Products in California

California Proposition 65 is a law that requires businesses to provide warning labels on products that contain certain chemicals known to cause cancer or reproductive harm. If a product that you manufacture can expose a consumer or occupational user to any of the over 990 substances on the Proposition 65 list, you must provide a warning prior to any exposure occurring. You are in the best position to make this determination and may need to put a warning label on your product or provide warning information to distributors and retailers.

Understanding the Definition of "Exposure" in California Proposition 65

It is important to have a clear understanding of the concept of "exposure" in Prop 65. Exposure is defined as any contact with a product through acquisition, purchase, storage, consumption, or any reasonably foreseeable use. This includes not only the direct use of a product but also exposure through food consumption. The concept of "reasonably foreseeable use" can be subjective and is dependent on how the product is marketed, and who it is sold to and intended for.

To remain compliant, manufacturers and suppliers must assess their products and supply chains to identify if any Prop 65 listed chemicals are present and at what levels. This assessment must be done in accordance with the exposure limits defined In CA Prop 65 regulation. These limits vary depending on the chemical and include

• No Significant Risk Level (NSRL) for cancer-causing chemicals and
• Maximum Allowable Dose Level (MADL) for chemicals that cause reproductive and/or developmental harm. If a product's exposure level exceeds the limits defined by Prop 65, a warning is required. If no levels are defined, any exposure to those substances requires a warning, unless a lack of harm can be demonstrated through a study.

Ensuring Compliance with California Proposition 65: What Information to Request from Sub-suppliers

As a manufacturer, it's essential to know which Prop 65 chemical substances are being made available to users of your products and to determine whether labeling is required. To do this, you should

• Request your suppliers for Full Material Disclosure (FMD).
• Ask about the presence of Prop 65 substances in their products
• Request for CA Prop 65 "Certificate of Compliance" stating that the product contains no Prop 65 substances on accessible surfaces, or identifying the specific substances and their concentrations.

It's important to remember that it is ultimately your responsibility to ensure compliance with Prop 65, so it's essential to stay informed and to clearly communicate any requirements to your suppliers and customers.

Key requirements for manufacturers selling products in California under Proposition 65:

• Identification of Harmful Chemicals: Manufacturers must identify and understand whether their products contain any of the chemicals listed by the state of California as known to cause cancer, birth defects, or reproductive harm. The state maintains a list of these chemicals, which is regularly updated.
• Warning Labels: If a product contains any of these chemicals, the manufacturer is generally required to place warning labels on the product or its packaging. The label must include a warning symbol and a specific warning message, as prescribed by Proposition 65.

Click here to Understanding the Warning Label Requirement with examples.

• Online Retailers: For products sold online, the warning must be displayed on the product's webpage. This means that e-commerce retailers and businesses that sell products online are also subject to these requirements.
• Clear and Reasonable Warnings: The warnings provided must be clear, reasonable, and prominently displayed. They should effectively communicate the potential risks associated with the product.
• Notification of Retailers: Manufacturers are required to notify retailers if their products require Proposition 65 warnings, and they must also provide warning materials to the retailers.
• Record Keeping: Manufacturers must maintain records of their compliance with Proposition 65, including records related to product testing, the use of chemicals, and warning efforts.

Prop 65 Compliance Challenges Faced by Article Manufacturers:

As a manufacturer, complying with California's Proposition 65 (Prop 65) can be a significant challenge. The top CA Prop 65 compliance challenges faced by manufacturers today include:

1. Keeping up with the ever-changing list of chemicals: Proposition 65 is updated regularly with new chemicals being added to the list all the time. It can be tough for manufacturers to stay informed and ensure that their products are in compliance.
2. Determining product labeling requirements: Not all products will require warning labels, but it can be difficult to determine which ones do. It's important to assess your products and supply chain to identify if any Prop 65 chemicals are present and at what levels.
3. Implementing a supplier engagement and testing program: In order to ensure compliance, manufacturers may need to source data from suppliers, have products tested for the presence of Prop 65 chemicals, and consult with toxicologists to understand the level of exposure. This can be a time-consuming and costly process, but it's necessary to avoid potential fines and damage to your business's reputation.
4. Developing an effective labeling strategy: Once you've determined which products require warning labels, you'll need to decide on the language and placement of those labels. This can be a challenging process, as the labels must be clear and easy to understand.
5. Managing the financial impact: Complying with Prop 65 can be expensive, from sourcing, validating, testing, and labeling costs to the potential fines for non-compliance. It's important for manufacturers to budget for these expenses and plan for any potential financial impact.

Managing Prop 65 Compliance can be a daunting task, by staying informed and following best practices, you can ensure that your business is in compliance with this important law. Don't let compliance challenges hold you back, Reach out to our Compliance Experts to take the necessary steps to protect your business and its reputation.