When is a Proposition 65 warning required?

A warning is generally required when a product can expose a person in California to a listed chemical above the safe harbor level. A warning is generally not required if the exposure is below the No Significant Risk Level (NSRL) for carcinogens or the Maximum Allowable Dose Level (MADL) for reproductive toxicants. Businesses with fewer than 10 employees are generally exempt. An exposure assessment is used to determine which situation applies to your product.

What are NSRL and MADL safe harbor levels?

Safe harbor levels are exposure thresholds set by OEHHA. The No Significant Risk Level (NSRL) applies to carcinogens and represents the exposure level calculated to result in no significant cancer risk. The Maximum Allowable Dose Level (MADL) applies to reproductive toxicants. If a business can show that the exposure from its product is below the relevant safe harbor level, a Proposition 65 warning is generally not required.

How can a toxicological exposure assessment help avoid a Prop 65 warning?

An exposure assessment estimates how much of a listed chemical a consumer would actually be exposed to from normal product use. SciQra compares that estimated exposure to the applicable NSRL or MADL safe harbor level. If the exposure is below the safe harbor level, the assessment can support a determination that no warning is required, which also strengthens a company's position against enforcement actions.

What is a Proposition 65 60-day notice and how does SciQra help?

Proposition 65 is enforced by the California Attorney General, district attorneys, and private plaintiffs. Private plaintiffs initiate enforcement by serving a 60-day notice of violation alleging a missing or inadequate warning. SciQra provides the exposure and toxicological risk assessment work needed to evaluate the claim, determine whether exposures are below safe harbor levels, and support the response, typically alongside the company's legal counsel.

How do I get started with SciQra's Proposition 65 services?

Contact SciQra at info@sciqra.com or +1-609-917-6181, or use the contact form at sciqra.com/contact-us. Scope, timeline, and cost depend on the product, its formulation and materials, the chemicals involved, and whether you are seeking a proactive assessment or responding to a notice.

California Prop 65

Q: What is California Proposition 65?

California Proposition 65, formally the Safe Drinking Water and Toxic Enforcement Act of 1986, is a California law administered by OEHHA (the Office of Environmental Health Hazard Assessment). It requires businesses to provide a clear and reasonable warning before knowingly exposing people in California to chemicals on the Proposition 65 list, which are known to the state to cause cancer or reproductive harm. The list contains roughly 900 or more chemicals and is updated regularly.

California Proposition 65 Compliance Services for Consumer Products and Chemicals

California Prop 65

Prop 65 Compliance Assessment: Identify the presence of California Prop 65 positive substances in the product through product assessment
Exposure Assessment: Determine exposure to the Prop 65 substances by conducting exposure assessments
Toxicology Evaluation: Perform a toxicological risk assessment to determine if the exposure to the Prop 65 substances exceeds the safe harbor level
Labeling Review: Review the product labeling to ensure compliance with Prop 65 labeling requirements
Analytical Testing: Arrange analytical study placement to quantify the identified Prop 65 chemicals
Risk Communication: Assist in developing risk management strategies to communicate the risks associated with Prop 65 substances

Frequently Asked Questions

What is California Proposition 65?

California Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986, mandates that businesses provide "clear and reasonable" warnings to Californians if products expose consumers to chemicals known to cause cancer, birth defects, or reproductive harm.

What does Proposition 65 warning label mean?

A Proposition 65 warning label informs consumers that a product may contain listed chemicals above the state-defined safe harbor levels. It helps Californians make informed decisions about product use while maintaining transparency and compliance with state law.

Does my product need a California Proposition 65 warning?

If your product is sold in California and contains any Proposition 65 listed chemicals at levels above the safe harbor threshold under normal or foreseeable use. Even trace amounts can trigger labeling obligations if exposure exceeds state-established limits.

Why is Proposition 65 compliance important for my business?

Failure to comply exposes companies to civil penalties per violation, lawsuits from private enforcers, forced labeling changes, and reputational harm. Compliance not only mitigates legal risk but also demonstrates a proactive commitment to consumer transparency.

Can Proposition 65 apply even if my product meets FDA or EU standards?

Yes. Proposition 65 is a state-level requirement that operates independently of federal agencies. A product may fully comply with FDA or EU standards yet still be subject to Prop 65 warnings and enforcement. This unique overlap often leads to lawsuits, making expert risk assessment essential.