Prop 65 Safe Harbor Assessment
Proposition 65 Exposure Assessment
How can Taobé Consulting help cosmetic brands assess Prop 65 warning and safe harbor requirements?
- No Prop 65 safe harbor level: Where California has not set an official threshold, we can determine a scientifically supported safe harbor level for your cosmetic.
- Evidence through assessment: Receive a signed assessment to determine whether a warning is required and avoid precautionary labelling where the evidence does not support it.
- Cosmetic compliance expertise: Work with safety assessors who understand your product and the requirements of the US cosmetics market.
What Is a Proposition 65 Safe Harbor Assessment?
A Proposition 65 safe harbor level is a defined exposure threshold for certain chemicals listed under California’s Proposition 65. When exposure is at or below the applicable safe harbor level, a Proposition 65 warning is generally not required for that exposure.
Not every Proposition 65-listed chemical has an officially established safe harbor level. Where no level exists, a business may need to assess whether the level of exposure presents a significant risk under Proposition 65. For cosmetics, this can require a detailed assessment of the substance, product use and expected consumer exposure.
Why Avoiding a Default Proposition 65 Warning Matters
A Proposition 65 warning may have commercial implications for your cosmetic brand.
Applying a warning by default may appear to be the simplest approach, but it can create challenges for brands seeking to meet retailer or distributor requirements, maintain a premium brand position, or avoid unnecessary warnings on their products.
California’s Proposition 65 list contains more than 1,000 substances, some of which may be present in cosmetics as trace impurities rather than intentional ingredients. Heavy metals, for example, can occur naturally in certain mineral-based raw materials.
Where a listed substance does not have an established safe harbor level, such as a No Significant Risk Level (NSRL) or Maximum Allowable Dose Level (MADL), a scientific assessment may be needed to determine whether the level of exposure presents a significant risk under Proposition 65.
Our Proposition 65 Safe Harbor Assessment evaluates the available scientific and exposure data to provide a documented, defensible basis for determining whether a warning may be necessary.
When to Use a Proposition 65 Safe Harbor Assessment?
A Proposition 65 Safe Harbor Assessment can be particularly valuable when:
- A distributor or retailer will not accept a product with a Proposition 65 warning. Your product listing or distribution may be held up until you can establish whether the warning is actually required.
- A Proposition 65 warning conflicts with your brand. For prestige or clean beauty brands, a cancer or reproductive harm warning may be inconsistent with your product positioning.
- A trace impurity raises a Proposition 65 concern. Heavy metals such as lead, mercury, arsenic, cadmium and nickel can occur as trace impurities in cosmetic raw materials. Where no official safe harbor level exists, an exposure assessment may be needed to determine whether a warning is warranted.
- You have received a 60-day notice. A private enforcer has identified a potential Proposition 65 violation and you need a documented, scientifically supported assessment to establish whether a warning is required.
What Does Our Proposition 65 Safe Harbor Assessment Include?
Where no official safe harbor level exists, we derive a risk-based level using available toxicological data and current OEHHA methodology. For carcinogens, this involves a No Significant Risk Level (NSRL); for reproductive toxicants, a Maximum Allowable Dose Level (MADL).
We then assess exposure based on how your cosmetic product is actually used, including the concentration of the substance, amount applied, frequency of use, whether the product is leave-on or rinse-off, and dermal absorption. A daily leave-on face cream presents a different exposure scenario from a cleanser that is quickly rinsed away, and the assessment reflects that.
The estimated exposure is compared with the derived level to determine whether the exposure presents a significant risk under Proposition 65. Our risk assessment provides a clear conclusion on whether a warning is required, set out in a technical report signed by the safety assessor.
How Is a Proposition 65 Safe Harbor Assessment Conducted?
1 · Screening
Your US Compliance Check identifies the Proposition 65-listed substance and confirms that no official safe harbor level exists.
2 · Assessment
We derive a risk-based threshold and model exposure based on your product’s actual conditions of use.
3 · Refinement, if needed
If the result is borderline, we recommend laboratory quantification and recalculate the exposure using the measured values.
4 · Decision
You receive a documented scientific basis for deciding whether to keep or remove the warning based on evidence rather than assumption.
What Proposition 65 Report Do You Receive?
A clear, documented assessment you can use to support your Proposition 65 position.
- A derived safe harbor level (NSRL/MADL) for each substance, supported by the relevant scientific literature.
- A route-specific exposure calculation based on the actual use of your cosmetic product.
- A risk assessment conclusion and clear determination of whether a Proposition 65 warning is required.
- A signed technical report that can be provided to a distributor, retailer or enforcer.
Contact us
Ready to make an evidence based Prop 65 decision?
A Proposition 65 warning should be a choice you make, not one the absence of a safe harbor level makes for you. We can assess the risk, evaluate exposure and build the documented evidence you need to make an informed decision.
Contact us to discuss your assessment.
FAQs about Prop 65 exposure assessment
Do I need a Prop 65 warning if there is no safe harbor level?
Not necessarily. Where no official safe harbor level exists, you may demonstrate that consumer exposure is low enough to pose no significant risk and, on that basis, omit the warning. The burden of proof rests with the brand, and this assessment provides the documented scientific evidence to support that determination.
Can I sell a cosmetic in California without a Prop 65 warning?
Yes, if exposure to any listed substance remains below the level that would trigger a warning. Where California has not established a safe harbor level, that level must be derived and the exposure assessed, which is exactly what this service does.
What are NSRL and MADL?
They are Proposition 65 safe harbor levels. The NSRL (No Significant Risk Level) applies to carcinogens, while the MADL (Maximum Allowable Dose Level) applies to reproductive toxicants. Where California has not established a safe harbor level for a substance, one can be derived from the available toxicological literature.
Does naturally occurring lead in a cosmetic require a warning?
It depends. A limited exemption exists for substances naturally present in a raw material and outside the producer’s control, but the exemption is narrow and may be contested. An exposure assessment can help establish whether the exemption applies and where your product stands.
How long does a Prop 65 assessment take?
Once we have your formula, the substance concentrations and your product-use data, a single-substance assessment is typically completed within a few working days. A full impurity panel takes longer.
What if the Prop 65 assessment shows the warning is required?
Then you have a clear, documented answer and can continue with the warning. The fee covers the assessment work; it does not guarantee a particular outcome. Either way, you can make your decision based on evidence.
We received a Prop 65 60 day notice. Can you help?
Yes. We can assess the substance in question and provide a documented position to help inform your response. For legal advice or handling the notice itself, you should also consult your attorney.
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