Navigating California’s Proposition 65

Join Intertek Assuris experts Cyrielle Birhart and Toquyen Legay as they unpack California’s Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986. From regulatory scope to practical strategies for compliance, this episode offers valuable insights for companies navigating chemical safety in consumer products.

Tune in to learn how to stay compliant and keep your products on the California market.

Speakers:

• Cyrielle Birhart- Regulatory and Safety Manager - Cosmetics, Intertek Assuris
• Toquyen Legay- Pharmacist Toxicologist, Intertek Assuris

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Transcript

00:16 --> 00:55
 Speaker 1 – Cyrielle Birhart, Regulatory and Safety Manager - Cosmetics, Intertek Assuris

Hello, everyone! Welcome to the Assurance in Action podcast. Today’s episode is dedicated to a Californian regulation, the Safe Drinking Water and Toxic Enforcement Act of 1986, commonly called Proposition 65. 

My name is Cyrielle Birhart, and I am with Toquyen Legay. We are both toxicology experts with Intertek Assuris in France. In this episode, we will give you an overview of the Proposition 65 text, and suggest a strategy to market Prop‑65–‍compliant products.

00:55 --> 01:02
 Speaker 2 – Toquyen Legay, Pharmacist Toxicologist, Intertek Assuris

Hi, Cyrielle. Welcome everyone! 

So, what is Proposition 65? We can see that it’s not a recent regulation.

01:02 --> 01:35
 Speaker 1 – Cyrielle Birhart, Regulatory and Safety Manager - Cosmetics, Intertek Assuris

Correct Toquyen. The first version of Prop 65 was published in 1986.

First, we need to know that it applies to almost any product being sold in California, with some exceptions like pharmaceuticals. The law covers a wide range of applications: electricals, textiles, cosmetics, and much more.

Put simply, it is a list of substances that are known cancer hazards or known to cause toxicity to development and reproduction.

01:35 --> 01:39
 Speaker 2 – Toquyen Legay, Pharmacist Toxicologist, Intertek Assuris

So, this is essentially a list of forbidden substances?

01:39 --> 01:58
 Speaker 1 – Cyrielle Birhart, Regulatory and Safety Manager - Cosmetics, Intertek Assuris

Not exactly. Prop 65 does not itself prohibit any substances. Instead, it mandates warning labels on products that contain the listed substances at levels above certain limits, to inform consumers of potential exposure risk.

01:58 --> 02:09
 Speaker 2 – Toquyen Legay, Pharmacist Toxicologist, Intertek Assuris

I see. So what kind of substances are on the list?

02:09 --> 03:13
 Speaker 1 – Cyrielle Birhart, Regulatory and Safety Manager - Cosmetics, Intertek Assuris

Well, some are drugs, others are pesticides, others are heavy metals, solvents... 

There are approximately 900 substances under Prop 65 and the list is regularly updated, at least annually. The last update was in January of this year.

What’s notable is that, out of the more than 900 substances listed, only about 300 of them have “Safe Harbor Levels”, or “SHL”s--levels of exposure that must not be exceeded. Another interesting nuance is that, when an SHL is listed for toxicity to development and reproduction, it is termed an “MADL” (for “Maximum Allowable Dose Level”) by the regulation. When an SHL is listed for toxicity for cancer hazard, it is instead termed an “NRSL” (for “No Significant Risk Level”).

03:13 --> 03:19
 Speaker 2 – Toquyen Legay, Pharmacist Toxicologist, Intertek Assuris

Interesting. So how does California apply or enforce this regulation?

03:19 --> 04:29
 Speaker 1 – Cyrielle Birhart, Regulatory and Safety Manager - Cosmetics, Intertek Assuris

That’s a great question! Given the size of the California market and the array of products captured by this regulation, it isn’t possible for Californian authorities to “apply” the regulation per se to the whole market. Instead, regulators depend on essentially private agents who “act in the public interest”—for example, lawyers—to report violations of the regulation. These private agents are often termed “bounty hunters.”

Once a violation is reported, the company selling the non-compliant product  receives a “Notice of Violation,” or NOV. Once a company receives an NOV, they then have to demonstrate that their product does not contain concerning levels of the substance in question. If they can’t, they face penalties of up to $2,500 per day, per violation… and per product!

04:29 --> 04:40
 Speaker 2 – Toquyen Legay, Pharmacist Toxicologist, Intertek Assuris

Wow, so the financial stakes are pretty high! Do these bounty hunters search for all kinds of violation all the time, or are there certain higher-stakes substances they tend to look out for?

04:40 --> 05:06
 Speaker 1 – Cyrielle Birhart, Regulatory and Safety Manager - Cosmetics, Intertek Assuris

Another great question. Theoretically, any Prop 65 substance can be targeted with an NOV. However, NOVs are commonly issued for heavy metals like arsenic, cadmium, lead, hexavalent compounds of chromium, as well as sensitive chemicals like diethanolamine, PFAS, and phthalates.

05:06 --> 05:23
 Speaker 2 – Toquyen Legay, Pharmacist Toxicologist, Intertek Assuris

That makes sense. Okay, so, what should listeners who are selling or trying to sell their products in California do to make sure they don’t receive an NOV? It sounds like a big risk to violate this regulation, knowingly or unknowingly.

05:23 --> 05:59
 Speaker 1 – Cyrielle Birhart, Regulatory and Safety Manager - Cosmetics, Intertek Assuris

Well, the first thing to do is perform a thorough analysis on your product based on technical documentation. Check the technical data sheets and certificates of analysis of your raw materials, and ask your suppliers to disclose the absence or presence of any substances listed in Prop 65, even at trace levels in the ingredients. You also need to consider any packaging for your product, given these substances can migrate.

05:59 --> 06:11
 Speaker 2 – Toquyen Legay, Pharmacist Toxicologist, Intertek Assuris

I see! And if I find any Prop 65–‍listed substance in the technical data sheet of a raw material, for example, does it mean that I need to systematically add a warning on my product?

06:11 --> 06:47
 Speaker 1 – Cyrielle Birhart, Regulatory and Safety Manager - Cosmetics, Intertek Assuris

Hopefully not! The next step is often to perform physico-chemical analysis to obtain real and measurable data that completes—and verifies—the theoretical information obtained from your suppliers’ documents. As we all know, documentation isn’t always correct or accurate. A supplier’s information may mistakenly include, and just as easily omit, the presence of a listed chemical at levels of concern. 

06:47 --> 06:58
 Speaker 2 – Toquyen Legay, Pharmacist Toxicologist, Intertek Assuris

Right. You definitely need reliable data before making any consequential decisions. Does the Prop 65 regulation prescribe any methods for analyses like these?

06:58 --> 07:23
 Speaker 1 – Cyrielle Birhart, Regulatory and Safety Manager - Cosmetics, Intertek Assuris

Unfortunately, it does not. Without testing guidance—and this may seem obvious—it’s best to use recognized and validated analytical methods suitable for your product. It’s also essential to test different batches to ensure your manufacturing process is producing consistent results.

07:23 --> 07:37
 Speaker 2 – Toquyen Legay, Pharmacist Toxicologist, Intertek Assuris

Got it. So after the analysis step, we should have a good understanding of any listed substances that are present in the product, and at what concentrations. After this, what next? 

07:37 --> 09:00
 Speaker 1 – Cyrielle Birhart, Regulatory and Safety Manager - Cosmetics, Intertek Assuris

Well, once you have these concentrations for each substance, you’ll need to convert them (for example, from parts per million or percentage) to levels of exposure (in µg per day) for consumers. The exposure really depends on the product type: factors like the route of exposure (do you eat the product? or are you exposed by skin contact?); the frequency of use (is it a product expected to be consumed every day, or only occasionally?); who will use it (children, or adults only?), etc.

Once you’ve determined this, you have to look at two factors:

·         If a safe harbor level is in place for the listed substance—‍as derived by California’s OEHHA (the Office of Environmental Health Hazard Assessment)—‍you need to compare it to the exposure from your product. 
 
 

·         Then, if the exposure to the listed substance from your product is higher than the threshold in Prop 65, you know a warning label is required on your product, informing consumers of the presence of a hazardous substance. 

09:00 --> 09:11
 Speaker 2 – Toquyen Legay, Pharmacist Toxicologist, Intertek Assuris

I see. If I do determine that the exposure is too high for Prop 65, couldn’t I also decide to change the product formulation to avoid warning labels?

09:11 --> 09:37
 Speaker 1 – Cyrielle Birhart, Regulatory and Safety Manager - Cosmetics, Intertek Assuris

Yes, correct, this is always an option!

There is also a second outcome once you’ve finished your analysis: that no safe harbor level is in place by OEHHA for a listed substance in your product. If this is the case, you need to derive a safe threshold yourself, and this requires the work of a professional toxicologist.

09:37 --> 09:41
 Speaker 2 – Toquyen Legay, Pharmacist Toxicologist, Intertek Assuris

Ah. Of course. Can you explain in a few words what that would entail?

09:41 --> 10:16
 Speaker 1 – Cyrielle Birhart, Regulatory and Safety Manager - Cosmetics, Intertek Assuris

Yes—in general, the toxicologist would need to follow some guidelines provided by OEHHA. They would start by searching published scientific literature, analyzing any available reports on carcinogenicity or reproductive and developmental toxicity, and selecting the most relevant data to derive a threshold. It can be a very time‑consuming process, depending on the level of information available on your substance.

10:16 --> 10:29
 Speaker 2 – Toquyen Legay, Pharmacist Toxicologist, Intertek Assuris

Got it. And one more question: you mention the need for warning labels if you fail to prove that exposure from the product is below the safe harbor level. What kind of warning are we talking about?

10:29 --> 10:52
 Speaker 1 – Cyrielle Birhart, Regulatory and Safety Manager - Cosmetics, Intertek Assuris

The warning is clear and reasonable: it’s a pictogram associated with some text, for example “this product can expose you to chemicals including lead, which is known to the State of California to cause cancer. For more information go to the website of OEHHA.” 

10:52 --> 11:05
 Speaker 2 – Toquyen Legay, Pharmacist Toxicologist, Intertek Assuris

Ah, I see. A warning like this may be a minor detail in many products, but I imagine for others, like cosmetics, it’s quite alarming and you’d absolutely need to avoid it!

11:05 --> 11:07
 Speaker 1 – Cyrielle Birhart, Regulatory and Safety Manager - Cosmetics, Intertek Assuris

Yes, exactly!

11:07 --> 11:25
 Speaker 2 – Toquyen Legay, Pharmacist Toxicologist, Intertek Assuris

Well, this was all very helpful. I’ll have to remember that the key aspect of this regulation is “exposure,” and that if I want to stay compliant in California, I need to know exactly which chemicals can be detected in my product, and at what levels. 

11:25 --> 11:35
 Speaker 1 – Cyrielle Birhart, Regulatory and Safety Manager - Cosmetics, Intertek Assuris

Yes, that about captures it! If you’re interested in learning more, contact our Intertek Assuris team. We’re always happy to help!

11:35 --> 11:40
 Speaker 2 – Toquyen Legay, Pharmacist Toxicologist, Intertek Assuris

Thank you Cyrielle for this great conversation, and thanks to our listeners too.

11:40 --> 11:43
 Speaker 1 – Cyrielle Birhart, Regulatory and Safety Manager - Cosmetics, Intertek Assuris

Thank you for listening everyone! Goodbye.