Beyond the Label - The Overlooked Risk of Cosmetic Packaging

Join Intertek Assuris’ Taylor Cavanaugh and Ashli Span on Assurance in Action as they uncover the hidden risks of cosmetic packaging, risks that could impact both consumer health and brand reputation.

Tune in to explore why packaging matters just as much as what’s inside, and how you can stay ahead of evolving safety regulations.

Speakers:

Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

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Transcript

00:16 --> 00:18
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

Welcome back to Assurance in Action! I’m Taylor…

00:18 --> 00:33
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

…and I’m Ashli. Today, we’re diving into a topic that’s often underestimated, the safety of cosmetic packaging. When people think about product safety, they typically think about the formulation. But the packaging itself can introduce risks that are just as important.

00:33 --> 00:58
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

Right, and those risks aren’t just theoretical. From a regulatory standpoint, the FDA has very clear language under 21 CFR Chapter 9, which ties back to Section 361 of the Food Drug & Cosmetics Act. It says a cosmetic is considered adulterated if it contains any poisonous or toxic substance that may render it harmful under the labeled conditions of use or those that are customary.

00:58 --> 01:15
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Which means if your packaging leaches harmful substances into the product, like unreacted monomers, photo-initiators from inks or coatings, or plasticizers from flexible components, it could actually make the product unsafe and noncompliant, even if the base formula is clean.

01:15 --> 01:33
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

Exactly. And this is something we’ve seen trip up even really thoughtful brands, especially those using complex or custom packaging with decorative coatings, recycled content, or multi-layer assemblies. The packaging might look beautiful, but if it’s not stable or compatible with the formulation, it’s a liability.

01:33 --> 01:56
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

And this has become even more relevant under MoCRA (the Modernization of Cosmetics Regulation Act). One of the big changes MoCRA introduced is the requirement for product safety substantiation, and packaging is part of that equation. Brands now need to be able to prove their product, as marketed, is safe, including anything migrating into it from the packaging.

01:56 --> 02:13
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

Yes! MoCRA also added more robust recordkeeping requirements. So you can’t just say, “Well, our supplier told us it’s fine.” You have to be able to demonstrate that you’ve evaluated the packaging, assessed its potential impact on the product, and made sound decisions around risk mitigation.

02:13 --> 02:38
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

So, let’s talk about what that evaluation actually looks like. One common path is to start with FDA food contact compliance, especially if the packaging is in direct contact with the formula. If the packaging meets food contact standards, it usually has a foundation of safety testing and migration limits, which is helpful. If you’re curious about the food contact compliance evaluations, our team has also done previous podcasts covering US and EU food contact regulations. 

02:38 --> 03:02
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

But we always remind clients, food contact compliance isn’t always enough. Cosmetic applications often involve long-term storage, changes in temperature, and sometimes direct skin or mucosal contact, which might not be factored into food packaging evaluations. So, if the material isn’t food-contact compliant, or you’re unsure, the next step is risk assessment.

03:02 --> 03:20
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

Exactly. Risk assessment is where toxicology and regulatory strategy come together. We look at the chemical composition of the packaging, evaluate potential migrants, estimate how much could migrate into the formulation, and then model systemic exposure, essentially how much of that material might reach the consumer under typical use conditions.

03:20 --> 03:36
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

And that’s where migration testing or modeling comes in. You can run lab studies that simulate worst-case storage conditions to see what substances leach out. Or, if you have good compositional data, you might use modeling to estimate migration behavior based on known diffusion parameters.

03:36 --> 03:55
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

We also get questions about USP <661> and <661.2>, which are extractables and leachables standards more commonly used in pharma packaging. They can be incredibly valuable in the cosmetic space, too—especially for products stored long-term, or for packaging systems used around sensitive areas like the eyes or lips.

03:55 --> 04:10
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

And an important takeaway here: detecting a migrant doesn’t automatically mean your packaging is unsafe or noncompliant. This is where toxicological context matters. You can detect something, assess its potential exposure, and still determine that the level of risk is low or negligible.

04:10 --> 04:33
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

That’s a great point. And this is where tools like CosPaTox come into play for polyolefin packaging. It’s a scientific framework developed specifically to assess the safety of cosmetic packaging, especially when dealing with trace-level migrants or substances that aren’t clearly regulated. CosPaTox allows you to look at toxicological thresholds, exposure levels, and worst-case scenarios, all with the goal of demonstrating that your product is safe as used.

04:33 --> 04:50
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

And in some cases, CosPaTox can even support clearance for non-listed or novel substances, where there’s no formal regulatory threshold. As long as the exposure is well-characterized and a systematic safety evaluation is in place, you can still substantiate that the packaging doesn’t pose a risk to human health.

04:50 --> 05:11
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

So for anyone listening who’s thinking, “This sounds like a lot”—you’re not wrong. But the good news is, there’s a clear roadmap. Start by gathering compositional and migration data from your packaging supplier. Look for materials that are already food-contact compliant or evaluated under USP or similar frameworks. And if those aren’t available, don’t panic, toxicological risk assessment can fill the gap.

05:11 --> 05:25
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

Exactly. The key is to not ignore the packaging just because it’s not on your ingredient list. It’s still part of the product. And under MoCRA, it’s your responsibility to make sure everything in that final package is safe under the intended conditions of use.

05:25 --> 05:40
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

And just like formulation compliance, it’s not about checking a single box, it’s about understanding the system and using the right scientific tools to manage any potential risk. That includes supplier documentation, analytical testing, migration modeling, and expert toxicological review.

05:40 --> 05:54
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

So whether you’re launching a new product, changing packaging vendors, or just trying to get your MoCRA documentation in order, don’t forget to look at the packaging with a critical eye. It may seem like a small part of the product, but it plays a big role in overall safety and compliance.

05:54 --> 06:01
 Speaker 2 – Ashli Span, Project Manager, Regulatory Market Access, Intertek Assuris

If you have questions about how to evaluate your packaging, CosPaTox, MoCRA, or where to even start, we’re always here to support and partner with you!

06:01 --> 06:11
 Speaker 1 – Taylor Cavanaugh, Senior Manager, Regulatory Market Access, Intertek Assuris

Thanks so much for tuning in to Assurance in Action. Until next time, stay smart, stay compliant, and don’t forget to look beyond the formulation.