What Are the Heavy Metal Limits for Cosmetics in the US and Canada?

Heavy metals reach cosmetics by two routes; a few are added for functional reasons, but for most products, the larger challenge is impurity from mineral raw materials. In this white paper, Sarayu Rao, PhD, QC Manager for trace metals at Element Toronto, explains why US and Canadian rules diverge and why brands in both markets should design to the lowest applicable limit and hold data that supports it.

Where do trace metals in cosmetics come from?

In finished cosmetics, the heavy metals of toxicological concern are mostly impurities carried in with the earth-derived minerals that serve as pigments, opacifiers, and bulking agents rather than substances introduced by design. The FDA's own market surveys make that distinction concrete. Across the two studies the agency completed in 2012 and 2013, the categories carrying the highest burdens of arsenic, cadmium, chromium, cobalt, lead, mercury, and nickel were eye shadows, blushes, and compact powders, a distribution the FDA attributed to the minerals used as pigments and fillers, principally clays and talc.¹

Because those minerals are geological products, the elemental burden they carry is set by the deposit rather than by the formulation, varying both between sources and between lots drawn from a single source. Kaolin and bentonite clays, mica, iron oxides, and talc all behave this way. In our experience, the same pigment from the same supplier can return noticeably different elemental profiles across lots, which is why the companies that manage this well treat raw-material screening as an ongoing control rather than a one-time qualification.

That origin carries a direct consequence for program design. Because the metals enter with the minerals, finished-product testing is the wrong place to site a program's primary control: it detects upstream variability only after formulation and fill, at the most expensive possible point, and well after the information that would have shaped an ingredient or supplier decision was already sitting in the incoming-material record. The same compositional logic explains why color cosmetics and clay-based formats occupy the high end of the observed range as a matter of what they are made from rather than manufacturing failure, and why a single analytical approach applied indiscriminately, a pressed eyeshadow handled as though it were a clear lotion, mischaracterizes both.

Although these elements are most commonly encountered as impurities, they may also be intentionally added for specific purposes. Such cases highlight the basis for the regulatory distinction between deliberate addition and unintentional impurity.. Mercury suppresses melanin synthesis, which is why it still appears, illegally, in skin-lightening preparations,⁴ while keeping a narrow sanctioned use as a preservative in eye-area products.² Lead acetate served as the active colorant in progressive hair dyes until the FDA repealed its color-additive approval, a 2018 final rule that took effect in 2022 once objections were resolved.¹⁸ Iron oxides, by contrast, are routine colorants across color cosmetics, and chromium oxide greens are approved for externally applied products, including the eye area.¹⁷ A single element can therefore be a declared color additive in one product and an unlabeled impurity in the next, so an identical measured concentration carries a different regulatory meaning depending on the formulation behind it, a distinction of direct legal consequence given that several of the more recent state statutes are triggered specifically by whether a metal was intentionally added.⁶

What limits apply to heavy metals in US cosmetics?

No single federal limit governs heavy metals as impurities in finished cosmetics; what exists instead is a set of narrower provisions, each tied to a particular circumstance. Color additives are the clearest instance, since they require affirmative FDA approval where other cosmetic ingredients do not, and the impurity specifications for approved color additives, set listing by listing rather than as one blanket ceiling, commonly run to 3 ppm arsenic, 20 ppm lead, and 1 ppm mercury.¹⁷ Mercury is constrained further in its own right. It is permitted only as a preservative in eye-area products, capped at 65 ppm in the finished product and only where no other safe and effective preservative is available, and held everywhere else to an unavoidable trace of no more than 1 ppm under good manufacturing practice.² Chromium carries no general ceiling as a cosmetic ingredient, though the listing regulation for FD&C Blue No. 1 caps it as an impurity at 50 ppm.¹⁷ Lead sits under recommendation rather than rule; FDA draft guidance proposes a maximum of 10 ppm in lip products and externally applied cosmetics, but that guidance has not been finalized.³

The cumulative effect is a gap that no reading of the specific provisions closes: for lead, cadmium, or nickel present as impurities, there is no single federal number to design against, because outside the color-additive and mercury provisions, none was ever established. What the statute requires in its place is both broader and, in practice, more exacting. A cosmetic must be safe under its labeled and customary conditions of use,¹⁹ an obligation that places the burden of characterization on the manufacturer and makes the product form part of the analysis. A lip product subject to incidental ingestion and a rinse-off cleanser present materially different exposure profiles at the same measured concentration. One category falls outside the discussion altogether: a product bearing a sunscreen or other drug claim, such as an SPF moisturizer, is regulated as an over-the-counter drug rather than a cosmetic and is therefore held to the distinct elemental impurity expectations that apply to drug products.

The practical implication: with no general federal ceiling to certify against, a US compliance position rests on the manufacturer's own safety substantiation for each product, which itself rests on analytical data specific enough to support it rather than on meeting any published number.

How does MoCRA change the picture if it sets no metal limits?

The Modernization of Cosmetics Regulation Act of 2022 restructured federal oversight of cosmetics for the first time since 1938, and although it set no heavy-metal limits, its bearing on metals is substantial precisely because it is indirect. MoCRA established facility registration and product listing, adverse-event reporting, and a safety-substantiation obligation under which a responsible person must hold adequate evidence that each product is safe as used; it directed FDA to promulgate cosmetic good manufacturing practice regulations; and it granted the agency inspection, records-access, and mandatory-recall authority.⁵ For trace metals, the effect is to convert testing data from a discretionary quality measure into part of the evidentiary record an inspector may demand, tied to identified raw materials and finished lots. As enforcement matures from the registration phase toward routine oversight, the operative question shifts from whether a product met a number to whether the responsible person can demonstrate the basis on which it was released.

Which state rules set heavy-metal limits for cosmetics?

Where the federal framework leaves impurities unquantified, the states have not done so, and they have harmonized neither their thresholds nor their mechanisms. Washington's Toxic-Free Cosmetics Act, effective January 1, 2025, prohibits intentionally added lead and mercury and treats lead at or above 1 ppm as a violation, the most stringent lead position in the country.⁶ Minnesota approaches the same elements through numeric caps, limiting lead to 90 ppm and cadmium to 75 ppm by weight in consumer products that include cosmetics.⁷ That near-hundredfold spread has direct analytical consequences: a method that comfortably clears a 90 ppm limit may lack the sensitivity to defend a result against a 1 ppm line. Washington's own implementation underscores the mineral origin of the contaminant: acknowledging that lead occurs naturally in the clays and minerals feeding many formulations, the state issued an interim policy with tiered safe harbors, on the order of 2 ppm for general cosmetics and up to 5 ppm, and in defined cases up to 10 ppm, for color cosmetics and clay masks,⁶ exceptions drawn around precisely the product classes in which mineral loading is highest. That interim policy is temporary, set to run only through December 31, 2026, or until Washington adopts a permanent lead rule, which is already in rulemaking. Several other states regulate by prohibiting intentional addition rather than by setting numbers. Maryland bans intentionally added mercury, among other listed ingredients, and reinforced its enforcement and penalties through the 2026 Crown and Care Act,⁸ while Oregon⁹ and Vermont¹⁰ have enacted comparable prohibitions taking effect January 1, 2027 and January 1, 2026, respectively.

California imposes an obligation of a different character on top of any threshold. Under the California Safe Cosmetics Act and its Safe Cosmetics Program, manufacturers must report products sold in the state that contain ingredients known or suspected to cause cancer or reproductive toxicity, a category that captures several of these metals.¹¹ Proposition 65 adds a separate warning duty for significant exposures to listed chemicals, including lead, cadmium, and arsenic, its naturally-occurring exemption narrow enough that mineral-sourced metals cannot be presumed to fall outside it.¹² For a company distributing nationally, the consequence is that the effective specification is set by the most stringent jurisdiction a product reaches, so a method must be sensitive and defensible against a 1 ppm line rather than a 10 or 90 ppm one.

Why are Canada's cosmetic metal rules different?

Canada reaches the same scientific problem by a more consolidated route. Health Canada treats these metals first as prohibited ingredients, listing lead, arsenic, cadmium, mercury, antimony, and chromium on the Cosmetic Ingredient Hotlist as substances liable to injure health and therefore caught by the general prohibition in section 16 of the Food and Drugs Act.¹³ With deliberate use foreclosed, its guidance then addresses what remains as unavoidable impurity, setting finished-product limits of 10 ppm lead, 3 ppm each for arsenic and cadmium, 1 ppm mercury, and 5 ppm antimony. The stated rationale is that such impurities are unavoidable given the ubiquity of these elements in the environment, but are to be reduced wherever technically feasible.¹³

Two features of the Canadian framework warrant attention from a program built on US sources alone. It names antimony, which the FDA survey and the broader US framework largely omit, so a program scoped only to US expectations may never test for it. And although the Canadian guidance is interpretive rather than a standalone regulation, it carries real force, since Health Canada may request compliance test results at any time and the manufacturer bears responsibility for holding finished product within the stated limits.¹³ The obligation therefore parallels what MoCRA now imposes in the US, arrived at by a different regulatory route.

Set side by side, the North American jurisdictions reveal both the range of thresholds applied to a single element and the range of mechanisms through which those thresholds are imposed: numeric caps, intentional-addition bans, and disclosure or warning duties.

Table 1. Selected enacted heavy-metal limits and obligations for cosmetics across North American jurisdictions. Current as of July 2026.

This is a selected comparison of heavy-metal provisions and is not exhaustive; it does not cover state laws addressing PFAS or other chemical classes. Broader bills in New York (the Beauty Justice Act) and Illinois are pending, and a Maine bill (the Safe Cosmetics Act, LD 317) failed in 2026. State requirements in this area are changing quickly; confirm the current rule for each market before relying on this summary.

Whichever of these requirements proves binding in a given market, the figure it sets is only as reliable as the method that produced it, and that is where the practical work of a metals program lies.

How should a metals testing method be built?

According to the U.S. EPA's Toxicological Review of Thallium and Compounds, thallium may occur as an impurity in zinc oxide (ZnO). Thallium commonly co-occurs in nature with zinc (Zn), lead (Pb), copper (Cu), and iron (Fe), and is therefore frequently encountered as a trace impurity in ores and minerals containing these metals. Consequently, thallium may persist as an impurity in metal-derived materials, including ZnO.²⁰ Although sunscreens are regulated as OTC drug products and are subject to more stringent requirements for elemental impurity testing, ZnO used in other cosmetic and personal care products, such as makeup colorants, diaper rash creams, barrier creams, acne treatments, and anti-dandruff formulations, may not be subject to the same level of regulatory scrutiny. Given that thallium is readily absorbed through human skin and exhibits high systemic toxicity, its presence as an impurity warrants consideration.²¹ Notably, the ICH Q3D guideline establishes a cutaneous permitted daily exposure (PDE) of 8 µg/day for thallium, corresponding to a concentration limit of 0.8 µg/g assuming a maximum daily product use of 10 g/day.²²

If one factor decides whether a cosmetic passes or fails a metals specification more than any other, it is sample preparation rather than the instrument. A result is largely settled before the sample reaches the plasma, in how completely it is brought into solution. The FDA's two surveys establish the point quantitatively: the earlier survey, which used total dissolution with hydrofluoric acid, returned values equal to or higher than the milder extraction used in the second, so the reported concentration is in part an artifact of how thoroughly the mineral matrix was digested.¹ A preparation that leaves a talc or mica particle only partially dissolved will understate the true content, the wrong direction of error when the objective is to demonstrate that a product sits below a low limit. Mineral-heavy matrices accordingly call for microwave-assisted acid digestion, in some cases incorporating hydrofluoric acid, to release metals bound within the silicate lattice. We have seen finished-product results come back low simply because a milder digestion left part of the mineral matrix intact. This is particularly important when demonstrating compliance with specification limits at the low ppm level, where incomplete recovery can result in underestimation of the true elemental content. Consequently, sample preparation and matrix digestion are critical aspects of method development, with the goal of achieving complete dissolution of the sample and a clear, homogeneous solution.

Method accuracy should also be verified through spike recovery studies, which provide evidence that the analytical procedure can quantitatively recover target elements from the sample matrix. Robust recovery studies are especially important for elements known to present analytical challenges. For example, osmium, an element included in ICH Q3D, can form highly volatile osmium tetroxide (OsO₄) under oxidative nitric acid digestion conditions, potentially affecting recovery if appropriate stabilization and analytical controls are not implemented.

On the measurement side, ISO 21392:2021 provides a harmonized ICP-MS method covering precisely this set of elements, chromium, cobalt, nickel, arsenic, cadmium, antimony, and lead, which is part of why it has become a common reference point.¹⁴ Inductively coupled plasma techniques, more generally, ICP-MS, ICP-OES, and triple-quadrupole ICP-QQQ, are the established means of quantifying these elements at the concentrations current limits require, with ICP-MS and ICP-QQQ affording the sensitivity to resolve a result confidently near a 1 ppm lead line. Sensitivity alone does not make a result defensible. That depends instead on a validated method with an adequately low limit of quantitation, demonstrated spike recovery in the actual sample matrix, and certified reference materials to anchor accuracy, since an iron-oxide-laden eyeshadow and a clear serum are not interchangeable analytical problems and a method validated on one does not transfer to the other by default. In our work across cosmetic matrices, products containing microcrystalline cellulose, silica, titanium dioxide (TiO₂), zinc oxide (ZnO), and similar mineral-based ingredients are among the most analytically challenging, as incomplete digestion of these materials may prevent the quantitative extraction of elemental impurities, leading to an underestimation of their true concentration..

A full elemental panel also covers ground the limits tables do not, which is why the harmonized method includes cobalt and nickel even though neither carries a finished-product impurity limit in the US or Canadian frameworks. Their principal risk is not systemic toxicity, but skin sensitization. Nickel is the most frequent cause of allergic contact dermatitis and can provoke a reaction in a sensitized individual at low concentrations,¹⁵ while cobalt is a strong skin sensitizer in its own right, and the thin skin of the eyelid has been shown to increase nickel absorption from cosmetics, which makes eye-area products a particular concern.¹⁶ Because that exposure concentrates in the same eye and face categories that carry the highest mineral-derived metal burden, a result set scoped only to the metals named in a limits table can miss a dermatological risk that a broader elemental panel would capture.

According to ICH Q3D, both the cutaneous permitted daily exposure (PDE) and the cutaneous and transcutaneous concentration limit (CTCL) must be considered for sensitizing elements such as nickel and cobalt. Compliance with both criteria is required, and when the limits result in different allowable concentrations, the more stringent limit applies. For example, cobalt has a cutaneous PDE of 50 µg/day and a CTCL of 35 µg/g. Assuming a maximum daily product use of 1 g/day, the PDE corresponds to a concentration limit of 50 µg/g, which exceeds the CTCL. Therefore, the CTCL of 35 µg/g is the controlling limit. This additional concentration-based restriction is intended to reduce the risk of eliciting allergic skin reactions in previously sensitized individuals.²²

Deploying those techniques is as much a question of sequence as of capability. ICP-OES quantifies a broad multi-element panel quickly and at lower cost, which suits it to screening incoming raw-material lots and flagging anything that approaches a limit, while ICP-MS and ICP-QQQ, with sensitivity well beyond what optical emission provides, are best reserved for confirming results where the applicable limit is low enough, near a 1 ppm lead line, that emission-based detection or spectral interference could leave the call in doubt. Tiering a fast quantitative screen against a precise confirmatory method places analytical effort in proportion to risk rather than running every sample at maximum sensitivity by default.

Anchoring the program in raw materials rather than in finished product alone follows directly from where the metals originate. Qualifying incoming minerals and pigments, working with suppliers on their certificates and supporting data, and then confirming those findings downstream in finished product yields what no end-of-line test can: a connected evidentiary record that accounts for its own numbers in whichever market a regulator asks. Supplier and manufacturer are working the same problem from opposite ends, and the raw-material dataset is the common reference that makes a finished-product result interpretable. The strongest programs we see are the ones that connect supplier data to finished-product testing, so a result can always be traced back to where the metal came from.

The practical implication: the decision that most often determines a metals result is not the choice of instrument but where the control sits and how the sample is prepared. A finished-product number rests on a digestion step capable of moving a value across a limit, so a program built on that number alone is defending the hardest specification at its least controlled point.

 

What does a defensible cosmetics metals testing program look like across the US and Canada?

Trace metals in cosmetics resist a single tidy rule because the regulatory and scientific pictures are organized along different lines. On the regulatory side, the US provides firm figures only for color additives and mercury, keeps its lead recommendation in draft, sets no general federal limit for most metals as impurities, and overlays state thresholds and California's reporting and warning duties, while Canada offers a compact set of impurity limits built on technical feasibility. On the scientific side, the picture is far more uniform: the metals derive predominantly from the mineral raw materials on which a product is built, which locates the effective control point upstream and rewards an analytical method matched honestly to the matrix it measures. For a brand selling into both markets, the useful answer is less about chasing the lowest published number than about where the program sites its control. Design to the lowest applicable limit, but treat raw-material qualification and matrix-appropriate sample preparation as the primary safeguard rather than finished-product testing, and hold the connected data that substantiates the position. That evidentiary record is precisely what MoCRA's substantiation expectations and Health Canada's readiness to request results both ultimately require, and assembling it makes raw-material qualification and validated, matrix-appropriate testing one continuous program rather than two separable exercises.

Element supports this work through trace-metal and elemental-impurities analysis by ICP-MS, ICP-OES, and ICP-QQQ, sample preparation and digestion methods developed for difficult mineral matrices, and method development, validation, and verification spanning raw materials and finished products, with laboratories in both the US and Canada. Connect with our team to discuss how we can support your metals testing program, or learn more about Element on our About Us page. 

 

References

1. FDA, "FDA's Testing of Cosmetics for Arsenic, Cadmium, Chromium, Cobalt, Lead, Mercury, and Nickel Content."
2. 21 CFR 700.13, Use of mercury compounds in cosmetics.
3. FDA, "Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Maximum Level," draft guidance for industry.
4. FDA, "FDA Warns Consumers of Skin Products Containing Mercury and/or Hydroquinone."
5. FDA, "Cosmetics and U.S. Law" (Modernization of Cosmetics Regulation Act of 2022, MoCRA).
6. Washington State Department of Ecology, Toxic-Free Cosmetics Act (HB 1047) and Interim Policy on Lead in Cosmetics.
7. Minnesota Statutes, Section 325E.3892, Lead and Cadmium in Consumer Products.
8. Maryland HB 643, Public Health, Cosmetic Products, Ingredient Prohibition; and the Crown and Care Act, HB 1533 / SB 656, 2026 Regular Session, Maryland General Assembly.
9. Oregon SB 546, Toxic-Free Cosmetics Act.
10. Vermont, 9 V.S.A. Section 2494b, Prohibited Chemicals in Cosmetic and Menstrual Products (Act 131, 2024).
11. California Department of Public Health, California Safe Cosmetics Program, established by the California Safe Cosmetics Act of 2005.
12. California OEHHA, Proposition 65.
13. Health Canada, "Guidance on Heavy Metal Impurities in Cosmetics."
14. ISO 21392:2021, Cosmetics, Analytical methods, Measurement of traces of heavy metals in cosmetic finished products using ICP/MS technique.
15. Ahlstrom MG, et al. "Nickel allergy and allergic contact dermatitis: A clinical review of immunology, epidemiology, exposure, and treatment." Contact Dermatitis, 2019.
16. Yoshihisa Y, Shimizu T. "Metal Allergy and Systemic Contact Dermatitis: An Overview." Dermatology Research and Practice, 2012.
17. Color additive specifications for cosmetics, 21 CFR Parts 73 and 74, Subpart C, including FD&C Blue No. 1 (Sec. 74.101), iron oxides (Sec. 73.2250, approved for cosmetics including the eye area), and chromium oxide greens (Sec. 73.2327, externally applied cosmetics).
18. FDA, "Termination of Listing of Color Additive Exempt From Certification; Lead Acetate," final rule, 83 FR 54665 (October 31, 2018); stay removed effective January 6, 2022, repealing 21 CFR 73.2396.
19. Federal Food, Drug, and Cosmetic Act, Section 601 (adulterated cosmetics).
20. U.S. EPA, Toxicological Review of Thallium and Compounds (EPA/635/R-08/001F). National Center for Environmental Assessment, 2009.
21. Kemnic TR, Coleman M. Thallium Toxicity. [Updated 2025 Dec 13]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing, 2026.
22. ICH, Q3D(R2) Guideline for Elemental Impurities. International Council for Harmonisation; FDA guidance for industry, 2022.