Overview
The United States has no binding finished-product lead limit for cosmetics. FDA’s only numeric finished-cosmetic lead value is a draft guidance (December 2016) recommending a maximum of 10 ppm lead as an impurity — it is not for implementation and binds no one. For mercury, a binding regulation exists: 21 CFR 700.13 treats any cosmetic containing mercury as adulterated unless the mercury is an unavoidable GMP trace below 1 ppm (or, for eye-area preservatives only, at or below 65 ppm). Both values are transcribed below with their different legal statuses kept explicit.
Scope
- Lead draft guidance applies to cosmetic lip products (such as lipsticks, lip glosses, and lip liners) and externally applied cosmetics (such as eye shadows, blushes, shampoos, and body lotions) marketed in the United States. It does not cover products regulated as drugs in the US (fluoride anticaries toothpaste, sunscreens, zinc-oxide skin-protectant diaper creams).
- 21 CFR 700.13 applies to all cosmetics, including products also regarded as drugs in the case of skin-bleaching preparations.
Exact limit and units
| Provision | Instrument text value | SI equivalents (conversion shown) | Legal status |
|---|---|---|---|
| Lead as an impurity in cosmetic lip products and externally applied cosmetics | 10 parts per million | 10 ppm = 10 mg/kg = 10,000 µg/kg | Draft guidance, December 2016 — not for implementation, non-binding |
| Mercury in any cosmetic — trace unavoidable under good manufacturing practice (21 CFR 700.13(d)(2)(i)), calculated as elemental mercury | less than 1 part per million (0.0001 percent) | 1 ppm = 1 mg/kg = 1,000 µg/kg | Binding regulation (adulteration rule) |
| Mercury in eye-area cosmetics as a preservative where no effective safe nonmercurial alternative exists (21 CFR 700.13(d)(2)(ii)), calculated as elemental mercury | no more than 65 parts per million (0.0065 percent) | 65 ppm = 65 mg/kg = 65,000 µg/kg | Binding regulation, narrow exception |
The lead guidance states verbatim: “we are recommending a maximum level of 10 ppm for lead as an impurity in cosmetic lip products (such as lipsticks, lip glosses, and lip liners) and externally applied cosmetics (such as eye shadows, blushes, shampoos, and body lotions) marketed in the United States.” The mercury regulation states verbatim that FDA “will regard as adulterated within the meaning of section 601(a) of the Act any cosmetic containing mercury” unless the mercury content “is unavoidable under good manufacturing practice and is less than 1 part per million (0.0001 percent), calculated as elemental mercury” or the product “is intended for use only in the area of the eye” with “no more than 65 parts per million (0.0065 percent) of mercury, calculated as elemental mercury,” where no effective and safe nonmercurial preservative is available.
Separately, certifiable color additives carry FDA ingredient-level heavy-metal specifications — arsenic not more than 3 ppm and mercury not more than 1 ppm in color additives generally — these are ingredient approvals, not finished-product limits, and are not registered as caps in this wiki.
No numeric finished-cosmetic limits exist for cadmium, arsenic (other than the color-additive specifications), nickel, or chromium in the US federal framework.
How tested
FDA surveys cosmetics by ICP-MS-based multi-element methods (see FDA’s testing page for arsenic, cadmium, chromium, cobalt, lead, mercury, and nickel in cosmetics). The draft guidance does not prescribe a method; enforcement is by the adulteration doctrine (FD&C Act § 601) supported by FDA survey data.
Enforcement posture
The 10 ppm lead value is a recommendation; FDA stated it would not itself constitute a basis for enforcement and the guidance was never finalized. Real-world federal action against metal-contaminated cosmetics proceeds case-by-case as adulteration. The mercury rule, by contrast, is codified and directly enforceable. Several states fill the federal lead gap with their own numeric limits (e.g., Washington TFCA’s 1000 µg/kg lead limit in toothpaste — Washington State Toxic-Free Cosmetics Act — Toothpaste Pb 1000 ppb statutory limit).
History of changes
- 1974-03-15: 21 CFR 700.13 published (39 FR 10054), codifying the mercury-in-cosmetics adulteration position (trade-correspondence opinions TC-9 and TC-412 withdrawn; skin-bleaching mercury action dating to 1973-01-05).
- 2016-12: FDA issued the draft guidance “Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Maximum Level” and a supporting document. Still draft as of 2026-07-29.
Comparison with other jurisdictions
- Canada: Health Canada’s impurity guidance sets Pb 10 ppm — numerically equal to the FDA draft recommendation — plus Cd 3, As 3, Hg 1, Sb 5 ppm as administrative guidance (Health Canada — Guidance on Heavy Metal Impurities in Cosmetics: Pb 10, As 3, Cd 3, Hg 1, Sb 5 ppm). The FDA supporting document notes the 10 ppm level is consistent with ICCR members’ recommendations including Canada.
- EU: Regulation 1223/2009 prohibits these metals as ingredients (Annex II) with an Article 17 technically-unavoidable-trace allowance, and sets no numeric limit (EU Cosmetics Regulation (EC) No 1223/2009 — prohibited-substance framework, no numeric heavy-metal maximum levels).
- California: AB 2762 prohibits intentionally added mercury from 2025-01-01 (California Prop 65 / AB 2762 — exposure-based warnings and intentionally-added mercury prohibition; no numeric heavy-metal concentration limit for cosmetics).
- Children’s products: non-cosmetic children’s articles fall to CPSIA’s 100 ppm lead substrate cap (US CPSIA — lead in children's products: 100 ppm total lead (substrate), 90 ppm (paint and surface coatings)).
Sources
- Draft Guidance for Industry: Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Maximum Level (December 2016): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-lead-cosmetic-lip-products-and-externally-applied-cosmetics-recommended
- Supporting Document for Recommended Maximum Lead Level (FDA): https://www.fda.gov/cosmetics/cosmetics-guidance-documents/supporting-document-recommended-maximum-lead-level-cosmetic-lip-products-and-externally-applied
- 21 CFR 700.13 — Use of mercury compounds in cosmetics: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-G/part-700/subpart-B/section-700.13
- FDA, “FDA’s Testing of Cosmetics for Arsenic, Cadmium, Chromium, Cobalt, Lead, Mercury, and Nickel Content”: https://www.fda.gov/cosmetics/potential-contaminants-cosmetics/fdas-testing-cosmetics-arsenic-cadmium-chromium-cobalt-lead-mercury-and-nickel-content
Update history
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