Heavy metal content in cosmetic products: a comparative review on permissible levels in global regulatory requirements and available analytical tests

Overview

Modddaresi and Yu review cosmetic heavy-metal impurity controls across the EU/UK, United States, Canada, China, India, and German BVL technical guidance. The paper does not report new finished-product measurements; its useful content is regulatory context and method comparison for lead (Pb), arsenic (As), cadmium (Cd), mercury (Hg), Sb, and related trace metals. This page is therefore context-only and should not be routed into product occurrence pools.

Key numbers

• Source identity: IFSCC 2022 full paper by Personal Care Regulatory Ltd, Cambridge, UK; no DOI printed in extracted text.
• Scope: comparative review of major cosmetic markets and whether heavy-metal contamination in finished cosmetic products is limited through self-regulatory notification systems, mandatory notification, or obligatory registration.
• EU Cosmetic Regulation EC 1223/2009 rows in Table 1: Pb prohibited in Annex II/289; As prohibited in Annex II/43; Cd prohibited in Annex II/68; Hg prohibited in Annex II/221; Sb prohibited in Annex II/40.
• EU REACH rows in Table 1: Pb controlled under Annex XVII entry 63; As under entry 19; Cd under entry 23; Hg under entry 18; antimony not controlled as antimony on its own.
• German BVL technically unavoidable limits in Table 1: Pb 2.0 mg/kg in general products and 0.5 mg/kg in toothpaste; As 0.5 mg/kg in general products and toothpaste; Cd 0.1 mg/kg in general products and toothpaste; Hg 0.1 mg/kg in general products and toothpaste; Sb 0.5 mg/kg in general products and toothpaste.
• Canada Cosmetic Ingredient Hotlist row: Pb, As, Cd, Hg, and Sb are listed as prohibited.
• US FDA rows in Table 1: Pb maximum 10 mg/kg as an impurity in cosmetics and 20 mg/kg in colour additives; As not more than 3 mg/kg in colour additives; Hg allowed only as preservatives in eye-area products, must not exceed 65 ppm in the finished product when no other effective safe preservative is available, and not more than 1 mg/kg in colour additives.
• China Safety & Technical Standard 2015 rows in Table 1: Pb must not exceed 10 mg/kg in finished product; As 2 mg/kg; Cd 5 mg/kg; Hg 1 mg/kg.
• India Cosmetic Rules 2020 rows in Table 1: permitted synthetic organic colours and natural organic colours used in cosmetics must not contain more than 2 mg/kg Pb calculated as lead or more than 2 mg/kg As calculated as arsenic trioxide; use of lead compounds and arsenic compounds for colouring cosmetics is prohibited; eye-area preservatives may contain mercury up to 70 mg/kg calculated as metal, while unintentional mercury in other finished cosmetic products must not exceed 1 mg/kg.
• Analytical methods: China Safety & Technical Standard 2015 specifies hydride generation atomic fluorescence spectrometry for mercury and arsenic, graphite furnace atomic absorption spectrometry for lead, and flame atomic absorption spectrophotometry for cadmium.
• FDA method context: the review describes an FDA-validated total-dissolution method using hydrofluoric acid; arsenic, cadmium, chromium, cobalt, lead, and nickel were analysed by ICP-MS and mercury by cold vapor atomic fluorescence spectrometry in the cited FDA market survey.
• ISO context: ISO/TR 17276:2014 gave general screening and measurement guidance for heavy metals in cosmetic raw materials and finished products, while ISO 21392:2021 details ICP-MS and is described as detecting trace metals down to 0.02 mg/kg.
• Discussion examples: the review states that arsenic acceptable levels differ across jurisdictions, using 2 ppm in the United States, 3 ppm in China, and 0.5 ppm in Germany as examples; it also states that US and China lead limits of 10 ppm are five times the German value.

Methods (brief)

This is a narrative/comparative review, not a laboratory study. The authors selected representative regulatory systems: the United Kingdom, Canada, European Union, and United States for self-regulatory or notification systems, and China and India for obligatory registration systems. They reviewed cosmetic regulations, horizontal chemical regulations, heavy-metal impurity limits, and analytical-test guidance relevant to finished cosmetic products and raw materials.

No primary samples were collected, no extraction/digestion experiment was performed by this source, and no product-level concentration table is reported. The analytical methods described are cited regulatory/standard methods rather than methods applied by the authors to new samples.

Speciation: arsenic and mercury limits are mostly presented as elemental/regulatory totals unless a regulation specifies a compound calculation basis, such as India calculating arsenic as arsenic trioxide. This page does not infer inorganic arsenic or methylmercury occurrence values from those regulatory rows.

Related evidence

• Regulations by jurisdiction
• ICP-MS — Inductively coupled plasma mass spectrometry
• Lead
• Arsenic, Total
• Cadmium
• Mercury, Total
• Antimony
• Nickel
• Chromium
• Cobalt

Update history

The five most recent substantive edits to this page, classified major (evidence or structure moved), correction (a published value or statement was wrong and has been fixed), or minor (narrative rewritten without changing the underlying evidence). Each description is derived from what the edit did to this page; the linked commit is the authoritative record, routine regeneration passes are excluded, and the full version history lives in git. When DOI minting comes online (see schema docs), each entry below will also link to a version-pinned DataCite DOI.