Overview
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) is the EU’s binding framework for cosmetic products. For heavy metals it operates as a prohibited-substance plus technically-unavoidable-trace framework, not a maximum-level framework: the Regulation sets no numeric heavy-metal concentration limit for any metal in any cosmetic product. HMI handling: standards rows governed by this instrument are ADJUDICATE, not CAP_MAP — there is no numeric cap to transcribe, and none is inferred here.
Scope
The Regulation applies to “cosmetic products” — any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours (Article 2(1)(a)). Sunscreens, toothpaste, and soap are cosmetics in the EU framework, unlike in the US and Canadian frameworks.
Annex II heavy-metal entries (prohibited substances)
Annex II is the list of substances prohibited in cosmetic products. The heavy-metal entries, transcribed from the Annex II table (substance / CAS / EC number), are:
| Annex II entry | Substance | CAS No. | EC No. |
|---|---|---|---|
| 40 | Antimony and its compounds | 7440-36-0 | 231-146-5 |
| 43 | Arsenic and its compounds | 7440-38-2 | 231-148-6 |
| 54 | Beryllium and its compounds | 7440-41-7 | 231-150-7 |
| 68 | Cadmium and its compounds | 7440-43-9 | 231-152-8 |
| 97 | Chromium; chromic acid and its salts | 7440-47-3 | 231-157-5 |
| 221 | Mercury and its compounds, except those special cases included in Annex V | 7439-97-6 | 231-106-7 |
| 289 | Lead and its compounds | 7439-92-1 | 231-100-4 |
Entry numbering verified 2026-07-29 against the legislation.gov.uk retained-EU-law reproduction of Annex II (Regulation (EC) No 1223/2009, revised version), which reproduces the EU consolidated Annex; users in live disputes should confirm against the current EUR-Lex consolidated version (CELEX 02009R1223).
Exact limit and units
None. The Regulation contains no numeric maximum level, in any unit, for lead, cadmium, arsenic, mercury, or any other heavy metal in a finished cosmetic product. The operative heavy-metal provisions are the Annex II prohibitions above plus Article 17, which permits traces of prohibited substances under strict conditions. Article 17 (Traces of prohibited substances), verbatim:
The non-intended presence of a small quantity of a prohibited substance, stemming from impurities of natural or synthetic ingredients, the manufacturing process, storage, migration from packaging, which is technically unavoidable in good manufacturing practice, shall be permitted provided that such presence is in conformity with Article 3.
Article 3 requires that a cosmetic product placed on the market be safe for human health under normal or reasonably foreseeable conditions of use, assessed via the cosmetic product safety report. “Technically unavoidable” is therefore a case-by-case safety-assessment determination, not a fixed ppm value. Any page or dataset that quotes an “EU cosmetics limit” of 0.5 ppm, 1 ppm, 5 ppm, or 10 ppm for a heavy metal is citing something other than Regulation 1223/2009 — no such number exists in the instrument.
How tested
The Regulation does not prescribe analytical methods for heavy metals. Compliance is demonstrated through the product safety report (Annex I of the Regulation) and good manufacturing practice; compliance with the relevant harmonized standard (EN ISO 22716) gives a presumption of conformity with GMP (Article 8).
Enforcement posture
Binding in its entirety and directly applicable in all Member States since 2013-07-11. Member States carry out market surveillance; the responsible person must hold a product information file with the safety assessment. Presence of an Annex II substance is prohibited unless the Article 17 trace conditions are met; there is no de minimis concentration written into the Regulation.
History of changes
- 2009-11-30: Regulation (EC) No 1223/2009 adopted (recast of Cosmetics Directive 76/768/EEC).
- 2013-07-11: Regulation applied in full, replacing Directive 76/768/EEC.
- Annexes amended frequently by Commission regulations; the heavy-metal prohibition entries above are stable legacy entries carried from the Directive.
Comparison with other jurisdictions
- Canada: Health Canada’s Guidance on Heavy Metal Impurities in Cosmetics sets numeric impurity limits (Pb 10, As 3, Cd 3, Hg 1, Sb 5 ppm) under the same prohibition-plus-impurity logic (Health Canada — Guidance on Heavy Metal Impurities in Cosmetics: Pb 10, As 3, Cd 3, Hg 1, Sb 5 ppm).
- US (FDA): no binding finished-product lead limit; a 2016 draft guidance recommends 10 ppm lead in lip products and externally applied cosmetics; 21 CFR 700.13 binds mercury to <1 ppm as an unavoidable trace (US FDA cosmetics heavy-metal policy — draft lead guidance (10 ppm) and the binding mercury trace rule (21 CFR 700.13, <1 ppm)).
- US (California): AB 2762 prohibits intentionally added mercury (among 24 substances) from 2025-01-01, with a technically-unavoidable-trace exception modelled on the EU framework (California Prop 65 / AB 2762 — exposure-based warnings and intentionally-added mercury prohibition; no numeric heavy-metal concentration limit for cosmetics).
- US (Washington State): the Toxic-Free Cosmetics Act sets a statutory 1000 µg/kg lead limit for toothpaste — a numeric limit of the kind the EU Regulation does not contain (Washington State Toxic-Free Cosmetics Act — Toothpaste Pb 1000 ppb statutory limit).
Sources
- Regulation (EC) No 1223/2009, OJ L 342, 22.12.2009, p. 59 — EUR-Lex CELEX 32009R1223 (original) and 02009R1223 (consolidated): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32009R1223
- Annex II entry numbering and substance wording verified against the retained-EU-law reproduction at legislation.gov.uk: https://www.legislation.gov.uk/eur/2009/1223/annex/II
- Article 17 text verified at https://www.legislation.gov.uk/eur/2009/1223/article/17
Update history
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