Heavy Metals in EU Cosmetics: What Regulation 1223/2009 Actually Requires (and What It Doesn't)

Heavy metals in EU cosmetics occupy a strange regulatory space: simultaneously over-prohibited and under-specified. Every safety assessor we work with eventually encounters this contradiction — usually when a formula containing mineral pigments, kaolin clay, or a botanical extract gets flagged during PIF review, and nobody can point to a clear regulatory limit to test against.

Here’s the situation as it actually stands, and what it means for your product documentation.

What Annex II of Regulation 1223/2009 Prohibits

Annex II of Regulation 1223/2009 lists the substances that cannot be used as intentional cosmetic ingredients. The list runs to over 1,300 entries, and several heavy metal compounds appear there by name. Cadmium and its compounds are prohibited. Arsenic compounds are prohibited. Various lead salts, including lead acetate, were prohibited via Commission Regulation (EU) 2018/978 following an SCCS safety opinion that found no acceptable use level for the substance.

Mercury carries the one significant nuance. Mercury compounds are prohibited — except for a narrow carve-out permitting thiomersal and phenylmercuric salts as preservatives specifically in eye cosmetics, at a maximum concentration of 0.007%. That’s 70 ppm, with the additional requirement that no non-mercury preservative alternative is technically feasible. In practice, almost no EU manufacturer still relies on this exception.

So the prohibition framework is reasonably clear: you don’t add these metals deliberately. But that’s not what most formulation problems actually involve.

The Gap That Catches European Brands Off Guard

The more common scenario is this: you’re using an iron oxide pigment, mica-based interference particles, or a kaolin clay. These ingredients can carry trace levels of lead, arsenic, or cadmium absorbed from agricultural soils or geological deposits — not because anyone added them intentionally, but because the raw material source contains them. Annex II says nothing about this. The prohibition on “cadmium and its compounds” covers intentional use as a cosmetic ingredient, not background contamination carried in from the supply chain.

Here EU cosmetics law diverges sharply from EU food law. Commission Regulation (EC) No 1881/2006 sets specific maximum contaminant levels for heavy metals in foodstuffs — 0.10 mg/kg lead in most fruit and vegetables, 0.30 mg/kg cadmium in certain cereals, and so on. No equivalent instrument exists for cosmetics. The EU has not enacted a regulation setting permissible contamination thresholds for lead, arsenic, cadmium, or nickel in finished cosmetic products.

Compliance therefore rests on Article 10 of Regulation 1223/2009. This article requires a cosmetic product safety report prepared by a qualified safety assessor, covering the toxicological profile of each substance and a safety evaluation of the finished product. Heavy metal contaminants from raw materials fall squarely within that obligation — but the regulation doesn’t prescribe the specific number the assessor should use.

What the SCCS Has Said About Key Metals

Because statutory contaminant limits don’t exist, EU safety assessors rely on SCCS opinions as the closest thing to authoritative guidance values. Here’s what the science committee has established for the metals most likely to appear in cosmetic formulations.

Lead. Following the SCCS opinion on lead acetate that contributed to the 2018 prohibition, EU scientific guidance on tolerable lead exposure in cosmetics effectively points toward minimisation rather than a permissible threshold. The most widely cited reference among EU safety assessors is Cosmetics Europe’s technical guidance document on heavy metals, which recommends an internal quality limit of 10 mg/kg (10 ppm) for lead as a practical target for manufacturers. This document carries no regulatory force, but it represents the EU industry consensus and is routinely accepted by national competent authorities reviewing PIFs.

Nickel. The SCCS has repeatedly addressed nickel as a sensitiser. In leave-on products applied to the face — moisturisers, foundations, lip products — nickel’s low sensitisation threshold creates meaningful risk for consumers with pre-existing nickel contact allergy, which affects an estimated 8–15% of European women. Safety assessors typically treat any detectable nickel in face-contact leave-on products as requiring a full systemic exposure dose calculation, not a simple pass/fail comparison against a threshold.

Aluminum. Not classically grouped with “heavy metals” toxicologically, but relevant for antiperspirant formulations: the SCCS revised its opinion on aluminum in cosmetics to address systemic absorption from axillary application. The methodology it used — calculating a systemic exposure dose and comparing it against a health-based guidance value — is the same template assessors apply to other metals in cosmetic products, regardless of whether a specific SCCS opinion on that metal exists.

Arsenic and cadmium. Neither has a dedicated SCCS opinion addressing contamination levels in finished cosmetics directly. Assessors typically reference WHO health-based guidance values and EFSA tolerable weekly intakes, applying appropriate bioavailability corrections for the relevant exposure route. For lip products, which assume some degree of accidental oral ingestion, the assessment must apply oral — not dermal — toxicokinetics.

How to Address Heavy Metals in Your Product Information File

A compliant PIF for any product containing mineral pigments, natural clays, or botanical powders should document the following, in a traceable and auditable sequence.

1. Identify the risk-bearing raw materials. Iron oxides, natural and synthetic mica, titanium dioxide from rutile ore, kaolin, bentonite, hydroxyapatite, and plant-derived powders from high-arsenic agricultural regions are the primary candidates. List them explicitly in the raw materials section of your PIF rather than treating contamination risk as implicit.

2. Require supplier CoAs that include heavy metals data. Your supplier qualification process should make this non-negotiable. ICP-OES (inductively coupled plasma optical emission spectrometry) or ICP-MS analysis covering lead, arsenic, cadmium, mercury, and nickel is the standard for this kind of work. If your current CoAs don’t include this panel, issue a formal data request before your next PIF update or regulatory review.

3. Calculate the worst-case finished product concentration. Using your formulation percentages and the maximum reported contamination levels from supplier CoAs, calculate the highest possible amount of each metal in the finished product. This gives your safety assessor an auditable, traceable input number.

4. Apply a reference limit and document the rationale. Cosmetics Europe’s guidance values — 10 ppm lead, 5 ppm arsenic, 1 ppm cadmium as common reference thresholds — are the accepted EU industry benchmarks. If your calculated level falls below these thresholds, document that explicitly and close the section. If it comes in above, your assessor will need a full systemic exposure dose calculation, or the raw material sourcing needs to be reviewed.

5. For high-mineral formulations, commission finished product testing. CoA extrapolation is defensible for most formulations. But a pressed powder foundation at 70–85% mineral content, or a detox clay mask at 20%+ kaolin, warrants direct ICP-MS analysis of the finished product. A comprehensive heavy metals panel at a European contract lab typically runs €150–€350 per sample — negligible against the cost of a delayed market launch or a competent authority challenge to your PIF.

Why US Market Access Adds a Second Layer of Scrutiny

European brands exporting to the United States face a more prescriptive standard, at least for lip products. In 2016, FDA issued guidance recommending a maximum of 10 ppm lead in cosmetic lip products and externally applied cosmetics. Technically non-binding, it functions in practice as a de facto threshold: products flagged above that level at US import risk detention and formal response requirements.

The practical problem is that an EU safety assessment may never explicitly benchmark against this threshold. An assessor working entirely within the EU framework has no regulatory obligation to do so. If you’re selling the same formulation in both markets, your testing protocol needs to address both reference frameworks — and that should be a standing instruction to your contract lab, not a reactive response when a US shipment gets held.

For tinted lip products containing iron oxide pigments sourced from natural mineral deposits, lead levels between 2 and 12 ppm are not unusual depending on origin and processing. A product sitting at 8 ppm comfortably clears the Cosmetics Europe guidance value and raises no concern under EU law. That same product sits at 80% of FDA’s recommended maximum — worth knowing before it arrives at a US port of entry.

And that asymmetry — compliant in Brussels, borderline in Baltimore — is something a competent EU-based safety assessor will flag. Not every one does.

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If your PIFs for mineral-heavy or botanical-based products don’t yet include an explicit heavy metals section with quantitative raw material data, that’s the first gap to close before your next product audit. Get supplier CoAs with metals panels, calculate finished product levels, and ensure your safety assessor’s rationale is documented rather than assumed. It’s the kind of detail that moves a PIF from defensible to genuinely auditable — on both sides of the Atlantic.

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Written by Nour Abochama, Quality & Regulatory Advisor, Care Europe | VP Operations, Qalitex. Learn more about our team

Talk to our team about EU market entry. Contact us

Related from our network

• ICP-MS and ICP-OES testing for cosmetic raw materials and finished products — ISO 17025-accredited heavy metals analysis for cosmetic ingredients and finished formulations, based in California.
• Heavy metal testing for Natural Health Products under Health Canada guidelines — Canadian NHP-compliant testing for mineral-derived supplement and cosmetic ingredients.