Overview
Health Canada issued this guidance to communicate technically avoidable impurity limits for lead, arsenic, cadmium, mercury, and antimony in cosmetics sold in Canada. The PDF is a regulatory guidance document, not a market-sampling paper: it states policy limits and toxicological context but does not print the underlying Health Canada laboratory dataset. This page records the source-stated limits as Canadian regulatory context, with total arsenic and total mercury kept distinct from inorganic arsenic and methylmercury occurrence.
Key numbers
- Document identity:
Guidance on Heavy Metal Impurities in Cosmetics, effective date2012-07-20, date modified2016-02-29. A later copy of the same web page, printed 2026-09-25 and showing “Date modified: 2017-10-02”, carries the same five limits, effective date and mercury footnote (PDF pp. 11, 12 and 15 of that copy). - Scope for sunscreens: in Canada, primary sunscreens are licensed as natural health products or non-prescription drugs under the Primary Sunscreen Monograph, whose finished-product specifications follow the NNHPD Quality of Natural Health Products Guide; that guide’s topical limits (arsenic 3, cadmium 3, lead 10, total mercury 1, antimony 5 ppm) are numerically the same as these cosmetic limits. See Primary Sunscreen Monograph and Quality of Natural Health Products Guide.
- Scope for baby lotions, oils, and powders: the policy applies to cosmetics in general, which includes baby lotions, baby oils, and baby powders sold as cosmetics in Canada. Products authorised as natural health products or non-prescription drugs (for example diaper-rash powders and ointments) fall outside it.
- Scope: the guidance focuses on heavy metals with known significant toxicological properties in cosmetics: lead, arsenic, cadmium, mercury, and antimony.
- Unit definitions in the source:
1 ppb = 1 µg/kg = 1 µg/L;1 ppm = 1µg/g, 1 mg/kg, 1 mg/L. - Health Canada policy limits for cosmetic-product impurities: lead
10 ppm; arsenic3 ppm; cadmium3 ppm; mercury1 ppm; antimony5 ppm. - Health Canada enforcement framing: heavy metal impurity concentrations above those limits are considered technically avoidable; occurrences above the limits are evaluated case by case for risk and enforcement action.
- German technical-avoidability comparator for cosmetic products: lead
20 ppm; arsenic5 ppm; cadmium5 ppm; mercury1 ppm; antimony10 ppm. - German toothpaste comparator: lead
1 ppm; arsenic0.5 ppm; cadmium0.1 ppm; mercury0.2 ppm; antimony0.5 ppm. - Source-side exposure context: dermal exposure is expected to be the most significant route for most cosmetics, oral exposure can occur for products used in and around the mouth or through hand-to-mouth contact, and inhalation exposure is expected to be negligible.
- Source-side metal context: children absorb about
50%of ingested lead; one arsenic dermal-exposure study predicted dermal exposure may contribute less than1%of exposure from ingestion; cadmium absorption through skin is described as low (0.5%); organic methylmercury is described as a greater concern than inorganic mercury, but the cosmetic impurity limit is stated for mercury generally. - Comparator values cited by the guidance: Canadian drinking-water MACs are
0.010 mg/L (0.010 ppm)for lead,0.01 mg/L (0.01 ppm)for arsenic,0.005 mg/L (0.005 ppm)for cadmium,0.001 mg/L (0.001 ppm)for mercury, and0.006 mg/L (0.006 ppm)for antimony. The US FDA limit for arsenic in certain colorants is<3 ppm; the US FDA limit for mercury impurities in some colourants is<1 ppm. - Mercury footnote: the source says the cosmetic impurity limit for mercury was amended from
3 ppmto1 ppmas per the Minamata Convention on Mercury signed by Canada onOctober 10, 2013.
A later web copy of the same guidance, printed 2026-09-25, shows “Date modified: 2017-10-02”. Its effective date (2012-07-20) and the five policy limits are unchanged. That copy also prints the following figures:
| Figure | Value as printed | Section |
|---|---|---|
| Inorganic lead skin permeability coefficient | about 10-4 cm/hour | 3.2.1 |
| Acceptable lead impurity in candy likely consumed by small children (US) | 0.1 ppm | 3.2.1 |
| Lead impurity limit for monograph-stream natural health products applied to the skin | 10 ppm | 3.2.1 |
| US EPA oral reference dose, arsenic | 0.3 µg/kg bw/day | 3.2.2 |
| US EPA oral reference dose, cadmium | 0.5 µg/kg bw/day | 3.2.3 |
| Mercury in most commercial fish (Health Canada) | 0.5 ppm | 3.2.4 |
| WHO provisional tolerable daily intake, total mercury | 2 µg/kg bw/day | 3.2.4 |
| WHO provisional tolerable weekly intake, methylmercury | 1.6 µg/kg bw | 3.2.4 |
| Thimerosal in eye cosmetics (US) | 65 ppm | 3.2.4 |
| Average antimony intake | about 5 µg per day | 3.2.5 |
| WHO provisional tolerable daily intake, antimony | 6 µg/kg bw/day | 3.2.5 |
The guidance says that in 2010 the German government concluded its recommended limits could be lowered, as ongoing monitoring had shown. The German values it quotes (lead 20, arsenic 5, cadmium 5, mercury 1, antimony 10 ppm) are the older Federal Health Office figures. The later German table is much lower (lead 2.0, cadmium 0.1, mercury 0.1, arsenic 0.5, antimony 0.5 mg/kg for cosmetics in general; Technically avoidable heavy metal contents in cosmetic products). It lists lead, arsenic, cadmium, mercury, antimony and chromium as prohibited ingredients on the Cosmetic Ingredient Hotlist. It develops no impurity limits for selenium, barium or chromium. It places responsibility on the manufacturer to keep heavy-metal impurities in the finished cosmetic “as few … as possible”, and states that Health Canada may request test results where a risk is suspected.
Methods (brief)
This is a Health Canada guidance document. It summarizes toxicological properties, exposure-route considerations, comparator limits from Canada, Germany, the United States, WHO, and other program areas, and Health Canada’s policy position under the Food and Drugs Act and Cosmetic Regulations. The guidance says Health Canada reviewed and analysed Product Safety Laboratory heavy-metal testing results from a number of cosmetics sold in Canada, but it does not report sample counts, product categories, concentration distributions, analytical methods, LOD/LOQ values, or QA/QC details for those tests.
Speciation: the policy limits are for lead, arsenic, cadmium, mercury, and antimony as cosmetic impurities. This page records arsenic as tAs and mercury as tHg context because the guidance does not specify inorganic arsenic or methylmercury limits for cosmetics.
Related evidence
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.