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Heavy Metal Index

Health Canada natural health product heavy-metal quality limits

Scope The guide applies to natural health products, including oral and topical products.

Scope

The guide applies to natural health products, including oral and topical products. The loaded register rows cover the topical concentration table.

Exact limit and units

MetalMatrixLimitUnitBasis
ArsenicTopical natural health products3ppmFinished topical product
CadmiumTopical natural health products3ppmFinished topical product
LeadTopical natural health products10ppmFinished topical product
Total mercuryTopical natural health products1ppmFinished topical product
AntimonyTopical natural health products5ppmFinished topical product

For oral products, the guide states daily exposure limits rather than concentration limits: total arsenic <10.0 µg/day or inorganic arsenic <2.1 µg/day, cadmium <6.0 µg/day, lead <10.0 µg/day, total mercury <20.0 µg/day, and methyl mercury <2.0 µg/day.

How tested

The guide allows elemental impurities to be tested individually or as total heavy metals expressed as lead, and refers to pharmacopoeial or internationally accepted methods for individual elements.

Enforcement posture

Health Canada describes the guide as a guidance document for product quality. The topical ppm rows are loaded as guidance impurity limits.

History of changes

The extracted guide is dated May 1, 2015, Version 3.1.

How it compares

The topical Pb and Hg concentration limits are close to Singapore and ASEAN health-supplement values; Health Canada also adds antimony and dose-based oral limits.

Sources

Update history

No substantive edit history is available in this build. The full commit record is available in git.