“Our supplements meet EU heavy metal limits” is the bare minimum, not a quality claim. Here’s why every batch we release is held to one fifth of the EU maximum, the figure we shorten to 5× stricter, and why that matters to the person actually swallowing the capsule.
Where the EU limits actually come from
EU Regulation 2023/915 sets contaminant limits in food. For supplements, the relevant cells of that regulation give the upper bound that any product can legally contain. They’re calculated based on tolerable weekly intake at average consumption volumes.
The problem: real people don’t consume “average” volumes. A health-conscious customer might be taking 5–10 different supplements daily, each one quietly accumulating below its individual threshold but together delivering a meaningful heavy metal load.
The four metals we obsess over
Lead (Pb)
Most common contaminant in herbal extracts (plants pull lead from soil), calcium carbonate (often from limestone deposits with traces of lead), and some clays used as flow agents.
EU food supplement limit: set from tolerable weekly intake, not from a daily dose.
California Prop 65 daily limit: 0.5 µg/day, the strictest practical standard in the world.
Our hold: we target levels that comfortably pass Prop 65 at the recommended daily dose.
Cadmium (Cd)
Common in cocoa, sunflower seeds, certain marine sources. Builds up in kidneys over decades.
Source typically: botanical raw materials grown in cadmium-rich soil regions (parts of South America, Asia).
Our practice: qualify every botanical supplier with cadmium testing on incoming raw material, not just on finished product.
Mercury (Hg)
Most relevant for fish-oil and marine algae products. Mostly methylmercury, the bioaccumulating form.
Source typically: oily fish.
Our practice: all fish oil sourced from molecularly distilled, mercury-tested suppliers; final product retested.
Arsenic (As)
Two forms: organic (less toxic, common in seafood) and inorganic (highly toxic, common in rice-based ingredients and some Asian botanicals).
Source typically: rice-derived flow agents, kelp/seaweed extracts.
Our practice: we test for both forms separately, and target inorganic arsenic at <20% of the EU limit.
Why one fifth, specifically?
It’s the safety margin we’ve found necessary to satisfy:
- California Prop 65, the de facto U.S. consumer safety standard
- Stiftung Warentest and other German consumer-test publications that periodically publish “supplement contamination” rankings
- Amazon’s own internal thresholds, not published, but tighter than EU max
- Customer-stack thinking, leaving room for someone taking five or ten other supplements a day without crossing a safety threshold
Hitting the EU max means a product legally passes. Holding to one fifth of it is what lets us sleep at night, and we set that number knowing our own name is on the bottle.
Where heavy metal failures actually happen
It’s almost never the manufacturing process, it’s the raw material. The two leverage points:
- Supplier qualification. Most contamination is supplier-driven. Vetting suppliers, requiring their certificates of analysis on every shipment, and re-testing on intake catches 90% of issues before they enter the building.
- Source diversification. Rather than rely on the cheapest single supplier, we source critical actives from multiple qualified suppliers and rotate based on test results.
What to ask any supplement company
Whether you’re buying one bottle or putting a product on a shelf, four questions separate a real quality programme from a claim on a label. Ask for:
- The CoA for the batch you actually hold, showing measured heavy metal values against spec, not the word “compliant” on its own
- Their internal heavy metal acceptance limits, as distinct from the legal limit
- Whether they test on raw material intake AND finished product (we do both)
- Their supplier qualification process for botanical ingredients
Then ask who did the testing. A company checking its own work is marking its own homework. Every batch we release is cleared by two laboratories: our internal lab, and one independent accredited third-party lab from a network of three, chosen for the market that batch is shipping into.
If a company answers “we meet EU limits”, that’s the floor. If it can tell you the internal ceiling it holds to, and show you the number for the batch in your hand, that’s a different conversation. Ours is one fifth of the EU limit, and any customer can get the report by emailing the batch number printed near the expiry date to info@pharmscale.com.