“Our supplements meet EU heavy metal limits” is the bare minimum, not a quality claim. Here’s why we hold every batch to 5× stricter than the EU maximum, and why your brand should care.
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 you the upper bound that any product can legally contain. They’re calculated based on tolerable weekly intake at average consumption volumes.
The problem: actual customers 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: generally tolerable.
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 5× stricter, 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, allowing room for your customer to take other supplements without crossing safety thresholds
Hitting the EU max means you legally pass. Hitting 5× stricter means you sleep at night.
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 you can ask for as a brand owner
If you’re evaluating any contract manufacturer (us included), ask for:
- A redacted recent CoA showing actual heavy metal values vs spec
- Their internal heavy metal acceptance limits (vs the legal limit)
- Whether they test on raw material intake AND finished product (we do both)
- Their supplier qualification process for botanical ingredients
If they say “we meet EU limits”, they’re telling you the floor. If they say “we hold 5× stricter than EU”, they’re telling you the ceiling. Different conversations.