Food law sets limits on the food as sold. The raw material specification has to be derived from the dose, and the derivation is where suppliers and buyers most often talk past each other.
A 700 mg capsule contains 500 mg of curcumin extract and 200 mg of excipients. The EU lead limit for a food supplement is 3.0 mg/kg of the product as sold. Per capsule that is 2.1 µg of lead. If all of it came from the extract, the extract could carry up to 2.1 µg ÷ 0.5 g = 4.2 mg/kg of lead and the capsule would still comply.
A capsule made of 500 mg of pure extract, with no excipients, has no such headroom: the raw material limit equals the product limit. This is why "is it under 3 ppm?" is the wrong question without the dose.
Two consequences follow. First, a raw material at 4 mg/kg is not automatically non-compliant — it depends on the formula. Second, a customer who asks for "the strictest limit" without giving the dose is asking you to pay for headroom they may not need.
| Element | EU · food supplements | US · dietary supplements | Method |
|---|---|---|---|
| Lead (Pb) | 3.0 mg/kg | USP <2232> elemental limits; no general FDA limit | ICP-MS |
| Cadmium (Cd) | 3.0 mg/kg | USP <2232> | ICP-MS |
| Mercury (Hg) | 0.1 mg/kg | USP <2232> | ICP-MS |
| Arsenic (As) | No general limit for supplements; inorganic arsenic limits apply to rice-based products | USP <2232> | ICP-MS |
EU limits from Regulation (EU) 2023/915 (which replaced 1881/2006). USP <2232> expresses limits as daily exposure rather than concentration, so the permitted concentration depends on the daily dose. Confirm the applicable text with your regulatory team before fixing a specification.
Our release specification for the standard grade is set at the EU supplement limits — Pb ≤3, Cd ≤3, Hg ≤0.1 mg/kg — with arsenic set together with the customer because there is no single EU number to default to. Customers who need tighter limits (Pb ≤1, for example) can have batches selected; expect a longer lead time and a dedicated batch.
This is the parameter most likely to fail an EU import check, and the one most often described vaguely in a COA. Three things matter:
"Pesticides: negative" means nothing. Ask for the number of compounds tested, the reporting limit for each, and the list version. A 200-compound panel and a 500-compound panel are different products, and different test scopes.
Curcumin is usually extracted with ethanol or ethyl acetate, both Class 3 under ICH Q3C. If a process uses hexane, that is Class 2 and the limit is two orders of magnitude lower.
| Solvent | Class | Limit | Note |
|---|---|---|---|
| Ethanol | 3 | 5,000 ppm (50 mg/day) | Standard extraction solvent |
| Ethyl acetate | 3 | 5,000 ppm (50 mg/day) | Standard extraction solvent |
| Acetone | 3 | 5,000 ppm (50 mg/day) | — |
| Hexane | 2 | 290 ppm | Must be declared if used |
| Toluene | 2 | 890 ppm | — |
| Methanol | 2 | 3,000 ppm | — |
| Acetonitrile | 2 | 410 ppm | — |
| Dichloromethane | 2 | 600 ppm | — |
Batch-specific results are on the COA supplied with each shipment. A summary of the last twelve months is available on request, together with the third-party report if one was commissioned.
Curcumin sits in two different regulatory boxes depending on how it is used: a colour, and a dietary ingredient. The status below is a summary as of October 2026, not legal advice.
| Market | As a colour | As an ingredient | Claims |
|---|---|---|---|
| EU | E100 curcumin, authorised colour | Food supplement ingredient; check novel food status for the specific extract | No curcumin health claim is authorised in the EU register |
| US | Turmeric oleoresin, 21 CFR 73.600, colour additive exempt from certification | Dietary ingredient; NDI status depends on the ingredient's history | Structure/function only, with the FDA disclaimer; no disease claims |
| China | Food additive under GB 2760, use categories apply | Health-food raw material rules apply separately | Health-food claims are restricted to the registered function list |
| Japan | Listed food additive | Check the scope for supplements | Claims regulated separately |
EU claims: there is no authorised health claim for curcumin. A European customer asking for "joint health" wording on the label is asking for something the register does not support.
US colour: 21 CFR 73.600 covers turmeric and turmeric oleoresin. A highly purified curcumin may fall outside that description; confirm the colour additive status before using it as a colour in food sold in the US.
| Document | What it covers | When |
|---|---|---|
| COA | Batch results against the release specification | Every shipment |
| TDS | Specification, methods, solubility, packaging, storage | On request |
| MSDS | Handling, transport classification, first aid | Every shipment |
| Allergen statement | Declarable allergens, cross-contamination controls | On request |
| Non-GMO statement | Source and process declaration | On request |
| Halal certificate | Scope and certifying body | On request |
| ISO 9001 / ISO 22000 | Scope and validity | On request |
| Third-party report | SGS or Eurofins, panel as agreed | On request |
Limits and listings change. This summary is written for procurement and QA to have a starting point, not to replace your regulatory review. If you tell us the market and the dosage form, we will send the current text we are working from with the quotation.
Related: Curcumin extract 95% · COA and batch testing · Grade comparison · Stability · MOQ and ordering
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