The label is where a compliant product becomes a non-compliant one.
Heavy metals are the first test a buyer asks about, and the one most likely to fail on a botanical or a mineral. The limits depend on the market and on the daily dose; the method is ICP-MS after microwave digestion.
| Element | Typical limit | Method | Notes |
|---|---|---|---|
| Lead (Pb) | ≤3 mg/kg | ICP-MS | Tighter limits for some markets |
| Cadmium (Cd) | ≤3 mg/kg | ICP-MS | Botanicals and algae need attention |
| Mercury (Hg) | ≤0.1 mg/kg | ICP-MS | Fish-derived materials need attention |
| Arsenic (As) | Set with the market | ICP-MS | Inorganic arsenic may be specified separately |
Shilajit, algae and mineral blends carry the highest risk in this category. They are tested per batch, not per supplier certificate. If your market has a Prop 65 limit or a state-specific limit, send it before the batch.
Residual solvents follow ICH Q3C. Ethanol and ethyl acetate are Class 3 and have a high permitted limit; hexane is Class 2 and has a much lower limit. The extraction and coating processes decide which solvents can appear.
| Class | Examples | Limit | What to ask |
|---|---|---|---|
| Class 1 | Benzene, carbon tetrachloride | Avoid | Declaration that none is used |
| Class 2 | Hexane, toluene | Low limit | Test if the process uses it |
| Class 3 | Ethanol, ethyl acetate | Higher limit | Test or declaration, per market |
A COA that says “solvents: conforms” without naming the panel is not auditable. Ask for the panel and the detection limit.
Pesticides are tested against the destination market's MRL list. The EU list is the most detailed; the US and Japan have their own. A multi-residue panel by GC-MS/MS and LC-MS/MS is the standard approach.
For algae and botanicals, the pesticide panel is agreed with the raw-material supplier and verified on the finished batch when the market requires it.
Microbial limits follow the pharmacopoeia or the customer's specification. The standard panel is total plate count, yeast and mould, E. coli and Salmonella. Water activity and moisture are the process controls that keep the result inside the limit.
| Test | Typical limit | Method |
|---|---|---|
| Total plate count | ≤10³ cfu/g | Ph. Eur. 2.6.12 |
| Yeast and mould | ≤10² cfu/g | Ph. Eur. 2.6.12 |
| E. coli | Absent / 1 g | Ph. Eur. 2.6.13 |
| Salmonella | Absent / 25 g | Ph. Eur. 2.6.13 |
The limits are set with the market and the product. A raw material that passes the incoming test can still fail after tableting if the process water or the environment is not controlled.
The label is where a compliant product becomes a non-compliant one. The rules differ by market, and the brand owner is responsible for the final label; we review the artwork against the specification before print.
No disease claims, no claims to treat or prevent a disease, and no comparison to a drug. If the artwork contains one, we ask for it to be removed before print.
The site holds ISO 9001, ISO 22000, HACCP and Halal certificates. Organic certificates are available for the spirulina and chlorella lines when the raw material is certified. A customer-specific questionnaire can be completed before the order.
| Document | When it is issued | What it covers |
|---|---|---|
| COA | Per batch | Method, limit and batch result |
| TDS | Before the order | Specification and packaging |
| Allergen statement | Before the order | Allergen and gelatin source |
| GMO statement | Before the order | GMO status of the formula |
| Halal certificate | On request | Site and product scope |
| Organic certificate | On request | Spirulina and chlorella lines |
| MSDS | On request | Handling and transport |
The document pack is part of the quotation, not an afterthought. If your importer needs a specific document, name it in the RFQ so it can be included in the schedule.
Each row maps one product in this range to the parameter this document controls. The product pages link back to their own row; when you compare two products, compare the method column before the number.
| Product | Key limit | Document to request |
|---|---|---|
| Fish Oil Softgel | Heavy metals, PCBs, oxidation | COA, TDS, fish allergen statement |
| Black Seed Oil Softgel | Heavy metals, solvents | COA, TDS, allergen statement |
| Oregano Oil Softgel | Heavy metals, solvents | COA, TDS, essential-oil declaration |
| Oregano & Black Seed Oil Softgel | Heavy metals, solvents | COA, TDS, allergen statement |
| Spirulina Tablets | Heavy metals, pesticides, microbiology | COA, organic certificate, pesticide panel |
| Chlorella Tablets | Heavy metals, pesticides, microbiology | COA, organic certificate, rupture statement |
| Spirulina & Chlorella Tablets | Heavy metals, pesticides, microbiology | COA, two organic certificates |
| Shilajit Tablets | Heavy metals (Pb, Cd, Hg, As) | COA, heavy-metal panel, resin source |
| Shilajit & Ashwagandha Tablets | Heavy metals, withanolides | COA, heavy-metal panel, both marker results |
| Multi-Mineral Tablets | Heavy metals, elemental limits | COA, elemental panel, label review |
| Multi-Magnesium Tablets | Heavy metals, elemental limits | COA, elemental panel |
| Magnesium Glycinate Tablets | Heavy metals, elemental limits | COA, elemental panel |
| SAMe Tablets | Heavy metals, solvents, market status | COA, TDS, import-status note |
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