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bulk ingredients compliance-0

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Heavy metals, solvents and the compliance file for bulk ingredients

Time : 2026-10-28
05Compliance & documents
In one line

The label is where a compliant product becomes a non-compliant one.

Heavy metals

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.

Heavy metals: typical limits
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 cocoa 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

Botanical extracts, mineral salts and cocoa-derived materials carry the highest risk in this range. 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

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 the coating processes decide which solvents can appear.

Solvent classes and what to declare
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

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.

  • EU — EU MRLs, with the panel size stated.
  • US — EPA tolerances and state-specific requirements.
  • Japan — positive list and market-specific limits.

For botanical powders and extracts, the pesticide panel is agreed with the raw-material supplier and verified on the finished batch when the market requires it.

Microbiology

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.

Microbial panel
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 blending or gummy depositing if the process water or the environment is not controlled.

Labeling and claims

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.

  • US — DSHEA structure/function statements are allowed with the required disclaimer; disease claims are not. The FDA does not approve supplement labels.
  • EU — Regulation 1169/2011 for food information and Regulation 1924/2006 for health claims. Only authorised claims may be used.
  • Allergens — declared in the required format; collagen source and gummy base are part of the declaration.
  • Country of origin — stated where the market requires it.
What we will not write

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.

Certifications and the document pack

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.

Typical document pack
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/collagen source
GMO statement Before the order GMO status of the formula
Halal certificate On request Site and product scope
Organic certificate On request Where the raw material is certified
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.

Product-specific notes

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-specific limit and document
Product Key limit Document to request
Magnesium Malate Powder Heavy metals, elemental limits COA, elemental panel
NAD+ Powder Heavy metals, solvents COA, TDS, identity
Ashwagandha Root Powder Heavy metals, pesticides COA, pesticide panel
Fisetin Powder Heavy metals, pesticides COA, pesticide panel
Silymarin Powder Heavy metals, pesticides COA, pesticide panel
Apple Cider Vinegar Gummies Heavy metals, microbiology COA, TDS, allergen statement
Collagen Gummies Heavy metals, microbiology COA, TDS, collagen source
Spermidine Powder Heavy metals, solvents COA, TDS, related polyamines
Melatonin Powder Heavy metals, market status COA, TDS, import-status note
Oat Beta-Glucan Powder Heavy metals, allergens COA, TDS, gluten/allergen statement

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