In brief
A Certificate of Analysis (COA) is a formal laboratory report that describes the results of the analysis of one specific batch of kratom powder or extract. It is issued by an accredited laboratory, and in the Czech Republic the COA is one of the documents that a distributor with a PML licence retains as part of the batch records under Act No. 167/1998 Coll., as amended with effect from 1 January 2026.
What a COA is
A COA is a standardised document that identifies the tested material (batch number, production date, supplier) and states the results of laboratory tests, including:
- the content of the main alkaloids (mitragynine, 7-hydroxymitragynine, possibly others),
- the content of selected heavy metals (Pb, Cd, Hg, As, possibly Ni),
- the content of mycotoxins (aflatoxins B1, B2, G1, G2; ochratoxin A),
- microbiological parameters (TAMC, TYMC, E. coli, salmonella),
- the content of polycyclic aromatic hydrocarbons (PAH), if relevant for the given type of processing,
- granulometry and water content.
A COA contains no recommendation for use and no "quality rating" - it is the measured state of the sample at a specific point in time.
The main sections of the report
Header
Contains the identification of the laboratory (name, address, accreditation number per ISO/IEC 17025, in the Czech Republic accreditation by ČIA), the identification of the client, the batch number, the date the sample was received and the date the report was issued.
Active substances
States the content of the main alkaloids, typically expressed as a percentage of dry matter or mg/g. For kratom the standard is the determination of mitragynine and 7-hydroxymitragynine by HPLC-DAD or HPLC-MS/MS.
Heavy metals
Determination performed by ICP-MS, the result expressed in mg/kg. Standard monitored elements: lead (Pb), cadmium (Cd), mercury (Hg), arsenic (As), possibly nickel (Ni).
Mycotoxins
HPLC or LC-MS/MS analysis with detection of aflatoxins (B1, B2, G1, G2 and their sum) and ochratoxin A. The result in μg/kg.
Microbiology
TAMC (total aerobic microbial count), TYMC (total yeast and mould count), specific pathogens (E. coli, Salmonella spp.). Values in CFU/g.
Conclusion
An overall status ("complies" / "does not comply") with respect to the reference standard stated in the report header.
What a batch (lot) number is and why it matters
A batch number (lot, batch number) is a unique identifier of a specific volume of material produced in one production cycle (typically one field, one drying day, one fermentation batch). The batch is the key link between the COA and the physical product:
- each batch has a separate COA,
- a distributor with a PML licence must be able to locate the COA in the records by the batch number,
- on import the batch number is part of the customs declaration.
Without a batch number, a COA cannot be unambiguously matched to the physical material - such documentation is insufficient for the purposes of 167/1998 Coll.
How to interpret the results (status V, Vn, N)
Some laboratories use an abbreviated status code:
- V (complies) - the value is below the legislative limit,
- Vn (complies with a note) - the value is below the limit but approaches it or is above the usual value; an extended comment is in the note,
- N (does not comply) - the value has exceeded the legislative limit.
It is always necessary to know against which standard the result is assessed - limits for kratom as PML may derive from a different legal basis than limits for food supplements (for example, the cadmium limit in plant raw materials under EU Regulation 2023/915 versus the pharmacopoeial limit under USP <232>).
The relationship of the COA to regulation from 2026
Under the amendment to Act No. 167/1998 Coll., effective from 1 January 2026, the COA is one of the documents that a PML distributor must have available for each batch. SÚKL and the Czech Trade Inspection may require the COA during an inspection. Without a COA, distribution is in breach of the record-keeping obligation under Sections 3 and 5 of the Act.
Frequently asked questions
Must every batch have a COA?
Yes. Under the PML regime under 167/1998 Coll., the COA is part of the mandatory batch records. A distributor without a COA does not fulfil the record-keeping obligation.
Who performs the tests?
An accredited testing laboratory under the standard ČSN EN ISO/IEC 17025. In the Czech Republic accreditation is granted by the Czech Accreditation Institute (ČIA). The accreditation number is stated in the report header.
How can the authenticity of a COA be verified?
Three steps: (1) verify the laboratory's accreditation number in the ČIA register, (2) contact the laboratory with the report number to confirm issuance, (3) compare the sample parameters in the COA with the physical packaging (batch number, date).
Is a COA the same as a label?
No. A label is information for the consumer on the packaging; a COA is a laboratory report stored by the distributor. Some data (the content of the main alkaloids) may be transferred from the COA to the label.
References
- ČSN EN ISO/IEC 17025:2018. General requirements for the competence of testing and calibration laboratories.
- Czech Accreditation Institute (ČIA). Register of accredited entities.
- Act No. 167/1998 Coll., on addictive substances, as amended (amendment effective from 1 January 2026).
