What a certificate of analysis actually contains

By Therapium

A certificate is about one batch and nothing else

This is the part most people skip, and it decides whether the rest of the document means anything.

A batch is a single production run: one filling, on one day, from one set of raw materials. It is given a code, the code is printed on the pack, and everything the laboratory says applies to that code and nothing else. A certificate for a different batch, however clean its numbers, tells you nothing about the bottle in your hand.

So the first thing to do with any certificate is not to read the results. It is to compare the batch on the document with the batch on the pack.

What is actually on the page

The header

A usable certificate names five things before it names a single result: the laboratory, the report number, the date, the sample as received, and the batch. Ours reads PLENUM Dr. Born, Ennepetal, report BOD/17/02/25, dated 17 February 2025, batch V0206.

Those five make it checkable. A laboratory with a town attached can be looked up. A report number can be quoted back. A date tells you whether this is recent work or a document from three product generations ago. Remove any of the five and the page becomes decoration.

Heavy metals

Four elements appear on almost every food supplement certificate: lead, arsenic, cadmium and mercury. Nobody adds them. They occur in soil and water and travel into food through plants and through processing, so the question is never whether they exist but whether they are present above a limit.

The limits are set in law. Commission Regulation (EU) 2023/915 lays down maximum levels for certain contaminants in food, food supplements included. A result only means something when you can see it next to that maximum. A certificate that prints a figure with no limit beside it is asking you to be impressed by a number.

On report BOD/17/02/25, lead, arsenic, cadmium and mercury each came back below the laboratory’s reporting limit.

Why “below the reporting limit” is not “zero”

This is the most misread line on any certificate, and it is worth being exact about.

Every analytical method has a floor. Below a certain concentration an instrument can still see something but cannot say reliably how much; below a lower concentration it sees nothing at all. Laboratories express this as a limit of detection and a limit of quantitation, and the figure they report against is usually the second, often called the reporting limit.

So < 0.01 mg/kg means: whatever is there, this method could not measure it above one hundredth of a milligram per kilogram. It does not mean nothing is there. It means nothing was measurable at that sensitivity.

That is not evasion — a laboratory writing “0” would be claiming a precision no instrument has. What you want is the reporting limit printed beside the result, because the two together are the statement. A very low reporting limit with a “below” result is a strong finding. A high one with a “below” result is a much weaker finding wearing the same words.

Microbiology

Two kinds of number appear here and they work differently.

Some organisms are counted. Total viable count, yeasts, moulds: the result is colony-forming units per gram, with a threshold it has to stay under.

Others are tested for presence or absence in a stated mass of sample. Salmonella is the standard example, and the convention set out in Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs is absence in 25 g. There is no such thing as a low level of salmonella on a certificate. It is found or it is not.

On our report, salmonella and E. coli were negative.

A free-sale certificate is a different document

The second document we hold is not an analysis and should not be read as one.

A certificate of free sale attests that a product may lawfully be placed on the market in the country where it is made. It is a marketability document, used mostly for export. It says the product is legal there. It tests nothing.

Ours was issued by UBF GmbH in Altlandsberg on 14 July 2026 for batch A0206BODDK, best before 06/2028. That is a different batch code from the one on the analysis report above, because the two documents were produced at different times for different purposes. Ordinary — and exactly why the batch check comes first. If you want to know what the analysis says for the batch printed on the bottle you were sent, ask by that number.

HACCP, GMP and ISO 22000 certify three different things

These three usually appear in one breath, which makes them look like three grades of one badge. They are not.

HACCP — Hazard Analysis and Critical Control Points — is a method: work out where in a process something can go wrong, decide what to measure there, and document what happens when a measurement falls out of range. In the EU it is not optional. Article 5 of Regulation (EC) No 852/2004 requires food business operators to put HACCP-based procedures in place. A manufacturer telling you it works to HACCP is telling you it obeys the law. That is a floor, not a distinction.

ISO 22000 is an international standard for a food safety management system. It is certifiable: a third-party certification body audits the site and issues a certificate with a scope and an expiry date. This is the one where a document exists to ask for, and the useful questions are who certified it, for what scope, and when it runs out.

GMP — good manufacturing practice — is the loosest of the three on a food. For medicines, GMP is a statutory regime with inspections by a medicines regulator. For food supplements it is generally a private or industry scheme, and there is more than one. “Made under GMP” is incomplete until you know which scheme and who audited against it.

Our bottles are filled by Brands on Demand UG in Berlin under HACCP, GMP and ISO 22000 certified conditions. We write it that way because that is what the manufacturer certifies. You now know what each of the three words is worth on its own, which is more useful than the sentence.

What a certificate of analysis cannot tell you

  • Whether the product does anything. A certificate measures composition and contamination. It has no opinion about effect, and nobody should present it as though it had one.
  • Whether your bottle is covered, unless the batch matches.
  • Anything that was not tested. A certificate states its scope. Substances outside it were not looked for, and their absence from the page is not a result.
  • Whether the sample was representative. It reports on the sample the laboratory received.

Asking for one

Any seller can be asked for the certificate covering a named batch. It is a reasonable question, it costs nothing to answer, and the answer is informative either way — including when there is no answer.

For ours: email office@therapiummed.com with the batch code from your bottle and we will tell you what the report for that batch says — laboratory, report number, and each result against its limit. Not a summary, and not the figures from a different batch.