A bestiary of the testing world: the regulations, certificates and acronyms, one by one
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A bestiary of the testing world: the regulations, certificates and acronyms, one by one
You have a product and a question. Between you and the answer stand about sixty capital letters. Some are certificates. Some are laws. Some are instruments. Some are numbers that look like results but are not. They are easy to confuse, and confusing them costs money. This is a field guide. Each entry states what the thing is, what it is not, and how much damage follows from mixing it up with its neighbour. Orders I to V cover the EU and the international species. Order VI covers the same ground for the United States, the United Kingdom, Australia and New Zealand, and Canada, where the same animals wear different names.
1Order I — The certificates
Every document in this order ends in a word like "certified" or "accredited". The two words do not mean the same thing. That is the first and most expensive confusion in the whole guide.
Accreditation means a national body has checked that a laboratory is competent to perform specific tests, listed one by one in a scope document. Certification means an auditor has checked that an organisation follows its own written procedures. A certified company may follow its procedures perfectly and still produce a wrong number. Accreditation is about the number. Certification is about the paperwork.
ISO/IEC 17025
The alpha species.
The standard for the competence of testing and calibration laboratories. A laboratory accredited to ISO/IEC 17025 has been assessed by a national accreditation body and holds a scope: a list of the exact tests, matrices and methods it is accredited for. A lab can be accredited for lead in wine and not for lead in honey. The scope is the document to read. The certificate on the wall is only the cover page.
Confusion risk: high. "ISO-accredited lab" without a scope is a phrase, not a fact. Ask what is on the scope.
ISO 9001
The domestic cousin.
A quality-management standard. It applies to any organisation, from a bakery to a bank. It says nothing about whether a measurement is correct. A laboratory certified to ISO 9001 and nothing else has proved that it has a manual and follows it.
Confusion risk: high. ISO 9001 is often quoted where ISO/IEC 17025 was expected. The digits differ; so does the meaning.
ISO/IEC 17043
The examiner.
The standard for proficiency-testing providers. A proficiency test sends the same blind sample to many laboratories and compares their answers. Accredited labs take part in these schemes as a condition of staying accredited. If a laboratory tells you its results are checked externally, this is usually the mechanism.
Confusion risk: low. Rarely misquoted, because rarely quoted at all.
ISO 17034
The keeper of the standards.
The standard for producers of certified reference materials, the samples of known composition that laboratories use to check their instruments. Not a laboratory standard. A supplier of reference materials accredited to ISO 17034 is not thereby accredited to test your sample.
Confusion risk: moderate. The number is close to 17025 and the word "certified" appears on the product.
GLP — Good Laboratory Practice
The regulatory-submission species.
An OECD quality system for non-clinical safety studies submitted to regulators: toxicology, ecotoxicology, physicochemical studies for a REACH dossier. GLP governs how a study is planned, recorded, archived and audited. It is not a measure of analytical accuracy and it is not required for routine testing of a product for sale. If you are not submitting a study to a regulator, you do not need GLP, and a lab that offers it will charge for it.
Confusion risk: moderate. "GLP-compliant" is sometimes used loosely to mean "careful". It has a legal meaning and it is not that.
GMP — Good Manufacturing Practice
The factory species.
A regulatory framework for the manufacture of medicines, and in adapted forms for food, cosmetics and supplements. It applies to the site that makes the product, not to the laboratory that tests it. A GMP certificate for a supplement factory says the factory is inspected. It does not say the batch was tested. Whether GMP requires batch testing, and whether it requires the testing laboratory to be accredited, differs by country. Order VI gives the answer for four of them.
Confusion risk: moderate. Frequently offered as proof of product quality. It is proof of process control at the manufacturer.
CE marking
The mimic.
Two letters that declare a product conforms to the EU legislation that applies to it. For most product categories the manufacturer applies the mark to its own product on its own declaration. No laboratory is involved unless the specific legislation requires one. CE marking is not a test result, not a quality mark and not a certificate issued by anyone else.
Confusion risk: high. It looks like a stamp of approval. It is a statement by the seller.
CoA — Certificate of Analysis
The free-living species.
A document listing the results of tests performed on a batch. No standard defines what a CoA must contain. The word "certificate" carries no legal weight of its own. A CoA is exactly as good as the laboratory that issued it, the method it used and the scope it was accredited for at the time. It can be excellent. It can also be a table typed by the supplier.
Confusion risk: very high. This is the document most often waved as proof, and the one that most often proves nothing. Check who issued it, under what accreditation, and whether the sample described is the batch you received.
2Order II — The bodies
Organisations whose acronyms appear on the certificates above. Two kinds: those that check laboratories, and those that write the rules.
National accreditation bodies — FINAS, UKAS, DAkkS and relatives
The wardens.
Each country has at least one body that accredits laboratories to ISO/IEC 17025. FINAS in Finland, UKAS in the United Kingdom, DAkkS in Germany, and so on. The accreditation body's logo and the lab's accreditation number appear on an accredited test report. If a report carries neither, the results in it are not accredited, whatever the covering letter says.
Global ACI MRA — formerly the ILAC MRA
The treaty, recently renamed.
The international arrangement under which accreditation bodies recognise each other's accreditations. It is the reason a report from a Lithuanian accredited lab is accepted in Finland, Germany or Canada without re-testing. Until the end of 2025 this was the ILAC MRA. On 1 January 2026 ILAC and IAF ceased operations and were replaced by one body, Global Accreditation Cooperation Incorporated (Global ACI), and the arrangement became the Global ACI Multilateral Recognition Arrangement. Existing signatories carried over. The old ILAC mark is still valid for a transition period, so reports issued this year may carry either.
Confusion risk: newly high. Many laboratory websites still say "ILAC MRA signatory" in the present tense. The claim is not wrong; the name is out of date.
ECHA, EFSA, EMA
The EU rule-writers.
The European Chemicals Agency (REACH, CLP), the European Food Safety Authority (risk assessment for food, including contaminant limits) and the European Medicines Agency (medicines). None of them tests your product. They set the numbers that your test result is compared against.
Confusion risk: low, except for the belief that a regulator will tell you whether your batch passes. It will not. That comparison is yours to make.
3Order III — The regulations
Legal texts. Each one has a number, a scope and a habit of being cited in full by people who have not read it.
REACH — Regulation (EC) No 1907/2006
The largest herbivore.
Registration, Evaluation, Authorisation and Restriction of Chemicals. Governs the manufacture and import of chemical substances in the EU. Relevant to you if you make or import a substance in quantity, or if a substance you use is restricted in Annex XVII. Not relevant to a finished food or supplement as such. Its Annex II defines the safety data sheet, which is the part most people meet.
CLP — Regulation (EC) No 1272/2008
The labeller.
Classification, Labelling and Packaging of substances and mixtures. The EU implementation of the UN GHS. It decides the pictograms, signal word and hazard statements on a chemical's label and in its SDS. Applies to chemicals, not to foods or supplements.
GHS
The ancestor.
The UN Globally Harmonized System of Classification and Labelling of Chemicals. Not a law in itself. Each jurisdiction adopts it into its own legislation, and each adopts a different revision at a different time. The four countries in Order VI are on Revision 7 or thereabouts in 2026, and the details differ. CLP is the EU adoption. The H- and P-codes on a label come from here.
SDS — Safety Data Sheet
The sixteen-section species.
The hazard-communication document for a chemical, laid out in sixteen fixed sections under REACH Annex II. Contains classification, handling, storage, transport and disposal information. It is not a certificate of analysis and it does not state purity. MSDS is the older name and is still in use in North America. Same animal, older plumage. The sixteen headings are the same in the EU, the UK, the US, Australia and Canada; what differs is the fine print inside them.
Regulation (EU) 2023/915
The one that matters for food in the EU.
The EU regulation setting maximum levels for contaminants in foodstuffs, including lead, cadmium, mercury and inorganic arsenic. It replaced Regulation (EC) No 1881/2006. Each product category has its own row in Annex I. A supplement, a wine and a rice grain have different limits for the same metal. When a test report says "within limits", this is usually the text being referred to, and the report should say which row. It applies in the EU and, under the Windsor Framework, in Northern Ireland. It does not apply in Great Britain, which still uses the older 1881/2006. See Order VI.
ICH Q3D
The pharmaceutical pack leader.
The international guideline on elemental impurities in medicines. Limits are expressed as a permitted daily exposure in micrograms per day, not per kilogram of product, so a result in mg/kg has to be multiplied by the daily dose before it can be compared. Q3D(R2) sets the oral limits for the four "Class 1" metals at cadmium 5, lead 5, arsenic 15 and mercury 30 µg/day. Several countries borrow these figures for supplements when they have none of their own.
Confusion risk: moderate. A number that passes on a mg/kg basis can fail on a per-dose basis for a high-dose product, and the reverse.
USP <232>, <233> and <2232>
The American branch of the same pack.
United States Pharmacopeia general chapters: <232> sets elemental-impurity limits for medicines, <233> sets the procedures, and <2232> is the dietary-supplement counterpart. All three work per daily dose, like ICH Q3D. The <2232> figures are behind a paywall, and two documents traceable to USP disagree on the lead limit (10 µg/day in the 2013 official text, 5 µg/day in a 2024 printout marked not official). Anyone quoting a <2232> lead figure should say which edition they read.
Novel Food — Regulation (EU) 2015/2283
The gatekeeper.
Governs foods without a significant history of consumption in the EU before 15 May 1997. Relevant to some supplement ingredients, including CBD. Not a testing regulation, but it determines whether a product may be sold at all, which is a question that comes before any test.
4Order IV — The methods and the numbers
Small, fast, and where the actual biting happens. A report is full of these.
ICP-MS, ICP-OES, AAS
The metal-eaters.
Three techniques for measuring elements. ICP-MS (inductively coupled plasma mass spectrometry) is the most sensitive and the routine choice for heavy metals in food at regulatory levels. ICP-OES (optical emission) is less sensitive and suited to higher concentrations. AAS (atomic absorption) is the older technique, still valid, usually one element at a time.
EN 15763
The recipe.
A European standard method: determination of arsenic, cadmium, mercury and lead in foodstuffs by ICP-MS after pressure digestion. When a laboratory is accredited "to EN 15763", that is the method on its scope. It is the method, not the limit. The limit is in Regulation 2023/915.
NMR and qNMR
The structure-readers.
Nuclear magnetic resonance identifies and characterises molecules. qNMR (quantitative NMR) additionally measures how much of a compound is present, against an internal standard, without needing a reference sample of the same compound. Relevant for purity of a defined substance; not a technique for heavy metals.
HPLC, GC-MS, LC-MS/MS
The separators.
Chromatographic techniques that separate the components of a mixture and then detect them. HPLC (liquid chromatography) with UV detection is the workhorse for purity and assay. GC-MS (gas chromatography with mass spectrometry) suits volatile compounds, including residual solvents and many pesticides. LC-MS/MS is the sensitive option for trace organics: mycotoxins, pesticide residues, pharmaceuticals. "HPLC purity 98 %" means 98 % of the detected peak area, under that method. It does not mean 98 % by weight.
LOD and LOQ
The horizon.
Limit of detection and limit of quantification. Below the LOD the method cannot tell the analyte from nothing. Between LOD and LOQ it can tell something is there but cannot put a reliable number on it. Above the LOQ it reports a value. "Not detected" means below the LOD, and the LOD should be stated. A report that says "not detected" without a number has told you very little.
MU — Measurement uncertainty, and k = 2
The honest margin.
Every measured value has an uncertainty. On an accredited report it is stated, usually as ± a value with a coverage factor k = 2, meaning roughly 95 % confidence that the true value lies within the interval. A result of 0.95 mg/kg ± 0.20 against a limit of 1.0 mg/kg is not clearly below the limit. How that case is decided is called the decision rule, and the report should state which one was used. Part 3 of the Heavy Metals series covers this in full.
CRM
The known quantity.
Certified reference material. A sample with a certified value and uncertainty, produced under ISO 17034, that the laboratory runs alongside yours to prove the method is working that day. Not the same as a CoA. Not the same as a reagent.
Recovery and RSD
The housekeeping numbers.
Recovery is what fraction of a known added amount the method finds; 90–110 % is the usual acceptable range. RSD (relative standard deviation) is the repeatability. Both appear in validation data rather than on a routine report. If you see them, the lab is showing its working.
Total arsenic and inorganic arsenic
Two species with one name.
Arsenic in food exists in organic forms, which are largely harmless and common in seafood, and inorganic forms, which are toxic. A routine ICP-MS result gives total arsenic. Most modern limits, such as the EU rows for rice, the US action levels and the Australian entries for fish and seaweed, are written for inorganic arsenic, which needs a separate speciation analysis. A total-arsenic result compared against an inorganic-arsenic limit is not a comparison. Check which one the limit names and which one the report measured.
Confusion risk: very high, and the cost runs both ways. Total arsenic can fail a product that would pass on speciation.
5Order V — The identifiers
Tags on the animals. Each one identifies a substance or a consignment, and each one is regularly given to the wrong thing.
- CAS number — a registry number for a chemical substance, assigned by the Chemical Abstracts Service. One substance, one number; but hydrates, salts and isomers each have their own. The most reliable way to say which substance you mean.
- EC number — the EU inventory number for a substance (EINECS, ELINCS or the NLP list). Appears on SDSs and REACH registrations. Not the same as the CAS number and not interchangeable with it.
- InChIKey — a fixed-length hash of a molecule's structure. Machine-readable, searchable, and the reason a database can tell two names for the same compound apart.
- UN number — a four-digit code for a dangerous good in transport, used under ADR (road), IMDG (sea) and IATA DGR (air). Identifies the hazard class, not the substance uniquely; many substances share a UN number.
- HS code — the customs tariff code. Identifies what the product is for duty purposes. Says nothing about its chemistry or safety.
- RTECS — a toxicological database registry number. Occasionally still printed on SDSs. Of historical interest.
6Order VI — The same animals abroad
The EU species above have relatives in the United States, the United Kingdom, Australia and New Zealand, and Canada. The relatives look similar, answer to different names, and in several cases have no number at all where the EU has one. Each country below is taken in the same order: food limits, supplements, chemicals and safety data sheets, accreditation, manufacturing, and transport. A table at the end of the section puts the supplement limits side by side.
United States
FDA action levels. The non-binding species. The FDA sets "action levels" for some contaminants in some foods: lead in processed food for children under two (10 ppb for most categories, 20 ppb for root vegetables and dry infant cereals), inorganic arsenic in infant rice cereal (100 ppb) and apple juice (10 ppb), methylmercury in fish (1 ppm). By the FDA's own wording, action levels "do not establish a permissible level of contamination" and guidance "is not legally binding". They are the threshold at which the FDA will consider enforcement. There is no FDA action level for cadmium in any food, and no FDA numeric limit for any heavy metal in dietary supplements.
DSHEA and the NDI notification. The gatekeeper that mostly waves you through. Under the Dietary Supplement Health and Education Act of 1994 the manufacturer is responsible for safety and labelling, with no FDA approval before sale. An ingredient not marketed in the US before 15 October 1994 needs a New Dietary Ingredient notification 75 days before sale. It is a notification, not an approval: silence from the FDA is not a finding that the ingredient is safe.
21 CFR Part 111. American GMP for supplements. Binding regulation for supplement manufacture. It requires identity testing of each ingredient, and finished-product testing of a statistically chosen subset of batches or of every batch, against specifications the firm itself sets. It contains no contaminant numbers. It does not require the testing laboratory to be accredited.
LAAF. The narrow-scope species. The FDA's Laboratory Accreditation for Analyses of Foods programme requires ISO/IEC 17025:2017 accreditation by an FDA-recognised body, but only for testing in a closed list of circumstances: sprouts, shell eggs, bottled water, directed laboratory orders, evidence in regulatory proceedings, import admission and removal from an import alert. Routine quality testing is not on the list.
Proposition 65. The Californian, measured in micrograms per day. Safe-harbour levels are daily exposure figures, not concentrations in the product, and they are far below anything in food law. Lead: 0.5 µg/day (reproductive harm); cadmium: 4.1 µg/day oral; inorganic arsenic: 10 µg/day oral for cancer. There is no Proposition 65 safe-harbour figure for mercury at all. To compare a mg/kg result you need the daily serving size.
OSHA Hazard Communication Standard, 29 CFR 1910.1200. The American CLP, currently changing coat. The US adoption of UN GHS, updated in 2024 to Revision 7. Manufacturers had until 19 May 2026 for substances and have until 19 November 2027 for mixtures; employers follow six months later in each case. Until then the old and new versions are both acceptable, so SDSs from US suppliers may follow either. TSCA, the chemicals inventory law, excludes food, drugs, cosmetics and pesticides.
A2LA, ANAB, PJLA. Several wardens, none governmental. The US has no single national accreditation body. These three private bodies accredit laboratories to ISO/IEC 17025 and are recognised under the Global ACI arrangement.
NSF/ANSI 173. The voluntary badge. An American National Standard for dietary supplements, covering heavy metals, pesticides, microbes, label claims and GMP. A certification scheme, not law. Its numeric limits are inside a paid standard.
49 CFR Hazardous Materials Regulations. The US transport rules, from the Department of Transportation. Derived from the UN Model Regulations like ADR, but a distinct instrument; ADR itself does not apply in the US.
United Kingdom
Assimilated Regulation 1881/2006. The retired EU ancestor, still working in Great Britain. Great Britain never adopted Regulation 2023/915, which entered into force after the UK left the EU. England, Wales and Scotland apply the old 1881/2006, frozen as "assimilated" law. Its food-supplement rows: lead 3.0 mg/kg, cadmium 1.0 mg/kg (3.0 for supplements mainly of seaweed or dried bivalves), mercury 0.1 mg/kg. There is no arsenic row for supplements; the only arsenic entries are inorganic arsenic in rice. Northern Ireland applies 2023/915 under the Windsor Framework. One island, two limit tables.
Food Supplements Regulations 2003. Defines what a supplement is, which vitamins and minerals it may contain and how it is labelled. Sets no contaminant limits.
GB CLP and UK REACH. The post-Brexit twins. GB CLP is the assimilated 1272/2008 with the HSE as the agency; it does not apply in Northern Ireland, where EU CLP does. UK REACH is the GB registration system; its transitional registration deadlines were moved in July 2026 to 27 October 2029, 2030 and 2031 by tonnage band. The GB safety data sheet is still on the 2015 EU format: no unique formula identifier, no endocrine-disruptor line, no section 11.2. A GB SDS and an EU SDS for the same product now differ, and both are correct where they were issued.
UKAS. The sole national accreditation body for the UK, appointed by the Secretary of State. One warden, not several.
MHRA GMP. Applies to medicines. Its guidance does not mention food or supplements. Supplements in Great Britain fall under food hygiene law (assimilated Regulation 852/2004), which requires HACCP procedures and nothing about batch testing or accredited laboratories.
Novel foods and CBD. The assimilated 2015/2283 applies in Great Britain, with the same 15 May 1997 cut-off and the Food Standards Agency as the authority. The FSA classes CBD extracts and isolates as novel foods; none has been authorised. Its stated figures: CBD 10 mg/day for healthy adults, delta-9-THC 70 µg/day.
CDG 2009. The Carriage of Dangerous Goods Regulations apply ADR by reference in Great Britain, "as revised or reissued from time to time", so the ADR edition in force follows automatically.
Australia and New Zealand
Food Standards Code, Standard 1.4.1 and Schedule 19. The joint species. Food Standards Australia New Zealand sets maximum levels for contaminants in Schedule 19, section S19—4, in mg/kg by food. It distinguishes "Arsenic (total)" (cereals 1, salt 0.5) from "Arsenic (inorganic)" (fish and crustacea 2, molluscs and seaweed 1). Mercury in fish is handled by a sampling table, S19—7, with mean and maximum levels per lot. There is no row for supplements, complementary medicines, vitamins or minerals anywhere in the Schedule. FSANZ writes the Code; the states and territories enforce it.
TGA and the ARTG. The list you join by declaring yourself fit. Complementary medicines in Australia are therapeutic goods, regulated by the Therapeutic Goods Administration. A "listed medicine" (AUST L) is entered on the Australian Register of Therapeutic Goods on the sponsor's own certification; the TGA states plainly that listed medicines "are not individually evaluated by the TGA before they are released onto the market". Testing and release for supply are legally steps in manufacture, so the site doing them needs a TGA manufacturing licence or a GMP clearance. We found no requirement for a NATA-accredited laboratory.
TGO 101. The standard for tablets, capsules and pills. Where no pharmacopoeial monograph applies, TGO 101 sets the heavy-metal requirement for tablets and capsules by pointing at either USP <2232> or ICH Q3D. For pills it also sets concentration caps: arsenic 2 ppm, cadmium 1 ppm, lead 5 ppm, mercury 0.2 ppm. Australia's own instrument therefore prints no per-day metal limit for tablets and capsules; it borrows one.
PIC/S GMP. Australia adopts the PIC/S Guide to GMP (PE009-17 from September 2025). Every finished batch must pass release for supply, signed off by an authorised person with the batch certificate of analysis to hand.
GHS 7, the WHS Regulations and AICIS. Since 1 January 2023 only GHS Revision 7 may be used for workplace chemicals, in every state including Victoria, which runs its own regulations. An Australian SDS must carry an Australian address and an Australian emergency telephone number. AICIS is the industrial-chemicals introduction scheme; it excludes food, therapeutic goods and agricultural chemicals.
NATA. The National Association of Testing Authorities, Australia: the accreditation body recognised by government for ISO/IEC 17025, and a Global ACI signatory.
ADG Code 7.9. The Australian Code for the Transport of Dangerous Goods by Road and Rail, mandatory nationally from 1 October 2025. Each state gives it legal force separately.
New Zealand: Dietary Supplements Regulations 1985. The species with no limits. Since December 2024 the regulations state that the joint food standards do not apply to dietary supplements, so Schedule 19 does not reach them. The regulations themselves set maximum daily doses for a few vitamins and minerals and no contaminant limits of any kind. There is no pre-approval process.
Canada
Natural Health Products Regulations and the NPN. The licensed species. Supplements in Canada are natural health products. No one may sell one without a product licence, which carries a Natural Product Number printed on the label. Manufacturers, packagers, labellers and importers also need a site licence. Testing laboratories do not. Every lot must be approved by a quality assurance person before sale; the GMP guide says you should "ideally" use an accredited laboratory, naming ISO/IEC 17025:2017 as one acceptable qualification, but nothing makes it mandatory.
NNHPD Quality Guide, version 3.1. The per-day table that is about to change. The guide in force sets adult limits per day at the maximum recommended dose: total arsenic under 10.0 µg, inorganic arsenic under 2.1 µg, cadmium under 6.0 µg, lead under 10.0 µg, total mercury under 20.0 µg, methylmercury under 2.0 µg. A draft version 4.0, published July 2026 and not in force, realigns them to ICH Q3D: lead and cadmium would fall to 5 µg/day, total arsenic would rise to 15. Anyone testing for the Canadian market should ask which version the customer's specification follows.
List of Contaminants and Other Adulterating Substances in Foods. The binding list with gaps. Incorporated by reference into the Food and Drug Regulations, so its maximum levels are law. It carries lead (fruit juice 0.05 ppm, beverages 0.2 ppm, infant formula 0.01 ppm, among others) and inorganic and total arsenic (white rice 0.2 ppm, brown rice 0.35 ppm, fruit juice 0.01 ppm). It has no entry for cadmium and none for mercury. Mercury in fish (0.5 mg/kg, 1 mg/kg for named large species) sits on a separate Health Canada maximum-levels page with a different legal footing. Health Canada sets the standards; the CFIA enforces them.
WHMIS, the Hazardous Products Act and the HPR. Canadian CLP, transition complete. The Hazardous Products Regulations align with GHS Revision 7 and parts of Revision 8; the three-year transition ended on 14 December 2025 and all products must now comply. The Hazardous Products Act excludes food, drugs, cosmetics, consumer products and pesticides. Suppliers classify and write the SDS under federal law; employers train workers under provincial law. Health Canada now calls it plain "WHMIS"; "WHMIS 2015" is the older name still on some government pages.
SCC and CALA. Two wardens, one governmental. The Standards Council of Canada is a federal Crown corporation that accredits laboratories to ISO/IEC 17025. The Canadian Association for Laboratory Accreditation is a private body doing the same in six fields, including food and cannabis, with its own international recognition. Neither is subordinate to the other.
TDG Act and Regulations. The Transportation of Dangerous Goods regime, from Transport Canada, covers road, rail, marine and air in one set of regulations. It incorporates the UN Model Regulations, the ICAO Technical Instructions and the IMDG Code "as amended from time to time". It is separate from WHMIS: a shipping document is not an SDS.
One table to keep: heavy-metal limits for supplements, by country
The table below puts the supplement limits of each jurisdiction side by side. The column "basis" is the one to read first: a limit per kilogram of product and a limit per day of intake cannot be compared without the daily dose.
| Jurisdiction | Instrument | Basis | Lead | Cadmium | Mercury | Arsenic |
|---|---|---|---|---|---|---|
| Per kilogram of product | ||||||
| EU and Northern Ireland | Regulation (EU) 2023/915, food-supplement rows | mg/kg | 3.0 | 1.0 (3.0 seaweed or bivalve supplements) | 0.10 | no row |
| Great Britain | Assimilated Regulation 1881/2006, food-supplement rows | mg/kg | 3.0 | 1.0 (3.0 seaweed or bivalve supplements) | 0.1 | no row |
| Australia, pills only | TGO 101, Schedule 3 Part 6 | ppm, plus a per-day cap | 5 | 1 | 0.2 | 2 |
| Per day of intake | ||||||
| Canada | NNHPD Quality Guide v3.1, in force | µg/day at maximum daily dose | < 10.0 | < 6.0 | < 20.0 total; < 2.0 methylmercury | < 10.0 total; < 2.1 inorganic |
| Canada | NNHPD Quality Guide v4.0, draft, not in force | µg/day | < 5.0 | < 5.0 | < 15.0 total; < 2.0 methylmercury | < 15.0 total |
| Australia, tablets and capsules | TGO 101 s16, by reference to USP <2232> or ICH Q3D | µg/day | the figures of whichever chapter is used; see the two rows below | |||
| International | ICH Q3D(R2), Class 1 oral | µg/day | 5 | 5 | 30 | 15 |
| United States | USP <2232> | µg/day | paywalled; lead is 10 in the 2013 official text and 5 in a 2024 printout marked not official | |||
| California | Proposition 65 safe-harbour levels | µg/day of exposure | 0.5 | 4.1 (oral) | no figure | 10 (oral, inorganic) |
| No numeric limit | ||||||
| United States | FDA | — | no action level or maximum for any heavy metal in dietary supplements | |||
| New Zealand | Dietary Supplements Regulations 1985 | — | no contaminant limits; the joint food standards do not apply to dietary supplements | |||
The simple rule is:
Before comparing a result with a limit, find out which country the product is sold in, whether the limit is per kilogram or per day, and whether the arsenic figure means total or inorganic arsenic. Three questions, and most mistakes are one of the three.
7How to read a test report in four questions
The bestiary is long. The practical use of it is short.
- Who measured it, and are they accredited for this test? Look for the accreditation body's mark and the lab's number on the report. Then check that this test, on this kind of sample, is on the scope.
- What method, and what are the reporting limits? The method name (EN 15763, a USP chapter, an in-house validated method) and the LOQ for each analyte.
- What is the uncertainty? A value without ± is a value without context.
- What is the result being compared against, if anything? A regulation row, a per-day limit multiplied by the dose, a customer specification, and in which country. That comparison is not the laboratory's job. It is yours, and now you have the vocabulary for it.
Testing from NorrChemica
We arrange heavy metals by ICP-MS and NMR analysis through EU laboratories accredited to ISO/IEC 17025, and report the measured values with the method, the reporting limits, the uncertainty and the accreditation status of the measuring laboratory. Tell us what the product is, where it is sold and what question you need answered; we work out which analysis answers it, what it costs and how long it takes, at no charge and with no obligation to order. Anyone can order. You do not need to be a company.
Request testing → How to read a test report The EU maximum levelsSources
- Commission Regulation (EU) 2023/915 on maximum levels for certain contaminants in food, consolidated text: the food-supplement rows for lead, cadmium and mercury and the arsenic section, which has no supplement row. EUR-Lex
- Regulation (EC) No 1907/2006 (REACH), Article 31 and Annex II; Regulation (EC) No 1272/2008 (CLP); Regulation (EU) 2015/2283 on novel foods. REACH · CLP · Novel foods
- ICH Harmonised Guideline Q3D(R2), Guideline for Elemental Impurities, adopted 26 April 2022: Class 1 oral permitted daily exposures. ICH
- Global Accreditation Cooperation Incorporated: launch on 1 January 2026, replacement of the ILAC MRA and IAF MLA by the Global ACI MRA, carry-over of signatories, and document MRA-006 on transitional use of the old marks. Global ACI · ILAC notice
- US FDA: Closer to Zero programme; Guidance for Industry, Action Levels for Lead in Processed Food Intended for Babies and Young Children (January 2025); action level for inorganic arsenic in infant rice cereal (2020) and in apple juice (2023); CPG Sec. 540.600 on methylmercury; Lead in Food, Foodwares, and Dietary Supplements page. Closer to Zero · Lead and supplements
- US Code of Federal Regulations: 21 CFR Part 111 (dietary supplement CGMP, sections 111.75 and Subpart J); 21 CFR 190.6 (new dietary ingredient notification); 21 CFR Part 1 Subpart R (LAAF); 29 CFR 1910.1200 (Hazard Communication Standard) and the final rules of 20 May 2024 and 15 January 2026; 49 CFR Subchapter C (Hazardous Materials Regulations). Part 111 · LAAF · HCS · Extension of compliance dates
- US FDA, Dietary Supplements and New Dietary Ingredient notification pages; US EPA, Summary of the Toxic Substances Control Act. FDA · EPA
- California OEHHA, Proposition 65 No Significant Risk Levels and Maximum Allowable Dose Levels, live table (page modified 30 April 2026). OEHHA
- USP, Elemental Impurities updates page, and the 2013 official text of General Chapter <2232> posted on uspnf.com; the current chapter is paywalled. NSF/ANSI 173-2024, Dietary Supplements, ANSI webstore listing. USP · ANSI
- legislation.gov.uk: assimilated Commission Regulation (EC) No 1881/2006, Annex, Section 3; assimilated REACH Annex II; assimilated CLP; The Food Supplements (England) Regulations 2003; The Carriage of Dangerous Goods and Use of Transportable Pressure Equipment Regulations 2009; The REACH (Amendment) (No. 2) Regulations 2026. 1881/2006 Annex · REACH Annex II · SI 2026/849
- Food Standards Agency: Chemical contaminants guidance (England and Wales under 1881/2006, Northern Ireland under 2023/915); Cannabidiol (CBD) guidance (updated 28 August 2026); Novel foods authorisation guidance. Contaminants · CBD
- Health and Safety Executive: the CLP Regulation in Great Britain; UK REACH registration deadlines; Carriage of dangerous goods regulations. UKAS, About UKAS. MHRA, Good manufacturing practice and good distribution practice. GB CLP · UK REACH · UKAS · MHRA GMP
- Australia New Zealand Food Standards Code: Standard 1.4.1 (Contaminants and natural toxicants) and Schedule 19 (compilation of 13 September 2024); Standard 1.5.1 (Novel foods). FSANZ, What we do. Schedule 19 · Standard 1.4.1
- Therapeutic Goods (Standard for Tablets, Capsules and Pills) (TGO 101) Order 2019, sections 16 and 28 and Schedule 3; TGA guidance on complying with TGO 101, on release for supply, on sampling and testing for listed and complementary medicines, and on listed medicines for new sponsors; Therapeutic Goods (Manufacturing Principles) Determination 2020. TGO 101 · TGA guidance · Release for supply
- Safe Work Australia, Transition to GHS 7; WorkSafe Victoria, Transition to GHS 7; AICIS, Who we are and what we do; NATA, About NATA; Victoria Government Gazette No. S 151, 1 April 2025 (ADG Code 7.9). GHS 7 · NATA · ADG 7.9
- New Zealand: Dietary Supplements Regulations 1985 (version as at 18 December 2024, regulation 2B); Medsafe, Regulation of Dietary Supplements. DS Regulations · Medsafe
- Health Canada: Quality of Natural Health Products Guide, version 3.1, Table 1; draft Quality of natural health products guide, version 4.0 (July 2026, consultation); Site Licensing Guidance Document, version 3.0; Good manufacturing practices guide for natural health products (GUI-0158), version 4.0; Natural Health Products Regulations, SOR/2003-196, sections 4, 8, 44, 51 and 93. Quality Guide · GUI-0158 · NHPR
- Health Canada: List of Contaminants and Other Adulterating Substances in Foods (modified 24 July 2026); Maximum Levels for Chemical Contaminants in Foods. CFIA, Food safety standards and guidelines. List of Contaminants · Maximum levels
- Hazardous Products Act, R.S.C. 1985, c. H-3, section 12 and Schedule 1; Hazardous Products Regulations, SOR/2015-17, section 4 and Schedule 1; Health Canada, Amended Hazardous Products Regulations and the WHMIS programme newsletter of March 2026. HPA · Amended HPR
- Standards Council of Canada, Testing and calibration laboratories; Canadian Association for Laboratory Accreditation, Accreditation; Transportation of Dangerous Goods Act, 1992 and Regulations, SOR/2001-286 (last amended 17 June 2026). SCC · CALA · TDGR
About this article
We read the EU regulations, the legal texts and the regulator pages of the four non-EU jurisdictions on 5 and 6 September 2026, on the regulators' own sites or on the official legislation portals. The ISO standards and the USP chapters are sold, not published free; their entries are based on their published titles and scopes, and where two USP-traceable documents disagree we say so rather than choose. Legislation changes; the figures here are those in force on the reading date, and the draft Canadian guide is marked as a draft. This article is not legal advice and does not assess any particular product. We will date future revisions.
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