A label that is lawful in Cape Town can be unlawful in Chicago, Copenhagen, Osaka and Riyadh on the same day, for four different reasons. Sesame is a major food allergen in the United States and not a named allergen under South African law. Rye is a mandatory declaration in the European Union and not a major food allergen in the United States. India collapses peanut and every tree nut into the prescribed word “Nut” where the United States requires the species. Japan decides on an analytical result, not your recipe.
Each reflects the prevalence pattern of the population an authority regulates for. The consequence for a South African exporter is that R146’s eight groupings are not a starting point for an export label — they are a different label. This states the position as at September 2026 and is not legal advice: confirm every destination requirement with the competent authority or a qualified adviser before artwork goes to plate.
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Which allergens must each export market require?
No two mandatory lists are the same, and none is a superset of the others. The European fourteen omit pine nut and buckwheat; the American nine omit molluscs, celery, mustard and lupin and cover only wheat among the cereals; Codex names tree nuts by species and puts soy in a discretionary tier. Build a market register, never an “international” list.
| Market | Instrument | Mandatory list | Mechanics |
|---|---|---|---|
| South Africa | R146 of 2010 under Act 54 of 1972; draft R3337 not in force | Eight groupings; crustaceans and molluscs combined; tree nuts as a group; no sesame, mustard, celery or lupin; sulphur dioxide from 10 mg/kg | Parenthesis and/or a “Contains” block; no emphasis rule |
| European Union | Regulation (EU) No 1169/2011, Article 9(1)(c), Annex II | Fourteen. Item 1 names wheat, rye, barley and oats; item 8 names eight tree nuts and not pine nut; item 12 sulphites above 10 mg/kg | Article 21 emphasis in the ingredient list, every occurrence |
| United States | FALCPA and the FASTER Act; 21 CFR Part 117; 21 CFR 101.91 | Nine. Wheat only among cereals; no molluscs, celery, mustard or lupin; sesame since 1 January 2023; species required for tree nuts, fish and crustacean shellfish | Parenthesis or a “Contains” statement; no emphasis requirement |
| Canada | Food and Drug Regulations, B.01.010.1 onwards | Nine tree nuts individually, including pine nut; triticale; mustard; molluscs via “shellfish”; gluten sources include oats; added sulphites from 10 ppm | A “Contains” statement must be exhaustive and share the ingredient list’s background colour or borders |
| Japan | Food Labeling Standards under the Food Labeling Act | Nine specified ingredients from 1 April 2026; twenty recommended items, which include soy and sesame | Triggered at 10 µg allergenic soluble protein per gram; ELISA screening with Western blot or PCR confirmation |
| China | GB 7718-2025, published 27 March 2025, implementation 16 March 2027 | Eight categories, mandatory for the first time; molluscs and sesame not among the reported eight | Bold or underline in the ingredient list, or a dedicated allergen statement beside it |
| India | Labelling and Display Regulations 2020, regulation 5(14) | Eight items; peanut and every tree nut declared as “Nut”; sulphite from 10 mg/kg | A separate “Contains…” statement in prescribed words |
| Australia and New Zealand | Food Standards Code, Standard 1.2.3 and Schedule 9 | Wheat; barley, oats, rye where they contain gluten; nine tree nuts individually; fish, crustacean and mollusc separately; egg, milk, peanut, soy, sesame, lupin; sulphites | Two declarations: bold prescribed names in the ingredient list and a bold “Contains” summary in the same field of view |
Behind every one of those labels sit two domestic instruments made under Act 54 of 1972 — R146 of 2010 for the declaration, R638 of 2018 for premises, transport and recall notification — with the Consumer Protection Act 68 of 2008 running alongside. The ASC export compliance module builds the market register from them.
Does a South African allergen label comply in the EU?
No. Regulation (EU) No 1169/2011 requires fourteen allergens, four of which — sesame, celery, mustard and lupin — are not common allergens under R146, and it requires each one to be emphasised in the ingredient list by a typeset that clearly distinguishes it, every time it appears. A South African pack with an unemphasised ingredient list does not comply, whatever its “Contains” box says.
Three further divergences catch exporters. Annex II item 1 names wheat, rye, barley and oats separately, so “gluten” alone never substitutes for naming the cereal. Item 8 names eight tree nuts and does not include pine nut, which is declarable in Canada, Australia and New Zealand. And item 12 applies to sulphites at more than 10 mg/kg, against Codex’s “10 mg/kg or more”: at exactly 10 mg/kg the texts do not agree.
Article 44 makes allergen information mandatory for non-prepacked food, so a European food-service customer needs a clean allergen summary in your specification. The United Kingdom retains the same fourteen and adds, under Natasha’s Law, full ingredient labelling with emphasis for food prepacked for direct sale — so your specification becomes the raw material for a British operator’s statutory label.
What the European Union does not do is regulate precautionary labelling. A draft act and an EFSA review of the Codex reference doses are reported as in progress; both are secondary reports and neither is law, so treat them as you treat draft R3337 in South Africa — a readiness item, not a requirement.
Which allergens does the US require that South Africa does not?
Sesame, and the species names. FALCPA as amended by the FASTER Act gives the United States nine major food allergens, sesame since 1 January 2023, and requires the label to identify the specific type of tree nut and the species of fish and crustacean shellfish. “Contains tree nuts” does not comply; “Contains almond” does.
The traffic runs both ways, which is what makes the comparison useful. South Africa covers rye, barley and oats and not sesame; the United States covers sesame and not rye, barley or oats. Neither list contains the other, so a single artwork for both must carry all four cereals plus sesame — lawful in both, because declaring an allergen that is genuinely present is lawful everywhere.
Two American features are worth building in. There is no emphasis requirement, which makes emphasis a safe common denominator: design to the strictest rule you face and you remove a variable permanently. And under 21 CFR Part 117 allergen control is a named preventive control with two limbs — preventing cross-contact, and labelling to prevent misbranding. A validated changeover with the wrong label is a failed preventive control, and so is a correct label with an unvalidated clean; see our cleaning validation guide.
Two items we will not state for you, because only secondary sources were available: the citation and threshold for sulphite declaration in United States labelling law, and whether your product falls under FDA or under USDA’s Food Safety and Inspection Service, which runs its own labelling regime. Resolve both at specification stage.
What does Codex now require, and why does the tier matter?
CXS 1-1985, as revised in 2024, splits the allergen list in two. Section 4.2.1.4 is the mandatory tier: the listed foods “shall always be declared” using the specified name. Section 4.2.1.5 is a second list that “may also be required” regionally or nationally, based on available risk assessment data. Sesame is in the mandatory tier. Soy is not.
Three consequences follow. “Tree nuts” is no longer a Codex category, so “tree nuts: yes” on a specification no longer maps onto the standard. Sulphite is on neither list: it has its own provision, threshold and prescribed word, and is concentration-triggered where the allergen duties are intent-triggered. And molluscs are on neither list either, yet they are mandatory in the European Union, the United Kingdom, Canada, Australia, New Zealand and South Africa — so a register built to the Codex structure has no mollusc row.
Two provisions are read backwards constantly. Section 4.2.1.6 lets competent authorities exempt derivatives subject to a risk assessment; it grants nothing to an operator, so the European Annex II exemption for fully refined soybean oil does not travel. And 4.2.1.3’s relief for compound ingredients below five per cent does not extend to the listed allergenic foods — the highest-frequency undeclared-allergen route in dry blending. CXC 80-2020 carries no allergen list and its dominant modal is “should”.
Worked example: the compound ingredient that is not a trace
A seasoning carries a bought-in smoke flavour blend at 4.2 per cent of the finished product, and mustard flour is 15 per cent of that blend. Mustard in the finished product is 0.042 × 0.15 = 0.0063, that is 0.63 per cent, or 6,300 mg/kg. Against the VITAL 4.0 ED05 reference dose for mustard of 1.0 mg total protein over a 30 g reference amount, the action level is 1.0 ÷ 0.030 = 33.3 mg/kg. The mustard present is roughly 189 times the action level: an ingredient, not a trace, and mandatory in the European Union, the United Kingdom and Canada. The route in is the sub-five-per-cent compound-ingredient relief, which does not cover allergens.
Mid-article checkpoint. If your allergen register does not break out every compound ingredient at any inclusion level, with a second-person check, that is the gap to close first. Enrol in the advanced allergen programme — R3,450, nine modules, multi-framework toolkit included.
Why does Japan change what you do, not just what you print?
Japan makes allergen declaration a function of measured concentration rather than recipe intent. The Food Labeling Standards set a trigger of 10 micrograms of allergenic soluble protein per gram of food — 10 ppm — with official ELISA screening and Western blot or PCR confirmation. Above it, the answer is to declare the allergen as present or control it below the threshold.
Worked example, and it is the reason this matters. A changeover leaves a worst-case corrected swab of 4.2 mg milk protein per 100 cm² on 2.5 m² of product-contact surface: 4.2 × 25,000 ÷ 100 = 1,050 mg. Into a 60 kg batch: 1,050 ÷ 60 = 17.5 mg/kg, that is 17.5 ppm. Now compare three yardsticks for the same number:
- VITAL 4.0 ED05, reference dose 2.0 mg over a 30 g reference amount: action level 2.0 ÷ 0.030 = 66.67 ppm. 17.5 ppm is below it — not actionable.
- VITAL 3.0 ED01, reference dose 0.2 mg: action level 0.2 ÷ 0.030 = 6.67 ppm. 17.5 ppm is above it — actionable.
- Japan’s statutory trigger, 10 ppm: 17.5 ppm is above it, so for Japanese-market product the route is to declare milk as present or to clean harder. A “may contain milk” is reported not to be accepted there.
One residue, three answers — which is why the framework and its version must be named in your assessment procedure, and why a result reported as commodity or as a marker protein cannot be compared with a limit expressed as allergenic soluble protein. Our comparison of Codex and VITAL 4.0 works the divergence.
Note too that soy and sesame are on the Japanese recommended list, not the mandatory one — the opposite way round to most of the world. The lists, the 2026 amendment and the reported rejection of precautionary statements come from secondary and peer-reviewed sources, not the Consumer Affairs Agency notification; confirm them before designing a release specification.
Why does one artwork for several markets fail?
Because “declare everything everywhere” cannot resolve conflicts of vocabulary, layout or precaution. India prescribes the word “Nut” while the United States requires the species; Australia and New Zealand require the “Contains” statement in the same field of view as the ingredient list, while Canada requires it inside the same background colour or borders. Adding text reconciles none of it.
Apply four tests in order; split the group the moment one fails.
- Superset. Can one set of declarations be built that is lawful for every market in the group — declaring everything each requires and nothing that is not actually present? Declaring an allergen you do not have is a misdeclaration in the other direction.
- Vocabulary. Is there one form of words that satisfies every prescribed vocabulary, including a combined construction such as “Nut (cashew)”, and has each importer or adviser accepted it in writing?
- Layout and language. Can one panel carry the strictest emphasis rule, the strictest adjacency rule and every required language at once, in the pack real estate you have?
- Precaution and claims. Does the precautionary position resolve to the same statement everywhere, and is every claim valid everywhere? A gluten-free claim built below 20 ppm in the United States, where oats are not a gluten-containing grain, is not automatically valid in Canada, where oats are a gluten source.
Two house rules follow, both lawful everywhere: design every export panel to the strictest emphasis rule you face, and make every “Contains” statement exhaustive. What the tests usually reveal is that the mandatory declarations reconcile while the words, the layout and the precautionary statement do not. Under BRCGS Issue 9 clause 5.3, a fundamental requirement, what is examined is whether the system that produced your labels can show how it knows they are right.
Three more reasons the union approach fails
A precautionary statement cannot be unioned: one appropriate in South Africa may be unacceptable in Japan. Exemptions never travel. And diversion makes a compliant label non-compliant with nothing having gone wrong.
Which export markets cannot be verified from open sources?
Several, and saying so is the professional answer. The current Gulf allergen clause, the edition of the East African standard in force, and the allergen provisions of Nigeria, Egypt, Ghana, Botswana, Namibia and Zimbabwe could not be established from open sources as at September 2026. An honest gap with an owner and a due date is a controlled risk; a confident guess is not.
- Gulf states. The current standard is GSO 9:2022 Edition 4, approved 19 October 2022, as amended by Amd1:2025 of 22 April 2025 — both in the GSO catalogue, but sold rather than published, so the allergen clause could not be read. The superseded 2013 edition, freely available, listed thirteen categories with peanut and soybean as one item, walnut as the only named tree nut and molluscs as “clams”. Do not use it for artwork. Buy the current standard, and record the Arabic allergen terms in the artwork specification.
- Kenya and the East African Community. The framework is KS EAS 38, adopted nationally by the partner states and structured on Codex. The edition in force could not be verified, and the difference matters: a pre-2024 Codex basis means the older eight-group list, a revised one the two-tier structure. Obtain the standard and confirm the edition.
- Nigeria. The Pre-Packaged Food (Labelling) Regulations 2022 appear to impose a mandatory allergen declaration, but the gazetted text was not machine-readable and the clause could not be read. A secondary commentary’s illustration of “nuts, dairy, gluten and soy” is not a statutory list — it omits egg, fish and crustacea. Obtain the regulations from NAFDAC.
- Egypt, Ghana, Botswana, Namibia, Zimbabwe. Instruments were identified in each case; allergen provisions were not established. Enquire of the competent authority in writing, ask the importer what has been rejected rather than what is required, and obtain the customer specification — usually the binding requirement in these markets.
- SADC is not a harmonised baseline. The Regional Guidelines for the Regulation of Food Safety in SADC Member States, published November 2011, are non-binding and contain no allergen labelling provisions. There is no SADC allergen requirement to comply with, and none to rely on.
Where a market cannot be verified, design to a defensible floor — the stricter of Codex CXS 1-1985 sections 4.2.1.4 and 4.2.1.7 and the customer specification — and record it. Put the gap on the register with an owner and a review date, and re-verify annually.
Frequently asked questions
Does a South African allergen label comply in the EU?
No. Regulation (EU) No 1169/2011 requires fourteen allergens, four of which — sesame, celery, mustard and lupin — are not common allergens under R146, and Article 21 requires each to be emphasised in the ingredient list every time it appears.
Which allergens does the US require that South Africa does not?
Sesame, mandatory since 1 January 2023 under the FASTER Act, and the species names: the label must identify the specific type of tree nut and the species of fish and crustacean shellfish. Conversely the United States covers only wheat among the cereals, while R146 also covers rye, barley and oats.
When does GB 7718-2025 apply in China?
GB 7718-2025 was published on 27 March 2025 with an implementation date of 16 March 2027, making allergen declaration mandatory in China for the first time; GB 7718-2011 applies until then. The reported eight categories come from secondary sources and should be confirmed with the importer.
Is a “Contains” statement mandatory in Australia and New Zealand?
Yes. Under Standard 1.2.3 and Schedule 9 of the Food Standards Code, Plain English Allergen Labelling requires two declarations: the prescribed allergen names in bold in the ingredient list, and a separate bold “Contains” summary in the same field of view as, and directly next to, the ingredient statement.
Does Japan accept a “may contain” statement?
Reportedly not. Japan sets a statutory trigger of 10 micrograms of allergenic soluble protein per gram, so the obligation is to declare the allergen as present or control it below the threshold. That position is reported from secondary and peer-reviewed sources and should be confirmed before shipping.
What is the current Gulf allergen labelling requirement?
It could not be verified. The current standard is GSO 9:2022 Edition 4 as amended by Amd1:2025, but the text is sold rather than published, so the allergen clause could not be read. The freely available 2013 edition is superseded and must not be used for artwork.
Build the export register before the next order, not the next shipment
Advanced Allergen Management & Validation — R3,450, no VAT charged.
Nine modules, approximately 40 hours, self-paced, instructed by Mthokozisi Nkosi, with dedicated modules on the South African and international frameworks. Includes the ASC Allergen Validation Toolkit: an Excel workbook whose risk assessment calculator switches between Codex Table A1/A2, VITAL 4.0 ED05, VITAL 3.0 ED01 and Netherlands ED05 reference doses, with a swab recovery calculator, a result interpretation tool, a two-tier Codex allergen matrix and a changeover risk assessment — plus a Cleaning Validation Protocol template.
Assessment is a 90-question proctored exam at an 80% pass mark — 72 of 90 — in 150 minutes, from a 180-item two-form bank, so a re-sit is a different paper. One re-sit included. A Certificate of Achievement issues on passing. Provider-level accreditation: FoodBev SETA (587/00337/1900), HPCSA CPD, SAATCA TC 065; content aligned to GFSI-benchmarked scheme expectations.
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Related: R146 requirements · Cleaning validation · Codex versus VITAL 4.0 · Processing and allergens · BRCGS clause 5.3