Every South African manufacturer can name R146. Almost none can produce what regulation 45 asks for. That is what happens when an Environmental Health Practitioner asks a site to show the risk, the manner of assessing the risk, and the steps taken to avoid the risk behind a “may contain” statement — and the site produces a HACCP plan, a cleaning schedule and a certificate.
R146 of 2010 is made under section 15(1) of the Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972. Section 18(1) attaches a fine or imprisonment on conviction, the custodial ceiling escalating from six months on a first conviction to twenty-four on a third. Allergen non-compliance here is criminal, not administrative. This is not legal advice: the gazetted text governs, and confirm your position with a qualified adviser before changing a label, a claim or a recall procedure.
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Which regulations of R146 carry the allergen duty?
The duty sits in regulations 43 to 46, but those four cannot be read without regulation 1’s definitions, regulation 27 on compound ingredients, regulations 42 and 54(1)(b) on additives and carriers, regulation 38(2) on sulphur dioxide, and regulation 5’s two-working-day record duty.
| Regulation | What it requires |
|---|---|
| 1 | Defines “common allergen”, “significant cereals”, “tree nuts” as a closed species list, “uncommon allergen” |
| 5 | Failure to produce the documentation within two working days of a request is an offence in itself |
| 27, 42, 54(1)(b) | Compound ingredients broken out; an additive or its carrier derived from or contaminated with a common allergen must indicate the origin; the carrier naming exemption is conditional on the carrier not containing one |
| 38(2) | Sulphur dioxide need not be declared below 10 mg/kg as packed or ready to eat — so declaration applies at or above it |
| 43(1) | A common allergen in a product or its packaging material: in parenthesis after the ingredient name where not self-evident, and/or in a “Contains” block nearby |
| 43(2) | The cereal species in the ingredient name, with “gluten” in parenthesis |
| 44 | Uncommon allergens disclosed on request from the Supplier Ingredient Information File; goat’s milk labelled as for a common allergen |
| 45 | An allergen control policy; precautionary labelling shall not circumvent GMPs; where used, the risk, the manner of assessing it and the avoidance steps documented |
| 46 | “Gluten-free” on four cumulative conditions including not more than 20 mg/kg gluten by R5 Mendez ELISA; every “free from” claim requires testing |
| 54(3) | Exempts non-prepacked bread and catering food from labelling except allergen information, available at point of sale on request |
Which allergens must be declared in South Africa?
R146 defines a “common allergen” as egg, cow’s milk, crustaceans and molluscs, fish, peanuts, soybeans, tree nuts and any significant cereals, together with ingredients derived from these that have “retained its allergenicity in the final product”. Everything else — sesame, mustard, celery, lupin, pine nut, chestnut, goat’s milk — is an uncommon allergen with its own duty.
- “Retained its allergenicity” is the only route to non-declaration, and there is no domestic exemption list. The European Union grants Annex II exemptions for fully refined soybean oil and wheat-based glucose syrups; South Africa grants none. The determination is yours, on documented evidence, producible within two working days — so the safe default is to declare. Whey, caseinate, lactose and soy lecithin are common allergens under their own source names.
- “Significant cereals” runs by genus: wheat (any Triticum species, including kamut and spelt), rye, barley, oats and hybrids such as triticale. Oats are in, without qualification. “Tree nuts” is a closed list of eight: almond, brazil, cashew, hazel, macadamia, pecan, pistachio, walnut — pine nut and chestnut sit outside it, as uncommon allergens with a regulation 44 duty.
How must the declaration appear under regulation 43?
Regulation 43(1) permits two routes and their combination: in parenthesis after the ingredient name where the allergen is not self-evident from that name, and/or in a “Contains: (allergen(s))” list or block in close proximity to the ingredient list. The duty attaches where a product or its packaging material contains a common allergen.
“Not self-evident” is tested against the consumer, not the technologist: “peanut butter” is self-evident, “whey” is not. A “Contains” block alone complies and is the fragile option — one omitting an allergen in the ingredient list is a contravention, one naming an absent allergen is a misleading description engaging regulation 47, so reconcile them line by line at artwork approval with a named approver. And there is no domestic emphasis requirement: adopt bold voluntarily, since several export markets require it, but do not call it law.
Regulation 43(2) is stricter for significant cereals: the species must be specified in the ingredient name with “gluten” in parenthesis — “Wheat flour (gluten)”, “Oat flakes (gluten)”. “Cereal (gluten)” satisfies one limb and fails the other, and a specification reading “cereal starch” is a supplier non-conformance, not a puzzle for artwork.
Does South Africa require sulphite declaration?
Sulphites are not one of the eight common allergen groupings; they sit in the additive regime. Regulation 38(2) provides that sulphur dioxide and the named related compounds need not be declared below 10 mg/kg of foodstuff as packed or ready to eat — an exemption below a level, whose operational effect is that declaration applies at or above 10 mg/kg.
Because sulphites sit outside the common allergen definition, regulation 43’s mechanics do not reach them: they need not appear in a “Contains” block, although many labels include them voluntarily. The basis matters, though. A dilutable cordial carries sulphur dioxide at 42 mg/kg as packed, to be diluted one part in six. As packed: 42 mg/kg, above the trigger. As consumed: 42 × 1 ÷ 6 = 7.0 mg/kg, below it. The regulation names both bases and the arithmetics give opposite answers, so record the basis in the specification and take advice.
What does regulation 44 require about sesame, celery and goat’s milk?
Regulation 44(1) requires the presence of uncommon allergens in or on the foodstuff or its packaging material to be disclosed on request by a consumer, an inspector or the Department, based on the Supplier Ingredient Information File provided in Guideline 6, which must be kept on record. It is disclosure on demand backed by a record duty — not a labelling duty.
If your specification records “spice blend, proprietary” you cannot answer — and when the request arrives in writing from an inspector, regulation 5 gives you two working days. A slow supplier becomes your offence.
Regulation 44(2) is small and sharp: goat’s milk must be labelled in the same manner as for common allergens under regulation 43. The definition says “cow’s milk”, so goat’s-milk cheese escapes that entry — and 44(2) brings it back. Sheep’s and buffalo milk are not named, and remain uncommon allergens under 44(1).
Mid-article checkpoint. If you have recognised two or three gaps already, they are systemic, not clerical. Enrol in the advanced allergen validation programme — R3,450, nine modules, toolkit and Cleaning Validation Protocol template included.
What does regulation 45 of R146 require?
Where there is a risk of cross-contamination of a common allergen in a food processing facility: (a) due diligence shall be exercised to prevent occurrence and an allergen control policy shall be implemented in accordance with the guidelines; (b) where precautionary labelling is utilised, it shall not be utilised to circumvent the implementation of GMPs and an effective allergen control policy; and (c) where precautionary labelling is utilised, the risk, the manner of assessing the risk, and the steps taken to avoid the risk shall be documented.
45(a) is a positive domestic duty to control cross-contact — the allergen management system practitioners attribute to BRCGS Issue 9 clause 5.3 or to the Codex code of practice CXC 80-2020 has a domestic legal footing here, so a site with no allergen control policy is not merely uncertifiable but non-compliant. 45(b) is an anti-circumvention prohibition, making the substitution itself the contravention. 45(c) is a three-limb file specification: the risk, the manner of assessing it, the steps taken to avoid it.
The silences matter as much: no threshold, no prescribed wording, no exemption list, no de minimis, no emphasis rule — and no positive trigger, the drafting being conditional, so the decision not to label is as much a documented decision as the decision to label. The law sets the duty without the method, so you import one: Codex CXS 1-1985 now carries an annex on precautionary allergen labelling with published reference doses and an action-level formula, and VITAL 4.0 supplies an Action Level Grid on an ED05 basis. Neither is South African law — but adopting one converts “the manner of assessing the risk” into a reproducible, externally referenced method. See our comparison of Codex and VITAL 4.0.
Worked example: the regulation 45(c) file for one changeover
A sauce line runs a cow’s-milk product, then one declaring no milk; the pack carries “may contain milk”. The risk is milk protein reaching the next batch as residue on shared product-contact surfaces.
- The manner of assessing it. Reference dose 2.0 mg total milk protein (VITAL 4.0 ED05; the Codex annex Table A1 value for milk is the same). Reference amount 30 g. Action level = 2.0 ÷ 0.030 = 66.67 mg/kg, equivalently 2.0 ÷ 30 × 1000 = 66.67 ppm.
- The measurement. Worst-case corrected swab 0.55 mg per 100 cm²; product-contact area 3.2 m² = 32,000 cm². Surface residue = 0.55 × 32,000 ÷ 100 = 176 mg. Batch 900 kg: 176 ÷ 900 = 0.196 mg/kg, that is 0.20 ppm.
- The decision. 0.20 ppm against 66.67 ppm — roughly 340 times below the action level, so the statement comes off. That is the decision needing the strongest file, because it is the one a claimant attacks: sign it, date it, name the assessor.
- The avoidance steps. The validated changeover clean, the scheduling rule, the rework rule, and the record of controls considered and rejected. Regulation 45(b) requires these to precede the label.
Four lines of arithmetic and one signature. Our cleaning validation guide covers the swab recovery behind step 2, and the ASC allergen validation toolkit automates the whole calculation.
What do regulation 46’s gluten-free and free-from claims require?
Regulation 46(1)(a) permits “gluten-free” only on four cumulative conditions: no ingredient that is any species of significant cereal; no cereal-derived ingredient not processed to remove gluten; no processed-to-remove-gluten ingredient whose use results in more than 20 mg/kg gluten in the end product; and not more than 20 mg/kg gluten, determined by the R5 Mendez ELISA or other Codex recommended methods.
Paragraph (i) is absolute: if wheat flour or oat flakes are in the recipe the claim is unavailable whatever the result, and a lateral flow negative does not meet paragraph (iv). On paragraph (iii): a wheat-derived glucose syrup processed to remove gluten, testing at 60 mg/kg and used at 25 per cent inclusion, contributes 60 × 0.25 = 15.0 mg/kg — within the limit alone. Add a second cereal-derived ingredient contributing 8 mg/kg and the end product sits at 15.0 + 8 = 23.0 mg/kg: above 20, claim unavailable. Mind the basis — gluten is conventionally reported as gliadin × 2, so 9 mg/kg gliadin is 18 mg/kg gluten and passes, while 11 mg/kg is 22 mg/kg and does not.
Regulation 46(2) should stop a marketing department. “Hypoallergenic” and “non-allergenic” are prohibited unless the foodstuff is modified by chemical or genetic means to reduce endogenous allergens to undetectability, and no free-from claim may be made unless the foodstuff has been tested to confirm absence, using testing suitable for the specific allergen. Note the asymmetry: 46(2) demands testing to say an allergen is absent, while regulation 45 demands only documented risk assessment to say it may be present.
How does R638 of 2018 reach allergen practice?
R638 of 2018 contains no allergen labelling duty — citing it as the authority for a declaration is a recognised error. It is the instrument under which your site is inspected, and it reaches allergen practice through the Certificate of Acceptability, the duties of the person in charge, food-handler practice and recall notification.
- Regulation 10(17) requires the person in charge to ensure that foodstuff manufactured, kept or sold from the premises complies in all respects with the Act and its regulations, including the labelling thereof. An Environmental Health Practitioner inspecting under R638 can therefore ask whether your label complies with R146.
- Regulation 11(1)(c)(viii) is the only explicit allergen-specific operational instruction in South African law — hand washing after handling a non-prepacked foodstuff classified as a common allergen where contamination can result in cross contamination of other food not associated with common allergens. Quote it verbatim in your hand-hygiene instruction.
- Regulation 10(18) requires any incident requiring recall activation to be reported to the local inspector and the National Directorate: Food Control — most often failed on the notification limb. Regulation 10(1) requires training with an assessment of impact, not an attendance register.
Certification answers none of it: an auditor holds no statutory powers and audits against the standard and your own specifications, not the gazette. A site can hold a clean BRCGS clause 5.3 outcome and breach regulation 43 on every pack.
Where does the Consumer Protection Act bite?
An allergen mislabel is two exposures. The regulatory exposure under Act 54 of 1972 is criminal. The Consumer Protection Act 68 of 2008 exposure — sections 24 and 41 on misleading trade descriptions and representations, 55 and 56 on safe goods, 60 on recall — is civil and administrative, enforced by the National Consumer Commission, and generally the larger financial risk.
Section 61 imposes liability for harm caused by unsafe goods, a defect or hazard, or inadequate warnings, across producer, importer, distributor and retailer, irrespective of negligence. An undeclared allergen is close to the ideal section 61 claim: the consumer read the label, relied on it and reacted; the harm is in a clinical record; the defect is on the pack. Your validated clean answers a negligence claim — not this one. The section 61(4) defences are records questions first: “the defect did not exist when I supplied the goods” is provable only with artwork version tied to specific runs, line clearance and first-off checks, and retained samples. The width of a recall is set by what your records can prove, not by the size of the defect.
Is draft R3337 in force?
No. Draft R3337 is not law. The Department of Health’s published draft is dated 21 April 2023, the comment period was extended with 21 September 2023 reported as the closing date, and as at September 2026 nothing had been promulgated, no final text gazetted and no commencement date existed. R146 of 2010 binds today.
A customer asserting non-compliance against R3337 is asserting it against a document that is not law, and printing artwork to it risks total waste. Reported direction of travel: emphasis in bold; sulphites brought inside the common allergen framework at or above 10 ppm; a lupin cross-reactivity warning; some derivative exemptions; tighter claim substantiation. So choose readiness actions with standalone value today: measure your real artwork cycle time; close the sulphite limit-of-quantification gap; find your lupin; audit every claim against analytical evidence; adopt emphasis at the next redraw; complete the Supplier Ingredient Information File to the wider allergen set.
The export gap all of this creates
R146 omits sesame, mustard, celery and lupin and groups tree nuts. Codex CXS 1-1985 names tree nuts individually and puts sesame in the mandatory tier; Regulation (EU) No 1169/2011 requires fourteen with emphasis, retained in the United Kingdom, which adds full labelling for food prepacked for direct sale under Natasha’s Law; FALCPA and the FASTER Act give the United States nine; GB 7718-2025 makes declaration mandatory in China from 16 March 2027; Australia and New Zealand require two declarations under Plain English Allergen Labelling. See also processing and allergens.
Frequently asked questions
What does regulation 45 of R146 require?
Regulation 45 requires due diligence to prevent cross-contamination and an allergen control policy implemented in accordance with the guidelines; that precautionary labelling shall not be utilised to circumvent GMPs and an effective policy; and that where it is utilised, the risk, the manner of assessing it and the steps taken to avoid it shall be documented.
Which allergens must be declared in South Africa?
Egg, cow’s milk, crustaceans and molluscs, fish, peanuts, soybeans, tree nuts and any significant cereals, plus derivatives that have retained their allergenicity. Sulphur dioxide sits separately under regulation 38(2) at 10 mg/kg. Sesame, mustard, celery, lupin, pine nut and chestnut are uncommon allergens with a disclosure duty under regulation 44(1).
Is draft R3337 in force?
No. The published draft is dated 21 April 2023 and the comment period was extended, with 21 September 2023 reported as the closing date. As at September 2026 nothing had been promulgated and no commencement date existed.
Can we claim “nut free” if we use no nut ingredients?
Not on formulation reasoning alone. Regulation 46(2) permits a free-from claim only where the foodstuff has been tested to confirm absence, using testing suitable for the specific allergen. Substantiate analytically against a defined method, matrix and limit of quantification, or remove the claim.
Does R146 require sesame to be declared on the label?
No. Sesame is not one of the eight common allergen groupings, so there is no duty to print it. It is an uncommon allergen, and regulation 44(1) requires its presence to be disclosed on request from the Supplier Ingredient Information File. Answering from the ingredient list is wrong in law.
How long do we have to produce allergen documentation to an inspector?
Two working days. Regulation 5 makes failure to produce the documentation within two working days of a request an offence in itself, independently of whether the label was compliant. The duty attaches to importers and sellers as well as manufacturers.
Close the regulation 45 gap before someone else finds it
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Nine modules, approximately 40 hours, online and self-paced, instructed by Mthokozisi Nkosi, with a module that takes the South African framework apart regulation by regulation. 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 Codex allergen matrix and a changeover risk assessment — plus a document-controlled Cleaning Validation Protocol template.
Assessment is a 90-question proctored exam at an 80% pass mark — 72 of 90 — in 150 minutes, drawn 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: Cleaning validation · Codex versus VITAL 4.0 · Processing and allergens · BRCGS clause 5.3