RISK ASSESSMENT · ALLERGEN MANAGEMENT

Allergen Risk Assessment: Scoring Cross Contact Before You Print a May Contain Statement

By Mthokozisi Nkosi, Food Safety Specialist & Lead Auditor, ASC Food Safety · 14 min read

Regulation 45 of R146 of 2010 requires due diligence against allergen cross contamination and an implemented allergen control policy, and it states that precautionary labelling may not be used to circumvent good manufacturing practices. A “may contain” statement is the conclusion of a scored risk assessment, never a replacement for one. The Allergen Management Risk Assessment Template (RA17) is R690.

Which allergens South African law requires you to declare

Regulation 43 of R146 of 2010 lists the common allergens for South Africa: egg, cow’s milk, crustaceans and molluscs, fish, peanuts, soybeans, tree nuts, and cereals containing gluten, which covers wheat, rye, barley, oats and hybrids such as spelt and kamut. That is the South African list. The fourteen allergen list belongs to the European Union and has no legal standing here.

I raise this because a great many of the allergen matrices I am handed on site have been copied from a European template. They carry celery, mustard, lupin and sesame as legal allergens, and they carry sulphites in the allergen box. The site then builds a control programme, a label and a training deck around a list that South African law does not use, and misses the parts that R146 does require.

Regulation 43 also governs how the declaration appears. The presence of a common allergen is indicated either in parenthesis after the name of the ingredient in the ingredient list, or in a separate block stating “Contains” followed by the allergens. For cereals, the specific significant cereal species is named in the ingredient list with the word “gluten” shown in parenthesis, so “wheat flour (gluten)” rather than a vague reference to cereal. Regulation 44 covers uncommon allergens, which manufacturers must disclose on request from a consumer, an inspector or the Department, based on the information held in the Supplier Ingredient Information File. That same regulation requires goat’s milk to be labelled in the same manner as a common allergen.

Sulphur dioxide sits outside the regulation 43 list entirely. It is a preservative, and regulation 38 is the clause that governs it. Sulphur dioxide and related compounds must be declared where they are present at 10 mg per kilogram or more of the foodstuff as packed or ready to eat, and at any level in certain cases, including transfer from packaging materials and treated fresh produce. It is a mandatory declaration with its own threshold, which is why it belongs on your ingredient specification and your incoming raw material checks rather than in your allergen cross contact matrix.

One more clause belongs in this section because it is where sites talk themselves into trouble. Regulation 46 permits a gluten free claim only where the foodstuff contains not more than 20 mg per kilogram of gluten, and permits an allergen free claim only where the foodstuff has been tested to confirm the absence of that allergen. Hypoallergenic and non-allergenic claims are reserved for foods modified by chemical or genetic means to reduce endogenous allergens. A clean changeover does not entitle you to any of those claims. Analytical evidence does. Our allergen labelling guide works through the declaration mechanics in detail, so this article stays on the risk assessment that sits behind them.

What an allergen control policy is, and what regulation 45 expects

Regulation 45 of R146 requires due diligence to prevent allergen cross contamination and requires an allergen control policy to be implemented. It goes further and states that precautionary labelling may not be used to circumvent good manufacturing practices and an effective allergen control policy. Read plainly, the regulation treats “may contain” as the last option after control, not the first option instead of it.

An allergen control policy is a short, signed document that states which allergens are handled on site, who owns allergen control, how allergens are segregated in storage and in process, how the production sequence is set, how changeover cleaning is validated and verified, how rework is handled, how suppliers are approved for allergen status, how labels are checked against the formulation, and how the site decides whether a precautionary statement is warranted. It is usually two to four pages. The weight sits in the documents it points at, and the heaviest of those is the cross contact risk assessment. Sites certified to BRCGS Global Standard Food Safety Issue 9, published 1 August 2022, meet the same expectations expressed as auditable clauses, and our BRCGS Issue 9 implementation guide covers the wider system those clauses sit in.

A “may contain” statement with no risk assessment behind it is not a warning. It is an admission that nobody looked.

The policy is also the document that carries your defence outside the food safety regulations. Section 61 of the Consumer Protection Act 68 of 2008 imposes liability on producers, importers, distributors and retailers for harm caused by unsafe goods, product failure, defects or hazards, or by inadequate instructions or warnings, and it does so irrespective of negligence. Section 55 gives the consumer a right to safe, good quality goods, and section 58 deals with warnings about the fact and nature of risks. An allergen incident is exactly the fact pattern those sections were written for, and our guide to South African food legislation sets out how the Acts and regulations fit together. The question that follows an incident is always the same: show me what you assessed, and show me what you did about it.

Where cross contact actually happens on a line

Cross contact is the unintended transfer of a regulation 43 allergen into a food whose label does not declare it. It is not a hygiene failure in the microbiological sense, because the transfer can happen on visually clean equipment and survive processes that would kill any pathogen. Protein does not care about your cook step. The four mechanisms below and the eight routes in the table account for almost every allergen finding I have written on a South African site.

Map each route on your own line, not on the generic list. Walk it in the direction the product moves, then walk it again in the direction people and cleaning equipment move, because the second walk is where the surprises are. Then write each route into the register as a separate line with its own score, its own control and its own owner.

Storage and transport are the routes most often left off the register, because the assessment stops at the factory door. They belong on it. The Storage, Warehousing and Transport Risk Assessment Template (RA12) at R690 covers racking, segregation and vehicle controls in the same register format, so the two assessments cross reference cleanly.

How to build an allergen risk assessment step by step

Build the assessment in one direction: material in, product out, then back through everything that touches it. The guidance published alongside R146 describes allergen risk analysis as a four step process beginning with risk assessment, asking what the risk is of an allergen being present unintentionally in a foodstuff. The steps below turn that into a register you can defend line by line.

1. List every allergen that enters the siteNot every allergen in the world. Work from your raw material specifications and your Supplier Ingredient Information File entries, and list each regulation 43 allergen that arrives at goods receiving in any form, including as a carry over declaration from a supplier.
2. Map the allergen against every product and lineBuild a simple grid of products down the side and allergens across the top. Mark intentional presence in one colour and possible unintentional presence in another. The second colour is your assessment scope.
3. Walk the routes physicallyTake the grid to the floor with the production manager and a cleaner. Identify each transfer point where an allergen could reach a product that does not declare it. Photograph shared equipment and dead legs. This walk usually produces routes nobody had written down.
4. Score each route before controlGive each route a likelihood and a consequence rating and record the raw score. Score honestly. A raw score that is already low for every route is a sign that the scoring is being managed rather than done.
5. Record the control and its evidenceFor each route, name the control, the document that describes it, the person who owns it, and the record that proves it happened. A control with no record is not a control, and it must not reduce the score.
6. Score the residual riskRe-score with the control applied and validated. Where the control has not been validated, the residual score stays at the raw level. This is the discipline that keeps the assessment honest.
7. Decide the label from the residual scoreTake the label decision from the residual score, record the reasoning in the register, and reference that entry from the artwork approval so the two documents point at each other.
8. Set the review triggerReview the assessment on a fixed cycle and on any new raw material, new supplier, new product, line modification, layout change, allergen complaint or positive verification swab.

If your HACCP study already treats allergens as a hazard, this register is the supporting document that justifies whatever control measure you selected there. Our guide to what a HACCP plan contains shows where the two documents meet.

How to score a cross contact route

Score each route on likelihood of transfer and on consequence for an allergic consumer, then multiply. Consequence rarely scores below four for a regulation 43 allergen in a product that does not declare it, so likelihood and control effectiveness carry the assessment. Record the raw score, the control, and the residual score after control. The residual score drives both the label decision and the verification frequency.

Sites often build an elaborate five by five matrix and then quietly score every consequence as a three, because a five makes the numbers uncomfortable. That is backwards. The consequence of an undeclared allergen reaching a consumer who reacts to it is severe by definition, and the assessment should say so. What you are really assessing is how likely the transfer is and how well the control holds, and that is where the honest work sits.

The band boundaries above are the ones we use in the RA17 register. They are a management convention, not a legal threshold, and you may set your own as long as the register states them and applies them consistently. What you must not do is publish a numeric allergen action level in parts per million as though it were a legal limit. R146 sets no cross contact action level for the regulation 43 allergens. The only numeric ceiling in the allergen part of the regulation is the 20 mg per kilogram gluten limit that regulation 46 attaches to a gluten free claim, and that governs a claim, not a cross contact decision.

How production sequencing and changeover controls reduce the score

Sequencing is the cheapest evidence of due diligence regulation 45 of R146 will accept, and the allergen control most often left undocumented. Running from the lowest allergen load to the highest, then cleaning once at the end of the block, removes whole changeover cleans and the routes they were meant to control. A documented sequencing rule can move a route from a residual score in the teens to below six.

The rule has to be written, though, and it has to bind the planner. I have audited sites with a perfect sequencing philosophy in the allergen policy and a production schedule that ran a peanut product before a plain product twice in the audited month, because a customer order came in late and nobody was authorised to say no. Score the worst sequence the plan permits, not the sequence you usually run. If the planner can override the rule without a documented deviation and an escalated clean, the rule is not a control.

Changeover cleaning is where sequencing hands over to the cleaning programme, and the two must be scored together. A dry clean between two products that share an allergen is adequate. The same dry clean between an allergen product and a product that does not declare it is not, and no amount of sequencing discipline fixes it. The Cleaning and Disinfection Risk Assessment Template (RA03) at R690 is the pack that scores cleaning method, frequency and validation status, and it is the document your allergen register should cross reference at every route where a clean is the named control.

What to do about rework

Rework is the route most likely to turn a controlled site into a recall, because it carries a regulation 43 allergen into a product whose label never declared it. The rule that holds is like into like: rework goes back only into the same product, or into a product that declares every allergen the rework carries. Any other movement must be scored as a deliberate allergen addition, declared on the label, or stopped.

Most sites do not have a rework problem in the procedure. They have one in the tote bin, and the failures are consistent. Rework held in an unlabelled container. Rework held over a shift change so that the person who adds it is not the person who made it. Rework from a start up run that included the tail of the previous product. Rework quantities added by eye rather than recorded, so traceability cannot say which batches carry it. Each of those is a separate register line, and each has a control that is simple to write and hard to sustain without training.

• Every rework container is labelled with product name, allergens carried, batch, date and time of creation
• Rework has a maximum hold time, and expired rework has a named disposal route
• The formulation or batch sheet declares rework as an ingredient with its permitted quantity
• The quantity added and the destination batch are recorded, so traceability runs both ways
• Start up and shut down product is treated as rework only where the previous product is known and compatible
• Rework decisions are made by a named role, not by whoever is on the line at the time

Score rework by the number of destination products it can legitimately enter. One destination scores low. Four destinations across two allergen profiles scores high, regardless of how carefully the procedure is written, because likelihood scales with opportunity. The Rework Risk Assessment Template (RA13) at R690 scores rework as its own hazard route with its own register, which is what BRCGS and FSSC auditors expect to see rather than two lines buried in the allergen document.

How suppliers and raw materials carry allergen risk into your site

Every allergen on your line arrived through goods receiving. Regulation 44 of R146 already assumes you hold a Supplier Ingredient Information File, because that file is the source of the uncommon allergen disclosure you owe a consumer, an inspector or the Department on request. That same file is the input to your allergen risk assessment, and it is usually the weakest document in the system.

Three questions decide the score for a raw material. First, does the material contain a regulation 43 allergen as an intentional ingredient. Second, does the supplier declare a cross contact risk on their own site, and if so for which allergen and on what basis. Third, can you tell from the delivered packaging alone, without opening a file, which allergens the material carries. A material that scores badly on the third question is a storage and decanting risk regardless of how clean the supplier is.

Approval is the control. Score a supplier on whether they hold a certified food safety management system, whether their allergen declarations are material specific rather than blanket, whether they notify you of formulation changes before delivery, and whether their allergen statements have ever been contradicted by your own testing or by a customer complaint. The Supplier and Purchased Material Approval Risk Assessment Template (RA11) at R690 carries that scoring in a register format that maps to the supplier approval clauses in BRCGS, IFS and SQF, so the allergen register can reference it rather than repeat it.

Validating an allergen clean, and what verification does not prove

Validation and verification are different activities, and the due diligence regulation 45 of R146 requires rests on validation rather than on a folder of verification swabs. Validation proves once, with evidence, that the written cleaning procedure removes the allergen protein to the point where the residual score you claimed is real. Verification proves on the day that the validated procedure was actually followed. Use allergen specific methods to validate. Verify at every changeover with that same allergen specific test, using protein swabs and documented visual clearance as supporting evidence rather than as the release test.

An allergen specific method means an ELISA test for the protein in question, or a lateral flow test that has been validated for that allergen and that matrix. It tells you whether the particular protein is present. A general protein swab and an ATP result do not. They tell you whether the surface is clean, which is a useful and necessary thing to know at every changeover, and it is not the same claim. I have seen sites present a folder of negative protein swabs as validation of an allergen clean, and that folder does not support the conclusion.

• Written cleaning procedure with named chemical, concentration, contact time, temperature, tools and dismantling instructions
• Worst case validation trial on the hardest to clean product and the hardest to reach equipment location
• Sample sites chosen and justified, including dead legs, gaskets, seals, blades, augers and product contact hoses
• Allergen specific results, with the test method, kit, detection basis and date recorded
• Repeat trials sufficient to show the result is reproducible, not a single lucky clean
• Signed validation report that names the residual score it supports on the allergen register
• Verification plan setting who swabs, where, how often and what happens on a positive result
• Revalidation trigger on any change of chemical, equipment, product formulation or cleaning frequency

On the positive result, decide the action before you need it. A positive verification swab on a line already released is a traceability and withdrawal decision, not a cleaning decision, and the people on shift at 02:00 must know which one they are making. Set the escalation route in the procedure and practise it. Where your certification body has already raised this, our summary of the most common FSSC 22000 non conformances shows how often validation evidence is the underlying cause of an allergen finding.

One caution on numbers. Do not publish an internal allergen action level in your procedure unless you can defend where it came from, what analytical method it assumes, and what consumption assumption sits behind it. Reference doses used in some international frameworks are not incorporated into South African law, and quoting one in your procedure creates a standard you will be audited against. State the method, state the detection basis of the kit you use, and state that any detection triggers investigation.

When the score justifies a statement, and when it does not

R146 prescribes no precautionary wording. There is no legal phrase, no legal format and no legal position on the label. Regulation 45 says only that precautionary labelling may not be used to circumvent good manufacturing practices and an effective allergen control policy. A precautionary statement is justified in one situation: a credible residual risk you have tried and failed to control, documented in the register.

The blanket statement is the compliance problem. Printing “may contain milk, egg, soya, wheat, peanuts and tree nuts” on every product in the range because the legal team suggested it does four things, none of them good. It signals to an inspector that no assessment exists. It breaches the spirit of regulation 45, which was written precisely to stop precautionary labelling from replacing control. It removes your product from every allergic consumer in the country, which is a commercial loss you can measure. And it weakens the statements that are genuine, because consumers who see the phrase everywhere stop treating it as a warning anywhere.

The other half of the problem is the statement that should be there and is not. A route scored in the teens, with the control acknowledged as partial, and a label that carries nothing. That is the version that ends in a product withdrawal, and section 61 of the Consumer Protection Act does not require anyone to prove you were negligent. The register is what makes both decisions defensible, in both directions.

There is a third failure that has nothing to do with the risk assessment: the label is simply wrong. The formulation changed and the artwork did not. The allergen is declared in the ingredient list but the cereal species is not named with “gluten” in parenthesis as regulation 43 requires. An old artwork version is still on the packaging line. Our article on common food labelling mistakes lists the ones we find most often. If you are not certain your artwork survives a clause by clause read against R146, ASC reviews label artwork and returns a redlined report against the regulation, standard turnaround five to seven business days, or 48 hours on the express option.

Who on site needs allergen training

Regulation 10(1) of R638 of 2018 requires the person in charge of food premises to be suitably qualified or adequately trained, and on allergens the list of people who need that training runs well past the production team. It covers operators, line leaders, cleaners, warehouse and receiving staff, rework handlers, maintenance fitters, contractors, the planners who set the production sequence, and the technical and marketing people who sign off artwork. A correct process with an incorrect label still produces a recall.

Train to the role, not to the topic. A cleaner needs to know why the changeover clean is different from the daily clean, and what a verification swab is for. A planner needs to know what the sequencing rule protects and who authorises a deviation. A receiving clerk needs to know that a damaged bag of milk powder in a shared bay is an allergen event, not a stock loss. A rework handler needs to know the like into like rule and the hold time. Generic annual allergen awareness delivered to all staff in one session satisfies almost none of that.

Record the training against the role and the date, and record the assessment of whether it worked. That same regulation requires routine assessments of the impact of training, with training records kept and available to an inspector. R638 names no approved provider, no minimum hours and no delivery mode, so what matters is that the training is relevant, recorded and demonstrably effective.

For structured content that covers the supply chain view rather than one line, the Allergen Management in Food Supply Chain course is R1,450, self paced online with lifetime access and a QR verifiable certificate. ASC does not charge VAT on training, so the price shown is the price paid. The training site also publishes a longer read on allergen management, cross contact and labelling in South Africa that pairs with this article.

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Published by ASC Food Safety, South African food safety and quality consultants. This article is general guidance and not a substitute for certification-specific advice.