A "May Contain" Label Is Not an Allergen Plan: Why Food Factories Must Control Allergens on the Floor, Not on the Pack

By Isaac Muthui, CEO, Tamalaki Business Network Ltd

Most food factories in Kenya know which of their products contain milk, wheat, peanuts or soya. Ask the production lead, and the answer comes quickly.

Ask a harder question: "Which of your other products could pick up one of those allergens on the way through your plant, and what record proves they did not?" The answer usually takes longer.

An allergen is not like most food safety hazards. You cannot see it, you cannot smell it and, unlike most bacteria, you cannot cook it out. The Codex code of practice on allergen management says treatments that kill pathogens, such as heating and high pressure processing, generally do not destroy allergenic proteins. A peanut trace that gets into a "plain" maize snack stays in that snack all the way to the consumer.

This article is for production leads, QA officers, store managers and owners of small and mid-sized food and agro factories in Kenya and East Africa: millers, bakeries, snack makers, dairies, juice and beverage makers, confectioners, spice and blend packers and edible-oil processors. It gives you an eight-step allergen control checklist for food factories that you can run with your own team. It is operations guidance, not legal or medical advice; confirm the specifics with KEBS, your county public health office and your customers' specifications.

What the standards actually say

Codex, the international baseline. The General Principles of Food Hygiene (CXC 1-1969) has a dedicated section on allergen management (13.2.7). It says the presence of allergens should be identified in raw materials, other ingredients and products, and that a system of allergen management should be in place at receipt, during processing and during storage. That system should include controls to prevent allergens being present in foods where they are not labelled, and controls to prevent cross-contact, "e.g. separation either physically or by time (with effective cleaning between foods with different allergen profiles)". Where cross-contact cannot be prevented despite well-implemented controls, consumers should be informed, and food handlers should receive specific allergen training where necessary.

The same code defines allergen cross-contact as the unintentional incorporation of an allergenic food or ingredient into another food that is not intended to contain it. It also says storage should allow segregation of allergenic and non-allergenic food (section 9.2.7), that cleaning should remove food residues "including allergens" (section 11.1.1), that protein and allergen test swabs are one way to verify cleaning (section 11.1.1), and that incoming ingredients may be inspected for declared allergens before processing.

Codex goes into more detail in the Code of Practice on Food Allergen Management for Food Business Operators (CXC 80-2020) (listed on the Codex codes of practice page). It notes that most food allergies globally are caused by proteins in eight foods or food groups: cereals containing gluten, crustaceans, eggs, fish, milk, peanuts, soybeans and tree nuts. It also lists undeclared allergens in supplier ingredients and inadequate staff training among the common causes of allergen problems.

Labelling. The Codex General Standard for the Labelling of Prepackaged Foods (CXS 1-1985), section 4.2.1.4, lists foods and ingredients that must always be declared: cereals containing gluten, crustacea, egg, fish, peanuts, soybeans, milk and milk products (lactose included), tree nuts, and sulphites at 10 mg/kg or more. A review of food allergy labelling laws quotes that list and notes that EAS 38:2014, Labelling of pre-packaged foods — General requirements, is in force across the East African Community. In Kenya, KS EAS 38:2014 is the labelling standard, and KEBS has said it requires the declaration of allergens on products that commonly cause allergic reactions. Buy the standard from KEBS and check the exact wording against your labels.

Hygiene and licensing in Kenya. The Food, Drugs and Chemical Substances (Food Hygiene) Regulations, 1978 require food plants, grounds and equipment to be kept free from conditions that may contaminate food. The Ministry of Health Checklist for Food Hygiene Licensing (April 2023) expects SOPs for hygiene, cleaning and disinfection, and a HACCP plan. EAS 39:2001, the hygiene code of practice for the food and drink manufacturing industry, sets out documented cleaning programmes with records showing they were followed.

Put together, the floor rule is simple: know where every allergen is, keep it where it belongs, clean it out when it moves, label what is left, and keep the records that prove it.

Why "everybody knows the peanut line" is not a control

Undeclared allergens usually get in through ordinary gaps, not dramatic failures:

1. A supplier changes something. A spice blend, a flour improver or a flavouring arrives with a new formulation that now contains milk powder or soya, and nobody reads the new specification.
2. A product shares equipment. The same mixer, hopper, filler or conveyor runs an allergen product in the morning and a non-allergen product in the afternoon, and the clean in between is "the usual wash".
3. Rework goes in the wrong place. Broken biscuits or off-spec batches are added back to a product that is not supposed to contain their allergens.
4. The label lags the recipe. The recipe changed last month; the label stock did not. Our label control checklist covers that gap from the packaging side.

Illustration (not real customer data): a snack maker runs a groundnut-coated product and a plain salted maize snack on the same seasoning drum. One Friday, the plain snack is moved ahead of the weekly deep clean to meet an order. The drum is brushed down, not washed. Nobody records the changeover type. When a parent complains two weeks later, the plant cannot say which plain-snack batches followed a groundnut run or how the drum was cleaned in between. One line in a changeover log would have answered both questions.

The 8-step allergen control checklist

1. Build an allergen matrix for every material and product

• List every raw material, ingredient, processing aid and rework stream, and mark which allergens each contains. Start from the Codex list (gluten cereals, crustaceans, eggs, fish, milk, peanuts, soybeans, tree nuts, plus sulphites at 10 mg/kg or more) and add anything your customers or export markets require.
• Do the same for every finished product, based on its current recipe or bill of materials.
• Include the less obvious sources: flavourings, seasonings, improvers, glazes, release agents and carriers.
• Review the matrix whenever a recipe, supplier or specification changes. An out-of-date matrix is worse than none, because people trust it.

2. Check allergen status at intake

• Ask every supplier for a specification that states allergens, and for notice before any change. Add an allergen line to your supplier intake checklist.
• At receipt, check the label on the bag or drum against the approved specification. Codex mentions inspecting incoming materials for declared allergens before processing.
• Hold any material whose label does not match its specification until QA has checked it. A "new improved formula" sticker is a reason to stop, not a reason to celebrate.

3. Segregate and identify allergens in storage

• Store allergen-containing materials in a defined, labelled area, below and away from non-allergen materials, so a spill cannot fall into them. Codex section 9.2.7 expects storage that allows segregation of allergenic and non-allergenic food.
• Use colour-coded tags, bins or shelf labels for each allergen, and keep opened bags closed and labelled.
• Clean up spills straight away, with dedicated tools.

4. Plan production to reduce cross-contact

• Where you can, dedicate lines, equipment or rooms to allergen products.
• Where you share, sequence production: allergen-free products first, allergen products last, then a full clean. Codex accepts separation "physically or by time" with effective cleaning between allergen profiles.
• Watch the shared things people forget: scoops, sieves, scales, shovels, aprons and gloves, airborne flour or powder, and the drip from an overhead conveyor.
• Make the schedule visible, so nobody squeezes a plain run in after a peanut run without a full clean.

5. Validate the allergen changeover clean, then verify it every time

• Define a separate changeover type for "allergen to non-allergen" in your line clearance checklist, with its own cleaning method, tools and sign-off.
• Take apart the equipment that traps residue (seals, valves, dead legs, seasoning drums, hoppers), and clean it, rather than rinsing it through.
• Verify the clean every time: visual inspection by someone other than the cleaner, and, where your risk assessment calls for it, protein or allergen swabs, as Codex section 11.1.1 suggests.
• Record the line, the time, the product before and after, the method, the person who cleaned, the person who checked, and any swab result.

6. Control rework

• Only add rework back into the same product, or into a product with the same or a wider allergen profile.
• Label rework with its product, batch and allergens, and store it like any allergen material.
• Record where every kilogram of rework went. If you cannot trace it, do not use it.

7. Match labels to recipes, and use precautionary labelling honestly

• Before each pack run, check that the label's ingredients list and allergen statement match the current recipe. Make allergen changes part of your recipe change approval.
• Use "may contain" statements only where your own assessment shows cross-contact cannot be prevented despite good controls, which is how Codex frames informing consumers. A "may contain" label is not a substitute for cleaning, and putting it on everything makes it meaningless to the people who rely on it.
• Treat a wrong allergen label as a food safety event, not a packaging error.

8. Train people, act on failures and keep the file

• Train everyone who handles food, cleans or stores materials on what allergens are, which ones your plant handles, and what the rules are. Codex calls for specific allergen awareness training where necessary. Record who was trained and when.
• When something fails (a mislabelled bag, a skipped clean, a failed swab or a complaint), stop, find the cause, and place the affected batches on a QA hold until they are assessed.
• If product has already left, you need to find every affected pack fast. That is what a mock recall tests.
• Keep the matrix, supplier specifications, intake checks, production schedules, changeover and cleaning records, swab results, label approvals, training records and corrective actions together, for longer than the shelf life of your products, as Codex section 13.4 suggests for records.

Habits that make allergen control stick

• The matrix is the source of truth. Every recipe, supplier or label change updates it first.
• Every changeover has a type. "Allergen to non-allergen" is never a light clean.
• Allergen-free first. Sequencing is the cheapest control you have.
• Rework follows the allergen, not the convenience.
• A wrong label opens a hold. Allergen errors are batch problems.

Allergen control also overlaps with the rest of your hygiene programme: pest control, water quality and the preventive maintenance that stops worn seals and cracked scrapers from holding residue.

Where an ERP helps

A clear matrix, colour-coded tags and a changeover log can run this checklist in one small plant. It gets harder with many SKUs, shared lines, frequent recipe changes and a lot of batches to trace.

FactoraERP links production orders to recipes and BOM versions, issued material lots and batch records, and tracks stock status including QA holds, non-conformance records and stock adjustments with reason codes. That means a recipe change and the label it needs can be tied to the same version, a changeover can be recorded against the line before the next order starts, a failed check can be logged as a non-conformance and linked to the batches it affects, and those lots can be put on hold. See factoraerp.com.

Free download: eTIMS readiness checklist for factories

Hygiene records, stock records and invoices increasingly have to tell the same story for Kenyan manufacturers. If you want a free eTIMS readiness checklist for factories, sign up for the FactoraERP Insights newsletter at https://isaacmuthui.substack.com. You will get practical operations notes for food and agro manufacturers. No spam; unsubscribe anytime. For background, see our guide to eTIMS for food and agro manufacturers.

FAQ

What should an allergen control checklist for a food factory include?
An allergen matrix for every material and product, allergen checks at intake, segregated and labelled storage, production planning that reduces cross-contact, validated and verified allergen changeover cleans, rework rules, label-to-recipe checks, staff training, and a procedure for failures that includes holding affected batches and keeping records.

Which allergens must be declared on food labels in Kenya?
KS EAS 38:2014, Labelling of pre-packaged foods, is Kenya's labelling standard, and KEBS has said it requires allergen declaration. The Codex General Standard (CXS 1-1985, section 4.2.1.4) lists cereals containing gluten, crustacea, egg, fish, peanuts, soybeans, milk and milk products, tree nuts, and sulphites at 10 mg/kg or more. Check the exact list in your copy of the standard and any export market rules.

Does cooking or pasteurising remove allergens?
No. The Codex code of practice on allergen management (CXC 80-2020) says treatments that kill pathogens, such as heating and high pressure processing, generally do not destroy allergenic proteins, and protein-degrading processes should not be relied on to eliminate them. Allergens have to be kept out or cleaned out.

Is a "may contain" label enough?
No. Codex says consumers should be informed where cross-contact cannot be prevented despite well-implemented controls. A precautionary label is the last step after segregation, scheduling and cleaning, not a replacement for them.

Can we run allergen and non-allergen products on the same line?
Yes, if you control it. Codex allows separation by time with effective cleaning between foods with different allergen profiles. Run allergen-free products first, define an allergen changeover clean, verify it every time and record it.

How do we check that an allergen clean worked?
Visual inspection by someone other than the cleaner is the minimum. Codex section 11.1.1 also mentions protein and allergen test swabs to verify that cleaning programmes are effective. Agree the method and frequency with your QA team and laboratory, based on your risk assessment.

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Isaac Muthui, CEO, Tamalaki Business Network Ltd

Originally published at factoraerp.com.