Undeclared allergens are one of the leading causes of food recalls worldwide. We build allergen risk assessments, validate cleaning procedures, and get your labelling right across every market you sell into.
Allergen management is the set of processes a food business uses to identify, control and communicate the presence of allergenic ingredients in its products. It sits at the intersection of food safety, regulatory compliance and product labelling.
It covers supplier ingredient declarations, recipe and formulation control, production scheduling, cleaning between allergen changeovers, equipment and storage segregation, staff training, and accurate labelling. Effective allergen management prevents two distinct types of failure: cross-contact, where an allergen unintentionally ends up in a product that should not contain it, and labelling errors, where a label fails to declare an allergen that is genuinely present.
Allergen management is required under EU Regulation 1169/2011 for labelling and Regulation 2021/382 for cross-contact controls on equipment, vehicles and containers. In the US, the Food Allergen Labeling and Consumer Protection Act, as amended by the FASTER Act, governs allergen declaration. Codex Alimentarius published a dedicated Code of Practice on Food Allergen Management for Food Business Operators, CXC 80-2020, providing international guidance.
Within certification standards, allergen management is consistently one of the highest non-conformance areas. FSSC 22000's additional requirements specifically expand on the ISO 22000 baseline, and BRCGS Issue 9 includes allergen management within product control, where it is among the most cited non-conformances of any clause.
The reasons allergen management causes so many problems are structural and not a sign of carelessness. A single product can contain dozens of ingredients, each sourced from a supplier whose own formulation can change without notice. A single production line can run multiple recipes in a day, each with a different allergen profile. And a single label, once printed, has no way of knowing that the recipe behind it has changed. Closing these gaps requires a system that connects supplier declarations, recipe records, production scheduling, cleaning records and labels into a single chain where a change at any point is reflected everywhere else.
Regulation 1169/2011 requires these 14 allergens to be declared in bold or otherwise emphasised within the ingredients list, including for non-prepacked food. The US requires 9 of these under FALCPA, with sesame added as the ninth in 2023.
Wheat, rye, barley, oats
Prawns, crab, lobster
Including lactose
Almonds, hazelnuts, etc.
Added to US list 2023
Above 10mg/kg or 10mg/L
Mussels, oysters, snails
Businesses trading across the EU, UK and US often design labels meeting both sets of requirements simultaneously, using bold ingredient text for the 14 EU and UK allergens alongside a separate "Contains" statement for the 9 US allergens, to simplify compliance across markets without maintaining entirely separate label formats.
Allergen management is required by every food business, regardless of size, since allergen labelling is a legal requirement everywhere food is sold. The scale of the programme should match the complexity of the operation, but the underlying obligation does not disappear for smaller businesses.
Manufacturers handling multiple allergens across shared lines and equipment face the highest cross-contact risk and the greatest documentation burden for risk assessments and cleaning validation.
Allergen information must be available for non-prepacked food in the EU and UK, and cross-contact in kitchens, such as shared fryers or utensils, is a frequent source of incidents in dining settings.
In-store bakeries, delis and hot food counters need allergen controls covering shared equipment and surfaces, separate from the allergen labelling already in place for pre-packed goods.
FSSC 22000, BRCGS, IFS Food and SQF all require a documented allergen management programme as part of certification, and allergen-related non-conformances are among the most common findings.
Differences between the 14 EU and UK allergens and the 9 US allergens mean labels and risk assessments need to address both sets of requirements where products are sold in multiple markets.
Businesses manufacturing products under multiple brand labels with varying formulations face elevated risk of label mix-ups and require robust changeover and verification controls.
We build allergen management programmes that prevent both cross-contact incidents and labelling errors, the two failure modes behind almost every allergen recall.
A site and product-specific risk assessment identifying every allergen present across your raw materials, recipes and processes, and mapping cross-contact risk across shared lines, equipment, storage and the wider production environment.
Review and correction of allergen labelling against EU Regulation 1169/2011, UK requirements and US FALCPA as amended by the FASTER Act, including review of precautionary "may contain" statements.
Validation studies confirming that cleaning procedures reduce allergen residue to an acceptable level before the next product run, using visual inspection, ATP swabbing and allergen-specific testing such as lateral flow or ELISA.
Review and redesign of production schedules to sequence allergen-containing products last where possible, minimising the frequency and risk of allergen changeovers.
Design of physical segregation controls for allergen-containing ingredients and products, including dedicated equipment, colour-coding and storage layout reviews.
Systems for collecting, reviewing and maintaining current allergen declarations from suppliers, with a change control process to catch formulation changes that introduce new allergens.
A review of your current allergen controls against relevant regulations and certification standard requirements, producing a written action plan covering risk assessment, labelling, cleaning and training.
A mock recall exercise specifically simulating an undeclared allergen incident, testing your traceability, communication and withdrawal procedures under the scenario most likely to trigger a real recall.
Training for production, packing and labelling staff on allergen risks, cross-contact prevention, label verification and what to do if an allergen incident is identified.
Our allergen awareness training courses build staff competency in cross-contact prevention and label verification. We also offer HACCP training and food safety culture training that reinforce allergen controls.
Building or correcting an allergen management programme follows a defined sequence. Our part of the process typically takes a few weeks.
| Stage | What happens | Our role | Duration |
|---|---|---|---|
| 1. Gap assessment | Current allergen controls, labelling and documentation are reviewed against regulatory and certification requirements. | We conduct the assessment and deliver a written action plan. | 2 to 3 days |
| 2. Allergen risk assessment | Every allergen across raw materials, recipes and processes is mapped, and cross-contact risk is assessed across lines, equipment and storage. | We conduct the risk assessment and document findings for every product and process. | 3 to 5 days |
| 3. Labelling review | Current labels are reviewed against EU, UK and US allergen declaration requirements, including precautionary statements. | We review labels and recipes and identify any gaps or inconsistencies. | 2 to 3 days |
| 4. Cleaning validation | Cleaning procedures for allergen changeovers are tested and validated using visual inspection and allergen-specific testing methods. | We design and conduct the validation study and document the results. | 3 to 5 days |
| 5. Scheduling and segregation | Production schedules and physical segregation controls are reviewed and redesigned where needed to reduce cross-contact risk. | We review schedules and propose segregation and sequencing changes. | 2 to 3 days |
| 6. Documentation | The full allergen management programme is documented, including risk assessments, cleaning validation records, supplier declaration systems and labelling procedures. | We write the complete documentation in collaboration with your team. | 1 to 2 weeks |
| 7. Staff training | Production, packing and labelling staff are trained on allergen risks, cross-contact prevention and label verification. | We deliver staff training tailored to your specific products and processes. | 2 to 3 days |
| 8. Mock recall exercise | A simulated undeclared allergen incident tests traceability, communication and withdrawal procedures end to end. | We design and run the exercise and issue a findings report. | 1 to 2 days |
Our gap assessment reviews every part of your allergen management programme, from risk assessment through to labelling, and identifies the gaps most likely to cause an incident or audit non-conformance.
Our allergen management gap assessment reviews risk assessment, supplier declarations, recipe and formulation control, production scheduling, cleaning validation, equipment segregation, staff training and labelling against the requirements of relevant regulations and the certification standards you hold or are pursuing.
The assessment is designed to identify the specific gaps most likely to result in either a cross-contact incident or a labelling error, since these are the two failure modes behind a large share of allergen-related recalls and a large share of allergen non-conformances in certification audits.
We review existing risk assessments, supplier declarations, cleaning validation records and labelling procedures.
We observe production, changeovers, storage and labelling areas to compare documented controls against actual practice.
We cross-check current labels against current recipes and supplier declarations to identify any mismatches.
We produce a written gap assessment with a prioritised action plan covering risk assessment, cleaning, segregation, scheduling and labelling.
If your business is pursuing or maintaining certification, this assessment aligns directly with the allergen requirements of FSSC 22000, BRCGS Issue 9 and IFS Food Version 8.
The same failures appear across food businesses of every size and are responsible for both recalls and certification non-conformances.
A formulation change, even a small one such as a supplier switching an ingredient source, can introduce a new allergen. If the label is not updated to match, the product is mislabelled. This is one of the most common root causes of allergen recalls and requires a robust change control process linking supplier declarations, recipes and labels.
The correct product placed in the wrong packaging, or the wrong label applied to the right product, results in an allergen declaration that does not match the actual contents. Verification checks at changeover and packaging line start-up are critical controls for this failure mode.
A cleaning procedure that is effective for general hygiene may not be effective for removing a specific allergen residue. Without validation testing, there is no evidence that the cleaning method achieves the allergen control it is relied upon for in practice, which is a frequent non-conformance in FSSC 22000 and BRCGS audits.
Risk assessments that focus only on direct ingredients and miss airborne risks, such as flour dust settling on adjacent lines, or shared storage and transport equipment, leave significant cross-contact pathways unaddressed. Regulation 2021/382 specifically extends allergen controls to equipment, vehicles and containers for this reason.
Because precautionary "may contain" labelling is largely voluntary and unstandardised, businesses often apply it inconsistently, either over-using it in a way that reduces consumer trust, or under-using it where genuine cross-contact risk exists. A risk-based approach to precautionary labelling, informed by the allergen risk assessment, produces more consistent and defensible outcomes.
General food hygiene training does not necessarily cover allergen-specific risks such as which equipment requires dedicated cleaning, how to handle an allergen spillage, or how to verify a label before a changeover. Allergen-specific training for production and packing staff closes this gap.
The two most commonly compared allergen labelling frameworks for businesses trading internationally.
| EU and UK | United States | |
|---|---|---|
| Governing regulation | Regulation 1169/2011 | FALCPA, as amended by the FASTER Act |
| Number of allergens | 14 | 9 |
| Most recent addition | All 14 in place since 2011 | Sesame, added 2023 |
| Cross-contact controls | Explicit requirements under Regulation 2021/382 for equipment, vehicles and containers | Addressed through FSMA modernised CGMPs as an explicit allergen cross-contact requirement |
| Non-prepacked food | Allergen information required for non-prepacked food | Varies. Primarily applies to packaged foods with some state-level requirements for food service |
| Our consulting | Allergen management consulting, covering both frameworks | |
What drives the timeline and cost of allergen management consulting. We provide a written proposal with a fixed fee after the initial consultation.
Timeline
How long our consulting work takes
Cost factors
What drives the consulting fee
No existing allergen risk assessment, cleaning validation or labelling review. Our consulting work typically takes 2 to 3 weeks depending on the number of products and allergens involved.
A site handling several major allergens across multiple product lines requires a more extensive risk assessment and cleaning validation programme than a single-allergen, single-line operation.
For businesses with an otherwise adequate programme needing a labelling compliance check across markets. Our consulting work typically takes 2 to 4 days.
On-site testing required for each allergen and equipment combination. The number of combinations directly affects the scope and cost of the validation programme.
Businesses selling into EU, UK and US markets need labels and risk assessments addressing both the 14-allergen and 9-allergen frameworks, adding to the scope of the labelling review.
A gap assessment only, a full programme build, or cleaning validation studies each carry different fees. All scopes are defined in writing before work begins.
Allergen management overlaps significantly with FSSC 22000, BRCGS and IFS Food requirements. Where combined, this work is scoped within the broader consulting engagement.
Allergen awareness training is often combined with the programme build. Training fees are scoped separately based on the number of staff and delivery format.
Answers to the questions we hear most often from businesses building or correcting their allergen management programme.
Allergen management is the set of processes a food business uses to identify, control and communicate the presence of allergenic ingredients in its products. It covers supplier ingredient declarations, recipe and formulation control, production scheduling, cleaning between allergen changeovers, equipment and storage segregation, staff training, and accurate labelling. Effective allergen management prevents both cross-contact, where an allergen unintentionally ends up in a product that should not contain it, and labelling errors, where a product label fails to declare an allergen that is present.
The number of allergens requiring mandatory declaration varies by jurisdiction. The EU and UK require 14 allergens to be declared under Regulation 1169/2011, including cereals containing gluten, crustaceans, eggs, fish, peanuts, soybeans, milk, tree nuts, celery, mustard, sesame, sulphur dioxide and sulphites, lupin, and molluscs. The US requires declaration of 9 major allergens under FALCPA as amended by the FASTER Act: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame, with sesame added as the ninth allergen in 2023.
Allergen cross-contact is the unintentional transfer of an allergen into a food product that is not intended to contain it. It commonly occurs through shared equipment, production lines, utensils, storage areas, or airborne particles such as flour dust. Cross-contact is distinct from a recipe deliberately containing an allergen as an ingredient, and is the focus of cleaning validation, production scheduling and physical segregation controls within an allergen management programme.
Undeclared allergens are consistently one of the leading causes of food product recalls globally, often accounting for a substantial share of recalls in some markets. The most frequent root causes are labelling errors, such as using an outdated label after a recipe change, packaging mix-ups where product is placed in the wrong packaging, and supplier ingredient changes that introduce a new allergen without the formulation or label being updated accordingly.
An allergen risk assessment identifies every allergen present across your raw materials, recipes and processes, and maps where cross-contact risk exists, such as shared lines, equipment, storage areas and the wider production environment. It assesses the adequacy of current controls, including segregation, cleaning, scheduling and labelling, and is required under Regulation 2021/382 in the EU, the FSSC 22000 additional requirements, and the allergen sections of BRCGS, IFS Food and SQF.
Allergen cleaning validation confirms that a cleaning procedure is capable of reducing allergen residue on equipment and surfaces to below an acceptable level before the next product is run. This typically involves visual inspection, ATP swabbing as an indicator of general cleanliness, and allergen-specific testing such as lateral flow devices or ELISA kits during the validation study. Once a cleaning method is validated for a given allergen and piece of equipment, routine verification, such as visual checks or periodic swabbing, confirms the validated method continues to work in practice.
Precautionary allergen labelling, such as "may contain" statements, indicates that a product could contain trace amounts of an allergen due to the production environment, even though the allergen is not a deliberate ingredient. While allergen declaration for ingredients is a legal requirement in the EU, UK and US, precautionary labelling is generally voluntary and not standardised, which means "may contain" statements can be inconsistent in meaning between manufacturers. The VITAL programme is one voluntary framework used to apply precautionary labelling more consistently based on quantitative risk assessment.
Certification standards require a documented allergen management programme covering risk assessment, segregation, cleaning validation and labelling controls. The FSSC 22000 additional requirements specifically expand allergen management beyond the baseline ISO 22000 requirements. BRCGS Issue 9 includes allergen management within product control and is consistently one of the highest non-conformance areas in audits. IFS Food Version 8 addresses allergen risk through its hazard analysis and product information requirements, particularly relevant for products carrying PDO or PGI designations.
An allergen management gap assessment reviews your current allergen controls, including risk assessment, supplier declarations, recipe and formulation control, production scheduling, cleaning validation, equipment segregation, staff training and labelling, against the requirements of relevant regulations and certification standards. It identifies gaps, prioritises them by risk, and produces a written action plan with a realistic timeline.
Yes. Risk assessment reviews, labelling audits, documentation development and cleaning procedure design are all available remotely. We work with clients in any country. On-site visits are available for cleaning validation studies, which require physical testing, and for site reviews of segregation and cross-contact controls.
You can commission any of these on their own, with an agreed scope and a written quote, without taking on ongoing consulting. See all food safety services.
To assess the controls the declaration depends on.
Read about An allergen management review →For a deeper check of how allergens are declared.
Read about An allergen declaration review →Where changeover cleaning has never been validated.
Read about A cleaning and sanitation review →To check a label against the information law of each market.
Read about A food label compliance review →Tell us about your products and the markets you sell into. We will tell you exactly where your allergen controls stand.