Explore the factory map, click on each icon to learn about the allergen risks, and discover ways to address these challenges.
Allergen risk review is the process of thoroughly investigating the allergen status of food. It begins with raw materials and continues throughout the manufacturing process until the food is packed and labelled.
The review includes identifying the presence of allergens that are intentionally added, as well as identifying and quantifying the allergens that may be unintentionally present (cross contact allergens).
Information collected in an allergen risk review can be used to inform a VITAL risk assessment.
Have an allergen management program in place.
An Allergen Management Program (AMP) is a documented systematic approach towards identifying and controlling allergens in a food facility. It is applicable to all levels and all areas of a food company and sets the approach to the control and management of allergens.
An allergen risk review can assist in identifying areas that need to be included while developing an AMP or when updating one that is already in place. An allergen risk review requires the support of many parts of the business including management. It should be repeated regularly (such as when HACCP reviews are conducted) as well as after any changes to staff, suppliers, equipment, materials, scheduling, recipes, sites etc and the AMP should be updated accordingly.
Gather a cross-functional team
Form a team of people from all parts of the business who understand how raw materials and processing can impact on the allergen status of a food. The team may include a representative from and is not exclusive to:
- Raw materials & supply chain management
- Raw material receipt, storage & handling
- Product development
- Production design & scheduling
- Operations, engineering, maintenance & cleaning
- Quality assurance
- Regulatory affairs
Each manufacturing facility is different, so it is not possible for this website to cover allergen risk review comprehensively, but exploring the factory map and using the guidance is a great way to begin the risk review process.
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Step 1 of 15
Raw material specifications should be checked thoroughly to obtain a clear understanding of the allergen status of ingredients, raw materials and processing aids. Investigating the allergens status of raw materials is essential to preventing allergens being unknowingly added to a product.
A risk review is the process of assessing raw material specifications. It involves having confidence in supplier information, identifying the presence intentionally added allergens, and understanding the form and concentration of cross contact allergens.
A VITAL risk assessment for a recipe should only be conducted after the allergen status of each ingredient and processing aid is fully understood.
Step 2 of 15
Procurement of raw materials including ingredients, additives, processing aids, lubricants, cleaning materials etc. should be conducted with care because they may potentially contain allergens.
A risk review involves investigating the potential for purchasing raw materials that unknowingly contain food allergens. This includes checking that each material is purchased against its approved raw material (supplier) specification and from an approved supplier list.
For a VITAL risk assessment, it is necessary to know which ingredients contain allergens that are intentionally included as part of their recipe, and details about allergens that may be present due to cross contact. A VITAL risk assessment cannot be conducted correctly if the raw material contains allergens that are not identified.
Step 3 of 15
Raw materials receipt
The receipt of raw materials and ingredients should follow procedures that ensure the overall allergen status of the material is delivered and received as expected.
A risk review involves investigating the steps that are used to control incoming raw materials, so that the materials that are delivered are of the expected allergen profile, that they have not come into contact with other allergens during transportation and are accepted on site according to the site’s allergen management procedures.
Materials are accepted on site with known allergen status informs a VITAL risk assessment.
Step 4 of 15
Raw materials storage
Raw materials and ingredients should be stored such that allergen cross contact is prevented. Processes to manage spillages of ingredients in storage and returns to warehouse should be in place.
A risk review involves investigating the steps that are used to ensure that allergen cross contact is prevented during storage
A VITAL risk assessment includes understanding the allergen profile of each ingredient. Any changes to the allergen profile during storage (for example through cross contact occurring) can impact upon the allergen status of the finished product.
Step 5 of 15
Production scheduling should take into account the allergens in each of the foods produced. This involves scheduling products that contain no allergens first, followed by foods that contain allergens, and ensuring that the line is cleaned between foods that have different allergen profiles. Well thought out production schedules are a key technique for minimising allergen cross contact.
A risk review involves investigating the production sequencing practices that are in place and identifying any scheduling orders where allergen cross contact may occur.
For a VITAL risk assessment, a thorough understanding of the potential for allergen cross contact caused by the production scheduling order is required. If allergen cross contact occurs because a food with an allergen is run before a food without the allergen, the residue should be quantified during the risk review process and applied to the VITAL risk assessment as Hang Up.
Step 6 of 15
Material staging, batch assembly
When preparing ingredients for addition to batches (including transferring them from storage or weighing or measuring out the materials) care should be taken to ensure the correct ingredients are used, and handling is such that cross contact does not occur.
A risk review involves confirming that the ingredients used in a product batch are of a known allergen status
A VITAL risk assessment can only be conducted correctly when the allergen status of an ingredient is known and does not change prior to addition to the batch.
Step 7 of 15
Rework or food that is removed from processing with the intention to add it back to the process at a later stage, may contain allergens. If rework is added to a batch that is of a different allergen profile, allergens can be accidentally (and potentially unknowingly) added to a food.
A risk review involves confirming that the allergen status of all rework is known, and when rework is used, it does not introduce new allergens into the food being processed.
A VITAL risk assessment of the food being processed can only be conducted correctly when the allergen status of all raw materials, including the addition of any rework is known.
Step 8 of 15
Maintenance & Engineering
Maintenance and engineering practices can impact upon the allergen status of foods even when not directly involved in the food production. Staff who have detailed knowledge of equipment and points where product may accumulate play a key role in allergen management.
A risk review involves identifying when and where the allergen profile of food can be changed due to maintenance and engineering activities.
For a VITAL risk assessment, all sources of cross contact must be identified and quantified. Any cross contact due to the manufacturing process must be eliminated or reduced wherever possible.
Step 9 of 15
Cleaning equipment, preparation areas and the production lines of a food manufacturing site is necessary to eliminate allergen residue and the potential for cross contact. As facilities can vary in complexity, food materials, the allergen type, number, and nature, equipment type, and food contact surfaces, cleaning parameters may be unique to each process or site.
A risk review involves understanding the effectiveness of cleaning practices by investigating the cleaning controls, identifying cleaning trouble spots, validating and verifying cleaning procedures that can lead to allergen cross contact occurring.
For a VITAL risk assessment, it is necessary to conduct a risk review to determine the potential impact of allergen cross contact. A combination of scheduling and cleaning can be an effective method for the minimisation of allergen cross contact. If cleaning cannot remove all allergen residue however, the residue should be quantified during the risk review process and applied to the VITAL risk assessment as Hang Up.
Step 10 of 15
Process, Premises & Equipment
Manufacturing site design, equipment, processes, and product range impact on the presence, risk and control of allergens. This section provides information about reviewing allergen risks during production.
A risk review involves identifying when and where the allergen profile of food can change during production.
For a VITAL risk assessment, sources of cross contact due to processing must be identified and quantified.
Labelling & Packing
Step 11 of 15
When food labels declare the presence of allergens in an accurate, clear and consistent manner, people with food allergy can quickly and easily identify which foods they can eat.
A risk review that assesses the impact of allergen cross contact from raw materials and the processing environment will provide information to inform a VITAL risk assessment.
A VITAL risk assessment that is conducted correctly will provide a labelling outcome setting out the intentionally added allergens and any cross contact allergens and their Action Levels. The labelling outcome can be used for allergen declarations on foods and ingredients.
Labelling & Packing
Step 12 of 15
Any labels or packaging should correctly communicate the allergen status of the food it is attached to.
A risk review involves investigating the effectiveness of the processes used to ensure that the food or ingredient bears the correct label.
Step 13 of 15
People & Training
Trained staff who are aware of food allergen risks can support a business in successfully controlling and managing food allergens. Staff from all parts of the business (including contractors and temporary staff) should understand their role in allergen management. Encourage staff to look for allergen risks and have processes in place so that the risks are addressed.
A risk review involves identifying areas within the business that require food allergen training, confirming that allergen training is provided, and staff competence can be demonstrated.
Step 14 of 15
Any product development activities should take into consideration the impact of food allergens.
A risk review involves investigating the effectiveness of the processes used to ensure that the allergen status of a food or ingredient does not inadvertently change due to product development processes.
Step 15 of 15
Analysis & Testing
Food allergen analysis is the testing of a material or a surface to identify and/or quantify the presence of a food allergen. Analytical test results are a useful tool for allergen management in food processing and may be used to enhance an allergen management plan and can be a valuable tool for a risk–based approach to allergen management.
A risk review utilises allergen analysis in two ways. Analytical testing can be used to confirm the allergen status of an incoming ingredient (ensure raw materials are as specified) and can be used to validate and verify allergen controls and cleaning procedures.
Allergen analysis can be useful for validating a VITAL risk assessment. Although allergen testing is not a mandatory component of the VITAL Program, it can be used to confirm any assumptions made concerning Hang Up, processing impact or environmental cross contact, as well as to confirm the theoretical concentration of cross contact allergen in the finished product.