The prime objective of an investigation into undeclared allergens in a food is to ensure that public health and safety is protected and to ensure the incident will not occur again. The action plan depends on the outcome of the investigation. Action should always be taken in a timely manner to ensure further incidents do not occur, and public health and safety is protected.
Key considerations:
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Nature and magnitude of the non-compliance
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Are there records of similar complaints against the business?
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What is the compliance history for the business?
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What is the likelihood of further and ongoing compliance?
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Has the business demonstrated awareness and/or the capacity to meet regulatory requirements?
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Type of allergen (e.g. is the allergen commonly associated with severe anaphylaxis reactions or mild gastroenteritis?).
As part of the investigation, always ensure that any other foods which are likely to contain undeclared allergens are removed from sale.
6.3.1Corrective action
Corrective action should be taken in accordance with the enforcement agency’s policies and procedures and the type of corrective action should be evaluated based on the risk to public health and safety. For example, if products containing undeclared allergens are available for sale in the market place, product recall should always be considered. Corrective action should always be taken promptly to protect the health and safety of consumers.
Some examples of corrective action include:
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food product recall re-label the package of food by placing a new label over the incorrect one in accordance with standard 1.1.1 clause 11 of the Code
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reformulation of the food product
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seizure
Due to the risk of allergens to public health and safety, it is recommended that the corrective actions required be communicated to the business as soon as possible. Suitable timeframes for completing corrective actions should be determined by the enforcement agency to protect public health and safety.
6.3.2Food product recall considerations
The need and scale of a recall is dependent on the nature of the offence and allergen specific risk assessments. Laboratory analysis of the sample may be required to determine the level of allergen. Deciding whether a business is required to recall or withdraw a product due to undeclared allergens should be based on assessing the risk to public health and safety.
If a packaged food product has undeclared allergen(s) and is a risk to public health, and has been sold to customers or supplied to businesses the food product should be recalled. The food business has the primary responsibility for the supply of the food product and if the product is deemed unsafe, the business would normally initiate the food recall. Food businesses need to liaise with Food Standards Australia New Zealand (FSANZ) and their state or territory food enforcement agency where the head office of their business is located as soon as they consider a food recall is or may be needed.
Enforcement agencies and food businesses considering a food recall should refer to the Food Standards Australia New Zealand Food Industry Recall Protocol 7th Edition May 2014. A copy of this document can be obtained from www.foodstandards.gov.au.
7. Checklists
7.1 Retail/Foodservice Allergen Investigation Checklist
Statutory Requirements for Allergen Investigations
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Does the food business prepare and/or receive food containing key allergens as prescribed by Standard 1.2.3 of the FSC:
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Tree nuts & tree nut products
Peanuts & peanut products
Soybeans & soybean products
Milk & milk products
Sesame seeds & sesame seed products
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Egg & egg products
Crustaceans & their products
Cereals containing gluten & their products
Sulphites (≥10mg/kg)
Fish & fish products
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Does the food business declare mandatory allergen information for the above allergens as required by Standard 1.2.3 of the FSC for the following foods:
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Packaged retail food has a label detailing an accurate allergen declaration
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Unpackaged food have allergen(s) declared on or in connection with the displayed food or to the purchaser verbally or in writing upon request of the customer
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Food for catering purposes has allergens declared on the label or allergens are declared in documentation accompanying the catering food
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Packaged food sold in a hamper has a label that contains accurate allergen
declarations
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Food sold from vending machines has allergen declaration provided on or in
connection with the food (e.g. displayed on outside of vending machine)
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Comments/Observations:
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Allergen Investigation Assessment
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Has the food business prepared and/or sold food product(s) which “claim” to be allergen free?
Food/Product__________________________________________________________________________________________________
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Has the food business received a complaint regarding a product suspected of containing undeclared allergen/s?
Food product __________________________________________________________________________________________________
*Refer to Food Product Allergen Investigation Table
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Does the food business have a documented policy or procedure for allergen control?
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Does this procedure cover allergen declarations on product labels, store signage and/or handling specific customer requests?
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Are all food handlers trained in food allergen control procedures?
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Is there a training register/records available?
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Can food handlers identify allergens of concern?
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Can food handlers demonstrate process control measures to prevent allergen contamination?
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Comments/Observations:
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Supplier Management and Product Receipt
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Does the food business purchase food/ingredients from a commercial supplier with a certified food safety program?
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Does the supplier provide validation that the food/ingredients supplied are free of specific allergens?
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Does the food business have valid invoices to enable trace back to the food supplier?
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Does the food business have a procedure/policy for assessing the allergen status of foods/ingredients received from suppliers?
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Is there a procedure/policy for ensuring any change in supplier is accompanied by an allergen status review of the product?
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Does the food business review all product specifications/labelling of food/ingredients received and used in the preparation/sale of foods for allergen status?
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Do suppliers notify the food business of any changes in the allergen status of foods/ingredients they supply?
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Has the business requested this notification from their suppliers?
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Does the food business only accept foods that are adequately protected from contamination?
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Does the food business only accept foods with adequate labelling and/or provided with appropriate documentation (unpackaged foods for catering purposes) to determine the allergen status of the food?
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Comments/Observations:
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Food Storage
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Are allergenic/non-allergenic ingredients/foods stored separately and/or adequately contained to prevent contamination? E.g. use of clean, enclosed storage containers
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Is there a procedure/policy in place to identify allergenic/non-allergenic foods/ingredients? E.g. colour coding, tags
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Comments/Observations:
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Food Processing
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Does the business prepare food free of specific allergens at the request of customers?
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Does the food business have a procedure in place to ensure all ingredients used in the preparation of foods requested to be free of specific allergens are reviewed for their allergen status? E.g. product specifications/work instructions
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Are recipes/product specifications regularly reviewed to validate their allergen status?
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Has the business validated the preparation process and end food product to determine the allergen status of the food?
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Is evidence available e.g. sample results, food safety program records
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Is dedicated equipment used for the preparation/handling of allergenic/non-allergenic foods? E.g. dedicated serving utensils
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Is there a dedicated area for the preparation of foods free of specific allergens?
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Are equipment and preparation areas adequately cleaned/sanitised between preparing allergenic and non-allergenic foods to prevent cross-contamination?
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Do food handlers wear dedicated protective clothing when preparing foods free of specific allergens to prevent contamination?
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Is dedicated cooking media, such as water or oil used for allergenic/non-allergenic foods to prevent contamination?
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Is there a risk of airborne allergen contamination throughout the processing area?
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Are there adequate hand wash basin(s) situated in the relevant areas?
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Hand wash basin(s) supplied with soap and paper towels?
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Hand wash basin(s) only used for hand washing?
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Comments/Observations:
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Cleaning and Sanitising
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Is adequate cleaning and sanitising demonstrated to control allergen contamination throughout all aspects of the processing environment, equipment and utensils?
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Are designated cleaning cloths/equipment used in areas where non-allergenic foods are prepared?
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Comments/Observations:
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Food Display
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Are foods free of specific allergens adequately protected from contamination during display?
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Is allergen information provided on or in connection with the displayed food or is it able to be provided upon request by the purchaser?
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Are designated serving utensils provided for foods free of specific allergens?
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Comments/Observations:
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Food Packaging
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Are foods free from specific allergens packaged in a clean, dedicated area to prevent contamination?
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Do food handlers take all practicable measures to prevent unnecessary contact with food to prevent contamination?
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Is packaging material stored adequately to prevent contamination?
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Are labels/product specifications for foods regularly reviewed to ensure they contain an accurate ingredient list and any required allergen declarations?
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Is there a procedure for destroying old packaging and/or product specifications when recipe formulations have been changed?
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Comments/Observations:
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Product Distribution
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Are foods distributed to other retail businesses or food service facilities?
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Does the food business only distribute foods that have compliant labelling and/or provided with appropriate documentation (unpackaged foods for catering purposes) to determine the allergen status of the food?
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Are all foods for distribution adequately contained or packaged to protect against contamination?
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Does the food business have a documented food recall plan?
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Can the business demonstrate compliance with their recall plan when recalling unsafe food?
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Comments/Observations:
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Sampling / Evidence
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Sample of implicated batch ingredients
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Sample of product (same batch if available)
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Sample of end product (validate relevant process(es))
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Photograph storage, processing and display areas
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Photograph food samples and swab sites, relevant processing areas, ingredient and product packaging/labelling
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Photograph/copy menus, recipes, product specifications
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Comments/Observations:
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Signature
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Date
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