Undeclared Allergen Incident & Investigation Protocol Guidelines & checklists for allergen investigations at retail/foodservice, manufacturing and food import businesses

7.1.1 Retail/Food Service Sector Food Product Allergen Investigation Table

Food Product	Manufacturer	Suspected Undeclared Allergen	Food Product Allergen Review (label/product specification review)		Allergen Identified
			Ingredient	Ingredient List Review
Apple Pie	On-site	dairy	Pre-made Pastry apple filling	flour-wheat flour sugar eggs margarine - canola oil, salt, milk protein solids, emulsifiers(322 from soy), preservative 222apple, all-spice, sugar	Wheat Milk protein Soy

7.2 Manufacturing Sector Allergen Investigation Checklist

Statutory Requirements for Allergen Investigations
Does the food business receive and manufacture food containing allergens as prescribed by Standard 1.2.3 of the FSC:
 Tree nuts & tree nut products  Peanuts & peanut products  Soybeans & soybean products  Milk & milk products  Sesame seeds & sesame seed products		 Egg & egg products  Crustaceans & their products  Cereals containing gluten & their products  Sulphites (≥10mg/kg)  Fish & fish products
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:
Packaged retail food has a label detailing an accurate allergen declaration			
Unpackaged foods 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			
Food for catering purposes has allergens declared on the label or allergens are declared in documentation accompanying the catering food			
Packaged food sold in a hamper has a label that contains accurate allergen declarations			
Food sold from vending machines has allergen declaration provided on or in connection with the food (e.g. displayed on outside of vending machine)			
Comments/Observations:___Supplier_Management_and_Product_Receipt'>Comments/Observations:____Allergen_Investigation_Assessment'>Comments/Observations:
Allergen Investigation Assessment
Has the food business prepared and/or sold food product/s which “claim” to be allergen free? Food/Product__________________________________________________________________________________________________ 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			
			
Does the food business have a documented policy or procedure for allergen control? Does this procedure cover allergen declarations on product labels and documentation required for unpackaged (catering) food?			 
Are all employees trained in food allergen control procedures? Is there a training register available to verify training?			 
Can employees identify allergens of concern?			
Can employees demonstrate process control measures to prevent allergen contamination?			
Comments/Observations:
Supplier Management and Product Receipt
Does the food business purchase food/ingredients from a commercial supplier with a certified food safety program? Does the supplier provide validation that the food/ingredients supplied are free of specific allergens?			 
Does the food business have valid invoices to enable trace back to the food supplier?			
Does the food business have a procedure/policy for assessing the allergen status of foods/ingredients received from suppliers? Does the food business validate the allergen status of foods from suppliers? E.g. Supplier audit/survey (Assess supplier’s allergen control plan, cleaning program & range of allergenic foods produced at their site)			 
Is there a procedure/policy for ensuring any change in supplier is accompanied by an allergen status review of the product?			
Do suppliers notify the food business of any changes in the allergen status of foods/ingredients they supply? Has the business requested this notification from their suppliers?			
Does the food business only accept foods with adequate labelling and/or provided with appropriate documentation (unpackaged foods) to determine the allergen status of the food?			
Does the food business review all product specifications documentation/labelling of incoming raw ingredients for their allergen status?			
Does the food business have a system in place to clearly identify foods containing allergens at Receipt? E.g. Tags/colour coding of cases/pallets/bags			
Does the food business only accept foods that are adequately protected from contamination? Does the food business have a system in place to remove damaged containers/packages of foods containing allergens at Receipt to prevent contamination?			 
Comments/Observations:__Food_Labelling_/_Packaging'>Comments/Observations:__Cleaning_and_Sanitising'>Comments/Observations:
Food Storage
Are allergenic/non-allergenic ingredients/foods stored separately and/or adequately contained to prevent contamination? E.g. use of clean, enclosed storage containers			
Is there a procedure/policy in place to identify allergenic/non-allergenic foods/ingredients? E.g. colour coding, tags			
Comments/Observations:
Food Processing
Are product specifications regularly reviewed to validate their allergen status? Has the business validated the preparation process and end food product to determine the allergen status of the food? Is evidence available e.g. sample results, food safety program records			  
Is there a dedicated production area for the preparation of allergenic/non-allergenic foods? If same production area used, are non-allergenic foods processed before foods with allergens?			 
Are dedicated processing lines used for the processing of allergenic/non-allergenic foods?			
If separate production lines are used for allergenic & non-allergenic foods, are they in close proximity or have cross-over points? Are there adequate protection/barriers to prevent contamination?			 
Is dedicated equipment, utensils, containers used for the production of allergenic/non-allergenic foods? Is there a system in place to clearly identify them? E.g. colour coded, marked			 
Is equipment, utensils, containers adequately cleaned/sanitised immediately after the production of allergenic foods to prevent contamination?			
Do food handlers wear dedicated protective clothing when preparing non-allergenic foods to prevent contamination?			
Is dedicated cooking media, such as water or oil used for allergenic/non-allergenic foods to prevent contamination? If re-used, is it tested to validate the contamination risk?			 
Is there a risk of airborne allergen contamination throughout the processing area?			
Is there a system in place to clearly identify allergenic foods during processing? E.g. colour coding, tagging			
Is the traffic flow of raw materials, packaging supplies & employees limited during the manufacture of allergenic foods to prevent contamination?			
Are employees working on allergenic processing lines restricted from non-allergenic lines? Is there a system to clearly identify employees working on allergenic lines? E.g. different coloured uniform/hair net			 
Do employees wear clean protective clothing when processing allergenic/non-allergenic foods in a way to prevent cross-contamination?			
Are there adequate hand wash basin(s) situated in the relevant areas?			
Hand wash basin(s) supplied with soap and paper towels?			
Hand wash basin(s) only used for hand washing?			
Is equipment designed and located to allow for easy and effective cleaning and inspection?			
Comments/Observations:
Cleaning and Sanitising
Does the business have an effective, regular cleaning program in place? Does the food business use Clean in Place (CIP) systems to clean pipe work, equipment and machinery? Is the CIP system verified for allergen status? (swabs/rinse waters)			 
Are cleaning times scheduled appropriately to prevent cross-contact? Are processing lines adequately cleaned / sanitised immediately after the production of allergenic foods to prevent contamination?			 
Are designated cleaning cloths/equipment used in areas where allergenic/non-allergenic foods are manufactured?			
Is adequate cleaning and sanitising demonstrated throughout all aspects of the processing environment, equipment and utensils? Does the food business have cleaning records to verify cleaning procedures? Does the business have any verification procedures e.g. environmental swabs to verify cleaning and sanitising			  
Comments/Observations:
Food Labelling / Packaging
Is there a procedure in place to review and approve labels and product specifications for new products and/or changes to current products? Does the procedure address the allergen status of the ingredients list and any required allergen declarations? Has the food business demonstrated compliance with this procedure? Do product labels comply with the Food Standard Code requirements to ensure information is correct & product traceability is achievable? E.g. batch coding, accurate ingredients list			   
Is there a procedure for destroying old packaging and/or product specifications when product formulations have been changed? Has the food business demonstrated compliance with this procedure?			 
Is packaging material stored adequately to prevent contamination?			
Is there a procedure in place to ensure and verify correct product labels are used on the production line when packaging products? Are employees adequately trained in complying with this procedure? Has the food business demonstrated compliance with this procedure?			  
Are non-allergenic foods packaged separately and/or in a clean, dedicated area to prevent contamination?			
Do employees take all practicable measures to prevent unnecessary contact when packaging food to prevent contamination?			
Is there a procedure in place to verify correct labels have been placed on products prior to distribution? Has the food business demonstrated compliance with this procedure?			 
Comments/Observations:
Product Distribution
Are foods products distributed to other manufacturing / retail / food service facilities?			
Are all foods for distribution adequately contained or packaged to protect against contamination?			
Does the food business only distribute foods that have adequate labelling and/or provided with appropriate documentation (unpackaged foods for catering purposes) to determine the allergen status of the food?			
Does the food business have a documented food recall plan?			
Can the food business demonstrate compliance with their recall plan when recalling unsafe food?