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

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

Implementation Subcommittee for Food Regulation

March 2015


The information presented here is distributed by ISFR for and on behalf of FRSC and is presented as an information source only.

The information is provided solely on the basis that readers will be responsible for making their own assessment of the matters presented herein and are advised to verify all relevant representations, statements and information. The information does not constitute legal or professional advice and should not be relied upon as such. Formal advice from appropriate advisers should be sought in particular matters.

ISFR does not accept liability to any person for the information or advice provided in the document, or incorporated into it by reference or for loss or damages incurred as a result of reliance upon the material contained herein. In no event shall ISFR be liable (including liability for negligence) for any damages (including without limitation, direct, indirect, punitive, special or consequential) whatsoever arising out of a person’s use of, access to or inability to use or access the document.

Contents Page






5.1Food Allergy 4

5.2REQUIREMENTs OF the food standards code 5


6.1Assess Food Allergen Complaint 6

6.2Investigation 7

6.3Action and outcome 9

Undeclared Food Allergen Incident & Investigation


The purpose of this document is to provide procedures for investigating and reporting of consumer complaints of undeclared food allergens supplementary to standard food investigation protocols.


This protocol covers the requirements of the Australia New Zealand Food Standards Code (the Code) in relation to allergen control, guidelines for the investigation of food allergen complaints, and checklists for allergen investigations.



a serious allergic reaction that is rapid in onset, usually within 2 hours of exposure to the triggering agent, and may cause death

food allergy

adverse immune reaction to food proteins


an examination of circumstances including the use of statutory powers to determine a contravention of legislation


Australia New Zealand Food Standards Code

Australian Society of Clinical Immunology and Allergy Inc. (2013) Allergy and Immune Diseases in Australia (AIDA) Report 2013
Australian Society of Clinical Immunology and Allergy Inc. (2013) ASCIA Health Professional Information Paper: Nutritional Management of Food Allergy
European Food Safety Authority (2014) Scientific Opinion on the evaluation of allergenic foods and food ingredients for labelling purposes. Accessible: http://www.efsa.europa.eu/en/consultations/call/140523.pdf
Fitzharris, P. & Ameratunga, R. (2007). Food allergy. New Zealand Family Physicians, 34(3), 202-206.
Food Standards Australia New Zealand. (2010). Review of the regulatory management of food allergens, FSANZ, Canberra.
Food Standards Australia New Zealand. (2004). Quantitative Consumer Survey on Allergen Labelling: Benchmark 2003 – NFO Donovan Research Report, FSANZ, Canberra.


5.1Food Allergy

Food allergy is an important health issue due to the potential for severe and life threatening reactions. Rigorous declaration requirements are considered the most appropriate risk management option for food allergens since even small amounts of the allergen may trigger allergic reactions. Australia and New Zealand were among the first countries to recognise the need to regulate food allergens with the introduction, in 2002, of mandatory declaration requirements in the Code.

Food allergy is estimated to occur in 10% of Australian infants, 4 to 8% of children under five years of age, and around 2% of the adult population. Most food allergy cases are caused by an adverse immune reaction (hypersensitivity) to certain food proteins. Allergy to food can be classified by their immune mechanism:

  • immunoglobulin E (IgE)-mediated,

  • non-IgE mediated, and

  • mixed IgE and non-IgE mediated

Once an individual develops IgE-mediated sensitivity to a certain food protein, the presence of allergen can cause life-threatening anaphylactic reactions. It is important to note that intolerance to food is not an IgE-mediated immune response and does not cause anaphylaxis. Coeliac disease is an autoimmune disease that is neither an allergy nor intolerance.
The Code sets out labelling requirements for certain foods that commonly cause adverse reactions related to allergy, intolerance or autoimmune conditions. Common causes of IgE-mediated allergies are wheat, milk and milk products, eggs, peanuts, tree-nuts, soy, fish and shellfish. Gluten, which can be found in certain cereals, triggers symptoms in individuals suffering from Coeliac disease. Symptoms of Coeliac disease can be severe but generally not life threatening. Gluten-containing cereals include wheat, rye, barley, oats, spelt and their hybridised strain. The Code also recognises bee pollen, royal jelly and added sulphites (≥10mg/g) in food as potential causes of adverse reactions in sensitive populations.

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