Frequently Asked Questions
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Wheat (of the genus Triticum, including spelt, and its hybridised strains such as triticale); specifically named tree nuts: almond, Brazil nut, cashew, hazelnut, macadamia, pecan, pine nut, pistachio, and walnut; fish (finfish); crustacea; molluscs; egg; lupin; milk; peanut; sesame; and soybean are the allergens which must be declared. In addition to allergens, gluten (from wheat, rye, barley, or oats) and added sulphites (present at 10mg/kg or higher) must also be declared due to their potential to cause non-allergic, hypersensitivity reactions.
These products and their derivatives are used widely in the manufacture of food. Small, medium and large businesses in the food industry in Australia and New Zealand need to be able to trace ingredients through their supply chains to identify any containing food allergens or at risk of cross contact.
For an allergic consumer there is no safe limit for the allergens that they are sensitised to. The only successful management strategy is avoidance of those allergens.
However, to enable risk-based management of precautionary labelling for cross-contact allergens, the Allergen Bureau, in collaboration with the Food Allergy Research & Resource Program (FARRP) of the University of Nebraska (USA) & the Netherlands Organization for Applied Scientific Research (TNO), established the VITAL Scientific Expert Panel (VSEP). The VSEP reviewed the data from clinical (low-dose oral) food challenges from both published and unpublished studies. The papers were sourced from Australia, the United States and the European Union and over 3,400 clinical data points were collated. The data included in the review was required to meet defined quality criteria to ensure that resulting allergen thresholds were statistically sound. The VSEP identified the ED01 (which is the dose of the total allergen protein that is predicted to produce objective symptoms in 1% of the allergic population) which were adopted as the Reference Doses for VITAL 3.0.
1. Remington et al (2020) Updated population minimal eliciting dose distributions for use in risk assessment of 14 priority food allergens. Food Chem Toxicol. 2020 Mar 13;139:111259.
How do we know if our products need labelling for food allergens?
If your products contain any of the key allergens – wheat (of the genus Triticum, including spelt, and its hybridised strains such as triticale), specifically named tree nuts: almond, Brazil nut, cashew, hazelnut, macadamia, pecan, pine nut; pistachio and walnut; fish (finfish); crustacea; molluscs; egg; lupin; milk; peanut; sesame; and soybean – or derivatives of them, because they have been added via an ingredient, food additive or processing aid, or contains gluten (from wheat, barley rye, or oats) or >10 mg/kg of added sulphites it is mandatory under the Australia New Zealand Food Standards Code (the Code) for your product labels to identify the allergen.
Standard 1.2.3 and Schedule 9 of the Code set out the specific labelling requirements for each allergen. The requirements include how each allergen must be identified in the ingredient list and what must be included in a “Contains …” summary statement.
If you are concerned about the presence of food allergens in your products that you are not deliberately adding, you may need to test the product or conduct a thorough HACCP (Hazard Analysis Critical Control Point) analysis of your supply chain to identify where the food allergens may be entering it. Food allergens may also be present due, for example, to shared equipment or use of ingredients containing undisclosed allergen.
The Allergen Bureau provides industry guidance resources to assist with food allergen management, labelling, identifying potential allergens in your product, and determining whether and how they should be declared.
These best practice guidance resources are designed to help food industry to approach allergen management and labelling in a consistent manner.
Once you have identified potential allergens in your products, the Allergen Bureau recommends you use the VITAL® Program to provide meaningful risk-based precautionary labelling.
For more advice, please contact the Allergen Bureau email@example.com
Wheat (and its hybrid strains) is listed as an allergen because it is associated with IgE mediated allergic reactions in some individuals. The Food Standards Code requires added wheat to be declared by name in the ingredient list and the summary statement.
Independently, gluten (a protein in wheat, barley, rye, and oats) induces non-allergic adverse immune responses in individuals with coeliac disease. Cereals, or their derivatives, containing gluten must be declared by name in the ingredient list but as ‘gluten’ in the summary statement.
Allergy to wheat is often confused with coeliac disease.
A food allergy is an immune response to protein to which an individual has become sensitised. In contrast, coeliac disease is a digestive condition due to an abnormal immune response in the small intestine to gluten.
Unlike an allergic response, that may be fatal, coeliac disease is a chronic condition that can cause serious complications, including malnutrition and intestinal damage, if left untreated. Individuals with coeliac disease must avoid gluten, found in wheat, and related storage proteins found in cereals such as spelt, rye, barley and triticale.
In Australia and New Zealand, ‘gluten free’ is a nutrition content claim, the conditions of which are set out in Standard 1.2.7 of the Australia New Zealand Food Standards Code (the Code). The Code’s conditions are that the food bearing the claim must not contain:
- (a) detectable gluten; or
- (b) oats or their products; or
- (c) cereals containing gluten that have been malted, or products of such cereals.
The cereals that contain gluten are listed in Schedule 9 in the table to section S9—3, Mandatory declarations.
Although the Code requires that the food must not contain detectable gluten, it does not define the LOQ (Limit of Quantitation) for such a test. The recommendations from the Allergen Bureau are that the test should be a validated or approved technique or kit (normally by AOAC); performed by an accredited laboratory; performed routinely as part of a proficiency program, and widely accepted in industry. The current industry view is that available tests with an LOQ of 5ppm meet this criteria.
Whilst there are test kits that claim lower limits of detection, they have generally not been validated for all relevant food matrices and do not meet all of the above criteria, consequently, a positive test below 5ppm is unlikely to be taken as verified evidence of detectable gluten. It should be noted that there is variability amongst kits in their ability to detect oats, and many are unable to detect gluten from oats. Additionally, foods containing gluten that have undergone fermentation or hydrolysis should be analysed using a kit designed to detected fragments of the gluten proteins. These kits will have a higher LOQ but are considered more sensitive in detecting gluten from these types of products. It is recommended that the question of a suitable test for individual product matrices should be discussed with either an accredited laboratory or the test kit suppliers.
In general, ‘gluten free’ claims should be supported by evidence of adequate due diligence including, for example, through a relevant Food Safety Program and confirmation with the product’s ingredient suppliers that all raw materials do not contain gluten (and oats and malted cereals as per Standard 1.2.7). Evidence should be available to support this. Additionally, there should also be no possibility of cross contact with gluten or ingredients containing gluten during the storage, handling, manufacture and packing of the product.
If a product bearing an ‘gluten free’ claim is tested by an enforcement agency, possibly as a result of a customer complaint or incident, and found to contain detectable gluten, the manufacturer would likely be required to conduct a product recall or withdrawal whilst they addressed the problem(s) in their production process. Depending on the severity of the situation, food enforcement agencies can apply a suite of actions including issuing fines, issuing directions for a mandatory product recall, or other legal challenges.
In many regions of the world, including in North America, the EU and those countries that adopt Codex Alimentarius standards, the limit for a ‘gluten free’ food is 20 ppm gluten or less. If you are an importer, you should be aware that many of the ‘gluten-free’ foods sold in these markets do not meet the standard for ‘gluten free’ in Australia and New Zealand.
Gluten Free Certification
There is no specific requirement for the certification of gluten free foods. It is the responsibility of the business making or supplying the food to the customer to operate their business in a manner which ensures that products labelled “gluten free” meet required food standards.
The BRC Global Standard Gluten-Free Certification Program (GFCP) is a voluntary certification Global Standard based on a preventative, science-based approach for managing the safe manufacturing and production of gluten-free products.
Coeliac organisations in different countries or regions may license or endorse food producers and retailers to use the ‘Crossed Grain Trademark’ on their gluten-free products. However, the requirements for using the crossed grain logo are not consistent between different regions (see Coeliac Australia, Coeliac New Zealand, AOECS).
In Australia and New Zealand, ‘lactose free’ and ‘gluten free’ are nutrition content claims, the conditions of which are set out in Standard 1.2.7 of the Australia New Zealand Food Standards Code (the Code). However, criteria for allergen free claims such as ‘dairy free’ or ‘peanut free’ are not included in the Code. Free claims instead fall under the Australian Competition and Consumer Commission and the New Zealand Commerce Commission consumer laws and relevant State-Territory agencies which prohibit misleading and deceptive conduct. These organisations can view free claims as to literally mean zero or no traces.
In general allergen free claims should be supported by evidence of adequate due diligence. It is likely that a higher level of validation will be required to substantiate an allergen free claim than that used in the VITAL® Program, even when it concludes that the allergen is not likely to be present under normal Good Manufacturing Practice, and should be verified by regular product testing using an appropriate sampling program.
There is no intrinsic reason why a production line that makes products containing an allergen cannot also make a product free of the same allergen. In these cases, specific validated cleaning steps at changeover may be an appropriate inclusion in the allergen management plan.
When a VITAL risk assessment has been applied and the labelling outcome indicates the allergen is present at Action Level 1 this would contradict and be incompatible with a free claim for that allergen.
If a product bearing an ‘allergen name free’ claim is tested by an enforcement agency, possibly as a result of a customer complaint or incident, and found to contain detectable ‘allergen name’, the manufacturer would likely be required to conduct a product recall or withdrawal whilst they addressed the problem(s) in their production process. Depending on the severity of the situation, food enforcement agencies can apply a suite of actions including issuing fines, issuing directions for a mandatory product recall, or other legal challenges.
Agricultural co-mingling is the result of different crops being grown in close proximity with each other; sharing the same fields due to crop rotation; and / or sharing the same facilities for harvesting, transport and, storage despite the application of allergen controls as part of Good Agricultural Practices (GAPs). This means that the presence of variable amounts of one crop may be found in another crop. This is of particular concern in relation to the potential presence of allergens, such as cereals containing gluten, peanuts, soy and lupins. Although it is possible to apply processes to “clean” crops and reduce the concentration of co-mingled grains, seeds or pulses, these do not generally remove all traces of them and thus allergen identification and declaration is an important consideration.
Mandatory allergen labelling: The Australian and New Zealand legislation does not expressly cover labelling of the presence of allergens due to agricultural co-mingling.
However, the ANZ Food Standards Code Standard 1.2.3-4 does require named allergens (or their products) to be declared when they are present as any of the following:
- an ingredient or as an ingredient of a *compound ingredient; or
- a substance *used as a food additive, or an ingredient or component of such a substance; or
- a substance *used as a processing aid, or an ingredient or component of such a substance.
Allergens present due to agricultural co-mingling do not fall under the requirements for mandatory labelling in the ANZ Food Standards Code. However, this does not remove the responsibility of manufacturers to communicate to their consumers the possible presence of an allergen to which they may be sensitive. This is similar to cross contact allergens present due to manufacturing which are also not expressly required to be labelled by the legislation and where the manufacturer must consider whether these allergens should be declared voluntarily on a product label.
Precautionary allergen labelling: The VITAL Program was developed to provide a standardised science-based risk assessment for voluntary cross contact allergen labelling and it may be appropriate to apply the same principles to the presence of allergens due to agricultural co-mingling in the absence of any mandatory requirements.
An important consideration in the use of the VITAL Program for co-mingled crops is to identify the physical form of the allergen. Where a grain or pulse has been milled or crushed, the allergen may be readily and homogeneously dispersed through the resulting meal or flour. In these cases, it may be possible to apply monitoring and analysis to assess the risk of a consumer being exposed to the minimum eliciting dose (Reference Dose) of the allergen. This approach may not be appropriate where levels of the allergen are highly variable and a further more detailed risk assessment may need to be applied. It is also important to consider that when the allergen is present in a particulate form, a lower level of co-mingling may still present a significant risk, especially when one or two particles (grains, beans, seeds etc.) may comprise an eliciting dose (Reference Dose). See the VITAL Program Guide for more details.
In order to make an informed risk based decision regarding these issues, further information should be collated to consider the nature of the allergen, the likely distribution and level of the allergen and whether the commodity implicated destined for further processing or immediate use by the consumer. All these factors need to be considered to make an appropriate risk based decision.
Cross contamination, or cross contact, with food allergens may occur at any stage from harvest to food preparation. The use of shared headers, for example, may allow lupins or soy to be contaminated with gluten containing cereals such as wheat, or vice versa. Cross contact can occur within food storage and manufacturing facilities via open containers or from spillage. Also shared food production equipment can mean cross contact could occur from ingredient residues with subsequent batches.
The principal methods of preventing cross contact with, or between food allergens include:
- the use of dedicated handling, storage and processing equipment where possible
- dedicated, sealed storage for allergens
- verified cleaning systems and procedures and production scheduling to minimise the potential for allergen residues on process equipment
- the implementation of HACCP based food production systems.
There are a number of commercial testing laboratories in Australia and New Zealand which offer food allergen testing. These laboratories usually carry out an Enzyme-Linked Immuno-Sorbent Assay (ELISA) on the samples. However, some laboratories also perform DNA based tests where a more definitive answer is required on a difficult sample matrix.
For companies with in-house laboratory capabilities ELISA kits can be purchased and the tests carried out in-house. While there are several disadvantages to in-house testing, the main benefit is the ability to deliver a rapid turn-around time.
Contacts for some testing laboratories and kit suppliers in Australia and New Zealand are listed on the Allergen Bureau Services Directory.
What is Oral Allergy Syndrome and symptoms?
Oral Allergy Syndrome (OAS) is usually experienced as mild itching and/or swelling of all, or part of, the lips, tongue, mouth or throat, after eating certain raw of lightly cooked foods. The symptoms normally start within minutes of eating and settle down within an hour – but can on occasions be severe and also include nausea and vomiting. The foods most commonly associated with OAS include apples, avocado, mango, peaches, kiwi fruit, tomato, raw hazelnuts and almonds – although most fruits, vegetables or nuts can be implicated. The foods to which people react vary considerably and can be highly individual.
What causes Oral Allergy Syndrome?
OAS is also sometimes called Pollen Food Syndrome (PFS), which provides a clue to its origins. OAS normally occurs in people who are allergic to pollen (from trees, grasses or weeds) or to latex. Pollens and natural rubber latex both contain proteins that are similar to proteins found in many fruits, vegetables and raw nuts. Pollen allergy may also trigger hay fever in susceptible individuals, although this is not a prerequisite for OAS. In OAS, proteins in fruits, vegetables or nuts are identified by the immune system of a pollen or latex allergic individual, triggering an allergic response when these foods are eaten.
How is Oral Allergy Syndrome different to other food allergies?
OAS is a cross-reactive response to a non-food allergy. In most cases, the cross reacting fruit and vegetable proteins are easily inactivated by cooking, processing and digestion. As a result, the symptoms tend to be limited to the mouth and throat and are generally limited to raw or lightly cooked foods.
OAS is distinct from other major food allergies of concern, such as those to tree nut storage proteins which are not inactivated by heat, that may lead to severe and potentially fatal responses, including anaphylaxis.
Information to members
Allergen Bureau Member enquiries and VITAL Online subscriber enquiries will be acknowledged within 2 working days and considered responses given within 5 working days – although we are pleased to say we are usually much quicker than that and generally respond on the same or next day!
Information for non-members
Non-members are only able to access the Allergen Bureau phone and email information service as a priority for one enquiry. Subsequent enquiries and requests for assistance by non-members will be considered on a case-by-case basis, as time and resources allow.
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