What are the key food allergens in ANZ?
The 10 key food allergens are: peanuts; tree nuts; soy; milk, egg; cereals; crustacea; fish (including shellfish); sesame; and lupin.
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.
Frequently asked questions
- Can I label my product as “allergen name free”?
- Can I label my product as “gluten free”?
- How can I get my products tested?
- How do we stop cross contact?
- What are the food allergen labelling requirements in ANZ?
- What are the safe limits for food allergens?
- Why isn’t gluten in the list of allergenic foods?
- What is Oral Allergy Syndrome?
- How should I label a commodity or product which is subject to agricultural co-mingling?
1. Can I label my product as “allergen name free”?
In Australia and New Zealand, allergen free claims such as “dairy free” or “peanut free” are not regulated under the ANZ Food Standards Code but fall under the general provisions of fair trading legislation intended to prevent misleading & deceptive conduct. These claims are allowed provided they are truthful.
In general “free” claims should be supported by evidence of adequate due diligence. This could include a desktop audit, similar to that used in the VITAL® Program, which concludes that the allergen is not likely to be present under normal Good Manufacturing Practice, possibly supported by periodic 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 cleaning steps, with validation, at changeover may be an appropriate inclusion in the allergen management plan.
If a VITAL assessment concludes that there is a risk the product may contain an allergen and especially if the conclusion is that a “may be present” label is warranted, this would contradict and be incompatible with a “free” claim for that allergen.
If an allergen “free” product 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 recall it whilst they addressed the problem(s) in their production process. Depending of the severity of the situation, they may also face prosecution.
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2. Can I label my product as “gluten free”?
There is no specific requirements 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.
Under the Australia New Zealand Food Standards Code, Standard 1.2.7 and Schedule 4, gluten free foods must not contain:
(a) detectable gluten; or
(b) oats or their products; or
(c) cereals containing gluten that have been malted, or their products.
In general “gluten free” claims should be supported by evidence of adequate due diligence, including, for example through a relevant Food Safety Program and correspondence with ingredient suppliers about the absence of gluten in the products supplied.
If a “gluten free” product is tested by an enforcement agency, possibly as a result of a customer complaint, and found to contain detectable gluten, the manufacturer would likely be required to withdraw it whilst they addressed the problem(s) in their production process. They may also face prosecution.
In many part 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.
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3. How can I get my products tested?
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.
4. How do we stop cross contact?
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.
5. What are the food allergen labelling requirements in ANZ?
How do we know if our products need labelling for food allergens?
If your products contain any of the 10 key allergens or allergen groups (peanuts; tree nuts; soy; milk; egg; cereals; crustacea, fish (including shellfish); sesame; and lupin), or derivatives of them, because they have been added via an ingredient, food additive or processing aid, it is mandatory under the Australia New Zealand Food Standards Code for your product labels to identify the allergen.
Best Practice is that food allergen information should be included in the ingredient list in common language consumers will understand e.g. ‘milk’ rather than ‘sodium caseinate’.
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. In these cases, the Allergen Bureau recommends you use the VITAL® Program to provide meaningful risk-based precautionary labelling.
6. What are the safe limits for food allergens?
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.
7. Why isn’t gluten in the list of allergenic foods?
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.
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8. What is Oral Allergy Syndrome?
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.
9. How should I label a commodity or product which is subject to agricultural co-mingling?
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 however require named allergens (or their products) to be declared when they are present as:
(a) an ingredient or as an ingredient of a compound ingredient; or
(b) a substance used as a food additive, or an ingredient or component of such a substance; or
(c) a substance or food used as a processing aid, or an ingredient or component of such a substance or food.
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.