Regulation7 min read

FSANZ Allergen Labelling: A Practical Guide for Food Businesses

Allergen mislabelling is one of the leading causes of food recalls in Australia and New Zealand. Here's what's required under the current Food Standards Code and how to get it right.

Ingredible Team·

Allergen mislabelling is one of the leading causes of food recalls in Australia and New Zealand. Whether you're a food manufacturer, importer, retailer selling private-label products, or co-packer working on behalf of a brand, getting allergen declarations right is a non-negotiable part of compliance and a critical safeguard for your customers.

This guide covers what's required under the current FSANZ Food Standards Code, what changed with the 2023 amendments, and the practical steps for keeping your labels accurate.


Who Does This Apply To?

If you're responsible for placing a packaged food product on the Australian or New Zealand market (regardless of where it was made), allergen labelling requirements apply to you. This includes:

  • Manufacturers producing food domestically
  • Importers bringing food into Australia or New Zealand for retail sale
  • Co-packers and contract manufacturers producing food on behalf of a brand owner
  • Retailers selling products under a private label
  • Brand owners whose name appears on the label, even if they don't produce the food themselves

The legal responsibility for label compliance generally sits with the business whose name and address appears on the label as the supplier.


The Priority Allergens

Standard 1.2.3 of the Food Standards Code requires declaration of the following allergens whenever they're present in a food, including when they appear as an ingredient within a compound ingredient:

Cereals containing gluten

  • Wheat
  • Rye
  • Barley
  • Oats
  • Spelt
  • Kamut (Khorasan wheat)
  • Their hybridised strains

Tree nuts

  • Almonds, Brazil nuts, cashews, hazelnuts, macadamias, pecans, pine nuts, pistachios, walnuts

Other priority allergens

  • Peanuts
  • Milk
  • Eggs
  • Fish
  • Crustacean (e.g. prawns, crab, lobster)
  • Mollusc (e.g. oysters, squid, mussels)
  • Soy
  • Sesame seeds
  • Lupin
  • Sulphites (when present at 10 mg/kg or more in the final food)

Note: Gluten is listed separately from wheat because some people react to gluten from non-wheat sources (such as barley or rye). Wheat also triggers separate IgE-mediated wheat allergies independent of gluten sensitivity, so both must be declared when present.


How Allergens Must Be Declared

In the Ingredient List

Every allergen must be emphasised (bold is the accepted industry standard) each time it appears in the ingredient list, including within compound ingredient names.

For example, if a product contains wheat flour and soy sauce:

Ingredients: Wheat flour, water, sugar, soy sauce [water, soybeans (soy), salt, spirit], salt.

This applies at every level of the ingredient hierarchy. If an allergen appears three times in the list, it should be bolded three times.

The "Contains" Statement

A "Contains" statement placed directly below the ingredient list is required for quick identification of allergens present in the product. This should list all priority allergens present, even if they're already bolded in the ingredient list above.

Example:

Contains: Wheat, Gluten, Soy, Milk.

The "Contains" statement must be clearly legible and not buried in other label text.


Precautionary Allergen Labelling (PAL)

Precautionary allergen statements (sometimes called "may contain" statements) communicate the risk of unintentional cross-contact during production, rather than the deliberate presence of an allergen in the recipe.

What Changed in 2023

The 2023 amendments to Standard 1.2.3 standardised the permitted wording for precautionary allergen statements. If you choose to include one, it must use one of the following approved formats:

  • "May contain: [allergen]"
  • "May be present: [allergen]"
  • "May contain traces of [allergen]"

Informal or non-standard phrases are no longer acceptable. Examples of non-compliant wording include:

  • "Made in a facility that also processes nuts"
  • "Not suitable for people with a nut allergy"
  • "Produced on shared equipment"

PAL Is Still Voluntary, But Think Carefully

You are not legally required to include a precautionary statement. However, if a genuine risk of cross-contact exists and you choose not to declare it, you're exposing both your customers and your business to significant risk.

Conversely, overuse of precautionary statements (applying them as a blanket disclaimer when there's no actual cross-contact risk) undermines their credibility for people with allergies who rely on them to make safe food choices. FSANZ's position is that PAL should reflect a genuine, assessed risk.

For importers in particular: if the overseas manufacturer's label uses non-standard precautionary wording, that wording must be corrected before the product is sold in Australia or New Zealand. A sticker override is acceptable provided it fully covers the non-compliant text and meets all other label legibility requirements.


The Compound Ingredient Trap

One of the most common allergen labelling errors involves compound ingredients: pre-made inputs that themselves contain multiple sub-ingredients.

Under the Food Standards Code, allergens must be declared regardless of how they enter the final product. If a compound ingredient contains soy, soy must appear in the "Contains" statement, even if it doesn't appear anywhere else in the formulation.

This applies at every level of nesting. If you use a marinade that contains a sauce that contains wheat, wheat must still be declared.

For importers and brand owners: This rule applies to the finished product on shelf, regardless of what the original overseas specification says. If you don't have full sub-ingredient visibility from your supplier, you need to get it. An incomplete allergen declaration based on incomplete information is still a compliance failure.

Practical tip: When onboarding new ingredients or overseas-sourced products, always request a full allergen declaration from your supplier alongside the specification sheet. Make it standard practice to re-request updated declarations whenever a supplier revises their formulation, as a single supplier change can make a previously compliant label non-compliant overnight.


Sulphites: A Threshold-Based Rule

Unlike most allergens, sulphites (sulphur dioxide and sulphite salts) are only required to be declared when present at 10 mg/kg or more in the final food. This threshold applies to the cumulative level across all ingredients, not just to any sulphites added directly.

This means tracking sulphite levels ingredient by ingredient and calculating the final concentration. If multiple ingredients each contribute small amounts of sulphites, those contributions can push the product over the threshold.

Sulphites are typically declared in two places:

  1. In the ingredient list by their function and additive number (e.g. preservative (220))
  2. In the "Contains" statement (e.g. Contains: Sulphites)

Exemptions

A small number of allergen-derived ingredients are exempt from declaration because the allergenic protein has been removed through processing. These include:

  • Highly refined soy oil (not cold-pressed or unrefined)
  • Highly refined peanut oil
  • Glucose syrups derived from wheat
  • Distilled alcoholic beverages derived from wheat or other gluten-containing cereals

These exemptions are defined in Schedule 9 of the Food Standards Code. "Soy oil" or "peanut oil" alone is not sufficient to claim an exemption; the refining process must meet the criteria specified in the Code. If in doubt, request processing documentation from your supplier or seek advice from a food technologist.


Checklist for Food Businesses

Use this as a practical review when auditing your labels:

  • Checklist item: All priority allergens are declared, including those from compound sub-ingredients
  • Checklist item: Every allergen is bolded in the ingredient list, every time it appears
  • Checklist item: A "Contains" statement is present directly below the ingredient list
  • Checklist item: If a precautionary statement is included, it uses only the approved wording
  • Checklist item: Sulphite levels have been calculated across all ingredients and declared if ≥ 10 mg/kg
  • Checklist item: Supplier allergen declarations are current and on file
  • Checklist item: Any claimed exemptions (e.g. highly refined oils) are documented and verified
  • Checklist item: For imported products: any non-compliant overseas label wording has been corrected for the local market

A Note on Ongoing Compliance

Allergen compliance isn't a set-and-forget exercise. Supplier formulation changes, new ingredient sources, and updates to the Food Standards Code can all affect your compliance status without any action on your part. Building a process for periodic label review, and linking it to your supplier change management procedure, is the most reliable way to stay ahead of recall risk.

If you're using Ingredible, allergen declarations are generated automatically from your formulation, including allergens from compound sub-ingredients and sulphite threshold tracking.

Stay compliant with less effort

Ingredible automates FSANZ-compliant ingredient lists, NIP tables, allergen declarations, and more — directly from your recipe.