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Australia Compliance

Australia Food & SupplementCompliance Made Simple

Navigate FSANZ Food Standards Code and TGA therapeutic goods regulations with confidence. Our AI-powered tool ensures your food and supplement labels meet all Australian requirements for allergens, nutrition information, ARTG compliance, and therapeutic claims.

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Understanding Australian Food & Supplement Labeling Requirements

Australia has comprehensive labeling regulations: FSANZ governs food through the Food Standards Code, while TGA regulates therapeutic goods and supplements through the ARTG framework.

FSANZ Standards
Food Standards Australia New Zealand sets national food standards and labeling requirements
  • Food Standards Code
  • Labeling Requirements
  • Safety Standards
State Enforcement
Individual states and territories enforce food labeling laws and conduct inspections
  • State Health Departments
  • Local Council Inspections
  • Compliance Monitoring
TGA Standards
Therapeutic Goods Administration regulates supplements and therapeutic goods
  • ARTG Registration
  • Therapeutic Claims
  • GMP Compliance

Food vs Supplement Regulations in Australia

Different regulatory frameworks apply to foods (FSANZ) and supplements (TGA), each with distinct requirements

Food Products (FSANZ)
Regulated by Food Standards Australia New Zealand under the Food Standards Code

Major Allergens (10 required):

• Peanuts• Tree nuts• Milk• Eggs• Fish• Crustacea• Molluscs• Soybeans• Wheat• Sesame seeds

Key Requirements:

  • • Nutrition Information Panel (NIP)
  • • Ingredient list with allergen emphasis
  • • Date marking (best before/use by)
  • • Country of origin labeling
  • • Storage instructions when required
Supplements (TGA)
Regulated by Therapeutic Goods Administration as complementary medicines

ARTG Registration:

  • • AUST L (Listed) for lower risk
  • • AUST R (Registered) for higher risk
  • • Unique ARTG number required
  • • Annual listing fees apply

Labeling Requirements:

  • • Directions for use
  • • Approved indications only
  • • Warning statements
  • • Active ingredient quantities
  • • GMP batch number
  • • TGA-compliant therapeutic claims

Australian Allergen Declaration Requirements

Both food and supplement products must declare the same 10 major allergens recognized by FSANZ

Peanuts

Tree nuts

Milk

Eggs

Fish

Crustacea

Molluscs

Soybeans

Wheat

Sesame seeds

Food Products: FSANZ Allergen Requirements

Allergens must be declared in the ingredient list and can also be listed in a separate "Contains" statement. Allergen names must be written in English and be clearly legible. Standard 1.2.3 applies to all packaged foods.

Supplements: TGA Additional Considerations

Complementary medicines must declare the same allergens as food products, plus additional warnings for contraindications and adverse reactions. Active ingredients must be quantified and excipients listed.

Nutrition Information vs Supplement Facts

Different information panels are required for food products (NIP) and supplements (directions/ingredients)

Food Products: Nutrition Information Panel (NIP)
FSANZ Standard 1.2.8 requirements for nutrition labeling

Mandatory Nutrients:

  • • Energy (kJ and optionally kcal)
  • • Protein (g)
  • • Fat, total (g)
  • • Fat, saturated (g)
  • • Carbohydrate, total (g)
  • • Carbohydrate, sugars (g)
  • • Sodium (mg)

Format Requirements:

  • • Per 100g/100ml basis
  • • Per serving (optional)
  • • % Daily Intake values
  • • Tabular format preferred
Supplements: Active Ingredients & Directions
TGA requirements for complementary medicine labeling

Active Ingredients:

  • • Quantity per dosage unit
  • • Standardised extract ratios
  • • Equivalent dry weight where applicable
  • • International units (IU) for vitamins

Required Information:

  • • Directions for use
  • • Approved indications
  • • Warning statements
  • • Storage conditions
  • • Batch number and expiry
  • • ARTG number (AUST L/R)

TGA Supplement Compliance Requirements

Complementary medicines in Australia require ARTG registration and compliance with therapeutic goods regulations

ARTG Listed (AUST L)
Lower risk complementary medicines
  • • Self-assessment pathway
  • • Pre-approved ingredients only
  • • Limited therapeutic claims
  • • Annual listing fee required
  • • Post-market surveillance
ARTG Registered (AUST R)
Higher risk complementary medicines
  • • Full evaluation pathway
  • • Evidence-based claims
  • • Clinical trial data may be required
  • • Higher registration fees
  • • Regular compliance audits

Therapeutic Claims Restrictions

Only TGA-approved therapeutic claims may be made. Claims must be substantiated by acceptable evidence. Serious health conditions (Schedule 1) cannot be referenced in complementary medicine advertising.

Food Standards Code vs TGA Requirements

Comparing mandatory labeling requirements for food products and therapeutic goods in Australia

Food Products (FSANZ)
Food Standards Code mandatory requirements
  • Product name and description
  • Ingredient list with allergens emphasized
  • Nutrition Information Panel (NIP)
  • Date marking (best before/use by)
  • Country of origin labeling
  • Business name and address
Supplements (TGA)
Therapeutic goods mandatory requirements
  • ARTG number (AUST L or AUST R)
  • Active ingredients with quantities
  • Directions for use
  • Warning statements and contraindications
  • Batch number and expiry date
  • Sponsor name and address

Common Australian Compliance Issues

Avoid these frequent mistakes in both food and supplement labeling that can lead to enforcement action

Food Product Issues:

Incomplete Allergen Information

Missing or unclear allergen declarations in ingredient lists or Contains statements

FSANZ violation, product recall
Nutrition Panel Errors

Incorrect NIP format, missing mandatory nutrients, or calculation errors

Label revision required
Country of Origin Issues

Missing or misleading CoOL information, especially for priority foods

Consumer protection violation

Supplement Issues:

Missing ARTG Numbers

Products sold without valid AUST L or AUST R registration numbers

TGA violation, product seizure
Unapproved Therapeutic Claims

Making health claims not substantiated by acceptable evidence or TGA approval

Therapeutic claims violation
Incorrect Active Ingredient Listing

Missing quantities, wrong standardization, or unlisted excipients

ARTG compliance failure

How LabelGuard Ensures Australian Compliance

Our AI platform validates both food and supplement labels against FSANZ Food Standards Code and TGA therapeutic goods regulations

Dual Regulatory Validation

Checks both FSANZ Food Standards Code for foods and TGA requirements for supplements

Australian Allergen Validation

Comprehensive checking of all 10 major allergens for both food and supplement products

ARTG Compliance Checking

Validates supplement labels for TGA registration requirements and therapeutic claims compliance

Nutrition Panel vs Supplement Facts

Validates NIP format for foods and active ingredient disclosure for supplements

Therapeutic Claims Assessment

Identifies unapproved health claims and ensures TGA compliance for supplement marketing

Real-time Regulatory Updates

Stay current with FSANZ food standards and TGA therapeutic goods regulation changes

Ready to Ensure Australian Compliance?

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