Australia’s Regulatory authorities prioritize consumer safety by enforcing strict controls on all food supplements intended for sale or import. Both the Food Standards Australia New Zealand (FSANZ) and the Therapeutic Goods Administration (TGA) uphold rigorous Regulatory frameworks to ensure product safety, accurate labeling, and compliance.
To legally import or market food products, companies must comply with FSANZ food standards. However, for food supplements classified as complementary medicines in Australia, registration with the TGA in the Australian Register of Therapeutic Goods (ARTG) is mandatory.
Why Registering Your Food Supplements Is Essential
Regulatory Compliance Ensures your product meets the requirements of the Australia New Zealand Food Standards Code and TGA regulations, enabling legal market access.
Smooth Customs Clearance Facilitates faster, more reliable import processing and reduces the risk of border delays or rejections.
Avoidance of Penalties Protects your business from fines, product seizures, and costly non-compliance issues.
Consumer Trust & Brand Protection Demonstrates your commitment to safety and quality—reinforcing brand reputation and consumer confidence.
Australia’s Regulatory landscape also incorporates key standards, including:
- Food safety and compositional standards under FSANZ
- Mandatory registration for complementary medicines with TGA, including ARTG listing
- Labeling requirements, including “AUST L” and “AUST R” identification
- Good Manufacturing Practice (GMP) compliance
How to Register Food Supplements in Australia?
1
Product Classification
Obtain official classification to determine whether your product is regulated as a food supplement or a complementary medicine under FSANZ or TGA regulations, based on ingredients and product claims.
2
Regulatory Consultation and Strategy
Develop a Regulatory strategy customized to Australian requirements, addressing FSANZ food standards and TGA complementary medicine guidelines.
3
Document and Dossier Preparation
Compile documents including:
- Product formulation and ingredient safety assessments
- GMP certification
- Scientific evidence supporting health claims
- Labeling compliant with Australian regulations, including necessary ARTG identifiers
4
Label and Claims Review
Ensure product labels and marketing claims comply with FSANZ and TGA guidelines, including required declarations and allergen information.
5
Regulatory Submission
Submit the food product compliance documentation to FSANZ and/or the product listing or registration dossier to TGA, depending on the classification.
6
Follow-up and Approvals
Address Regulatory queries and facilitate clarifications to expedite approval and inclusion in FSANZ or ARTG registers.
7
Post-Registration Support
Provide ongoing support for label updates, renewals, and compliance with evolving Australian food supplement regulations.
What Documents Are Needed for Australian Food Supplement Registration?
|
Document Type |
Description / Notes |
|---|---|
|
Product Formulation Details |
Complete ingredient list and formulation data |
|
GMP Certification |
Proof of Good Manufacturing Practice compliance accredited by the TGA |
|
Scientific Claim Reports |
Evidence supporting any health or nutrient claims (Scientific or Traditional) |
|
Product Labels |
Labels compliant with FSANZ and TGA requirements, including “AUST L”, AUST L(A), or “AUST R” numbers |
|
Free Sale Certificate |
From the country of origin (if applicable) |
How Freyr Can Help You Register Food Supplements in Australia
Freyr provides comprehensive Regulatory support to simplify your food supplement registration with the Therapeutic Goods Administration (TGA) and food compliance with Food Standards Australia New Zealand (FSANZ). Our experienced team guides you through every step, including:
- Product classification according to FSANZ and TGA requirements
- Ingredient and formulation compliance assessments
- Label and claims review to meet Australian standards, including ARTG requirements
- Compilation of thorough technical dossiers for submissions
- Managing all Regulatory submissions and communication with Australian health authorities
- Assistance with Good Manufacturing Practice (GMP) certification and in-desk audits
- Post-approval support, including renewals, label updates, and compliance monitoring
With Freyr as your partner, you can ensure faster approvals, risk mitigation, and market-ready products aligned with evolving Australian regulations.
Why Choose Freyr?
- Global Expertise with Local Knowledge: Deep understanding of FSANZ, TGA, and Australian market nuances backed by our strong presence in over 120 countries.
- Experienced Regulatory Professionals: Dedicated specialists with extensive experience in food supplements and complementary medicines.
- End-to-End Service: Complete Regulatory lifecycle support—from initial classification to post-market compliance and renewals.
- Strong Regulatory Relationships: Established connections with Australian authorities to facilitate smoother approvals and timely responses.
- Tailored, Cost-Effective Solutions: Customized strategies that meet your product’s specific needs while optimizing time and budget.
- Technology-Enabled Compliance: Access to advanced Regulatory intelligence platforms and tools to stay updated on Regulatory changes and streamline submissions.
Ready to Navigate FSANZ and TGA Requirements with Confidence?
Partner with our Regulatory experts to streamline your food supplements registration in Australia. We help ensure full compliance with FSANZ and TGA standards – so you can focus on bringing your products to market efficiently and without risk.
Frequently Asked Questions
Find answers to common queries about food supplement registration and compliance in Australia.
01. What is the typical timeline for supplement registration in Australia?
Registration with FSANZ and TGA can vary; FSANZ compliance review depends on product complexity, while TGA complementary medicine listings usually take 1–3 months.
02. Which authority should I register with for food supplements registration in Australia?
FSANZ regulates food standards for supplements, while TGA handles complementary medicines and therapeutic products requiring ARTG listing.
03. Are “AUST L” and “AUST R” numbers mandatory?
Yes, these identifiers are required on labels for therapeutic goods included in the ARTG.
04. Is GMP certification required for food supplements registration in Australia?
Yes, GMP certification is mandatory for complementary medicines and strongly recommended for food supplements to ensure quality.
05. What happens if my product labeling changes after registration?
Any labeling or formulation changes must be notified to the relevant authority and may require an updated approval or re-listing.
06. Can I sell food supplements in Australia without TGA registration?
Yes, you can sell food supplements in Australia without TGA registration if the product is regulated as a food under FSANZ and does not carry therapeutic or medicinal claims. These products must comply with the Australia New Zealand Food Standards Code (covering safety, labeling, composition, and claims).
07. How often must I renew my TGA registration or listing?
TGA listings for complementary medicines require annual payments and ongoing compliance with quality standards. Registered medicines may have periodic evaluation schedules.
08. Are novel food ingredients subject to additional regulation?
Yes, novel foods or ingredients not previously used in Australia require pre-market approval from FSANZ before inclusion in food or food supplements.
09. What labeling language requirements apply to food supplements in Australia?
Labels must be in English and comply with FSANZ for ingredient declarations, allergens, nutrition information, and health claims.
10. What are the penalties for non-compliance with Australian supplement regulations?
Penalties can include fines, product recalls, import refusals, and seizure of non-compliant products by Australian authorities.