Introduction
Compliance with Australia’s cosmetic regulations can be challenging for manufacturers, importers, and overseas suppliers, due to the dual oversight of AICIS for ingredients and the ACCC for product safety, labeling, and advertising, as well as the complex distinctions between cosmetics and therapeutic goods. This guide provides a clear overview of Australia’s regulatory framework, registration obligations, and key compliance procedures to help companies navigate the Australia's cosmetic regulations efficiently and avoid potential legal pitfalls.
The Definition of Cosmetics in Australia
In Australia, products are determined to be either ‘cosmetics’ or ‘therapeutic goods’ based on three factors: the primary use of the product, the ingredients in the product and the claims made about the product.
According to the Industrial Chemicals Act 2019, cosmetics means: a substance or preparation intended for placement in contact with any external part of the human body, including:
(i) the mucous membranes of the oral cavity; and
(ii) the teeth; with a view to:
(iii) altering the odours of the body; or
(iv) changing its appearance; or
(v) cleansing it; or
(vi) maintaining it in good condition; or
(vii) perfuming it; or
(viii) protecting it.
The Definition of Therapeutic Goods in Australia
Therapeutic goods are broadly defined as products for use in humans in connection with:
preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury;
influencing, inhibiting or modifying a physiological process;
testing the susceptibility of persons to a disease or ailment;
influencing, controlling or preventing conception;
testing for pregnancy.
This includes things that are:
used as an ingredient or component in the manufacture of therapeutic goods;
used to replace or modify parts of the anatomy.
Hence, certain products with specific therapeutic functions/claims, such as sunscreens may be classified as therapeutic goods and are subject to more stringent regulation of the Therapeutic Goods Administration (TGA).
Notably, under the Therapeutic Goods (Excluded Goods) Determination 2018, certain products—such as secondary sunscreens, specific anti-acne skincare, and anti-dandruff products—are not considered therapeutic goods if they meet particular conditions and are instead regulated as cosmetics.
Australia’s Regulatory Framework for Cosmetics
Australia does not operate a dedicated cosmetic product notification system. Instead, cosmetics are regulated through a multi-authority regulatory framework, with different regulatory authorities responsible for ingredient control and product-level compliance.
AICIS – Regulatory Authority for Cosmetic Ingredients
All ingredients in cosmetic products are regarded as industrial chemicals and are regulated under the Australian Industrial Chemicals Introduction Scheme (AICIS).
AICIS supervises the introduction (importing or manufacturing) of industrial chemicals through business registration, chemical reporting, chemical assessment, and risk management recommendations.
ACCC – Regulatory Authority for Product Safety and Consumer Protection
While AICIS focuses on ingredient-level regulation, product safety, labeling, and advertising compliance for cosmetic products fall under the supervision of the Australian Competition & Consumer Commission (ACCC), in accordance with Australian consumer protection legislation.
Key Legislative Foundations
Australia’s cosmetic regulatory system is primarily underpinned by:
Who Must Register Under the Industrial Chemicals Act
Entities involved in the introduction (importation or manufacture) of industrial chemicals to Australia must comply with the Industrial Chemicals Act, including:
Australian importers who intend to import industrial chemicals to the country;
Australian manufacturers who manufacture industrial chemicals domestically;
Overseas suppliers who export directly to Australia—these entities must obtain an Australian Registered Body Number (ARBN) and complete the necessary business registration and fee payments;
Note: For imported products, the overseas suppliers can register and apply for introduction directly, without requiring a responsible person (RP) in Australia.
Key AICIS Compliance Obligations
According to the requirements of AICIS, the main compliance procedures for cosmetic companies are as follows:
Business registration: All entities introducing industrial chemicals must register their business on AICIS Business Services portal prior to introducing any chemicals into Australia. Annual registration fees apply.
Categorization of chemical introduction for each ingredient: Introducing entities must determine the risk level of each ingredient based on factors such as its inclusion in the Australian Inventory of Industrial Chemicals (AIIC), annual volume, and hazard profile. This process determines whether an introduction is exempted or falls into a specific category requiring further action (e.g., Reported or Assessed).
Compliant introduction: Based on the assigned category, entities must submit the necessary reports or apply for assessments in accordance with the applicable introduction category.
Record keeping and annual declaration: Entities must maintain detailed records of all introduced chemicals for at least five years. Additionally, at the end of each registration year, an online Annual Declaration must be submitted to confirm that all introductions were authorized under the law.
Our Services
• Management Classification Analysis: Distinguishing between Cosmetics and Therapeutic Goods to ensure regulatory compliance.
• AICIS Business Registration: Facilitating the registration process on the AICIS portal.
• Ingredient Review: Conducting chemical inventory (AIIC) searches and compliance checks.
• Introduction Categorization: Determining the appropriate category (Listed, Exempted, Reported, or Assessed).
• Chemical Introduction Applications: Preparing and submitting required reports.
• Annual Declaration Support: Ensuring timely submission of year-end compliance statements.
• Labeling Review: Verifying cosmetic labeling against Australian standards (ACCC and AICIS).
For more information and inquiries regarding Australia's cosmetics regulations or chemical introduction, please feel free to contact us at customer@reach24h.com.
