Cosmetics Regulation in Australia
Cosmetics and personal care products are regulated in different ways according to the country they are manufactured and made available. Regulatory compliance with international regulations is a critical factor for the internationalization of a cosmetic product. Since 1st July 2020, the Australian Industrial Chemicals Introduction Scheme (AICIS) is the entity responsible for controlling cosmetics. Cosmetic products must be used, advertised and presented in a specific way to be considered cosmetics rather than therapeutic goods.


Marta Pinto

Marta Pinto

Regulatory Affairs Associate


In Australia, beauty products are classified in two categories according to their use: cosmetics and therapeutic goods. The distinction between these two categories is not always clear and it can be made by a combination of factors: primary use or purpose of the product; the ingredients present and their effects on the body; how the product is applied and how the product is promoted, represented, presented or labelled.  

Australia’s Government defines cosmetic as a “substance that is designed to be used on any external part of the human body – or inside the mouth – to change its odours, change its appearance, cleanse it, keep it in good condition, perfume it or protect it”. 

Therapeutic good are “products that prevent, diagnose or treat diseases, or that affect the structure or functions of the human body”. The Therapeutic Goods Administration (TGA) is responsible for the management of the therapeutic goods. TGA only assesses cosmetic products that make therapeutic claims. 

The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) was the former entity responsible for controlling cosmetics and soaps. Since 1st July 2020, NICNAS was replaced by a new scheme known as Australian Industrial Chemicals Introduction Scheme (AICIS). The product safety and cosmetic labelling standards are regulated by the Australian Competition and Consumer Commission (ACCC). All cosmetic products must be labelled in accordance with the mandatory standard for labelling cosmetic products (Trade Practices (Consumer Product Information Standards) (Cosmetics) Regulation 1991).  


AICIS does not regulate therapeutic goods and it does not ban ingredients in products. AICIS may restrict the concentrations which companies can use and establish other conditions that companies need to follow. AICIS restricts the importation and manufacture of industrial chemicals by including conditions of use or secondary notification conditions on the chemicals it assesses. However, AICIS is not responsible for the following uses of chemicals. 

If a chemical is not for a therapeutic, agricultural, veterinary or food use, it is considered an industrial chemical. Nearly all cosmetic ingredients are regulated as industrial chemicals under the Industrial Chemicals Act 2019 (IC Act 2019 – new regulatory scheme), which is administered by AICIS. 

Manufacturers and importers of cosmetics or cosmetic ingredients must be registered with AICIS and all of the ingredients contained in a cosmetic must be listed on the Australian Inventory of Industrial Chemicals (AIIC) or notified to AICIS for pre-market assessment (unless an exemption applies). If an ingredient is not listed on the Inventory (AIIC) and notified to AICIS, it will be subject to public health, work health and safety (WHS), and environmental risk assessment.  

The AIIC lists more than 40 000 industrial chemicals that can be manufactured or imported into Australia and contains chemical identity information and regulatory obligations regarding that chemical.  

Importers and manufacturers introducing industrial chemicals for commercial purposes in this country must register their business and pay a fee (if not already registered with the former scheme – NICNAS) and categorize each chemical importation or manufacture into 1 of 5 categories. Importers and manufacturers have also the responsibility to submit declarations and reports, to keep records and provide information to AICIS when asked. 

Until 31st August 2022, there are categories of chemicals that are exempt from notification (according to former NICNAS exemptions). After this date, the company will need to categorize its introductions to ensure they comply with AICIS. The exemption categories are as follows:  

  • Research and development (less than 100 kg); 
  • Cosmetic use not exceeding 100 kg: 
  • Must pose no unreasonable risk to human health and the environment. 
  • Non-cosmetic use not exceeding 100 kg: 
  • Must pose no unreasonable risk to human health and the environment 
  • Cosmetic use at a concentration of less than 1%: 
  • Must be non-hazardous. 

Additionally, there is no need for notification if all ingredients (imported or manufactured) included in the product meet the definition of a “naturally-occurring chemical”. To legally meet this category, a “naturally-occurring chemical” must be one of the following: 

  • an unprocessed chemical that is found in nature (such as chemicals from plants, micro-organisms, animals, the earth and the sea); 
  • a chemical that is found in nature and extracted using a process that does not change its chemical composition. 


  1. Australian Government, Department of Health – Australian Industrial Chemicals Introduction Scheme (AICIS) – Overview of AICIS. Available at: 
  1. Australian Government – Industrial Chemicals (Notification and Assessment) Act 1989 (ICNA Act) 
  1. Australian Government – Industrial Chemicals Act 2019 
  1. Australian Industrial Chemicals Introduction Scheme (AICIS) – Industrial Chemicals Categorisation Guidelines – Final Draft, 2019 


cosmetic products

BREXIT e os Produtos Cosméticos Comercializados em Portugal

No passado dia 22 deste mês, o INFARMED, I.P., emitiu uma Circular Informativa, onde concede um período transitório de 6 meses às empresas, cuja Pessoa Responsável está sediada no Reino Unido e que desejam continuar a ter os seus produtos cosméticos disponíveis no mercado nacional, para que possam enviar toda a documentação e informação necessárias.

Read More »
cosmetic products

Virginia – The Fourth State to Ban Animal Testing in the U.S.

In the United States (U.S.), Virginia is the fourth state to ban animal testing in cosmetic products. The Governor of this state (Ralph Northam) has signed this month (March 2021) a bill and the ban will start on January 1st, 2022. The sale of cosmetics tested on animals will also be prohibited from July 1st, 2022.

Read More »
cosmetic products

France Anti-Waste Law

On February 11th, 2020, the Loi relative à la lute contre le gaspillage et a l’économie circulaire (Anti-Waste for a circular economy) has come officially into force in France. The law provides for a ban on all single-use plastics by 2040.

Read More »
cosmetic products

EU Reduction of the Impact of Certain Plastic Products on the Environment

Cosmetics and personal care industry are a growing business, but with this growth comes a major concern: plastic pollution.
The European Commission has published the Directive (EU) 2019/904, known as Single-Use Plastic Directive. This directive addresses the reduction of the impact of certain plastic products on the environment. Harmonized marking specifications are laid down on the Commission Implementing Regulation (EU) 2020/2151.

Read More »
medical devices

BREXIT – Impact on Medical Devices placed in the UK market

From 31 of December 2020, the UK will be regarded as a third country and not a Member State of the European Union. There will be some changes regarding medical devices placed in the UK. The UK’s MHRA has published guidance regarding the regulation of medical devices from 1 January 2021, where it explains what changes and what there is to know about placing a medical device in the Great Britain, Northern Ireland and EU markets.

Read More »
medical devices

Brazil – Class II Medical Devices – New Resolution

A new Resolution of the Collegiate Board of Directors (RDC No. 423/2020) has been published by Brazil’s National Agency of Health Surveillance (ANVISA). This new Resolution announces the elimination of the ‘Cadastro’ pathway regarding the registration of medical devices (Class II) and IVDs, substituting it with a notification registration system.

Read More »
cosmetic products

Butylphenyl Methylpropional to be prohibited in cosmetics placed in the EU market

Butylphenyl Methylpropional, also known as Lilial, is a fragrance ingredient that has been used for years in several cosmetic and non-cosmetic products. Nevertheless, some concerns have been expressed regarding the use of this ingredient and its risk to consumers. According to an amendment to the CLP Regulation (Commission Delegated Regulation No. 2020/1182), Butylphenyl Methylpropional is now classified as toxic to reproduction (Repr. 1B – CMR 1B) and it shall be prohibited in cosmetic products from 1st March 2022.

Read More »
cosmetic products

China Bans Microbeads in Cosmetics

On 16th January 2020, China’s National Development and Reform Commission (NDRC) issued the Notice [2020] No. 80, with the aim of prohibiting the use of microbeads in cosmetics and personal care products. More detailed information was given in the Notice [2020] No. 1146, issued by the NDRC on 10th July 2020.

Read More »
medical devices

EU Medical Devices Regulation – Unique Device Identifier (UDI)

In 2017, two Regulations on medical devices (MDR) and in in vitro diagnostic medical devices (IVDR) entered into force in the European Union (EU), establishing a modernized and more robust EU legislative framework and safeguarding a better public health protection and patient safety. According to the these Regulations, the Unique Device Identifier (UDI) will be mandatory for all medical devices and in vitro medical devices.

Read More »

FDA updates on hand sanitizers safety for use

The U.S. Food and Drug Administration (FDA) has announced that it is providing a new laboratory testing method to assess the quality of finished hand sanitizers. Moreover, the FDA has issued a new press release on August 27th 2020, where it warns consumers about hand sanitizers packaged in food and drink containers. Earlier this month, the FDA expanded hand sanitizer warnings to include 1-propanol contamination.

Read More »
cosmetic products

RAPEX System 2019 Report

Every week, the RAPEX system publishes notifications of urgent measures taken by EU Member-States to prevent, restrict or impose conditions on the marketing of products due to the serious and immediate danger they pose to the health and safety of consumers.

Read More »
cosmetic products

Cosmetic Packaging in European Union

Packaging material is defined as the container (or primary packaging) that is in direct contact with the formulation. According to the European Cosmetic Regulation No. 1223/2009, packaging evaluation is mandatory to guarantee cosmetic product safety. To meet this Regulation requirements, the European Commission issued the Decision 2013/674/EU, establishing guidelines on the practical application of such requirements and identifying information that should be collected on the packaging materials and the potential migration of substances from packaging.

Read More »