Cosmetic products are regulated differently depending on where they are sold. A product developed for Australia may need changes before it can be sold in the European Union or United States.
For brands planning to enter more than one market, it helps to understand these differences while the product is still being developed. Ingredients, claims, testing, labelling and documentation can all be affected by the intended market.
This guide looks at some of the main regulatory considerations for cosmetic products in Australia, the European Union and the United States.
Cosmetic Regulation in Australia
Australia does not have one regulator responsible for every aspect of a cosmetic product.
For many cosmetics, the Australian Industrial Chemicals Introduction Scheme, known as AICIS, regulates the industrial chemicals used as ingredients. Other requirements apply to areas such as ingredient labelling and products that fall within the therapeutic goods framework.
Whether a product is considered a cosmetic or therapeutic good can depend on what the product does, the ingredients it contains and the claims being made.
AICIS and Cosmetic Ingredients
AICIS regulates the importation and manufacture of industrial chemicals in Australia. Almost all ingredients used in skincare, personal care, make-up and other cosmetic products are considered industrial chemicals for these purposes.
AICIS does not approve finished cosmetic products. Instead, businesses importing or manufacturing relevant chemicals need to understand how those chemical introductions are authorised.
Depending on the ingredient and how it is introduced, this may involve checking its status on the Australian Inventory of Industrial Chemicals, determining the relevant introduction category and meeting any applicable reporting or record-keeping requirements.
For brands, the key point is that ingredient requirements need to be considered as part of product development, particularly when new or imported ingredients are involved.
Cosmetic or Therapeutic?
The claims made about a product can also affect how it is regulated.
A moisturiser positioned around hydration and maintaining the skin in good condition may be treated differently from a product making therapeutic claims.
This is important to consider before claims and marketing language are finalised. Changing how a product is presented can change the regulatory requirements that apply to it.
What Should Brands Consider in Australia?
For a cosmetic product intended for the Australian market, brands may need to consider:
- The AICIS status of relevant ingredients
- Whether registration or other AICIS obligations apply
- Product classification
- Ingredient labelling
- Claims and intended use
- Record-keeping requirements
- Whether another Australian regulatory framework applies
The pathway should be considered for the individual product rather than assuming all cosmetics follow exactly the same process.
Cosmetic Regulation in the European Union
Cosmetics sold in the European Union are regulated under Regulation (EC) No 1223/2009.
The EU framework places specific responsibilities on the person or business responsible for placing the product on the market. It also requires safety documentation to be completed before the product is sold.
The Responsible Person
Every cosmetic product placed on the EU market needs a designated Responsible Person based within the European Union.
The Responsible Person has defined responsibilities under the EU Cosmetics Regulation and is responsible for ensuring the relevant requirements for the product are met.
For an Australian brand entering the EU, identifying who will take on this role is an important part of planning the launch.
Cosmetic Product Safety Report
Before a cosmetic product is placed on the EU market, it needs to undergo a safety assessment and have a Cosmetic Product Safety Report, commonly called a CPSR.
The safety assessment must be completed by someone with the appropriate qualifications.
This means the safety assessment is not simply a document produced by the manufacturer at the end of development. The appropriate specialist needs to be involved as part of the EU market-entry process.
Product Information File
Each cosmetic product also requires a Product Information File, or PIF.
The PIF brings together information relating to the product, including its safety report, manufacturing information and other documentation required under the EU Cosmetics Regulation.
The Responsible Person is responsible for keeping the PIF available for the required period.
CPNP Notification
Before the product is placed on the EU market, it must also be notified through the Cosmetic Products Notification Portal, known as the CPNP.
The CPNP is a notification system. Notification does not mean that the product has been individually approved by the European Commission.
Planning for the EU
An Australian brand preparing a cosmetic product for the European Union will generally need to consider:
- Who will act as the EU Responsible Person
- Whether the formulation meets EU ingredient requirements
- The required safety assessment and CPSR
- The Product Information File
- Labelling and claims
- CPNP notification
These requirements are easier to address before the formulation and artwork have been completely finalised.
Cosmetic Regulation in the United States
Cosmetics in the United States are regulated by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act.
The Modernization of Cosmetics Regulation Act of 2022, known as MoCRA, also introduced additional requirements for the cosmetics industry.
The responsibilities that apply depend on the product and the businesses involved.
Facility Registration
Cosmetic manufacturing and processing facilities that fall within the MoCRA registration requirements need to register with the FDA and renew their registration every two years.
There are exemptions for some businesses and products, so the requirement should be confirmed for the individual situation.
Facility registration is not the same as FDA approval of the products manufactured at that facility.
Cosmetic Product Listing
MoCRA also introduced cosmetic product listing requirements.
The responsible person, generally the manufacturer, packer or distributor whose name appears on the product label, is responsible for listing marketed cosmetic products with the FDA where the requirement applies.
These listings need to contain specified information about the product and be updated as required.
Like facility registration, product listing should not be described as FDA product approval.
Safety Substantiation
The responsible person also needs to maintain records supporting adequate safety substantiation for the cosmetic products they market.
What is appropriate will depend on the product and the information available to support its safety.
This is one reason product documentation should be considered throughout development rather than assembled only when a product is ready to launch.
Other US Considerations
Brands planning to sell cosmetics in the United States may also need to consider:
- Ingredient requirements
- Colour additive requirements
- Labelling and claims
- Adverse event reporting obligations
- Facility registration, where applicable
- Cosmetic product listing, where applicable
- Safety substantiation records
The brand, manufacturer and any regulatory partners should be clear about who is responsible for each requirement.
How Do Australia, the EU and US Differ?
The three markets regulate cosmetics in different ways.
In Australia, AICIS regulates the introduction of many of the industrial chemicals used in cosmetics. Product classification and labelling also need to be considered separately.
In the European Union, cosmetic products need an EU-based Responsible Person, a safety assessment, a CPSR, a PIF and CPNP notification before being placed on the market.
In the United States, brands need to consider the requirements of the Federal Food, Drug, and Cosmetic Act and MoCRA. Depending on the product and business, this can include facility registration, product listing, safety substantiation and adverse event reporting.
These differences matter when a brand wants to use the same formulation in several markets.
An ingredient that can be used in one region may have different requirements in another. Claims and labelling may also need to change.
Can the Same Cosmetic Formula Be Sold in Multiple Markets?
Potentially, but it should not be assumed.
The formulation needs to be considered against the requirements of each intended market. This is particularly important for ingredients that are restricted, used at specific levels or treated differently between regions.
The claims made about the finished product also matter. A claim that is appropriate for a cosmetic in one market may create different regulatory considerations somewhere else.
Brands considering international expansion should make their intended markets clear while the product is still being developed.
This gives the formulation and manufacturing team more opportunity to identify requirements that could affect the finished product.
What About Product Testing?
Testing requirements depend on the type of cosmetic, the formulation and where the product will be sold.
Depending on the product, development may include:
- Stability testing
- Bacterial, yeast and mould testing
- Preservative efficacy testing
Other testing, documentation or specialist assessments may be needed for particular products or markets.
There is no single testing program that applies to every cosmetic product, so the appropriate requirements should be considered on a product-by-product basis.
When Should Regulatory Requirements Be Considered?
Ideally, brands should start thinking about their intended markets before the formulation, packaging and claims are locked in.
This does not mean every regulatory detail needs to be resolved before development begins.
It does mean the formulation and manufacturing team should know where the brand plans to sell the product.
For example, if a brand knows from the beginning that it wants to launch in Australia and later expand into the EU, that information can be considered when ingredients and product claims are being discussed.
It is much easier to review these areas while the product is still in development than once packaging has been ordered and artwork approved.
Delta’s Role in Product Development
Delta works with cosmetic and personal care brands from formulation development through to commercial manufacturing.
When the intended market is known, requirements that may affect the formulation, testing, packaging or manufacturing process can be considered during development.
Depending on the project, this may involve discussions around:
- Ingredient requirements
- Product classification
- Testing
- Claims
- Packaging and artwork
- Manufacturing requirements
Some regulatory activities require specialist regulatory providers or other parties outside Delta’s role as manufacturer.
For example, an EU safety assessment, Responsible Person services or market-specific regulatory submissions may need to be managed by the brand or an external regulatory specialist.
Establishing these responsibilities early helps everyone involved understand what needs to happen as the product progresses towards market.
FAQ: Cosmetic Regulatory Compliance
Are cosmetics regulated differently in Australia, the EU and US?
Yes. Each market has its own framework for cosmetics, with different requirements around ingredients, product documentation, labelling and market entry.
Does AICIS approve cosmetic products in Australia?
No. AICIS regulates the importation and manufacture of industrial chemicals, including almost all ingredients used in cosmetics. Finished cosmetic products are not approved by AICIS.
What does an Australian brand need to sell cosmetics in the EU?
EU cosmetics need to meet the requirements of the EU Cosmetics Regulation. This includes having an EU-based Responsible Person, completing the required safety assessment and CPSR, maintaining a PIF and notifying the product through the CPNP before it is placed on the market.
Does the FDA approve cosmetic products?
Cosmetic facility registration and product listing under MoCRA are not FDA product approval. Businesses still need to understand and meet the requirements that apply to their cosmetic products.
What is MoCRA?
MoCRA is the Modernization of Cosmetics Regulation Act of 2022. It introduced new requirements for the US cosmetics industry, including areas such as facility registration, product listing, safety substantiation and adverse event reporting.
When should brands start thinking about international requirements?
As early as practical. If a brand intends to enter several markets, sharing those plans during product development can help identify requirements that may affect the formulation, claims or packaging.
Planning a Product for More Than One Market?
Different markets can require different approaches to formulation, documentation, claims and labelling.
Knowing where you plan to sell your product early gives your formulation and manufacturing team useful context during development.
Delta works with cosmetic and personal care brands from initial formulation development through to commercial manufacturing.
Speak to Delta
Talk to Delta about your product, intended markets and manufacturing requirements.