EU Cosmetics Compliance Checklist for Australian Brands
EU Cosmetics Compliance Checklist for Australian Brands
Australian cosmetic brands, manufacturers and exporters preparing to sell products in the European Union need to complete a defined set of safety, documentation, Responsible Person, labelling and notification requirements before market entry.
EU cosmetic products are primarily regulated by Regulation (EC) No 1223/2009. For an Australian business, the compliance process normally begins with confirming that the product qualifies as a cosmetic, reviewing the formula and ingredients, preparing the safety assessment and Product Information File, appointing an EU Responsible Person and completing the required CPNP notification before the product is placed on the market.
The Australian formulation, packaging or product documentation should not automatically be assumed to satisfy EU requirements. The final EU product should be assessed against the European cosmetics framework and the requirements applicable on the intended launch date.
Quick answer
What does an Australian cosmetics brand need before selling in the EU?
Before placing a cosmetic product on the EU market, an Australian brand should confirm the product classification, review the formula against EU ingredient rules, ensure manufacturing follows good manufacturing practice, complete the cosmetic-product safety assessment and CPSR, prepare the PIF, establish an EU Responsible Person, verify the label and claims, complete CPNP notification and perform a final market-readiness review.
Product & formula
Confirm the cosmetic classification, intended use and compliance of the finished formulation.
Safety & documentation
Prepare the CPSR, PIF and supporting product, ingredient and manufacturing evidence.
EU Responsible Person
Establish the Responsible Person who will fulfil the applicable EU regulatory responsibilities.
Notification & launch
Complete the label, claims review, CPNP notification and final pre-market compliance check.
10-step checklist
EU cosmetics compliance checklist for Australian brands
Select a step to move directly to it and expand the corresponding guidance.
01Define the cosmetic productFunction, intended use, presentation and classification
02Review formula and ingredientsRestrictions, prohibited substances and ingredient conditions
03Confirm manufacturing complianceGood manufacturing practice and production information
04Prepare the CPSRSafety assessment and qualified safety assessor
05Build the Product Information FilePIF content, evidence and document control
06Appoint the EU Responsible PersonEU presence, responsibilities and document access
07Verify EU cosmetics labellingMandatory information, languages and fragrance allergens
08Review cosmetic claimsEvidence, presentation and advertising statements
09Complete CPNP notificationPre-market EU cosmetic-product notification
10Complete the final market reviewLaunch, traceability and post-market responsibilities
Step 1Define the cosmetic product and confirm its regulatory classification
The first step is confirming that the product falls within the EU definition of a cosmetic product. The regulatory route depends on the product’s intended purpose, composition, presentation, claims and location of application.
Under the EU Cosmetics Regulation, cosmetic products are generally substances or mixtures intended to be placed in contact with external parts of the human body, teeth or oral mucous membranes mainly for purposes such as cleaning, perfuming, changing appearance, protecting, keeping in good condition or correcting body odours.
Document the product clearly
- Product name, SKU, variant and formulation version.
- Intended cosmetic function.
- Area of application.
- Leave-on or rinse-off use.
- Target consumers and any age limitations.
- Frequency and duration of intended use.
- Packaging type and application method.
- Marketing claims and presentation.
Step 2Review the cosmetic formula and ingredient compliance
An Australian formulation should be reviewed specifically against the EU Cosmetics Regulation before the product is prepared for European launch. An ingredient permitted or commonly used in another market may be prohibited, restricted or subject to different conditions in the European Union.
Review the full formulation
- Full qualitative and quantitative composition.
- INCI names and ingredient identity.
- Prohibited substances.
- Restricted substances and applicable concentration limits.
- Permitted colourants.
- Permitted preservatives.
- Permitted UV filters.
- Nanomaterials where applicable.
- Fragrance composition and allergens.
- Impurities and technically unavoidable traces where relevant.
- Raw-material specifications and supplier documentation.
Control formulation changes
A change in fragrance, preservative, colourant, supplier, concentration or raw-material specification may affect the safety assessment, ingredient list, claims, CPNP data or other compliance records. Maintain version control and reassess compliance when the formula changes.
Step 3Confirm manufacturing and good manufacturing practice
Manufacture of cosmetic products supplied in the European Union must comply with good manufacturing practice. This requirement applies even when the finished product is manufactured outside Europe.
Prepare manufacturing evidence
- Name and address of the manufacturing site.
- Description of the manufacturing process.
- Quality-control procedures.
- Raw-material and finished-product specifications.
- Batch and traceability records.
- Microbiological controls where relevant.
- Stability and compatibility information.
- Statement of compliance with good manufacturing practice.
EN ISO 22716 is commonly used as the relevant cosmetics good-manufacturing-practice standard. The Product Information File should include a description of the manufacturing method and a statement concerning GMP compliance.
Step 4Prepare the Cosmetic Product Safety Report (CPSR)
Before a cosmetic product is placed on the EU market, the Responsible Person must ensure that the product has undergone a safety assessment and that a Cosmetic Product Safety Report is prepared in accordance with Annex I of the Cosmetics Regulation.
The safety assessment may require information on
- Quantitative and qualitative composition.
- Physical and chemical characteristics.
- Stability of the cosmetic product.
- Microbiological quality.
- Impurities, traces and packaging material.
- Normal and reasonably foreseeable use.
- Exposure to the cosmetic product.
- Exposure to individual substances.
- Toxicological profile of ingredients.
- Undesirable and serious undesirable effects.
- Other relevant information about the product.
Use an appropriately qualified safety assessor
The safety assessment must be carried out by a person meeting the qualification requirements established by the Cosmetics Regulation. Product-specific exposure, toxicology and use conditions should be considered rather than relying only on generic ingredient statements.
Step 5Build and maintain the Product Information File (PIF)
The Product Information File is the central regulatory record for an EU cosmetic product. It connects the product identity, safety assessment, manufacturing information and claims evidence in one controlled file.
The PIF should include
- A description of the cosmetic product that clearly identifies it.
- The Cosmetic Product Safety Report.
- A description of the manufacturing method.
- A statement of compliance with good manufacturing practice.
- Proof of the effect claimed for the cosmetic product where justified by the nature or effect of the product.
- Relevant animal-testing information required by the Regulation.
- Controlled supporting records and updated product information.
The PIF must be kept for ten years following the date on which the last batch of the cosmetic product was placed on the EU market.
The Responsible Person must make the PIF readily accessible to the competent authority at the address indicated on the cosmetic-product label.
Step 6Appoint the EU Responsible Person
A cosmetic product may only be placed on the EU market where a legal or natural person established within the European Union has been designated as the Responsible Person for that product.
For cosmetics imported from outside the EU, the importer can become the Responsible Person unless another qualifying EU-established person is designated by written mandate and accepts the role in writing.
Confirm the arrangement before launch
- Name and address of the EU Responsible Person.
- Written contractual or mandate structure where applicable.
- Access to the Product Information File.
- Communication procedure with the Australian brand and manufacturer.
- Process for regulatory updates and product changes.
- Procedure for authority requests.
- Procedure for serious undesirable effects and corrective action.
- Correct Responsible Person details for the final product label.
Step 7Verify the EU cosmetics label and packaging information
The final product label should be reviewed after the formulation, safety assessment and Responsible Person structure are confirmed. Mandatory information and language requirements should be checked for the destination EU markets.
Review the required label information
- Name or registered name and address of the Responsible Person.
- Country of origin for imported cosmetic products.
- Nominal content where required.
- Date of minimum durability or period-after-opening information as applicable.
- Particular precautions for use and required warnings.
- Batch number or product reference.
- Function of the cosmetic product unless clear from its presentation.
- Ingredient list using the required cosmetic ingredient nomenclature.
- Applicable fragrance-allergen declarations.
- Information in the language required by the destination Member State where applicable.
Pay particular attention to fragrance allergens in 2026
The expanded EU fragrance-allergen labelling requirements are now particularly important for new market entries. Cosmetic products that do not comply with the updated requirements and were not already placed on the EU market before 31 July 2026 should not be newly placed on the market under the transition rules. Products placed on the market before that date may continue to be made available until 31 July 2028 under the applicable conditions.
Step 8Review cosmetic claims and supporting evidence
Cosmetic claims should be truthful, supported by adequate evidence and consistent with the product’s actual characteristics and regulatory classification.
Review claims appearing in
- Product packaging.
- Website and online marketplace listings.
- Advertising.
- Social-media content.
- Retailer descriptions.
- Technical or marketing material supplied to distributors.
Check the evidence
- Ensure claims are supported by appropriate evidence.
- Avoid implying characteristics the product does not possess.
- Ensure claims remain consistent with the CPSR and intended cosmetic function.
- Review environmental and sustainability statements carefully.
- Avoid claims that could cause the product to be presented as a medicine or another regulated product category.
Step 9Complete the Cosmetic Products Notification Portal (CPNP) notification
Before the cosmetic product is placed on the EU market, the Responsible Person must electronically submit the required product information through the Cosmetic Products Notification Portal.
Prepare the notification data
- Cosmetic-product category.
- Product name or names.
- Responsible Person name and address.
- Country of origin for imported cosmetics.
- Member State in which the product will be placed on the market.
- Emergency contact information.
- Nanomaterial information where applicable.
- Relevant substance and formulation information.
- Original labelling.
- Photograph of the corresponding packaging where reasonably legible.
Step 10Complete the final EU market-readiness and post-market review
Before launch, perform a final documented review of the actual formula, packaging, label, Responsible Person arrangement, PIF and CPNP record. Compliance should be confirmed for the exact version that will be supplied to European consumers.
Final cosmetics launch checklist
- The product qualifies as a cosmetic under the intended EU presentation.
- The final formulation has been reviewed against current EU ingredient rules.
- The manufacturing and GMP information is available.
- The CPSR is complete for the final formulation.
- The Product Information File is complete and controlled.
- The EU Responsible Person is formally established.
- The label matches the formula, CPSR and Responsible Person arrangement.
- Fragrance-allergen and other current labelling requirements have been reviewed.
- Claims are supported and appropriately presented.
- CPNP notification is complete.
- Packaging obligations have been considered separately where applicable.
- Complaint and undesirable-effect procedures are operational.
Prepare for post-market responsibilities
Compliance continues after launch. Product complaints, undesirable effects, serious undesirable effects, formulation changes, regulatory updates and corrective actions should feed into the ongoing safety and product-file review process.
Australia-to-EU example
Example: Australian skincare brand preparing its first EU launch
An Australian skincare company already sells a moisturiser domestically and wants to launch the same product in Germany and France through an EU distributor and online channels. The Australian product formulation and packaging provide a useful starting point, but the company should complete a separate EU cosmetics assessment before launch.
Formula review
Confirm that every ingredient and concentration meets the current EU cosmetics requirements.
Safety & PIF
Prepare the CPSR and organise the Product Information File around the actual EU product version.
EU market structure
Establish the Responsible Person and confirm importer and distributor responsibilities.
Launch preparation
Finalise the EU label, substantiate claims, complete CPNP notification and approve the final product.
Common mistakes
EU cosmetics compliance mistakes Australian brands should avoid
Treating CPNP as registration approval
CPNP notification is an important pre-market requirement, but it does not replace the broader cosmetics compliance process.
Reusing Australian labels unchanged
EU Responsible Person details, ingredient declarations, warnings, languages and other information may require changes.
Preparing the PIF too late
The PIF and CPSR should be part of pre-market preparation rather than assembled only after launch.
Using unsupported claims
Claims should remain within the cosmetic framework and be supported by adequate evidence.
No formula change control
A seemingly small formulation or supplier change can affect multiple compliance documents.
Confusing the importer and Responsible Person
The actual Responsible Person arrangement should be determined and documented rather than assumed.
Ignoring fragrance updates
Ingredient lists and artwork should be checked against the current fragrance-allergen requirements.
Forgetting post-market duties
Safety monitoring and regulatory responsibility continue after the cosmetic product enters the market.
Frequently asked questions
EU cosmetics compliance FAQ for Australian brands
Can an Australian cosmetics company sell products directly in the EU?
Yes, but the cosmetic product must satisfy the applicable EU requirements before it is placed on the market. This includes the required Responsible Person structure, safety assessment, CPSR, PIF, labelling and CPNP notification.
Do cosmetics need to be registered in the EU?
The EU system is not based on one general cosmetic-product registration certificate. Before market entry, the Responsible Person must ensure compliance with the Cosmetics Regulation and submit the required product information through the CPNP.
What is a Cosmetic Product Safety Report?
The CPSR documents the cosmetic-product safety assessment required before the product is placed on the EU market. It is prepared in accordance with Annex I of Regulation (EC) No 1223/2009 and forms part of the Product Information File.
What is a Product Information File?
The PIF is the controlled regulatory file for the cosmetic product. It includes the product description, CPSR, manufacturing and GMP information, relevant claims evidence and other information required by the Cosmetics Regulation.
Does an Australian cosmetic brand need an EU Responsible Person?
A cosmetic product can only be placed on the EU market where a Responsible Person established within the European Union has been designated for the product.
How long must the cosmetic Product Information File be retained?
The PIF must be retained for ten years following the date on which the last batch of the cosmetic product was placed on the market.
Do EU cosmetics need CE marking?
Cosmetic products do not generally use CE marking under Regulation (EC) No 1223/2009. The relevant cosmetics compliance requirements should instead be completed before market entry.
Can an Australian cosmetic label remain entirely in English?
Not necessarily. The Cosmetics Regulation leaves language requirements for certain mandatory label information to the law of the Member States where the product is made available. The required languages should therefore be checked for each destination market.
What changed with EU fragrance-allergen labelling?
The EU expanded the individual labelling requirements for fragrance allergens through Regulation (EU) 2023/1545. The transition rules distinguish between products placed on the market before 31 July 2026 and the later deadline of 31 July 2028 for continued making available of qualifying existing products.
Official references
Official EU cosmetics regulatory sources
Always confirm current consolidated legislation, annexes, amendments and European Commission guidance for the exact formulation and market-entry date.
01Regulation (EC) No 1223/2009EU Cosmetics Regulation
02European Commission cosmetics legislationOfficial regulatory overview and updates
03Cosmetic Products Notification PortalOfficial European Commission CPNP information
04Regulation (EU) No 655/2013Common criteria for cosmetic-product claims
05Regulation (EU) 2023/1545Expanded fragrance-allergen labelling requirements
06European Commission fragrance-allergen guidanceCurrent transition information for cosmetic labels
Need product-specific support?
Prepare your cosmetic products for the EU market
EKOTOX supports Australian cosmetic brands, manufacturers and exporters with formula review, CPSR and PIF preparation, EU Responsible Person arrangements, CPNP preparation, labelling, claims review and wider EU market-entry compliance.