Published: 31st August 2026
Reviewed by: David Small BSc (Hons), MSc, MTOPRA (Founder and CEO)
What Is a Cosmetic Product Safety Report (CPSR)?
A Cosmetic Product Safety Report (CPSR) is a scientific document that demonstrates a cosmetic product is safe for human health when used under normal or reasonably foreseeable conditions. It is a mandatory requirement before a cosmetic product can legally be placed on the market in Great Britain and forms one of the core components of the Product Information File (PIF).
Unlike many regulated products, cosmetics do not require approval from a government authority before they can be sold. Instead, the responsibility for ensuring product safety rests with the manufacturer and the Responsible Person. The CPSR provides the documented evidence that an independent Safety Assessor has reviewed the formulation, supporting data and intended use of the product before concluding that it is safe for consumers.
The report considers every aspect of the finished cosmetic product that could influence consumer safety. This includes the ingredients used within the formulation, their concentrations, toxicological profiles, expected consumer exposure, microbiological quality, chemical stability, packaging compatibility and any foreseeable risks associated with normal use.
A CPSR is not simply a checklist or regulatory formality. It is a comprehensive scientific assessment that applies recognised toxicological principles to determine whether the product presents an acceptable level of risk throughout its intended shelf life.
Because every cosmetic formulation is unique, each Cosmetic Product Safety Report is specific to the individual product being assessed. Even products that appear very similar may require separate assessments if they contain different fragrances, preservatives, colourants, packaging materials or intended uses.
Ultimately, the CPSR provides the scientific foundation that supports cosmetic compliance and gives manufacturers, Responsible Persons, retailers and consumers confidence that the product has undergone an objective safety evaluation before entering the market.
New to UK & EU Cosmetics Regulation?
A Cosmetic Product Safety Report (CPSR) is a fundamental part of demonstrating that a cosmetic product is safe, but it is only one element of regulatory compliance. For a practical introduction to Responsible Persons, Product Information Files (PIFs), safety assessments, labelling, product notification and the wider requirements for placing cosmetics on the UK and EU markets, read our Cosmetics Regulation for Beginners: Understanding EU Cosmetic Compliance.
What Is the Purpose of a CPSR?
The primary purpose of a Cosmetic Product Safety Report is to demonstrate that a cosmetic product can be used safely by consumers.
Rather than relying on adverse event reporting after a product has been launched, the CPSR identifies and evaluates potential risks before the product reaches the market.
During the assessment, the Safety Assessor considers questions such as:
- Are the ingredients permitted for use in cosmetic products?
- Are the ingredient concentrations within acceptable safety limits?
- Could any ingredient present a toxicological concern?
- Does repeated consumer exposure remain within safe limits?
- Is the preservative system effective?
- Is the packaging compatible with the formulation?
- Are any warnings or directions for use required?
Answering these questions helps ensure that the product can be marketed safely while complying with the requirements of the UK Cosmetics Regulation.
What Does a CPSR Assess?
A Cosmetic Product Safety Report evaluates the finished cosmetic product as a whole rather than assessing individual ingredients in isolation.
The assessment typically considers:
- The complete qualitative and quantitative formulation.
- The toxicological profile of every ingredient.
- Consumer exposure during normal use.
- The Margin of Safety (MoS) for relevant ingredients.
- Physical and chemical characteristics of the product.
- Microbiological quality.
- Product stability throughout its shelf life.
- Packaging compatibility.
- Intended method of application.
- Target consumer groups.
- Foreseeable misuse where relevant.
The Safety Assessor reviews all of this information before determining whether the finished cosmetic product is safe for its intended purpose.
Who Prepares a Cosmetic Product Safety Report?
A CPSR must be prepared by a suitably qualified Cosmetic Safety Assessor with the appropriate scientific knowledge and experience to perform a cosmetic safety assessment.
Safety Assessors typically have qualifications in disciplines such as:
- Toxicology.
- Pharmacy.
- Chemistry.
- Medicine.
- Dermatology.
- Another relevant life science.
In addition to formal qualifications, Safety Assessors must have a thorough understanding of cosmetic legislation, ingredient safety, toxicological risk assessment and consumer exposure calculations.
Their role is to independently evaluate the available evidence and determine whether the cosmetic product is safe under its intended conditions of use.
Is a CPSR the Same as a Product Information File (PIF)?
No.
A Cosmetic Product Safety Report is one document within the wider Product Information File (PIF).
The Product Information File contains all of the documentation supporting cosmetic compliance, including information relating to product manufacture, claims, Good Manufacturing Practice (GMP) and safety.
The CPSR provides the scientific safety assessment that underpins the Product Information File, while the PIF brings together all of the technical documentation required under the UK Cosmetics Regulation.
Without a compliant CPSR, the Product Information File cannot be considered complete.
How Does the CPSR Fit into the Product Information File?
The Cosmetic Product Safety Report (CPSR) is a key component of the Product Information File (PIF), but the PIF contains additional information needed to demonstrate ongoing cosmetic compliance. Learn what must be included, who is responsible for maintaining it and how long it must be retained in our Cosmetics Product Information File (PIF): UK & EU Guide.
Is Every Cosmetic Product Required to Have a CPSR?
Yes.
Every cosmetic product placed on the market in Great Britain must be supported by a Cosmetic Product Safety Report before it is supplied to consumers.
This applies regardless of whether the product is:
- Manufactured in the UK.
- Imported from overseas.
- Sold online.
- Supplied through retailers.
- Produced by a small business.
- Handmade.
- White-labelled.
- Manufactured under contract.
There are no exemptions based on company size or production volume. If a product falls within the legal definition of a cosmetic product, a CPSR is required before it can be placed on the market.
Why Is the CPSR So Important?
The Cosmetic Product Safety Report is often described as the scientific foundation of cosmetic compliance because it demonstrates that a product has been independently assessed before reaching consumers.
A well-prepared CPSR helps manufacturers:
- Meet their legal obligations.
- Protect consumer health.
- Support Product Information File (PIF) compliance.
- Prepare for SCPN notification.
- Reduce regulatory risk.
- Demonstrate due diligence.
- Build confidence with retailers and distributors.
Rather than being viewed simply as a regulatory requirement, the CPSR should be regarded as an important investment in product quality, consumer safety and long-term business success.
When Do You Need a Cosmetic Product Safety Report?
A Cosmetic Product Safety Report (CPSR) must be completed before a cosmetic product is first placed on the market in Great Britain. However, obtaining a CPSR is not simply a one-off exercise. Throughout the lifecycle of a cosmetic product, changes to the formulation, packaging, intended use or supporting scientific information may require the product to be reassessed to ensure it continues to meet the safety requirements of the UK Cosmetics Regulation.
Many manufacturers mistakenly believe that once a CPSR has been issued it remains valid indefinitely. In reality, the report is based on the specific formulation, packaging and conditions of use that existed at the time of the assessment. If any of these factors change significantly, the Safety Assessor may need to review the product and determine whether the existing CPSR remains appropriate or whether a new assessment is required.
Understanding when a CPSR is needed helps manufacturers avoid compliance issues while ensuring that consumers continue to receive safe cosmetic products.
Launching a New Cosmetic Product
Every new cosmetic product requires its own Cosmetic Product Safety Report before it is placed on the market.
Whether you are introducing:
- A new facial moisturiser
- A shampoo
- A beard oil
- A body lotion
- A lip balm
- A cosmetic serum
- A hand cream
- A cleansing product
the formulation must be independently assessed by a qualified Safety Assessor before the product can be legally supplied.
The completed CPSR then becomes part of the Product Information File (PIF) and supports the wider cosmetic compliance process.
Reformulating an Existing Product
One of the most common reasons for reviewing a CPSR is a change to the formulation.
Examples include:
- Adding a new ingredient.
- Removing an ingredient.
- Changing ingredient concentrations.
- Replacing a preservative.
- Introducing a different fragrance.
- Changing a colourant.
- Using an alternative raw material supplier where specifications differ.
Even relatively small formulation changes may alter the toxicological profile or consumer exposure calculations used during the original safety assessment.
For this reason, manufacturers should always consult their Safety Assessor before implementing formulation changes.
Changing the Packaging
Packaging plays an important role in cosmetic safety and forms part of the overall CPSR assessment.
A review may be required if you change:
- The primary container.
- Pump dispensers.
- Airless packaging.
- Tubes or jars.
- Applicators.
- Packaging materials.
- Components that come into direct contact with the formulation.
Different packaging materials can affect product stability, ingredient compatibility and consumer exposure. For example, certain formulations may interact differently with plastic, aluminium or glass containers.
Although not every packaging change will require a completely new CPSR, the Safety Assessor should review the proposed changes before the updated product is placed on the market.
Changing the Intended Use
The intended use of a cosmetic product has a direct impact on the safety assessment.
Examples of changes that may require reassessment include:
- Marketing a face cream for use around the eyes.
- Changing a rinse-off product to a leave-on product.
- Extending use to children.
- Introducing use on sensitive skin.
- Changing the frequency of recommended application.
- Expanding the areas of the body where the product is intended to be used.
These changes may alter consumer exposure and therefore affect the conclusions reached within the original CPSR.
New Scientific or Regulatory Information
Cosmetic science and legislation continue to evolve.
Over time:
- New toxicological studies may be published.
- Ingredients may become restricted or prohibited.
- SCCS opinions may be updated.
- Allergen labelling requirements may change.
- Safety guidance may be revised.
Where significant new information becomes available, manufacturers should determine whether their existing Cosmetic Product Safety Report should be reviewed.
Keeping the CPSR up to date demonstrates a proactive approach to cosmetic compliance and helps ensure that products continue to meet current regulatory expectations.
Product Variations
Many cosmetic ranges include multiple product variants.
For example:
- Different fragrances.
- Alternative colours.
- Seasonal editions.
- Different active ingredients.
- Multiple shades.
Whether each variation requires a separate CPSR depends on the extent of the differences between the products.
Minor variations may sometimes be assessed together where scientifically justified, while significant formulation changes will generally require separate assessments.
Your Safety Assessor can advise whether a family of products can be covered by one assessment or whether individual reports are required.
Imported Cosmetic Products
Importing a cosmetic product into Great Britain does not remove the requirement for a Cosmetic Product Safety Report.
If you import cosmetic products manufactured overseas, the Responsible Person must ensure that:
- A compliant CPSR exists.
- The Product Information File is available.
- The product has been notified through the SCPN portal.
- UK labelling requirements have been met.
Where an existing safety assessment has been prepared for another market, it should be reviewed to confirm that it satisfies the requirements applicable in Great Britain before the product is placed on the market.
Reviewing Your CPSR Regularly
Even if no significant product changes have occurred, manufacturers should periodically review their Cosmetic Product Safety Reports as part of their wider quality and regulatory management processes.
Regular reviews help confirm that:
- The formulation has not changed.
- Ingredient restrictions remain current.
- Supporting test reports are still relevant.
- Packaging remains unchanged.
- Product claims continue to reflect the assessed formulation.
- The Product Information File remains complete.
By treating the CPSR as a living document rather than a one-time regulatory requirement, manufacturers can maintain confidence that their products continue to meet the safety expectations of both regulators and consumers.
What Information Does a Safety Assessor Need?
Preparing a Cosmetic Product Safety Report (CPSR) begins long before the Safety Assessor starts evaluating the product. The quality, completeness and accuracy of the information provided by the manufacturer has a direct impact on how quickly the assessment can be completed and whether additional testing or clarification will be required.
One of the most common causes of delays is incomplete documentation. Missing ingredient information, absent Safety Data Sheets (SDSs), incomplete stability studies or unfinished artwork can all prevent the Safety Assessor from completing the evaluation. Gathering the necessary documentation before requesting a CPSR can significantly reduce turnaround times and help avoid unnecessary delays.
Although the exact information required varies depending on the type of cosmetic product, most Safety Assessors will request the following documentation before beginning the assessment.
Complete Product Formulation
The formulation is the foundation of every Cosmetic Product Safety Report.
To perform a meaningful safety assessment, the Safety Assessor must understand exactly what the finished product contains and in what quantities.
Manufacturers should provide:
- Complete ingredient list.
- INCI names for every ingredient.
- Exact percentage (%) of each ingredient.
- Fragrance concentration.
- Colourants used.
- Water content where applicable.
Providing ingredient percentages is essential because the Safety Assessor uses this information to calculate consumer exposure and determine the Margin of Safety (MoS) for relevant ingredients.
Without a complete formulation, it is generally not possible to prepare a compliant CPSR.
Safety Data Sheets (SDS) and Raw Material Information
Every raw material should be supported by appropriate supplier documentation.
This typically includes:
- Safety Data Sheets (SDS).
- Technical Data Sheets (TDS).
- Certificates of Analysis (CoA), where available.
- Ingredient specifications.
- Purity information.
- Details of known impurities.
These documents help the Safety Assessor understand the characteristics of each ingredient and identify any impurities or contaminants that could influence product safety.
Where ingredients are supplied by multiple manufacturers, documentation should relate to the specific raw materials used within the formulation.
Fragrance Documentation
Fragrance ingredients require additional consideration because they are among the most common causes of cosmetic sensitivity and allergic reactions.
Where fragrances or essential oils are used, manufacturers should normally provide:
- IFRA Certificate.
- Fragrance allergen declaration.
- Compliance with the latest IFRA Standards.
- Supporting documentation supplied by the fragrance manufacturer.
This information allows the Safety Assessor to verify that fragrance materials comply with recognised industry standards and to determine whether allergen declarations are required on the product label.
Stability Testing
The Safety Assessor must be satisfied that the cosmetic product remains stable throughout its intended shelf life.
Stability testing helps demonstrate that the product maintains its quality, safety and performance during storage and normal consumer use.
Typical stability studies evaluate:
- Appearance.
- Colour.
- Odour.
- pH.
- Viscosity.
- Product separation.
- Physical stability.
- Chemical stability.
The results support the proposed shelf life and, where appropriate, the Period After Opening (PAO) or Best Before Date displayed on the product packaging.
Microbiological Testing
Microbiological quality is an essential aspect of cosmetic safety, particularly for products that contain water or are susceptible to microbial contamination.
Manufacturers should provide microbiological test reports where appropriate, including:
- Total viable count.
- Yeast and mould count.
- Absence of specified pathogens.
- Overall microbiological quality assessment.
These results help demonstrate that the finished product is microbiologically safe before it is supplied to consumers.
Preservative Efficacy Testing (Challenge Testing)
For most water-based cosmetic products, the Safety Assessor will expect evidence that the preservative system effectively controls microbial growth throughout the product’s intended shelf life.
This is demonstrated through Preservative Efficacy Testing (PET), more commonly known as Challenge Testing.
Challenge testing evaluates the effectiveness of the preservative system against recognised test microorganisms, including:
- Staphylococcus aureus
- Pseudomonas aeruginosa
- Escherichia coli
- Candida albicans
- Aspergillus brasiliensis
Successful Challenge Test results provide confidence that the product will remain safe during normal consumer use, even after repeated opening and handling.
Packaging Information
The packaging used for a cosmetic product forms part of the overall safety assessment because the formulation may interact with the container over time.
Manufacturers should provide information relating to:
- Primary packaging materials.
- Bottle, tube or jar specifications.
- Pumps and dispensing systems.
- Closures and applicators.
- Material compatibility data where available.
The Safety Assessor will consider whether the packaging is suitable for the formulation and whether there is any potential for interaction, degradation or migration that could affect product safety.
Product Artwork and Labelling
Draft artwork should be available before the Cosmetic Product Safety Report is finalised.
This enables the Safety Assessor to review:
- Product name.
- Intended use.
- Directions for use.
- Ingredient declaration.
- Warning statements.
- Mandatory labelling.
- Product claims.
If additional warnings are required following the safety assessment, these can be incorporated into the artwork before the product is placed on the market.
Intended Use of the Product
Understanding how the cosmetic product will be used is fundamental to the safety assessment.
Manufacturers should provide details including:
- Product category.
- Intended purpose.
- Area of application.
- Target users.
- Frequency of use.
- Amount typically applied.
- Whether the product is leave-on or rinse-off.
- Any foreseeable misuse.
This information is used to calculate consumer exposure and determine whether the formulation remains safe under its intended conditions of use.
Why Complete Documentation Matters
Providing complete and accurate documentation at the start of the assessment helps ensure that the Safety Assessor can perform a thorough scientific evaluation without unnecessary delays.
Before requesting a CPSR, it is good practice to have the following information available:
✔ Complete formulation with ingredient percentages.
✔ Safety Data Sheets (SDS) for all raw materials.
✔ IFRA Certificate (where applicable).
✔ Stability test report.
✔ Microbiological test report.
✔ Challenge Test (PET) report where required.
✔ Packaging specifications.
✔ Product artwork.
✔ Intended use information.
✔ Manufacturing details.
Preparing this information in advance not only speeds up the CPSR process but also helps ensure that the resulting Product Information File (PIF) is complete, accurate and ready to support cosmetic compliance before the product is placed on the market.
How Is a Cosmetic Safety Assessment Performed?
Once all of the necessary documentation has been received, the Safety Assessor begins a structured scientific evaluation of the cosmetic product. This process goes far beyond reviewing the ingredient list. Every aspect of the formulation, its intended use and the supporting evidence is assessed to determine whether the finished product can be considered safe for consumers under normal or reasonably foreseeable conditions of use.
Rather than applying a simple checklist, the Safety Assessor evaluates the product using established toxicological principles, current scientific literature and the latest regulatory requirements. The objective is to identify any potential safety concerns before the product reaches the market and determine whether any changes to the formulation, packaging or labelling are required.
Although every cosmetic product is different, the assessment generally follows a series of well-defined stages.
Step 1 – Reviewing the Formulation
The assessment begins with a detailed review of the complete product formulation.
The Safety Assessor examines:
- Every ingredient present in the formulation.
- The concentration of each ingredient.
- The function of each ingredient.
- Ingredient purity.
- Known impurities.
- Regulatory restrictions.
- Potential interactions between ingredients.
This review helps confirm that the formulation complies with current cosmetic legislation and provides the foundation for the remainder of the assessment.
Step 2 – Assessing Individual Ingredient Safety
Each ingredient is then assessed individually using published toxicological data and recognised scientific sources.
The Safety Assessor considers factors such as:
- Acute toxicity.
- Skin irritation.
- Eye irritation.
- Skin sensitisation.
- Repeated dose toxicity.
- Genotoxicity.
- Carcinogenicity.
- Reproductive toxicity where relevant.
Where ingredients are subject to specific regulatory restrictions or maximum permitted concentrations, these limits are also verified during the assessment.
Step 3 – Calculating Consumer Exposure
An ingredient can only be assessed properly if the Safety Assessor understands how much of it consumers are likely to be exposed to during normal use.
Exposure calculations consider:
- The amount of product typically applied.
- Frequency of application.
- Area of the body where the product is used.
- Whether the product is leave-on or rinse-off.
- Duration of exposure.
- Target consumer group.
For example, a leave-on facial cream generally results in greater exposure than a rinse-off shampoo, while a lip balm may involve incidental ingestion. These differences are important because they directly influence the overall safety assessment.
Step 4 – Determining the Margin of Safety (MoS)
For many ingredients, the Safety Assessor calculates the Margin of Safety (MoS).
The Margin of Safety compares the level at which an ingredient is known to cause no harmful effects with the amount consumers are expected to be exposed to during normal use.
A satisfactory Margin of Safety provides confidence that the ingredient can be used safely at its intended concentration within the finished cosmetic product.
Where the calculated Margin of Safety is considered insufficient, the assessor may recommend:
- Reducing the ingredient concentration.
- Reformulating the product.
- Introducing additional warnings.
- Restricting the intended use.
- Carrying out further investigations before approval.
Step 5 – Reviewing Supporting Test Reports
The Safety Assessor then evaluates the supporting technical documentation supplied with the product.
Depending on the formulation, this may include:
- Stability testing.
- Microbiological testing.
- Preservative Efficacy Testing (Challenge Testing).
- Packaging compatibility studies.
- Raw material specifications.
- Safety Data Sheets (SDS).
- IFRA Certificates.
- Certificates of Analysis where available.
These reports help demonstrate that the finished product remains safe throughout its intended shelf life and under normal storage conditions.
Step 6 – Assessing Packaging and Labelling
The assessment also considers whether the packaging and product labelling support the safe use of the cosmetic product.
The Safety Assessor reviews:
- Packaging compatibility.
- Method of dispensing.
- Directions for use.
- Warning statements.
- Ingredient declaration.
- Product claims.
- Target consumer information.
If additional precautions or warnings are necessary to ensure safe use, these should be incorporated into the final artwork before the product is placed on the market.
Step 7 – Reaching a Safety Conclusion
After evaluating all available evidence, the Safety Assessor determines whether the cosmetic product can be considered safe under its intended conditions of use.
The final conclusion may include:
- Confirmation that the product is safe.
- Recommendations for specific warning statements.
- Restrictions on use where appropriate.
- Recommendations for reformulation if necessary.
- Requests for additional supporting information before a conclusion can be reached.
Where the available evidence supports a positive conclusion, the Safety Assessor completes and signs the Cosmetic Product Safety Report.
What Happens After the CPSR Is Completed?
Once the Cosmetic Product Safety Report has been finalised, it becomes a key component of the Product Information File (PIF).
The Responsible Person should then ensure that:
- The CPSR is included within the PIF.
- The Product Information File is complete.
- Product artwork reflects any required warnings.
- The product is notified through the Submit Cosmetic Product Notifications (SCPN) portal before being placed on the Great Britain market.
- The documentation is maintained and reviewed whenever significant changes occur.
Although obtaining the CPSR represents a major milestone, manufacturers should remember that cosmetic compliance is an ongoing process. If the formulation, packaging or intended use changes in the future, the Safety Assessor may need to review the product to confirm that the existing assessment remains valid.
The Most Common Reasons CPSRs Are Delayed
Preparing a Cosmetic Product Safety Report (CPSR) is generally a straightforward process when all of the required information is available. However, in practice, many assessments are delayed because key documentation is missing, incomplete or inconsistent. These delays can postpone product launches, increase costs and create unnecessary frustration for manufacturers who are eager to bring new products to market.
Most delays are avoidable with good preparation. By understanding the information a Safety Assessor requires and ensuring it is available before the assessment begins, manufacturers can significantly reduce turnaround times and minimise requests for additional information.
Below are some of the most common issues encountered during the preparation of Cosmetic Product Safety Reports.
Incomplete Formulations
One of the most frequent causes of delay is receiving an incomplete product formulation.
For a CPSR to be completed, the Safety Assessor must know exactly what is contained within the finished cosmetic product. In many cases, manufacturers provide a list of ingredients but omit the percentage concentration of each ingredient or use trade names instead of International Nomenclature Cosmetic Ingredient (INCI) names.
Common formulation issues include:
- Missing ingredient percentages.
- Trade names used instead of INCI names.
- Ingredients listed in the wrong order.
- Missing fragrance concentrations.
- Incomplete information for colourants or preservatives.
Without accurate formulation data, it is not possible to perform exposure calculations or assess the Margin of Safety (MoS), meaning the safety assessment cannot proceed.
Missing Supplier Documentation
Every raw material used within a cosmetic product should be supported by appropriate technical documentation from the supplier.
It is common for manufacturers to provide some Safety Data Sheets (SDSs) while others are missing or out of date.
Documentation frequently requested includes:
- Safety Data Sheets (SDS).
- Technical Data Sheets (TDS).
- Certificates of Analysis (CoA), where available.
- IFRA Certificates for fragrances.
- Allergen declarations.
If documentation is missing, the Safety Assessor may need to request additional information before the assessment can continue.
Insufficient Stability or Microbiological Testing
A Cosmetic Product Safety Report relies on evidence that the finished product remains safe throughout its intended shelf life.
Delays often occur where manufacturers have not yet completed:
- Stability testing.
- Microbiological quality testing.
- Preservative Efficacy Testing (Challenge Testing), where appropriate.
- Packaging compatibility studies.
Without appropriate supporting evidence, the Safety Assessor may be unable to confirm that the product will remain safe under normal storage and use conditions.
Planning these studies early in the product development process can help prevent unnecessary delays before launch.
Product Artwork Is Not Finalised
Many manufacturers request a CPSR before their product labels or artwork have been completed.
While a draft label is often sufficient for the initial assessment, the final artwork should be reviewed before the product is placed on the market to ensure it accurately reflects the conclusions of the safety assessment.
Common artwork issues include:
- Missing ingredient declarations.
- Incorrect INCI names.
- Mandatory warnings omitted.
- Claims that are inconsistent with the assessed product.
- Missing Responsible Person details.
- Incorrect Period After Opening (PAO) or Best Before information.
Reviewing artwork alongside the CPSR helps avoid costly reprints and ensures that the final product complies with regulatory requirements.
Reformulations During the Assessment
It is not unusual for manufacturers to continue refining a formulation while the CPSR is being prepared.
However, changing ingredients or concentrations after the assessment has started may require parts of the evaluation to be repeated.
Examples include:
- Replacing a preservative.
- Changing a fragrance.
- Adding a new active ingredient.
- Altering ingredient concentrations.
- Changing the intended use of the product.
Whenever significant changes are made, manufacturers should notify the Safety Assessor as soon as possible to determine whether additional assessment is required.
Assuming One CPSR Covers Every Product
A common misconception is that a single Cosmetic Product Safety Report can be used for an entire product range.
While some closely related product variants may be assessed together where scientifically justified, products with different formulations, fragrances, colours or intended uses often require separate assessments or updates.
Manufacturers should seek advice before assuming that one CPSR can be applied across multiple products.
Leaving the CPSR Until the Last Minute
One of the biggest causes of launch delays is treating the CPSR as the final administrative task before a product goes on sale.
In reality, the safety assessment often identifies issues that need to be addressed before the product can be marketed, such as:
- Reformulation.
- Additional testing.
- Packaging changes.
- New warning statements.
- Labelling amendments.
Engaging with a Safety Assessor early in the product development process provides time to resolve any issues without delaying the planned launch date.
How to Avoid Unnecessary Delays
Most Cosmetic Product Safety Reports can be completed efficiently when manufacturers provide complete and well-organised documentation from the outset.
Before requesting a CPSR, it is worth checking that you have:
✔ A complete formulation with ingredient percentages.
✔ Current Safety Data Sheets (SDS) for all raw materials.
✔ IFRA Certificates for fragrances, where applicable.
✔ Stability test results.
✔ Microbiological testing results.
✔ Preservative Efficacy Test (Challenge Test) results, where required.
✔ Packaging specifications.
✔ Draft product artwork.
✔ Clear information about the product’s intended use.
Preparing this information in advance helps streamline the assessment process, reduces the need for follow-up queries and allows the Safety Assessor to focus on evaluating the safety of the product rather than chasing missing documentation.
By adopting this proactive approach, manufacturers can avoid many of the common issues that delay product launches and ensure their Cosmetic Product Safety Report is completed as efficiently as possible.
Conclusion
A Cosmetic Product Safety Report (CPSR) is one of the most important documents required before a cosmetic product can be placed on the Great Britain market. It provides independent scientific evidence that the product has been assessed for safety under its intended conditions of use and forms a key part of the Product Information File (PIF).
Although obtaining a CPSR is a legal requirement, it should also be viewed as an opportunity to identify potential safety concerns before launch, improve product quality and demonstrate a commitment to consumer safety. By providing complete documentation, engaging with a qualified Safety Assessor early in the development process and keeping the assessment up to date whenever significant changes occur, manufacturers can avoid unnecessary delays and maintain confidence in the safety of their products.
Whether you’re developing your first cosmetic product or expanding an established range, understanding the CPSR process will help ensure your products are supported by robust scientific evidence and are ready for market with confidence.
Ready to Prepare Your Cosmetic Product Safety Report?
Patient Guard provides practical, science-led support for cosmetic manufacturers throughout the compliance process. From reviewing formulations and preparing Cosmetic Product Safety Reports to compiling Product Information Files and providing UK Responsible Person services, our experienced regulatory specialists can help you bring your cosmetic products to market efficiently and with confidence.
Frequently Asked Questions About Cosmetic Product Safety Reports (CPSRs)
A Cosmetic Product Safety Report (CPSR) is a scientific assessment confirming that a cosmetic product is safe for human health when used under normal or reasonably foreseeable conditions. It is a legal requirement before cosmetic products can be placed on the Great Britain market and forms part of the Product Information File (PIF).
Yes.
Every cosmetic product placed on the Great Britain market must be supported by a Cosmetic Product Safety Report prepared by a suitably qualified Safety Assessor. Without a compliant CPSR, a cosmetic product cannot be considered fully compliant with the UK Cosmetics Regulation.
A CPSR must be prepared by a suitably qualified Safety Assessor with appropriate expertise in toxicology, pharmacy, medicine, chemistry or another relevant scientific discipline. The assessor must have sufficient knowledge of cosmetic ingredients, exposure assessment and cosmetic legislation to carry out a scientifically robust safety evaluation.
Although the exact requirements vary depending on the product, manufacturers will typically need to provide:
- Complete formulation with ingredient percentages.
- Safety Data Sheets (SDS) for raw materials.
- IFRA Certificate where applicable.
- Stability testing.
- Microbiological testing.
- Preservative Efficacy (Challenge Test) results where required.
- Packaging information.
- Draft product artwork.
- Intended use of the product.
Providing complete documentation at the outset helps minimise delays during the assessment.
The timeframe depends largely on the quality and completeness of the information provided.
Where all required documentation is available and no significant issues are identified, a Cosmetic Product Safety Report can often be completed relatively quickly. If additional testing or supporting documentation is required, the process may take longer.
A CPSR does not have a fixed expiry date.
However, it should be reviewed whenever significant changes are made to the product, including:
- Reformulating the product.
- Changing ingredient concentrations.
- Introducing new fragrances or colourants.
- Changing the packaging where compatibility may be affected.
- Changing the intended use.
- Significant changes to cosmetic legislation or scientific knowledge.
Keeping the CPSR under review helps ensure continued compliance throughout the product lifecycle.
In most cases, yes.
Each Cosmetic Product Safety Report relates to a specific formulation and intended use. Where products differ significantly in their ingredients, concentrations, packaging or intended use, separate assessments are normally required.
Closely related product variants may sometimes be assessed together where scientifically justified.
No.
A Cosmetic Product Safety Report is one component of the Product Information File (PIF).
The PIF contains a broader collection of documentation supporting cosmetic compliance, including manufacturing information, evidence supporting product claims and Good Manufacturing Practice (GMP). The CPSR provides the scientific safety assessment within that wider file.
Yes.
The legal requirements apply regardless of production volume. Handmade cosmetics, artisan products and small-batch products all require a Cosmetic Product Safety Report before they are placed on the Great Britain market.
Possibly, but it should be reviewed carefully.
Where a product has already been assessed for another market, the Responsible Person should ensure that the assessment remains appropriate for the product being supplied in Great Britain and that it supports compliance with the applicable UK requirements.
Any significant change to the formulation should be reviewed by the Safety Assessor.
Depending on the nature of the change, the existing CPSR may need to be updated or a new assessment completed before the revised product is placed on the market.
Packaging forms part of the overall safety assessment because it can influence product stability and compatibility.
If the primary packaging changes, manufacturers should consult their Safety Assessor to determine whether the existing CPSR remains valid or whether further assessment is required.
In many cases, yes.
The Safety Assessor needs sufficient evidence to demonstrate that the cosmetic product remains safe throughout its intended shelf life. Depending on the formulation, this may include stability testing, microbiological testing and Preservative Efficacy Testing (Challenge Testing).
The exact testing required will depend on the characteristics of the product.
Common causes of delay include:
- Missing formulation percentages.
- Incomplete Safety Data Sheets.
- Missing IFRA Certificates.
- Stability testing not completed.
- Challenge Test results unavailable.
- Product artwork not finalised.
- Changes to the formulation during the assessment.
Providing complete documentation before requesting the assessment can significantly reduce delays.
Yes.
Patient Guard supports cosmetic manufacturers with the preparation and review of Cosmetic Product Safety Reports (CPSRs), Product Information Files (PIFs), UK Responsible Person services and wider cosmetic regulatory compliance. We work with businesses ranging from start-ups launching their first products to established manufacturers expanding their cosmetic portfolios.
References
This guide is based on the following UK and European cosmetics legislation, international standards and official regulatory guidance relating to Cosmetic Product Safety Reports (CPSRs), cosmetic safety assessment, Product Information Files (PIFs), Responsible Persons, Good Manufacturing Practice and cosmetic product compliance.
| Organisation | Reference | Why it's relevant |
|---|---|---|
| European Union | Regulation (EC) No 1223/2009 on Cosmetic Products | Provides the principal regulatory framework governing cosmetic products placed on the European Union market. It establishes requirements for product safety, Responsible Persons, safety assessment, Product Information Files, notification, Good Manufacturing Practice, labelling and market surveillance. |
| European Union | Article 10 and Annex I – Cosmetic Product Safety Report | Establishes the requirement for a cosmetic product to undergo a safety assessment before being placed on the market and specifies the minimum content of the Cosmetic Product Safety Report. Annex I divides the CPSR into Part A – Cosmetic Product Safety Information and Part B – Cosmetic Product Safety Assessment. |
| UK Government / Office for Product Safety and Standards (OPSS) | Regulation 1223/2009 and the Cosmetic Products Enforcement Regulations 2013: Great Britain | Provides current UK Government guidance on the requirements applying to cosmetic products placed on the Great Britain market, including the UK Responsible Person, CPSR, qualified safety assessor, Product Information File, Good Manufacturing Practice, notification and labelling requirements. |
| Scientific Committee on Consumer Safety (SCCS) | SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation – 12th Revision | Provides detailed scientific guidance supporting the safety evaluation of cosmetic ingredients. It addresses toxicological assessment, exposure calculations, Margin of Safety, systemic exposure, alternative testing methods and other considerations relevant to preparation of a robust CPSR. |
| International Organization for Standardization (ISO) | ISO 22716:2007 – Cosmetics – Good Manufacturing Practices (GMP) – Guidelines on Good Manufacturing Practices | Provides internationally recognised guidance for the production, control, storage and shipment of cosmetic products. Compliance with appropriate cosmetic GMP supports the manufacturing information maintained within the Product Information File and the wider demonstration of cosmetic product compliance. |
| European Union | Commission Regulation (EU) No 655/2013 – Common Criteria for Cosmetic Product Claims | Establishes common criteria for the justification of cosmetic product claims, including legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making. Claims should be supported by appropriate evidence and reflected within the Product Information File where applicable. |
| UK Government / Office for Product Safety and Standards (OPSS) | Submit Cosmetic Product Notifications (SCPN) | The official UK service used to notify OPSS of cosmetic products made available to consumers in Great Britain. Notification is a separate requirement from preparation of the CPSR and must be completed before a cosmetic product is placed on the GB market. |
| Scientific Committee on Consumer Safety (SCCS) | SCCS Opinions, Statements and Safety Assessment Guidance | Provides current scientific opinions and guidance concerning the safety of cosmetic ingredients and substances. Relevant SCCS opinions should be considered by safety assessors where ingredients within a cosmetic formulation have been specifically assessed by the Committee. |
A Cosmetic Product Safety Report should be treated as a living safety assessment rather than a one-time document. The Responsible Person should ensure that the CPSR and Product Information File remain up to date when new safety information, formulation changes, new test results, changes in intended use or relevant regulatory developments could affect the safety assessment or its conclusions.
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