A Cosmetic Product Safety Report (CPSR) is the formal scientific safety assessment required under EU Cosmetic Regulation (EC) No 1223/2009 to demonstrate that a cosmetic product is safe for human health under normal or reasonably foreseeable conditions of use.
Before a cosmetic product can be placed on the European Union market, its safety must be evaluated and documented through a structured regulatory process. One of the central elements of this process is the Cosmetic Product Safety Report, commonly referred to as the CPSR. This report forms a core component of the Product Information File (PIF) and provides the scientific justification that the formulation, ingredients, and intended use of the product meet EU safety standards.
For cosmetic manufacturers located both inside and outside the European Union, understanding the CPSR is essential when preparing products for the EU market. The CPSR combines toxicological analysis, ingredient safety evaluation, and exposure calculations to determine whether a cosmetic formulation can be considered safe for consumers.
Cosmetic manufacturers exporting products to the European market must also appoint an EU Responsible Person who ensures that the CPSR and other regulatory documentation are properly prepared before products are placed on the market. You can read more in our guide: Do cosmetic brands outside the EU need an EU Responsible Person?.
The Legal Basis of the CPSR
The requirement for a Cosmetic Product Safety Report is established under Article 10 of EU Cosmetic Regulation (EC) No 1223/2009. According to this regulation, cosmetic products must undergo a safety assessment before they are placed on the market.
This safety assessment must be documented in the form of a CPSR and included in the Product Information File. The CPSR must be prepared by a qualified safety assessor and must demonstrate that the cosmetic product does not pose a risk to human health when used under normal conditions.
The purpose of the CPSR is to ensure that cosmetic products sold in the EU market are scientifically evaluated using toxicological principles and safety assessment methodologies. Rather than relying on government pre-approval, the EU system places responsibility on the manufacturer and the Responsible Person to ensure that safety has been properly assessed before the product enters the market.
The Structure of the Cosmetic Product Safety Report
The CPSR follows a standardized structure defined in Annex I of EU Cosmetic Regulation. The report is divided into two main sections:
Part A – Cosmetic Product Safety Information
Part B – Cosmetic Product Safety Assessment
These two sections together form the complete safety evaluation for the cosmetic product.
Part A – Cosmetic Product Safety Information
Part A contains the scientific data required for the safety assessment. It provides detailed information about the cosmetic product formulation, ingredients, and exposure conditions.
The objective of Part A is to compile all relevant safety information that will allow the safety assessor to evaluate potential risks associated with the product.
- Quantitative and Qualitative Composition
This section lists all ingredients present in the cosmetic formulation together with their concentrations. The composition is usually presented as a complete formulation table including:
ingredient names
INCI nomenclature
concentration percentages
function of each ingredient
This information allows the safety assessor to evaluate whether the formulation contains substances that are restricted or prohibited under EU cosmetic legislation.
- Physicochemical Characteristics and Stability
This section describes the physical and chemical properties of the product and evaluates its stability over time.
pH values
viscosity
appearance and color
stability testing results
Stability testing ensures that the product maintains its safety and quality throughout its shelf life.
- Microbiological Quality
Cosmetic products must meet microbiological safety standards. This section provides microbiological testing results to confirm that the product does not contain harmful microorganisms.
Preservation efficacy tests, often referred to as challenge tests, may also be included to demonstrate that preservatives effectively prevent microbial growth.
- Impurities and Packaging Material
This section identifies potential impurities present in raw materials and evaluates whether packaging materials could interact with the cosmetic product.
For example, heavy metal traces in pigments or contaminants in raw materials may need to be assessed to ensure that they remain within safe limits.
- Normal and Reasonably Foreseeable Use
The safety assessment must consider how the cosmetic product is intended to be used by consumers.
application area of the body
frequency of use
amount applied per use
target population (adults, children, etc.)
These parameters are essential for calculating consumer exposure to ingredients.
- Exposure to the Cosmetic Product
Exposure calculations estimate how much of the product is applied and how frequently it is used. These values are often based on standardized exposure data used in cosmetic risk assessment.
The exposure assessment forms the basis for evaluating ingredient safety.
- Toxicological Profiles of Ingredients
This section summarizes toxicological data for each ingredient in the formulation.
acute toxicity
skin irritation
eye irritation
sensitization potential
systemic toxicity
genotoxicity or carcinogenicity
These data are typically derived from toxicological databases, scientific literature, or regulatory assessments.
Part B – Cosmetic Product Safety Assessment
Part B contains the formal scientific evaluation prepared by the safety assessor.
This section interprets the data collected in Part A and determines whether the cosmetic product can be considered safe under its intended conditions of use.
Safety Conclusion
The safety assessor must provide a clear conclusion stating whether the product is considered safe for human use.
If necessary, specific warnings or restrictions may be recommended for the product label.
Labeling Considerations
The safety assessor may identify precautions that should appear on the product label, such as warnings for sensitive skin or instructions for safe use.
Reasoning and Scientific Justification
The safety assessor must explain the scientific reasoning behind the safety conclusion. This includes referencing toxicological data, exposure calculations, and ingredient safety limits.
The Role of the Safety Assessor
The Cosmetic Product Safety Report must be prepared by a qualified safety assessor with appropriate expertise.
EU cosmetic regulation requires that the safety assessor hold a university degree in a relevant scientific discipline such as:
toxicology
pharmacy
medicine
a related life science discipline
The safety assessor is responsible for evaluating the safety of the cosmetic formulation based on scientific evidence and regulatory requirements.
The name and signature of the safety assessor must appear in the CPSR.
Toxicological Assessment of Cosmetic Ingredients
A key element of the CPSR is the toxicological assessment of each ingredient in the cosmetic formulation.
The safety assessor evaluates toxicological data to determine whether an ingredient can be safely used at the concentration present in the formulation.
Particular attention is given to ingredients that may pose potential risks such as allergens, irritants, or substances with systemic toxicity.
The toxicological assessment often involves comparing exposure levels with toxicological thresholds derived from scientific studies.
Ingredient Safety Evaluation
The safety evaluation must also consider regulatory restrictions on cosmetic ingredients.
EU cosmetic regulation contains several annexes listing ingredients that are either prohibited or restricted.
Annex II – prohibited substances
Annex III – restricted substances
Annex IV – permitted colorants
Annex V – preservatives
Annex VI – UV filters
The safety assessor must verify that the formulation complies with these restrictions.
Exposure Calculations in Cosmetic Safety Assessment
Exposure calculations play an important role in determining whether cosmetic ingredients are safe at their intended concentrations.
Exposure assessments estimate the amount of an ingredient that may be absorbed by the human body during normal product use.
amount of product applied per use
frequency of application
concentration of the ingredient in the formulation
skin absorption rate
This exposure is then compared with toxicological thresholds such as the No Observed Adverse Effect Level (NOAEL) to determine whether the margin of safety is acceptable.
The CPSR as Part of the Product Information File
The Cosmetic Product Safety Report is not a standalone document but part of the Product Information File.
The Responsible Person must maintain the Product Information File at their EU address and ensure that it is available to authorities upon request.
Authorities may review the CPSR during regulatory inspections or market surveillance activities.
The Product Information File must be retained for at least ten years after the last batch of the product has been placed on the market.
Ensuring EU Cosmetic Compliance
The Cosmetic Product Safety Report is one of the most important regulatory documents required for cosmetic products sold in the European Union. It provides the scientific evidence that a cosmetic formulation is safe for consumers and compliant with EU cosmetic legislation.
By combining ingredient toxicology, exposure assessment, and scientific evaluation, the CPSR ensures that cosmetic products entering the EU market meet the safety standards required under EU Cosmetic Regulation (EC) No 1223/2009.
If your company is preparing cosmetic products for export to the European Union, ensuring that a CPSR and other regulatory documentation are properly prepared is a critical step in achieving EU compliance.
Request a consultation to discuss EU cosmetic compliance and market entry requirements.
Structure of the CPSR: Part A and Part B
The CPSR is generally understood in two main parts. Part A contains the cosmetic product safety information, while Part B contains the actual safety assessment conclusion. Part A gathers the underlying data needed for evaluation, such as the qualitative and quantitative composition, physico-chemical characteristics, microbiological quality, impurities, traces, packaging material considerations, normal and reasonably foreseeable use, exposure to the product, exposure to individual substances, toxicological profiles, undesirable effects, and other relevant product information.
Part B then turns that data into a formal regulatory opinion. The assessor considers the relevant information, provides reasoning, defines any warnings or conditions of use that should apply, and reaches a conclusion on whether the product is safe under the intended conditions of use.
What manufacturers need to provide
Non-EU manufacturers often underestimate how much input is needed for a robust CPSR. In practice, assessors typically need more than just a formula spreadsheet. They often need raw material specifications, impurity information, fragrance allergen details, microbiological support, stability data, packaging information, and proposed label text. If the product makes specific claims, the assessor may also need to understand how the product is intended to be positioned in the market.
Where the data is incomplete, the assessor may still provide preliminary comments, but a final CPSR often cannot be completed confidently until the information gaps are resolved.
How the CPSR fits into the broader compliance file
The CPSR is one required component of the Product Information File (PIF), and it should remain aligned with the final marketed product, its label, and the CPNP notification. That means the safety report should not be treated as a standalone PDF produced once and then forgotten. If the formula changes, if the pack changes in a way that affects safety, or if the legal status of an ingredient changes, the CPSR may need review or revision.
This ongoing relevance is one reason the CPSR should be built into a broader documentation process rather than commissioned at the last possible moment before launch.
Common reasons a CPSR is delayed or rejected
the formula provided does not match the final marketed product;
raw material documents are incomplete or inconsistent;
microbiological or stability information is missing where needed;
impurities or restricted substances have not been properly addressed;
the label does not reflect the conditions of safe use; and
there is inadequate support for a special use case or sensitive target population.
Manufacturers that organize their input material early usually move through the CPSR process more efficiently and with fewer late-stage corrections.
