The European Union applies strict rules to cosmetic products. Every cosmetic product must undergo a scientific safety assessment before entering the EU market. This requirement applies to all products, from simple lip balms to advanced skincare formulations. The Cosmetic Product Safety Report, known as the CPSR, documents this assessment.
The CPSR forms a mandatory part of the Product Information File (PIF). It demonstrates compliance with EU Cosmetic Regulation (EC) No 1223/2009. Without a valid CPSR, authorities do not allow a cosmetic product to be placed on the EU market.
Why Is the CPSR Required Under EU Law?
The CPSR proves that a cosmetic product is safe for human health. It evaluates safety under normal and reasonably foreseeable conditions of use.
A qualified cosmetic safety assessor must prepare and sign the report. The assessor applies expertise in toxicology, pharmacy, medicine, or a related field. This requirement ensures that safety conclusions rely on sound scientific principles and remain defensible during inspections.
Regulatory authorities use the CPSR to verify compliance. Market surveillance bodies also rely on it when assessing product safety.
Structure of the Cosmetic Product Safety Report
The CPSR consists of two connected parts. Each part plays a distinct role in the safety evaluation process.
Together, these sections form a complete and legally valid safety assessment.
Part A: Cosmetic Product Safety Information
Part A contains the technical and scientific data needed for the safety evaluation. The cosmetic brand owner or the Responsible Person collects this information.
This section describes the full qualitative and quantitative composition of the product. It lists all ingredients with their exact concentrations. It also includes physical and chemical characteristics of the formulation.
Stability data demonstrate that the product remains safe throughout its shelf life. Packaging compatibility information confirms that the container does not affect product quality or safety.
Microbiological quality data show that the product resists microbial growth. Challenge test results usually support this evaluation. Information on impurities and trace substances addresses unavoidable contaminants and their safety impact.
Part A also includes toxicological profiles for all ingredients. An exposure assessment evaluates how consumers use the product, including application area, frequency, and target population.
Part B: Cosmetic Product Safety Assessment
Part B provides the expert safety conclusion. In this section, the safety assessor evaluates all data from Part A and performs the final risk assessment.
The assessor issues a clear conclusion on product safety. This conclusion confirms whether the product meets EU safety requirements for its intended use. The assessor verifies that all margins of safety remain within acceptable limits.
Part B also identifies required warnings and instructions for use. These statements must appear on the product label. The assessor documents the scientific reasoning behind each conclusion to ensure transparency.
Finally, this section includes the assessor’s qualifications. These credentials confirm legal eligibility to sign the CPSR.
Key Difference Between Part A and Part B
Part A explains what the product contains and identifies potential risks. Part B delivers the final regulatory decision on safety.
Together, both parts create a legally binding safety document under EU cosmetic legislation.
Why a Professionally Prepared CPSR Matters
A professionally prepared CPSR supports smooth market entry. It also reduces the risk of non-compliance during inspections.
Incomplete or incorrect CPSRs often lead to regulatory findings. Authorities may request corrections, suspend sales, or remove products from the market. A compliant CPSR helps prevent these outcomes.
If you need a Cosmetic Product Safety Report prepared in accordance with EU Regulation (EC) No 1223/2009, Lexora provides professional CPSR preparation by qualified safety assessors. Order your Cosmetic Product Safety Report (CPSR) through our shop page and ensure your cosmetic products are fully compliant with EU cosmetic legislation.
