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.
What goes into Part A
Annex I of the Regulation divides the safety report into two parts with different purposes. Part A is the evidence file: it gathers everything needed to judge the product, without drawing conclusions. Assembling it is largely a data-collection exercise, and it is where most of the elapsed time in a CPSR project is spent.
Part A must cover the quantitative and qualitative composition, the physical and chemical characteristics and stability of both the raw materials and the finished product, and its microbiological quality — including the preservative efficacy result where one applies. It also covers impurities, traces and information about the packaging material, notably whether anything can migrate from the container into the product.
Beyond the formulation itself, Part A addresses normal and reasonably foreseeable use, the resulting exposure to the product and to each substance in it, the toxicological profile of every ingredient, and any undesirable effects already reported for the product or comparable ones. Exposure is where product type does most of the work: a leave-on face cream, a rinse-off wash and a lip product generate very different exposures from the same formula.
What the assessor does in Part B
Part B is the judgement. Here the qualified safety assessor evaluates the Part A evidence and reaches a reasoned conclusion on whether the product is safe for human health under normal and reasonably foreseeable conditions of use.
The core of that reasoning is a margin of safety calculation for substances of toxicological concern, comparing the systemic exposure the product produces against the level at which no adverse effect is observed. The assessor also records any warnings and instructions for use that must appear on the label, provides the reasoning behind the conclusion, and signs the report with their credentials and the date.
Two points follow from this that brands regularly miss. First, the label warnings are an output of Part B, not something marketing decides — artwork cannot be finalised before the assessment is complete. Second, the conclusion is specific to the formulation, packaging and intended use presented; it does not automatically extend to a variant or a new pack format.
When the CPSR must be updated
The safety report is a living document. It has to reflect the product as it is currently placed on the market, which means several events trigger a review:
- Any change to the formulation, including a fragrance change or a raw material substitution
- A change of packaging or supplier, which can affect stability, migration and the justified Period After Opening
- An amendment to the Annexes that restricts or prohibits an ingredient used in the product
- New toxicological data or an SCCS opinion on a substance in the formula
- Undesirable effects reported by consumers, which must be evaluated and recorded
- A change in intended use or target group, such as extending a product to children
A CPSR that no longer matches the product on shelf is a compliance gap in itself, independent of whether the product is actually safe. Because the report sits inside the Product Information File, which must remain accessible for ten years after the last batch, keeping it current is an ongoing duty of the Responsible Person rather than a one-off task at launch.
Frequently asked questions
Is a CPSR the same as a certificate?
No. It is a technical safety report held in your own Product Information File, not a certificate issued by an authority. No body approves or certifies a cosmetic product in the EU, and there is no registration number to display.
Who is qualified to sign the CPSR?
Only an assessor holding a university-level qualification in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State. Practical industry experience alone does not satisfy the requirement, and a report signed by an unqualified person does not meet the law.
Does every shade in a range need its own CPSR?
Not usually. Shades built on a common base often sit under one assessment covering the colorant variations, provided the assessor is satisfied the differences do not change the safety profile. Genuinely different formulations need separate assessments.
How long does a CPSR remain valid?
There is no expiry date. It stays valid while the product, its packaging, its intended use and the applicable legislation remain unchanged — and must be revisited whenever any of those change.
