If you want to sell a cosmetic product in the EU, you will hear the same three letters again and again: CPSR. It is one of the most important documents you will ever need for a product, and also one of the most misunderstood. This article explains what a Cosmetic Product Safety Report is, what it contains, who prepares it and what you need to provide to get one.
Contents
- What is a CPSR?
- Who needs a CPSR and who is responsible?
- What is inside: Part A and Part B
- Who can sign a CPSR?
- What data does the assessor need?
- CPSR vs PIF: what is the difference?
- How long does it take?
- When does a CPSR need to be updated?
- A worked example: what an assessor checks in a face cream
- What happens during an inspection
- Common reasons a CPSR is questioned
- Do other markets accept it?
- Why a CPSR matters beyond the law
- Frequently asked questions
- Key takeaways
What is a CPSR?
A CPSR, short for Cosmetic Product Safety Report, is the written safety assessment of a finished cosmetic product. It shows that the product is safe for human health under normal and reasonably foreseeable conditions of use. The obligation comes from Article 10 and Annex I of Regulation (EC) No 1223/2009, and the European Commission has published detailed guidelines on how the report must be built.
Without a valid CPSR, a product cannot be legally placed on the EU market, and the same is true for the UK, Switzerland and several other markets that follow similar rules.
Who needs a CPSR and who is responsible?
Every cosmetic product placed on the EU market needs one, whether it is a global brand or a small handmade range. The legal responsibility sits with the Responsible Person, who must make sure the safety assessment exists, is correct and is kept in the Product Information File (PIF). The assessment itself, however, has to be carried out by a suitably qualified person.
Read also CPSR Annex I Checklist: Every Element a Safety Report Must Contain
What is inside: Part A and Part B
The CPSR has two parts, and both are mandatory.
Part A: cosmetic product safety information
Part A collects the facts about your product. According to Annex I it covers:
- the quantitative and qualitative composition of the product
- physical and chemical characteristics and stability
- microbiological quality
- impurities, traces and information about the packaging material
- normal and reasonably foreseeable use
- exposure to the product and to each substance
- the toxicological profile of the substances
- undesirable effects and serious undesirable effects
- other relevant information about the product
Part B: cosmetic product safety assessment
Part B is the assessor’s professional judgement. It includes:
- the assessment conclusion, stating whether the product is safe
- labelled warnings and instructions of use
- the reasoning behind the conclusion
- the assessor’s credentials and the approval of Part B, with date and signature
Who can sign a CPSR?
Part B must be prepared by a person holding a diploma in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State. This is why you cannot simply complete the document yourself, and why the quality and name of the assessor matter. At Cosmetic Testing Lab, every CPSR is signed by a qualified safety assessor.
What data does the assessor need?
The more complete your information, the faster and cheaper the assessment. Prepare these before you order:
- the full ingredient list with exact percentages
- supplier documents for raw materials where available
- packaging type and material
- intended use, application area, frequency and the target user
- the name and address of the manufacturer
The assessor also relies on test results. Stability, microbiological and, for water-containing products, challenge test data feed straight into Part A. A patch test is useful when you want to claim that a product is gentle or suitable for sensitive skin.
Read also CPSR Example: What a Finished Cosmetic Safety Report Looks Like
CPSR vs PIF: what is the difference?
The CPSR is one part of the larger Product Information File. The PIF also holds the product description, a statement on good manufacturing practice, proof of claimed effects and data on animal testing. Think of the PIF as the folder and the CPSR as the most important document inside it. You must keep the PIF available for ten years after the last batch was placed on the market.
How long does it take?
The writing of the report itself is quick when the information is complete. At CTL a signed CPSR is delivered in about 10 business days. The real delay is usually missing test data, since the stability and challenge tests need weeks of laboratory time. Order the tests early and the report can follow almost straight away.
When does a CPSR need to be updated?
The safety assessment has to be kept up to date. You should review it when you:
- change an ingredient or its percentage
- switch to different packaging
- change the intended use or the target group
- receive new safety information, for example a new restriction on an ingredient, or undesirable effects reports
Read also CPSR FAQ: 20 Questions Brands Ask Before Ordering a Report
A worked example: what an assessor checks in a face cream
To see how the sections connect, imagine a water-based face cream with 18 ingredients. The assessor begins with the exact formula and the function of each ingredient. For each one, they look at its regulatory status (is it banned, restricted, or limited to a maximum concentration?), its toxicological profile and its typical purity. They then calculate how much of each substance a consumer is exposed to, based on how much product is applied, how often, and on what area of the body. The result is compared with a safe level to produce a margin of safety for the substances that need one.
The stability and microbiological data show that the product stays the same over its shelf life and is free of harmful microbes. The packaging information confirms that nothing relevant migrates into the cream. Only then does the assessor write the conclusion, add any warnings that must appear on the label and sign Part B.
What happens during an inspection
National market surveillance authorities can ask the Responsible Person for the PIF at any time. They typically check that the CPSR exists, covers the exact product on the shelf and is signed by a qualified assessor, and that the formula in the report matches the formula you actually sell. A report written for a different formula, or one that is missing Part A data, is treated as non-compliant.
Common reasons a CPSR is questioned
- The formula changed after the report was written and nobody updated it.
- Missing test data, such as no stability or microbiological results in Part A.
- Unqualified or unnamed assessor, so that Part B cannot be traced to a competent person.
- Copied content that does not reflect the real use of the product.
- Inconsistent label. Warnings or instructions in the report do not appear on the pack.
Do other markets accept it?
A CPSR prepared to the EU standard is the foundation for several other markets, including the UK, Switzerland and others that use a similar system. Some markets require local adaptations, so tell your provider where you intend to sell.
Why a CPSR matters beyond the law
The report is a legal requirement, but it also has a commercial value. Retailers, distributors and marketplaces ask for it before they list a product. It supports the claims you make on your packaging, shortens due diligence when you look for investors or partners and gives you a clear record to fall back on if a customer reports a reaction. A brand that can show a complete safety file within minutes looks professional and builds trust quickly.
Frequently asked questions
Is a CPSR the same as a certificate?
No. There is no EU “certificate” for cosmetics. The CPSR is a safety assessment that supports your own declaration of conformity and is checked by authorities, not issued by them.
Do I need a CPSR for a product made in small batches?
Yes. The requirement does not depend on the size of the business or the batch.
Does the CPSR need to be uploaded to the CPNP?
No. The CPNP notification does not include the CPSR, but the report must be available in the PIF whenever an authority asks for it.
Key takeaways
- A CPSR is the mandatory safety assessment of a finished cosmetic product.
- It has two parts: Part A with the safety data and Part B with the assessor’s conclusion.
- It must be signed by a qualified safety assessor and kept in your PIF.
- Complete formula data and test results make it faster.