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Cosmetic Safety Report: Everything you need to know about the CPSR and the role of the cosmetic toxicologist

  • Photo du rédacteur: Charline Radola
    Charline Radola
  • 3 sept.
  • 3 min de lecture

In the development of cosmetic products, consumer safety is a top priority.

The Cosmetic Product Safety Report (CPSR) is the key regulatory tool to ensure this safety and demonstrate the compliance of your products.


Understanding its role, knowing who can write it and how to optimize it is essential for any brand wishing to market products in Europe.



What is the RSPC and why is it mandatory?


The cosmetic safety report is a regulatory document required by European Cosmetic Regulation (EC) No. 1223/2009 .

It provides a comprehensive scientific assessment of the product's safety before it is placed on the market.


Why is the CPSR mandatory?

• It guarantees consumer safety by identifying potential risks (irritation, allergy, toxicity).

• It ensures regulatory compliance with European authorities.

• It constitutes scientific proof in the event of a control or audit.


👉 Without a complete and valid CPSR, a product cannot be legally sold in the European Union.


Cosmetic Regulations




Who can write an CPSR ? The role of the cosmetic toxicologist


The drafting of an CPSR cannot be entrusted to just anyone: it must be carried out by a qualified cosmetic toxicologist .


The central role of the toxicologist


Cosmetic toxicologist

The cosmetic toxicologist is responsible, among other things, for:

  • assess the safety of ingredients and the complete formulation,

  • check the effectiveness of preservatives and protection systems,

  • analyze potential interactions between ingredients,

  • write a reasoned scientific opinion in accordance with the requirements of EC Regulation 1223/2009.


👉 Working with an experienced toxicologist is essential to obtain an CPSR that is recognized and accepted by the authorities.




What elements should be included in a complete CPSR ?


PART A – Cosmetic Product Safety Information

1. Quantitative and qualitative formula of the cosmetic product

  • Identity and concentration of components

  • Regulatory limits

2. Physical/chemical characteristics and stability of the cosmetic product

3. Microbiological quality

  • Microbiological tests

4. Impurities, traces, information regarding the packaging material

5. Normal and reasonably foreseeable use

  • Product type

  • Intended use

  • Target group (adults, children, sensitive areas)

  • Frequency of use

6. Exposure to the cosmetic product

7. Exposure to substances

8. Toxicological profile of substances

  • Available toxicological data

9. Adverse reactions and serious adverse reactions

10. Information on the cosmetic product


PART B – Cosmetic Product Safety Assessment

1. Conclusion of the evaluation

2. Warnings and instructions for use on the label

3. Reasoning

  • Identification of potential risks

  • Calculation of safety margins

  • Analysis of interactions between ingredients

4. References of the person responsible for the assessment and approval of Part B


The toxicologist must conclude that the product is safe for its intended use , thus providing a sound scientific basis for the Product Information File (PIF) .




Steps to ensure a complete and valid CPSR



Cosmetic Safety Report

To write a reliable cosmetic safety report , the methodology must be rigorous:

1. Collect raw material data : Gather all available information on each ingredient.

2. Verification of stability and preservatives : ensure microbiological safety and consistency of the product.

3. Collaboration with a cosmetic toxicologist : expert scientific analysis and writing.

4. Documentation and traceability : keep a complete history of tests and evaluations.

5. Final validation : review and confirm that all regulatory requirements are met.




Common mistakes in an CPSR


Even with good intentions, some reports are rejected because:

  • raw material data is incomplete or missing, ⚠️ be careful when selecting your suppliers

  • the stability of the product or the effectiveness of the preservatives is not documented,

  • There is confusion between CPSR and PIF (CPSR focuses on safety, PIF groups together all regulatory information).


👉 Anticipating these pitfalls is essential to secure your products and avoid sanctions.


Cosmetic product



The CPSR, a strategic tool for your brand


The Cosmetic Safety Report (CPSR) is much more than a legal obligation: it is a strategic tool to guarantee consumer safety, regulatory compliance and the credibility of your products.


Using an experienced cosmetic toxicologist and following a strict methodology allows for the production of a complete, reliable and authority-recognized CPSR.


At Galeniform , we support brands in drafting and optimizing their CPSRs, so that each cosmetic product is ready to safely appeal to the European market.


👉 Contact us to build or audit your files and guarantee the compliance of your products.




 
 
 
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