Cosmetic chemist testing product for cosmetic product safety report (CPSR) and product information file.
Author

Jaclyn Bellomo

Senior Director of Cosmetic Science and Regulatory Affairs

Why CPSRs are Critical for Cosmetics Compliance

Jun 5, 2024

When marketing a cosmetic in certain regions, there is considerable documentation required to ensure that its use is safe, effective, and in accordance with regulations. A Cosmetic Product Safety Report (CPSR) is often one of those required items.

CPSRs are housed in Product Information Files (PIFs), which are required for cosmetic distribution in the EU, UK, and in the Association of Southeast Asian Nations (ASEAN) region.

A CPSR is a document that provides information about the safety and regulatory compliance of a cosmetic product. The CPSR’s purpose is to supply evidence that a cosmetic product and its ingredients are considered safe through documentation and a safety assessment.

CPSRs are not just a requirement for companies to market their products. They provide cosmetic brands confidence that the product in consumer’s hands has undergone a safety evaluation. The CPSR protects companies when any issues arise from the use of the cosmetic product in the field.

Companies should become familiar with the building blocks of a compliant CPSR and use this information to substantiate the products safety.

PIF Overview  

A CPSR is one of several elements required in a Cosmetic Product Information File (PIF). A PIF is a collection of documents that contains critical safety information about a cosmetic product, as required in the Official Journal of the European Union.

PIFs are mandatory for all cosmetic products sold in the EU, UK, and ASEAN countries, and must be updated regularly to reflect any changes made to the product’s formulation or packaging.

EU regulations state that PIFs should be accessible at a single address within the EU or United Kingdom (UK), regardless of how many regions sell the product.

PIFs must be kept for ten years following the final date the product was on the market.

 

What Information Should a CPSR Include?

The CPSR should contain detailed information about the cosmetic product, including its composition, manufacturing process, packaging, and storage. It should also provide an analysis of the potential risks associated with using the product, and how those risks will be addressed.  

The CPSR must be prepared by a qualified safety assessor, who will assess the hazards and risks associated with a cosmetic product. The assessor is responsible for providing recommendations on the safe use of the product, and any additional safety measures that may be required. 

A CPSR is comprised of two parts: 

  • Part A: Cosmetic Product Safety Information – a collection of documents and data that demonstrate a cosmetic’s safety.  
  • Part B: Cosmetic Product Safety Assessment – An evaluation of the cosmetic product’s safety, using data provided in Part A, including: 
    • A Safety Assessor’s references 
    • Information about the assessor’s education and credentials.
    • Specifications regarding warnings or instructions that should be included on the product’s label 

Who Is Responsible For the CPSR?

The designated responsible person (RP) is required to ensure a safety assessment has been completed for the cosmetic, and that the product is safe to be used according to the intended purpose. The RP is fully responsible for maintenance of the PIF, including the CPSR.

The RP must also ensure the PIF is readily accessible and that the data included in the PIF is regularly updated.

The Importance of CPSRs  for Cosmetic Safety

CPSRs are crucial for ensuring the safety of cosmetic products. These reports help to identify potential hazards associated with the use of a product and provide recommendations on how to mitigate those risks.  

Additionally, CPSRs help manufacturers ensure their products comply with all relevant regulations. This is important, as non-compliance can result in legal penalties, damage to brand reputation, and even product recalls. 

How to Manage Your CPSRs 

Managing multiple PIFs and CPSRs can be time consuming. But cosmetics companies can easily simplify CPSRs by employing software equipped with tools that assist with this function.

Seated within the Product Manager application, Cosmetri’s CPSR feature generates a complete PIF using cosmetics formulations already in the software.

This feature also streamlines essential steps in the CPSR workflow by enabling Safety Assessors to log in to the system, complete the CPSR section, and sign off when their assessment.

CPSRs are a vital component to overall cosmetics safety that should not be overlooked. Companies and consumers alike reap the benefits when cosmetics are manufactured with safety at the forefront of operations.

Simplify CPSRs for Your Cosmetics  

Discover Cosmetri’s powerful solutions for streamlining cosmetic documentation.

Get a Demo 

Author


Jaclyn Bellomo

Senior Director of Cosmetic Science and Regulatory Affairs

A seasoned expert on the cosmetic industry, Jaclyn's deep understanding and insights on cosmetic regulations brought on with the passage of the Modernization of Cosmetics Regulation Act (MoCRA) are unmatched. Her experience and reputation throughout the global cosmetic industry helps companies worldwide meet the newly enacted FDA regulations under MoCRA.

Related Article


Subscribe To Our News Feed

To top
This site is registered on wpml.org as a development site. Switch to a production site key to remove this banner.