A look inside the Cosmetic Product Safety Report

As we had the opportunity to explore on the last post, the Cosmetic Product Safety Report (CPSR) is one of the main elements of the Product Information File (PIF) and we can quickly understand why, as it may be considered the fundamental principle of the Cosmetic Regulation:

“In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I.”

_{Article 10 (1) of Regulation (EC) No 1223/2009}

However, performing the safety assessment and preparing the CPSR is not as quickly as understanding its value. So, let’s take a look at it.

The CPSR is a comprehensive report resulting from a detailed technical and scientific review on the safety of a cosmetic product.

As we have just seen, this report is mandatory by the Regulation and it comprises two parts:

• Part A - Cosmetic Product Safety Information: gathers all the necessary and relevant data to carry out the safety assessment, including the product formulation, the exposure assessment and the risk characterization.

• Part B - Cosmetic Product Safety Assessment: the final statement on the safety of the cosmetic product under its normal and reasonably foreseeable use, based on all the information provided in part A.

The minimum requirements for a CPSR are set out in Annex I of the Regulation and are also represented below:

It is also a requirement that the cosmetic product safety assessment shall be carried out by “a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State”, also known as the Safety Assessor.

The safety assessment is a detailed and complex screening process, mostly based on collecting and analysing technical and scientific data and a large amount of documentation on the cosmetic product and its individual constituents. The resulting CPSR can only be as accurate and robust as the data and documentation that is provided to the safety assessor.

So, to have all the information and documentation available and efficiently organized is a great start to get a high-quality CPSR. To have a tool that can do it for you is even better!

Cosmedesk is specially designed to help safety assessors save time with the safety assessment of cosmetic products, gathering all the required information in one place and easily accessible, automatically calculating the exposure to the cosmetic ingredients as well as the margins of safety, as part of the risk characterization, and finally generating the CPSR.

Try it for yourself, ensure the quality of your regulatory documents with Cosmedesk!