Cosmetic Safety Assessor and Cosmetic Product Safety Report

 

 

 

If you’re a first-time cosmetic distributor or manufacturer in Europe, all the EU regulations and requirements you should adhere to seem so confusing and difficult.

 

In particular, EU requires to comply with the requirements below. 

 

• First,  Perform Safety Assessment of the finished cosmetic product before the product can be placed on the European market
• Second, Create a Product Information File (PIF) for a cosmetic product including requirements on labeling and languages
• Third, Notify Cosmetic Product Notification Portal (CPNP) that a cosmetic product will be placed on the EU market

 

In this post, we’ll talk about performing safety assessment and the role of cosmetic safety assessor.

 

 

What is the Cosmetic Product Safety Report?

 

The Cosmetic Product Safety Report (CPSR) is one of the essential elements when building the Product Information File (PIF), and it is a mandatory requirement from the Cosmetics Regulation 1223/2009.

 

Safety Report includes two parts:

• Part A: Safety Information
• Part B:  Safety Assessment

 

Safety Information is Part A of the Safety Report, and it contains all the necessary data for the safety assessments.

 

Safety Assessment is Part B of the Safety Report, and it contains a safety assessor’s conclusion on the safety of the product.

 

 

 

 

Which Information Should Be Included in the Safety Report?

 

Safety Information (Part A) must contain :

 

• Quantitative and qualitative composition of the cosmetic product
• Physical/chemical characteristics and stability of the cosmetic product
• Microbiological quality
• Impurities, traces, information about the packaging material
• Normal and reasonably foreseeable use
• Exposure to the cosmetic product
• Exposure to the substances
• Toxicological profile of the substances
• Undesirable effects and serious undesirable effects
• Information on the cosmetic product

 

Safety Assessment (Part B) must contain :

 

• Assessment conclusions
• Labeled warnings and instructions for use
• The scientific reasoning for the conclusions drawn
• Assessors credentials and approval of Part B

 

Especially, Safety Assessment should be carried out by a qualified safety assessor as they understand what is required in a Cosmetic Product Safety Report (CPSR) under specific headings.

 

 

 

 

Who Can Be A Cosmetic Safety Assessor?

 

The Cosmetic Safety Assessor must hold a relevant degree (e.g. pharmacy, medicine, dermatology, toxicology, or another related discipline) from a European university.

 

If the Safety Assessor does not have a degree or relevant qualification issued by a member State but does have a qualification issued by another reputable body, they may apply to have the qualification officially recognized European countries.

 

 

With a deep understanding and a wide range of experiences in cosmetic compliance issues, Cosmereg can help you to comply with the Safety Assessment process. Our experts are highly qualified to serve you. Ensure the safety and the compliance of your products by entrusting Cosmereg.

 

For more information on Safety Assessment, Email Us today!