Safety Assessment

Safety Assessment

Safety Assessment (Cosmetic Product Safety Report) is one of key documentation a company has to submit in order to comply with the cosmetic regulations in the European market. It is an integral part of the Product Information File (PIF) that a cosmetic company has to have on every product that it is planning to launch in the market. Safety Assessment is compulsory for guaranteeing the safety and efficacy of a cosmetic product that is placed in the market.

Key aspects of Safety Assessment

The Safety Assessment is a comprehensive report that includes multiple modules and two distinct parts. The information must be provided for all the points given in the Annex 1 and Annex 2 of the product safety report defined by the regulations.

Annex 1 has contains all the data regarding the safety assessment of a product. This module has ten sections. It includes:

  • Qualitative and quantitative composition of the cosmetic product
  • Stability and characteristics of the cosmetic product
  • Microbiological specifications
  • Information about the packaging material
  • Foreseeable use of the product
  • Exposure to the cosmetic product and its secondary exposure routes
  • Exposure to the substances
  • Toxicological profile of the ingredients  
  • Undesirable effects and serious undesirable effects
  • Information cosmetic product

Annex 2 is about cosmetic product safety assessment. The safety assessor creates the notes on the safety and efficacy of the product. It has 4 sections. The sections include:

  • Conclusion of the safety assessment
  • Instructions and warnings about the usage and labelling of the product
  • Scientific reasoning
  • Assessor’s credentials and approval of part B

How we can help

For every product that is to be launched in the market, you need a safety assessor who can provide the information that is easily available and understood and follows the compliance modules as defined by the regulatory authority.

That is where we come in. We help you with:

  • Assessment of the cosmetic product
  • Creating the safety report
  • Safety Assessment is created case by case basis.
  • We use a step-by step method so that the report is comprehensive and complete.

To know more about our CPSR services

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