Safety Assessment Report

The Modernization of Cosmetic Regulations Act of 2022 requires that all companies manufacturing and marketing cosmetic products in the US must maintain records substantiating that their cosmetic products are safe for human use. The Safety Assessment Report is a component of safety substantiation.

The Safety Assessment is a MoCRA-compliant evaluation of individual product ingredients including toxicological, physico-chemical data, purity and purity & impurities analysis using a sophisticated database of toxicological profile and CIR-recommended safe usage rates cosmetic ingredients. To determine the risk factors, consumer use factors are taken into account including likely exposure to consumers taking into account who are the likely consumers, the topical application of the product on specific areas of the body and the amount of time the product remains on the body. We also provided EU-compliant Safety Assessments.

The Safety Assessment Report includes:

  • Qualitative and Quantitative composition of the product
  • Microbial quality
  • Toxicological profile
  • Physiochemical characteristics and product stability
  • Exposure to the product
  • Normal use of the product
  • Adverse events and serious adverse events
  • Impurities and trace contaminants in packaging

Or choose our comprehensive Safety Substantiation Package that includes Safety Assessment Report, Preservative Challenge Testing and Patch Testing