Factors Considered in Safety Evaluation

Cosmetics and personal care products companies utilize a multi-tiered scientific approach to extensively evaluate the safety of products and their ingredients. Key components of this strict and methodical safety process include:

  • Reviews of Latest, Up-To-Date Safety Research
    As part of the product evaluation process, numerous scientific research sources are examined for the latest, most up-to-date ingredient safety information. These sources include extensive scientific reviews by the Expert Panel for Cosmetic Ingredient Safety, as well as reviews of ingredients by other sources; information and data from cosmetics ingredient suppliers; published data in the scientific literature; and government sources, including the U.S. Food and Drug Administration (FDA), National Toxicology Program, National Cancer Institute, and other government entities and databases.
  • Determinations of Possible Ingredient Toxicology
    Safety evaluations take into consideration a number of key factors, including ingredient function and use concentration; degree of chemical purity and stability; and potential for ingredients to be absorbed through the skin and/or mucous membranes, or via oral ingestion or inhalation. Assessment for potential adverse effects includes: evaluation of exposure to cosmetics ingredients for short, intermediate or long periods of time (acute, subchronic and chronic systemic toxicity); skin irritation and skin allergy; photoirritation and photoallergy (irritation and sensitization caused after exposure to sunlight); and determination of the potential for ingredients to adversely affect the body’s genetic material (genotoxicity), cause cancer (carcinogenicity), or negatively affect reproduction and/or fetal development.
  • Evaluation & Testing of Human Health Impacts
    Following a thorough review of each ingredient in a formulation, additional safety data on the finished product are reviewed. This may include cell culture (in vitro) and clinical (human) tests conducted on the final product and products similar in composition. The potential for ingredient interactions within the product leading to unexpected adverse effects is also evaluated. Confirmatory testing of product compatibility and acceptability on human volunteers (clinical testing) is often undertaken with informed consent and the appropriate safeguards to detect any undesirable effects that could occur.
  • Examination of Cumulative Exposure to the Human Body
    The average consumer uses multiple cosmetics and personal care products each day. Therefore, the assessment of cumulative exposure to product ingredients from multiple sources is an important component in the overall assessment of product safety. It is also important to take into account inadvertent (secondary) exposures such as inhalation (from products such as hair spray), or ingestion (from products such as lipsticks), etc.

    Factors to be considered in determining exposure levels for cosmetics and personal care products and their ingredients include product type; amount used per application; frequency and method of application; site of body contact; duration of product contact; concentration of individual ingredients in the final product; use by sensitive subpopulations such as infants, the elderly and pregnant women; possible conditions of foreseeable misuse; and external factors such as variation in use related to weather, local or temporal habits, trends, and cultural considerations.

  • Testing & Evaluation Performed by Scientists Trained in Product Safety
    To ensure the reliability of testing, cosmetics studies and their results are designed, monitored and evaluated by scientists trained in both toxicology and safety evaluation, and who have a fundamental understanding of cosmetics, personal care and fragrance products and of the tests being used.