Factors Considered in Safety Evaluation

Factors Considered in Safety Evaluation

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

  • Reviews of Latest, Up-To-Date Safety Research.
    As part of the scientific cosmetic 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 Cosmetic Ingredient Review , an expert panel of independent scientists, as well as reviews of cosmetic ingredients by other sources; information and data from cosmetic ingredient suppliers; published data in the scientific literature; and government sources, including the U.S. Food and Drug Administration, the National Toxicology Program, the National Cancer Institute, and other government databases.
  • Determinations of Possible Ingredient Toxicology.
    Safety evaluations take into consideration a number of key factors, including cosmetic ingredient function and use concentration; degree of chemical purity and stability; and potential for cosmetic 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 cosmetic ingredients for short, intermediate or long periods of time (acute, subchronic, and chronic systemic toxicity); skin irritation; skin allergy; photoirritation (irritation caused after exposure to sunlight); photoallergy (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 effect reproduction and fetal development.
  • Evaluation & Testing of Human Health Impacts.
    Following a thorough review of each ingredient in a cosmetic formulation, additional safety data on the finished product are reviewed. These may include cell culture (in vitro) and clinical (human) tests conducted on the final product and on products similar in composition to the product being evaluated. The potential for ingredient interactions within the product leading to unexpected adverse effects also is evaluated. Confirmatory testing of cosmetic product compatibility and acceptability on human volunteers (clinical testing) is often undertaken with informed consent and with the appropriate safeguards to detect any undesirable effects that could occur.
  • Examination of Cumulative Exposure to the Human Body.
    The average consumer uses multiple cosmetic and personal care products each day. Therefore, 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 with hair spray use or ingestion from lipsticks, etc.
    Factors to be considered in determining exposure levels for personal care products and ingredients include product type; amount used per application; frequency 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; method of application; external factors such as sunlight exposure and variation in use related to weather, local or temporal habits, trends and cultural considerations; and possible conditions of foreseeable misuse.
  • Testing & Evaluation Performed by Scientists Trained in Product Safety.
    To ensure the reliability of testing, cosmetic product safety studies are designed and monitored, and the results are interpreted and evaluated by scientists who are specially trained and experienced in toxicology and safety evaluation. These scientists have a fundamental understanding of cosmetic, personal care and fragrance products and of the tests being used.