The cosmetic ingredient review self-regulatory safety program.
W F Bergfeld1, R L Elder, A L Schroeter
1Department of Dermatology, Cleveland Clinic Foundation, Ohio.
Dermatologic Clinics
|January 1, 1991
Summary
The Cosmetic Ingredient Review (CIR) program has scientifically assessed cosmetic ingredient safety for 13 years, prioritizing frequently used and biologically active chemicals. This review process demonstrates a robust system for addressing potential safety concerns with cosmetic ingredients.
Area of Science:
- Cosmetic Science
- Toxicology
- Regulatory Science
Background:
- The cosmetic industry utilizes a vast array of chemical ingredients.
- Ensuring the safety of these ingredients is paramount for public health.
- A systematic approach to safety assessment is necessary.
Purpose of the Study:
- To evaluate the effectiveness and history of the Cosmetic Ingredient Review (CIR) program.
- To assess the CIR's methodology for prioritizing cosmetic ingredient safety reviews.
- To determine the CIR's capability in addressing cosmetic ingredient safety concerns.
Main Methods:
- The CIR employs a prioritization method based on ingredient usage frequency and biological activity.
- A comprehensive review of 310 cosmetic ingredients has been completed.
- 33 additional ingredients are currently under review.
Main Results:
- The CIR has successfully reviewed cosmetic ingredient safety over a 13-year period.
- The prioritization method effectively identifies key chemicals for review.
- A significant number of cosmetic ingredients have undergone scientific safety assessment.
Conclusions:
- The CIR has established a scientifically sound process for cosmetic ingredient safety evaluation.
- The CIR functions as a vital system for documenting, reviewing, and analyzing ingredient safety.
- The CIR's methodology provides a framework for addressing existing and potential safety issues in cosmetic ingredients.
More Related Videos
Related Concept Videos
Drug Regulation
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
Clinically Relevant Drug Product Specifications: Methods of Establishment
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
FDA Approved Drugs: Changes to Approved Drugs
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...


