Customers of cosmetics and personal care products are blanketed using sturdy federal safety guidelines via the U.S. meals and Drug management (FDA). But, the FDA does no longer have the authority to approve beauty products or components, except coloration components. As a result, only a few ingredients are prohibited by the FDA (see below). To ensure the safety of cosmetic ingredients, the cosmetic industry, combined with the government, has undertaken a program to establish lists of safe elements for usage in cosmetics.
Resources for Safety InformationThere are regulations to identify cosmetic ingredients as either safe, unsafe, or undecided when further information is required to establish safety. Unfortunately, many websites publish lists of "unsafe cosmetic ingredients" based on hearsay evidence or pseudoscience, thereby discrediting many good and completely safe ingredients. Authentic scientific proof about the safety of both natural and chemical cosmetic components can be found at the following resources:
- Cosmetic Ingredient Review (CIR): An organization based in the USA, having toxicologists, dermatologists, and experts from the Consumer Federation of America, FDA & CTFA.
- EEC Cosmetic Directives: European directives framed by the European Union consist of principles, rules, and lists of safe and unsafe ingredients.
- FDA Monographs: The USA treats sunscreens, antiperspirants, and skin protectants as OTC (over-the-counter) drugs. Their usage and safety are assessed by experts.
- IFRA (International Fragrance Association): It is an association of fragrance manufacturers. The Technical Advisory Committee issues advisories about the safety of various scents.
- Journal of the American College of Toxicology: It is a scientific journal publishing reports and studies about the safety of cosmetics and other substances.
Regulation for Safety AssessmentThe first step in the safety assessment of an ingredient is determining toxic potential. It consists of a series of toxicity studies specific to distinct toxicological endpoints. The following tests are needed to develop a detailed toxicity evaluation. They indicate the current methodologies used for the safety evaluation of cosmetic ingredients as suggested by the EEC Cosmetic Directives:
- Acute toxicity
- Percutaneous absorption
- Skin irritancy
- Eye irritancy
- Skin sensitization and photosensitization
- Subchronic toxicity
- Mutagenicity & genotoxicity
- Phototoxicity & photoirritation
- Photomutagenicity photo-genotoxicity
- Metabolism studies
Long-term toxicity studies
Thus, the degree and route of consumer exposure must be ascertained before any safety evaluation of the product is made. The assessment must take into account the subjective nature of products. In calculating the exposure, the following factors may provide guidance:
- Class of cosmetics in which the ingredient is allowed to be used
- Method of application: rubbed-on, sprayed, rinse-off, etc.
- The concentration of ingredients in the product
- Quantity of product used at each application
- Frequency of application
- The total area of contact with the skin
- Place of contact (e.g., nose, arms, etc.)
- How long will the product be in contact (e.g., leave-on serums)
- Possible misuse which may amplify exposure
- Consumers (e.g., mature skin)
- The quantity that might enter the body
Application on body parts exposed to the Sun.
Prohibited or Highly Restricted Ingredients: FDA regulations specifically ban or control the use of the following components in cosmetics:
- Hexachlorophene (preservative),
- mercury compounds (preservative),
- chlorofluorocarbon (propellant),
- zirconium-containing complexes,
- methylene chloride.
- halogenated salicylanilides (di-, tri-, metabromsalan, and tetrachloro-salicylanilide),
- vinyl chloride, and
For example, the CIR Expert Panels named the following ingredients unsafe:
- Chloroacetamide (preservative),
- Acetyl ethyl-tetramethyl-tetralin (AETT), musk ambrette, 6-Methylcoumarin (6-MC).
- 4-methoxy-m-phenylenediamine HCl,
- p-hydroxyanisole (antioxidant),
- and 4-methoxy-m-phenylenediamine sulfate (hair dye ingredients), pyrocatechol (used in hair dyes and skincare preparations),
- ethoxyethanol and ethoxyethanol acetate (solvent),
- H.C. Blue No. 1 (hair coloring ingredient),