Consumers of cosmetics and personal care products are protected by strong federal safety regulations by the U.S Food and Drug Administration (FDA). However, the FDA does not have the authority to approve cosmetic products or ingredients, except color additives. There are only a few ingredients which are prohibited by the FDA (see below). To ensure safety of cosmetic ingredients the cosmetic industry in combination with government has therefore undertaken a program to establish lists of ingredients which are safe to use in cosmetics.
Resources for Safety Information
The established regulations identify cosmetic ingredients as either safe, unsafe, or also undecided when further information is required to establish safety. Unfortunately, there are many websites publishing lists of "unsafe cosmetic ingredients" based on hearsay evidence or pseudoscience, thereby discrediting many good and completely safe ingredients. True and validated scientific evidence about the safety of both natural and chemical cosmetic ingredients can be found at the following resources:
- Cosmetic Ingredient Review (CIR): USA-based organization consisting of toxicologists, dermatologists, and representatives from the Consumer Federation of America, CTFA, and FDA.
- EEC Cosmetic Directives: European directives formulated by the European Union consisting of a series of principles, rules, and lists of safe and unsafe ingredients.
- FDA Monographs: In the USA sunscreens, antiperspirants and skin protectants are treated as OTC (over the counter) drugs. Their use and safety are reviewed by expert scientists.
- IFRA (International Fragrance Association): Association of manufacturers of fragrances. The Technical Advisory Committee issues recommendations about the safety of various fragrances.
- Journal of the American College of Toxicology: Scientific journal publishing reports and studies about the safety of cosmetic and other environmental substances.
Criteria for Safety Assessment
Determination of toxic potential is the first step in the hazard assessment of an ingredient and consists of a series of toxicity studies, specific to distinct toxicological end points. The following tests are needed to develop specific toxicity evaluation and 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 sensitisation and photosensitisation
- Subchronic toxicity
- Mutagenicity & genotoxicity
- Phototoxicity & photoirritation
- Photomutagenicity photogenotoxicity
- Metabolism studies
- Long-term toxicity studies
Thus, before any safety evaluation and risk assessment of a finished product is made, the degree and route of consumer exposure must be ascertained. This has to be done on a case-by-case basis but the following may provide guidance. In calculating the exposure the following factors must be considered:
- Class of cosmetics in which the ingredient may be used
- Method of application: rubbed-on, sprayed, rinse-off etc.
- Concentration of ingredients in product
- Quantity of product used at each application
- Frequency of application
- Total area of skin contact
- Site of contact (e.g., mucous membrane, sunburn skin)
- Duration of contact (e.g., rinse-off products)
- Foreseeable misuse which may increase exposure
- Nature of consumers (e.g., children, people with sensitive skin)
- Quantity likely to enter the body
- Application on skin areas exposed to sunlight
Prohibited or Highly Restricted Ingredients: FDA regulations specifically prohibit or restrict the use of the following ingredients in cosmetics: Hexachlorophene (preservative), mercury compounds (preservative), chlorofluorocarbon (propellant), zirconium-containing complexes, halogenated salicylanilides (di-, tri-, metabromsalan and tetrachloro-salicylanilide), bithionol, chloroform, vinyl chloride, and methylene chloride.
Ingredients that Should Not Be Used: In addition to the ingredients that are controlled by regulation, cosmetic and fragrance trade associations have recommended eliminating or limiting maximum levels of certain ingredients associated with health risks. For example, the CIR and IFRA Expert Panels have found the following ingredients unsafe: Chloroacetamide (preservative), ethoxyethanol and ethoxyethanol acetate (solvent), HC Blue No. 1 (hair coloring ingredient), p-hydroxy-anisole (antioxidant), 4-methoxy-m-phenylenediamine, 4-methoxy-m-phenylenediamine HCl, and 4-methoxy-m-phenylenediamine sulfate (hair dye ingredients), pyrocatechol (used in hair dyes and skin care preparations), acetylethyl-tetramethyl-tetralin (AETT), musk ambrette, 6-Methylcoumarin (6-MC).
Ingredients that Should be Limited in Their Use: There are many cosmetic ingredients which do not exert a toxic effect as such, but may have unwanted effects if used at too high concentrations. Thus, such ingredients can still be used and can have favorable effects if added to cosmetics at the concentration as indicated. Some of them are mentioned below. In addition, the CIR Expert Panel has published a list of recommended limits for the use of a number of other ingredients which are still being widely used. You can purchase this list at CIR. A quick reference table can be founded here.