The number of different cosmetic products offered for sale in various parts of the world at any given time is staggering and limited only by the imagination of the talented scientists responsible for their design and development. Hundreds of millions of people use one or more cosmetic products one or more times a day. Use of cosmetics enhances well-being and can improve personal self-esteem. While there are countless different individual products, most if not all can be conveniently grouped under five categories – skincare, fragrance, haircare, oral care and makeup. Within these categories there are any number of subcategories – e.g., antiperspirants/deodorants, hair colorants, sunscreens, etc. For more information about the science behind cosmetics see http://www.thefactsabout.co.uk/ and http://www.cosmeticsinfo.org.
Government Regulation of Cosmetics and the Definition of Cosmetics. Cosmetic products are subject to regulation throughout the world. Above all, marketers of cosmetics are required to ensure their products are safe before being offered for sale.
Every country has its own specific requirements for cosmetic products but many base their cosmetic regulations on those of either the European Union (EU) or the United States. Within several geographic regions, a number of countries have agreed to adopt common requirements (see for example http://www.aseancosmetics.org/default/asean-cosmetics-directive).
In Europe, a cosmetic product is defined as any substance or preparation intended for placing in contact with external parts of the human body (epidermis, hair, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity, with a view exclusively or principally to cleaning them, perfuming them or protecting them, in order to keep them in good condition, change their appearance or correct body odors (Article 1.1; Regulation (EC) 1223/2009, as amended). Cosmetic products marketed within the EU “shall not be liable to cause damage to human health when they are applied under normal conditions of use” (Article 2; Regulation (EC) 1223/2009, as amended). For more about EU cosmetics legislation and the obligations of cosmetic companies wishing to market cosmetics in the EU, see https://www.cosmeticseurope.eu/safety-and-science-cosmetics-europe.html.
Cosmetic products marketed in the United States must be in compliance with the provisions of the Federal Food, Drug, and Cosmetic (FD&C) Act, the Fair Packaging and Labeling (FP&L) Act and the regulations published under the authority of these laws. The regulations published by the Food and Drug Administration (FDA) applicable to cosmetics are codified in Title 21, Code of Federal Regulations (21 CFR 700 to 740). The FD&C Act defines cosmetics by their intended use – i.e., as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.” Among the products included in this definition are skin creams, lotions, perfumes, lipsticks, nail polishes, eye and facial make-up preparations, shampoos, permanent waves, hair colors, toothpastes and deodorants. Products that are cosmetics but also intended to treat or prevent disease or affect the structure or function of the human body are also considered drugs and must comply with both the drug and cosmetic provisions of the law. Examples of products which are drugs as well as cosmetics are anticaries toothpastes (e.g., fluoride-containing toothpastes), sun tanning preparations intended to protect against sunburn, antiperspirants that are also deodorants, and antidandruff shampoos. For more information about the regulation of cosmetics in the United States see http://www.fda.gov/Cosmetics.
In addition to federal regulatory requirements, marketers of cosmetic products in the United States may also be subject to regulations promulgated by individual state legislatures. Proposition 65 was passed by California voters as a ballot initiative in the 1986 election under the title of the Safe Drinking Water and Toxic Enforcement Act of 1986. The law requires the state to identify and list chemicals “known to the state to cause cancer or reproductive toxicity.” Effective one year after a chemical is listed, a manufacturer of a product sold in California must warn consumers (by label warnings or other means that are determined to be “clear and reasonable”) of an exposure to such a chemical unless the manufacturer can demonstrate that the exposure poses either “no significant risk” for carcinogens, or “no effect at 1000 times the level (of exposure) in question” for reproductive toxicants. The burden is on the manufacturer to demonstrate no significant risk or no effect. The penalties for failure to warn can be significant, including substantial fees.
Safety Assessment of Cosmetic Products. The safety of cosmetic products should not be taken for granted – cosmetics are safe by design. Responsible marketers of cosmetic products’ commitment to product safety goes beyond legal requirements (see http://www.personalcarecouncil.org/about-us/personal-care-products-council-consumer-commitment-code).
In order to meet their own commitment to product safety (as well as to comply with government regulations world-wide), marketers must perform both a hazard assessment and a risk assessment on cosmetic products.
Hazard should not be confused with risk. A hazard is anything that can inherently cause harm, whereas risk is the inherent potential that a hazard will cause harm under given exposure conditions. The job of the cosmetic safety assessor is to ensure that the exposure conditions which could result in harm from a potential cosmetic ingredient are not met as a result of using a cosmetic. To do so the assessor must, amongst other considerations such as who will use the product (e.g., adults vs. children) and whether the product is intended for leave-on or rinse-off applications (see explanation of the difference in usage below in italics), take into account the amount of the ingredient (concentration) in the cosmetic as well as the intended amount of application, site of application (e.g., face, body, underarm, etc.) and frequency of use. An ingredient that may cause harm under some conditions (i.e., can be hazardous), can be used safely in a cosmetic if the amount (concentration) in the product is lower than the amount necessary to cause harm.
Rinse-Off/Leave-On Products. Leave-on products such as creams and lotions have a greater potential to deposit cosmetic ingredients on the skin than rinse-off products since with the latter, those cosmetic ingredients which have been deposited on the skin are invariably subsequently rinsed away. A rinse-off product is one designed to be applied to the hair or body in diluted or undiluted form for a short period of time (typically less than an hour) followed by thorough rinsing. Examples include shampoos, cleansers, hair conditioners, and depilatories. A leave-on product is one which is intended to be applied to the skin and left in place for a long enough period to achieve the desired benefit. Examples include hand and body lotions, sunscreen products and anti-perspirants.
In order to ensure that cosmetic ingredients and cosmetic products can be used safely, the cosmetic safety assessor has a wide variety of tools such as in vitro and in silico methods at his/her disposal as well as the ability to utilize existing animal safety testing data and to reference safety assessments of cosmetic ingredients published on an ongoing basis by the Cosmetic Ingredient Review (CIR) Expert Panel (see http://www.cir-safety.org), the EU Scientific Committee on Consumer Safety (SCCS) (see http://ec.europa.eu/health/scientific_committees/consumer_safety/index_en.htm) and by the Research Institute for Fragrance Materials (RIFM) (see http://www.rifm.org).
The search for better, more predictive methods to ensure cosmetics safety continues. In fact, the cosmetic industry has been at the leading edge of the development of alternative approaches to animal safety testing for over 25 years (the cosmetic industry founded the Center for Alternatives to Animal Testing at Johns Hopkins School of Public Health in 1981; see http://caat.jhsph.edu). For further information on the efforts by the cosmetic industry to identify, develop and adopt alternatives to animal safety testing, see https://www.cosmeticseurope.eu/safety-and-science-cosmetics-europe/alternative-methods.html.
Related topics: Hazard vs Risk, Toxicity Testing: Animals and Alternatives, Botulinum Toxin and Botox®, “Toxicity Today” (video)