By: Isabelle Nozari
November 11, 2022
When we buy personal care products to use in our daily routines, be it caring for our skin, hair, nails, or applying makeup, we assume that the products marketed for such usage are safe. Unfortunately, however, many recent reports have demonstrated that we may be unknowingly exposing ourselves to dangerous chemicals every day. The average woman utilizes 12 personal care products a day, exposing herself to 168 chemical ingredients. The cosmetics industry in the U.S. is a $47.7 billion-dollar industry and in Europe, an €11 billion industry. There are many different toxic chemicals to which our cosmetics expose us, including lead, per- and polyfluoroalkyl substances (PFAS), benzene, and even asbestos. Exposure to these toxic chemicals can have serious consequences for consumers. For example, PFAS are linked to severe health effects such as cancer, hormone disruptions, weakened immune systems, and low birth weights. Benzene is associated with leukemia and asbestos can cause cancer and mesothelioma.
We may assume that the cosmetics we purchase are safe for use because we might anticipate that a manufacturer’s inclusion of such chemicals in their products sold to customers would be in violation of certain laws and regulations. However, the current law is unable to ensure that the cosmetics sold to us are safe for our consumption. In the United States, the FDA does not have the same legal authority over cosmetics as they do over other products they regulate, such as drugs. The law does not require cosmetics to receive FDA premarket approval unless they contain color additives. While the FDA does advise manufacturers to use whatever testing is necessary to ensure the safety of their products and ingredients, the FDA also has no authority to recall a cosmetic from the market. However, if a manufacturer is known or seen to violate the law, the FDA can pursue enforcement action against it.
Generally, cosmetics in the United States are federally regulated since their sale affects interstate commerce. Federal laws about the regulation of cosmetics are primarily found in 21 C.F.R. §§700.11-700.35 (2022). These statutes focus primarily on the regulation of chemicals such as bithionol, mercury, vinyl chloride, halogenated salicylanilides, zirconium,chloroform, methylene chloride, and chlorofluorocarbons propellants. The federal statute does not restrict use of many of the aforementioned dangerous chemicals present in many cosmetics. This includes benzene, which was recently found in high levels in many dry-shampoo and aerosol products, leading to recall by manufacturers.
In comparison, the European Union has a much longer list of banned toxins in cosmetics than the United States. The European Union regulates the cosmetics within the single market via legislation titled the EU Cosmetics Products Regulation, also known as Regulation No 1223/2009 Of the European Parliament and of the Council. Specifically, the prohibited substances in cosmetics are listed within Annex II of the statute. In stark contrast with the number of forbidden chemicals by the FDA, there are over 1,300 prohibited substances listed. Further, Article 25(5)(a) authorizes “the competent authority” to “take all appropriate measures to prohibit or restrict the making available on the market of the cosmetic product or to withdraw the product from the market or to recall it . . . . where an immediate action is necessary in the event of serious risk to human health.”
Some argue that this striking difference with the American approach to regulation is rooted in the spirit of the law in the U.S. vs. the E.U; in the E.U., the laws are designed to protect the consumer, setting stricter directives and regulations, whereas in the U.S., the laws place a greater emphasis on freedom, particularly for the manufacturer. Ultimately the regulatory structure in the E.U. puts a greater burden upon the manufacturer than that in the U.S., which places a greater burden on the consumer.
One illustration of the disparity between the U.S. and Europe is the response to findings of asbestos in Claire’s cosmetics. While asbestos is not listed in the prohibited substances for cosmetics under FDA regulations in the U.S., it is explicitly prohibited (as number 762 on Annex II) by the EU Cosmetics Products regulation. Following an independent study by U.S. Public Interest Research Group (PIRG) discovering the existence of asbestos in several makeup products at Claire’s, which sells primarily to children and teens, European governments responded swiftly. In 2018, the Dutch government ordered those Claire’s products be taken off the shelves, and a warning was issued to all European Union countries. However, the FDA statement against the products from Claire’s was not issued until 2019. During this time, American children and teens continued to be exposed to asbestos as these products remained available for sale in stores. The FDA has since held a public meeting regarding the testing methods for asbestos in talc and cosmetic products containing talc.
But what are the implications of this? Does this mean that cosmetics are safer in the E.U. than in the U.S.?
The answer is unclear. Many argue that “the EU has got it right,” and that the regulatory structure in the U.S. fails to sufficiently protect the consumer. Looking at the difference in the quantity of prohibited chemicals in cosmetics, it is easy to understand why one may take this approach. This played out in the Claire’s asbestos cosmetics case when American children could purchase and utilize asbestos-contaminated cosmetics for a year longer than European children could. However, others do not believe there is a significant difference in the outcomes of the two regulatory regimes. Many of the forbidden substances in Annex II of the EU Cosmetics Products Regulation are those which would not have been utilized in cosmetics anyway, such as jet aircraft fuel, cyanide, and rat poison.
Ultimately, the effects of different approaches to cosmetic regulation are one of many ways in which government actions affect people. The extent to which administrative state places the burden of safety on manufacturers or consumers, the exhaustiveness of the laws and the power they confer upon regulatory agencies, and the legal processes by which ingredients are regulated are all factors that affect the safety of our cosmetics and personal care products. Whether the U.S. can or should adapt its regulatory schemes to match that of the EU is unclear, as not only does the U.S. have a different legal culture, but it also remains uncertain whether the different approaches ultimately do lead different results. What is clear is that manufacturers need to continue to act responsibly in regard to the ingredients they use in their cosmetics and ensure that they prioritize the well-being of their consumers.
