According to an alert published in February 2022 by the environmental health organisation Safer States, at least 32 US states have promulgated, or are in the process of promulgating, legislation to regulate "emerging contaminants" in various media.

While much of this legislation has focused on addressing the risks in groundwater, including PFASs and 1,4-dioxane, a secondary and increasingly significant focus has been on the regulation of the same contaminants in cosmetics and personal care products.

Four states – California, Maryland, Maine and New York – have spearheaded efforts through recently enacted legislation. New York's law took effect on 1 January, while laws in California and Maryland are set to take effect in 2025, and in Maine by 2030.

Now that the regulatory floodgates have opened, more states are likely to follow and promulgate regulations that either ban or significantly restrict the use of perand polyfluoroalkyl substances and other emerging contaminants in cosmetics and personal care products.

Moreover, as further discussed below, increased federal regulation is likely in the not-too-distant future.

Federal regulation

At the federal level, chemical substances in consumer products are primarily regulated under either TSCA or the Federal Food, Drug, and Cosmetic Act (FD&C Act).

While TSCA broadly regulates any chemical substance that is actively utilised in interstate commerce, chemicals may be exempt from TSCA when they are used in products that are directly regulated by other federal statutes. Such products include cosmetics regulated by the FD&C Act, which are defined 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".

The definition of cosmetics in the FD&C Act is far-reaching and encompasses many personal care products, such as:

  • skin moisturisers;
  • perfumes;
  • lipsticks;
  • fingernail polishes;
  • eye and facial makeup preparations; shampoos;
  • permanent waves;
  • hair colours;
  • toothpastes; and

Therefore, even if the EPA determines – pursuant to its authority under TSCA – that a specific chemical presents an unreasonable risk to public health or the environment under certain use conditions, its subsequent regulation or prohibition of the chemical will not extend to the substance's use in a cosmetic product.

For example, the agency is currently conducting TSCA risk evaluations for several chemicals that have been used in personal care products, including formaldehyde, 1,4-dioxane, diisodecyl phthalate (DIDP), diisononyl phthalate (DINP) and dibutyl phthalate (DBP). However, its scoping documents expressly acknowledge that uses of these chemicals in cosmetic products "fall under the regulatory purview" of the US Food and Drug Administration (FDA) and are therefore excluded from its risk evaluations and any subsequent TSCA regulation.

This is because cosmetic products and their ingredients are primarily regulated under the FD&C Act, which prohibits manufacturers and importers from "introdu[cing] into interstate commerce any ... cosmetic that is adulterated or misbranded".

Pursuant to this authority, the FDA requires that cosmetic products produced for retail distribution list their ingredients – except where they are incidental and present at insignificant levels – on the product's label. In addition, manufacturers and importers are prohibited from introducing into commerce any cosmetic product that contains a "deleterious substance which may render [the product] injurious to users under the conditions of use prescribed in the labelling".

However, organisations such as Safer States claim that these requirements are not stringent enough to ensure the safety of cosmetic products because the FDA generally does not require registration or preapproval of chemicals used in them, and the agency lacks the authority to require specific safety testing or demand a product recall where it believes a potential health hazard exists.

Organisations such as Safer States claim that these requirements are not stringent enough to ensure the safety of cosmetic products because the FDA generally does not require registration or preapproval of chemicals used in them

While there have been numerous efforts over the years to update the FD&C Act, the law has remained substantially unchanged since its original enactment more than 80 years ago. Most recently, in June 2021, Senators Dianne Feinstein (D-Calif) and Susan Collins (R-Maine) introduced the Personal Care Products Safety Act, legislation that would overhaul the FDA's regulatory authority over cosmetic products. Under the proposed bill, companies would be required to register their cosmetic products with the FDA and disclose the ingredients prior to placing their products into commerce. In addition, companies would have to inform the FDA of any serious adverse events (such as infections that require medical treatment) resulting from the use of their products. They would have to do this within 15 days of the reported event and submit annual reports to the agency identifying all reported adverse health events (including less serious reactions, such as rashes) on an annual basis.

A second bill, the Toxic-Free Beauty Act of 2021, introduced by Congresswoman Jan Schakowsky (D-IL) in October 2021, proposes an outright ban on 11 chemicals, including mercury, formaldehyde and PFASs, from beauty and personal care products sold in the US. The ban would match current prohibitions in place for similar products sold within the EU.

Both bills are currently in committees in the Senate and House, respectively. Whether either of the newly proposed bills will fare better than previous efforts to modify federal regulation over cosmetic products remains to be seen.

Newly enacted and anticipated future state legislation While the regulation of chemicals in cosmetic and personal care products has traditionally been left to the FDA, a few states have historically enacted legislation targeting substances in personal care products, particularly for personal care products that are marketed at children. Examples include:

  • California – in 2005, the state enacted the Safe Cosmetics Act, which requires manufacturers to inform the state of any cosmetic product sold within California that contains an ingredient known to the state to cause cancer or birth defects;
  • Minnesota – in 2013, the state enacted HB 458, which bans the use of formaldehyde in personal care products intended for use by children under the age of eight; and
  • Washington – in 2008, the state adopted the Children's Safe Product Act, which requires manufacturers of children's products – including personal care products – to report to the state if their product contains a chemical of high concern to children.

In recent years, a growing number of states have expressed interest in directly regulating chemicals in all types of cosmetic and personal care products sold within their jurisdictions. Beginning in 2019, state regulation of these chemicals took a significant step forward as New York signed into law a new bill regulating the presence of 1,4-dioxane in consumer products. This was followed shortly after by similar bills in Maryland, Maine and California (see box for summary).

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Originally published by Chemical Watch

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