How Is The Regulation Of Toxic Chemicals In Cosmetics Emerging In US States? – Chemicals

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.

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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