Health risks of chemicals in cosmetics: Unpacking the dangers

Used daily by millions around the world, cosmetics and personal care products contain a surprising array of chemicals that consumers are exposing themselves to on a regular basis. The growing awareness of potential side effects of various chemicals is driving new legislation in the cosmetics sector. In such a fast-paced industry, business owners need to stay ahead of chemical management regulations to ensure they’re providing customers with only the safest makeup and most sustainable cosmetic products.  

In this article, we’ll highlight the potential health risks triggered by some chemicals found in these products and the legislation rushing to the forefront of human health and safety.

Defining cosmetic products

The US Federal Food, Drug, and Cosmetic Act (FD&C) defines cosmetics as products “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 US Food and Drug Administration (FDA) adds that a cosmetic could be deodorant, perfumes, lotions, nail polish, shampoos and other hair products, as well as eye, lip, and face makeup. These definitions are important as they dictate which types of products are federally regulated, and therefore safety tested before they go to market.  

Cosmetics and personal care products include: 

• makeup products – lipstick and balm, eyeshadow, foundation and concealer, mascara, and spot treatments; 

• skincare products – creams, moisturizers, ointments, toners and serums; 

• haircare products – hair dye, shampoo, conditioner, hair oil and texturizing sprays; 

• soaps and feminine care; 

• toothpaste; 

• shaving foams and balms; 

• suncream and other lotions; and 

• period products – pads, tampons and menstrual cups. 

Chemicals in cosmetics: The good, the bad, the ugly

Personal care products contain added chemicals for various purposes, such as oxybenzone for UV filtering in suncreams, phthalates in perfumes to enhance the fragrance, and per- and polyfluoroalkyl substances (better known as PFAS) to increase durability and waterproofing. 

The EU estimates there are approximately 170 PFAS ingredients used in cosmetics and personal care products, with further research highlighting higher blood levels of PFAS in people who wear foundation, and higher PFAS levels in breast milk to those using cosmetics.  

Further, heavy metals such as lead, arsenic, mercury, aluminum, zinc, chromium and iron are often found in cosmetic products, disguised as more unfamiliar terms like chromium, lead acetate, thimerosal, sodium hexametaphosphate and hydrogenated cotton seed oil. These heavy metals are known for their toxicity in high quantities, with mercury poisoning a known historical illness.
 

Are chemicals in cosmetics a health risk?

Not all chemicals are dangerous, but many have been researched and found to be potentially harmful to human health. It’s important to note that many claims still require further research to substantiate the true risk. Often, chemical substances are linked to a process change in the body which can then lead to other diseases. 

Here are some examples of the most commonly found and discussed substances in cosmetics:
 

PFAS, parabens and phthalates

Used widely in cosmetics for their water and stain repellent capabilities, as well as durability, PFAS can enter the bloodstream through inhalation, ingestion and the skin barrier. Parabens are used as effective preservatives to increase the shelf life of products, and phthalates are often found in perfumes and creams to enhance fragrances and bind ingredients for flexibility or strengthening.  

Acting as endocrine disruptors, once inside the body, these chemicals can disrupt hormone receptors. Hormonal changes in the body can lead to myriad problems, including: 

• fertility issues such as poor sperm quality, miscarriage, and endometriosis; 

• thyroid disruption; 

• abnormal growth and development; 

• breast cancer; and 

• high blood pressure.
   

Lead, mercury and aluminum

Lead is present in lipsticks, primarily. As a known neurotoxin, the US eliminated the lead presence in gasoline by 1996. Lead poisoning is a known consequence of exposure to the toxin, and high levels of lead in blood are associated with decreased kidney function, high blood pressure, hypertension and degenerative disorders. 

Mercury is recognized as having high toxicity, affecting the nervous system, reproductive system, immune system and respiratory system. It’s not prohibited in many cosmetics regulated by the FDA, but some skin creams will contain traces of it.  

Aluminum is commonly found in deodorants, but you’re exposed to small amounts in nearly all food and water, as well as the air and soil. Low level exposure is typically not harmful, but high levels of aluminum has been shown to result in lung problems, as well as bone or brain diseases. 

Many heavy metals have also been found to be carcinogenic.  

Carcinogens

A common conversation surrounding cosmetics and associated chemicals is the potential increased risk of cancer. The following chemicals found in cosmetics are known carcinogens, as classified by the International Agency for Research on Cancer (IARC): 

• formaldehyde – found in hair and makeup products; 

• phenacetin – once a pain reducer banned by the FDA, it’s still found in some hair dye as a stabilizer; 

• coal tar – used in hair dyes, shampoos and scalp treatments, and rosacea treatment; 

• benzene – occasionally used in haircare products; 

• mineral oils – found in makeup, haircare and skincare products; and 

• silica – found in some makeup and skincare products. 

Professionals working in the cosmetics industry should be aware of the links between certain chemicals and human health, ensuring they always choose the safest substances for their products.  

Cosmetic and chemical management legislation

The UK, EU and US all have standard regulations for cosmetic products being placed on the market in their regions.
 

Europe

In Europe, Regulation (EC) No 1223 / 2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products is the main regulatory framework for cosmetics on the EU market, repealing the EU Cosmetics Directive.  

The regulation aims to simplify and streamline the process of cosmetic products going to market, and strengthen overall market control to ensure protection of human health. Its definition of a cosmetic product mirrors that of the UK’s.  

Some notable factors which will impact manufacturers in the EU include: 

• product safety assessment – manufacturers will need to produce a product safety report and notify their products via the CPNP. The assessment should report the intended use of the cosmetic product and the anticipated systemic exposure to individual ingredients; 

• Responsible Person – much like the UK, the EU also mandates that a Responsible Person undertakes regulatory obligations in place for a non-EU manufacturer. This appointed person will be responsible for completing the product safety assessment, submitting product notifications, keeping information updated, and reporting any potential risks; 

• product information file (PIF) – when a cosmetic product is placed on the market, the PIF must be kept for ten years following the launch. It should contain the following data, which is mandatorily updated as needed – 

• a description of the cosmetic product; 

• the cosmetic product safety report; 

• a description of the method of manufacturing and a statement on compliance; 

• proof of any effects claimed for the cosmetic product; and 

• data on any animal testing by the manufacturer, agents, or suppliers 

• banned ingredients – the EU has established a set of banned and restricted substances in cosmetics, which manufacturers will need to comply with to go to market in Europe. The annexes can be found on the EU Cosmetic Ingredient Database; and 

• animal testing ban – the regulation also prohibits the testing of finished cosmetics on animals and the prohibition to market finished cosmetic products which were tested on animals.
   

In summary, manufacturers need to review their ingredients against the restricted or banned lists, appoint a Responsible Person in the EU if they operate outside Europe, complete a product safety assessment and comply with the animal test ban – among the other laws set out by the regulation. 

United Kingdom

In the UK, The Regulation (EC) No 1223 / 2009 on Cosmetic Products as amended by the Product Safety and Metrology etc (Amendment etc) (EU Exit) Regulations 2019 controls the placing of cosmetic products on the market in the country. By establishing requirements that manufacturers must meet before their cosmetic product can be sold in the UK, the policy aims to safeguard public health and wellbeing against harmful substances.  

To be considered a cosmetic product, the regulation lays out six functions: 

• to clean; 

• to perfume; 

• to change the appearance; 

• to protect; 

• to keep in good condition; and 

• to correct body odors. 

The field of application comprises of the epidermis (skin), hair, nails, lips, external genital organs, teeth and oral cavity.  

Some notable amendments, which took effect at the end of 2020, include: 

• Responsible Person – there must be an allocated Responsible Person based in the UK for companies outside the region, to ensure smooth communication; 

• product information file – a file including updated product information must be kept in English and made available to market surveillance and enforcement authorities; 

• labeling – businesses must include the UK Responsible Person details on product labels to enable existing stock to be tracked back through the supply chain; and 

• notification of cosmetic products to Secretary of State – for products that haven’t previously been notified to the Commission via the Cosmetic Products Notification Portal (CPNP) or haven’t been placed on the EEA market, UK Responsible Persons need to provide information via the UK’s SCPN service before they can go to market. 

Companies operating, or wishing to operate, in the UK will need to ensure their cosmetic products meet the requirements established by this regulation. Those outside of the UK need to employ a Responsible Person to be the point of contact in the country.

United States

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) regulates cosmetic products at the federal level, and provides a major update to the FD&C Act of 1938.  

MoCRA enforces regulatory requirements on a range of cosmetic and personal care products, including hair products and hair removal, makeup, nails, soaps and lotions, and tanning products. Here are some of the major updates that companies will need to be aware of if they wish to sell in the US: 

• mandatory facility registration – companies that manufacture cosmetics with the intent to sell, package containers with a cosmetic product, or repackage cosmetics, must register with the FDA to market their products. New facilities must register within 60 days of commencing manufacturing. All registrations must be renewed biennially; 

• product listing – MoCRA doesn’t include a pre–market approval requirement for cosmetics, but the Responsible Person (the name on the label of the product eg manufacturer) is required to list each cosmetic product with the FDA. Each listing must include – 

• place of manufacture; 

• cosmetic category; 

• all product ingredients, including fragrances, flavors and colors; and 

• product listing number 

• adverse event reporting – manufacturers must maintain health-related adverse events records for six years, and report any issues within 15 days of discovery to the FDA. MoCRA clarifies what a serious adverse event could include, such as an infection, disfigurement, rashes or burns, hair loss, or persistent alteration of appearance; and 

• safety substantiation – cosmetic companies and manufacturers are responsible for ensuring the safety of their products. Though FDA regulations don’t require specific tests, a Responsible Person is legally required to maintain records supporting safety substantiation of the product.
   

It’s helpful to note that MoCRA does exempt certain small businesses, so it’s important that companies review the regulation thoroughly to understand which laws apply to them.  

Chemical restrictions

PFAS

Many states in the US and countries in Europe are implementing bills to restrict or ban PFAS in its entirety or within certain sectors, such as cosmetics and food packaging.  

In January 2023, Germany, the Netherlands, Denmark, Norway and Sweden submitted a restriction proposal under REACH to target over 10,000 substances classified as PFAS. 

In the US, more than 20 states are considering policies to address and phase out PFAS, including California, Colorado, Illinois, Maine, Minnesota, New York and Washington. Further, in Maine, an NGO is partnering with a developer to create an app that alerts consumers to the chemicals in products while shopping online.
 

Heavy metals

The FDA lays out the following restrictions and uses of heavy metals in cosmetics: 

• mercury – allowed in eye cosmetic products only, at no more than 65 parts per million (ppm) and if no other safer preservative is available; 

• lead – set at a maximum level of 10ppm as an impurity in cosmetics; 

• arsenic, lead and mercury in color additives – color additives must have FDA approval and not exceed the following limits 

• arsenic – no more than 3pmm; 

• lead – no more than 20ppm; and 

• mercury – no more than 1ppm 

• Chromium –permitted as a color additive in externally applied cosmetics. There’s no regulation on its limit, but FD&C Blue No1 limits chromium as an impurity to 50ppm. 

How to reduce chemical exposure in cosmetics

In light of the growing awareness of the impacts of certain substances and chemicals in cosmetic ingredients, consumers and manufacturers alike should be more cautious of the types of products they’re using.  

Companies should avoid greenwashing consumers with false claims on safety, while consumers should be wary of greenwashing claims on their products. Businesses selling cosmetics also need to ensure they’re meeting regulations and completing the necessary product safety assessments before pushing to market in various regions.  

Increasing supply chain transparency will allow manufacturers to better understand the substances being used throughout the product’s lifecycle, and negotiate safer and more sustainable alternatives to both comply with emerging restrictions and protect consumer welfare.