Protect Your Consumers and Your Brand from Heavy Metals

Heavy metals such as lead, arsenic, mercury, antimony, cadmium, chromium and nickel are frequently found in personal care products, including lipsticks, whitening toothpastes, eyeliners, and nail polishes. These metals may be in finished products due to their presence in the raw material or as a contaminant. Exposure to these elemental impurities can cause health issues, including reproductive, immune, and nervous system toxicity.

heavy metals in cosmetics
24 MAR 2025 ALS

What Are Heavy Metals?

Heavy metals are elements that naturally occur within the earth's crust. Consequently, they are found in soil and water. Plants can absorb these heavy metals, leading to their accumulation in seeds and other plant parts. Ingredients derived from the earth, such as kaolin clay, bentonite clay, mica, talc, diatomaceous earth, and iron oxides, may contain metallic impurities. These impurities can become contaminants during the manufacturing process or using earth-based raw materials, eventually making their way into cosmetic products.

Some metals are essential for normal body functions, such as iron, which is necessary for blood oxygenation. Other metals, like lead and mercury, have no normal biological functions in the body. However, the accumulation of these toxic heavy metals can have serious negative effects.

While some metals are contaminants from the manufacturing process, others are used as colorants. For example, chromium is used in a small number of products as a colorant, and iron oxides are common in eyeshadows, blushes, and concealers. Aluminum compounds are employed in lip glosses, lipsticks, and nail polishes. Furthermore, they are frequently used in antiperspirants, deodorants, and various personal care products because of their ability to minimize perspiration and neutralize odors. Additionally, some color additives can be contaminated with heavy metals, such as arsenic, lead, and mercury.

Exposure and Health Concerns

Exposure to high concentrations of heavy metals can lead to numerous health issues. These include neurological damage, skin irritation, allergic reactions, skin lesions, pigmentation changes, inflammation, organ toxicity, and developmental issues. Heavy metals in cosmetics can pose several health risks, depending on the type and level of exposure. Here are some of the potential health risks associated with common heavy metals found in cosmetics:

Lead: Present as an impurity in many colored cosmetics, including lipsticks. It is a well-known neurotoxin associated with learning, language, and behavioral problems, especially in children.

Mercury: Associated with toxicity to the nervous system, as well as adverse effects on reproductive, immune, and respiratory systems. It is widely recognized as an environmental health hazard.

Arsenic: Linked to skin disorders, cancer, and heart diseases.

Cadmium: Can cause kidney damage, weaken bones, and is classified as a carcinogen.

Nickel, Chromium, and Cobalt: Known to trigger skin allergies and sensitization.

Other Metals: Aluminum compounds vary in toxicity, with some linked to neurotoxicity, reproductive toxicity, and cancer.

Heavy metals are deemed harmful to living organisms, even when exposure occurs at low levels. Over time, these metals can build up in the body, resulting in long-term health issues. It's important to be aware of these risks and choose cosmetics that comply with safety regulations to minimize exposure.

Global Regulations

There are no coordinated international standards for heavy metals in cosmetics, but some states, countries, and governing bodies have set regulations to control their use:

  • California: Lead, mercury, arsenic, cadmium, antimony, nickel, and chromium are listed under Proposition 65 as harmful due to cancer and developmental risks.
  • Washington: The Toxic-Free Cosmetics Act (TFCA) bans the sale of cosmetics containing lead or lead compounds at or above 1 part per million (ppm).
  • Canada: Canadian regulations set specific limits for heavy metals in cosmetics.
  • US FDA: The U.S. Food and Drug Administration (FDA) has established limits for heavy metals in cosmetics.
  • European Union (EU): Regulation 1223/2009 strictly prohibits heavy metals in cosmetic products.
  • ASEAN: The Association of Southeast Asian Nations (ASEAN) enforces limits on heavy metals in cosmetics.
RegionAntimonyArsenicCadmiumLeadMercuryNickel
European Union (EU)0.5 ppm0.5 ppm0.1 ppm2 ppm0.1 ppm10 ppm
Canada5 ppm3 ppm3 ppm10 ppm1 ppm--
South Korea--10 ppm--20 ppm1 ppm10 ppm
ASEAN--5 ppm5 ppm20 ppm1 ppm--
USA *--3 ppm--20 (10 for lip care)1 ppm--

*In color additives

In addition to the regulations set by the US FDA, some states have their own specific rules:

  • California: Prohibits the use of lead and other metals in cosmetics and includes them on the Proposition 65 list.
  • Washington: Enforces a limit of 1 ppm for lead in cosmetics, effective from January 1, 2025, under the Toxic-Free Cosmetics Act (TFCA).
  • Vermont: Bans the use of lead, mercury, and other harmful chemicals in personal care products.

Clinical Testing Recommended by ALS

Clinical safety studies prevent harmful ingredients from reaching the market, reducing health risks and ensuring product efficacy. By identifying adverse effects and setting safe usage guidelines, they help brands meet regulations, avoid costly reformulations, and speed up approvals.

Rigorous testing strengthens consumer trust, boosts credibility, and keeps product launches on track.

ALS recommends trace analytical testing to detect heavy metal contamination in formulations containing plant-based or earth-derived ingredients. Using Inductively Coupled Plasma-Mass Spectroscopy (ICP-MS), ALS delivers precise, low-level detection to ensure compliance with safety regulations and retailer requirements.

Routine analysis includes lead (Pb), mercury (Hg), arsenic (As), cadmium (Cd), and antimony (Sb), with additional testing available for cobalt (Co), nickel (Ni), and chromium (Cr).

Following modified USP and EPA methodologies, ALS helps brands minimize contamination risks, prevent compliance issues, and maintain product integrity, ensuring smoother approvals and stronger market positioning.

ISO 17025 Certification

ALS operates two laboratories in the USA, both accredited with ISO 17025 for metals testing. This dual certification is a unique advantage for clients needing to meet Amazon’s requirement for heavy metal testing with two separate ISO 17025 certified labs.

Start implementing these strategies today to ensure the safety and compliance of your beauty, personal care, and cosmetic products. By conducting thorough safety studies, you can protect consumers and enhance your brand's reputation. Reach out to experts and begin your journey towards safer products now.

pharma.usa@alsglobal.com

310 214-0043

Helpful links:

cosmetic cream in jar

Enforcement of the Modernization of Cosmetics Regulation Act: What You Need to Know

Ensuring Compliance with MoCRA