Education and Research

Bismuth is a naturally occurring brittle metal found in several applications, especially in cosmetics and personal care products. As a naturally sourced element, bismuth may contain trace amounts of heavy metals. However, the U.S. Food and Drug Administration (FDA) regulates these trace elements to ensure they remain within safe limits, consistent with good manufacturing practices.

FDA Restrictions on Heavy Metals in Cosmetics:

• Lead: Not more than 20 parts per million (ppm)
• Arsenic: Not more than 3 ppm
• Mercury: Not more than 1 ppm
• Bismuth Oxychloride: Not less than 98% purity

These regulations ensure that any bismuth-containing compounds used in cosmetics remain safe for consumers.

Cyclomethicone is a clear, alcohol-free, and odorless liquid commonly used in personal skin care products. It helps to improve the texture of the product, making it easier to apply and providing a smoother feel on the skin.

Safety and Research Findings

Safety assessments published by the International Journal of Toxicology indicate that cyclomethicone has minimal absorption through the skin. Available data do not suggest that it poses a risk for skin irritation or sensitization. Furthermore, it is unlikely that dermal exposure to cyclomethicone in cosmetics would result in significant systemic exposure.

The Cosmetic Ingredient Review expert panel has concluded that cyclomethicone is safe for use in personal care products when applied according to modern practices and at typical concentrations.

Ferric ferrocyanide is a ferric hexacyanoferrate pigment commonly used in externally applied drugs, including those intended for use around the eyes. The FDA indicates that this dye may be safely used in amounts consistent with good manufacturing practices. The following restrictions apply to ensure its safe use:

• Lead: Not more than 20 parts per million (ppm)
• Arsenic: Not more than 3 ppm
• Nickel: Not more than 200 ppm
• Cobalt: Not more than 200 ppm
• Mercury: Not more than 1 ppm

Heavy Metals in Cosmetics

Lead
Lead is a dense, soft bluish-gray metal naturally occurring in the earth's crust. It is listed as a human carcinogen in the Twelfth Report on Carcinogens by the National Toxicology Program. Short-term exposure to lead in cosmetics can cause eye irritation.

Arsenic
Arsenic is a silver-gray or white metallic element that occurs naturally in the earth's crust. It is also classified as a human carcinogen in the Twelfth Report on Carcinogens. Short-term exposure to arsenic in cosmetics can lead to skin warts and red or swollen skin.

Mercury
Mercury is a naturally occurring metal found in the environment. Short-term exposure may cause skin rashes and eye irritation.

Formaldehyde is a colorless, flammable, and strong-smelling chemical commonly used in building materials and the production of household products. Common sources of formaldehyde in the home include:

• Pressed-wood products
• Cigarette smoke
• Fuel-burning appliances

Health Effects of Formaldehyde Exposure

Short-term exposure to formaldehyde can cause various health effects in some individuals. It is classified as a known human carcinogen (cancer-causing substance) by the International Agency for Research on Cancer (IARC) and as a probable human carcinogen by the U.S. Environmental Protection Agency (EPA).

Studies involving workers exposed to formaldehyde have shown an association between exposure and several types of cancer, including:

• Nasopharyngeal cancer
• Leukemia

There is growing concern regarding the interaction of nanoparticles with human health and their potential effects on the environment. The risks of pollution caused by nanoparticles, as well as the health problems associated with the manufacturing and use of products containing them, are not yet fully understood.

Health Risks of Nanoparticles

Scientists are particularly concerned about the possible health risks of inhaled nanoparticles and those absorbed through the skin. The Centers for Disease Control and Prevention (CDC) states that more research is needed to understand the human health risks linked to exposure to commercially engineered nanomaterials and the potential dangers associated with consumer products that contain nanoparticles.

Parabens are chemicals commonly used as preservatives in cosmetics and personal care products. These substances may interfere with the production or activity of hormones in the endocrine system, potentially leading to various health concerns. Some of the potential risks associated with parabens include:

• Reduced fertility
• Increased risk of diseases, including endometriosis and some cancers
• Changes to sperm levels and reproductive abnormalities
• Early puberty

Effects on Development and Health

Exposure to endocrine disruptors like parabens can be particularly harmful to infants and fetuses, affecting the development of reproductive and nervous systems, as well as other organs. Additional concerns include potential changes to the nervous system and immune functions.

Scientific Findings

Studies from California Pacific Medical Center in San Francisco have found that methylparaben (along with BPA, a chemical used in food can linings and other products) can not only cause healthy breast cells to behave like cancer cells, but it may also interfere with the effectiveness of tamoxifen, a critical drug used in the treatment of breast cancer.

Regulatory Oversight

The U.S. Food and Drug Administration (FDA) continues to evaluate new data regarding the safety of parabens. If the FDA determines that a health hazard exists, they will take action to advise the industry and the public, and will consider legal options under the authority of the FD&C Act to protect consumer health and welfare.

Pesticides are substances designed to prevent, destroy, repel, or reduce the severity of pests. These chemicals are commonly found in a wide range of household and industrial products, including cosmetics and personal care items.

Health Risks of Pesticides

Different types of pesticides can affect human health in various ways, including:

• Carcinogenic effects: Some pesticides are known carcinogens, capable of causing cancer.
• Congenital defects: Certain pesticides have been linked to birth defects.
• Nervous system changes: Exposure to some pesticides can alter nervous system function.
• Endocrine disruption: Some pesticides act as endocrine disruptors, interfering with hormones and the body’s endocrine system.
• Irritation: Other pesticides may irritate the skin and eyes.

Exposure Levels and Toxicity

The level of exposure to pesticides is as important as their toxicity. Both the concentration of the pesticide and the duration of exposure play a role in determining the potential health risks.

The human health effects of phthalates are still being studied, but several government agencies, including the Food and Drug Administration (FDA), the National Institute of Environmental Health Sciences (NIEHS), and the National Toxicology Program's Center for the Evaluation of Risks to Human Reproduction, are actively researching their impact.

Phthalates are esters of plastic commonly used to add flexibility and help dissolve other ingredients in a wide range of products. They are found in industrial adhesives as well as medical and consumer goods made with polyvinyl chloride (PVC) plastic.

Health Risks Associated with Phthalates

• Carcinogenic Concerns: Di(2-ethylhexyl) phthalate is listed as a substance "reasonably anticipated to be a human carcinogen" in the Eleventh Report on Carcinogens by the National Toxicology Program.
• Reproductive and Developmental Effects: The National Institute of Environmental Health Sciences reports that current levels of seven phthalates pose “minimal” concern for reproductive effects. However, high levels of di-n-butyl phthalate may adversely affect human reproduction or development.
• Infant Exposure: High levels of exposure to di(2-ethylhexyl) phthalate through medical tubing and plastic devices used in the feeding, medicating, and breathing support of newborn infants may disrupt the development of the male reproductive system.

Fragrance Oils and Neurotoxic Potential

Although the International Fragrance Association generally regards fragrance oils as safe, Coastal Classic Creations® does not use phthalate-containing fragrances in our products. Research strongly suggests that synthetic fragrance oils may have neurotoxic effects.

As early as 1986, the National Academy of Sciences identified synthetic fragrances as one of the six categories of chemicals that should be prioritized for neurotoxicity testing. The report highlighted that 95% of chemicals used in fragrances are synthetic compounds derived from petroleum, including benzene derivatives, aldehydes, and other known toxins. These chemicals are capable of causing:

Cancer

Congenital disabilities

Central nervous system disorders

New data suggests that the systemic exposure to triclosan, an active ingredient used in many antiseptic products, is higher than previously thought. This information highlights the potential risks from systemic absorption and long-term exposure. The Food and Drug Administration (FDA) has issued its final rule stating that certain active ingredients, including triclosan, used in over-the-counter (OTC) consumer antiseptic products intended for use with water, are not generally recognized as safe and effective (GRAS/GRAE) and are considered misbranded (PMC6126357).

1,4-Dioxane is not typically listed on ingredient labels but is a petroleum-derived contaminant found in many personal care products, including shampoos, body washes, children's bath products, and other foaming cosmetics. It is formed during the manufacturing process of these products.

The International Agency for Research on Cancer (IARC) has classified 1,4-dioxane as a possible carcinogen, while the National Toxicology Program (NTP) has identified it as a reasonably anticipated carcinogen.

1,4-Dioxane is a byproduct of ethoxylation, a petrochemical process in which ethylene oxide (a known breast carcinogen) is used to process other chemicals, making them less harsh. For example, sodium lauryl sulfate is often converted to the gentler sodium laureth sulfate through ethoxylation. The process can leave behind traces of 1,4-dioxane, which may contaminate the final product.

Sources:

• American Cancer Society. Learn about Cancer: Cosmetics. American Cancer Society. Retrieved from https://www.cancer.org/
• National Institute of Health. Chemical Carcinogenesis Research Information System (CCRIS). National Library of Medicine. Retrieved from https://pmc.ncbi.nlm.nih.gov/articles/PMC6126357/
• Centers for Disease Control and Prevention (CDC). National Health and Nutrition Examination Survey. National Center for Health Statistics. Retrieved from https://www.cdc.gov/
• National Toxicology Program's Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR). Retrieved from https://ntp.niehs.nih.gov/