Debated Ingredients

A major driver behind the will to buy more natural products is the awareness that some ingredients and chemicals included in commercial products could pose health hazards. With weak regulations, and the

FDA’s limited role, manufacturers enjoy a large amount of freedom in formulating their cosmetics. 

The Federal Food, Drug, and Cosmetic Act (FD&C) defines cosmetics by their intended use, 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.” With the exception of authorized colors and sunscreens (for which proof of SPF level is required), the vast majority of cosmetics remain poorly regulated. The FDA has not been able to impose regulations pertaining to cosmetics the way it has for pharmaceuticals, mainly because the cosmetics lobby has succeeded in protecting the industry’s interests from such constraints. Lack of regulation and continued use of ingredients banned in other parts of the world, such as the European Union, Japan, and Sweden, incited multiple organizations, such as the Environmental Working Group, to interact with legislators in an attempt to create some order.

The resulting Safe Cosmetics Act (introduced in June 2011) aimed at

avoiding harmful ingredients, making personal care products safer for both

workers and consumers, and requiring full disclosure of ingredients. The act also

encouraged ingredient safety data-sharing, and the development of alternatives

to animal testing.

With increasing reports on the poor safety profiles of certain ingredients and the failure of some studies to demonstrate their inoffensiveness, a lot of noise

has been made to warn consumers, mainly women, about the potential hazards of

those ingredients. Even though there are numerous data gaps, and often not

enough solid research to draw conclusive results, many ingredients have been

under fire for a while and for various reasons. Most of those ingredients are

listed and discussed in the following paragraphs.

Aluminum

Aluminum is a ubiquitous metal that is widely used in cookware, antacids, and

antiperspirants. Even though it seems to be less toxic than other heavy metals,

there are concerns related to chronic aluminum toxicity. Because some studies

have shown higher deposits of aluminum in the brain plaque of people with

Alzheimer’s disease, it is thought to be linked to Alzheimer’s. Evidence is still

inconclusive, however, as to whether the deposit is a cause or a consequence of

the condition. Aluminum is also a metalloestrogen, which means that it is a

metal that has some estrogenic activity; that is why there are concerns arising

from its use in antiperspirants.

Avobenzone

Avobenzone is an oil-soluble dibenzoylmethane derivative that belongs to the class of chemical sunscreens. While mineral sunscreens (zinc oxide, titanium

dioxide) reflect UV light, chemical sunscreens absorb it. Avobenzone is

effective in absorbing UVAs, but it is photosensitive; sun exposure promotes its

disintegration, which compromises its efficacy. One single hour of sun exposure

can lead to the loss of more than a third of the avobenzone initially present.

Manufacturers have tried to counteract this by adding photo-stabilizers, such as

octocrylene, to the formulation. The much higher stability of mineral sunscreens,

however, as well as their limited absorption through the skin, has led to their increased popularity versus chemical sunscreens such as avobenzone.

Benzalkonium Chloride

This is a commonly used, potent antimicrobial, with applications ranging from eye drop preservative to household cleaners. It is used in various hand sanitizers, disinfecting wipes, pharmaceutical antiseptics, mouthwash, among other products.

The typical concentration in eye drops ranges from 0.002 to 0.01 percent.

Studies suggest that concentrations of 0.02 percent or more can denature corneal

protein and inflict irreversible damage on the eyes. Concentrations within the

usage range may lead to corneal punctures.

Benzalkonium chloride is also a skin-sensitizing agent. Concentrations of 10

percent or more are capable of producing a strong irritation to the skin and

mucous membranes; it is potentially lethal when taken internally. Benzalkonium

chloride has been used for decades to disinfect cuts and wounds because it is less painful than rubbing alcohol when applied.

Benzoic Acid and Sodium Benzoate

Sodium benzoate is obtained by neutralizing benzoic acid with sodium

hydroxide or sodium bicarbonate. Even though benzoic acid is a more effective

preservative, sodium benzoate is more commonly used because it has better

water solubility. Sodium benzoate (also called E211) is used as a bacteriostatic

and fungistatic in acidic foods and beverages, cosmetics, and pharmaceutical

preparations. The FDA requires a maximum concentration of 0.1 percent. The International Program on Chemical Safety found no adverse effects of daily

doses ranging from 647 to 825mg/kg of body weight.

Sodium benzoate reacts with ascorbic acid (vitamin C, or E300) and yields

benzene, which is a known carcinogen. Soft drinks have very low concentrations

of sodium benzoate, and some companies are phasing it out. Poor storage

conditions—in heat and light, for example—increase the speed at which benzene

is formed.

BHT and BHA

BHT (butylated hydroxytoluene, also known as E321) is used as a food additive

to maintain freshness. It is also commonly used in cosmetics and pharmaceutical

preparations. It is thought to be linked to hyperactivity disorder, with conflicting

data in regards to its carcinogenicity. Some food brands have chosen to exclude

it from their ingredients; others have chosen to replace it with BHA.

BHA (butylated hydroxyanisole, or E320) is also a food additive, with applications similar to those of BHT. Data behind BHA is controversial and limited. The state of California, however, has listed BHA as a known carcinogen.

Borax

Borax (E285) is a naturally occurring element that is widely used in an array of

industrial and chemical applications. It is a fire retardant, buffering agent,

laundry booster, ant bait, preservative, and more. It is banned for use as a food

additive in the United States but is still used in some other countries. Borax is

among the ingredients of many natural cosmetics sold on the U.S. market. The

European Union has classified it as “toxic for reproduction” and requires a

printed warning on all borax-containing preparations.

Colors

FD&C colors are synthetic colorings that have been approved by the FDA for

use in foods, beverages, cosmetics, and drugs. Each of the nine approved

synthetic dyes has a specific FD&C number. Synthetic food colorings are

preferred by some manufacturers over naturally derived colors because they are

cheaper and do not affect flavor.

The safety of synthetic dyes has been evaluated by many national and

international groups, with various conclusions and opinions. The main concern is their link to an increased prevalence of ADD (attention deficit disorder) and ADHD (attention deficit and hyperactivity disorder). Even though studies have not been able to demonstrate a causal link, some studies have shown better academic performance in non-ADD groups when such food additives were

eliminated.

There are many highly purified, naturally derived colorants that can be

incorporated into foods and personal care products. Naturally derived colors

include annatto, beet, caramel, chlorophyllin, turmeric, and beta-carotene,

among others. There may be carryover ingredients (mainly extraction solvents)

in the final color, but the percentage is usually so low that it is not obligatory to

mention it on the label.

Coal Tar

Coal tar is a thick black liquid, a by-product of the coal industry. It is a blend of

hundreds of different organic compounds, not all of which have been identified.

It is considered an OTC (over the counter) pharmaceutical drug and is used in

lotions and shampoos to treat dandruff, psoriasis, and head lice. Coal tar is a

known carcinogen, especially in preparations in which it exceeds 5 percent

concentration.

Dihydroxyacetone

Dihydroxyacetone (DHA) is the most widely used ingredient in sunless tanners.

It reacts with the amino acids of epidermal skin cells to produce a melanin-like

color. Most products contain 3–5 percent DHA, although some professional

products may contain up to 15 percent.

Even though the FDA has approved DHA for topical use, the agency has

issued a warning to avoid accidental swallowing or inhaling it when it’s applied

as a mist in sun booths. Some reports have demonstrated an increase in free

radicals after application, as well as cell-damaging effects. There is also some

decrease in vitamin D production through the skin.

Hydroquinone

This skin-lightening ingredient is banned in Europe and many other regions of

the world. It is still included in many OTC preparations in the United States,

however, even though the FDA has declared that it cannot be ruled out as a

potential human carcinogen. It is also a strong skin sensitizer poorly tolerated by

sensitive skin.

Formaldehyde and formaldehyde-releasing agents

Formaldehyde (chemically called methanal) is a gaseous aldehyde that is

colorless and has a pungent smell. Commercial solutions of formaldehyde in

water are called formaline and are used to preserve animal tissues.

Formaldehyde is a fixative and an embalming agent. It is used in woodwork and many other products. It is also widely used in the medical field as a biocide

(except where banned, as in the European Union). Other related compounds,

such as imidazolidinyl urea, diazolidinyl urea, and DMDM hydantoin are

capable or releasing formaldehyde. The U.S. national toxicology program

considers formaldehyde to be a known human carcinogen. It is also a respiratory

irritant and a skin-sensitizing agent, which might cause dermatitis. It is present in

many personal care products, such as keratin hair treatments, whose use is

considered an occupational hazard by some hair care professionals.

Mineral Oil

Also known as white oil, liquid paraffin, and liquid petroleum, mineral oil is a

by-product of crude oil distillation. It is produced in large quantities and has a

relatively low price. White petroleum is a solid form of mineral oil and is also known as petroleum jelly. Unrefined and poorly refined mineral oils are classified as carcinogenic to humans by the World Health Organization.

Theoretically, the risk decreases as purity increases. Refined oils are widely used

in cosmetics, in which they act as moisturizers and emollients. Mineral oil is also used as a makeup remover because of its solvent properties.

Monoethanolamine, Diethanolamine, and

Triethanolamine

Monoethanolamine (MEA or EDA) is a corrosive and toxic liquid. It is a weak

base used as a buffering agent in some pharmaceutical emulsions. Excessive,

prolonged, or widespread exposure through the skin may result in kidney or liver damage.

Diethanolamine (DEA or DEOA) is used in the production of diethanolamides such as cocamide DEA, lauramide DEA, oleamide DEA, myristamide DEA, and DEA cetyl phosphate, which are widely used in

cosmetics and shampoos to improve the creamy texture and the foaming

capacity. Skin irritation and sensitization are the primary concerns arising from

DEA-containing products.

Triethanolamine (TEA or TEOA) is a stronger base used as a buffering agent

in many cosmetics to adjust the final pH of the product. It is also a surfactant and

an emulsifier. When added to facial cleansers, for example, it improves makeup removal. It is also added to many other products, such as laundry detergents, liquid cleaners, polishes, and others. Because it may convert to nitrosamines, which are known carcinogens, its use has raised concerns. It is also a strong allergen.

Musk

Musk is a naturally occurring, highly fragrant substance that has long been used in perfumery. Natural sources are mainly animal, such as the musk deer (from musk-secreting glands), and botanical (plants, flowers, or seeds). However, because of the scarcity of these natural resources and the increasing demand, synthetic musk, also called white musk, has been developed and has replaced natural musk almost totally. Most kinds of synthetic musk (such as musk-xylene) are suspected carcinogens, and there are efforts to replace them with less

harmful types.

Nanoparticles in Sunscreens

New technologies have allowed a reduction of the size of particles in sunscreens to micron and nano levels. These practices create much smaller sized particles with multiple pharmaceutical and industrial applications. Nanoparticle diameter ranges from 1 to 100 nanometers. Pharmaceutical formulations using nanoparticles capable of penetrating biological membranes promise enhanced

delivery of the active ingredient and superior targeting. 

In cosmetics, the most famous nanoparticle is zinc oxide. Zinc oxide is a naturally occurring element that is widely used in mineral sunscreens, mineral makeup, and diaper rash creams. Its initial-size molecule is not absorbed into the skin and is capable of reflecting UVAs and UVBs from the skin surface.

However, reducing the size of the zinc oxide molecule tremendously increases

the surface versus volume, rendering those particles unstable and highly reactive. Their effects at the cellular level have raised safety concerns, especially as some studies have established their mutagenicity and cytotoxicity. The depth of skin penetration remains poorly established.

While the FDA is still investigating the safety of nanoparticles in cosmetics,

many manufacturers have voluntarily chosen to withhold them from their

formulas. Labeling regulations do not require specifying whether zinc oxide is

micronized, nano, or regular size, and consumers are left to research that

information.

PABA

Para-aminobenzoic acid (PABA) is a chemical ingredient used mainly in

sunscreens and included in numerous oral supplements. The FDA has not

determined a recommended daily intake for PABA, and the health benefits of

oral supplementation remain vague. As for its use in sunscreens, it is losing its

popularity as a chemical UVA and UVB filter because of the high incidence of

allergic reactions among consumers. Also, the emergence of negative reports on

PABA’s mutagenicity has led to its replacement by other chemical and mineral filters.

Parabens

Parabens are esters of parahydroxybenzoic acid. Paraben-based preservatives include methylparaben (E218), ethylparaben (E214), propylparaben (E216), and butylparaben. Germaben, Germaben II, Phenonip, and other types, such as Germall and LiquaPar Oil, are alternative names for paraben-based preservatives. Parabens have slight estrogenic activity, which means that they

can weakly mimic the natural female hormone estrogen. This is why they are

said to be endocrine disruptors and have been found in breast cancer tissue. Even

though parabens do have estrogenic activity, in vivo (in humans) activity

remains weak compared to the activity of estrogen itself.

Phenoxyethanol

Phenoxyethanol is a preservative used in a great number of skin care and makeup products. It is also used in a number of biological drugs and pharmaceutical preparations.

It can cause skin allergies and might depress the central nervous system; it

may lead to vomiting and diarrhea (in high concentrations). It is considered safe by many manufacturers, however, and is approved for all ages.

Phthalates

Phthalates are esters of phthalic acid with short-or long-chain radicals. They are

mainly used as plasticizers in applications from pharmaceutical pills and medical

supplies to toys, paints, nail polish, perfumes, shower curtains, packaging

materials, and more. Diethyl and dibutyl phthalates are the main two phthalates

present in personal care products.

While some European countries are banning the use of phthalates, they

remain ubiquitous and even though they do not accumulate in nature, they are

common pollutants of homes, especially in urban and suburban areas. They

evaporate and are easily released into the immediate environment. They can be

inhaled, ingested with food, and absorbed through the skin. Carcinogenicity,

birth defects, endocrine disruption, asthma, and behavioral changes are among the health concerns raised by phthalates.

Synthetic Fragrances

Fragrance is often added to products to mask an unpleasant odor or to impart a

pleasant smell. Sometimes it is added to a gas such as propane to make potential

leaks noticeable.

The chemical name of a synthetic fragrance (or blend of fragrances) does not have to be mentioned on the ingredients label of a product, which is a source of concern for some consumers. There are various chemical categories of

fragrances, such as terpenes, aldehydes, esters, amines, alcohols, ketones, and

lactones.

Fragrance components are both inhaled and absorbed through the skin, and

many are highly sensitizing, which means that they are capable of triggering

allergies and dermatitis. Many fragrance chemicals are also endocrine disruptors

(affecting mainly estrogen and thyroid hormones), bio-accumulating substances

(substances that accumulate in the human body, especially in fat tissues), and

simply unevaluated components that are often not listed on labels.

The perfume industry relies on thousands of chemicals, sometimes natural

but mostly synthetic, to compound various scents. Many ingredients are petroleum-derived. The Research Institute for Fragrance Materials does assess

the safety of many chemicals used in the fragrance industry, but many components remain unstudied. People with asthma or migraines might be less tolerant of specific scents.

People with asthma or migraines might be less tolerant of specific scents. Essential oils, which are much more expensive than fragrances, are still often preferred in natural skin care because of their better tolerability profile and natural origins.

Talcum Powder

Talcum powder (magnesium silicate) is a naturally occurring whitish substance

with a wide array of applications. In cosmetics, it serves as a lubricant and an

astringent powder. Long used for diaper rash, talcum powder became less

popular after a link to ovarian and lung cancer was suspected. There have also

been toxicity reports due to impurities in talcum powder.

Titanium Dioxide

Titanium dioxide is a naturally occurring white pigment used in multiple

industrial, pharmaceutical, and cosmetic applications. It is also an approved food

additive. Titanium dioxide is a reactive pigment that generates damaging free

radicals. It is coated with silica or alumina to prevent the acceleration of a

photoreaction. A number of commercially available mineral-based sunscreens

offer titanium-free option to consumers.

Triclosan

This ingredient was initially developed as a surgical scrubbing agent and has

gained popularity as the active ingredient in many disinfecting products such as

soaps, hand sanitizers, mouthwashes, toothpastes, and disinfecting wipes.

Some studies have shown that triclosan might compromise the immune system, cause allergies, and make humans more susceptible to the hazardous effects of BPA (bisphenol A, commonly present in plastics and the lining of food cans). Other studies have shown that it affects muscles in other animal species, and there may be similar concerns for humans. The FDA is reviewing the safety of triclosan.

Note that washing your hands for 20–30 seconds with soap and water or

using a hand sanitizer with 60 percent or more alcohol content is an effective and

reliable way to kill most common germs.

Other Ingredients

Many other ingredients—propylene glycol, polyethylene glycol (PEG), isopropyl alcohol (rubbing alcohol), silicones, and others—have been criticized for various reasons. Most of those products have various pharmaceutical and medical applications. It is very important, however, for such ingredients to be produced according to solid GMP (good manufacturing practice) standards and

yield highly purified products quasi-free from contaminants that might

compromise the quality of the product.