With all this being said, are parabens as dangerous as alleged?

 A public debate was triggered in Europe in 2004 over the use of parabens in cosmetics. Since then parabens have been the most judged preservatives and the most controversial.

 However, between 2004 and today the use of parabens has not decreased. The FDA, the European Commission and the Australian and Japanese Ministries of Health continue to authorize and approve the use of parabens after a series of studies showed no significant signs of possible harm in cosmetic products.

 “Paraben free, preservatives free…” That is the selling point used by many “natural” and “organic” cosmetic brands to market their products. They play on the bad reputation of those preservatives using these misleading terms to sell products that are not necessarily better than others.

What are parabens?

Parabens are a family of esters of para-hydroxybenzoic acid. Parabens most commonly used are: methylparaben (E218), ethylparaben (E214), propylparaben (E216), butylparaben.  The least common paraben is isobutylparaben, isopropylparaben.

Parabens are present almost everywhere. They are found in strawberry, raspberry, peach, carrot, onion, white bean, vanilla, cucumber, olive etc. They are anti-microbial, antibacterial and antifungal which are effective protective agents. They are also found in animals and insects in the mucous membranes where they act as antibacterial. In humans, the para-hydroxybenzoate (parabens) is a precursor of coenzyme Q10 an essential element of energetic metabolism.

  Parabens are used in your food everyday and are legislated under the codes from E 214 to E 219.

 Parabens are used by pharmaceutical companies and legislated medications like baby‘s syrup and many others for over 70 years and continue to be the safest and most stable.

 Subsequently, they are extracted and synthesized for industrial use because they have replaced toxic and carcinogenic substances formerly used in cosmetic formulations such as formaldehyde.

They are preservatives that are more effective and better tolerated by the skin. Even those who are allergic to parabens tolerate it.

The controversy surrounding parabens
The controversy began in 2004 following three articles published in the British Journal of Applied Toxicology by Philippa Darbre an oncologist who brought to the public a relationship between parabens and breast cancer.

Without confirming if these women had parabens in their blood,  20 women with breast cancer participated in a study on parabens where 18 of them had a concentration ratio of parabens from 2 to 12 nanograms per gram of tumor.  

Dr. Darbre subsequently issued the following assumptions: the ingredients used in deodorants and applied daily to the armpits can be linked to breast cancer. Parabens found in deodorants may play a role in the development of breast cancer found in tumor tissues and have an “estrogen-like” effect meaning they have an activity similar to that of estrogen. Background: Breast cancer is hormone-dependent. It is the action of estrogen that activates mutated genes responsible for the degeneration of cells that evolves into cancer cells.

This study was immediately taken up by the media (television, radio, newspaper articles, internet) who misinterpreted and exaggerated the study. They spread the idea of a relationship between parabens used in cosmetics and the development of breast cancer. However, the studies done by Dr. Darbre have been heavily criticized by the scientific community. Critics have said the following:

• Dr. Darbre suggests that some control measures are inadequate.
• The number of subjects was considered low (20 people) and there was no control group. The fact is no test can show where the paraben concentration is observed in healthy women who regularly use cosmetics containing parabens.
• The possible link between parabens and breast cancer development is only a hypothesis not a proven fact.
• Other natural substances have an “estrogen-like” effect (soybean, contraceptive pill) and their potential effects are not mentioned.

Immediately after the media broadcasting the international health authorities ordered studies take place to test all potential hypotheses.The various studies on this subject conducted by committees of scientific experts have revealed the following:

• Parabens found in cosmetics can go no deeper than the stratum corneum (the superficial layer of the epidermis)
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• The effect on the cells is not conclusive
• Scientific studies were performed at elevated levels unrelated to the reality of the application of cosmetics.
• No studies on human populations demonstrate a link between the development of breast cancer and parabens used in cosmetics.
• The toxicity, sensitization and mutagenicity of parabens are very good compared to many other preservatives.
• Parabens have been used for more than 70 years in cosmetics with minor side effects.

The affinity of parabens for estrogen receptors is very low and much lower than that of phytoestrogens (like soya) and other agents such as certain pesticides with estrogenic effect.

The Scientific Committee on Consumer Products (SCCP), under the European Commission in January 2005 issued a clear notice that there is no causal relationship between the use of deodorants and breast cancer. The FDA estimated that currently there is no reason why the use of cosmetics containing parabens should concern consumers, quite the contrary. The NICNAS (National Industrial Chemicals Notification and Assessment Scheme) established in April 2009 that “Parabens in cosmetic products are considered safe” and are the best preservatives in cosmetics if they are used as instructed.

” Paraben Free, Preservatives Free ” : Claims and warning
From the moment a cosmetic product contains 8% of water, preservative must be added. This is why cosmetics powder is deprived from preservatives. After opening a cosmetic, it is vulnerable to bacterial proliferation by environmental conditions (temperature, humidity, pH) and by its user. Protecting the consumer while ensuring the sustainable stability of the product is the goal of preservatives.

The few cases that fueled the controversy a few years ago have mainly contributed to some laboratories who took advantage of the situation and proposed “alternatives”. Observe the label “organic” or “Paraben FREE”. These laboratories have seen their sales skyrocket and those posting “without paraben” as well saw an increase in their sales.

 ” Paraben FREE “

The reasons that lead to the withdrawal of parabens in cosmetics are not for scientific reasons but for commercial reasons. Indeed, some manufacturers believe that it is cheaper to remove parabens from their products to adapt to the public’s unfounded opinion and  maintain their market presence.

Every product containing micro-organisms is damaging and may provide undesirable side effects. They can even be dangerous to the skin and to your own health . That is why using a preservative to counter these effects is essential.

So these manufacturers opt for alternative conservatives to replace parabens without worrying about the safety of its customers including:

• Organic halogen compounds: Much more dangerous than parabens these compounds are highly allergenic and very responsive. They can penetrate the tissues, break down, settle down and cause long term cellular damage.
• The releasing or formaldehyde derivatives: despite their antibacterial efficacy of these compounds they have a high allergenic potential and carcinogen activity.
• Glycol ethers (phenoxyethanol etc.): The toxicity of these preservatives has been demonstrated in many studies. The use of certain glycol ethers has been banned in cosmetics.

The words “preservative free” do not mean that no conservatives have been used to formulate the product.

Cosmetic brands advocating the words “preservative free” contain preservative systems for the products containing more than 8% of water.
Without a system of conservation the use of cosmetic products contaminated with pathogenic micro-organisms is much more dangerous than the possible effect of real preservatives in cosmetics. Even with empty packaging in unit doses it is essential to preserve the product because its ingredients are not sterile.

In reality, brands who indicate “preservative free “are using ingredients not listed in the official list of recognized and permitted preservatives by all governments. On the other hand, some preservatives  with natural ingredients can be used by organic brands and or “natural brands“ and could be considered as systems of conservation for only specific products or simple formulation. The conservation properties of these ingredients are more limited than the true preservatives of the official list (government) and may have side effects, unknown effect on the cells and potential damages l, which must also be taken into account. For example these are commonly used ingredients:

• Extracts of grapefruit seed, bactericides, whose use is banned in Europe and Japan for security reasons;
• Essential oils may cause severe allergies and cannot be used in high dosage as they may destroy the properties of the main actives ingredient in a cream for example, even its ability to preserve.
• Alcohol can cause drying of the skin and is not compatible with all formulas and assets
• Vitamin E and C: are often unstable and provide rancidity to the products when used in sufficient quantities.

Recently, the French agency for sanitary security health products (AFSSAPS) investigated a few  organic products. Some contained up to 5% of preservatives present in the natural ingredients (parabens, sodium benzoate, phenoxyethanol etc.) and two products were contaminated because they were inadequately maintained and harmful to skin health of our clients.

The ideal preservative must be effective over a wide range of microorganisms while having an action as a preservative and be compatible and stable for all formulation while following the legislated doses proven by governments for safety. In this context parabens appear to be the ideal preservative because:

• Parabens act on a broad spectrum of effectiveness against microorganism (fungus, bacteria, and microbes) and have a pH ranging from 4 to 8.5.
• Parabens are compatible with a wide range of formula and actives.
• Parabens are stable and durable against the heat and life span of the product.
• Parabens are harmless and “safe” when used in the legislated concentrations (non-toxic, non-irritating, no known side effects after 70 years …).
• Parabens are easily metabolized and eliminated from the body via the urine.
• Parabens are biodegradable.
• Parabens have been used for more than 70 years and are proven to be safe.
• Parabens are regulated and approved by the FDA, the European Commission, the Ministries of Health Japanese and Australian agencies worldwide.

In conclusion Parabens in the controlled form are back in the cosmetic industry for a good formulation and most importantly for your safety. 

Gaëlla Azzi
R&D, Biotechnologist
Europelab Inc. / Europe Cosmetiques Inc.

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