The Parabens, the Phthalates, the Silicones. These three cosmetic ingredients families are not chemically related and serve completely different purposes. Nevertheless, they all share the common point to be marked by the seal of infamy.
Abhorred by most of the journalists, products reviewers and, in general, by self-proclaimed experts, these ingredients have been blamed for every misfortune possible for years. From damaging the hair to causing breast cancers, from asphyxiating the skin to producing reproductive birth defects in babies. While it would be dishonest and irresponsible to claim that Parabens, Phthalates and Silicones are above reproach, it is obvious that these ingredients have been, for years, the object of a total and unfair misinformation. Some members of the families are truly infamous but where discernment was necessary, the market seems to have the perspective that all are unacceptable.
Is “free” the way to be?
Cosmetic brands started to label “free from” claims on their product labels and consumers got used to these new commercial arguments. With distance and hindsight, we all see today how bad was the idea to compete on the basis of safety. The day when all products are “Paraben free”, paraben will be dead and the competitive advantage of this claim will have vanished.
The bottom line is that the Cosmetic Industry is losing useful ingredients with no hope of return. Even worse maybe, the Cosmetic Industry also takes the risk to lose their alternatives. This happens when an ingredient is massively replaced by inappropriate substitutes, which in turn create real public safety issues.
A clear example is the replacement of safe parabens by Methylisothiazolinone (alone or in mixture with Methylchloroisothiazolinone). Both Methyl Paraben and Methylisothiazolinone are very effective preservatives but, unfortunately, the second one is a severe skin sensitizer. The explosion in demand for Methylisothiazolinone directly translated into a significant increase of the prevalence of skin sensitization to this allergen in the general population.
This increase did not go unnoticed by the European Authorities, who banned Methylisothiazolinone (alone or in mixture with Methylchloroisothiazolinone).1 For a number of reasons, the list of accepted preservatives is shrinking every year and there is no need for the cosmetic industry to accelerate this bad trend by shooting itself in the foot.
This article will summarize the regulatory status of Parabens; a follow-up article will address Phthalates and Silicones. We’ll also look at some viable alternatives. However, these alternatives should be considered with a critical eye. First because one-to-one substitutes are rare and the choice of an alternative is often a matter of compromise. Then because, as mentioned above, phasing out an ingredient is a serious decision that may finally make its use impossible. Look before you leap!
Parabens are a family of esters based on parahydroxybenzoic acid. All members of the families show strong antimicrobial properties and they are used in cosmetic products as preservative ingredients.
The ‘Paraben Crisis’ started in 2004 when a scientific article made a correlation between the presence of parabens in the human body and breast tumors.2 This controversial article got viral and was highlighted by the media3. From this point, Parabens became public enemy number one for many consumers and, very quickly, for many cosmetic brands too. Then the marketing claim “Paraben free” started to flourish everywhere. It should be noticed that this claim is considered as denigrating and should be prohibited soon at the European level.4
Parabens have been thoroughly evaluated5,6,7 by the Scientific Committee on Consumer Safety (SCCS), one of the most stringent scientific committees of the European Commission, and regulatory decisions were taken:
|Methyl Paraben||99-76-3||Restricted (V, 12)
· Max 0.4% for single ester (as acid)
· Max 0.8% for the sum of esters (as acid)
|Ethyl Paraben||120-47-8||Restricted (V, 12)
· Max 0.4% for single ester (as acid)
· Max 0.8% for the sum of esters (as acid)
|Propyl Paraben||94-13-3||Restricted (V, 12a)8
· Max 0.14% for the sum of Propyl Paraben and Butyl Paraben (as acid)
|Isopropyl Paraben||4191-73-5||Banned (II, 1374)|
|Butyl Paraben||94-26-8||Restricted (V, 12a)8
Max 0.14% for the sum of Propyl Paraben and Butyl Paraben (as acid)
|Isobutyl Paraben||4247-02-3||Banned (II, 1375)|
|Pentyl Paraben||6521-29-5||Banned (II, 1378)|
|Phenyl Paraben||17696-62-7||Banned (II, 1376)|
|Benzyl Paraben||94-18-8||Banned (II, 1377)|
In other words, the use of Methyl Paraben and Ethyl Paraben (and, in a lesser extent, of Propyl Paraben and Butyl Paraben) at effective concentrations is still legal and deemed safe. Despite all the disinformation that can be found on the internet, no direct links have been established between these parabens and cancer as of today.
Parabens have many advantages: they are effective against Gram+ and Gram- bacteria but also against yeast and mold at relatively low concentrations. Furthermore they are inexpensive and compatible with many product types although their optimum pH is typically below 7. They also have some drawbacks and, in particular, a recognized incompatibility with most of cationic and non-ionic surfactants, cellulose esters, PEG and gelatins.
One of the best alternative is probably Phenoxyethanol (CAS 122-99-6), which can be used in the EU at up to 1.0 % in all product categories. Its safety has been re-confirmed recently by the SCCS9 and no regulatory uncertainty is identified at mid to long term.
The optimum pH of Phenoxyethanol is between 4 and 9 and, like the parabens, it has the advantage to be inexpensive and the disadvantage to be incompatible with most of the non-ionic surfactants. However, despite its qualities, Phenoxyethanol is mainly active against Gram- bacteria. Like the Parabens, it is active against a broad spectrum of microorganisms but its activity against Gram+ bacteria, yeast and mold is not always totally convincing.
Sodium Benzoate (and Benzoic Acid), potentially in combination with Potassium Sorbate, is also an acceptable alternative. Sodium Benzoate can be used at the following levels:
- up to 2.5% in rinse-off products
- 1.7% in oral care products
- 0.5% in leave-on products
- 0.06% and above shows activity against yeast and mold
Sodium Benzoate (and Potassium Sorbate) are inexpensive and can be easily sourced from nature (and therefore have the advantage to be compatible with a natural certification). However, the ideal pH for Sodium Benzoate alone or in combination with Potassium Sorbate is mainly between 3 to 5, which could be a problem, because many products are formulated out of this range. Using this preservative would be a mistake, as its efficacy could be low or even negligible. Furthermore, Sodium Benzoate is not a broad-spectrum preservative and usually has to be combined with a preservative active against Pseudomonas (Gram- bacteria).
Similarly, Benzyl Alcohol can be a valid alternative. Active against Gram+ bacteria from 25 ppm, it will generally be combined with Dehydroacetic Acid, more active against yeast and mold. Benzyl Alcohol can be used at up to 1.0% and Dehydroacetic Acid at up to 0.6%. This combination will be preferably used at a pH between 3 and 5. Incompatibility is low except with the non-ionic surfactants and this combination can also be sourced from nature.
Other convincing alternatives exist and this article does not seek to list them all. However, it is worthwhile to highlight the possibility to formulate preservative-free cosmetic products. The most common option in skincare products is the use of airless devices, such as the airless pump bottles by The Packaging Company, combined with a rigorous quality control system to avoid microbiological contaminations during the manufacturing process.
The cosmetic product is then formulated without preservatives, which is acceptable as the finished product and the packaging are completely sterile and not in contact with the external environment.
The packaging is clearly more expensive than traditional pumps or jars but it gives access to interesting competitive advantages such as the marketing claim “Preservative free”. Please note that “Preservative free” is 100% EU compliant while “Paraben free” is not.
- Consumer Concern Over Parabens Leads to Trending Alternatives
- The Bad, the Banned, and the Maligned: Formulating with Your Hands Tied
- The Challenge of Natural Cosmetics
- Preservation Strategies for Global Personal Care Formulations
- Methylisothiazolinone is prohibited by the EU Cosmetics Regulation (EC No 1223/2009) in leave-on cosmetic products and will be restricted at only 15 ppm in rinse-off cosmetic products in the next few months. Kathon CG is also prohibited in leave-on products and is already restricted at 15 ppm in rinse-off products.
- Concentrations of Parabens in Human Breast Tumors by P.D. Darbre, A. Alijarrah, W.R. Miller, N.G. Coldham, M.J. Sauer and G.S. Pope, Journal of Applied Toxicology, 24, 5-13 (2004).
- g. “Envoyé Spécial”, airdate March, 3rd, 2005
- Report from the Commission to the European Parliament and the Council on product claims made based on common criteria in the field of cosmetics [PDF] (see section 3.3.3)
- Scientific Committee on Consumer Safety (SCCS) Opinion on Parabens COLIPA n° P82 [PDF]
- SCCS Opinion on Parabens UPDATED request for a scientific opinion on propyl- and butylparaben COLIPA n° P82 [PDF]
- Scientific Committee on Consumer Products (SCCP) Extended Opinion on the Safety Evaluation of Parabens [PDF]
- Prohibited in leave-on products designed for application on the nappy area of children under three years of age.
- SCCS OPINION ON Phenoxyethanol [PDF]
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