Ingredient
PROPYLPARABEN
Name / description
Propylparaben; Propyl 4-Hydroxybenzoate; in food: E 216
Function(s) of this ingredient in cosmetic products
PRESERVATIVE
Protects cosmetic products from microbial spoilage
Origin
synthetic
Occurrence in cosmetics
In skin care and cleansing products such as emulsions, creams, shampoos as well as in styling products and many other cosmetic products
Occurrence in other products
Parabens also increase the shelf life of medicinal products and certain foodstuffs (such as salads, fish or mayonnaise). Like all preservatives, they protect against microbial spoilage and hence ensure the safety of the products for the consumer.
Background information on use in cosmetics
Preservatives protect cosmetic products against microbial spoilage and hence make a major contribution to consumer health. Preservatives are particularly required in cosmetic formulations containing water, because microorganisms can colonise and reproduce in an aqueous (water-containing) environment. Cosmetics often contain more than one preservative substances and these preservative systems act simultaneously against different bacteria, yeasts or moulds. Each of these substances has been comprehensively tested and assessed for safety (individually and in combination). Manufacturers always use only the lowest possible effective concentration in a product so that an optimum shelf life and safe application are ensured. Parabens are salts and esters of para-hydroxybenzoic acid. Like the related benzoic acid, they have an antimicrobial and fungicide effect. For that reason some esters have been added since more than 80 years as preservatives to cosmetics. The following are allowed in cosmetic products: para-hydroxybenzoic acid (paraben), methyl paraben, ethyl paraben, propyl paraben, butyl paraben, as well as some of their sodium, potassium and calcium salts. In nature parabens occur in many plants such as cucumbers, carrots, onions, cherries, blueberries or strawberries.
Information on safe use
In accordance with the EC Cosmetics Regulation (Regulation (EC) No. 1223/2009), which applies to the entire EU market, preservatives means substances which are exclusively or mainly intended to inhibit the development of microorganisms in the cosmetic product. Annex V of the Regulation defines the substances which may be used as preservatives in cosmetic products. In this so-called positive list of preservatives, maximum concentrations are defined for the use of these substances in cosmetic products as well as the permissible uses. Preservatives are examined in respect of their toxicological safety prior to their approval in Annex V and undergo extensive tests. Manufacturers must prove the health safety in extensive scientific studies. From a scientific point of view, parabens are the currently best investigated and safest preservatives on the market. BfR (German Federal Institute for Risk Assessment) classifies them as safe. In 2010 the SCCS reviewed the concentrations of the individual parabens in cosmetic products and re-confirmed in May 2013 that parabens can be classified as safe in the concentration in which they are used in cosmetic products. Current literature proves that parabens are in allergological terms amongst the preservatives with a particularly low allergenic potential. There are reports about allergies but if one relates them to the frequency of use (many products on the market are preserved with parabens), parabens can be designated as allergologically inconspicuous.
Links to scientific assessments
Opinion of the SCCS (2013) on the safety of propyl and butyl parabens
Position paper of BfR (2011) on the use of parabens in cosmetic products (in German)
Opinion of the SCCS (2010) on the safety of parabens as preservatives in cosmetics
Opinion of the SCCS (2021) on the safety of propylparaben
Why are we talking about it?
Propylparaben is suspected of being an endocrine disruptor and of causing breast cancer. The facts: The safety of propylparaben, a well-tolerated preservative authorised for use in cosmetic products, has been widely evaluated by numerous expert committees (European, American, Dutch etc.) (2, 3 and 4). In Europe alone, the safety of use of propylparaben in cosmetic products was evaluated in 2005, 2006, 2008, 2010, 2011, 2013 and again in 2020 taking into account all existing scientific data, including those on endocrine disruption. In vitro studies (i.e. studies or manipulations carried out in an artificial laboratory environment, for instance in a test tube) show a low activity of parabens on oestrogen receptors, which is overall 20,000 to 700,000 times lower than that of the female reference hormone (oestradiol). Furthermore, the shorter the molecule, the less it is absorbed by the skin and the lower its activity, and parabens are rapidly transformed by the skin into a molecule that does not show these low effects. The in vivo results (i.e. studies or manipulations carried out on living organisms) are contradictory (1) (2). It is because of the contradictions observed between several studies that, in 2020, European experts have analysed all the relevant information available in the literature, focusing on the study of its potential endocrine effects. They concluded that the current level of evidence is not sufficient to conclusively consider propylparaben as an endocrine disruptive substance (5). The safety of use of propylparaben was therefore assessed by applying the "worst case scenario", i.e. the highest exposure and dermal absorption values are considered alongside the lowest no-effect dose value. European and American experts therefore now consider propylparaben to be safe for use in cosmetic products at the authorised concentrations. Furthermore, current scientific studies do not show any causal link between exposure to parabens and the development of breast cancer (Académie de pharmacie, 2013) (5)(6). Key points to take away: Like all preservatives, propylparaben is highly regulated by European legislation. Its safety of use in cosmetic products has been studied many times over the last fifteen years, and again recently in 2020 (5). Propylparaben is not considered a proven endocrine disruptor, is not genotoxic, nor carcinogenic, nor allergenic. Finally, there is no evidence that people who use products containing propylparaben have an increased risk of developing cancer. In conclusion, propylparaben is considered safe for use by the competent health authorities at the very low concentrations currently authorised in cosmetic products. Sources: (1) In vitro data allow to identify a mechanism of action. To find out whether this mechanism has an effect on a living organism, in vivo studies are carried out. (2) Opinions of the European Scientific Committee on Consumer Safety a. SCCP/0873/05: https://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_019.pdf b. Extended Opinion on Parabens, underarm cosmetics, and breast cancer, SCCP/0874/05: http://www.alegesanatos.ro/dbimg/files/Parabens.pdf c. SCCP/1017/06: https://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_074.pdf d. SCCP/1183/08: https://ec.europa.eu/health/archive/ph_risk/committees/04_sccp/docs/sccp_o_138.pdf e. SCCS/1348/10: https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_041.pdf f. "Clarification on Opinion SCCS/1348/10 in the light of the Danish clause of safeguard banning the use of parabens in cosmetic products intended for children under three years of age", SCCS/1446/11: https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_069.pdf g. SCCS/1514/13: https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_132.pdf (3) Cosmetic Ingredient Review (CIR): Amended Safety Assessment of Parabens as Used in Cosmetics (2020): https://pubmed.ncbi.nlm.nih.gov/32723119/ (4) National Institute for Public Health and the Environment (RIVM report 2017-0028): Exposure to and toxicity of methyl-, ethyl- and propyl paraben (https://www.rivm.nl/bibliotheek/rapporten/2017-0028.html) (5) European Scientific Committee on Consumer Safety - SCCS/1623/20: https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_243.pdf (6) French Pharmaceutical Academy (Académie Nationale de Pharmacie): Parabènes & médicaments: un problème de santé publique? (2013): https://www.acadpharm.org/dos_public/Recommandations_parabenes_et_mEdiments_Conseil_22.05.2013_VF_27.05.2013.pdf
Further information
For the clarification of a suspicion of a contact allergy this substance can be routinely tested in the epicutaneous test at the dermatologist.
Belongs to the following substance groups
Database
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