Focus Preservatives: Phenoxyethanol
One of the most widely used cosmetic preservatives since parabens were heavily criticised is undoubtedly Phenoxyethanol. Thanks to its broad spectrum of action and excellent efficacy against a wide range of Gram-negative and Gram-positive bacteria, yeasts and moulds, it remains a preferred choice when developing an effective preservative system.
Phenoxyethanol is regulated under Annex V / 29 of the Cosmetics Regulation (EC) No 1223/2009. According to Regulation (EC) No 1223/2009, Phenoxyethanol is authorised as a preservative in cosmetic formulations at a maximum concentration of 1.0%.
Concerns and requests for restrictions
In September 2012, the European Commission received a risk assessment submitted by the French agency ANSM, which raised concerns about the use of Phenoxyethanol as a preservative in cosmetics.
The ANSM report concluded that the currently authorised maximum concentration of 1% should be reduced to 0.4% in cosmetic products for children under three years old. Moreover, Phenoxyethanol should not be used in products intended for the nappy area. Similar concerns were raised by other Member States, particularly in relation to children.
Toxicological profile of Phenoxyethanol
The toxicity profile of Phenoxyethanol has been investigated in preclinical studies assessing acute and repeated-dose toxicity, genotoxicity, reproductive toxicity, developmental toxicity, irritation, sensitisation, percutaneous absorption, toxicokinetics and specific investigations such as in vitro hematotoxicity in various species. Human exposure data and human irritation / sensitisation data are also available. Hematotoxicity represents the predominant toxicological concern for Phenoxyethanol both in vivo and in vitro.
Calculation of the MoS of Phenoxyethanol
The comparison between oral toxicity studies in rats, mice and rabbits shows that rabbits are the most sensitive species to hematotoxic effects. Furthermore, dermal exposure to Phenoxyethanol in rats resulted in much higher blood concentrations of the parent compound than oral exposure. For these reasons, and because dermal exposure is the most relevant route for cosmetic products, dermal studies in rabbits are given priority.
Because humans metabolise Phenoxyethanol more efficiently than rabbits, the default toxicokinetic factor of 4.0 can be reduced to 1.0, leading to a minimum Margin of Safety (MoS) of 25 instead of 100 for safety evaluation purposes.
For MoS calculation, the SCCS uses:
- A NOAEL of 357 mg/kg bw/day obtained from a 90-day dermal repeated-dose toxicity study in rabbits
- The cumulative exposure to preservatives in cosmetics
For adults, an MoS of 130 was derived. This value also covers the safety assessment for babies and children exposed to Phenoxyethanol through cosmetic products.
Conclusions
On the basis of the available information, the SCCS considers the use of Phenoxyethanol safe at a maximum concentration of 1%, including in products intended for children under three years old.