May 18, 2016
Phenoxyethanol is one of the most common synthetic preservatives used in cosmetics as an alternative to parabens. The Scientific Committee on Consumer Safety (SCCS) was called on to run tests on the preservative following the submission of a risk assessment by the French agency ANSM in 2012, which rose concerns about its effect on children.
Background: The ANSM report concludes that the maximum authorised concentration (currently of 1%) of Phenoxyethanol for use as a preservative should be lowered to 0.4% in cosmetic products for children less than three years. In addition, Phenoxyethanol should not be used in cosmetic products intended for their nappy area. The Commission received information from other member States which raised similar concern on the use of Phenoxyethanol, in particular on children. In December 2013, in response to a call for data on Phenoxyethanol by the Commission, Cosmetics Europe submitted a safety dossier in order to defend the current use of Phenoxyethanol as preservative in cosmetic formulations at a maximum concentration of 1.0%. By July 2015, the submission of data was complemented with a safety assessment tool in order to provide a perspective on systemic exposure of Phenoxyethanol in humans (absorption, distribution, metabolism and excretion)
1. Does SCCS consider Phenoxyethanol safe for use as a preservative with a maximum concentration of 1.0 %, taking into account the information provided? The SCCS considers 2-phenoxyethanol safe for use as a preservative with a maximum concentration of 1.0%, taking into account the information provided.
2. The SCCS is asked, when making the assessment, to take into account the specific age groups who might be particularly susceptible to the effects of Phenoxyethanol used as preservatives in cosmetic products. The toxicokinetics default factor of 4.0 can be reduced to 1.0 yielding a minimum Margin of Safety (MoS) of 25 instead of 100 for the safety assessment of 2-phenoxyethanol. Therefore, the MoS of about 50 for children also covers this specific age group who might be higher exposed to 2-phenoxyethanol than adults.
3. Does the SCCS have any further scientific concerns with regard to the use of Phenoxyethanol in cosmetic products? This Opinion does not take into account exposure from other sources than cosmetics. The deadline for comments on this opinion is 31st May 2016. http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_195.pdf