Overview of proficiency testing results for the in vivo determination of sun protection factor

Abstract

A sunscreen product is allowed to be marketed if a protection is provided against ultraviolets (UV) including UVA rays and UVB rays expressed by the sun protection factor (SPF). UVB is radiation that is in the region of the ultraviolet spectrum which extends from about 290 to 320 nm in wavelength and that is primarily responsible for sunburn, ageing of the skin, and the development of skin cancer. Thus, since April 2009, the Bureau Interprofessionnel d'Etudes Analytiques (BIPEA) set up a proficiency testing scheme (PTS) for the determination of SPF in vivo of sunscreen products according to ISO 24444 standard [Cosmetics - Sun protection test methods - in vivo determination of the sun protection factor (SPF)] to evaluate the analytical performances of laboratories on these analyses. This PTS gathers twenty-six laboratories around the world with one trial a year. For each test, the statistical treatment of the data is performed according to ISO 13528 standard [Statistical methods for use in proficiency testing by interlaboratory comparison]. The assigned and tolerance values are calculated from the participants' data and the performances of the laboratories are evaluated individually and collectively according to ISO 17043 standard [Conformity assessment - General requirements for proficiency testing]. This paper presents the design of the PT program, its development, and an attentive analysis of laboratories results, which highlight the global performances obtained by laboratories on this type of analysis. The evaluation of the results shows, in fact, a relatively constant dispersion of data since the implementation of the PT program (variability between 10% and 50%).