title: Screening of preservatives by HPLC-PDA-ESI/MS: A focus on both allowed and recently forbidden compounds in the new EU cosmetics regulation.
abstract: Commission regulation (EU) No 358/2014 amending the new regulation (EC) No 1223/2009 on cosmetics has prohibited the use of isopropyl-, isobutyl-, phenyl-, benzyl- and pentylparaben. Furthermore, Commission regulation (EU) No 1004/2014 has lowered the maximum permitted concentration of butyl- and propylparaben in cosmetics and it has also banned them in leave-on products designed for application on the nappy area of children under three years of age. A HPLC-PDA-ESI/MS method has been developed herein for the detection of seventeen preservatives, both the most utilised and the recently forbidden by the new EU regulations. The separation of these compounds, including benzoic acid and its derivatives in a 1.10 - 3.04 log Pow range, has been performed with a gradient elution on a Symmetry(®) C18 column (250×4.6mm i.d., particle size 5μm) with water and acetonitrile (0.1% formic acid) as mobile phase. Quantification has been carried out by HPLC-PDA. The method has been validated and successfully applied to the analysis of a large number of cosmetics with different functions like rinse-off and leave-on, or composition like skin, hair, face and oral products.
authors.affiliation: Dipartimento del Farmaco, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Rome, Italy.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Lecce
authors.affiliation: Dipartimento di Scienze Farmaceutiche, Università degli Studi di Milano,Via Mangiagalli 25, 20133 Milan, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Regazzoni
authors.affiliation: Dipartimento del Farmaco, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Rome, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: Mustazza
authors.affiliation: Dipartimento del Farmaco, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Rome, Italy.
authors.forename: Giampaolo
authors.initials: G
authors.lastname: Incarnato
authors.affiliation: Dipartimento del Farmaco, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Rome, Italy.
authors.forename: Rita
authors.initials: R
authors.lastname: Porrà
authors.affiliation: Dipartimento del Farmaco, Istituto Superiore di Sanità, Viale Regina Elena 299, 00161 Rome, Italy. Electronic address: alessia.panusa@iss.it.
authors.forename: Alessia
authors.initials: A
authors.lastname: Panusa
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D003358:Cosmetics / Q000032:analysis*; D005062:European Union; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*
chemical_list: D003358:Cosmetics
keywords: 4-Hydroxybenzoic acid derivatives; Cosmetics; Parabens; Preservatives; Regulation (EC) No 1223/2009