Metals in cosmetics: an a posteriori safety evaluation.
According to EU Regulation No. 1223/2009/CE cosmetic products for daily use can contain 'technically unavoidable traces' of metals. This definition is too vague. Authorities should set well-defined limits, considering the risks associated with metal contamination of personal care products (PCPs). This paper characterizes the risk arising from a number of metals (antimony, arsenic, cadmium, cobalt, chromium, mercury, nickel, lead) that may occur in 'unavoidable traces" in raw materials and, consequently, in PCPs. A 'worst case scenario' was adopted, based on the following assumptions: (i) the individual ingredients contained the maximum amount in traces allowed for each metal; (ii) the hypothetical PCP was produced exclusively with that single ingredient; (iii) when absorption through the skin was not known, data related to oral absorption were used. Risk characterization was performed calculating the Systemic Exposure Dosage (SED) and the Margin of Safety (MoS=NOAEL or BMDL10/SED). Exposure to the allegedly 'technically unavoidable' maximum amounts of metals in cosmetic ingredients resulted in MoSs exceeding 100 (safety threshold) with one exception. This suggests that the availability of experimental dermal absorption rates could enable significant improvement in MoS, thus increasing safety levels. Although results are reassuring, the authors recommend minimization of contamination, according to the state of the art of manufacturing methods.
Lab. of Toxicology and Risk Assessment, Department of Pharmacological and Biomolecular Sciences, University of Milan, via Balzaretti 9, 20133 Milan, Italy.
Marina
M
Marinovich
Lab. of Toxicology and Risk Assessment, Department of Pharmacological and Biomolecular Sciences, University of Milan, via Balzaretti 9, 20133 Milan, Italy.
Maria Serena
MS
Boraso
Istituto Superiore di Sanità, Department of Environment and Primary Prevention, Mechanisms of Toxicity Unit, Viale Regina Elena 299, 00161 Rome, Italy.
Emanuela
E
Testai
Lab. of Toxicology and Risk Assessment, Department of Pharmacological and Biomolecular Sciences, University of Milan, via Balzaretti 9, 20133 Milan, Italy. Electronic address: corrado.galli@unimi.it.
Corrado L
CL
Galli
D003257:Consumer Product Safety; D003358:Cosmetics / Q000032:analysis* / Q000737:chemistry*; D006801:Humans; D008670:Metals / Q000009:adverse effects* / Q000737:chemistry*; D018570:Risk Assessment; D012449:Safety; D012867:Skin / Q000187:drug effects
D003358:Cosmetics; D008670:Metals
Contamination; Cosmetics; Metals; Personal care products; Risk assessment; Safety