title: Microbiological risk assessment for personal care products.
abstract: Regulatory decisions regarding microbiological safety of cosmetics and personal care products are primarily hazard-based, where the presence of a potential pathogen determines decision-making. This contrasts with the Food industry where it is a commonplace to use a risk-based approach for ensuring microbiological safety. A risk-based approach allows consideration of the degree of exposure to assess unacceptable health risks. As there can be a number of advantages in using a risk-based approach to safety, this study explores the Codex Alimentarius (Codex) four-step Microbiological Risk Assessment (MRA) framework frequently used in the Food industry and examines how it can be applied to the safety assessment of personal care products. The hazard identification and hazard characterization steps (one and two) of the Codex MRA framework consider the main microorganisms of concern. These are addressed by reviewing the current industry guidelines for objectionable organisms and analysing reports of contaminated products notified by government agencies over a recent 5-year period, together with examples of reported outbreaks. Data related to estimation of exposure (step three) are discussed, and examples of possible calculations and references are included. The fourth step, performed by the risk assessor (risk characterization), is specific to each assessment and brings together the information from the first three steps to assess the risk. Although there are very few documented uses of the MRA approach for personal care products, this study illustrates that it is a practicable and sound approach for producing products that are safe by design. It can be helpful in the context of designing products and processes going to market and with setting of microbiological specifications. Additionally, it can be applied reactively to facilitate decision-making when contaminated products are released on to the marketplace. Currently, the knowledge available may only allow a qualitative or semi-quantitative rather than fully quantitative risk assessment, but an added benefit is that the disciplined structuring of available knowledge enables clear identification of gaps to target resources and if appropriate, instigate data generation.
authors.affiliation: Safety and Environmental Assurance Centre, Unilever, Colworth Science Park, Sharnbrook, Bedfordshire, MK44 1LQ, UK.
authors.forename: S E
authors.initials: SE
authors.lastname: Stewart
authors.affiliation: Safety and Environmental Assurance Centre, Unilever, Colworth Science Park, Sharnbrook, Bedfordshire, MK44 1LQ, UK.
authors.forename: M D
authors.initials: MD
authors.lastname: Parker
authors.affiliation: Safety and Environmental Assurance Centre, Unilever, Colworth Science Park, Sharnbrook, Bedfordshire, MK44 1LQ, UK.
authors.forename: A
authors.initials: A
authors.lastname: Amézquita
authors.affiliation: 712 Kenton Lane, Harrow, Middlesex, HA3 6AB, UK.
authors.forename: T L
authors.initials: TL
authors.lastname: Pitt
mesh_terms: D001419:Bacteria / Q000302:isolation & purification; D003358:Cosmetics / Q000009:adverse effects; D006801:Humans; D018570:Risk Assessment
chemical_list: D003358:Cosmetics
keywords: microbiology; predictive microbiology; preservation systems; risk-based approach; safety testing