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.

Risk factors influencing contamination of customized cosmetics made on-the-spot: Evidence from the national pilot project for public health

“…The US FDA states that cosmetics need not be sterile; however, cosmetic products must not be contaminated with pathogenic microorganisms, and the level of nonpathogenic microorganisms should be low 12 . Achieving this standard requires a good quality management system for cosmetics, which consists of raw material quality and hygienic design of facilities 19 .…”

Microbiological safety of cosmetic products and potential risks for consumers

“…), a negde još i Bacillus cereus, zbog oftalmoloških infekcija. Neke potrošačke grupe (deca, naročito novorođenčad, stare osobe i one sa oslabljenim imunskim sistemom) su sklonije infekcijama oportunističkim patogenima (5). Ipak, Naučni komitet za bezbednost korisnika/potrošača (Scientific Committee on Consumer Safety, SCCP) u Vodiču za ispitivanje kozmetičkih sastojaka i procenu njihove bezbednosti 1 (Notes of Guidance for the testing of Cosmetic Ingredients and their Safety Evaluation) navodi da čak i kozmetički proizvodi namenjeni deci mlađoj od 3 godine, kao i proizvodi za područje oko oka i za primenu na sluzokožama, mogu da budu kontaminirani saprofitnim mikroorganizmima do 200 CFU po g ili ml proizvoda (6).…”

“…Smernice GMP koje su direktno povezane sa obezbeđenjem mikrobiološkog kvaliteta proizvoda, odnose se na kontrolu kvaliteta polaznih sirovina (naročito onih prirodnog porekla, za proizvode za oči) i pakovnog materijala pre korišćenja u prozvodnji, kontinuiranu kontrolu kvaliteta vode, korišćenje prethodno validiranih sistema konzervanasa, efikasno čišćenje prostorija (površina i prečišćavanje vazduha) i opreme validiranim postupcima, higijenu osoblja koje je uključeno u postupak proizvodnje (uz odgovarajuću obuku), kontrolu kvaliteta gotovog proizvoda i uslove skladištenja polaznih materijala i gotovog proizvoda (2). Sistem konzervansa se validira tokom razvoja proizvoda obično izvođenjem testa izazivanja ili drugog pogodnog ispitivanja (5).…”

“…Generalno, ozbiljni incidenti vezani za bezbednost kozmetičkih proizvoda su retki, naročito od uvođenja jasnih regulatornih zahteva, uključujući usaglašenost proizvodnje sa GMP. Pre uvođenja ovih propisa infekcije putem kozmetičkih proizvoda, uglavnom gram negativnim mikroorganizmima, javljale su se češće (5). Poslednjih godina, retke infekcije ovog porekla javile su se uglavnom kod hospitalizovanih osoba (38).…”

Preservatives, colorants and UV filters in cosmetic products: Safety aspects

“…Ipak, kako u toku upotrebe može doći do kontaminacije kozmetičkog proizvoda, posebno kada on predstavlja pogodnu sredinu za razvoj mikroorganizama, u formulaciji kozmetičkog proizvoda neophodno je prisustvo antimikrobnih supstanci -konzervanasa. Mikrobiološka kontaminacija može predstavljati rizik za zdravlje potrošača, i iako retki, zvanično jesu zabeleženi slučajevi bakterijskih infekcija kod korisnika koje su bile izazvane kozmetičkim proizvodima (5). Sa aspekta učestalosti pojavljivanja, daleko je značajnija činjenica, da usled mikrobiološke kontaminacije može doći do promena fizičko-hemijskih karakteristika proizvoda, pa i nastanka toksičnih supstanci, što je sve zajedno neprihvatljivo sa marketinškog aspekta svakog kozmetičkog proizvoda.…”