Between 2020 and 2021, a large number of food products such as packaged ice cream, sesame seeds, various spices, and supplements were withdrawn from the market in Italy and many other European states. The motivation behind the substantial recalls is the presence, beyond legal limits, of ethylene oxide. This substance is permitted for use as a fumigant to control pests and a broad spectrum of microorganisms, including bacterial pathogens, in several countries, e.g., India, Canada, and the United States. However, the use of EO as a pesticide has been banned in the European Union (EU) since 1991 because of its mutagenic and carcinogenic properties. In September 2020, Belgium initiated a RASFF notification on the unauthorized use of ethylene oxide in sesame seeds from India, reporting 30 mg/kg. From the information gathered, ethylene oxide in these food products served to reduce or eliminate microbiological salmonella contamination. This finding was significant, leading to recalls or market withdrawals of several products such as breads, hummus, sauces, and other foods containing sesame seeds. In this particular case, the European Commission quickly implemented Commission Regulation 2020/1540 requiring all imports of sesame seeds from India to comply with the MRL set at 0.02 mg/kg (sum of EO plus 2-CE, expressed as EO). In this thesis work, a method was validated and applied to determine the residues of ethylene oxide and its metabolite, 2-chloroethanol, directly as a summation as expressed in the legislation, using the GC-MS/MS technique in numerous matrices consisting of seeds of plant origin, cereals and their derivatives, bakery products, dried fruits, coffee, dry plant extracts, raw materials used as components in dietary supplements, and the supplements themselves. The thesis work was carried out at LabAnalysis S.r.l. Company in the pharmaceutical industry in accordance with Good Manufacturing Practices (GMP) standards.
Tra il 2020 e il 2021, in Italia e in molti altri Stati europei, sono stati ritirati dal mercato tantissimi prodotti alimentari come gelati confezionati, semi di sesamo, diverse spezie e integratori. La motivazione alla base dei consistenti ritiri è la presenza, oltre i limiti di legge, di ossido di etilene. Questa sostanza è consentita per l'uso come fumigante per controllare i parassiti e un ampio spettro di microrganismi, inclusi agenti patogeni batterici, in diversi paesi, ad esempio India, Canada e Stati Uniti. L'uso di EO come pesticida è, tuttavia, vietato nell'Unione europea (UE) a partire dal 1991 a causa delle sue proprietà mutagene e cancerogene. Nel settembre 2020, il Belgio ha avviato una notifica RASFF sull'uso non autorizzato di ossido di etilene nei semi di sesamo dall'India, riportando 30 mg/kg. Dalle informazioni raccolte, l’ossido di etilene presente in questi prodotti alimentari serviva a ridurre o eliminare la contaminazione microbiologica da salmonella. Questa scoperta è stata significativa, portando a richiami o ritiri dal mercato di diversi prodotti come ad esempio pane, hummus, salse e altri alimenti contenenti semi di sesamo. In questo caso particolare, la Commissione europea ha rapidamente attuato il regolamento 2020/1540 della Commissione che impone a tutte le importazioni di semi di sesamo dall'India di rispettare l'LMR fissato a 0,02 mg/kg (somma di EO più 2-CE, espressa come EO). In questo lavoro di tesi è stato validato e applicato un metodo che consente di determinare i residui di ossido di etilene e del suo metabolita, 2-cloroetanolo, direttamente come sommatoria così come viene espresso dalla legislazione, mediante la tecnica GC-MS/MS in numerose matrici costituite da semi di origine vegetale, cereali e derivati, prodotti da forno, frutta secca, caffè, estratti secchi vegetali, materie prime utilizzate come componenti in integratori alimentari e gli stessi integratori. Il lavoro di tesi è stato svolto presso l’Azienda LabAnalysis S.r.l. nel settore farmaceutico in conformità con le norme Good Manufacturing Practices (GMP).
Validazione e Applicazione di un metodo analitico che consente di determinare i residui di ossido di etilene e del suo metabolita, 2-cloro-etanolo, direttamente come sommatoria, mediante la tecnica GC-MS/MS in numerose matrici alimentari e integratori
ZITO, COSIMO
2021/2022
Abstract
Between 2020 and 2021, a large number of food products such as packaged ice cream, sesame seeds, various spices, and supplements were withdrawn from the market in Italy and many other European states. The motivation behind the substantial recalls is the presence, beyond legal limits, of ethylene oxide. This substance is permitted for use as a fumigant to control pests and a broad spectrum of microorganisms, including bacterial pathogens, in several countries, e.g., India, Canada, and the United States. However, the use of EO as a pesticide has been banned in the European Union (EU) since 1991 because of its mutagenic and carcinogenic properties. In September 2020, Belgium initiated a RASFF notification on the unauthorized use of ethylene oxide in sesame seeds from India, reporting 30 mg/kg. From the information gathered, ethylene oxide in these food products served to reduce or eliminate microbiological salmonella contamination. This finding was significant, leading to recalls or market withdrawals of several products such as breads, hummus, sauces, and other foods containing sesame seeds. In this particular case, the European Commission quickly implemented Commission Regulation 2020/1540 requiring all imports of sesame seeds from India to comply with the MRL set at 0.02 mg/kg (sum of EO plus 2-CE, expressed as EO). In this thesis work, a method was validated and applied to determine the residues of ethylene oxide and its metabolite, 2-chloroethanol, directly as a summation as expressed in the legislation, using the GC-MS/MS technique in numerous matrices consisting of seeds of plant origin, cereals and their derivatives, bakery products, dried fruits, coffee, dry plant extracts, raw materials used as components in dietary supplements, and the supplements themselves. The thesis work was carried out at LabAnalysis S.r.l. Company in the pharmaceutical industry in accordance with Good Manufacturing Practices (GMP) standards.È consentito all'utente scaricare e condividere i documenti disponibili a testo pieno in UNITESI UNIPV nel rispetto della licenza Creative Commons del tipo CC BY NC ND.
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https://hdl.handle.net/20.500.14239/15467