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Protocol for the hazard assessment as part of the risk assessment of phthalates, structurally similar substances and replacement substances potentially used as plasticisers in materials and articles intended to come into contact with food

2022; European Food Safety Authority; Volume: 19; Issue: 11 Linguagem: Inglês

10.2903/sp.efsa.2022.en-7660

2397-8325

Claudia Bolognesi, Emanuela Corsini, Riccardo Crebelli, Rex FitzGerald, Claude Lambré, Francesca Romana Mancini, Marcel Mengelers, Gilles Rivière, Emanuela Testai, Detlef Wölfle, Chantra Eskes, Marios Georgiadis, Irene Muñoz Guajardo, Katharina Volk, Laurence Castle,

Agricultural safety and regulations

EFSA Supporting PublicationsVolume 19, Issue 11 7660E Technical reportOpen Access Protocol for the hazard assessment as part of the risk assessment of phthalates, structurally similar substances and replacement substances potentially used as plasticisers in materials and articles intended to come into contact with food European Food Safety Authority (EFSA), Corresponding Author European Food Safety Authority (EFSA) fip@efsa.europa.eu Correspondence:fip@efsa.europa.euSearch for more papers by this authorClaudia Bolognesi, Claudia BolognesiSearch for more papers by this authorEmanuela Corsini, Emanuela CorsiniSearch for more papers by this authorRiccardo Crebelli, Riccardo CrebelliSearch for more papers by this authorRex FitzGerald, Rex FitzGeraldSearch for more papers by this authorClaude Lambré, Claude LambréSearch for more papers by this authorFrancesca Mancini, Francesca ManciniSearch for more papers by this authorMarcel Mengelers, Marcel MengelersSearch for more papers by this authorGilles Rivière, Gilles RivièreSearch for more papers by this authorEmanuela Testai, Emanuela TestaiSearch for more papers by this authorDetlef Wölfle, Detlef WölfleSearch for more papers by this authorChantra Eskes, Chantra EskesSearch for more papers by this authorMarios Georgiadis, Marios GeorgiadisSearch for more papers by this authorIrene Munoz Guajardo, Irene Munoz GuajardoSearch for more papers by this authorKatharina Volk, Katharina VolkSearch for more papers by this authorLaurence Castle, Laurence CastleSearch for more papers by this author European Food Safety Authority (EFSA), Corresponding Author European Food Safety Authority (EFSA) fip@efsa.europa.eu Correspondence:fip@efsa.europa.euSearch for more papers by this authorClaudia Bolognesi, Claudia BolognesiSearch for more papers by this authorEmanuela Corsini, Emanuela CorsiniSearch for more papers by this authorRiccardo Crebelli, Riccardo CrebelliSearch for more papers by this authorRex FitzGerald, Rex FitzGeraldSearch for more papers by this authorClaude Lambré, Claude LambréSearch for more papers by this authorFrancesca Mancini, Francesca ManciniSearch for more papers by this author … See all authors First published: 24 November 2022 https://doi.org/10.2903/sp.efsa.2022.EN-7660 Requestor: European Commission Question number: EFSA-Q-2021-00593 Note: The Outcome of the Public Consultation is available under the Supporting Information section AboutReferencesRelatedInformationPDFPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessClose modalShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Abstract EFSA was requested by the European Commission to re-evaluate the risks to public health related to the presence of plasticisers such as phthalates, structurally similar substances and replacement substances, as a consequence of migration from food contact materials (FCMs). In the first part of the two-part mandate, EFSA was tasked with drawing up a protocol for assessing the hazards of plasticiser substances. The current hazard assessment protocol has been developed using the principles of, and following the recommendations provided in, the 'Draft framework for protocol development for EFSA's scientific assessments' (EFSA et al., 2020). The protocol describes how the two central questions on hazard identification and hazard characterisation will be addressed. It aims to describe as far as possible the strategy for retrieving, selecting and extracting the data, appraising the relevant evidence, and summarising, analysing and integrating that evidence in order to perform hazard assessments that will be used for the risk assessment of the prioritised substances. Outputs addressing the following three related tasks in the mandate will be published separately: (i) identifying and prioritising those substances used or potentially used as plasticisers in FCMs that may warrant further data collection and risk assessment; (ii) drawing up a protocol for the exposure assessment of the prioritised substances; and (iii) setting up calls for data and other information on the occurrence of the prioritised substances. References Beronius A, Molander L, Rudén C and Hanberg A, 2014. Facilitating the use of non-standard in vivo studies in health risk assessment of chemicals: A proposal to improve evaluation criteria and reporting. 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