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

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.