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Protocol for the exposure 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 establishing a protocol for assessing the exposure of EU consumers to the plasticiser substances. Other tasks include: i) identifying and prioritising those plasticisers used in FCMs that may warrant further data collection and eventual risk assessment, ii) establishing a protocol for the hazard assessment of the prioritised substances, and iii) establishing calls for data and other information on the occurrence of the prioritised substances. Work to address those three additional tasks will be reported separately. Close collaboration with the European Chemicals Agency was requested in the mandate. This exposure protocol has been developed using the principles 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 three central questions will be addressed: what is the total dietary exposure, what is the exposure coming from FCMs, and what is the overall exposure (dietary and non‐dietary) to the prioritised substances in different population groups and age classes in the EU. The protocol aims to describe as far as possible the approach for identifying, extracting, cleaning and selecting data, appraising the relevant evidence, analysing and integrating that evidence and addressing the uncertainties, in order to perform exposure assessments that will be used for the risk assessment of the prioritised substances in the second part of the two‐part mandate.

This publication is linked to the following EFSA Journal article: