On November 5, 2021, the European Food Safety Authority (EFSA) announced the publication and launch of public consultations of its draft opinion “on the identification and prioritization for risk assessment of plasticizers used in food contact materials” (FCMs) and the draft protocol “for the exposure assessment of those substances that are prioritized.” The work was carried out at the request of the European Commission to “re-evaluate the risks to public health related to the presence of plasticizers such as phthalates, structurally similar substances, and replacement substances, as a consequence of migration from food contact materials (FCMs).” 

The draft opinion offers an overview of substances determined to potentially be used as plasticizers in FCMs and categorizes them into groups of high, medium, or low priority levels for further risk assessment based on the date of their most recent risk assessment. Substances last assessed before 2001 were placed in the highest priority group, and substances assessed since 2011 in the lowest priority group. Only substances authorized for use in FCMs at the EU or national level were considered for the prioritization. 

The draft protocol outlines how three central exposure sources within the re-evaluation of phthalate risks will be assessed, namely determining (i) the total dietary exposure to phthalates, (ii) the exposure coming specifically from FCMs, and (iii) and the overall exposure (dietary and non-dietary) from the prioritized substances across different population groups. The protocol covers the approaches to be applied for “identifying, extracting, cleaning and selecting data, appraising the relevant evidence, analyzing and integrating that evidence and addressing the uncertainties” to enable the exposure assessment needed for the later risk assessment of the prioritized substances. 

Both publications are open for public comment until December 16, 2021.  


Read More 

EFSA (November 5, 2021). “Phthalates: draft opinion and exposure protocol open for public consultation.” 


EFSA (November 5, 2021). “Identification and prioritisation for 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 (November 5, 2021). “Protocol for dietary exposure assessment of prioritised substances.”