In response to a mandate from the European Commission, the European Food Safety Authority (EFSA) will be reevaluating the health risks posed by plasticizers used in food contact materials (FCMs). The agency has published its scientific protocol for the hazard assessment of the substances, marking the latest step in EFSA’s preparation for such work.

The protocol for the hazard assessment was developed in consideration of EFSA’s May 2022 scientific opinion that identified which plasticizers used in FCMs may warrant further data collection and eventual risk assessment. Publication of the scientific opinion fulfilled the first part of the European Commission’s two-part mandate, and lays the groundwork for the reevaluation of the health hazards associated with plasticizers in FCMs.

The hazard analysis will target phthalates, structurally similar substances, and replacement substances used as plasticizers in FCMs across the EU. EFSA scientists will use the outcome of the hazard assessments in the subsequent risk assessments of substances that have been prioritized, taking into account updated exposure estimates (including dietary exposure, overall exposure, and contribution to exposure from FCMs).

Priority substances include ortho-phthalates DBP, BBP, DEHP, DINP, and DIDP, as well as common plasticizer replacements such as terephthalates, cyclohexanoates, and epoxy esters. The substances are often used in FCMs including plastics, rubber, and inks, and may migrate into foods from FCMs.

The protocol outlines EFSA’s approach to hazard identification and hazard characterization for the substances. Specifically, the scientists will examine the substances’ genotoxicity, adverse effects of exposure to the substances at any stage of life for humans and nonhuman animals, the mode of action of the substances, the substances’ toxicokinetic profiles in humans and nonhuman animals, and the substances’ dose-response relationship for adverse effects in humans and nonhuman animals.