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

Abstract

[EN] The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids 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). As the first part of the two-part mandate, EFSA was tasked with identifying and prioritising those plasticisers used in FCMs that may warrant further data collection and eventual risk assessment. Close collaboration with the European Chemicals Agency (ECHA) was requested in the mandate. Substances potentially used as plasticisers were identified using Annex II of the mandate, ECHA's PLASI inventory, the Plastics Regulation and the Regenerated Cellulose Film Directive, the ECHA database, the ECHA grouping approach, and consultation with the Member States. Only substances authorised for FCMs at EU or at national level were prioritised. Five substances classified either as carcinogenic, mutagenic, toxic to reproduction Cat. 1 (under CLP) or as endocrine disruptors, persistent, bioaccumulative and toxic, very persistent/very bioaccumulative (under REACH) were placed into an 'exclusion group'. Prioritisation was based on the date of the most recent risk assessment in the context of FCM, with substances assessed before 2001 being placed in the high-priority group, substances assessed between 2001 and 2011 in the medium-priority group and substances assessed after 2011 in the low-priority group. For the EU stream, the 76 substances were split into 59 high-, 14 medium- and 3 low-priority substances. For the nationally authorised stream, the split of the 72 substances is 66, 3 and 3, respectively. The outcome of follow-up calls for data in support of the exposure assessment will be used for a final ranking.