Phthalates and other plasticisers: priorities for reassessment

Feedback from two public consultations has helped EFSA’s scientists prioritise reassessments of plasticiser substances used in food contact materials (FCMs) and define a protocol for assessing consumer exposure Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time.. Full risk assessments will follow in a second step.

The European Commission asked EFSA to carry out preparatory work to re-evaluate the health risks from plasticisers such as phthalates, structurally similar substances, and substances used to replace phthalates in FCMs.

Our scientific opinion Opinions include risk assessments on general scientific issues, evaluations of an application for the authorisation of a product, substance or claim, or an evaluation of a risk assessment. focusses on plasticisers used in different types of FCMs (e.g. plastics, rubber and inks) across the food chain (e.g. food processing equipment and packaging).

For the identification and prioritisation process, we considered information provided by the Commission, the European Chemicals Agency (ECHA), and EU Member States. Two public consultations provided additional input and helped us further clarify the rationale for including substances in the prioritisation exercise.

Only substances authorised for use in FCMs at EU or at national level were prioritised. We ranked them into three groups based on their most recent risk assessment as an FCM substance: ‘high priority’ -  assessed before 2001, ‘medium priority’ – assessed between 2001 and 2011, and ‘low priority’ if assessed since 2011.

We will launch calls for data on the occurrence of prioritised substances in food and in FCMs before this summer to help finetune the prioritisation ranking and derive exposure estimates for the risk assessments.

The scientific protocol for the exposure assessment One of the key steps in risk assessment, this relates to a thorough evaluation of who, or what, has been exposed to a hazard and a quantification of the amounts involved. of the prioritised substances transparently details upfront the approach EFSA’s scientists intend to use to retrieve and select data as well as to integrate and analyse evidence for the exposure estimates (including dietary, overall exposure and contribution to exposure from FCMs).

We carried out this work in close collaboration with ECHA, in which we are piloting efforts to facilitate the implementation of the EC’s Chemicals Strategy for Sustainability, e.g. the “One-Substance, One-Assessment” approach.