EFSA launches consultations on risk assessment of plasticizers used in food contact materials

EUROPE – The European Food Safety Authority (EFSA) has launched consultations on its draft opinion on the identification and prioritization for risk assessment of plasticizers used in food contact materials and on its draft protocol for the exposure assessment of those substances that are prioritized.

The consultations will run for 6 weeks and all interested parties are encouraged to contribute. The two consultations respond to a request from the European Commission for EFSA to conduct preparatory work for the re-evaluation of the risks to public health from the presence of plasticizers such as phthalates, structurally similar substances, and replacement substances in food contact materials (FCMs).

EFSA recently updated the risk assessment of five phthalic acid esters (ortho-phthalates), namely DBP, BBP, DEHP, DINP and DIDP, authorized for use as additives in plastic food contact materials (FCMs), published in December 2019 (EFSA CEP Panel, 2019). Based on this new opinion, the Directorate-General for Health and Food Safety (DG SANTE) is considering whether any changes to the existing EU legislation are necessary.

The previous mandate sent by the Commission was limited to new scientific information which was  assessed by the European Chemicals Agency (ECHA) as regards reprotoxicity – chemicals that interfere with normal reproduction. The recently adopted EFSA opinion did not identify any risk to human health from current exposure to these five ortho-phthalates from dietary sources. Nevertheless, it highlighted limitations of the work carried out and has set the Tolerable Daily Intakes (TDIs) on a temporary basis. To this end, it is appropriate to address these limitations and establish a greater degree of certainty as regards the possible risks from these phthalates in food, from FCMs.

FCMS prioritization

For the draft opinion on the identification and prioritization of plasticizers, EFSA’s Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) considered data provided by the European Commission, the European Chemicals Agency, and EU Member States.

Only substances authorized for FCMs at EU or at national level were prioritized. Prioritization was based on the date that substances most recently underwent risk assessment as an FCM, with those assessed before 2001 being placed in the high-priority group, those assessed between 2001 and 2011 in the medium-priority group, and those assessed after 2011 in the low-priority group.

The second consultation on the draft protocol sets out the approach EFSA intends to use to retrieve and select data and to analyze and integrate evidence for the exposure assessment of the prioritized substances.

EFSA carried out the work on these two draft outputs in close collaboration with ECHA, piloting the “One-Substance, One-Assessment” approach under the EC’s Chemicals Strategy for Sustainability (CSS). The European Commission published a chemicals strategy for sustainability on 14 October 2020. It is part of the EU’s zero pollution ambition, which is a key commitment of the European Green Deal.

The commission has called on the interested parties to submit comments on the draft opinion and on the draft protocol via the dedicated consultation pages before 16/12/2021.