Phthalates: draft opinion and exposure protocol open for public consultation

Written by Embio Diagnostics

November 5, 2021

EFSA has launched consultations on its draft opinion on the identification and prioritisation for risk assessment of plasticisers used in food contact materials and on its draft protocol for the exposure assessment of those substances that are prioritised.

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 plasticisers such as phthalates, structurally similar substances, and replacement substances in food contact materials (FCMs).

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

Only substances authorised for FCMs at EU or at national level were prioritised. Prioritisation was based on the date that substances most recently underwent risk assessment as a 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 analyse and integrate evidence for the exposure assessment of the prioritised 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).

Interested parties are invited to submit comments on the draft opinion and on the draft protocol via the dedicated consultation pages. The deadline for comments is 16/12/2021.

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