EFSA | Public consultation on risk assessment of phthalates used in food contact materials

EFSA is launching a public consultation on the draft update of its 2005 risk assessments of five phthalates which are authorised for use in plastic food contact materials.

For the updated draft opinion, EFSA’s Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) has established a group tolerable daily intake (TDI) of 50 µg/kg bw per day for four of the substances – di-butylphthalate (DBP), butylbenzylphthalate (BBP), bis(2-ethylhexyl)phthalate (DEHP), and di-isononylphthalate (DINP).

The group TDI is based on a plausible common mode of action underlying the reproductive effects of these four phthalates. For DINP, liver – rather than reproductive – toxicity was nevertheless recognised as the most critical effect.

For di-isodecylphthalate (DIDP), the fifth phthalate not included in the group TDI, an individual TDI of 150 µg/kg bw per day is proposed based on liver toxicity.

Combined dietary exposure to DBP, BBP, DEHP and DINP is estimated to be less than one quarter of the group TDI for all European consumers, including the most sensitive population groups, even in the worst-case scenario. For DIDP, dietary exposure is approximately 1,500 fold below the individual TDI.

EFSA carried out the work in close collaboration with the European Chemicals Agency (ECHA), which recently assessed some phthalates under the REACH framework.

Interested parties are invited to submit comments on the draft opinion via the dedicated consultation page. The deadline for comments is 14 April 2019.

EFSA will hold a webinar on 15 March to present the CEP Panel’s approach to the draft assessment and its outcomes. Participants will have the opportunity to ask questions directly to the presenters. More information available here.