On December 10, 2019, the European Food Safety Authority (EFSA) announced the publication of the updated risk assessment completed by the Panel on Food Contact Materials, Enzymes and Processing Aids (CEP Panel) on the five phthalates di-butylphthalate (DBP, CAS 84-74-2), butylbenzylphthalate (BBP, CAS 85-68-7), bis(2-ethylhexyl)phthalate (DEHP, CAS 117-81-7), and di-isononylphthalate (DINP, CAS 28553-12-0). A separate frequently asked questions page about phthalates in plastic food contact materials (FCMs) was also published to help inform consumers about the outcomes of the assessment.
The final updated assessment retains the established group tolerable daily intake (TDI) of 50 µg/kg body weight (bw) per day for DBP, BBP, DEHP, and DINP as was set in the draft scientific opinion based on reduction of testosterone in fetuses. The phthalate DIDP also retains its own separate TDI of 150 µg/kg bw per day, calculated based on its effects on the liver. The assessment found that current exposure to these phthalates from food is not of concern for public health. For DBP, BBP, DEHP, and DINP, exposure was found to range from 7 µg/kg bw to a maximum of 12 µg/kg bw (between seven and four times below the set TDI). For DIDP, dietary exposure was found to be 1,500 times below the set TDI. However, EFSA cautions that these TDIs have all been set “on a temporary basis due to uncertainties about effects other than the reproductive ones and about the contribution of plastic FCM to overall consumer exposure of phthalates.”
EFSA launched a public consultation on its draft scientific opinion on the risk assessment in February 2019 (FPF reported), and a technical report documenting the feedback received has also been published. This updated assessment replaces the original risk assessments for these phthalates from 2005. It is described as being “in line” with the 2005 assessment regarding the most sensitive effects and individual TDIs. The primary difference is an improvement in the dietary exposure estimates and introduction of the group TDI for four of the phthalates to account for combined exposure.
EFSA (December 10, 2019). “FAQ: phthalates in plastic food contact materials.”
Vanessa Zainzinger (December 12, 2019). “EFSA sets group intake limit for four phthalates.” Chemical Watch
EFSA (December 10, 2019). “Update of the risk assessment of di-butylphthalate (DBP), butyl-benzyl-phthalate (BBP), bis(2-ethylhexyl)phthalate (DEHP), di-isononylphthalate (DINP) and diisodecylphthalate (DIDP) for use in food contact materials.” (pdf)
EFSA (December 10, 2019). “Technical report of the public consultation on the ‘Draft update of the risk assessment of di-butylphthalate (DBP), butyl-benzyl-phthalate (BBP), bis(2-ethylhexyl)phthalate (DEHP), di-isononylphthalate (DINP) and di-isodecylphthalate (DIDP) for use in food.” (pdf)