At the request of the European Commission, EFSA has published an updated draft of its 2005 opinion on dibutyl phthalate (DBP), butylbenzyl phthalate (BBP), bis(2-ethylhexyl) phthalate (DEHP), diisononyl phthalate (DINP) and diisodecyl phthalate (DIDP), which are currently authorised for use in plastic FCMs within Europe. A literature review focused mainly on the reproductive effects of these phthalates, arriving at the conclusion that male reproductive toxicity is the common critical effect for DBP, BBP, DEHP and DINP, and that a group tolerable daily intake (TDI) is appropriate. DEHP was identified as the index compound since it has the most robust underlying toxicological dataset. A no-observed-adverse-effect level (NOAEL) of 4.8 mg DEHP/kg bw/day for effects on the testes of F1 rats in a three‑generation reproductive toxicity study was used as the point of departure. A total uncertainty factor of 100 was applied to derive a group TDI of 0.05 mg/kg bw (as DEHP equivalents). Although DIDP is recognised to have reproductive effects (decreased survival in F2 generation), its mode of action is dissimilar to the anti-androgenic effect displayed by the other phthalates under consideration. Therefore, it was not added to the new group TDI, and instead retained its individual TDI of 0.15 mg/kg bw for liver effects.

Aggregated dietary exposures to DBP, BBP, DEHP and DINP (from all sources, including but not limited to FCMs) were estimated to be 0.9-7.2 and 1.6‑11.7 µg/kg bw/day for mean and high consumers, respectively, thus contributing up to 23% of the group TDI in the worst-case scenario. For DIDP, dietary exposure was estimated to be less than 0.1 µg/kg bw/day and therefore well below its individual TDI. EFSA noted that in general there is not enough information available to make firm conclusions on the specific contribution of plastic FCMs to these dietary intakes. In addition, EFSA recognised that other phthalates (not authorised for use in FCMs) such as diisobutyl phthalate (DIBP) may also have reprotoxic/anti-androgenic (and potentially other relevant) effects, and may substantially add to the overall exposure of consumers to phthalates from food and from other sources.

European Food Safety Authority (2019). Panel on Food Contact Materials, Enzymes and Processing Aids (CEP). 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 contact materials.


The above items were taken from the April 2019 issue of Toxicology and Regulatory News which is sent automatically to members of bibra.

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