EFSA Reviews Safe Levels for Five Phthalates in Plastic FCM and Packaging

European Food Safety Authority (EFSA) has issued an update of the risk assessment of the phthalates DBP, BBP, DEHP, DINP and DIDP for use in food contact materials. EFSA reviewed the safe levels for the five phthalates in plastic FCM and evaluated whether current dietary exposure to them posed a concern for public health.

Setting a New Safe Level

EFSA experts have now set a new safe level – a group Tolerable Daily Intake (TDI) – for four of the five phthalates (DBP, BBP, DEHP and DINP) of 50 micrograms per kilogram of body weight (µg/kg bw) per day based on their effects on the reproductive system.

The TDI is an estimate of the amount of a substance that people can ingest daily during their whole life without any appreciable risk to health. The key effect on which this group-TDI is based is a reduction in testosterone in fetuses. The fifth phthalate in the assessment, DIDP, does not affect testosterone levels in fetuses, therefore we set a separate TDI of 150 µg/kg bw per day based on its effects on the liver (as in our 2005 evaluation).

The TDIs are 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. The experts have identified a need to address these uncertainties by considering the whole body of evidence.

Current Exposure to Phthalates Not a Concern for Health

The current exposure to these five phthalates from food is not a concern for public health. Dietary exposure to the group of DBP, BBP, DEHP and DINP for average consumers is 7 µg/kg bw or seven times below the safe level, while for high consumers it is 12 µg/kg bw, which is four times lower. For DIDP, the dietary exposure for high consumers is 1,500 times below the safe level.

This new assessment of the five phthalates is in line with its 2005 assessment in terms of their most sensitive effects and the individual tolerable daily intakes. The main differences concern an improved estimate of dietary exposure to phthalates and the introduction of the group-TDI for four of the phthalates to account for combined exposure to several phthalates at the same time. This is a common occurrence and confirmed by data from studies with humans, e.g. traces found in urine.

Source: EFSA