EFSA launches public consultation on phthalates used in food contact materials

25 Feb 2019 --- The European Food Safety Authority (EFSA) has launched a public consultation on the draft update of its 2005 risk assessments of five phthalates, which are authorized for use in plastic Food Contact Materials (FCM). In July 2017, EFSA received a mandate from the European Commission (EC) requesting to evaluate whether the EFSA’s opinions on di-butylphthalate (DBP), butylbenzylphthalate (BBP) and bis (2-ethylhexyl)phthalate (DEHP) published by EFSA in 2005 and its authorization under Regulation (EU) No 10/2011 are still in line with the FCM Regulation.

Phthalates are substances which are commonly added to plastics to increase their flexibility, transparency, durability and longevity and some research has spurred consumer concern regarding their safety profile. Findings have occasionally linked phthalates to toxic health effects in humans.

According to the mandate, the assessment of the aforementioned phthalates should be conducted based on the data package used by the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) for performing an assessment of certain phthalates (DBP, BBP, DEHP and DIBP), published in the same year.

An updated mandate was sent by the EC to EFSA in May 2018 with the request to include DINP and DIDP in the update of the assessment of phthalates, since they are also authorized for use in plastic food contact materials and they increasingly replace the phthalates (DEHP, DBP,BBP) already covered by the initial mandate.

The draft opinion on the risk assessment of five phthalates for their use in plastic food contact materials was endorsed for public consultation by the CEP Panel during the fifth Plenary meeting, held on 5-7 February 2019, and consequently, the consultation was launched on 21 February.

“Considering the high complexity of the assessment both in terms of toxicology of and exposure to the five different phthalates, and in order to ensure openness, transparency and engagement of all interested parties during the process, it was decided to hold a public consultation on the draft opinion,” an EFSA spokesperson tells PackagingInsights.

“The aim of this public consultation is to gather comments from the interested parties on the evaluation made by the WG on Phthalates and the Panel on Food Contact Materials, Enzymes and Processing Aids (CEP panel),” they explain.

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 – DBP, BBP, 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 recognized 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.

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.