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ECHA Considers Additional Phthalate for REACH Authorization List; EFSA Publishes Updated Risk Assessment on Five Phthalates Authorized for Food Contact Plastics

March 19, 2020

Dicyclohexyl phthalate (DCHP) is among the substances that the European Chemicals Agency (ECHA) is considering recommending for inclusion on the Authorization List (Annex XIV) under REACH. ECHA stated in a March 5 press release that DCHP (used as a plasticizer) should potentially be considered as a substance of very high concern due to its reporductive toxicity and endrocrinedisrupting properties. Although, in a survey on the use of phthalates in food-contact materials, conducted in October 2019, the only mention of DCHP was that it is possibly used in some cellophane applications authorized in Directive 2007/42. Results of that survey can be found here.  Comments on adding DCHP to the Authorization List are due by May 5, 2020. A separate 2017 opinion by ECHA on three other phthalates—di-butylphthalate (DBP), butyl-benzyl-phthalate (BBP), and bis(2-ethylhexyl)phthalate (DEHP)—led the European Commission (EC) to request in 2017 that the European Food Safety Authority (EFSA) update its 2005 opinions on those three phthalates. In May 2018, the EC updated its request to EFSA to include two additional phthalates, di-isononylphthalate (DINP) and di-isodecylphthalate (DIDP), after the Commission found that these substances were being used as replacements for the three original phthalates.

In response to the request from the Commission, on December 10, 2019, EFSA published a scientific opinion and technical report on the updated risk assessments of the five phthalates, which are authorized for use as plasticizers and technical support agents in plastic food-contact materials under Commission Regulation (EU) No 10/2011. After public consultation with the scientific community and other stakeholders, EFSA concluded that the dietary intakes of the phthalates for mean and high European consumers of any age were below the group tolerable daily intake (TDI).  EFSA further concluded that, based on the limited scope of the EC’s mandate and the uncertainties in the assessment, the current conclusion that use of the five phthalates remains acceptable is established on a temporary basis.

EFSA’s Panel on Food Contact Materials, Enzymes, and Processing Aids (CEP Panel) conducted the updated exposure assessment, hazard characterization, and risk characterization based on the reproductive toxicity data used in the March 2017 ECHA opinion and other new reproductive toxicity data published after EFSA’s original 2005 opinions on DBP, BBP, and DEHP. In doing so, EFSA re-confirmed its 2005 analyses of critical effects and individual tolerable daily intakes (TDI) for each phthalate and concluded that dietary exposure was well below the group TDI. Moreover, the CEP Panel did not identify any study reviewed by ECHA in its 2019 report, which gave rise to a Lowest Observed Adverse Effect Level (LOAEL) or No Observed Adverse Effect Level (NOAEL) below those previously identified by EFSA.

EFSA recommended further analysis regarding health end points other than reproductive toxicity, such as potential effects on neurodevelopment, the immune system, and the metabolic systems. The CEP Panel also recommended analysis of other phthalates, such as DIBP, not authorized for use in plastic food contact materials but potentially contributing to the overall exposure levels and risk to consumers from such exposures. More information about the EFSA opinion and supporting documents can be found on the EFSA Website.