EC increases impurity thresholds for BASF’s supplement additive
Ethylene glycol and diethylene glycol are now deemed acceptable by the EC at levels ‘‘not more than 400 milligrams per kilogram (mg/kg) for ethylene glycol individually or in combination with diethylene glycol”.
The new figure replaces current limits set at 50 mg/kg for each of the impurities as outlined in accordance with Annex II to Regulation (EC) No 1333/2008.
Specifically, E 1209 is authorised as a food additive in the food category 17.1 “food supplements supplied in a solid form including capsules and tablets, excluding chewable forms”.
EFSA’s decision
The EC’s decision comes as an application was submitted back in 2015 by German chemicals company BASF for its co‐polymer to be used in aqueous instant‐release film coating for food supplements.
BASF’s request proposed that maximum individual limits for the two impurities to be increased to “Not more than 620 mg/kg for ethylene glycol individually or in combination with diethylene glycol”.
The applicant claimed that this specification was included in the original application that was assessed by the European Food Safety Authority (EFSA) in 2013.
They added that the proposed limit (620 mg/kg for ethylene glycol individually or in combination with diethylene glycol) was identical to the limit for ethylene glycol in pharmaceutical products.
EFSA’s opinion dated 18 May 2017 concluded that the BASF's request would result in total exposure from food additive uses below the group tolerable daily intake (TDI) of 0.5 mg/kg body weight/day allocated by the Scientific Committee on Food (SCF).
The Authority commented that the amendment to the level of the impurities ethylene glycol and diethylene glycol in polyvinyl alcohol-polyethylene glycol-graft-co-polymer (E 1209) proposed by the applicant was not of a safety concern.
Codex Alimentarius input
However, the Authority noted that the analytical results provided were consistently and considerably lower (up to 360 mg/kg) than the proposed level of 620 mg/kg for ethylene glycol individually or in combination with diethylene glycol in the EU specifications for E 1209.
In discussions with Member States at the Working Party of Governmental Experts on Food Additives, the EC agreed that the limit of 400 mg/kg was the maximum permitted for ethylene glycol and diethylene glycol as the lowest value possible “to limit their contribution to the TDI”.
The EC added that the update to specifications outlined in EC Regulation (EU) No 231/2012, concerning further specifications for food additives, also referenced specifications and analytical techniques for food additives set out in the Codex Alimentarius, drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).
