EC raises threshold limit for impurities in PVA-PEG-graft-co-polymer

The European Commission (EC) has reportedly increased the threshold frontier by a factor of eight, for two major impurities found in BASF’s food supplement additive. As per the new rules, levels not more than 400 mg/kg for ethylene glycol – individually or in combination with diethylene glycol will now be accepted by the EC.

The decision of the European Commission comes on the heels of an application submitted by the polyvinyl alcohol films market player, BASF, in 2015. The application had been given for the firm’s co‐polymer to be used in instant release film coatings, basically for food supplements. The company proposed that the maximum limits for both the impurities to be raised by must not exceed 620 mg/kg for ethylene glycol individually or with diethylene glycol.

According to BASF’s claim, this specification had also been included in the original application submitted and assessed by the EFSA (European Food Safety Authority) in 2013. The claim says that the proposed limit of 620 mg/kg had been identical to the level of ethylene glycol in pharma products. In response, EFSA states that BASF’s request would lead to the total exposure from the uses of food additives, below the group TDI (tolerable daily intake) of 0.5 mg/kg body weight/day as is standardized by the SCF (Scientific Committee on Food). Back then, the EFSA concluded that the amendment to impurity thresholds of ethylene glycol & diethylene glycol in polyvinyl alcohol polyethylene glycol graft co-polymer (E 1209) as requested by the polymers industry magnate BASF was not of a safety concern.

Reportedly, EC’s changed figure replaces the current limits of 50 mg/kg for each of the impurities, as is set according to the Annex II to Regulation (EC) No 1333/2008. The E 1209, claim sources, is authorized as a food additive in food category 17.1, under food supplements that are supplied in a solid form, inclusive of tablets and capsules, but exclusive of chewable forms. Meanwhile, it is still unclear as to what impact the amendment may have on polymer sub-verticals such as polyvinyl alcohol films industry.