Safety of the proposed amendment of the specifications for the food additive polyvinyl alcohol‐polyethylene glycol‐graft‐co‐polymer (E 1209)

• Main Authors: EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS), Alicja Mortensen, Fernando Aguilar, Riccardo Crebelli, Alessandro Di Domenico, Birgit Dusemund, Maria Jose Frutos, Pierre Galtier, Ursula Gundert‐Remy, Claude Lambré, Jean‐Charles Leblanc, Oliver Lindtner, Peter Moldeus, Pasquale Mosesso, Dominique Parent‐Massin, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens‐Berendsen, Rudolf Antonius Woutersen, Matthew Wright, Maged Younes, Ana Maria Rincon, Alexandra Tard, David Gott
• Format: Article
• Language: English
• Published: Wiley 2017-06-01
• Series: EFSA Journal
• Subjects: polyvinyl alcohol‐polyethylene glycol‐graft‐co‐polymer; PVA‐PEG graft‐co‐polymer; E 1209; ethylene glycol; diethylene glycol
• Online Access: https://doi.org/10.2903/j.efsa.2017.4865

Abstract The European Commission asked EFSA to provide a scientific opinion on the request for a modification of the EU specifications for polyvinyl alcohol‐polyethylene glycol‐graft‐co‐polymer (PVA‐PEG graft‐co‐polymer) (E 1209) and its possible impact on the safety. In accordance with Annex II to Regulation (EC) No 1333/2008, PVA‐PEG graft‐co‐polymer (E 1209) has a single authorisation for use as a food additive in the EU, in the food category food supplements in solid form. According to the current EU specifications, ethylene glycol and diethylene glycol can be present as impurities in other food additives authorised in the EU, namely in polysorbates (E 432–436) and polyethylene glycol (E 1521). The exposure to ethylene glycol and diethylene glycol from their presence in E 1209 and in the other food additives was estimated considering the maximum limit permitted according to the EU specifications and the new proposed maximum limit in E 1209 of 620 mg/kg for the ethylene glycol individually or in combination with diethylene glycol in E 1209. This proposed request would result in a total exposure from food additive uses below the group tolerable daily intake (TDI) of 0.5 mg/kg body weight (bw) per day allocated by the Scientific Committee on Food (SCF) for these contaminants. Therefore, the Panel concluded that the requested amendment of the EU specifications for E 1209 would not result in a safety concern. The Panel 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.