Vietnam Sanitary and Phytosanitary Notification Authority and Enquiry Point

The text revises the part of the EU specifications of food additives related to ethylene oxide. Currently, Regulation (EU) No 231/2012 provides that ethylene oxide may not be used for sterilizing purposes in food additives. However, there is no quantified limit for the presence of ethylene oxide regarding all food additives. Recently, in the European Union, there have been several notifications concerning findings of ethylene oxide in particular in a number of food additives used for the manufacture of a variety of foodstuffs. However, it is difficult to establish whether the presence of ethylene oxide results from its use in the sterilization of the food additives in breach of Regulation No 231/2012 or from any other reason.

In order to avoid those difficulties and to ensure a high level of protection of human health, it is therefore appropriate to lay down that the presence of ethylene oxide, irrespective of its origin, is not authorized for all food additives. For this purpose, a maximum limit for residues of ethylene oxide specific for food additives should be set out at the limit of quantification in those products, that is, at the validated lowest residue concentration, which can be currently quantified and reported by routine monitoring with validated control methods. This corresponds to maximum limit of 0.1 mg/kg of ethylene oxide (sum of ethylene oxide and 2-chloro-ethanol expressed as ethylene oxide) applicable to all authorized food additives.