Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on the safety in use of nisin as a food additive in an additional category of liquid eggs and on the safety of nisin produced using a modified production process as a food additive Question number EFSA Q-2005-031b Adopted on 20 October 2006 by written procedure

The Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Foods (AFC Panel) has been asked to advise on the safety in use of nisin in an additional food category of liquid eggs and on the safety of nisin produced using a modified production process. Nisin (E 234) is authorised for food preservation in the European Union by Directive 95/2/EC on food additives other than colours and sweeteners. Nisin is permitted in ripened cheese and processed cheese, certain puddings, clotted cream and mascarpone. Specifications for nisin are laid down in Directive 96/77/EC. The AFC Panel issued an opinion on January 26th, 2006, on the use of nisin as a food additive, which confirmed the Acceptable Daily Intake (ADI) of 0.13 mg/kg body weight established by the Scientific Committee for Food (SCF) in 1990. The opinion also addressed the issue of antimicrobial resistance. The Commission has received an application to additionally permit the use of nisin to preserve liquid eggs at a level not exceeding 6.25 mg/L. The manufacturer has also notified that they now use a modified manufacturing and extraction process for nisin. The modified process is based on fermentation of a sugar medium as a replacement for the milk medium. The Panel noted that nisin manufactured by the modified process was equivalent to the nisin produced by the original process. However, nisin produced by the modified process is more pure. It contains less protein (non-nisin) residues, fat, carbohydrate, and lactose. The Panel concluded that the previously established ADI of 0.13 mg nisin/kg bw is also valid for the nisin produced by the modified process. The Panel also concluded that the modified manufacturing and extraction process based upon fermentation of a sugar medium as a replacement for the milk medium would avoid a risk to individuals allergic to milk products, and that the additional use of nisin in liquid eggs is not of safety concern.