Open AccessSafety of nisin (E 234) as a food additive in the light of new toxicological data and the proposed extension of use
Author(s) -
Younes Maged,
Aggett Peter,
Aguilar Fernando,
Crebelli Riccardo,
Dusemund Birgit,
Filipič Metka,
Frutos Maria Jose,
Galtier Pierre,
GundertRemy Ursula,
Kuhnle Gunter Georg,
Lambré Claude,
Leblanc JeanCharles,
Lillegaard Inger Therese,
Moldeus Peter,
Mortensen Alicja,
Oskarsson Agneta,
Stankovic Ivan,
WaalkensBerendsen Ine,
Woutersen Rudolf Antonius,
Wright Matthew,
Herman Lieve,
Tobback Paul,
Pizzo Fabiola,
Smeraldi Camilla,
Tard Alexandra,
Papaioannou Adamantia,
Gott David
Publication year - 2017
Publication title -
efsa journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.076
H-Index - 97
ISSN - 1831-4732
DOI - 10.2903/j.efsa.2017.5063
Subject(s) - nisin , food additive , acceptable daily intake , no observed adverse effect level , food science , food safety , tolerable daily intake , toxicology , food contact materials , food contaminant , toxicity , food packaging , chemistry , body weight , medicine , biology , pesticide , antimicrobial , organic chemistry , agronomy
The present scientific opinion deals with the evaluation of the safety of nisin (E 234) in the light of new toxicological data and with the proposed extension of use in unripened cheese and heat‐treated meat products. Nisin (E 234) is currently an authorised food additive in the EU under Annex II of Regulation (EC) 1333/2008 for use in several food categories. The safety of nisin (E 234) as a food additive has been evaluated in 2006 by the EFSA Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food, where an acceptable daily intake (ADI) of 0.13 mg/kg body weight (bw) was confirmed as previously established by Scientific Committee on Food (SCF). In addition to the studies previously evaluated by EFSA in 2006, the Panel considered in the present opinion, data from a new subchronic toxicity study. No adverse effects were observed in a repeated dose oral toxicity study in which rats were administered nisin A for 90 days. A no observed adverse effect level (NOAEL) of 225 mg nisin A/kg bw per day, the highest dose tested, was identified for this study. Using this NOAEL, an ADI of 1 mg nisin A/kg bw per day for nisin (E 234) was calculated applying a default uncertainty factor of 200 for extrapolation of subchronic to chronic exposure and inter‐ and intra‐species variability. The Panel calculated exposure estimates for both the current and the proposed uses based on the data available in the EFSA Comprehensive Database. The Panel considered that the overall exposure estimate was below the new ADI for nisin A for all population groups. The Panel concluded that the proposed extension of use of nisin (E 234) as a food additive in unripened cheese (at maximum level of 12 mg/kg) and in heat‐treated meat products (at maximum level of 25 mg/kg) would not be of safety concern.