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, Younes M, Aggett P, et al. Safety of nisin (E 234) as a food additive in the light of new toxicological data and the proposed extension of use. EFSA J. 2017;15(12):e05063doi: 10.2903/j.efsa.2017.5063.
, Younes, M., Aggett, P., Aguilar, F., Crebelli, R., Dusemund, B., Filipič, M., Frutos, M. J., Galtier, P., Gundert-Remy, U., Kuhnle, G. G., Lambré, C., Leblanc, J. C., Lillegaard, I. T., Moldeus, P., Mortensen, A., Oskarsson, A., Stankovic, I., Waalkens-Berendsen, I., Woutersen, R. A., Wright, M., Herman, L., Tobback, P., Pizzo, F., Smeraldi, C., Tard, A., Papaioannou, A., & Gott, D. (2017). Safety of nisin (E 234) as a food additive in the light of new toxicological data and the proposed extension of use. EFSA journal. European Food Safety Authority, 15(12), e05063. https://doi.org/10.2903/j.efsa.2017.5063
, et al. "Safety of nisin (E 234) as a food additive in the light of new toxicological data and the proposed extension of use." EFSA journal. European Food Safety Authority vol. 15,12 (2017): e05063. doi: https://doi.org/10.2903/j.efsa.2017.5063
, Younes M, Aggett P, Aguilar F, Crebelli R, Dusemund B, Filipič M, Frutos MJ, Galtier P, Gundert-Remy U, Kuhnle GG, Lambré C, Leblanc JC, Lillegaard IT, Moldeus P, Mortensen A, Oskarsson A, Stankovic I, Waalkens-Berendsen I, Woutersen RA, Wright M, Herman L, Tobback P, Pizzo F, Smeraldi C, Tard A, Papaioannou A, Gott D. Safety of nisin (E 234) as a food additive in the light of new toxicological data and the proposed extension of use. EFSA J. 2017 Dec 11;15(12):e05063. doi: 10.2903/j.efsa.2017.5063. eCollection 2017 Dec. PMID: 32625365; PMCID: PMC7009836.
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EFSA J. 2017 Dec 11;15(12):e05063. doi: 10.2903/j.efsa.2017.5063. eCollection 2017 Dec.

Safety of nisin (E 234) as a food additive in the light of new toxicological data and the proposed extension of use.

EFSA journal. European Food Safety Authority

Maged Younes, Peter Aggett, Fernando Aguilar, Riccardo Crebelli, Birgit Dusemund, Metka Filipič, Maria Jose Frutos, Pierre Galtier, Ursula Gundert-Remy, Gunter Georg Kuhnle, Claude Lambré, Jean-Charles Leblanc, Inger Therese Lillegaard, Peter Moldeus, Alicja Mortensen, Agneta Oskarsson, Ivan Stankovic, Ine Waalkens-Berendsen, Rudolf Antonius Woutersen, Matthew Wright, Lieve Herman, Paul Tobback, Fabiola Pizzo, Camilla Smeraldi, Alexandra Tard, Adamantia Papaioannou, David Gott

PMID: 32625365 PMCID: PMC7009836 DOI: 10.2903/j.efsa.2017.5063

Abstract

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.

© 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

Keywords: E 234; extension of use; food additive; nisin

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