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. 2021 Nov 19;19(11):e06907.
doi: 10.2903/j.efsa.2021.6907. eCollection 2021 Nov.

Safety and efficacy of a feed additive consisting of Bacillus subtilis strains CNCM I-4606, CNCM I-5043 and CNCM I-4607 and Lactococcus lactis CNCM I-4609 for all animal species (Nolivade)

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP); Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Mojca Fašmon Durjava, Maryline Kouba, Marta López-Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa, Ruud Woutersen, Maria Saarela, Jaume Galobart, Matteo Innocenti, Joana Revez, Maria Vittoria Vettori, Rosella Brozzi

Safety and efficacy of a feed additive consisting of Bacillus subtilis strains CNCM I-4606, CNCM I-5043 and CNCM I-4607 and Lactococcus lactis CNCM I-4609 for all animal species (Nolivade)

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) et al. EFSA J. .

Abstract

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the preparation of Bacillus subtilis CNCM I-4606, B. subtilis CNCM I-5043, B. subtilis CNCM I-4607 and Lactococcus lactis CNCM I-4609 when used as a technological additive (hygiene condition enhancer) for all animal species. The product is intended for use in compound feeds and feed materials for all animal species at a minimum inclusion level of 1 × 109 CFU B. subtilis and 1 × 109 CFU L. lactis per kg or litre. The two bacterial species are considered by EFSA to be eligible for the qualified presumption of safety (QPS) approach. As the identity of the strains has been clearly established and they did not show acquired resistance to antibiotics of human and veterinary importance, the use of these strains in animal nutrition is considered safe for the target species, consumers and the environment. The additive is not irritant to skin and eyes or a skin sensitiser. Given the proteinaceous nature of the active agents, the additive should be considered a respiratory sensitiser. The Panel is not in the position to conclude on the efficacy of the additive to significantly reduce the growth of either Salmonella Typhimurium or Escherichia coli in feed.

Keywords: Bacillus subtilisCNCM I‐4606; Bacillus subtilisCNCM I‐4607; Bacillus subtilisCNCM I‐5043; Lactococcus lactisCNCM I‐4609; efficacy; hygiene condition enhancer; technological additive.

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