Safety and efficacy of Sorbiflore® ADVANCE (Lactobacillus rhamnosus CNCM I‐3698 and Lactobacillus farciminis CNCM I‐3699) as a feed additive for weaned piglets

zootechnical additives, Sorbiflore®, Lactobacillus rhamnosus CNCM I‐3698, Lactobacillus farciminis CNCM I‐3699, piglets, safety, efficacy
First published in the EFSA Journal
4 maggio 2020
Type
Scientific Opinion

Legal notice: Relevant information or parts of this scientific output have been blackened in accordance with the confidentiality requests formulated by the applicant pending a decision thereon by the European Commission. The full output has been shared with the European Commission, EU Member States and the applicant. The blackening will be subject to review once the decision on the confidentiality requests is adopted by the European Commission.

Abstract

Following a request from the European Commission, the EFSA Panel on Additives and products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Sorbiflore®ADVANCE when used as a zootechnical feed additive for weaned piglets. Sorbiflore®ADVANCE results from the fermentation of milk based‐broth with Lactobacillus rhamnosus CNCM I‐3698 and Lactobacillus farciminis CNCM I‐3699. The additive is intended for use in feed for weaned piglets at the minimum concentration of 1.25 × 108 viable forming units (VFU)/kg and the maximum concentration of 5 × 108VFU/kg complete feed. The data submitted did not allow a full characterisation of the additive, and therefore, uncertainty remains on the nature of the product in terms of viability, on the ratio between the active agents and on the stability of the additive. The active agents fulfil the requirements of the qualified presumption of safety (QPS) approach to the assessment of safety and no concerns are expected from other components of the additive. Consequently, Sorbiflore®ADVANCE is presumed to be safe for the target animals, consumers of products from animals receiving the additive and the environment. The additive should be considered a respiratory sensitiser. In the absence of data, no conclusions could be drawn on the irritancy of Sorbiflore®ADVANCE to skin and eyes and on its dermal sensitisation potential. Sorbiflore®ADVANCE at 1.25 × 108VFU/kg feed has the potential to be efficacious in weaned piglets.

Panel members at the time of adoption

Giovanna Azimonti, Vasileios Bampidis Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Mojca Kos Durjava, Maryline Kouba, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa and Ruud Woutersen.
Contact
feedap [at] efsa.europa.eu
doi
10.2903/j.efsa.2020.6081
EFSA Journal 2020;18(5):6081
Question Number
On request from
European Commission