Safety and efficacy of ZM16 10 (Bacillus amyloliquefaciens DSM 25840) as a feed additive for sows in order to have benefits in piglets, sows for reproduction, piglets (suckling and weaned), pigs for fattening and minor porcine species

zootechnical additive, digestibility enhancers, Bacillus amyloliquefaciens, safety, QPS, efficacy, pigs
First published in the EFSA Journal
13. November 2019
4. Oktober 2019
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.


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 ZM16 10 for all pigs. The additive is a preparation containing viable spores of a strain of Bacillus amyloliquefaciens intended for use in feed at the proposed dose of 5 × 108CFU/kg complete feedingstuffs and in water for drinking at 1.7 × 108CFU/L. The additive exists in two forms, ZM16 and ZM16 10, and has been previously characterised by the FEEDAP Panel. B. amyloliquefaciens is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to establishing safety. The active agent fulfils the requirements and consequently, the additive was presumed safe for the target animals, consumers of products from treated animals and the environment. Given the proteinaceous nature of the active agent, the additive should be considered a potential respiratory sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the irritancy potential of the additive to skin and eyes or its dermal sensitisation. The data made available by the applicant allowed the Panel to conclude that the additive, in either form, has a potential to be efficacious as a zootechnical additive when added to feed for piglets (suckling and weaned), pigs for fattening and sows at 5 × 108CFU/kg (corresponding to 1.7 × 108CFU/L). The conclusions on the efficacy were extrapolated to all Suidae species.

Panel members at the time of adoption

Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Maryline Kouba, Mojca Kos Durjava, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa and Ruud Woutersen.
Panel on Additives and Products or Substances used in Animal Feed
feedap [at]
EFSA Journal 2019;17(11):5883
Question Number
On request from
European Commission