EFSA - European Food Safety Authority

10/30/2023 | Press release | Distributed by Public on 10/30/2023 05:50

Safety and efficacy of the feed additive consisting of Enterococcus lactis NCIMB 10415 (Cylactin®) for all poultry for fattening or reared for laying/breeding and ornamental[...]

Safety and efficacy of the feed additive consisting of Enterococcus lactis NCIMB 10415 (Cylactin®) for all poultry for fattening or reared for laying/breeding and ornamental birds, all Suidae, calves and other ruminant species for fattening or rearing (DSM Nutritional products Ltd)

Published:
30 October 2023
Adopted:
27 September 2023
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Meta data

EFSA Journal 2023;21(10):8347
Keywords
zootechnical additive, gut flora stabiliser, Cylactin®, Enterococcus lactis NCIMB 10415, safety, efficacy, renewal
On request from
European Commission
Question Number
EFSA‐Q‐2020‐00391
Panel members at the time of adoption
Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Maryline Kouba, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Roberto Edoardo Villa and Ruud Woutersen.
Contact
feedap[at] efsa.europa.eu

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.

Acknowledgements: The Panel wishes to acknowledge the contribution to this opinion of Nicole Bozzi, Qasim Chaudhry, Jan Mast and Eveline Verleysen, the cross‐cutting Working Group nanotechnologies of the Scientific Committee and following Working Groups of the FEEDAP Panel: WG Environment, WG Microbiology and WG Toxicology.

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of Cylactin® as zootechnical additive. The active agent of the additive is Enterococcus lactis NCIMB 10415, and three additive formulations currently authorised: Cylactin® LBC G35, Cylactin® LBC ME10 and Cylactin® LBC ME20 plus. The additive is currently authorised in the EU for use in poultry (chickens and minor poultry species for fattening, chickens and minor species reared for laying), calves and kids for rearing and for fattening, sows, suckling and weaned piglets and pigs for fattening. The applicant is now seeking the renewal of its authorisation and the extension of use for chickens and minor poultry species reared for breeding, turkeys for fattening and reared for breeding, ornamental birds, lambs for rearing and for fattening, minor or other ruminants' species for rearing and fattening, minor suckling and weaned Suidae species, pigs and minor Suidae species for fattening, rearing or reproduction. In addition, the applicant is seeking authorisation for use in water for drinking for all above‐mentioned target species and categories. The applicant has provided evidence that the additive currently on the market complies with the conditions of authorisation. The FEEDAP Panel concludes that the additive is safe for the target animals, consumers and the environment under the authorised/new proposed conditions of use. The Cylactin® LBC ME10 and LBC ME20 plus are not skin and eye irritants, but no conclusion could be drawn on the potential of Cylactin® LBC G35 to be skin and eye irritant. Moreover, no conclusions could be drawn on the additive skin sensitisation potential. The additive is considered a potential respiratory sensitiser. The efficacy for the new target species/categories as well its use in water was extrapolated from the previous efficacy studies.

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