Safety and efficacy of Probiomix B (Lactobacillus plantarum KKP/593/p and Lactobacillus rhamnosus KKP 825) as a feed additive for chickens for fattening

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Article
Panel on Additives and Products or Substances used in Animal Feed
EFSA Journal
EFSA Journal 2016;14(2):4397 [11 pp.].
doi
10.2903/j.efsa.2016.4397
Panel members at the time of adoption
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester.
Contact
feedap@efsa.europa.eu
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2011-00125
Adopted
27 January 2016
Published
18 February 2016
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

Probiomix B is a preparation of Lactobacillus plantarum and Lactobacillus rhamnosus. EFSA was requested to evaluate the safety and efficacy of the additive when used in feeds for chickens for fattening in the range of 1 x 108–5 x 108 colony-forming units (CFU)/kg feedingstuffs and in water for drinking at the recommended dose of 1 x 108 CFU/L. The additive has never been authorised in the EU. The identity of the two strains has been established and no resistance to clinically relevant antibiotics detected. The strains satisfy the requirements for the qualified presumption of safety approach to safety assessment and thus are presumed safe for the target animals, consumers of products derived from animals fed the additive and the environment. In the absence of data, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) cannot conclude on the ocular and dermal irritancy of the additive or its dermal sensitisation. The additive apparently does not contain particles of inhalable size and the dusting potential measured is negligible. Therefore, exposure is unlikely and under practical conditions respiratory sensitisation of Probiomix B can be reasonably excluded. The FEEDAP Panel could not conclude on the efficacy of Probiomix B for chickens for fattening.

Summary

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 safety and efficacy of the product Probiomix B as a feed additive for chickens for fattening.

Probiomix B is a preparation of Lactobacillus plantarum and Lactobacillus rhamnosus which has never been authorised in the European Union. The applicant has requested an authorisation for use with chickens for fattening under the category of zootechnical additives (functional group: gut flora stabilisers). The additive is intended to be used at the minimum recommended dose of 5 x 108 colony-forming units (CFU)/kg feed in the starter feed, of 1.5 x 108 CFU/kg feed in the grower feed and of 1 x 108 CFU/kg feed in the finisher feed, and at the maximum recommended dose of 1 x 109 CFU/kg feed in the starter feed, of 3 x 108 CFU/kg feed in the grower feed and of 2 x 108 CFU/kg feed in the finisher feed. Probiomix B is also intended for use in water for drinking at the recommended dose of 1 x 108 CFU/L water.

The identity of two strains has been established and no resistance to clinically relevant antibiotic detected. The strains satisfy the requirements for the qualified presumption of safety approach to safety assessment and thus are presumed safe for the target animals, consumers of products derived from animals fed the additive and the environment.

In the absence of data, the FEEDAP Panel cannot conclude on the irritancy of the additive to skin and eyes or its dermal sensitisation. The additive apparently does not contain particles of inhalable size and the dusting potential measured is negligible. Therefore, exposure is unlikely and under practical conditions respiratory sensitisation of Probiomix B can be reasonably excluded.

The FEEDAP Panel could not conclude on the efficacy of Probiomix B for chickens for fattening.

Keywords
zootechnical additive, Probiomix B, Lactobacillus plantarum and Lactobacillus rhamnosus, chickens for fattening, efficacy, safety
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Number of Pages
11