Scientific Opinion on the safety and efficacy of Lactobacillus plantarum (NCIMB 40027) as a silage additive for all animal species

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Article
EFSA Journal 2013;11(5):3205 [13 pp.].
doi
10.2903/j.efsa.2013.3205
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Panel Members
Gabriele Aquilina, Alex Bach, Vasileios Bampidis, Maria De Lourdes Bastos, Lucio Guido Costa, Gerhard Flachowsky, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Fernando Ramos, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf
Acknowledgement

The Panel wishes to thank the members of the Working Group on Silage Additives, including Pier Sandro Cocconcelli, Andrew Chesson and Miklós Mézes, for the preparatory work on this scientific opinion.

Type
Opinion of the Scientific Committee/Scientific Panel
On Request From
European Commission
Question Number
EFSA-Q-2011-00944
Adopted
16 April 2013
Published
7 Mai 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (375.69 KB)375.69 KB
Abstract

The strain of Lactobacillus plantarum is intended to improve the ensiling process at proposed doses ranging from 1 x 108 to 1 x 109 CFU/kg fresh material. This speciesis considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been established and as no antibiotic resistance of concern was detected, the use of the strain in the production of silage is presumed safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. The active agent is not an eye or skin irritant or a skin sensitiser. Given the proteinaceous nature of the active agent and the high dusting potential of the product tested, the FEEDAP Panel considers it prudent to treat this additive as a respiratory sensitiser. A total of 20 laboratory-scale ensiling studies were conducted with L. plantarum applied at 1 x 109 or 1 x 108 CFU/kg forage. In all the studies, forage containing the additive was compared with untreated control materials, and the duration of the studies was at least 90 days. L. plantarum has the potential to improve the production of silage by increasing lactic acid content and the preservation of dry matter, by reducing the pH and protein degradation. This was demonstrated in a range of easy and moderately difficult to ensile forage materials at a minimum concentration of 1 x 108 CFU/kg fresh material and also in difficult to ensile forage materials when added at a concentration of 1 x 109 CFU/kg fresh material.

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 for the target animals, consumer, user and the environment and on the efficacy of a product based on a specific strain of Lactobacillus plantarum, when used as a technological additive intended to improve the ensiling process in the range of 1 x 108 to 1 x 109 CFU/kg fresh material.

The species L. plantarum is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. Therefore, it does not require any specific demonstration of safety other than confirming its susceptibility to antibiotics of human and veterinary clinical significance. As the identity of the strain has been clearly established and as no antibiotic resistance of concern was detected, the use of the strain in the production of silage is presumed safe for livestock species, for consumers of products from animals fed the treated silage and for the environment.

The active agent is not an eye or skin irritant or skin sensitiser. Although users at the farm level are exposed to the additive for only a short period of time when preparing the aqueous suspension, given the proteinaceous nature of the active agent and the high dusting potential of the product tested, the FEEDAP Panel considers it prudent to treat this additive as a respiratory sensitiser.

A total of 20 laboratory-scale ensiling studies were conducted with L. plantarum applied at 1 x 109 or 1 x 108 CFU/kg silage. In all studies, forage containing the additive was compared with untreated control materials, and the duration of the studies was at least 90 days. L. plantarum has the potential to improve the production of silage by increasing lactic acid content and the preservation of dry matter and by reducing the pH and protein degradation. This was demonstrated in a range of easy and moderately difficult to ensile forage materials at a minimum concentration of 1 x 108 CFU/kg fresh material and also in difficult to ensile forage materials when added at a concentration of 1 x 109 CFU/kg fresh material.

Keywords
Technological additive, silage additive, Lactobacillus plantarum, QPS, safety, efficacy
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Number of Pages
13