Sakari Pet

Assessment of the efficacy of a feed additive consisting ofLimosilactobacillus reuteri (formerly Lactobacillus reuteri)DSM 32203 for dogs (NBF LANES)

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP),Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen,Birgit Dusemund, Mojca Fasmon Durjava, Maryline Kouba, Marta Lopez-Alonso,Secundino Lopez Puente, Francesca Marcon, Baltasar Mayo, Alena Pechova, Mariana Petkova,Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa, Ruud Woutersen, Giovanna Martelli,Montserrat Anguita, Rosella Brozzi, Jaume Galobart, Jordi Ortu~no and Joana Revez

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion onthe efficacy of Limosilactobacillus reuteri (formerly Lactobacillus reuteri) DSM 32203 as a zootechnicaladditive for dogs. The additive is a preparation of viable cells of L. reuteri DSM 32203 and it has notbeen previously authorised as a feed additive in the European Union. The additive is intended for usein complete feed for dogs at a minimum use level of 6 9 109 colony forming units (CFU) per animaland day. In a previous opinion, the FEEDAP Panel could not conclude on the efficacy of L. reuteri DSM32203 for dogs. The applicant has provided supplementary information to support the efficacy of theadditive to dogs. Based on the data provided, the FEEDAP Panel concludes that L. reuteri DSM 32203 has the potential to improve faecal consistency by reducing the moisture content of stools from dogsreceiving the additive at 1 9 10-10 CFU/kg feed. However, the Panel has some reservations on theeffects in the moisture content of stools, which if maintained over time might cast doubts on thebenefits on the long-term use of the additive since it could lead to constipation.

Keywords: zootechnical additives, gut flora stabilisers, Limosilactobacillus reuteri DSM 32203, dogs,efficacy, NBF-1

Requestor: European Commission

Question number: EFSA-Q-2021-00534

Correspondence: feedap@efsa.europa.eu

1. Introduction

1.1. Background and Terms of Reference as provided by the requestor

Regulation (EC) No 1831/2003 1 establishes the rules governing the Community authorisation of additives for use in animal nutrition and, in particular Article 9 defines the terms of the authorization by the Commission. The applicant, NBF LANES, 2 is seeking a Community authorisation of Lactobacillus reuteri3 DSM32203 as a feed additive to be used as a gut flora stabiliser for dogs

On27 November 2018, the Panel on Additives and Products or Substances used in Animal Feed of the European Food Safety Authority (“Authority”), in its opinion on the safety and efficacy of the product, could not conclude on the efficacy of L. reuteri DSM 32203 for dogs. During the discussions with the Member States at a meeting of the Standing Committee on Plants, Animals, Food and Feed (Animal Nutrition section), it was suggested to check for the possibility to demonstrate the efficacy of the additive.The Commission gave the possibility to the applicant to submit supplementary information and data in order to complete the assessment and to allow a revision of the EFSA’s opinion. The new data have been received on 13 April 2021 and the applicant has been requested to transmit them to EFSA as well.

In view of the above, the Commission asks the Authority to deliver a new opinion on Lactobacillusreuteri DSM 32203 as a feed additive for dogs based on the additional data submitted by theapplicant, in accordance with Article 29(1)(a) of Regulation (EC) No 178/2002.

1.2. Additional information

The additive is a preparation containing viable cells of L. reuteri DSM 32203. It has not beenpreviously authorised as a feed additive in the European Union.EFSA issued one opinion on the safety and efficacy of this product when used in feed for dogs(EFSA FEEDAP Panel, 2019). In this latter, the FEEDAP Panel could not conclude on the efficacy ofL. reuteri NBF-1 (DSM 32203) for dogs.

2. Data and methodologies

2.1. Data

The present assessment is based on data submitted by the applicant in the form of supplementary information 4 to previous application on the same product.5In accordance with Article 38 of the Regulation (EC) No 178/2002 6 and taking into account the protection of confidential information and of personal data in accordance with Articles 39 to 39e of the

same Regulation, and of the Decision of EFSA’s Executive Director laying down practical arrangements concerning transparency and confidentiality,7 a non-confidential version of the supplementary information has been published on Open. EFSA. 8

2.2. Methodologies

The approach followed by the FEEDAP Panel to assess the safety and the efficacy of active substance (trade name of the product) is in line with the principles laid down in Regulation (EC) No429/2008 9 and the relevant guidance document: Guidance on the assessment of the efficacy of feed additives (EFSA FEEDAP Panel, 2018).

3. Assessment

The additive is a preparation of viable cells of L. reuteri DSM 32203 intended for use as azootechnical additive (functional group: gut flora stabilisers) in feed for dogs to exert beneficial effectsin their gastrointestinal tract leading to an increase in faecal consistency. Since the last opinion, thetaxonomic unit of the species under assessment has been updated from the basonym Lactobacillusreuteri to Limosilactobacillus reuteri (Zheng et al., 2020) and considered in the list of QPS-recommended biological agents (EFSA BIOHAZ Panel, 2020). The current taxonomic unit is usedhereafter in the opinion.The additive is intended for use in complete and complementary feed for dogs (with a moisturecontent < 14%) at a level of 6 9 109 CFU per animal and day, which would approximately equate to arange from 0.85–3 9 10 10 CFU/kg complete feedingstuffs for dogs.In a previous opinion (EFSA FEEDAP Panel, 2019), the FEEDAP Panel could not conclude on theefficacy of L. reuteri DSM 32203 for dogs, as none of the efficacy studies could be further considereddue to weaknesses in the experimental design and/or reporting. The applicant has providedsupplementary information to support efficacy in dogs.A total of three trials with dogs and sharing a common design were submitted. The details on thestudy design are provided in Table 2 and the main results in Table 3. The studies were conducted with healthy adult dogs of both sexes and of different body weight and breeds (French Bulldog,10Chihuahua 11 and Golden Retriever 12 ), fed three different commercial dry extruded dog food once a day based on their energy maintenance requirements. For each study, dogs were acclimatised to the kennel for 14 days before the start of the study and received unsupplemented feed. At the study start, dogs were randomly allocated to the two dietary treatments: control and L. reuteri DSM 32203 at 1 9 10 10 CFU/kg feed (not confirmed by analyses). 13The additive was mixed with the food directly in the bowl of the animals using a maltodextrin carrier before consumption. Control animals received the same carrier without the additive. Body weight (BW)and body condition score (BCS) were measured at days 0, 7, 14, 21, 28 and 35. On the same days, faecal samples were collected and assessed for moisture content (FM) and consistency (7-point scoringscale: 1 = very hard and dry, 7 = watery). 14 In addition, microbiological analyses (enumeration oflactobacilli and Escherichia coli/coliforms) were performed from the samples collected at days 0, 7, 21and 35. However, details on the analytical methodology for the enumeration of E. coli/coliforms were not provided despite being requested. 15The statistical analysis of the data was done using a repeated measurements model and means were compared with a t-test.

FULL ARTICLE: https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2022.7436

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