Assessment of the feed additive consisting of Enterococcus lactis DSM 7134 (Bonvital®) for sows for the renewal of its authorisation (Lactosan GmbH & Co.KG)

TL;DR

This paper evaluates the safety of Bonvital® for sows and concludes it remains safe under current usage conditions.

Contribution

The paper confirms the continued safety of Bonvital® for sows without new evidence contradicting prior conclusions.

Findings

Bonvital® remains safe for target species, consumers, and the environment under current authorization.

The powder form of Bonvital® is not irritating to skin and eyes, but the granulated form is not assessed.

Bonvital® is a skin and respiratory sensitiser, posing risks with exposure through these routes.

Abstract

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of the authorisation of Bonvital® as a zootechnical additive for sows. Bonvital® is currently authorised for use in weaned piglets, pigs for fattening, sows, chickens for fattening, laying hens, chickens reared for laying and minor poultry species (other than those used for laying). The active agent of Bonvital® was originally identified as Enterococcus faecium. In a previous opinion the strain was reassigned to Enterococcus lactis. The applicant provided evidence that the additive currently on the market complies with the existing terms of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for the target species, consumers and the environment under the authorised conditions of use. Bonvital® in its powder form is not irritant to the skin and eyes but no conclusion is possible for the granulated form. Bonvital® should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. There is no need to assess the efficacy of Bonvital® in the context of the renewal of the authorisation.

Full text

INTRODUCTION

1

Background and Terms of Reference

1.1

Regulation (EC) No 1831/20031 establishes the rules governing the Community authorisation of additives for use in animal nutrition. In particular, Article 14(1) of that Regulation lays down that an application for renewal shall be sent to the Commission at the latest 1 year before the expiry date of the authorisation.

The European Commission received a request from Lactosan GmbH & Co.KG2 for the renewal of the authorisation of the additive consisting of Enterococcus lactis 3 DSM 7134 (Bonvital®), when used as a feed additive for sows (category: zootechnical additives; functional group: gut flora stabilisers).

According to Article 7(1) of Regulation (EC) No 1831/2003, the Commission forwarded the application to the European Food Safety Authority (EFSA) as an application under Article 14(1) (renewal of the authorisation). The dossier was received on 01 December 2023 and the general information and supporting documentation are available at https://open.efsa.europa.eu/questions/EFSA‐Q‐2023‐00857. The particulars and documents in support of the application were considered valid by EFSA as of 10 April 2024.

According to Article 8 of Regulation (EC) No 1831/2003, EFSA, after verifying the particulars and documents submitted by the applicant, shall undertake an assessment in order to determine whether the feed additive complies with the conditions laid down in Article 5. EFSA shall deliver an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of the feed additive consisting of E. lactis DSM 7134 (Bonvital®), when used under the proposed conditions of use (see Section 3.1.3).

Additional information

1.2

The additive is a preparation containing Enterococcus lactis DSM 7134. Bonvital® is currently authorised for use in feed for chickens for fattening,4 laying hens,5 piglets (weaned), pigs for fattening,6 sows (entire reproductive cycle),7 chickens reared for laying and minor poultry species (other than those used for laying)8 and in water for drinking for sows (4b1841).9 The active agent E. lactis DSM 7134 is also authorised in combination with Lactocaseibacillus rhamnosus DSM 7133 under a different trade name for calves for rearing.10

EFSA has issued several opinions on the safety and efficacy of the additive for different target species (EFSA, 2004, 2007a, 2007b, 2009a, 2009b; EFSA FEEDAP Panel, 2010, 2013, 2014, 2019a, 2019b, 2021a, 2023).

DATA AND METHODOLOGIES

2

Data

2.1

The present assessment is based on data submitted by the applicant in the form of a technical dossier11 in support of the authorisation request for the use of E. lactis DSM 7134 (Bonvital®) as a feed additive.

The confidential version of the technical dossier was subject to a target consultation of the interested Member States from 12 April 2024 to 12 July 2024; the comments received were considered for the assessment.

In accordance with Article 38 of the Regulation (EC) No 178/200212 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,13 a non‐confidential version of the dossier has been published on Open.EFSA.

According to Article 32c(2) of Regulation (EC) No 178/2002 and to the Decision of EFSA's Executive Director laying down the practical arrangements on pre‐submission phase and public consultations, EFSA carried out a public consultation on the non‐confidential version of the technical dossier from 12 February to 5 March 2025 for which no comments were received.

The FEEDAP Panel used the data provided by the applicant together with data from other sources, such as previous risk assessments by EFSA, peer‐reviewed scientific papers, to deliver the present output.

The European Union Reference Laboratory (EURL) considered that the conclusions and recommendations reached in the previous assessment regarding the methods used for the control of the active agent in animal feed are valid and applicable for the current application.14

Methodologies

2.2

The approach followed by the FEEDAP Panel to assess the safety and the efficacy of E. lactis DSM 7134 (Bonvital®) is in line with the principles laid down in Regulation (EC) No 429/200815 and the relevant guidance documents: Guidance on the renewal of the authorisation of feed additives (EFSA FEEDAP Panel, 2021b).

ASSESSMENT

3

The additive (here and below referred to with its commercial name Bonvital®) consisting of viable cells of E. lactis DSM 7134 is currently authorised as a zootechnical additive (functional group: gut flora stabilisers) for use in feed and water for sows. This assessment regards the renewal of the authorisation of E. lactis DSM 7134 for use in feed the above‐mentioned animal species.

Characterisation

3.1

Characterisation of the additive

3.1.1

The additive currently authorised is a preparation of E. lactis DSM 7134 at a minimum concentration of 1 × 10^10^ colony forming unit (CFU)/g of additive. It is marketed in two forms:

• Bonvital® powder containing E. lactis DSM 7134 (■■■■■), sweet whey powder (■■■■■), lactose, sodium citrate, sodium glutamate, sodium ascorbate, sodium lactate and mannitol.
• Bonvital® granulated (micro‐encapsulated) containing E. lactis DSM 7134 (■■■■■), saccharose (■■■■■), maltodextrin (■■■■■), sodium citrate, sodium glutamate, sodium ascorbate, sodium lactate, mannitol and starch.16

The applicant declared that the composition and the manufacturing process of the additive have not been changed since the previous authorisation.17

The analysis of five batches of each form showed compliance with the specifications of the active agent with a mean of 1.5 × 10^10^ CFU/g additive (1.3–1.8 × 10^10^ CFU/g additive) in the powder form and 1.5 × 10^10^ CFU/g additive (1.3–1.6 × 10^10^ CFU/g additive) in the granular form.18 ^,^ 19

Microbiological contamination was investigated in three batches of each form of the additive by analysing Enterobacteriaceae and yeasts and moulds, all being < 1000 CFU/g. Salmonella spp. was not detected in 25 g of sample.20

Three batches of each form of the additive were tested for arsenic, lead, cadmium and mercury, aflatoxins (B1, B2, G1, G2), deoxynivalenol and zearalenone concentrations/levels.21 The results showed values below the limit of quantification (LOQ) of the analytical methods for all the analytes.

The FEEDAP Panel considers that the microbial contamination and the amounts of the detected impurities do not raise safety concerns.

Since the composition and the manufacturing process of the additive have not been changed since the last authorisation, the data on physical–chemical properties, shelf‐life, stability and homogeneity previously assessed in the context of previous assessments are still considered valid (EFSA FEEDAP Panel, 2014, 2023).

Characterisation of the active agent

3.1.2

The active agent was originally isolated from grass and is deposited in the Deutsche Sammlung von Mikroorganismen und Zellkulturen under the accession number DSM 7134.22 The applicant declared that it has not been genetically modified.

The active agent was originally assigned to the Enterococcus faecium species, but in a more recent opinion (EFSA FEEDAP Panel, 2023), based on bioinformatic analyses of the whole genome sequence (WGS) data, the DSM 7134 strain was identified as E. lactis and it was shown to be susceptible to all the relevant antibiotics and not to harbour virulence determinants.23 No new data have been provided in the context of the current application that would lead the Panel to modify previous conclusions.

The WGS data of the DSM 7134 strain were interrogated for the presence of antimicrobial resistance genes (AMR) against the ResFinder and the NCBI Bacterial Antimicrobial Resistance Reference Gene databases.24 The search identified two hits exceeding the thresholds recommended by EFSA (EFSA, 2021). Further analysis of these hits following EFSA's criteria (EFSA BIOHAZ Panel, 2023) did not reveal any acquired AMR gene. Therefore, the FEEDAP Panel concludes that the strain harbours no acquired AMR genes and raises no safety concerns.

Conditions of use

3.1.3

The additive is currently authorised for use in feed for sows at a minimum inclusion level of 5 × 10^8^ CFU/kg complete feed. Under other provisions of the authorisation, it is specified that:

• In the directions for use of the additive and premixtures, indicate the storage conditions and stability to pelleting.
• For safety: it is recommended to use breathing protection and gloves during handling.

The applicant did not request any change in the current conditions of the authorisation.

Safety

3.2

In previous opinions (EFSA FEEDAP Panel, 2014; EFSA FEEDAP Panel, 2019b, 2023), the FEEDAP Panel concluded that Bonvital® is considered safe for the target species, the consumer and the environment. Regarding user safety, the Panel concluded that Bonvital® is not irritant to skin and eyes but should be considered to have the potential to be a skin/respiratory sensitiser.

The applicant declared that no adverse effects have been reported for the target species, consumers, users and the environment since the first authorisation.25

The applicant performed six literature searches to provide evidence that in the light of the current knowledge, the additive remains safe under the approved conditions for the target species, consumers, users and the environment. Four of them were already assessed in the context of previous opinions (EFSA FEEDAP Panel, 2019a, 2021a, 2023) and two have been submitted in the context of this application. The last two covered the periods 2010–2023 and 2012–2023 and involved nine databases26 and search terms regarding the strain and additive's name and the safety for the target species, consumer, users and the environment.27 None of the four literature searches previously assessed reported any safety issue related to the use of the additive under assessment in animal nutrition. The only new hits identified in the more recent literature searches regarded papers aimed at investigating the effects of the additive on growth performance of pigs. None of these papers reported any safety issue related to the use of the additive under assessment in animal nutrition.

The identity of the DSM 7134 strain originally assigned to the E. faecium species, was reassigned to E. lactis and evidence that the strain does not harbour acquired AMR genes or virulence factors was provided. The FEEDAP Panel considers the criteria to assess the safety of E. faecium are applicable also to E. lactis strains. In addition, the manufacturing process of the additive, its composition and the conditions of use for the target species have not been modified. Consequently, the conclusions already reached are still valid, and the FEEDAP Panel considers that Bonvital® remains safe for the target species, consumers and the environment under the authorised conditions of use.

No new information was provided on user safety.28 Based on data obtained with the powder form of the additive submitted in the context of the previous assessments, the Panel concludes that this form of the additive is not irritant to skin and eyes. Owing to the lack of data on the granulated form,29 no conclusion is possible on its skin and eye irritation potential.

The additive consists of a microorganism, and therefore it should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk.

Conclusions on safety

3.2.1

The Panel concludes that Bonvital® remains safe for the target species, consumers and the environment under the authorised conditions of use. Bonvital®, in its powder form, is not irritant to the skin and eyes but no conclusion is possible for the granulated form. Both forms of Bonvital® should be considered skin and respiratory sensitisers and any exposure through skin and respiratory tract is considered a risk.

Efficacy

3.3

The present application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Post‐market monitoring

3.4

The FEEDAP Panel considers that there is no need for specific requirements for a post‐market monitoring plan other than those established in the Feed Hygiene Regulation30 and Good Manufacturing Practice.

CONCLUSIONS

4

The applicant has provided evidence that the additive currently on the market complies with the existing terms of authorisation.

The FEEDAP Panel concludes that the use of Bonvital® under the current authorised conditions of use remains safe for sows, consumers and the environment.

Bonvital® in its powder form is not irritant to the skin and eyes but no conclusion is possible for the granulated form. Both forms of Bonvital® should be considered skin and respiratory sensitisers and any exposure through skin and respiratory tract is considered a risk.

There is no need to assess the efficacy of Bonvital® in the context of the renewal of the authorisation.ABBREVIATIONSAMRantimicrobial resistanceCFUcolony forming unitEURLEuropean Union Reference LaboratoryFEEDAPEFSA Scientific Panel on Additives and Products or Substances used in Animal FeedLOQlimit of quantificationWGSwhole genome sequence

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2023‐00857

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PANEL MEMBERS

Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López‐Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto‐Maradona, Ilen Röhe, Katerina Theodoridou, Pier Sandro Cocconcelli, Montserrat Anguita, Matteo L. Innocenti and Rosella Brozzi.

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 EFSA. The full output has been shared with the European Commission, EU Member States (if applicable) and the applicant. The blackening may be subject to review once the decision on the confidentiality requests is adopted by EFSA and in case it rejects some of the confidentiality requests.