Assessment of the feed additive consisting of Lactiplantibacillus plantarum DSM 16627 for all animal species for the renewal of its authorisation (Microferm Ltd.)

TL;DR

This paper evaluates the safety of a microbial feed additive for animals and concludes it remains safe under current conditions.

Contribution

The paper confirms the safety of Lactiplantibacillus plantarum DSM 16627 for renewal of authorization without new evidence contradicting prior conclusions.

Findings

The additive is safe for all animal species, consumers, and the environment under current conditions.

The additive is a skin and respiratory sensitiser, posing risks through exposure.

No data was available to assess eye irritation potential.

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 a preparation Lactiplantibacillus plantarum DSM 16627 as a technological additive to improve ensiling of fresh plant material for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There was no new evidence that would lead the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) to reconsider its previous conclusions for all animal species, consumers and the environment, for which the additive is considered to remain safe. Regarding the user safety, the additive is a preparation containing a microorganism and therefore should be considered a skin and respiratory sensitiser, and any exposure through the skin and respiratory tract is considered a risk. In the absence of data, no conclusion could be drawn on the eye irritation potential of the additive. There is no need for assessing the efficacy of the additive in the context of 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 one year before the expiry date of the authorisation.

The European Commission received a request from Microferm Ltd.2 represented in the EU by Marigot Ltd., for the renewal of the authorisation of the additive consisting of Lactiplantibacillus plantarum DSM 16627,3 when used as a feed additive for all animal species (category: technological additives; functional group: silage additives).

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 7 August 2023 and the general information and supporting documentation are available at https://open.efsa.europa.eu/questions/EFSA‐Q‐2023‐00543. The particulars and documents in support of the application were considered valid by EFSA as of 20 November 2023.

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 L. plantarum DSM 16627, when used under the proposed conditions of use (see Section 3.1.3).

Additional information

1.2

The additive consisting of L. plantarum DSM 16627 is currently authorised for use in feed for all animal species (1k20749).4 EFSA issued one opinion on the safety and efficacy of this product when used in feed for all animal species (EFSA FEEDAP Panel, 2014).

DATA AND METHODOLOGIES

2

Data

2.1

The present assessment is based on data submitted by the applicant in the form of a technical dossier5 in support of the authorisation request for the use of L. plantarum DSM 16627 as a feed additive.

In accordance with Article 38 of the Regulation (EC) No 178/20026 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 dossier has been published on https://open.efsa.europa.eu/questions/EFSA‐Q‐2023‐00543.

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 23 August to 13 September 2024 for which no comments were received.

The confidential version of the technical dossier was subject to a target consultation of the interested Member States from 20 November 2023 to 20 February 2024 for which the received comments were considered for the assessment.

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 L. plantarum DSM 16627 in animal feed are valid and applicable for the current application.8

Methodologies

2.2

The approach followed by the FEEDAP Panel to assess the safety and the efficacy of L. plantarum DSM 16627 is in line with the principles laid down in Regulation (EC) No 429/20089 and the relevant guidance documents: Guidance on the renewal of the authorisation of feed additives (EFSA FEEDAP Panel, 2021).

ASSESSMENT

3

The additive is a preparation of viable cells of L. plantarum DSM 16627 and is currently authorised as a technological additive (functional group: silage additives) for use in fresh material for all animal species. This assessment regards the renewal of the authorisation of the above‐mentioned additive.

Characterisation

3.1

Characterisation of the additive

3.1.1

The additive is currently authorised as a preparation of viable cells of L. plantarum DSM 1662710 with a minimum content of 1 × 10^7^ colony forming units (CFU)/g of additive. In the current application, the applicant declared a minimum content of 2.5 × 10^10^ CFU/g of additive.11

The applicant declared that ■■■■■ and that no antimicrobial substances are used at any stage of the production process.12 The active agent ■■■■■ cryoprotectants (sucrose, skimmed milk and glycerine) ■■■■■. All the proposed cryoprotectants are feed materials. The additive, ■■■■■ may be standardised with carriers (anhydrous dextrose or maltodextrin) to form a preparation.13

Analysis of five batches of the additive showed compliance with the specifications regarding the minimum concentration of active agent with an average value of 4.31 × 10^11^ CFU/g additive (2.32–6.60 × 10^11^ CFU/g additive).14

Microbiological contamination was analysed in three batches of the additive for β‐glucuronidase‐positive Escherichia coli, Enterobacteriaceae, coliforms, Salmonella spp., yeasts and filamentous fungi. The counts of β‐glucuronidase‐positive E. coli, Enterobacteriaceae and coliforms were all < 10 CFU/g. The levels of yeasts were < 20 CFU/g in two batches and 20 CFU/g in one batch. The levels of filamentous fungi were < 20 CFU/g in one batch and 40 CFU/g in the other two batches tested. Salmonella spp. was not detected in 25 g of samples of the additive.15

Three batches of the additive were tested for mycotoxins (aflatoxins, deoxynivalenol (DON), fumonisins B1 + B2 + B3, ochratoxin A, zearalenone and citrinin), mercury, lead, cadmium and arsenic concentrations, and the results showed the following ranges: zearalenone 28.2–57.9 μg/kg; citrinin 806.4–952.0 μg/kg; ochratoxin A 3.0–3.9 μg/kg; lead 0.022–0.20 mg/kg; cadmium 0.019–0.057 mg/kg; mercury 0.0028–0.0044 mg/kg and arsenic 0.13–0.15 mg/kg. Fumonisins B1 + B2 + B3, DON and aflatoxins levels were below the limit of detection (LOD) of the analytical method,16 with the exception of one batch for aflatoxins (0.9 μg/kg).17

The FEEDAP Panel considers that the microbial contamination and the amounts of the detected impurities in the batches tested do not raise safety concerns. However, the FEEDAP Panel notes that the values found for citrinin are high and deserve attention/monitoring during the production process.

No information on dusting potential was made available on the additive under assessment. The applicant referred to data on commercial premixtures containing other active agents/additives or the additive under assessment in combination with other active agents/additives.18 The Panel considers these data not to be relevant for the current assessment.

No new data were provided regarding the stability of the additive. Considering that no changes have been introduced in the manufacturing process and composition, the Panel considers that the data described in the previous opinion (EFSA FEEDAP Panel, 2014) are still valid.

Characterisation of the active agent

3.1.2

The active agent is deposited in the Leibniz‐ Institute DSMZ–German Collection of Microorganisms and Cell Cultures under the deposition number DSM 16627.19 The applicant declared that it has not been genetically modified.

The taxonomical identification was confirmed ■■■■■■■■■■ ■■■■■

The antimicrobial susceptibility of the strain DSM 16627 was tested using a broth microdilution method against the battery of antibiotics recommended by the EFSA FEEDAP Panel (EFSA FEEDAP Panel, 2018).21 All the minimum inhibitory concentration values were equal or fell below the cut‐off values established in the FEEDAP Guidance. Therefore, the strain is considered to be susceptible to all the relevant antimicrobials.

The WGS of the strain■■■■■ was searched for the presence of antimicrobial resistance (AMR) genes in the NCBI Bacterial Antimicrobial Resistance Gene database and ResFinder databases.22 The search did not identify any hit above the thresholds established by EFSA (EFSA, 2021) and therefore the strain does not harbour AMR genes.

Conditions of use

3.1.3

The additive is currently authorised as a silage additive for all animal species. Under other provisions of the authorisation,23 it is specified that:

1. In the directions for use of the additive and premixture, indicate the storage conditions.
2. Recommended minimum content of the additive when used without combination with other microorganisms as silage additives: 5 × 10^7^ CFU/kg fresh material.
3. For safety: it is recommended to use breathing protection, eye protection and gloves during handling.

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

Safety

3.2

In its previous opinion, the Panel concluded that, following the qualified presumption of safety (QPS) approach to safety assessment, the use of L. plantarum DSM 16627 in the production of silage was considered safe for target species, consumers and the environment (EFSA FEEDAP Panel, 2014). Regarding user safety, the Panel concluded that the additive should be considered irritant to skin and eyes and as a skin and respiratory sensitiser.

The applicant declared that no incidents or safety issues for target animals, consumers, users and/or the environment have been documented or reported since its first authorisation.24

In the context of the current application, the identity of the strain L. plantarum DSM 16627 was confirmed and evidence was provided that the strain does not harbour acquired antimicrobial determinants for antibiotics of human and veterinary importance, confirming the applicability of the QPS approach to safety assessment (EFSA BIOHAZ Panel, 2023). Consequently, the conclusions already reached are still valid and the FEEDAP Panel considers that L. plantarum DSM 16627 remains safe for the target species, consumers and the environment.

The applicant performed a literature search to provide evidence that the additive remains safe under the approved conditions for target species, consumers, users and the environment.25 The literature search was conducted in eight databases (Agris, Cambridge Core, Google Scholar, Ingenta, JSTOR, PubMed, ScienceDirect and WordCat Library) and one website (FAO.org). None of the hits reported any adverse effects or indicated a safety concern.

The Panel concludes that the use of preparations of the active agent formulated with feed materials or other authorised technological feed additives remains safe for the target animals, consumers and the environment.

The additive consists of a microorganism and therefore should be considered as a skin and respiratory sensitiser. In the absence of data, the FEEDAP Panel is not in the position to conclude on the eye irritation potential of the additive.

Conclusions on safety

3.2.1

The FEEDAP Panel concludes that L. plantarum DSM 16627 remains safe for the target species, consumers and the environment under the authorised conditions of use.

The additive should be considered as a skin and respiratory sensitiser. Inhalation and dermal exposure are considered a risk. No conclusions for the additive can be drawn regarding its potential to be irritant to eyes. These conclusions would apply, in principle, to any preparation containing the active agent.

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.

CONCLUSIONS

4

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

The Panel concludes that the additive L. plantarum DSM 16627 remains safe for the target species, consumers and the environment.

Regarding user safety, the additive should be considered a skin and respiratory sensitiser, and any dermal and respiratory exposure is considered a risk. No conclusions can be drawn on the eye irritancy potential of the additive. These conclusions would apply, in principle, to any preparation containing the active agent.

There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

RECOMMENDATIONS

5

The Panel recommends that the authorisation is updated reflecting the minimum content of L. plantarum DSM 16627 in the additive declared by the applicant (i.e. from 1 × 10^7^ to 2.5 × 10^10^ CFU/g additive).

The FEEDAP Panel notes that the values found for citrinin are high and deserve attention/monitoring during the production process.ABBREVIATIONSCFUcolony forming unitEURLEuropean Union Reference LaboratoryFEEDAPEFSA Scientific Panel on Additives and Products or Substances used in Animal FeedLODlimit of detectionMICminimum inhibitory concentration

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2023‐00543

COPYRIGHT FOR NON‐EFSA CONTENT

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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.

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.