Assessment of the feed additive consisting of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) DSM 12837 for all animal species for the renewal of its authorisation (Lactosan GmbH & Co KG).

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 assessment of the application for renewal of authorisation of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) DSM 12837 as a technological additive for all animal species. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. There was no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. The additive was not irritant to skin and eyes but is considered a skin and respiratory sensitiser. The present application for renewal of the authorisation did 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 was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Introduction

Background and Terms of Reference as provided by the requestor

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 Lactosan GmbH & Co.KG2 for authorisation of the product Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) DSM 12837, 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 particulars and documents in support of the application were considered valid by EFSA as of 20 November 2020.

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 product Lactiplantibacillus plantarum DSM 12837, when used under the proposed conditions of use (see Section 3.1.3).

Additional information

The additive is a preparation containing viable cells of Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) DSM 12837. It is currently authorised as a feed additive in the European Union (1k2079).3

EFSA has adopted one opinion on the safety and efficacy of this product for all animal species (EFSA FEEDAP Panel, 2011).

Data and methodologies

Data

The present assessment is based on data submitted by the applicant in the form of a technical dossier4 in support of the authorisation request for the use of Lactiplantibacillus plantarum DSM 12837 as a feed additive.

The European Union Reference Laboratory (EURL) considered that the conclusions and recommendations reached in the previous assessment are valid and applicable for the current application.5

Methodologies

The approach followed by the FEEDAP Panel to assess the safety and the efficacy of Lactiplantibacillus plantarum DSM 12837 is in line with the principles laid down in Regulation (EC) No 429/20086 and the relevant guidance documents: Guidance on the characterisation of microorganisms used as feed additives or as production organisms (EFSA FEEDAP Panel, 2018) and Guidance on the renewal of the authorisation of feed additives (EFSA FEEDAP Panel, 2013).

Assessment

The additive is a preparation of viable cells of a single strain of L. plantarum currently authorised as a technological additive (functional group: silage additives) for use in forages for all animal species. This assessment regards the renewal of the authorisation of L. plantarum DSM 12837 for the above‐mentioned species.

Characterisation

Characterisation of the additive

The product currently authorised consists of approximately 35‐50% bacterial cells and 50‐65% carriers (■■■■■) and cryoprotectants (■■■■■). The minimum concentration of active agent L. plantarum DSM 12837 is 5 × 1011 colony forming units (CFU) per gram of additive.

The information submitted on the manufacturing process lists a series of modifications applied to the fermentation process and the composition of the additive which have been developed since the first authorisation was granted. The modifications regard the composition of the fermentation medium (e.g. ■■■■■). Regarding the composition of the additive, ■■■■■ are also used as cryoprotectants, and ■■■■■ is used in replacement of ■■■■■.

Analysis of three recent batches for viable lactic acid bacterial cells showed a mean value of 6.2 × 1011 CFU/g additive (range 5.9–6.5 × 1011 CFU/g additive).7

Limits are set for Enterobacteriaceae (102 CFU/g), yeasts and filamentous fungi (102 CFU/g) and Salmonella spp. (not detected in 25 g). Analysis of the above‐referred batches of the additive showed compliance with these limits.8 These recent batches were also tested for aflatoxins (B1, B2, G1 and G2), deoxynivalenol, zearalenone,9 lead, mercury, cadmium and arsenic concentration.10 Results showed levels below the respective limits of quantification.11

No new data have been provided regarding the physico‐chemical properties or stability of the additive. Since the changes introduced in the additive and its manufacturing process are not expected to have a significant effect on these characteristics, the data described in the previous opinion still apply.

Characterisation of the active agent

The active agent was isolated from silage. It was deposited in Deutsche Sammlung von Mikroorganismen und Zellkulturen (DSMZ) with the accession number DSM 12837.12 It has not been genetically modified.

The taxonomical identification was achieved by phylogenetic analysis13 comparing the whole genome sequence (WGS) of the active agent to genomes present ■■■■■ The analysis allocated the strain into the L. plantarum group (closest strains being the L. plantarum type strain). Moreover, the results of the ■■■■■

The bacterial strain was tested for antibiotic susceptibility using a broth microdilution method.14 The battery of antibiotics used included those recommended by EFSA (EFSA FEEDAP Panel, 2018). All the minimum inhibitory concentration values were equal or fell below the corresponding EFSA cut‐off values for ■■■■■ Therefore, the strain is considered to be susceptible to all the relevant antibiotics.

The WGS of the strain■■■■■ was searched for acquired antibiotic resistance genes in the databases ■■■■■ as thresholds.15 No hits were identified.

Conditions of use

The additive is currently authorised for use in forages for all animal species without a minimum inclusion level.

Under other provisions of the authorisation, it is specified that:

In the directions for use of the additive and premixture, indicate the storage temperature and storage life.

Minimum dose of the additive when used without combination with other micro‐organisms as silage additives: 1 × 108 CFU/kg fresh material.

For safety: it is recommended to use breathing protection and gloves during handling.

The applicant has requested to maintain the same conditions of use.

Safety

In the previous opinion, the FEEDAP Panel concluded that, following the qualified presumption of safety (QPS) approach, the use of this strain in the production of silage was considered safe for target species, consumers and the environment (EFSA FEEDAP Panel, 2011). In the context of this application, the identity of the strain as L. plantarum was confirmed and evidence that the strain does not show acquired antimicrobial determinants for antibiotics of human and veterinary importance was provided. Consequently, the conclusions already reached are still valid and L. plantarum DSM 12837 is safe for the target species, consumers and the environment.

The safety for the user was evaluated by the FEEDAP Panel in a previous assessment (EFSA FEEDAP Panel, 2011). The Panel concluded: ‘Evidence of a lack of irritancy was provided for one formulation of the additive. It is unlikely that given the nature of the alternative food grade excipients, different results would be obtained for other formulations containing L. plantarum DSM 12837. Given the proteinaceous nature of the active agent, its potential to be a skin/respiratory sensitiser cannot be excluded’. No additional data were provided in the current application.

The applicant declares that no adverse effects on the health of workers have been observed in the production plant or during usage of the additive.16

The applicant performed a literature search in order to provide evidence that in the light of the current knowledge the additive remains safe under the approved conditions for target species, consumers, users and the environment. The literature search was conducted in June 2020 without time restrictions.17 The search term used was ‘Lactobacillus plantarum DSM 12837’ and the strategy followed was reported. The applicant searched in a total of seven relevant databases: Agricola, Agris, Google Scholar, Ingenta, PubMed, Science Direct and World Cat Library. The literature search retrieved 15 publications. However, none was considered relevant because they referred to the previous EFSA opinions (four hits), or to the authorisation of the additive (four hits) or to the assessment of the effects of the use of the additive, in combination with other products, on the ensiling process (four hits) and/or on the performance of animals receiving them (three hits).

Therefore, the FEEDAP Panel concludes that there is no new evidence that would lead to reconsider the previous conclusions that L. plantarum DSM 12837 is safe for the target species, consumers and the environment under the authorised conditions of use. Regarding user safety L. plantarum DSM 12837 is not irritant to skin and eyes but is considered a skin and respiratory sensitiser.

Efficacy

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

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

There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. Regarding user safety Lactiplantibacillus plantarum DSM 12837 is not irritant to skin and eyes but is considered a skin and respiratory sensitiser.

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

Documentation as provided to EFSA/Chronology

Abbreviations

colony forming unit

coefficient of variation

dry matter

Deutsche Sammlung von Mikroorganismen und Zellkulturen

European Union Reference Laboratory

minimum inhibitory concentration

qualified presumption of safety

whole genome sequence

Date	Event
02/07/2020	Dossier received by EFSA. Lactobacillus plantarum DSM 12837. Submitted by Lactosan GmbH & Co. KG
09/07/2020	Reception mandate from the European Commission
16/11/2020	Application validated by EFSA – Start of the scientific assessment
10/06/2020	Reception of the Evaluation report of the European Union Reference Laboratory for Feed Additives
22/02/2021	Comments received from Member States
29/03/2021	Request of supplementary information to the applicant in line with Article 8(1)(2) of Regulation (EC) No 1831/2003 – Scientific assessment suspended. Issues: characterisation
09/04/2021	Reception of supplementary information from the applicant ‐ Scientific assessment re‐started
05/05/2021	Opinion adopted by the FEEDAP Panel. End of the Scientific assessment