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 the preparation containing viable cells of the bacterium DSM 11798 intended for use as a technological additive (functional group: substances for reduction of the contamination of feed by mycotoxins) in feed for pigs and all avian species. The applicant provided evidence that the additive currently on the market complies with the existing terms of the authorisation. The identification of the active agent has been changed and it belongs to the Eggerthellaceae family. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for piglets, pigs for fattening and all avian species, consumers and the environment under the approved terms of the authorisation. Regarding user safety, the additive is not a skin or eye irritant. However, it should be considered a skin and respiratory sensitiser, and any exposure through the skin and respiratory tract is a risk. This conclusion 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.
Keywords: DSM 11798, renewal, safety, substances for reduction of the contamination of feed by mycotoxins, technological additives
1. INTRODUCTION
1.1. Background and Terms of Reference
Regulation (EC) No 1831/2003 1 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 BIOMIN GmbH 2 for the renewal of the authorisation of the additive consisting of the microorganism strain DSM 11798 of the Coriobacteriaceae family, when used as a feed additive for pigs and all avian species (category: technological additives; functional group: substances for the reduction of the contamination of feed by mycotoxins: trichothecenes).
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 11 November 2022, and the general information and supporting documentation are available at https://open.efsa.europa.eu/questions/EFSA‐Q‐2022‐00793. The particulars and documents in support of the application were considered valid by EFSA as of 6 February 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 the bacterium DSM 11798 when used under the proposed conditions of use (see Section 3.1.3 ).
1.2. Additional information
The additive is currently authorised as a preparation containing viable cells of the bacterial strain DSM 11798 of the Coriobacteriaceae family for use in feed for pigs 3 and all avian species (1m01). 4
EFSA issued two opinions on the safety and efficacy of this product when used in feed for pigs and all avian species (EFSA FEEDAP Panel, 2013, 2017).
2. DATA AND METHODOLOGIES
2.1. Data
The present assessment is based on data submitted by the applicant in the form of a technical dossier 5 in support of the authorisation request for the use of the bacterium DSM 11798 as a feed additive.
In 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 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, 8 EFSA carried out a public consultation on the non‐confidential version of the technical dossier from 8 March to 12 March 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 6 February to 6 May 2023, for which the received comments were considered for the assessment.
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 and other scientific reports, 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 bacterium DSM 11798 in animal feed are valid and applicable to the current application. 9
2.2. Methodologies
The approach followed by the FEEDAP Panel to assess the safety and efficacy of microorganism strain DSM 11798 is in line with the principles laid down in Regulation (EC) No 429/2008 10 and the relevant guidance documents: Guidance on the renewal of the authorisation of feed additives (EFSA FEEDAP Panel, 2021).
3. ASSESSMENT
The additive under assessment is authorised as ‘microorganism strain DSM 11798 of the Coriobacteriaceae family’ for use as a technological additive (functional group: substances for reduction of the contamination of feed by mycotoxins: trichothecenes) in feed for pigs and all avian species. The applicant is requesting the renewal of this authorisation.
The active agent, originally identified as belonging to the family Coriobacteriaceae, has now been allocated to the family Eggerthellaceae (see Section 3.1.2).
3.1. Characterisation
3.1.1. Characterisation of the additive
The additive is currently authorised as a ‘preparation of a microorganism strain DSM 11798 of the Coriobacteriaceae family containing a minimum of 5 × 109 colony forming units (CFU)/g of additive’. 11
Analytical data to confirm the specifications were provided for five batches of the additive, showing an average value of 8.5 × 1010 CFU/g additive (6.0 × 1010–1.1 × 1011 CFU/g additive). 12
Three batches of the additive were analysed for cadmium, lead, mercury, arsenic and mycotoxins, including aflatoxins (B1, G1, B2, G2), deoxynivalenol, zearalenone, ochratoxin A, fumonisins (B1 and B2), HT‐2 toxin and T‐2 toxin concentrations. All the levels found fell below the limit of quantification (LOQ) or limit of detection (LOD) of the analytical methods. 13
Microbiological contamination was investigated in three batches of the additive by analysing coliforms (< 15 CFU/g), Escherichia coli (< 10 CFU/g), Enterobacteriaceae (< 10 CFU/g in two batches and 13 CFU/g in one batch), yeasts (< 13 CFU/g in two batches and 106 CFU/g in the third one) and moulds (< 10 CFU/g in two batches and 120 CFU/g in one batch) and Salmonella spp. (no detection in 25 g). 14
The FEEDAP Panel considers that the results of these analyses do not raise safety concerns.
The applicant declared that the composition and the manufacturing process of the additive have not been changed since the previous authorisation and that no antibiotics are used during the manufacturing process. 15 Therefore, data on physical–chemical properties, shelf‐life and stability assessed in previous opinions apply (EFSA FEEDAP Panel, 2013, 2017).
3.1.2. Characterisation of the active agent
The active agent was isolated from bovine rumen content 16 and is deposited in the Deutsche Sammlung von Mikroorganismen und Zellkulturen (DSMZ) with the accession number DSM 11798. 17
The active agent was originally assigned to a new taxonomic unit within the family of Coriobacteriaceae (EFSA FEEDAP Panel, 2013). However, a recent bioinformatic analysis comparing the whole genome sequence (WGS) data of the DSM 11798 strain with 28 reference genomes showed an average nucleotide identity (ANI) value of 79.9% with Raoultibacter massiliensis P2849T, of 76.8% with Eggerthella lenta DSM 2243T and of 73.5% with Raoultibacter timonensis P3277T, 18 the type strains of three species belonging to the family Eggerthellaceae. Alignment of the sequences of 20 core proteins also showed R. massiliensis P2849T as the closest type strain. The results suggest that the strain DSM 11798 may represent a new taxon within the family Eggerthellaceae.
The DSM 11798 strain was tested for antibiotic susceptibility in a strain‐specific, complex growth medium using a broth microdilution method. The battery of antibiotics used included those recommended by EFSA (EFSA FEEDAP Panel, 2018). All the minimum inhibitory concentration (MIC) values were below the corresponding EFSA cut‐off values for ‘Corynebacterium and other Gram‐positive’, except for ampicillin (8 mg/L vs. 1 mg/L). However, when the control strain Bifidobacterium longum ATCC 15707 was tested on the same growth medium, it also showed an elevated ampicillin MIC compared to typically used ■■■■■ (4 or 16 mg/L vs. 0.25 or 0.5 mg/L, respectively). The growth medium interference is likely the cause of the elevated ampicillin MIC for the active agent; however, this hypothesis could not be proven since the active agent does not grow on ■■■■■. 19 With the exception of ampicillin, the results showed that the DSM 11798 strain is susceptible to all antibiotics. Uncertainty remains on the susceptibility of the strain to ampicillin.
The WGS data of the DSM 11798 strain were interrogated for the presence of antimicrobial resistance (AMR) genes against the CARD and ResFinder databases. 20 Since no hits were identified exceeding the thresholds established by EFSA (EFSA, 2021), it can be concluded that the strain does not harbour AMR genes of concern, including ampicillin resistance. Therefore, the strain poses no risks regarding antimicrobial resistance.
In a previous opinion (EFSA FEEDAP Panel, 2013), the DSM 11798 strain was shown not to produce detectable antimicrobial activity against four indicator bacteria and one yeast strain. 21
The WGS data of the strain were also interrogated for the presence of virulence factors against the Virulence Factor database (VFDB) and no hits were identified exceeding the thresholds recommended by EFSA (EFSA, 2021). 22 Therefore, the DSM 11798 strain is considered not to be virulent/pathogenic.
3.1.3. Conditions of use
The additive is currently authorised for use in feedingstuffs for pigs and all avian species at a minimum inclusion level of 1.7 × 108 CFU/kg of complete feed. Under other provisions of the authorisation, it is specified that:
In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
The use of the additive is allowed in feedingstuffs complying with the European Union legislation on undesirable substances in animal feed.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment including breath protection.
The authorisation for all avian species also includes the following:
The use is permitted in feed containing the following authorised coccidiostats: narasin/nicarbazin, salinomycin sodium, monensin sodium, robenidine hydrochloride, diclazuril, narasin or nicarbazin.
The applicant did not request any changes in the current conditions of the authorisation.
3.2. Safety
The safety of the additive for the target species, consumers, users and the environment was evaluated in previous opinions (EFSA FEEDAP Panel, 2013, 2017). The Panel concluded that the additive is safe for piglets and pigs for fattening at the maximum proposed inclusion level of 2.2 × 109 CFU/kg complete feed and for all avian species at the recommended inclusion level of 1.7 × 108 CFU/kg complete feed. Moreover, the Panel concluded that the use of the product as a feed additive would be of no concern for the consumers or the environment. Regarding the safety for the user, the additive was considered to be non‐irritant to eyes and skin and not a skin sensitiser, but a potential respiratory sensitiser.
In the context of the current assessment, the applicant has (i) declared that no adverse effects or incidents were observed on workers or other persons exposed to the additive in the manufacturing plant, or adverse effects were recorded on target animals, consumers or the environment since the first authorisation, 23 (ii) conducted two literature reviews and (iii) an in vitro micronucleus test. The Panel assessed these data which are described below.
3.2.1. Literature searches
The applicant performed the literature searches to provide evidence that the additive remains safe under the approved conditions for the target species, consumers, users and the environment. The searches covered the period 2013–2021 using the following databases: PubMed, Scopus, Google Scholar and Wiley Online Library. 24 The search protocol described the inclusion and exclusion criteria applied for the screening process. A total of 639 hits were retrieved, and after applying the exclusion criteria and deduplication, a total of 31 hits were considered eligible and relevant by the applicant for the safety of the additive. The FEEDAP Panel assessed all the papers and concluded that none of them presented new information that would lead it to reconsider its previous conclusions on the safety of the additive.
3.2.2. In vitro micronucleus test
In view of the reports approved by the EFSA Scientific Committee (EFSA Scientific Committee, 2017, 2021) providing clarification on some aspects related to the assessment of genotoxicity, the toxicological studies submitted in the previous opinion (EFSA FEEDAP Panel, 2013) did not allow to properly assess the aneugenic potential of the test item. In the current application, the applicant submitted an in vitro micronucleus test performed in human peripheral blood lymphocytes to evaluate the potential of the additive to induce structural and numerical chromosomal damage. 25 The study was in line with OECD Test Guideline 487 (2016) and claimed to be GLP compliant. The additive was suspended in culture medium by ultrasonication prior to treatment. Based on the results of a preliminary cytotoxicity assay, three concentrations of the test item were selected for the analysis of micronuclei applying a short treatment (4 + 40 h of recovery) with and without metabolic activation (500, 1000 and 2500 μg/mL) and a continuous treatment (44 + 0 h of recovery) without metabolic activation (50, 500, 2500 μg/mL). Precipitation was detected at the highest concentration tested. The highest value of cytostasis (54%) was observed at 2500 μg/mL after continuous treatment. No increase in the frequency of micronuclei in binucleated cells was reported in any experimental condition. Therefore, the FEEDAP Panel concludes that the additive did not induce structural and numerical chromosomal aberrations under the experimental conditions applied in this study.
3.2.3. Safety for the user
The additive is not a skin and eye irritant (EFSA FEEDAP Panel, 2013); however, it consists of a microorganism and therefore should be considered a skin and respiratory sensitiser. Inhalation and dermal exposure are considered a risk.
3.2.3.1. Conclusions on safety
Based on the information provided and the fact that the manufacturing and composition of the additive have not been modified, the FEEDAP Panel concludes that there is no evidence to reconsider the conclusions reached in the previous opinions on the safety of the additive for piglets, pigs for fattening and all avian species. Therefore, the Panel concludes that the additive remains safe under the approved conditions for piglets, pigs for fattening and all avian species, consumers and the environment.
The additive is not a skin or eye irritant. However, it should be considered a skin and respiratory sensitiser, and any exposure through the skin and respiratory tract is a risk. This conclusion would apply, in principle, to any preparation containing the active agent.
3.2.4. Efficacy
The present application for renewal of the authorisation does not include a proposal to amend or supplement the conditions of the original authorisation, which 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.
4. CONCLUSIONS
The applicant has provided evidence that the additive currently on the market complies with the existing terms of authorisation. The identification of the active agent has been changed and belongs to the Eggerthellaceae family.
The Panel concludes that the additive remains safe for piglets, pigs for fattening and all avian species, consumers and the environment under the approved terms of the authorisation.
The additive is not a skin or eye irritant. However, it should be considered a skin and respiratory sensitiser, and any exposure through the skin and respiratory tract is a risk. This conclusion would apply, in principle, to any preparations containing the active agent.
There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
5. RECOMMENDATION
The active agent should be described as ‘bacterial strain DSM 11798 of the Eggerthellaceae family’.
ABBREVIATIONS
- ANI
average nucleotide identity
- CFU
colony forming unit
- EURL
European Union Reference Laboratory
- FEEDAP
EFSA Scientific Panel on Additives and Products or Substances used in Animal Feed
- LOD
limit of detection
- LOQ
limit of quantification
- MIC
minimum inhibitory concentration
- OECD
Organisation for Economic Co‐operation and Development
- WGS
Whole genome sequence
REQUESTOR
European Commission
QUESTION NUMBER
EFSA‐Q‐2022‐00793
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 and 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.
EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) , Villa, R. E. , Azimonti, G. , Bonos, E. , Christensen, H. , Durjava, M. , Dusemund, B. , Gehring, R. , Glandorf, B. , Kouba, M. , López‐Alonso, M. , Marcon, F. , Nebbia, C. , Pechová, A. , Prieto‐Maradona, M. , Röhe, I. , Theodoridou, K. , Mayo, B. , Anguita, M. , … Brozzi, R. (2025). Assessment of the feed additive consisting of a strain belonging to Eggerthellaceae family (DSM 11798) for pigs and all avian species (1m01) for the renewal of its authorisation (BIOMIN GmbH). EFSA Journal, 23(4), e9360. 10.2903/j.efsa.2025.9360
Adopted: 20 March 2025
The declarations of interest of all scientific experts active in EFSA's work are available at https://open.efsa.europa.eu/experts
Notes
Regulation (EC) No 1831/2003 of the European Parliament and of the council of 22 September 2003 on the additives for use in animal nutrition. OJ L 268, 18.10.2003, p. 29.
BIOMIN GmbH, Erber Campus 1, 3131 Getzersdorf, Austria.
Commission Implementing Regulation (EU) No 1016/2013 of 23 October 2013 concerning the authorisation of a preparation of a micro‐organism strain DSM 11798 of the Coriobacteriaceae family as a feed additive for pigs. OJ L 282, 24.10.2013, p. 36.
Commission Implementing Regulation (EU) 2017/930 of 31 May 2017 concerning the authorisation of a preparation of a microorganism strain DSM 11798 of the Coriobacteriaceae family as a feed additive for all avian species and amending Implementing Regulation (EU) No 1016/2013.
Dossier reference: FEED‐2022‐10090.
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. OJ L 31, 1.2.2002, pp. 1–48.
Decision available at: https://www.efsa.europa.eu/en/corporate‐pubs/transparency‐regulation‐practical‐arrangements.
Decision available at: https://www.efsa.europa.eu/en/corporate‐pubs/transparency‐regulation‐practical‐arrangements.
Evaluation report available on the EU Science Hub https://joint‐research‐centre.ec.europa.eu/eurl‐fa‐eurl‐feed‐additives/eurl‐fa‐authorisation/eurl‐fa‐evaluation‐reports_en.
Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives. OJ L 133, 22.5.2008, p. 1.
Sect_II_Identity.
Annex II_04.
Annex II_05. LOQ: Cd (0.20 mg/kg), Pb (0.50 mg/kg), Hg (0.02 mg/kg) and As (0.50 mg/kg) and Annex II_06. LOD: aflatoxin B1 (0.5 μg/kg), aflatoxins G1, B2 and G2 (1 μg/kg), deoxynivalenol (20 μg/kg), zearalenone (5 μg/kg), ochratoxin A (0.5 μg/kg), fumonisins B1 and B2 (10 μg/kg), HT‐2 toxin (15 μg/kg) and T‐2 toxin (10 μg/kg).
Annex II_07.
2_3 Sect_II Manufacturing.
2_1 and 2_2 Sect_II Identity_Characterisation.
Annex II_03.
Annex II_13.
Annex II_20A.
Annex II_13.
Annex II_19.
Annex II_13.
3_3 Sect III_Safety_User_Worker and Annexes III_01 and III_01A.
Annexes III_02, Annex III_02 BBSH797_ELS_update20250121 and Answer to RFI from 10.02.2025_Literature.
Annex III_04.
REFERENCES
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