Abstract
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of two technological additives consisting of Enterococcus faecium strains ATCC 53519 and ATCC 55593, respectively. The additives are intended for use with all types of fresh materials and for all animal species at a proposed minimum concentration of 1 × 107 colony forming units (CFU) of E. faecium ATCC 53519/kg forage or 5 × 106 CFU of E. faecium ATCC 55593/kg forage. In a previous opinion, the FEEDAP Panel could not conclude on their efficacy since the dry matter content of the ensiled materials at the end of the experiments was not corrected for volatiles, which led to an unreliable estimation of the dry matter loss, and the lack of positive effects on any of the other parameters. The supplementary information submitted by the applicant included updated data on the pH values and the dry matter loss corrected for volatiles. However, the estimation of the dry matter loss corrected for volatiles was wrongly calculated and thus, was not considered for the assessment of the efficacy of the additive. Considering the lack of effect on any other fermentation parameter, the Panel could not conclude on the efficacy of the additive to improve the production of silage under the proposed conditions of use.
Keywords: technological additives, silage additives, Enterococcus faecium ATCC 53519, Enterococcus faecium ATCC 55593, efficacy
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 authorisation by the Commission.
The applicant FEFANA asbl 2 is seeking a Community authorisation of Enterococcus faecium (ATCC 53519, ATCC 55593) as feed additives to be used as silage additives for all animal species (Table 1).
Table 1.
Description of the additive
| Category of additive | Technological additives |
|---|---|
| Functional group of additive | Silage additives |
| Description | Enterococcus faecium (ATC 53519, ATC 55593) |
| Target animal category | All animal species |
| Applicant | FEFANA asbl |
| Type of request | New opinion |
On 27 September 2022, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of the European Food Safety Authority (EFSA), in its opinion on the safety and efficacy of the product, could not conclude on the efficacy of Enterococcus faecium (ATCC 53519, ATCC 55593) in all animal species.
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 24 January 2023 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 Enterococcus faecium (ATCC 53519, ATCC 55593) as feed additives for all animal species based on the additional data submitted by the applicant, in accordance with Article 29(1)(a) of Regulation (EC) No 178/2002.
1.2. Additional information
EFSA issued two opinions on the safety and efficacy of the additives Enterococcus faecium ATCC 53519 and E. faecium ATCC 55593 when used in feed for all animal species (EFSA FEEDAP Panel, 2013, 2022). These opinions regarded the re‐evaluation of the additives as technological additives (functional group: silage additives).
2. Data and methodologies
2.1. Data
The present assessment is based on data submitted by the applicant in the form of supplementary information 3 to previous applications on the same product. 4
In accordance with Article 38 of Regulation (EC) No 178/2002 5 and taking into account the protection of confidential information and 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, 6 a non‐confidential version of the supplementary information has been published on Open.EFSA available at https://open.efsa.europa.eu/questions/EFSA-Q-2023-00019.
2.2. Methodologies
The approach followed by the FEEDAP Panel to assess the efficacy of E. faecium ATCC 53519 and ATCC 55593 is in line with the principles laid down in Regulation (EC) No 429/2008 7 and the relevant guidance documents: Guidance on the assessment of the efficacy of feed additives (EFSA FEEDAP Panel, 2018).
3. Assessment
The two additives under assessment contain viable cells of E. faecium strains (ATCC 53519 or ATCC 55593) and are intended to be added to all types of fresh materials to promote ensiling (technological additives, functional group: silage additives). The additive containing E. faecium strain ATCC 53519 is intended to be used at 1 × 107 colony forming units (CFUs)/kg fresh material and the additive with E. faecium strain ATCC 55593 at 5 × 106 CFU/kg fresh material.
In the original application from 2013, the FEEDAP Panel could not conclude on the efficacy of the two additives owing to the lack of sufficient evidence for an improvement in nutrient preservation during the ensiling process (EFSA FEEDAP Panel, 2013). In a second submission aimed to address the limitations on efficacy, the applicant provided three laboratory experiments conducted with different fresh materials representing easy‐to‐ensile (maize; trial 1), moderately difficult‐to‐ensile (alfalfa; trial 2) and difficult‐to‐ensile (high‐moisture maize; trial 3) materials, in line with the requirements of Regulation (EC) No 429/2008 (EFSA FEEDAP Panel, 2022). All the studies included a control (without inoculant), a group inoculated with E. faecium ATCC 53519 (1 × 107 CFU/kg forage) and a group inoculated with E. faecium ATCC 55593 (5 × 106 CFU/kg forage), with four replicates per treatment. At the end of the ensiling process, the dry matter (DM) loss of the forages treated with E. faecium ATCC 53519 or ATCC 55593 was significantly reduced compared to controls. These findings would suggest a positive effect on the preservation of nutrients. However, the DM content of the ensiled materials at the end of the experiments was not corrected for volatiles, which may lead to an unreliable estimation of the DM loss, and there were no other positive effects on any other parameter evaluated. Therefore, the FEEDAP Panel was not in the position to conclude on the efficacy of the additives.
In the current application, the same three studies were submitted with some updated information. The new data included amended pH values of the control samples at 90 days and an estimation of DM loss corrected for volatiles. 8 Still, the only positive effect observed in the treated samples at the end of the ensiling process was a reduction of the DM loss, in this case, corrected for volatiles. However, the correction of the DM loss was not adequately estimated, as the volatile fermentation products were detracted not only from the DM of the material at the end of the process (90 days) but also from the DM of the starting fresh material before fermentation. Besides, the formula applied for the correction of the DM was not appropriate for the type of ensiled material. 9 Therefore, the results of the only parameter showing an improvement in the silage quality were not reliable and were not considered further to assess the efficacy. Due to the lack of adequate data on the DM loss and the absence of effect on any other fermentation parameter, the Panel is not in the position to conclude on the efficacy of the additive under the proposed conditions of use.
4. Conclusions
The FEEDAP Panel is not in the position to conclude on the efficacy of E. faecium strains ATCC 53519 or ATCC 55593 when used as silage additives.
Abbreviations
- CFU
colony forming unit
- DM
dry matter
- FEEDAP
EFSA Scientific Panel on Additives and Products or Substances used in Animal Feed
Suggested citation: EFSA FEEDAP Panel (EFSA FEEDAP Panel on Additives and Products or Substances used in Animal Feed) , Bampidis, V ., Azimonti, G ., Bastos, M. L ., Christensen, H ., Durjava, M ., Dusemund, B ., Kouba, M ., López‐Alonso, M ., López Puente, S ., Marcon, F ., Mayo, B ., Pechová, A ., Petkova, M ., Ramos, F ., Sanz, Y ., Villa, R. E ., Woutersen, R ., Dierick, N ., … Ortuño, J . (2023). Efficacy of the feed additives consisting of Enterococcus faecium ATCC 53519 and E. faecium ATCC 55593 for all animal species (FEFANA asbl). EFSA Journal, 21(7), 1–6. 10.2903/j.efsa.2023.8166
Requestor European Commission
Question number EFSA‐Q‐2023‐00019
Panel members Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Maryline Kouba, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa and Ruud Woutersen.
Declaration of interest If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu.
Acknowledgements The Panel wishes to thank the following for the support provided to this scientific output (in alphabetical order of the last name): FEEDAP WG on Animal Nutrition
EFSA may include images or other content for which it does not hold copyright. In such cases, EFSA indicates the copyright holder and users should seek permission to reproduce the content from the original source.
Adopted: 4 July 2023
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.
FEFANA Asbl – SILAC “Silage Additives Authorisation Consortium”, Rue de Trèves 45, 1040 Brussels, Belgium.
Dossier reference: EFSA‐Q‐2023‐00019.
Dossiers reference: FAD‐2010‐0315 and EFSA‐Q‐2021‐00634.
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, p.1–48.
Decision available at: https://www.efsa.europa.eu/en/corporate-pubs/transparency-regulation-practical-arrangements
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.
Annex 1 Table 3_May2023.
Porter, MG and RS Murray, 2001. The volatility of components of grass silage on oven drying and the inter‐relationship between dry‐matter content estimated by different analytical methods. Grass and Forage Science 56: 405–411.
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