Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Apr 26;17(4):e05691.
doi: 10.2903/j.efsa.2019.5691. eCollection 2019 Apr.

Assessment of the application for renewal of authorisation of Bactocell® (Pediococcus acidilactici CNCM I-4622) as a feed additive for all fish and shrimps and its extension of use for all crustaceans

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP); Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Maryline Kouba, Mojca Kos Durjava, Marta López-Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa, Ruud Woutersen, Jaume Galobart, Lucilla Gregoretti, Matteo Innocenti, Gloria López-Gálvez, Konstantinos Sofianidis, Maria Vittoria Vettori, Rosella Brozzi

Assessment of the application for renewal of authorisation of Bactocell® (Pediococcus acidilactici CNCM I-4622) as a feed additive for all fish and shrimps and its extension of use for all crustaceans

EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) et al. EFSA J. .

Abstract

Bactocell® is the trade name for a feed additive based on viable cells of a strain of Pediococcus acidilactici. 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 Bactocell® in the context of the renewal of the authorisation for shrimps, salmonids and fish other than salmonids. In addition, the applicant requested the extension of use for all crustaceans. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The FEEDAP Panel concludes that Bactocell® Aqua 10 Md/100 Md is safe under the current conditions of authorisation for the target species (all fish, shrimps and all crustaceans), consumers of products from animals fed the additive and the environment. Bactocell® Aqua 10 Md/100 Md is non-irritant to skin and eyes and is not a dermal sensitiser, but should be considered a potential respiratory sensitiser. Exposure of users by inhalation is very likely. There is no need for assessing the efficacy of Bactocell® in the context of the renewal of the authorisation. The Panel concludes that the additive at the minimum inclusion level of 1 × 109 CFU/kg feed has the potential to be efficacious in salmonids and in the new species proposed, i.e. all crustaceans.

Keywords: Bactocell®; Pediococcus acidilactici CNCM I‐4622; fish; other zootechnical additives; safety; shrimps and crustaceans; zootechnical additives.

PubMed Disclaimer

References

    1. EFSA (European Food Safety Authority), 2007. Opinion of the Scientific Committee on a request from EFSA on the introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA. The EFSA Journal 2007;5(12):587, 16 pp. 10.2903/j.efsa.2007.587 - DOI
    1. EFSA (European Food Safety Authority), 2008. Technical Guidance: Extrapolation of data from major species to minor species regarding the assessment of additives for use in animal nutrition. EFSA Journal 2008;6(9):803, 5 pp. 10.2903/j.efsa.2008.803 - DOI
    1. EFSA (European Food Safety Authority), 2009a. Opinion of the Scientific Panel on additives and products or substances used in animal feed (FEEDAP) on the safety and efficacy of Bactocell PA (Pediococcus acidilactici) as feed additive for fish. EFSA Journal 2009;7(4):1037, 13 pp. 10.2903/j.efsa.2009.1037 - DOI
    1. EFSA (European Food Safety Authority), 2009b. Opinion of the Scientific Panel on additives and products or substances used in animal feed (FEEDAP) on the safety and efficacy of Bactocell PA (Pediococcus acidilactici) as feed additive for shrimp. EFSA Journal 2009;7(4):1038, 12 pp. 10.2903/j.efsa.2009.1038 - DOI
    1. EFSA BIOHAZ Panel (EFSA Panel on Biological Hazards), Ricci A, Allende A, Bolton D, Chemaly M, Davies R, Girones R, Herman L, Koutsoumanis K, Lindqvist R, Nørrung B, Robertson L, Ru G, Sanaa M, Simmons M, Skandamis P, Snary E, Speybroeck N, Ter Kuile B, Threlfall J, Wahlstr€om H, Cocconcelli PS, Klein G (deceased), Prieto Maradona M, Querol A, Peixe L, Suarez JE, Sundh I, Vlak JM, Aguilera‐Gomez M, Barizzone F, Brozzi R, Correia S, Heng L, Istace F, Lythgo C and Fernández Esc_amez PS, 2017. Scientific Opinion on the update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA. EFSA Journal 2017;15(3):4664, 177 pp. 10.2903/j.efsa.2017.4664 - DOI - PMC - PubMed

LinkOut - more resources