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
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 Bacto...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2019-04-01
|
| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2019.5691 |
| _version_ | 1818727547440988160 |
|---|---|
| author | 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 |
| author_facet | 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 |
| author_sort | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-17T22:15:50Z |
| format | Article |
| id | doaj.art-6a2a824fc4c44dce83fb570035e59e5f |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-12-17T22:15:50Z |
| publishDate | 2019-04-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-6a2a824fc4c44dce83fb570035e59e5f2022-12-21T21:30:36ZengWileyEFSA Journal1831-47322019-04-01174n/an/a10.2903/j.efsa.2019.5691Assessment 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 crustaceansEFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Vasileios BampidisGiovanna AzimontiMaria de Lourdes BastosHenrik ChristensenBirgit DusemundMaryline KoubaMojca Kos DurjavaMarta López‐AlonsoSecundino López PuenteFrancesca MarconBaltasar MayoAlena PechováMariana PetkovaFernando RamosYolanda SanzRoberto Edoardo VillaRuud WoutersenJaume GalobartLucilla GregorettiMatteo InnocentiGloria López‐GálvezKonstantinos SofianidisMaria Vittoria VettoriRosella BrozziAbstract 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.https://doi.org/10.2903/j.efsa.2019.5691zootechnical additivesother zootechnical additivesBactocell®Pediococcus acidilactici CNCM I‐4622safetyfish |
| spellingShingle | 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 Journal zootechnical additives other zootechnical additives Bactocell® Pediococcus acidilactici CNCM I‐4622 safety fish |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | assessment of the application for renewal of authorisation of bactocell r pediococcus acidilactici cncm i 4622 as a feed additive for all fish and shrimps and its extension of use for all crustaceans |
| topic | zootechnical additives other zootechnical additives Bactocell® Pediococcus acidilactici CNCM I‐4622 safety fish |
| url | https://doi.org/10.2903/j.efsa.2019.5691 |
| work_keys_str_mv | AT efsapanelonadditivesandproductsorsubstancesusedinanimalfeedfeedap assessmentoftheapplicationforrenewalofauthorisationofbactocellpediococcusacidilacticicncmi4622asafeedadditiveforallfishandshrimpsanditsextensionofuseforallcrustaceans AT vasileiosbampidis assessmentoftheapplicationforrenewalofauthorisationofbactocellpediococcusacidilacticicncmi4622asafeedadditiveforallfishandshrimpsanditsextensionofuseforallcrustaceans AT giovannaazimonti assessmentoftheapplicationforrenewalofauthorisationofbactocellpediococcusacidilacticicncmi4622asafeedadditiveforallfishandshrimpsanditsextensionofuseforallcrustaceans AT mariadelourdesbastos assessmentoftheapplicationforrenewalofauthorisationofbactocellpediococcusacidilacticicncmi4622asafeedadditiveforallfishandshrimpsanditsextensionofuseforallcrustaceans AT henrikchristensen assessmentoftheapplicationforrenewalofauthorisationofbactocellpediococcusacidilacticicncmi4622asafeedadditiveforallfishandshrimpsanditsextensionofuseforallcrustaceans AT birgitdusemund assessmentoftheapplicationforrenewalofauthorisationofbactocellpediococcusacidilacticicncmi4622asafeedadditiveforallfishandshrimpsanditsextensionofuseforallcrustaceans AT marylinekouba assessmentoftheapplicationforrenewalofauthorisationofbactocellpediococcusacidilacticicncmi4622asafeedadditiveforallfishandshrimpsanditsextensionofuseforallcrustaceans AT mojcakosdurjava assessmentoftheapplicationforrenewalofauthorisationofbactocellpediococcusacidilacticicncmi4622asafeedadditiveforallfishandshrimpsanditsextensionofuseforallcrustaceans AT martalopezalonso assessmentoftheapplicationforrenewalofauthorisationofbactocellpediococcusacidilacticicncmi4622asafeedadditiveforallfishandshrimpsanditsextensionofuseforallcrustaceans AT secundinolopezpuente assessmentoftheapplicationforrenewalofauthorisationofbactocellpediococcusacidilacticicncmi4622asafeedadditiveforallfishandshrimpsanditsextensionofuseforallcrustaceans AT francescamarcon assessmentoftheapplicationforrenewalofauthorisationofbactocellpediococcusacidilacticicncmi4622asafeedadditiveforallfishandshrimpsanditsextensionofuseforallcrustaceans AT baltasarmayo assessmentoftheapplicationforrenewalofauthorisationofbactocellpediococcusacidilacticicncmi4622asafeedadditiveforallfishandshrimpsanditsextensionofuseforallcrustaceans AT alenapechova assessmentoftheapplicationforrenewalofauthorisationofbactocellpediococcusacidilacticicncmi4622asafeedadditiveforallfishandshrimpsanditsextensionofuseforallcrustaceans AT marianapetkova assessmentoftheapplicationforrenewalofauthorisationofbactocellpediococcusacidilacticicncmi4622asafeedadditiveforallfishandshrimpsanditsextensionofuseforallcrustaceans AT fernandoramos assessmentoftheapplicationforrenewalofauthorisationofbactocellpediococcusacidilacticicncmi4622asafeedadditiveforallfishandshrimpsanditsextensionofuseforallcrustaceans AT yolandasanz assessmentoftheapplicationforrenewalofauthorisationofbactocellpediococcusacidilacticicncmi4622asafeedadditiveforallfishandshrimpsanditsextensionofuseforallcrustaceans AT robertoedoardovilla assessmentoftheapplicationforrenewalofauthorisationofbactocellpediococcusacidilacticicncmi4622asafeedadditiveforallfishandshrimpsanditsextensionofuseforallcrustaceans AT ruudwoutersen assessmentoftheapplicationforrenewalofauthorisationofbactocellpediococcusacidilacticicncmi4622asafeedadditiveforallfishandshrimpsanditsextensionofuseforallcrustaceans AT jaumegalobart assessmentoftheapplicationforrenewalofauthorisationofbactocellpediococcusacidilacticicncmi4622asafeedadditiveforallfishandshrimpsanditsextensionofuseforallcrustaceans AT lucillagregoretti assessmentoftheapplicationforrenewalofauthorisationofbactocellpediococcusacidilacticicncmi4622asafeedadditiveforallfishandshrimpsanditsextensionofuseforallcrustaceans AT matteoinnocenti assessmentoftheapplicationforrenewalofauthorisationofbactocellpediococcusacidilacticicncmi4622asafeedadditiveforallfishandshrimpsanditsextensionofuseforallcrustaceans AT glorialopezgalvez assessmentoftheapplicationforrenewalofauthorisationofbactocellpediococcusacidilacticicncmi4622asafeedadditiveforallfishandshrimpsanditsextensionofuseforallcrustaceans AT konstantinossofianidis assessmentoftheapplicationforrenewalofauthorisationofbactocellpediococcusacidilacticicncmi4622asafeedadditiveforallfishandshrimpsanditsextensionofuseforallcrustaceans AT mariavittoriavettori assessmentoftheapplicationforrenewalofauthorisationofbactocellpediococcusacidilacticicncmi4622asafeedadditiveforallfishandshrimpsanditsextensionofuseforallcrustaceans AT rosellabrozzi assessmentoftheapplicationforrenewalofauthorisationofbactocellpediococcusacidilacticicncmi4622asafeedadditiveforallfishandshrimpsanditsextensionofuseforallcrustaceans |