The additive Hemicell ® -L is a liquid preparation of endo-1,4-β-mannanase that is authorised as a zootechnical feed additive for chickens for fattening. The applicant has requested the renewal of the authorisation, new uses and the modification of the manufacturing process including the change of the production strain. The new production strain is a genetically modified strain of Paenibacillus lentus obtained from a strain that has been evaluated previously by EFSA and considered to be safe. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) evaluated the genetic modification and concluded that the sequences introduced to obtain the production strain did not raise safety concerns. The production strain and its DNA were not detected in the additive. The Panel concluded that the additive is safe for chickens for fattening and turkeys for fattening at the recommended level. These conclusions were extended or extrapolated to the other target species under application. The Panel concluded that the results obtained in the toxicological studies performed with the fermentation products of the recipient strain and of another genetically modified strain obtained from the same recipient strain could support the safety for the consumer of the product obtained with the new production strain. The additive is not a dermal or eye irritant and it is not a dermal sensitiser. However, considering that the active substance is a protein, the additive should be regarded as a potential sensitiser. The Panel concluded that the additive has a potential to be efficacious as a zootechnical additive for the target species at 79,200 U/kg.

Safety and efficacy of Hemicell ® -L (endo-1,4-β-mannanase) as a feed additive for chickens for fattening or reared for laying, turkeys for fattening or reared for breeding and minor poultry species / V. Bampidis, G. Azimonti, M.D.L. Bastos, H. Christensen, B. Dusemund, M. Kouba, M. Kos Durjava, M. Lopez-Alonso, S. Lopez Puente, F. Marcon, B. Mayo, A. Pechova, M. Petkova, F. Ramos, Y. Sanz, R.E. Villa, R. Woutersen, P. Brantom, P.S. Cocconcelli, N.A. Dierick, B. Glandorf, L. Herman, G. Rychen, M. Saarela, J. Aguilera, M. Anguita. - In: EFSA JOURNAL. - ISSN 1831-4732. - 17:4(2019 Apr). [10.2903/j.efsa.2019.5641]

Safety and efficacy of Hemicell ® -L (endo-1,4-β-mannanase) as a feed additive for chickens for fattening or reared for laying, turkeys for fattening or reared for breeding and minor poultry species

R.E. Villa
Membro del Collaboration Group
;
2019

Abstract

The additive Hemicell ® -L is a liquid preparation of endo-1,4-β-mannanase that is authorised as a zootechnical feed additive for chickens for fattening. The applicant has requested the renewal of the authorisation, new uses and the modification of the manufacturing process including the change of the production strain. The new production strain is a genetically modified strain of Paenibacillus lentus obtained from a strain that has been evaluated previously by EFSA and considered to be safe. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) evaluated the genetic modification and concluded that the sequences introduced to obtain the production strain did not raise safety concerns. The production strain and its DNA were not detected in the additive. The Panel concluded that the additive is safe for chickens for fattening and turkeys for fattening at the recommended level. These conclusions were extended or extrapolated to the other target species under application. The Panel concluded that the results obtained in the toxicological studies performed with the fermentation products of the recipient strain and of another genetically modified strain obtained from the same recipient strain could support the safety for the consumer of the product obtained with the new production strain. The additive is not a dermal or eye irritant and it is not a dermal sensitiser. However, considering that the active substance is a protein, the additive should be regarded as a potential sensitiser. The Panel concluded that the additive has a potential to be efficacious as a zootechnical additive for the target species at 79,200 U/kg.
English
4-β-mannanase; digestibility enhancers; efficacy; endo-1; poultry; safety; zootechnical additives
Settore VET/07 - Farmacologia e Tossicologia Veterinaria
Articolo
Sì, ma tipo non specificato
Pubblicazione scientifica
apr-2019
Wiley-Blackwell Publishing
17
4
e05641
17
Pubblicato
Periodico con rilevanza internazionale
scopus
crossref
Aderisco
info:eu-repo/semantics/article
Safety and efficacy of Hemicell ® -L (endo-1,4-β-mannanase) as a feed additive for chickens for fattening or reared for laying, turkeys for fattening or reared for breeding and minor poultry species / V. Bampidis, G. Azimonti, M.D.L. Bastos, H. Christensen, B. Dusemund, M. Kouba, M. Kos Durjava, M. Lopez-Alonso, S. Lopez Puente, F. Marcon, B. Mayo, A. Pechova, M. Petkova, F. Ramos, Y. Sanz, R.E. Villa, R. Woutersen, P. Brantom, P.S. Cocconcelli, N.A. Dierick, B. Glandorf, L. Herman, G. Rychen, M. Saarela, J. Aguilera, M. Anguita. - In: EFSA JOURNAL. - ISSN 1831-4732. - 17:4(2019 Apr). [10.2903/j.efsa.2019.5641]
open
Prodotti della ricerca::01 - Articolo su periodico
26
262
Article (author)
no
V. Bampidis, G. Azimonti, M.D.L. Bastos, H. Christensen, B. Dusemund, M. Kouba, M. Kos Durjava, M. Lopez-Alonso, S. Lopez Puente, F. Marcon, B. Mayo, A. Pechova, M. Petkova, F. Ramos, Y. Sanz, R.E. Villa, R. Woutersen, P. Brantom, P.S. Cocconcelli, N.A. Dierick, B. Glandorf, L. Herman, G. Rychen, M. Saarela, J. Aguilera, M. Anguita
File in questo prodotto:
File Dimensione Formato  
Panel)_et_al-2019-EFSA_Journal.pdf

accesso aperto

Tipologia: Publisher's version/PDF
Dimensione 1.84 MB
Formato Adobe PDF
1.84 MB Adobe PDF Visualizza/Apri
Pubblicazioni consigliate

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/703531
Citazioni
  • ???jsp.display-item.citation.pmc??? ND
  • Scopus 2
  • ???jsp.display-item.citation.isi??? 0
social impact