Safety and efficacy of 3‐phytase FLF1000 as a feed additive for chickens for fattening and laying hens
Abstract The additive is a preparation of 3‐phytase which is produced by a genetically modified strain of Komagataella pastoris. The production strain and its recombinant DNA were not detected in the final product. Therefore, the additive does not give rise to safety concerns with regard to the gene...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2016-11-01
|
| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2016.4622 |
| _version_ | 1818603545731006464 |
|---|---|
| author | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Guido Rychen Gabriele Aquilina Giovanna Azimonti Vasileios Bampidis Maria deLourdes Bastos Georges Bories Andrew Chesson Gerhard Flachowsky Jürgen Gropp Boris Kolar Maryline Kouba Secundino López Puente Marta López‐Alonso Alberto Mantovani Baltasar Mayo Fernando Ramos Maria Saarela Roberto Edoardo Villa Robert John Wallace Pieter Wester Paul Brantom Noël Dierick Lieve Herman Boet Glandorf Sirpa Kärenlampi Jaime Aguilera Montserrat Anguita Pier Sandro Cocconcelli |
| author_facet | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Guido Rychen Gabriele Aquilina Giovanna Azimonti Vasileios Bampidis Maria deLourdes Bastos Georges Bories Andrew Chesson Gerhard Flachowsky Jürgen Gropp Boris Kolar Maryline Kouba Secundino López Puente Marta López‐Alonso Alberto Mantovani Baltasar Mayo Fernando Ramos Maria Saarela Roberto Edoardo Villa Robert John Wallace Pieter Wester Paul Brantom Noël Dierick Lieve Herman Boet Glandorf Sirpa Kärenlampi Jaime Aguilera Montserrat Anguita Pier Sandro Cocconcelli |
| author_sort | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) |
| collection | DOAJ |
| description | Abstract The additive is a preparation of 3‐phytase which is produced by a genetically modified strain of Komagataella pastoris. The production strain and its recombinant DNA were not detected in the final product. Therefore, the additive does not give rise to safety concerns with regard to the genetic modification of the production strain. Based on the results of the tolerance studies provided, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for chickens for fattening and laying hens at the dose of 1,000 FTU/kg feed. However, a margin of safety could not be established for laying hens. The production strain belongs to a species considered to qualify for the qualified presumption of safety (QPS) approach to safety assessment when used for enzyme production. Since the identity of the strain was unambiguously established and the genetic modification raised no concerns, the FEEDAP Panel concludes that the use of the additive as a feed additive is of no concerns for consumers. The additive is not an irritant to eyes and skin, and it is not a dermal sensitiser. Owing to the proteinaceous nature of the active substance, the additive is a potential respiratory sensitiser, however, exposure may be limited. The use of the product as a feed additive does not pose risks to the environment. The Panel concluded that the additive has a potential to increase the availability of phytate phosphorus in chickens for fattening at 500 FTU/kg and in laying hens at 1,000 FTU/kg feed. |
| first_indexed | 2024-12-16T13:24:53Z |
| format | Article |
| id | doaj.art-fc09039f4b2e47349d4e9680cbe76b3d |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-12-16T13:24:53Z |
| publishDate | 2016-11-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-fc09039f4b2e47349d4e9680cbe76b3d2022-12-21T22:30:15ZengWileyEFSA Journal1831-47322016-11-011411n/an/a10.2903/j.efsa.2016.4622Safety and efficacy of 3‐phytase FLF1000 as a feed additive for chickens for fattening and laying hensEFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Guido RychenGabriele AquilinaGiovanna AzimontiVasileios BampidisMaria deLourdes BastosGeorges BoriesAndrew ChessonGerhard FlachowskyJürgen GroppBoris KolarMaryline KoubaSecundino López PuenteMarta López‐AlonsoAlberto MantovaniBaltasar MayoFernando RamosMaria SaarelaRoberto Edoardo VillaRobert John WallacePieter WesterPaul BrantomNoël DierickLieve HermanBoet GlandorfSirpa KärenlampiJaime AguileraMontserrat AnguitaPier Sandro CocconcelliAbstract The additive is a preparation of 3‐phytase which is produced by a genetically modified strain of Komagataella pastoris. The production strain and its recombinant DNA were not detected in the final product. Therefore, the additive does not give rise to safety concerns with regard to the genetic modification of the production strain. Based on the results of the tolerance studies provided, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for chickens for fattening and laying hens at the dose of 1,000 FTU/kg feed. However, a margin of safety could not be established for laying hens. The production strain belongs to a species considered to qualify for the qualified presumption of safety (QPS) approach to safety assessment when used for enzyme production. Since the identity of the strain was unambiguously established and the genetic modification raised no concerns, the FEEDAP Panel concludes that the use of the additive as a feed additive is of no concerns for consumers. The additive is not an irritant to eyes and skin, and it is not a dermal sensitiser. Owing to the proteinaceous nature of the active substance, the additive is a potential respiratory sensitiser, however, exposure may be limited. The use of the product as a feed additive does not pose risks to the environment. The Panel concluded that the additive has a potential to increase the availability of phytate phosphorus in chickens for fattening at 500 FTU/kg and in laying hens at 1,000 FTU/kg feed.https://doi.org/10.2903/j.efsa.2016.4622zootechnical additivesdigestibility enhancerssafetyefficacy3‐phytasechickens |
| spellingShingle | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Guido Rychen Gabriele Aquilina Giovanna Azimonti Vasileios Bampidis Maria deLourdes Bastos Georges Bories Andrew Chesson Gerhard Flachowsky Jürgen Gropp Boris Kolar Maryline Kouba Secundino López Puente Marta López‐Alonso Alberto Mantovani Baltasar Mayo Fernando Ramos Maria Saarela Roberto Edoardo Villa Robert John Wallace Pieter Wester Paul Brantom Noël Dierick Lieve Herman Boet Glandorf Sirpa Kärenlampi Jaime Aguilera Montserrat Anguita Pier Sandro Cocconcelli Safety and efficacy of 3‐phytase FLF1000 as a feed additive for chickens for fattening and laying hens EFSA Journal zootechnical additives digestibility enhancers safety efficacy 3‐phytase chickens |
| title | Safety and efficacy of 3‐phytase FLF1000 as a feed additive for chickens for fattening and laying hens |
| title_full | Safety and efficacy of 3‐phytase FLF1000 as a feed additive for chickens for fattening and laying hens |
| title_fullStr | Safety and efficacy of 3‐phytase FLF1000 as a feed additive for chickens for fattening and laying hens |
| title_full_unstemmed | Safety and efficacy of 3‐phytase FLF1000 as a feed additive for chickens for fattening and laying hens |
| title_short | Safety and efficacy of 3‐phytase FLF1000 as a feed additive for chickens for fattening and laying hens |
| title_sort | safety and efficacy of 3 phytase flf1000 as a feed additive for chickens for fattening and laying hens |
| topic | zootechnical additives digestibility enhancers safety efficacy 3‐phytase chickens |
| url | https://doi.org/10.2903/j.efsa.2016.4622 |
| work_keys_str_mv | AT efsapanelonadditivesandproductsorsubstancesusedinanimalfeedfeedap safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT guidorychen safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT gabrieleaquilina safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT giovannaazimonti safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT vasileiosbampidis safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT mariadelourdesbastos safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT georgesbories safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT andrewchesson safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT gerhardflachowsky safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT jurgengropp safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT boriskolar safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT marylinekouba safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT secundinolopezpuente safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT martalopezalonso safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT albertomantovani safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT baltasarmayo safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT fernandoramos safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT mariasaarela safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT robertoedoardovilla safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT robertjohnwallace safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT pieterwester safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT paulbrantom safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT noeldierick safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT lieveherman safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT boetglandorf safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT sirpakarenlampi safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT jaimeaguilera safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT montserratanguita safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens AT piersandrococconcelli safetyandefficacyof3phytaseflf1000asafeedadditiveforchickensforfatteningandlayinghens |