Safety and efficacy of a feed additive consisting of 3‐phytase produced by Komagataella phaffii (CECT 13171) (FSF10000/FLF1000) for poultry species, pigs for fattening and minor porcine species (FERTINAGRO BIOTECH S.L.)
Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of 3‐phytase produced by Komagataella phaffii (CECT 13171) (FSF10000/FLF1000) as a zootechnical additive for poultry species, pigs for fattening and minor porcine spec...
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2022-11-01
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| Series: | EFSA Journal |
| Subjects: | |
| Online Access: | https://doi.org/10.2903/j.efsa.2022.7614 |
| _version_ | 1811191089975001088 |
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| 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 Mojca Fašmon Durjava Maryline Kouba Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Noël Dierick Giovanna Martelli Elisa Pettenati Jaume Galobart Montserrat Anguita |
| 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 Mojca Fašmon Durjava Maryline Kouba Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Noël Dierick Giovanna Martelli Elisa Pettenati Jaume Galobart Montserrat Anguita |
| author_sort | EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) |
| collection | DOAJ |
| description | Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of 3‐phytase produced by Komagataella phaffii (CECT 13171) (FSF10000/FLF1000) as a zootechnical additive for poultry species, pigs for fattening and minor porcine species. The production strain (CECT 13171) is genetically modified and was developed from a strain that had been previously assessed by the FEEDAP Panel. The genetic modifications present in K. phaffii CECT 13171 do not raise safety concerns and no recombinant DNA was detected in the final formulations of the additive (FSF10000/FLF1000). However, the Panel could not conclude on the identity of the production strain and uncertainty remained on the possible presence of viable cells of the production strain in the final formulations. Owing to these uncertainties, the FEEDAP Panel could not conclude on the safety of the additive regarding the production strain. The additive in either form is not irritant to eyes and skin, the liquid formulation is not a dermal sensitiser but the solid formulation is, and the two formulations should be considered potential respiratory sensitisers. The FEEDAP Panel concluded that the 3‐phytase present in the additive is safe for the target species at a level of 1,000 FTU/kg feed and that would not raise safety concerns for the environment. However, considering the uncertainties on the identification of the production strain and the possible presence of viable cells in the final formulations, the Panel could not conclude on the safety of the additive for the target species, consumer, users, and the environment. The FEEDAP Panel concluded that the additive is efficacious at 500 FTU/kg feed in poultry species for fattening or reared for laying/breeding, pigs for fattening and minor porcine species and at 1,000 FTU/kg feed in laying hens. |
| first_indexed | 2024-04-11T15:00:03Z |
| format | Article |
| id | doaj.art-d12707b0a03e47b1b2846f5c63b9e1cd |
| institution | Directory Open Access Journal |
| issn | 1831-4732 |
| language | English |
| last_indexed | 2024-04-11T15:00:03Z |
| publishDate | 2022-11-01 |
| publisher | Wiley |
| record_format | Article |
| series | EFSA Journal |
| spelling | doaj.art-d12707b0a03e47b1b2846f5c63b9e1cd2022-12-22T04:17:02ZengWileyEFSA Journal1831-47322022-11-012011n/an/a10.2903/j.efsa.2022.7614Safety and efficacy of a feed additive consisting of 3‐phytase produced by Komagataella phaffii (CECT 13171) (FSF10000/FLF1000) for poultry species, pigs for fattening and minor porcine species (FERTINAGRO BIOTECH S.L.)EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)Vasileios BampidisGiovanna AzimontiMaria de Lourdes BastosHenrik ChristensenBirgit DusemundMojca Fašmon DurjavaMaryline KoubaMarta López‐AlonsoSecundino López PuenteFrancesca MarconBaltasar MayoAlena PechováMariana PetkovaFernando RamosYolanda SanzRoberto Edoardo VillaRuud WoutersenNoël DierickGiovanna MartelliElisa PettenatiJaume GalobartMontserrat AnguitaAbstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of 3‐phytase produced by Komagataella phaffii (CECT 13171) (FSF10000/FLF1000) as a zootechnical additive for poultry species, pigs for fattening and minor porcine species. The production strain (CECT 13171) is genetically modified and was developed from a strain that had been previously assessed by the FEEDAP Panel. The genetic modifications present in K. phaffii CECT 13171 do not raise safety concerns and no recombinant DNA was detected in the final formulations of the additive (FSF10000/FLF1000). However, the Panel could not conclude on the identity of the production strain and uncertainty remained on the possible presence of viable cells of the production strain in the final formulations. Owing to these uncertainties, the FEEDAP Panel could not conclude on the safety of the additive regarding the production strain. The additive in either form is not irritant to eyes and skin, the liquid formulation is not a dermal sensitiser but the solid formulation is, and the two formulations should be considered potential respiratory sensitisers. The FEEDAP Panel concluded that the 3‐phytase present in the additive is safe for the target species at a level of 1,000 FTU/kg feed and that would not raise safety concerns for the environment. However, considering the uncertainties on the identification of the production strain and the possible presence of viable cells in the final formulations, the Panel could not conclude on the safety of the additive for the target species, consumer, users, and the environment. The FEEDAP Panel concluded that the additive is efficacious at 500 FTU/kg feed in poultry species for fattening or reared for laying/breeding, pigs for fattening and minor porcine species and at 1,000 FTU/kg feed in laying hens.https://doi.org/10.2903/j.efsa.2022.7614zootechnical additivesdigestibility enhancerssubstances which favourably affect the environment3‐phytasesafetyefficacy |
| 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 Mojca Fašmon Durjava Maryline Kouba Marta López‐Alonso Secundino López Puente Francesca Marcon Baltasar Mayo Alena Pechová Mariana Petkova Fernando Ramos Yolanda Sanz Roberto Edoardo Villa Ruud Woutersen Noël Dierick Giovanna Martelli Elisa Pettenati Jaume Galobart Montserrat Anguita Safety and efficacy of a feed additive consisting of 3‐phytase produced by Komagataella phaffii (CECT 13171) (FSF10000/FLF1000) for poultry species, pigs for fattening and minor porcine species (FERTINAGRO BIOTECH S.L.) EFSA Journal zootechnical additives digestibility enhancers substances which favourably affect the environment 3‐phytase safety efficacy |
| title | Safety and efficacy of a feed additive consisting of 3‐phytase produced by Komagataella phaffii (CECT 13171) (FSF10000/FLF1000) for poultry species, pigs for fattening and minor porcine species (FERTINAGRO BIOTECH S.L.) |
| title_full | Safety and efficacy of a feed additive consisting of 3‐phytase produced by Komagataella phaffii (CECT 13171) (FSF10000/FLF1000) for poultry species, pigs for fattening and minor porcine species (FERTINAGRO BIOTECH S.L.) |
| title_fullStr | Safety and efficacy of a feed additive consisting of 3‐phytase produced by Komagataella phaffii (CECT 13171) (FSF10000/FLF1000) for poultry species, pigs for fattening and minor porcine species (FERTINAGRO BIOTECH S.L.) |
| title_full_unstemmed | Safety and efficacy of a feed additive consisting of 3‐phytase produced by Komagataella phaffii (CECT 13171) (FSF10000/FLF1000) for poultry species, pigs for fattening and minor porcine species (FERTINAGRO BIOTECH S.L.) |
| title_short | Safety and efficacy of a feed additive consisting of 3‐phytase produced by Komagataella phaffii (CECT 13171) (FSF10000/FLF1000) for poultry species, pigs for fattening and minor porcine species (FERTINAGRO BIOTECH S.L.) |
| title_sort | safety and efficacy of a feed additive consisting of 3 phytase produced by komagataella phaffii cect 13171 fsf10000 flf1000 for poultry species pigs for fattening and minor porcine species fertinagro biotech s l |
| topic | zootechnical additives digestibility enhancers substances which favourably affect the environment 3‐phytase safety efficacy |
| url | https://doi.org/10.2903/j.efsa.2022.7614 |
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