Safety and efficacy of FRA® Octazyme C Dry (endo‐1,4‐β‐xylanase, mannan‐endo‐1,4‐β‐mannosidase, α‐amylase, endo‐1,3(4)‐β‐glucanase, pectinase, endo‐1,4‐β‐glucanase, protease, α‐galactosidase) as a feed additive for weaned piglets and chickens for fattening
Abstract The product FRA® Octazyme C Dry contains eight enzymes and is intended to be used as a zootechnical additive for chickens for fattening and weaned piglets. In a previous opinion of the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), the additive was characte...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) [verfasserIn] Vasileios Bampidis [verfasserIn] Giovanna Azimonti [verfasserIn] Maria de LourdesBastos [verfasserIn] Henrik Christensen [verfasserIn] Birgit Dusemund [verfasserIn] Maryline Kouba [verfasserIn] Mojca Kos Durjava [verfasserIn] Marta López‐Alonso [verfasserIn] Secundino López Puente [verfasserIn] Francesca Marcon [verfasserIn] Baltasar Mayo [verfasserIn] Alena Pechová [verfasserIn] Mariana Petkova [verfasserIn] Fernando Ramos [verfasserIn] Yolanda Sanz [verfasserIn] Roberto Edoardo Villa [verfasserIn] Ruud Woutersen [verfasserIn] Montserrat Anguita [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2019 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
In: EFSA Journal - Wiley, 2018, 17(2019), 6, Seite n/a-n/a |
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| Übergeordnetes Werk: |
volume:17 ; year:2019 ; number:6 ; pages:n/a-n/a |
| Links: |
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| DOI / URN: |
10.2903/j.efsa.2019.5730 |
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| Katalog-ID: |
DOAJ061011185 |
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| 245 | 1 | 0 | |a Safety and efficacy of FRA® Octazyme C Dry (endo‐1,4‐β‐xylanase, mannan‐endo‐1,4‐β‐mannosidase, α‐amylase, endo‐1,3(4)‐β‐glucanase, pectinase, endo‐1,4‐β‐glucanase, protease, α‐galactosidase) as a feed additive for weaned piglets and chickens for fattening |
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| 520 | |a Abstract The product FRA® Octazyme C Dry contains eight enzymes and is intended to be used as a zootechnical additive for chickens for fattening and weaned piglets. In a previous opinion of the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), the additive was characterised in full, including the production strains of the enzymes, the safety and the efficacy of the product. In that assessment, the FEEDAP Panel concluded that the additive was safe for the consumers of food products obtained from animals fed with the additive and that the additive would pose no risks to the environment. Regarding the safety for the users, the Panel could not conclude on the potential of the additive to be irritant to the skin and eyes or on its skin sensitising properties, but the additive should be considered a potential respiratory sensitiser. In the trials submitted to support the safety for the target species and the efficacy of the additive, the analytical results of the enzyme activities did not confirm the intended enzyme activities and therefore the FEEDAP Panel could not draw conclusions on the tolerance and the efficacy of the additive. In the current application, the applicant has provided new analysis of the feeds used in the tolerance and efficacy trials. The data have been obtained using a modified extraction procedure which has demonstrated to permit a higher recovery of the enzyme activity in supplemented and non‐supplemented feeds. However, the enzyme activities obtained in the experimental diets using the new analytical method showed increases but also decreases of the enzyme activity compared to the previously submitted data. Therefore, the change in the enzyme activities could not be ascribed to the analytical method only. The Panel concluded that the new data cannot be considered as those reflecting the actual supplementation levels of the additive in the diets and therefore could not conclude on the safety and efficacy of the target species. | ||
| 650 | 4 | |a Zootechnical additives | |
| 650 | 4 | |a digestibility enhancers | |
| 650 | 4 | |a FRA® Octazyme C Dry | |
| 650 | 4 | |a safety | |
| 650 | 4 | |a efficacy | |
| 650 | 4 | |a chickens for fattening | |
| 653 | 0 | |a Nutrition. Foods and food supply | |
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| 700 | 0 | |a Vasileios Bampidis |e verfasserin |4 aut | |
| 700 | 0 | |a Giovanna Azimonti |e verfasserin |4 aut | |
| 700 | 0 | |a Maria de LourdesBastos |e verfasserin |4 aut | |
| 700 | 0 | |a Henrik Christensen |e verfasserin |4 aut | |
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| 700 | 0 | |a Marta López‐Alonso |e verfasserin |4 aut | |
| 700 | 0 | |a Secundino López Puente |e verfasserin |4 aut | |
| 700 | 0 | |a Francesca Marcon |e verfasserin |4 aut | |
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| 700 | 0 | |a Alena Pechová |e verfasserin |4 aut | |
| 700 | 0 | |a Mariana Petkova |e verfasserin |4 aut | |
| 700 | 0 | |a Fernando Ramos |e verfasserin |4 aut | |
| 700 | 0 | |a Yolanda Sanz |e verfasserin |4 aut | |
| 700 | 0 | |a Roberto Edoardo Villa |e verfasserin |4 aut | |
| 700 | 0 | |a Ruud Woutersen |e verfasserin |4 aut | |
| 700 | 0 | |a Montserrat Anguita |e verfasserin |4 aut | |
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10.2903/j.efsa.2019.5730 doi (DE-627)DOAJ061011185 (DE-599)DOAJdd0e90d4e6a7400a93420ee44eec300a DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) verfasserin aut Safety and efficacy of FRA® Octazyme C Dry (endo‐1,4‐β‐xylanase, mannan‐endo‐1,4‐β‐mannosidase, α‐amylase, endo‐1,3(4)‐β‐glucanase, pectinase, endo‐1,4‐β‐glucanase, protease, α‐galactosidase) as a feed additive for weaned piglets and chickens for fattening 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The product FRA® Octazyme C Dry contains eight enzymes and is intended to be used as a zootechnical additive for chickens for fattening and weaned piglets. In a previous opinion of the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), the additive was characterised in full, including the production strains of the enzymes, the safety and the efficacy of the product. In that assessment, the FEEDAP Panel concluded that the additive was safe for the consumers of food products obtained from animals fed with the additive and that the additive would pose no risks to the environment. Regarding the safety for the users, the Panel could not conclude on the potential of the additive to be irritant to the skin and eyes or on its skin sensitising properties, but the additive should be considered a potential respiratory sensitiser. In the trials submitted to support the safety for the target species and the efficacy of the additive, the analytical results of the enzyme activities did not confirm the intended enzyme activities and therefore the FEEDAP Panel could not draw conclusions on the tolerance and the efficacy of the additive. In the current application, the applicant has provided new analysis of the feeds used in the tolerance and efficacy trials. The data have been obtained using a modified extraction procedure which has demonstrated to permit a higher recovery of the enzyme activity in supplemented and non‐supplemented feeds. However, the enzyme activities obtained in the experimental diets using the new analytical method showed increases but also decreases of the enzyme activity compared to the previously submitted data. Therefore, the change in the enzyme activities could not be ascribed to the analytical method only. The Panel concluded that the new data cannot be considered as those reflecting the actual supplementation levels of the additive in the diets and therefore could not conclude on the safety and efficacy of the target species. Zootechnical additives digestibility enhancers FRA® Octazyme C Dry safety efficacy chickens for fattening Nutrition. Foods and food supply Chemical technology Vasileios Bampidis verfasserin aut Giovanna Azimonti verfasserin aut Maria de LourdesBastos verfasserin aut Henrik Christensen verfasserin aut Birgit Dusemund verfasserin aut Maryline Kouba verfasserin aut Mojca Kos Durjava verfasserin aut Marta López‐Alonso verfasserin aut Secundino López Puente verfasserin aut Francesca Marcon verfasserin aut Baltasar Mayo verfasserin aut Alena Pechová verfasserin aut Mariana Petkova verfasserin aut Fernando Ramos verfasserin aut Yolanda Sanz verfasserin aut Roberto Edoardo Villa verfasserin aut Ruud Woutersen verfasserin aut Montserrat Anguita verfasserin aut In EFSA Journal Wiley, 2018 17(2019), 6, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:17 year:2019 number:6 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2019.5730 kostenfrei https://doaj.org/article/dd0e90d4e6a7400a93420ee44eec300a kostenfrei https://doi.org/10.2903/j.efsa.2019.5730 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 17 2019 6 n/a-n/a |
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10.2903/j.efsa.2019.5730 doi (DE-627)DOAJ061011185 (DE-599)DOAJdd0e90d4e6a7400a93420ee44eec300a DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) verfasserin aut Safety and efficacy of FRA® Octazyme C Dry (endo‐1,4‐β‐xylanase, mannan‐endo‐1,4‐β‐mannosidase, α‐amylase, endo‐1,3(4)‐β‐glucanase, pectinase, endo‐1,4‐β‐glucanase, protease, α‐galactosidase) as a feed additive for weaned piglets and chickens for fattening 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The product FRA® Octazyme C Dry contains eight enzymes and is intended to be used as a zootechnical additive for chickens for fattening and weaned piglets. In a previous opinion of the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), the additive was characterised in full, including the production strains of the enzymes, the safety and the efficacy of the product. In that assessment, the FEEDAP Panel concluded that the additive was safe for the consumers of food products obtained from animals fed with the additive and that the additive would pose no risks to the environment. Regarding the safety for the users, the Panel could not conclude on the potential of the additive to be irritant to the skin and eyes or on its skin sensitising properties, but the additive should be considered a potential respiratory sensitiser. In the trials submitted to support the safety for the target species and the efficacy of the additive, the analytical results of the enzyme activities did not confirm the intended enzyme activities and therefore the FEEDAP Panel could not draw conclusions on the tolerance and the efficacy of the additive. In the current application, the applicant has provided new analysis of the feeds used in the tolerance and efficacy trials. The data have been obtained using a modified extraction procedure which has demonstrated to permit a higher recovery of the enzyme activity in supplemented and non‐supplemented feeds. However, the enzyme activities obtained in the experimental diets using the new analytical method showed increases but also decreases of the enzyme activity compared to the previously submitted data. Therefore, the change in the enzyme activities could not be ascribed to the analytical method only. The Panel concluded that the new data cannot be considered as those reflecting the actual supplementation levels of the additive in the diets and therefore could not conclude on the safety and efficacy of the target species. Zootechnical additives digestibility enhancers FRA® Octazyme C Dry safety efficacy chickens for fattening Nutrition. Foods and food supply Chemical technology Vasileios Bampidis verfasserin aut Giovanna Azimonti verfasserin aut Maria de LourdesBastos verfasserin aut Henrik Christensen verfasserin aut Birgit Dusemund verfasserin aut Maryline Kouba verfasserin aut Mojca Kos Durjava verfasserin aut Marta López‐Alonso verfasserin aut Secundino López Puente verfasserin aut Francesca Marcon verfasserin aut Baltasar Mayo verfasserin aut Alena Pechová verfasserin aut Mariana Petkova verfasserin aut Fernando Ramos verfasserin aut Yolanda Sanz verfasserin aut Roberto Edoardo Villa verfasserin aut Ruud Woutersen verfasserin aut Montserrat Anguita verfasserin aut In EFSA Journal Wiley, 2018 17(2019), 6, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:17 year:2019 number:6 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2019.5730 kostenfrei https://doaj.org/article/dd0e90d4e6a7400a93420ee44eec300a kostenfrei https://doi.org/10.2903/j.efsa.2019.5730 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 17 2019 6 n/a-n/a |
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10.2903/j.efsa.2019.5730 doi (DE-627)DOAJ061011185 (DE-599)DOAJdd0e90d4e6a7400a93420ee44eec300a DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) verfasserin aut Safety and efficacy of FRA® Octazyme C Dry (endo‐1,4‐β‐xylanase, mannan‐endo‐1,4‐β‐mannosidase, α‐amylase, endo‐1,3(4)‐β‐glucanase, pectinase, endo‐1,4‐β‐glucanase, protease, α‐galactosidase) as a feed additive for weaned piglets and chickens for fattening 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The product FRA® Octazyme C Dry contains eight enzymes and is intended to be used as a zootechnical additive for chickens for fattening and weaned piglets. In a previous opinion of the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), the additive was characterised in full, including the production strains of the enzymes, the safety and the efficacy of the product. In that assessment, the FEEDAP Panel concluded that the additive was safe for the consumers of food products obtained from animals fed with the additive and that the additive would pose no risks to the environment. Regarding the safety for the users, the Panel could not conclude on the potential of the additive to be irritant to the skin and eyes or on its skin sensitising properties, but the additive should be considered a potential respiratory sensitiser. In the trials submitted to support the safety for the target species and the efficacy of the additive, the analytical results of the enzyme activities did not confirm the intended enzyme activities and therefore the FEEDAP Panel could not draw conclusions on the tolerance and the efficacy of the additive. In the current application, the applicant has provided new analysis of the feeds used in the tolerance and efficacy trials. The data have been obtained using a modified extraction procedure which has demonstrated to permit a higher recovery of the enzyme activity in supplemented and non‐supplemented feeds. However, the enzyme activities obtained in the experimental diets using the new analytical method showed increases but also decreases of the enzyme activity compared to the previously submitted data. Therefore, the change in the enzyme activities could not be ascribed to the analytical method only. The Panel concluded that the new data cannot be considered as those reflecting the actual supplementation levels of the additive in the diets and therefore could not conclude on the safety and efficacy of the target species. Zootechnical additives digestibility enhancers FRA® Octazyme C Dry safety efficacy chickens for fattening Nutrition. Foods and food supply Chemical technology Vasileios Bampidis verfasserin aut Giovanna Azimonti verfasserin aut Maria de LourdesBastos verfasserin aut Henrik Christensen verfasserin aut Birgit Dusemund verfasserin aut Maryline Kouba verfasserin aut Mojca Kos Durjava verfasserin aut Marta López‐Alonso verfasserin aut Secundino López Puente verfasserin aut Francesca Marcon verfasserin aut Baltasar Mayo verfasserin aut Alena Pechová verfasserin aut Mariana Petkova verfasserin aut Fernando Ramos verfasserin aut Yolanda Sanz verfasserin aut Roberto Edoardo Villa verfasserin aut Ruud Woutersen verfasserin aut Montserrat Anguita verfasserin aut In EFSA Journal Wiley, 2018 17(2019), 6, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:17 year:2019 number:6 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2019.5730 kostenfrei https://doaj.org/article/dd0e90d4e6a7400a93420ee44eec300a kostenfrei https://doi.org/10.2903/j.efsa.2019.5730 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 17 2019 6 n/a-n/a |
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10.2903/j.efsa.2019.5730 doi (DE-627)DOAJ061011185 (DE-599)DOAJdd0e90d4e6a7400a93420ee44eec300a DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) verfasserin aut Safety and efficacy of FRA® Octazyme C Dry (endo‐1,4‐β‐xylanase, mannan‐endo‐1,4‐β‐mannosidase, α‐amylase, endo‐1,3(4)‐β‐glucanase, pectinase, endo‐1,4‐β‐glucanase, protease, α‐galactosidase) as a feed additive for weaned piglets and chickens for fattening 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The product FRA® Octazyme C Dry contains eight enzymes and is intended to be used as a zootechnical additive for chickens for fattening and weaned piglets. In a previous opinion of the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), the additive was characterised in full, including the production strains of the enzymes, the safety and the efficacy of the product. In that assessment, the FEEDAP Panel concluded that the additive was safe for the consumers of food products obtained from animals fed with the additive and that the additive would pose no risks to the environment. Regarding the safety for the users, the Panel could not conclude on the potential of the additive to be irritant to the skin and eyes or on its skin sensitising properties, but the additive should be considered a potential respiratory sensitiser. In the trials submitted to support the safety for the target species and the efficacy of the additive, the analytical results of the enzyme activities did not confirm the intended enzyme activities and therefore the FEEDAP Panel could not draw conclusions on the tolerance and the efficacy of the additive. In the current application, the applicant has provided new analysis of the feeds used in the tolerance and efficacy trials. The data have been obtained using a modified extraction procedure which has demonstrated to permit a higher recovery of the enzyme activity in supplemented and non‐supplemented feeds. However, the enzyme activities obtained in the experimental diets using the new analytical method showed increases but also decreases of the enzyme activity compared to the previously submitted data. Therefore, the change in the enzyme activities could not be ascribed to the analytical method only. The Panel concluded that the new data cannot be considered as those reflecting the actual supplementation levels of the additive in the diets and therefore could not conclude on the safety and efficacy of the target species. Zootechnical additives digestibility enhancers FRA® Octazyme C Dry safety efficacy chickens for fattening Nutrition. Foods and food supply Chemical technology Vasileios Bampidis verfasserin aut Giovanna Azimonti verfasserin aut Maria de LourdesBastos verfasserin aut Henrik Christensen verfasserin aut Birgit Dusemund verfasserin aut Maryline Kouba verfasserin aut Mojca Kos Durjava verfasserin aut Marta López‐Alonso verfasserin aut Secundino López Puente verfasserin aut Francesca Marcon verfasserin aut Baltasar Mayo verfasserin aut Alena Pechová verfasserin aut Mariana Petkova verfasserin aut Fernando Ramos verfasserin aut Yolanda Sanz verfasserin aut Roberto Edoardo Villa verfasserin aut Ruud Woutersen verfasserin aut Montserrat Anguita verfasserin aut In EFSA Journal Wiley, 2018 17(2019), 6, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:17 year:2019 number:6 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2019.5730 kostenfrei https://doaj.org/article/dd0e90d4e6a7400a93420ee44eec300a kostenfrei https://doi.org/10.2903/j.efsa.2019.5730 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 17 2019 6 n/a-n/a |
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10.2903/j.efsa.2019.5730 doi (DE-627)DOAJ061011185 (DE-599)DOAJdd0e90d4e6a7400a93420ee44eec300a DE-627 ger DE-627 rakwb eng TX341-641 TP1-1185 EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) verfasserin aut Safety and efficacy of FRA® Octazyme C Dry (endo‐1,4‐β‐xylanase, mannan‐endo‐1,4‐β‐mannosidase, α‐amylase, endo‐1,3(4)‐β‐glucanase, pectinase, endo‐1,4‐β‐glucanase, protease, α‐galactosidase) as a feed additive for weaned piglets and chickens for fattening 2019 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract The product FRA® Octazyme C Dry contains eight enzymes and is intended to be used as a zootechnical additive for chickens for fattening and weaned piglets. In a previous opinion of the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), the additive was characterised in full, including the production strains of the enzymes, the safety and the efficacy of the product. In that assessment, the FEEDAP Panel concluded that the additive was safe for the consumers of food products obtained from animals fed with the additive and that the additive would pose no risks to the environment. Regarding the safety for the users, the Panel could not conclude on the potential of the additive to be irritant to the skin and eyes or on its skin sensitising properties, but the additive should be considered a potential respiratory sensitiser. In the trials submitted to support the safety for the target species and the efficacy of the additive, the analytical results of the enzyme activities did not confirm the intended enzyme activities and therefore the FEEDAP Panel could not draw conclusions on the tolerance and the efficacy of the additive. In the current application, the applicant has provided new analysis of the feeds used in the tolerance and efficacy trials. The data have been obtained using a modified extraction procedure which has demonstrated to permit a higher recovery of the enzyme activity in supplemented and non‐supplemented feeds. However, the enzyme activities obtained in the experimental diets using the new analytical method showed increases but also decreases of the enzyme activity compared to the previously submitted data. Therefore, the change in the enzyme activities could not be ascribed to the analytical method only. The Panel concluded that the new data cannot be considered as those reflecting the actual supplementation levels of the additive in the diets and therefore could not conclude on the safety and efficacy of the target species. Zootechnical additives digestibility enhancers FRA® Octazyme C Dry safety efficacy chickens for fattening Nutrition. Foods and food supply Chemical technology Vasileios Bampidis verfasserin aut Giovanna Azimonti verfasserin aut Maria de LourdesBastos verfasserin aut Henrik Christensen verfasserin aut Birgit Dusemund verfasserin aut Maryline Kouba verfasserin aut Mojca Kos Durjava verfasserin aut Marta López‐Alonso verfasserin aut Secundino López Puente verfasserin aut Francesca Marcon verfasserin aut Baltasar Mayo verfasserin aut Alena Pechová verfasserin aut Mariana Petkova verfasserin aut Fernando Ramos verfasserin aut Yolanda Sanz verfasserin aut Roberto Edoardo Villa verfasserin aut Ruud Woutersen verfasserin aut Montserrat Anguita verfasserin aut In EFSA Journal Wiley, 2018 17(2019), 6, Seite n/a-n/a (DE-627)618834982 (DE-600)2540248-1 18314732 nnns volume:17 year:2019 number:6 pages:n/a-n/a https://doi.org/10.2903/j.efsa.2019.5730 kostenfrei https://doaj.org/article/dd0e90d4e6a7400a93420ee44eec300a kostenfrei https://doi.org/10.2903/j.efsa.2019.5730 kostenfrei https://doaj.org/toc/1831-4732 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_235 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_636 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2106 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2118 GBV_ILN_2122 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2232 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 17 2019 6 n/a-n/a |
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EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) @@aut@@ Vasileios Bampidis @@aut@@ Giovanna Azimonti @@aut@@ Maria de LourdesBastos @@aut@@ Henrik Christensen @@aut@@ Birgit Dusemund @@aut@@ Maryline Kouba @@aut@@ Mojca Kos Durjava @@aut@@ Marta López‐Alonso @@aut@@ Secundino López Puente @@aut@@ Francesca Marcon @@aut@@ Baltasar Mayo @@aut@@ Alena Pechová @@aut@@ Mariana Petkova @@aut@@ Fernando Ramos @@aut@@ Yolanda Sanz @@aut@@ Roberto Edoardo Villa @@aut@@ Ruud Woutersen @@aut@@ Montserrat Anguita @@aut@@ |
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In a previous opinion of the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), the additive was characterised in full, including the production strains of the enzymes, the safety and the efficacy of the product. In that assessment, the FEEDAP Panel concluded that the additive was safe for the consumers of food products obtained from animals fed with the additive and that the additive would pose no risks to the environment. Regarding the safety for the users, the Panel could not conclude on the potential of the additive to be irritant to the skin and eyes or on its skin sensitising properties, but the additive should be considered a potential respiratory sensitiser. In the trials submitted to support the safety for the target species and the efficacy of the additive, the analytical results of the enzyme activities did not confirm the intended enzyme activities and therefore the FEEDAP Panel could not draw conclusions on the tolerance and the efficacy of the additive. In the current application, the applicant has provided new analysis of the feeds used in the tolerance and efficacy trials. The data have been obtained using a modified extraction procedure which has demonstrated to permit a higher recovery of the enzyme activity in supplemented and non‐supplemented feeds. However, the enzyme activities obtained in the experimental diets using the new analytical method showed increases but also decreases of the enzyme activity compared to the previously submitted data. Therefore, the change in the enzyme activities could not be ascribed to the analytical method only. The Panel concluded that the new data cannot be considered as those reflecting the actual supplementation levels of the additive in the diets and therefore could not conclude on the safety and efficacy of the target species.</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Zootechnical additives</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">digestibility enhancers</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">FRA® Octazyme C Dry</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">safety</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">efficacy</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">chickens for fattening</subfield></datafield><datafield tag="653" ind1=" " ind2="0"><subfield code="a">Nutrition. 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TX341-641 TP1-1185 Safety and efficacy of FRA® Octazyme C Dry (endo‐1,4‐β‐xylanase, mannan‐endo‐1,4‐β‐mannosidase, α‐amylase, endo‐1,3(4)‐β‐glucanase, pectinase, endo‐1,4‐β‐glucanase, protease, α‐galactosidase) as a feed additive for weaned piglets and chickens for fattening Zootechnical additives digestibility enhancers FRA® Octazyme C Dry safety efficacy chickens for fattening |
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Safety and efficacy of FRA® Octazyme C Dry (endo‐1,4‐β‐xylanase, mannan‐endo‐1,4‐β‐mannosidase, α‐amylase, endo‐1,3(4)‐β‐glucanase, pectinase, endo‐1,4‐β‐glucanase, protease, α‐galactosidase) as a feed additive for weaned piglets and chickens for fattening |
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Safety and efficacy of FRA® Octazyme C Dry (endo‐1,4‐β‐xylanase, mannan‐endo‐1,4‐β‐mannosidase, α‐amylase, endo‐1,3(4)‐β‐glucanase, pectinase, endo‐1,4‐β‐glucanase, protease, α‐galactosidase) as a feed additive for weaned piglets and chickens for fattening |
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EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) |
| doi_str_mv |
10.2903/j.efsa.2019.5730 |
| author2-role |
verfasserin |
| title_sort |
safety and efficacy of fra® octazyme c dry (endo‐1,4‐β‐xylanase, mannan‐endo‐1,4‐β‐mannosidase, α‐amylase, endo‐1,3(4)‐β‐glucanase, pectinase, endo‐1,4‐β‐glucanase, protease, α‐galactosidase) as a feed additive for weaned piglets and chickens for fattening |
| callnumber |
TX341-641 |
| title_auth |
Safety and efficacy of FRA® Octazyme C Dry (endo‐1,4‐β‐xylanase, mannan‐endo‐1,4‐β‐mannosidase, α‐amylase, endo‐1,3(4)‐β‐glucanase, pectinase, endo‐1,4‐β‐glucanase, protease, α‐galactosidase) as a feed additive for weaned piglets and chickens for fattening |
| abstract |
Abstract The product FRA® Octazyme C Dry contains eight enzymes and is intended to be used as a zootechnical additive for chickens for fattening and weaned piglets. In a previous opinion of the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), the additive was characterised in full, including the production strains of the enzymes, the safety and the efficacy of the product. In that assessment, the FEEDAP Panel concluded that the additive was safe for the consumers of food products obtained from animals fed with the additive and that the additive would pose no risks to the environment. Regarding the safety for the users, the Panel could not conclude on the potential of the additive to be irritant to the skin and eyes or on its skin sensitising properties, but the additive should be considered a potential respiratory sensitiser. In the trials submitted to support the safety for the target species and the efficacy of the additive, the analytical results of the enzyme activities did not confirm the intended enzyme activities and therefore the FEEDAP Panel could not draw conclusions on the tolerance and the efficacy of the additive. In the current application, the applicant has provided new analysis of the feeds used in the tolerance and efficacy trials. The data have been obtained using a modified extraction procedure which has demonstrated to permit a higher recovery of the enzyme activity in supplemented and non‐supplemented feeds. However, the enzyme activities obtained in the experimental diets using the new analytical method showed increases but also decreases of the enzyme activity compared to the previously submitted data. Therefore, the change in the enzyme activities could not be ascribed to the analytical method only. The Panel concluded that the new data cannot be considered as those reflecting the actual supplementation levels of the additive in the diets and therefore could not conclude on the safety and efficacy of the target species. |
| abstractGer |
Abstract The product FRA® Octazyme C Dry contains eight enzymes and is intended to be used as a zootechnical additive for chickens for fattening and weaned piglets. In a previous opinion of the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), the additive was characterised in full, including the production strains of the enzymes, the safety and the efficacy of the product. In that assessment, the FEEDAP Panel concluded that the additive was safe for the consumers of food products obtained from animals fed with the additive and that the additive would pose no risks to the environment. Regarding the safety for the users, the Panel could not conclude on the potential of the additive to be irritant to the skin and eyes or on its skin sensitising properties, but the additive should be considered a potential respiratory sensitiser. In the trials submitted to support the safety for the target species and the efficacy of the additive, the analytical results of the enzyme activities did not confirm the intended enzyme activities and therefore the FEEDAP Panel could not draw conclusions on the tolerance and the efficacy of the additive. In the current application, the applicant has provided new analysis of the feeds used in the tolerance and efficacy trials. The data have been obtained using a modified extraction procedure which has demonstrated to permit a higher recovery of the enzyme activity in supplemented and non‐supplemented feeds. However, the enzyme activities obtained in the experimental diets using the new analytical method showed increases but also decreases of the enzyme activity compared to the previously submitted data. Therefore, the change in the enzyme activities could not be ascribed to the analytical method only. The Panel concluded that the new data cannot be considered as those reflecting the actual supplementation levels of the additive in the diets and therefore could not conclude on the safety and efficacy of the target species. |
| abstract_unstemmed |
Abstract The product FRA® Octazyme C Dry contains eight enzymes and is intended to be used as a zootechnical additive for chickens for fattening and weaned piglets. In a previous opinion of the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), the additive was characterised in full, including the production strains of the enzymes, the safety and the efficacy of the product. In that assessment, the FEEDAP Panel concluded that the additive was safe for the consumers of food products obtained from animals fed with the additive and that the additive would pose no risks to the environment. Regarding the safety for the users, the Panel could not conclude on the potential of the additive to be irritant to the skin and eyes or on its skin sensitising properties, but the additive should be considered a potential respiratory sensitiser. In the trials submitted to support the safety for the target species and the efficacy of the additive, the analytical results of the enzyme activities did not confirm the intended enzyme activities and therefore the FEEDAP Panel could not draw conclusions on the tolerance and the efficacy of the additive. In the current application, the applicant has provided new analysis of the feeds used in the tolerance and efficacy trials. The data have been obtained using a modified extraction procedure which has demonstrated to permit a higher recovery of the enzyme activity in supplemented and non‐supplemented feeds. However, the enzyme activities obtained in the experimental diets using the new analytical method showed increases but also decreases of the enzyme activity compared to the previously submitted data. Therefore, the change in the enzyme activities could not be ascribed to the analytical method only. The Panel concluded that the new data cannot be considered as those reflecting the actual supplementation levels of the additive in the diets and therefore could not conclude on the safety and efficacy of the target species. |
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| title_short |
Safety and efficacy of FRA® Octazyme C Dry (endo‐1,4‐β‐xylanase, mannan‐endo‐1,4‐β‐mannosidase, α‐amylase, endo‐1,3(4)‐β‐glucanase, pectinase, endo‐1,4‐β‐glucanase, protease, α‐galactosidase) as a feed additive for weaned piglets and chickens for fattening |
| url |
https://doi.org/10.2903/j.efsa.2019.5730 https://doaj.org/article/dd0e90d4e6a7400a93420ee44eec300a https://doaj.org/toc/1831-4732 |
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| author2 |
Vasileios Bampidis Giovanna Azimonti Maria de LourdesBastos 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 Montserrat Anguita |
| author2Str |
Vasileios Bampidis Giovanna Azimonti Maria de LourdesBastos 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 Montserrat Anguita |
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618834982 |
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TX - Home Economics |
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c |
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10.2903/j.efsa.2019.5730 |
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TX341-641 |
| up_date |
2024-07-03T18:19:37.731Z |
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| score |
7.400508 |