Robenidine

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J Gropp - One of the best experts on this subject based on the ideXlab platform.

  • Safety and efficacy of Alterion NE® (Bacillus subtilis DSM 29784) as a feed additive for chickens for fattening and chickens reared for laying
    'Wiley', 2017
    Co-Authors: G. Rychen, Georges Bories, Andrew Chesson, G. Aquilina, G. Azimonti, V. Bampidis, M.d. Bastos, P.s. Cocconcelli, G. Flachowsky, J Gropp
    Abstract:

    The additive Alterion NE\uae is a preparation containing viable spores of a strain of Bacillus subtilis. The additive is intended for use in feed for chickens for fattening and chickens reared for laying at the proposed dose of 1 9 108 CFU/kg complete feedingstuffs. B. subtilis is considered by EFSA to be suitable for the qualified presumption of safety approach to establish safety. As the identity of the active agent was established and the lack of toxigenic potential and of resistance to antibiotics of human or veterinary clinical significance demonstrated, the additive is presumed safe for the target species, consumers and the environment. Alterion NE\uae is not a dermal irritant but is irritant to eyes and should be considered a potential respiratory sensitiser. In the absence of data, no conclusion can be drawn on the dermal sensitisation of the additive. Alterion NE\uae at the recommended dose 1 9 108 CFU/kg feed has the potential to improve the zootechnical performance of chickens for fattening. This conclusion can be extended to chickens reared for laying when used at the same dose. B. subtilis DSM 29784 is compatible with monensin sodium, narasin/nicarbazin, salinomycin sodium, lasalocid sodium, diclazuril, narasin, maduramicin ammonium, Robenidine hydrochloride and decoquinate at the highest authorised levels

  • Safety and efficacy of microorganism DSM 11798 as a technological additive for all avian species
    'Wiley', 2017
    Co-Authors: G. Rychen, Georges Bories, Andrew Chesson, G. Aquilina, P.s. Cocconcelli, G. Flachowsky, M. De Lourdes Bastos, J Gropp
    Abstract:

    Biomin\uae BBSH 797 is the trade name for a feed additive containing viable cells of an unnamed bacterium (DSM 11798). The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) produced an opinion on the safety and efficacy of this additive when used with pigs concluding that the additive itself did not raise any safety concern. It was confirmed that the additive could reduce the trichothecene, deoxynivalenol (DON), producing the less toxic de-epoxy metabolite. The applicant is now seeking authorisation for the use of the additive in feed for all avian species and, since the current authorisation only covers DON, the amending of this authorisation to include all trichothecene mycotoxins. Chickens and turkeys for fattening and laying hens showed no adverse effects when the additive was added to diets at 1000 times the recommended dose. Consequently, the additive is considered safe for these species/categories when used at the recommended dose of 1.7 9 108 colony-forming units (CFU)/kg complete feed. This conclusion is extended to all avian species. The use of the additive in feed for all avian species is not expected to introduce concerns for consumers, users or the environment not previously considered. In vitro and in vivo studies showed that the inclusion of the additive at the recommended dose of 1.7 9 108 CFU/kg was effective in reducing contaminating DON in feed when given to avian species with a concomitant production of the less toxic de-epoxy metabolite. The additive was shown to reduce the 12,13-epoxide group of representative trichothecenes. It would be reasonable to assume a similar reaction with other mycotoxins of the same structural type independent of the animal species or category receiving contaminated feed. The additive is compatible with the coccidiostats monensin sodium, salinomycin sodium, narasin, narasin/nicarbazin, nicarbazin, Robenidine hydrochloride and diclazuril

  • safety and efficacy of b act bacillus licheniformis dsm 28710 for chickens for fattening and chickens reared for laying
    EFSA Journal, 2016
    Co-Authors: G. Rychen, Georges Bories, Andrew Chesson, G. Aquilina, G. Azimonti, V. Bampidis, P.s. Cocconcelli, G. Flachowsky, Maria De Lourdes Bastos, J Gropp
    Abstract:

    The additive B-Act® is a preparation containing viable spores of a strain of Bacillus licheniformis. The additive is intended for use in feed for chickens for fattening and chickens reared for laying at the proposed dose of 1.6 × 109 colony-forming unit (CFU)/kg complete feedingstuffs. B. licheniformis is considered by EFSA to be suitable for the qualified presumption of safety approach for establishing safety. As the identity of the active agent was established and the lack of toxigenic potential and resistance to antibiotics of human or veterinary clinical significance were demonstrated, the additive is presumed safe for the target species, consumers and the environment. In the absence of data, no conclusion can be drawn on the skin/eye irritation or skin sensitisation potential. The dustiness of the preparations tested indicated a potential for users to be exposed via inhalation. B-Act® should be considered to have the potential to be a respiratory sensitiser. B-Act® at the recommended dose 1.6 × 109 CFU/kg feed has some potential to improve the feed to gain ratio of chickens for fattening. This conclusion can be extended to chickens reared for laying when used at the same dose. B. licheniformis DSM 28710 is compatible with decoquinate, diclazuril, halofuginone, nicarbazin, Robenidine hydrochloride, lasalocid A sodium, maduramicin ammonium, monensin sodium, narasin and salinomycin sodium.

  • Safety and efficacy of Enviva® PRO 202 GT (Bacillus amyloliquefaciens PTA‐6507, Bacillus amyloliquefaciens NRRL B‐50013 and Bacillus amyloliquefaciens NRRL B‐50104) for chickens for fattening, chickens reared for
    'Wiley', 2016
    Co-Authors: G. Aquilina, Georges Bories, Andrew Chesson, J Gropp, G. Azimonti, V. Bampidis, P.s. Cocconcelli, G. Flachowsky, M. De Lourdes Bastos, B. Kolar
    Abstract:

    The additive Enviva\uae PRO 202 GT is a preparation containing viable spores of three strains of Bacillus amyloliquefaciens. The additive is intended for use in feed for chickens for fattening, chickens reared for laying and minor poultry species for fattening and to point of lay at a minimum dose of 30 mg/kg feed, which corresponds to 7.5 9 107 CFU/kg complete feedingstuffs. B. amyloliquefaciens is considered by EFSA to be suitable for the qualified presumption of safety approach to establishing safety. As the identity of the active agents was established and the lack of toxigenic potential and of resistance to antibiotics of human or veterinary clinical significance demonstrated, the additive is presumed safe for the target species, consumers and the environment. Enviva\uae PRO 202 GT is non- irritant to skin and eyes and is not a dermal sensitiser. Given the proteinaceous nature of the additive, there is a potential for respiratory sensitisation, although the risk is low due the low dusting potential. Data from three trials provide evidence that the inclusion of Enviva\uae PRO 202 GT at the recommended dose has the potential to improve the performance of chickens for fattening. This conclusion extends to the additive when used with chickens reared for laying and is extrapolated to minor avian species for fattening and to point of lay when used at the same dose. The three active agents are compatible with narasin/nicarbazin, maduramicin ammonium, lasalocid A sodium, salinomycin sodium, monensin sodium, diclazuril, Robenidine hydrochloride, decoquinate and semduramycin sodium and nicarbazin

  • Safety and efficacy of Bacillus subtilis DSM 28343 as a feed additive for chickens for fattening
    'Wiley', 2016
    Co-Authors: G. Aquilina, Georges Bories, Andrew Chesson, G. Azimonti, V. Bampidis, P.s. Cocconcelli, G. Flachowsky, M. De Lourdes Bastos, M.l. Fernandez-cruz, J Gropp
    Abstract:

    The additive is a preparation containing viable spores of a strain of Bacillus subtilis which has never been authorised in the EU. It is intended to be used in feeds for chickens for fattening at the recommended dose of 1 9 109 colony-forming unit (CFU)/kg complete feedingstuffs. The bacterial species B. subtilis is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the active agent has been established and the susceptibility to antibiotics and lack of toxigenic potential have been demonstrated, the use of Bacillus subtilis DSM 28343 can be presumed safe for the target species, consumers of products derived from animals fed the additive and the environment. Bacillus subtilis DSM 28343 is not an eye/ skin irritant but should be considered as a potential respiratory sensitiser. In the absence of data, no conclusion can be drawn on the skin sensitisation potential. Bacillus subtilis DSM 28343 at the proposed dose has the potential to be efficacious in improving growth of chickens for fattening. B. subtilis DSM 28343 is compatible with the coccidiostats lasalocid A sodium, diclazuril, monensin sodium, maduramicin ammonium, decoquinate, nicarbazin, Robenidine hydrochloride and halofuginone hydrobromide

V. Bampidis - One of the best experts on this subject based on the ideXlab platform.

  • Assessment of the feed additive consisting of Enterococcus faecium DSM 7134 (Bonvital®) for chickens for fattening for the renewal of its authorisation (Lactosan GmbH & Co. KG)
    'Wiley', 2021
    Co-Authors: Efsa Panel on Additives And Products Or Substances Used In Animal Feed, G. Azimonti, V. Bampidis, H. Christensen, B. Dusemund, M. Kouba, Maria De Lourdes Bastos, Mojca Fašmon Durjava, Marta López‐alonso, Secundino López Puente
    Abstract:

    Abstract 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 the assessment of the application for renewal of authorisation of the additive consisting of Enterococcus faecium DSM 7134 (trade name: Bonvital®) as a zootechnical additive (gut flora stabiliser) for chickens for fattening. The additive is produced in powder and granulate (microencapsulated) forms. The applicant has provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The FEEDAP Panel confirms that the use of Bonvital® under the current authorised conditions of use is safe for the target species, the consumers and the environment. Bonvital® is not irritant to skin and eyes but should be considered a potential skin sensitiser and a respiratory sensitiser. There is no need to assess the efficacy of Bonvital® in the context of the renewal of the authorisation. The FEEDAP Panel reiterates its previous conclusions that E. faecium DSM 7134 is compatible with the coccidiostats Robenidine hydrochloride, maduramicin ammonium, diclazuril, decoquinate, halofuginone hydrobromide, monensin sodium and lasalocid A sodium

  • Safety and efficacy of the feed additive consisting of Clostridium butyricum FERM BP‐2789 (Miya‐Gold® S) for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, minor avian species (excluding laying birds), piglets (suckling and weaned) and minor porcine species (Miyarisan Pharmaceutical Co. Ltd.)
    'Wiley', 2021
    Co-Authors: Efsa Panel on Additives And Products Or Substances Used In Animal Feed, G. Azimonti, V. Bampidis, H. Christensen, B. Dusemund, M. Kouba, Maria De Lourdes Bastos, Mojca Fašmon Durjava, Marta López‐alonso, Secundino López Puente
    Abstract:

    Abstract The feed additive under assessment (trade name: Miya‐Gold® S) is based on viable spores of Clostridium butyricum FERM BP‐2789. It is authorised for use in minor avian species (excluding laying birds), weaned piglets and minor weaned porcine species, chickens reared for laying, turkeys for fattening and turkeys reared for breeding. This opinion concerns the request for renewal of the authorisation of Miya‐Gold® S for the species/categories for which an authorisation exists, the use in chickens for fattening, for which the previous authorisation had expired, and the extension of use to suckling piglets and suckling minor porcine species. The applicant provided evidence that the additive currently in the market complies with the conditions of authorisation. There is no new evidence that would lead the Panel to reconsider previous conclusions that Miya‐Gold® S remains safe for the animal species/categories, the consumer and the environment under the current and previously authorised conditions of use. This conclusion applies also to the new target species for which a request of use is made. Regarding the safety for the user, the Panel concluded that the additive is not irritant to skin and eyes and that sensitisation via respiratory route cannot be excluded. There is no need for assessing the efficacy of Miya‐Gold® S in the context of the renewal of the authorisation in chickens reared for laying, turkeys for fattening and reared for breeding, minor avian species (excluding laying birds), weaned piglets and weaned minor porcine species. The additive has the potential to be efficacious in chickens for fattening, suckling piglets and suckling minor porcine species at the level of 2.5 × 108 CFU/kg complete feedingstuff. Miya‐Gold® S is compatible with decoquinate, diclazuril, lasalocid, maduramicin ammonium, narasin, narasin/nicarbazin, monensin sodium, Robenidine, salinomycin sodium and semduramicin

  • Modification of the conditions of the authorisation of BioPlus® 2B (Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750) for turkeys for fattening
    'Wiley', 2019
    Co-Authors: V. Bampidis, G. Azimonti, M. De Lourdes Bastos, H. Christensen, B. Dusemund, M. Kouba, Kos M. Durjava, M. Lopez-alonso, Lopez S. Puente, F. Marcon
    Abstract:

    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 the modification of the terms of the authorisation of BioPlus\uae 2B (Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750) in feeds for turkeys for fattening to allow the simultaneous use with a battery of permitted coccidiostats (diclazuril, halofuginone, monensin sodium, Robenidine hydrochloride, maduramicin ammonium, lasalocid sodium) and with the preservative formic acid. The proposed modification in the conditions of the authorisation would not modify the conclusions previously drawn regarding the safety of the additive. The additive is safe for the target species, consumers and the environment. The additive should be considered a potential respiratory sensitiser, but the Panel could not conclude on the irritancy of the additive to skin and eyes or its dermal sensitisation. Conclusions previously drawn by the FEEDAP Panel on the compatibility of the additive for chickens for fattening apply to the current application provided that the maximum authorised concentration of the coccidiostats semduramycin, maduramicin ammonium, lasalocid sodium and the preservative formic acid for turkeys for fattening (when maximum authorised concentrations exist), are equal or lower than those for chickens for fattening. Considering the data submitted, the FEEDAP Panel concludes that BioPlus\uae 2B (B. licheniformis DSM 5749 and B. subtilis DSM 5750) is compatible with diclazuril and monensin sodium. Based on the data provided, no conclusion can be drawn for Robenidine hydrochloride. In the absence of data, no conclusion can be drawn for halofuginone

  • Safety and efficacy of Robenz ® 66G (Robenidine hydrochloride) for chickens for fattening and turkeys for fattening
    'Wiley', 2019
    Co-Authors: V. Bampidis, G. Azimonti, H. Christensen, B. Dusemund, M. Kouba, Kos M. Durjava, M. Lopez-alonso, Lopez S. Puente, M.d.l. Bastos, F. Marcon
    Abstract:

    Following a request from European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Robenz \uae 66G (Robenidine hydrochloride (HCl)) when used as a feed additive for chickens for fattening and turkeys for fattening. The coccidiostat Robenz \uae 66G is considered safe for chickens for fattening at the highest proposed level of 36 mg Robenidine HCl/kg complete feed with a margin of safety of approximately 2.5. This conclusion is extrapolated to turkeys for fattening. Robenidine HCl is active against Gram-positive but not against Gram-negative bacteria. It is not expected that the use of Robenidine HCl as a feed additive would induce resistance or cross-resistance to antimicrobials used in human and animal therapy. The use of Robenidine HCl from Robenz \uae 66G at the highest proposed level of 36 mg/kg complete feed in chickens and turkeys for fattening is considered safe for the consumer. The existing maximum residues limits for both avian species are confirmed. Robenidine HCl is not a skin or eye irritant and not a skin sensitiser. The risk via inhalation is considered negligible. The use of Robenidine HCl from Robenz \uae in feed for chickens for fattening and turkeys for fattening up to 36 mg/kg complete feed does not pose a risk to either the terrestrial or the aquatic compartment. A risk for bioaccumulation cannot be excluded. The risk for secondary poisoning is not likely to occur. The FEEDAP Panel concludes that 36 mg Robenidine HCl/kg complete feed from Robenz \uae 66G has the potential to effectively control coccidiosis of chickens for fattening under field conditions but cannot conclude on the efficacy of Robenidine HCl in turkeys for fattening. The existing 5-day withdrawal period to avoid off-flavours in edible tissues should be maintained

  • Safety and efficacy of Alterion NE® (Bacillus subtilis DSM 29784) as a feed additive for chickens for fattening and chickens reared for laying
    'Wiley', 2017
    Co-Authors: G. Rychen, Georges Bories, Andrew Chesson, G. Aquilina, G. Azimonti, V. Bampidis, M.d. Bastos, P.s. Cocconcelli, G. Flachowsky, J Gropp
    Abstract:

    The additive Alterion NE\uae is a preparation containing viable spores of a strain of Bacillus subtilis. The additive is intended for use in feed for chickens for fattening and chickens reared for laying at the proposed dose of 1 9 108 CFU/kg complete feedingstuffs. B. subtilis is considered by EFSA to be suitable for the qualified presumption of safety approach to establish safety. As the identity of the active agent was established and the lack of toxigenic potential and of resistance to antibiotics of human or veterinary clinical significance demonstrated, the additive is presumed safe for the target species, consumers and the environment. Alterion NE\uae is not a dermal irritant but is irritant to eyes and should be considered a potential respiratory sensitiser. In the absence of data, no conclusion can be drawn on the dermal sensitisation of the additive. Alterion NE\uae at the recommended dose 1 9 108 CFU/kg feed has the potential to improve the zootechnical performance of chickens for fattening. This conclusion can be extended to chickens reared for laying when used at the same dose. B. subtilis DSM 29784 is compatible with monensin sodium, narasin/nicarbazin, salinomycin sodium, lasalocid sodium, diclazuril, narasin, maduramicin ammonium, Robenidine hydrochloride and decoquinate at the highest authorised levels

Georges Bories - One of the best experts on this subject based on the ideXlab platform.

  • Safety and efficacy of Alterion NE® (Bacillus subtilis DSM 29784) as a feed additive for chickens for fattening and chickens reared for laying
    'Wiley', 2017
    Co-Authors: G. Rychen, Georges Bories, Andrew Chesson, G. Aquilina, G. Azimonti, V. Bampidis, M.d. Bastos, P.s. Cocconcelli, G. Flachowsky, J Gropp
    Abstract:

    The additive Alterion NE\uae is a preparation containing viable spores of a strain of Bacillus subtilis. The additive is intended for use in feed for chickens for fattening and chickens reared for laying at the proposed dose of 1 9 108 CFU/kg complete feedingstuffs. B. subtilis is considered by EFSA to be suitable for the qualified presumption of safety approach to establish safety. As the identity of the active agent was established and the lack of toxigenic potential and of resistance to antibiotics of human or veterinary clinical significance demonstrated, the additive is presumed safe for the target species, consumers and the environment. Alterion NE\uae is not a dermal irritant but is irritant to eyes and should be considered a potential respiratory sensitiser. In the absence of data, no conclusion can be drawn on the dermal sensitisation of the additive. Alterion NE\uae at the recommended dose 1 9 108 CFU/kg feed has the potential to improve the zootechnical performance of chickens for fattening. This conclusion can be extended to chickens reared for laying when used at the same dose. B. subtilis DSM 29784 is compatible with monensin sodium, narasin/nicarbazin, salinomycin sodium, lasalocid sodium, diclazuril, narasin, maduramicin ammonium, Robenidine hydrochloride and decoquinate at the highest authorised levels

  • Safety and efficacy of microorganism DSM 11798 as a technological additive for all avian species
    'Wiley', 2017
    Co-Authors: G. Rychen, Georges Bories, Andrew Chesson, G. Aquilina, P.s. Cocconcelli, G. Flachowsky, M. De Lourdes Bastos, J Gropp
    Abstract:

    Biomin\uae BBSH 797 is the trade name for a feed additive containing viable cells of an unnamed bacterium (DSM 11798). The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) produced an opinion on the safety and efficacy of this additive when used with pigs concluding that the additive itself did not raise any safety concern. It was confirmed that the additive could reduce the trichothecene, deoxynivalenol (DON), producing the less toxic de-epoxy metabolite. The applicant is now seeking authorisation for the use of the additive in feed for all avian species and, since the current authorisation only covers DON, the amending of this authorisation to include all trichothecene mycotoxins. Chickens and turkeys for fattening and laying hens showed no adverse effects when the additive was added to diets at 1000 times the recommended dose. Consequently, the additive is considered safe for these species/categories when used at the recommended dose of 1.7 9 108 colony-forming units (CFU)/kg complete feed. This conclusion is extended to all avian species. The use of the additive in feed for all avian species is not expected to introduce concerns for consumers, users or the environment not previously considered. In vitro and in vivo studies showed that the inclusion of the additive at the recommended dose of 1.7 9 108 CFU/kg was effective in reducing contaminating DON in feed when given to avian species with a concomitant production of the less toxic de-epoxy metabolite. The additive was shown to reduce the 12,13-epoxide group of representative trichothecenes. It would be reasonable to assume a similar reaction with other mycotoxins of the same structural type independent of the animal species or category receiving contaminated feed. The additive is compatible with the coccidiostats monensin sodium, salinomycin sodium, narasin, narasin/nicarbazin, nicarbazin, Robenidine hydrochloride and diclazuril

  • Safety and efficacy of Alterion NE® (Bacillus subtilis DSM 29784) as a feed additive for chickens for fattening and chickens reared for laying
    'Wiley', 2017
    Co-Authors: Efsa Panel on Additives And Products Or Substances Used In Animal Feed, Georges Bories, Andrew Chesson, G. Rychen, G. Aquilina, G. Azimonti, V. Bampidis, P.s. Cocconcelli, Maria De Lourdes Bastos, G. Flachowsky
    Abstract:

    Abstract The additive Alterion NE® is a preparation containing viable spores of a strain of Bacillus subtilis. The additive is intended for use in feed for chickens for fattening and chickens reared for laying at the proposed dose of 1 × 108 CFU/kg complete feedingstuffs. B. subtilis is considered by EFSA to be suitable for the qualified presumption of safety approach to establish safety. As the identity of the active agent was established and the lack of toxigenic potential and of resistance to antibiotics of human or veterinary clinical significance demonstrated, the additive is presumed safe for the target species, consumers and the environment. Alterion NE® is not a dermal irritant but is irritant to eyes and should be considered a potential respiratory sensitiser. In the absence of data, no conclusion can be drawn on the dermal sensitisation of the additive. Alterion NE® at the recommended dose 1 × 108 CFU/kg feed has the potential to improve the zootechnical performance of chickens for fattening. This conclusion can be extended to chickens reared for laying when used at the same dose. B. subtilis DSM 29784 is compatible with monensin sodium, narasin/nicarbazin, salinomycin sodium, lasalocid sodium, diclazuril, narasin, maduramicin ammonium, Robenidine hydrochloride and decoquinate at the highest authorised levels

  • safety and efficacy of b act bacillus licheniformis dsm 28710 for chickens for fattening and chickens reared for laying
    EFSA Journal, 2016
    Co-Authors: G. Rychen, Georges Bories, Andrew Chesson, G. Aquilina, G. Azimonti, V. Bampidis, P.s. Cocconcelli, G. Flachowsky, Maria De Lourdes Bastos, J Gropp
    Abstract:

    The additive B-Act® is a preparation containing viable spores of a strain of Bacillus licheniformis. The additive is intended for use in feed for chickens for fattening and chickens reared for laying at the proposed dose of 1.6 × 109 colony-forming unit (CFU)/kg complete feedingstuffs. B. licheniformis is considered by EFSA to be suitable for the qualified presumption of safety approach for establishing safety. As the identity of the active agent was established and the lack of toxigenic potential and resistance to antibiotics of human or veterinary clinical significance were demonstrated, the additive is presumed safe for the target species, consumers and the environment. In the absence of data, no conclusion can be drawn on the skin/eye irritation or skin sensitisation potential. The dustiness of the preparations tested indicated a potential for users to be exposed via inhalation. B-Act® should be considered to have the potential to be a respiratory sensitiser. B-Act® at the recommended dose 1.6 × 109 CFU/kg feed has some potential to improve the feed to gain ratio of chickens for fattening. This conclusion can be extended to chickens reared for laying when used at the same dose. B. licheniformis DSM 28710 is compatible with decoquinate, diclazuril, halofuginone, nicarbazin, Robenidine hydrochloride, lasalocid A sodium, maduramicin ammonium, monensin sodium, narasin and salinomycin sodium.

  • Safety and efficacy of Enviva® PRO 202 GT (Bacillus amyloliquefaciens PTA‐6507, Bacillus amyloliquefaciens NRRL B‐50013 and Bacillus amyloliquefaciens NRRL B‐50104) for chickens for fattening, chickens reared for
    'Wiley', 2016
    Co-Authors: G. Aquilina, Georges Bories, Andrew Chesson, J Gropp, G. Azimonti, V. Bampidis, P.s. Cocconcelli, G. Flachowsky, M. De Lourdes Bastos, B. Kolar
    Abstract:

    The additive Enviva\uae PRO 202 GT is a preparation containing viable spores of three strains of Bacillus amyloliquefaciens. The additive is intended for use in feed for chickens for fattening, chickens reared for laying and minor poultry species for fattening and to point of lay at a minimum dose of 30 mg/kg feed, which corresponds to 7.5 9 107 CFU/kg complete feedingstuffs. B. amyloliquefaciens is considered by EFSA to be suitable for the qualified presumption of safety approach to establishing safety. As the identity of the active agents was established and the lack of toxigenic potential and of resistance to antibiotics of human or veterinary clinical significance demonstrated, the additive is presumed safe for the target species, consumers and the environment. Enviva\uae PRO 202 GT is non- irritant to skin and eyes and is not a dermal sensitiser. Given the proteinaceous nature of the additive, there is a potential for respiratory sensitisation, although the risk is low due the low dusting potential. Data from three trials provide evidence that the inclusion of Enviva\uae PRO 202 GT at the recommended dose has the potential to improve the performance of chickens for fattening. This conclusion extends to the additive when used with chickens reared for laying and is extrapolated to minor avian species for fattening and to point of lay when used at the same dose. The three active agents are compatible with narasin/nicarbazin, maduramicin ammonium, lasalocid A sodium, salinomycin sodium, monensin sodium, diclazuril, Robenidine hydrochloride, decoquinate and semduramycin sodium and nicarbazin

G. Azimonti - One of the best experts on this subject based on the ideXlab platform.

  • Assessment of the feed additive consisting of Enterococcus faecium DSM 7134 (Bonvital®) for chickens for fattening for the renewal of its authorisation (Lactosan GmbH & Co. KG)
    'Wiley', 2021
    Co-Authors: Efsa Panel on Additives And Products Or Substances Used In Animal Feed, G. Azimonti, V. Bampidis, H. Christensen, B. Dusemund, M. Kouba, Maria De Lourdes Bastos, Mojca Fašmon Durjava, Marta López‐alonso, Secundino López Puente
    Abstract:

    Abstract 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 the assessment of the application for renewal of authorisation of the additive consisting of Enterococcus faecium DSM 7134 (trade name: Bonvital®) as a zootechnical additive (gut flora stabiliser) for chickens for fattening. The additive is produced in powder and granulate (microencapsulated) forms. The applicant has provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The FEEDAP Panel confirms that the use of Bonvital® under the current authorised conditions of use is safe for the target species, the consumers and the environment. Bonvital® is not irritant to skin and eyes but should be considered a potential skin sensitiser and a respiratory sensitiser. There is no need to assess the efficacy of Bonvital® in the context of the renewal of the authorisation. The FEEDAP Panel reiterates its previous conclusions that E. faecium DSM 7134 is compatible with the coccidiostats Robenidine hydrochloride, maduramicin ammonium, diclazuril, decoquinate, halofuginone hydrobromide, monensin sodium and lasalocid A sodium

  • Safety and efficacy of the feed additive consisting of Clostridium butyricum FERM BP‐2789 (Miya‐Gold® S) for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, minor avian species (excluding laying birds), piglets (suckling and weaned) and minor porcine species (Miyarisan Pharmaceutical Co. Ltd.)
    'Wiley', 2021
    Co-Authors: Efsa Panel on Additives And Products Or Substances Used In Animal Feed, G. Azimonti, V. Bampidis, H. Christensen, B. Dusemund, M. Kouba, Maria De Lourdes Bastos, Mojca Fašmon Durjava, Marta López‐alonso, Secundino López Puente
    Abstract:

    Abstract The feed additive under assessment (trade name: Miya‐Gold® S) is based on viable spores of Clostridium butyricum FERM BP‐2789. It is authorised for use in minor avian species (excluding laying birds), weaned piglets and minor weaned porcine species, chickens reared for laying, turkeys for fattening and turkeys reared for breeding. This opinion concerns the request for renewal of the authorisation of Miya‐Gold® S for the species/categories for which an authorisation exists, the use in chickens for fattening, for which the previous authorisation had expired, and the extension of use to suckling piglets and suckling minor porcine species. The applicant provided evidence that the additive currently in the market complies with the conditions of authorisation. There is no new evidence that would lead the Panel to reconsider previous conclusions that Miya‐Gold® S remains safe for the animal species/categories, the consumer and the environment under the current and previously authorised conditions of use. This conclusion applies also to the new target species for which a request of use is made. Regarding the safety for the user, the Panel concluded that the additive is not irritant to skin and eyes and that sensitisation via respiratory route cannot be excluded. There is no need for assessing the efficacy of Miya‐Gold® S in the context of the renewal of the authorisation in chickens reared for laying, turkeys for fattening and reared for breeding, minor avian species (excluding laying birds), weaned piglets and weaned minor porcine species. The additive has the potential to be efficacious in chickens for fattening, suckling piglets and suckling minor porcine species at the level of 2.5 × 108 CFU/kg complete feedingstuff. Miya‐Gold® S is compatible with decoquinate, diclazuril, lasalocid, maduramicin ammonium, narasin, narasin/nicarbazin, monensin sodium, Robenidine, salinomycin sodium and semduramicin

  • Modification of the conditions of the authorisation of BioPlus® 2B (Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750) for turkeys for fattening
    'Wiley', 2019
    Co-Authors: V. Bampidis, G. Azimonti, M. De Lourdes Bastos, H. Christensen, B. Dusemund, M. Kouba, Kos M. Durjava, M. Lopez-alonso, Lopez S. Puente, F. Marcon
    Abstract:

    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 the modification of the terms of the authorisation of BioPlus\uae 2B (Bacillus licheniformis DSM 5749 and Bacillus subtilis DSM 5750) in feeds for turkeys for fattening to allow the simultaneous use with a battery of permitted coccidiostats (diclazuril, halofuginone, monensin sodium, Robenidine hydrochloride, maduramicin ammonium, lasalocid sodium) and with the preservative formic acid. The proposed modification in the conditions of the authorisation would not modify the conclusions previously drawn regarding the safety of the additive. The additive is safe for the target species, consumers and the environment. The additive should be considered a potential respiratory sensitiser, but the Panel could not conclude on the irritancy of the additive to skin and eyes or its dermal sensitisation. Conclusions previously drawn by the FEEDAP Panel on the compatibility of the additive for chickens for fattening apply to the current application provided that the maximum authorised concentration of the coccidiostats semduramycin, maduramicin ammonium, lasalocid sodium and the preservative formic acid for turkeys for fattening (when maximum authorised concentrations exist), are equal or lower than those for chickens for fattening. Considering the data submitted, the FEEDAP Panel concludes that BioPlus\uae 2B (B. licheniformis DSM 5749 and B. subtilis DSM 5750) is compatible with diclazuril and monensin sodium. Based on the data provided, no conclusion can be drawn for Robenidine hydrochloride. In the absence of data, no conclusion can be drawn for halofuginone

  • Safety and efficacy of Robenz ® 66G (Robenidine hydrochloride) for chickens for fattening and turkeys for fattening
    'Wiley', 2019
    Co-Authors: V. Bampidis, G. Azimonti, H. Christensen, B. Dusemund, M. Kouba, Kos M. Durjava, M. Lopez-alonso, Lopez S. Puente, M.d.l. Bastos, F. Marcon
    Abstract:

    Following a request from European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Robenz \uae 66G (Robenidine hydrochloride (HCl)) when used as a feed additive for chickens for fattening and turkeys for fattening. The coccidiostat Robenz \uae 66G is considered safe for chickens for fattening at the highest proposed level of 36 mg Robenidine HCl/kg complete feed with a margin of safety of approximately 2.5. This conclusion is extrapolated to turkeys for fattening. Robenidine HCl is active against Gram-positive but not against Gram-negative bacteria. It is not expected that the use of Robenidine HCl as a feed additive would induce resistance or cross-resistance to antimicrobials used in human and animal therapy. The use of Robenidine HCl from Robenz \uae 66G at the highest proposed level of 36 mg/kg complete feed in chickens and turkeys for fattening is considered safe for the consumer. The existing maximum residues limits for both avian species are confirmed. Robenidine HCl is not a skin or eye irritant and not a skin sensitiser. The risk via inhalation is considered negligible. The use of Robenidine HCl from Robenz \uae in feed for chickens for fattening and turkeys for fattening up to 36 mg/kg complete feed does not pose a risk to either the terrestrial or the aquatic compartment. A risk for bioaccumulation cannot be excluded. The risk for secondary poisoning is not likely to occur. The FEEDAP Panel concludes that 36 mg Robenidine HCl/kg complete feed from Robenz \uae 66G has the potential to effectively control coccidiosis of chickens for fattening under field conditions but cannot conclude on the efficacy of Robenidine HCl in turkeys for fattening. The existing 5-day withdrawal period to avoid off-flavours in edible tissues should be maintained

  • Safety and efficacy of Alterion NE® (Bacillus subtilis DSM 29784) as a feed additive for chickens for fattening and chickens reared for laying
    'Wiley', 2017
    Co-Authors: G. Rychen, Georges Bories, Andrew Chesson, G. Aquilina, G. Azimonti, V. Bampidis, M.d. Bastos, P.s. Cocconcelli, G. Flachowsky, J Gropp
    Abstract:

    The additive Alterion NE\uae is a preparation containing viable spores of a strain of Bacillus subtilis. The additive is intended for use in feed for chickens for fattening and chickens reared for laying at the proposed dose of 1 9 108 CFU/kg complete feedingstuffs. B. subtilis is considered by EFSA to be suitable for the qualified presumption of safety approach to establish safety. As the identity of the active agent was established and the lack of toxigenic potential and of resistance to antibiotics of human or veterinary clinical significance demonstrated, the additive is presumed safe for the target species, consumers and the environment. Alterion NE\uae is not a dermal irritant but is irritant to eyes and should be considered a potential respiratory sensitiser. In the absence of data, no conclusion can be drawn on the dermal sensitisation of the additive. Alterion NE\uae at the recommended dose 1 9 108 CFU/kg feed has the potential to improve the zootechnical performance of chickens for fattening. This conclusion can be extended to chickens reared for laying when used at the same dose. B. subtilis DSM 29784 is compatible with monensin sodium, narasin/nicarbazin, salinomycin sodium, lasalocid sodium, diclazuril, narasin, maduramicin ammonium, Robenidine hydrochloride and decoquinate at the highest authorised levels

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  • Safety and efficacy of Alterion NE® (Bacillus subtilis DSM 29784) as a feed additive for chickens for fattening and chickens reared for laying
    'Wiley', 2017
    Co-Authors: G. Rychen, Georges Bories, Andrew Chesson, G. Aquilina, G. Azimonti, V. Bampidis, M.d. Bastos, P.s. Cocconcelli, G. Flachowsky, J Gropp
    Abstract:

    The additive Alterion NE\uae is a preparation containing viable spores of a strain of Bacillus subtilis. The additive is intended for use in feed for chickens for fattening and chickens reared for laying at the proposed dose of 1 9 108 CFU/kg complete feedingstuffs. B. subtilis is considered by EFSA to be suitable for the qualified presumption of safety approach to establish safety. As the identity of the active agent was established and the lack of toxigenic potential and of resistance to antibiotics of human or veterinary clinical significance demonstrated, the additive is presumed safe for the target species, consumers and the environment. Alterion NE\uae is not a dermal irritant but is irritant to eyes and should be considered a potential respiratory sensitiser. In the absence of data, no conclusion can be drawn on the dermal sensitisation of the additive. Alterion NE\uae at the recommended dose 1 9 108 CFU/kg feed has the potential to improve the zootechnical performance of chickens for fattening. This conclusion can be extended to chickens reared for laying when used at the same dose. B. subtilis DSM 29784 is compatible with monensin sodium, narasin/nicarbazin, salinomycin sodium, lasalocid sodium, diclazuril, narasin, maduramicin ammonium, Robenidine hydrochloride and decoquinate at the highest authorised levels

  • Safety and efficacy of microorganism DSM 11798 as a technological additive for all avian species
    'Wiley', 2017
    Co-Authors: G. Rychen, Georges Bories, Andrew Chesson, G. Aquilina, P.s. Cocconcelli, G. Flachowsky, M. De Lourdes Bastos, J Gropp
    Abstract:

    Biomin\uae BBSH 797 is the trade name for a feed additive containing viable cells of an unnamed bacterium (DSM 11798). The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) produced an opinion on the safety and efficacy of this additive when used with pigs concluding that the additive itself did not raise any safety concern. It was confirmed that the additive could reduce the trichothecene, deoxynivalenol (DON), producing the less toxic de-epoxy metabolite. The applicant is now seeking authorisation for the use of the additive in feed for all avian species and, since the current authorisation only covers DON, the amending of this authorisation to include all trichothecene mycotoxins. Chickens and turkeys for fattening and laying hens showed no adverse effects when the additive was added to diets at 1000 times the recommended dose. Consequently, the additive is considered safe for these species/categories when used at the recommended dose of 1.7 9 108 colony-forming units (CFU)/kg complete feed. This conclusion is extended to all avian species. The use of the additive in feed for all avian species is not expected to introduce concerns for consumers, users or the environment not previously considered. In vitro and in vivo studies showed that the inclusion of the additive at the recommended dose of 1.7 9 108 CFU/kg was effective in reducing contaminating DON in feed when given to avian species with a concomitant production of the less toxic de-epoxy metabolite. The additive was shown to reduce the 12,13-epoxide group of representative trichothecenes. It would be reasonable to assume a similar reaction with other mycotoxins of the same structural type independent of the animal species or category receiving contaminated feed. The additive is compatible with the coccidiostats monensin sodium, salinomycin sodium, narasin, narasin/nicarbazin, nicarbazin, Robenidine hydrochloride and diclazuril

  • Safety and efficacy of Alterion NE® (Bacillus subtilis DSM 29784) as a feed additive for chickens for fattening and chickens reared for laying
    'Wiley', 2017
    Co-Authors: Efsa Panel on Additives And Products Or Substances Used In Animal Feed, Georges Bories, Andrew Chesson, G. Rychen, G. Aquilina, G. Azimonti, V. Bampidis, P.s. Cocconcelli, Maria De Lourdes Bastos, G. Flachowsky
    Abstract:

    Abstract The additive Alterion NE® is a preparation containing viable spores of a strain of Bacillus subtilis. The additive is intended for use in feed for chickens for fattening and chickens reared for laying at the proposed dose of 1 × 108 CFU/kg complete feedingstuffs. B. subtilis is considered by EFSA to be suitable for the qualified presumption of safety approach to establish safety. As the identity of the active agent was established and the lack of toxigenic potential and of resistance to antibiotics of human or veterinary clinical significance demonstrated, the additive is presumed safe for the target species, consumers and the environment. Alterion NE® is not a dermal irritant but is irritant to eyes and should be considered a potential respiratory sensitiser. In the absence of data, no conclusion can be drawn on the dermal sensitisation of the additive. Alterion NE® at the recommended dose 1 × 108 CFU/kg feed has the potential to improve the zootechnical performance of chickens for fattening. This conclusion can be extended to chickens reared for laying when used at the same dose. B. subtilis DSM 29784 is compatible with monensin sodium, narasin/nicarbazin, salinomycin sodium, lasalocid sodium, diclazuril, narasin, maduramicin ammonium, Robenidine hydrochloride and decoquinate at the highest authorised levels

  • safety and efficacy of b act bacillus licheniformis dsm 28710 for chickens for fattening and chickens reared for laying
    EFSA Journal, 2016
    Co-Authors: G. Rychen, Georges Bories, Andrew Chesson, G. Aquilina, G. Azimonti, V. Bampidis, P.s. Cocconcelli, G. Flachowsky, Maria De Lourdes Bastos, J Gropp
    Abstract:

    The additive B-Act® is a preparation containing viable spores of a strain of Bacillus licheniformis. The additive is intended for use in feed for chickens for fattening and chickens reared for laying at the proposed dose of 1.6 × 109 colony-forming unit (CFU)/kg complete feedingstuffs. B. licheniformis is considered by EFSA to be suitable for the qualified presumption of safety approach for establishing safety. As the identity of the active agent was established and the lack of toxigenic potential and resistance to antibiotics of human or veterinary clinical significance were demonstrated, the additive is presumed safe for the target species, consumers and the environment. In the absence of data, no conclusion can be drawn on the skin/eye irritation or skin sensitisation potential. The dustiness of the preparations tested indicated a potential for users to be exposed via inhalation. B-Act® should be considered to have the potential to be a respiratory sensitiser. B-Act® at the recommended dose 1.6 × 109 CFU/kg feed has some potential to improve the feed to gain ratio of chickens for fattening. This conclusion can be extended to chickens reared for laying when used at the same dose. B. licheniformis DSM 28710 is compatible with decoquinate, diclazuril, halofuginone, nicarbazin, Robenidine hydrochloride, lasalocid A sodium, maduramicin ammonium, monensin sodium, narasin and salinomycin sodium.

  • Safety and efficacy of Enviva® PRO 202 GT (Bacillus amyloliquefaciens PTA‐6507, Bacillus amyloliquefaciens NRRL B‐50013 and Bacillus amyloliquefaciens NRRL B‐50104) for chickens for fattening, chickens reared for
    'Wiley', 2016
    Co-Authors: G. Aquilina, Georges Bories, Andrew Chesson, J Gropp, G. Azimonti, V. Bampidis, P.s. Cocconcelli, G. Flachowsky, M. De Lourdes Bastos, B. Kolar
    Abstract:

    The additive Enviva\uae PRO 202 GT is a preparation containing viable spores of three strains of Bacillus amyloliquefaciens. The additive is intended for use in feed for chickens for fattening, chickens reared for laying and minor poultry species for fattening and to point of lay at a minimum dose of 30 mg/kg feed, which corresponds to 7.5 9 107 CFU/kg complete feedingstuffs. B. amyloliquefaciens is considered by EFSA to be suitable for the qualified presumption of safety approach to establishing safety. As the identity of the active agents was established and the lack of toxigenic potential and of resistance to antibiotics of human or veterinary clinical significance demonstrated, the additive is presumed safe for the target species, consumers and the environment. Enviva\uae PRO 202 GT is non- irritant to skin and eyes and is not a dermal sensitiser. Given the proteinaceous nature of the additive, there is a potential for respiratory sensitisation, although the risk is low due the low dusting potential. Data from three trials provide evidence that the inclusion of Enviva\uae PRO 202 GT at the recommended dose has the potential to improve the performance of chickens for fattening. This conclusion extends to the additive when used with chickens reared for laying and is extrapolated to minor avian species for fattening and to point of lay when used at the same dose. The three active agents are compatible with narasin/nicarbazin, maduramicin ammonium, lasalocid A sodium, salinomycin sodium, monensin sodium, diclazuril, Robenidine hydrochloride, decoquinate and semduramycin sodium and nicarbazin

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