888 results on '"Bampidis, V"'
Search Results
2. Safety and efficacy of a feed additive consisting of copper(II)-betaine complex for all animal species (Biochem Zusatzstoffe Handels- und Produktionsges. mbH)
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Bampidis V., Azimonti G., Bastos M. d. L., Christensen H., Dusemund B., Durjava M., Kouba M., López-Alonso M., López Puente S., Marcon F., Mayo B., Pechová A., Petkova M., Ramos F., Sanz Y., Villa R. E., Woutersen R., Finizio A., Poiger T., Teodorović I., Amaduzzi A., Anguita M., Galobart J., Innocenti M. L., Manini P., Ortuño J., Pizzo F., Tarrés-Call J., Vettori M. V., Radovnikovic A., Bampidis, V, Azimonti, G, Bastos, M, Christensen, H, Dusemund, B, Durjava, M, Kouba, M, López-Alonso, M, López Puente, S, Marcon, F, Mayo, B, Pechová, A, Petkova, M, Ramos, F, Sanz, Y, Villa, R, Woutersen, R, Finizio, A, Poiger, T, Teodorović, I, Amaduzzi, A, Anguita, M, Galobart, J, Innocenti, M, Manini, P, Ortuño, J, Pizzo, F, Tarrés-Call, J, Vettori, M, and Radovnikovic, A
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safety ,copper ,copper complex of betaine ,efficacy ,nutritional additive ,compounds of trace element - Abstract
Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the safety and efficacy of a copper(II)-betaine complex as nutritional feed additive for all animal species. Based on the results of a tolerance study carried out in chicken, the FEEDAP Panel concluded that the additive is safe for chickens for fattening when used up to the current maximum authorised levels of copper in feed; this conclusion was extrapolated to all animal species and categories at the respective maximum copper levels in complete feed authorised in the European Union. The FEEDAP Panel concluded that the use of the copper(II)-betaine complex in animal nutrition at the maximum copper levels authorised for the animal species poses no concern to the safety of consumers. Regarding the safety for the environment, the use of the additive in feed for terrestrial animals and land-based aquaculture is considered safe under proposed conditions of use. The data available do not allow the conclusion to be made on the safety of the additive for marine sediment when it is used in sea cages. The additive is not a skin irritant, but it is an irritant to the eyes. Due to the traces of nickel, the additive is considered to be a respiratory and skin sensitiser. The Panel could not conclude on the efficacy of the product.
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- 2023
3. Safety and efficacy of a feed additive consisting of halofuginone hydrobromide (STENOROL®) for chickens for fattening and turkeys for fattening/reared for breeding (Huvepharma N.V.)
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Bampidis V., Azimonti G., Bastos M. D. L., Christensen H., Durjava M., Dusemund B., Kouba M., Lopez-Alonso M., Lopez Puente S., Marcon F., Mayo B., Pechova A., Petkova M., Ramos F., Sanz Y., Villa R. E., Woutersen R., Gropp J., Rychen G., Finizio A., Poiger T., Teodorovic I., Aquilina G., Bories G., Brantom P., Holczknecht O., Navarro-Villa A., Rossi B., Vettori M. V., Bampidis, V, Azimonti, G, Bastos, M, Christensen, H, Durjava, M, Dusemund, B, Kouba, M, Lopez-Alonso, M, Lopez Puente, S, Marcon, F, Mayo, B, Pechova, A, Petkova, M, Ramos, F, Sanz, Y, Villa, R, Woutersen, R, Gropp, J, Rychen, G, Finizio, A, Poiger, T, Teodorovic, I, Aquilina, G, Bories, G, Brantom, P, Holczknecht, O, Navarro-Villa, A, Rossi, B, and Vettori, M
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safety ,halofuginone hydrobromide ,efficacy ,turkeys reared for breeding ,chickens for fattening ,turkeys for fattening ,coccidiostat - Abstract
Following a request from the European Commission, EFSA was asked to deliver a new scientific opinion on the coccidiostat halofuginone hydrobromide (STENOROL®) when used as a feed additive for chickens for fattening and turkeys for fattening/reared for breeding. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that the safety for turkeys for fattening established in its previous opinion can be extended to turkeys for breeding up to 12 weeks of age. Based on the new data provided on the safety for consumer, environment and efficacy, the Panel updates its previous conclusions as follows: halofuginone hydrobromide is not genotoxic. Applying an uncertainty factor of 100 to the lowest no observed adverse effect level (NOAEL) of 0.03 mg/kg body weight (bw) per day, an acceptable daily intake (ADI) of 0.3 μg halofuginone/kg bw is established. The chronic exposure of consumers to residues of halofuginone would amount to 6–19% of the ADI after 3 days of withdrawal. Therefore, the Panel considers that the additive is safe for the consumer of tissues obtained from chickens for fattening and turkeys for fattening fed the additive at a maximum level of 3 mg/kg complete feed at a 3-day withdrawal time. For control purposes, the Panel recommends the setting of the following maximum residue limits (MRLs): liver, 50 μg/kg; kidney, 40 μg/kg; muscle, 3 μg/kg; skin/fat, 10 μg/kg wet tissue. Based on an updated environmental risk assessment, no concern for groundwater is expected. Halofuginone is unlikely to bioaccumulate and the risk of secondary poisoning is not likely to occur. No safety concerns are expected for terrestrial and aquatic environments. The additive has the potential to control coccidiosis in chickens for fattening and turkeys for fattening/reared for breeding up to 12 weeks of age at a minimum level of 2 mg/kg complete feed.
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- 2023
4. Safety and efficacy of a feed additive consisting of a zinc(II)–betaine complex for all animal species (Biochem Zusatzstoffe Handels- und Produktionsges. mbH)
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Bampidis V., Azimonti G., Bastos M. D. L., Christensen H., Dusemund B., Durjava M., Kouba M., Lopez-Alonso M., Puente S. L., Marcon F., Mayo B., Pechova A., Petkova M., Ramos F., Sanz Y., Villa R. E., Woutersen R., Finizio A., Poiger T., Teodorovic I., Anguita M., Galobart J., Holczknecht O., Innocenti M. L., Ortuno J. C., Manini P., Pizzo F., Radovnikovic A., Vettori M. V., Amaduzzi A., Bampidis, V, Azimonti, G, Bastos, M, Christensen, H, Dusemund, B, Durjava, M, Kouba, M, Lopez-Alonso, M, Puente, S, Marcon, F, Mayo, B, Pechova, A, Petkova, M, Ramos, F, Sanz, Y, Villa, R, Woutersen, R, Finizio, A, Poiger, T, Teodorovic, I, Anguita, M, Galobart, J, Holczknecht, O, Innocenti, M, Ortuno, J, Manini, P, Pizzo, F, Radovnikovic, A, Vettori, M, and Amaduzzi, A
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safety ,zinc(II)–betaine complex ,efficacy ,nutritional additive ,zinc sulfate and betaine ,compounds of trace element - Abstract
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a zinc(II)–betaine complex as nutritional additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for chickens for fattening. This conclusion could be extrapolated to all animal species and categories provided that the maximum authorised levels in the EU for total zinc in feed are not exceeded. The FEEDAP Panel concluded that the use of the zinc(II)–betaine complex in animal nutrition is of no concern for consumer safety provided that the maximum authorised total zinc levels in feed are respected. The additive is considered to be a skin and respiratory sensitiser due to the presence of nickel; it is irritant to the eyes, but not to the skin. The use of the additive in animal nutrition for terrestrial animals and land-based aquaculture at the proposed use levels is considered safe for terrestrial and aquatic ecosystems. The available data do not allow the conclusion to be made on the safety of the additive for the marine sediment when it is used in sea cages. Based on the deposition of zinc in edible tissues/organs in chickens for fattening, the FEEDAP Panel concluded that the additive is a source of bioavailable zinc, comparable to the standard inorganic zinc source, and therefore, the additive is efficacious in meeting the birds zinc requirements. This conclusion can be extrapolated to all animal species and categories.
- Published
- 2023
5. A comparative assessment of two different methods, using devices Optiscan-TP and Optigrade-MCP, for predicting the lean meat percentage of pig carcasses in Greece in relation to the European reference method
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Schina, V, primary, Dotas, V, additional, Gourdouvelis, D, additional, Kaimakamis, I, additional, Mitsopoulos, I, additional, Tsakanikas, G, additional, and Bampidis, V, additional
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- 2023
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6. Economic and Social Importance of the Breeding of Fur Animals in Greece and its Development Strategies.
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Semos, N. A., Dotas, V. D., and Bampidis, V.
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ANIMAL breeds ,STANDARD of living ,SWOT analysis ,AGRICULTURE ,ANIMAL breeding ,FUR - Abstract
Background: In the present work, a thorough research and study was carried out to determine the conditions prevailing in the creation and operation of fur farms in Greece, which are bred exclusively in the region of Western Macedonia in the northwestern part of Greece. In particular, all the parameters that affect the efficiency of breeding units were analyzed, the appropriate answers to the problems and weaknesses of the breeding of fur-bearing animals were evaluated and given. Methods: The paper mainly deals with the applied practices and the situation prevailing in the field, from a technical, social and economic point of view and explored the development perspectives through proposed strategies, which are based on findings, literature, theoretical analyzes, statistical analyzes and primary sources from direct personal contacts. For the analysis of data of the fur industry, PESTLE and SWOT method of analyses applied. Result: The general conclusion that emerges from the whole effort is a dynamic development of the fur-bearing sector since everything points in this direction and this development will significantly contribute to the improvement of the living standard of the inhabitants of the area. [ABSTRACT FROM AUTHOR]
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- 2023
- Full Text
- View/download PDF
7. Short Lectures “Effects of offering a combination of Curcuma and Scutellaria plant extracts on laying hen thermal tolerance under hot temperate conditions”
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Sakkas, P, primary, Papadopoulos, G, additional, Mitsopoulos, I, additional, Stylianaki, I, additional, Dokou, S, additional, Tsiouris, V, additional, Papagrigoriou, T, additional, Panheleux, M, additional, Robert, F, additional, Bampidis, V, additional, and Giannenas, I, additional
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- 2022
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8. Safety and efficacy of a feed additive consisting of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced with Talaromyces versatilis IMI 378536 and DSM 26702 (ROVABIO® ADVANCE) for weaned piglets and pigs for fattening (ADISSEO France S.A.S)
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Bampidis V., Azimonti G., Bastos M. D. L., Christensen H., Dusemund B., Fasmon Durjava M., Kouba M., Lopez-Alonso M., Lopez Puente S., Marcon F., Mayo B., Pechova A., Petkova M., Ramos F., Sanz Y., Villa R. E., Woutersen R., Dierick N., Martelli G., Galobart J., Ortuno J., Anguita M., Bampidis V., Azimonti G., Bastos M.D.L., Christensen H., Dusemund B., Fasmon Durjava M., Kouba M., Lopez-Alonso M., Lopez Puente S., Marcon F., Mayo B., Pechova A., Petkova M., Ramos F., Sanz Y., Villa R.E., Woutersen R., Dierick N., Martelli G., Galobart J., Ortuno J., and Anguita M.
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safety ,xylanase ,T. versatili ,glucanase ,Veterinary (miscellaneous) ,efficacy ,Animal Science and Zoology ,Parasitology ,Plant Science ,Microbiology ,Food Science ,digestibility enhancer ,zootechnical additives - Abstract
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of ROVABIO® ADVANCE (liquid and solid) which contains endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase. The enzymes present in the additive are produced by two strains of Talaromyces versatilis, one of them genetically modified. The additive is intended to be used as a feed additive for weaned piglets and pigs for fattening. Viable cells of the production strains and DNA of the genetically modified strain were not detected in the fermentation product used to formulate the additive. Based on the results of a tolerance trial in weaned piglets, the FEEDAP Panel concluded that ROVABIO® ADVANCE is safe for weaned piglets under the recommended conditions of use. This conclusion was extended to pigs for fattening. Based on the outcome of the toxicological studies performed, the Panel concluded that the additive is of no concern regarding consumer safety. ROVABIO® ADVANCE is not irritant to the skin or eyes but it is a skin and respiratory sensitiser. No risks to the environment are expected from the use of the additive in animal nutrition. Owing to the lack of sufficient data, the FEEDAP Panel could not conclude on the efficacy of ROVABIO® ADVANCE.
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- 2022
9. Safety and efficacy of a feed additive consisting of Bifidobacterium longum CNCM I-5642 (PP102I) for cats and dogs (Nestlé Enterprises S.A.)
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Bampidis V., Azimonti G., Bastos M. D. L., Christensen H., Dusemund B., Fasmon Durjava M., Kouba M., Lopez-Alonso M., Lopez Puente S., Marcon F., Mayo B., Pechova A., Petkova M., Ramos F., Sanz Y., Villa R. E., Woutersen R., Martelli G., Raj M., Anguita M., Brozzi R., Galobart J., Pettenati E., Revez J., Tarres-Call J., Ortuno J., Bampidis V., Azimonti G., Bastos M.D.L., Christensen H., Dusemund B., Fasmon Durjava M., Kouba M., Lopez-Alonso M., Lopez Puente S., Marcon F., Mayo B., Pechova A., Petkova M., Ramos F., Sanz Y., Villa R.E., Woutersen R., Martelli G., Raj M., Anguita M., Brozzi R., Galobart J., Pettenati E., Revez J., Tarres-Call J., and Ortuno J.
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Bifidobacterium longum CNCM I-5642 ,Veterinary (miscellaneous) ,dog ,PP102I ,cat ,physiological condition stabiliser ,Animal Science and Zoology ,Parasitology ,Plant Science ,Microbiology ,Food Science ,QPS ,zootechnical additives - Abstract
Following a request from the European Commission, the Panelon Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Bifidobacterium longum CNCM I-5642 (PP102I) when used as a feed additive for cats and dogs. The product under assessment consists of viable cells of a strain of B. longum, a species considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The strain was unambiguously identified as B. longum and was shown not to harbour antimicrobial resistance determinants for antibiotics of human and veterinary importance, thus meeting the QPS requirements. Following the QPS approach to safety assessment and since no concerns are expected from maltodextrin, the other component of the additive, PP102I was considered safe for the target species and the environment. Owing to the lack of data, no conclusions could be drawn on the skin/eye irritancy potential of PP102I. However, it should be considered a skin and respiratory sensitiser. The Panelwas not in the position to conclude on the efficacy of PP102I for the target species.
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- 2022
10. Efficacy of a feed additive consisting of endo-1,4-beta-xylanase produced by Trichoderma citrinoviride (IMI SD 135) (HOSTAZYM® X) for sows in order to have benefits in piglets (Huvepharma NV)
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Bampidis V., Azimonti G., Bastos M. D. L., Christensen H., Dusemund B., Durjava M. F., Kouba M., Lopez-Alonso M., Lopez Puente S., Marcon F., Mayo B., Pechova A., Petkova M., Ramos F., Sanz Y., Villa R. E., Woutersen R., Dierick N. A., Martelli G., Galobart J., Anguita M., Bampidis V., Azimonti G., Bastos M.D.L., Christensen H., Dusemund B., Durjava M.F., Kouba M., Lopez-Alonso M., Lopez Puente S., Marcon F., Mayo B., Pechova A., Petkova M., Ramos F., Sanz Y., Villa R.E., Woutersen R., Dierick N.A., Martelli G., Galobart J., and Anguita M.
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xylanase ,Veterinary (miscellaneous) ,sows ,efficacy ,Plant Science ,Microbiology ,zootechnical additives ,sow ,Animal Science and Zoology ,Parasitology ,digestibility enhancers ,Food Science ,digestibility enhancer - 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 efficacy of HOSTAZYM® X as a feed additive for sows in order to have benefits in piglets. This additive consists of endo-1,4-β-xylanase produced by a non-genetically modified strain of Trichoderma citroviride. The additive is to be used in sows at 1,500 EPU/kg feed. In a previous opinion, the FEEDAP Panel could not conclude on the efficacy of the additive when added to feed for sows in order to have benefits in piglets. The applicant provided new efficacy data to complete the assessment of the efficacy of the additive. Based on the previously assessed data and the newly submitted one, the Panel could not conclude on the efficacy of the additive.
- Published
- 2022
11. Safety and efficacy of a feed additive consisting of Sepiolitic clay for all animal species (Mineria y Tecnologia de Arcillas SA - MYTA)
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Azimonti, G., Bampidis, V., Bastos, M., Christensen, H., Dusemund, B., Kouba, M., Durjava, M., Lopez-Alonso, M., Puente, S., Marcon, F., Mayo, B., Pechova, A., Petkova, M., Ramos, F., Sanz, Y., Villa, R., Woutersen, R., Aquilina, G., Bories, G., Tosti, L., Anguita, M., Galobart, J., Holczknecht, O., Casanova, J., Innocenti, M., Manini, P., and Pizzo, F.
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safety ,Settore VET/07 - Farmacologia e Tossicologia Veterinaria ,Veterinary (miscellaneous) ,anticaking agent ,efficacy ,Plant Science ,Microbiology ,all animal species ,Settore MED/44 - Medicina del Lavoro ,Animal Science and Zoology ,Parasitology ,Sepiolitic clay ,binder ,Food Science - Published
- 2022
12. Safety and efficacy of a feed additive consisting of l-methionine produced by the combined activities of Corynebacterium glutamicum KCCM 80245 and Escherichia coli KCCM 80246 for all animal species (CJ Europe GmbH)
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Bampidis, V., Azimonti, G., Bastos, M.D.L., Christensen, H., Dusemund, B., Fašmon Durjava, M., Kouba, M., López-Alonso, M., López Puente, S., Marcon, F., Mayo, B., Pechová, A., Petkova, M., Ramos, F., Sanz, Y., Villa, R.E., Woutersen, R., Anguita, M., Galobart, J., Pettenati, E., and Tarrés-Call, J.
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Corynebacterium glutamicum KCCM 80245 ,Escherichia coli KCCM 80246 ,amino acids ,efficacy ,methionine ,nutritional additives ,safety ,their salts and analogues ,Settore VET/07 - Farmacologia e Tossicologia Veterinaria ,Veterinary (miscellaneous) ,Plant Science ,Microbiology ,Animal Science and Zoology ,Parasitology ,Food Science - Abstract
Following a request from the European Commission, the FEEDAP Panel was asked to deliver a scientific opinion on the safety and efficacy of l-methionine ≥ 98.5% or ≥ 90% produced by the combined activities of Corynebacterium glutamicum KCCM 80245 and Escherichia coli KCCM 80246) as nutritional additive for all animal species. The two production strains are genetically modified. l-Methionine is intended to be used in feed or water for drinking for all animal species. Neither viable cells nor recombinant DNA of the production strains were detected in the final products. The additive does not pose any safety concern associated with the genetic modification of the production strains. The use of both products of l-methionine produced by C. glutamicum KCCM 80245 and E. coli KCCM 80246 in supplementing feed to compensate for l-methionine deficiency in feedingstuffs is safe for the target species. The FEEDAP Panel has concerns about the use of amino acids in water for drinking for hygienic reasons, and due to the risk of imbalances when administered simultaneously via feed. The use of both products of l-methionine produced by C. glutamicum KCCM 80245 and E. coli KCCM 80246 in animal nutrition is considered safe for the consumers and for the environment. The additive, in either product, is not an irritant to skin/eyes and not a dermal sensitiser and shows no toxicity by inhalation. Considering the respiratory exposure to endotoxins, l-methionine ≥ 90% is a risk for the user. Both products of the additive produced by C. glutamicum KCCM 80245 and E. coli KCCM 80246 are considered as an efficacious source of the essential amino acid l-methionine for non-ruminant animal species. For the supplemental l-methionine to be as efficacious in ruminants as in non-ruminant species, it would require protection against degradation in the rumen.
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- 2022
13. Safety and efficacy of a feed additive consisting of Enterococcus faecium NBIMCC 8270, Lactobacillus acidophilus NBIMCC 8242, Lactobacillus helveticus NBIMCC 8269, Lactobacillus delbrueckii ssp. lactis NBIMCC 8250, L. delbrueckii ssp. bulgaricus NBIMCC 8244 and Streptococcus thermophilus NBIMCC 8253 (Probiotic Lactina®) for chickens for fattening and suckling and weaned rabbits (Lactina Ltd.)
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Bampidis, V., Azimonti, G., Bastos, M.D.L., Christensen, H., Dusemund, B., Fašmon Durjava, M., Kouba, M., López-Alonso, M., López Puente, S., Marcon, F., Mayo, B., Pechová, A., Petkova, M., Ramos, F., Sanz, Y., Villa, R.E., Woutersen, R., Anguita, M., Galobart, J., Ortuño, J., and Brozzi, R.
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safety ,Settore VET/07 - Farmacologia e Tossicologia Veterinaria ,suckling/weaned rabbits ,Veterinary (miscellaneous) ,efficacy ,chickens for fattening ,Probiotic Lactina® ,gut flora stabiliser ,zootechnical additives ,Plant Science ,Microbiology ,Animal Science and Zoology ,Parasitology ,Food Science - Published
- 2022
14. Economic and Social Importance of the Breeding of Fur Animals in Greece and its Development Strategies
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Semos, N.A., primary, Dotas, V.D., additional, and Bampidis, V., additional
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- 2022
- Full Text
- View/download PDF
15. Safety and efficacy of the feed additives consisting of l‐glutamic acid and monosodium l‐glutamate monohydrate produced by Corynebacterium glutamicum NITE BP‐01681 for all animal species (METEX NOOVISTAGO)
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Bampidis, V., Azimonti, G., Bastos, M.D.L., Christensen, H., Dusemund, B., Fašmon Durjava, M., Kouba, M., López-Alonso, M., López Puente, S., Marcon, F., Mayo, B., Pechová, A., Petkova, M., Ramos, F., Sanz, Y., Villa, R.E., Woutersen, R., Gropp, J., Herman, L., Tosti, L., Galobart, J., Pizzo, F., Revez, J., and Anguita, M.
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monosodium l-glutamate monohydrate ,safety ,Settore VET/07 - Farmacologia e Tossicologia Veterinaria ,l‐glutamic acid ,Veterinary (miscellaneous) ,efficacy ,Plant Science ,Microbiology ,flavouring compounds ,Corynebacterium glutamicum ,‘amino acids their salts and analogues’ ,monosodium l‐glutamate monohydrate ,Settore MED/44 - Medicina del Lavoro ,l-glutamic acid ,Animal Science and Zoology ,Parasitology ,Food Science - 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 safety and efficacy of l-glutamic acid and monosodium l-glutamate monohydrate produced by fermentation using the genetically modified strain Corynebacterium glutamicum NITE BP-01681. The additives are intended to be used in feed and water for drinking for all animal species and categories as nutritional additives (amino acids) or as sensory additives (flavouring compounds). Viable cells of the production strain and its DNA were not detected in the final additives. The additives do not give rise to any safety concern regarding the production strain. l-Glutamic acid and monosodium l-glutamate monohydrate produced using C. glutamicum NITE BP-01681 are considered safe for the target species, for the consumer and for the environment. However, the Panel raised concerns on the use in water for drinking for hygienic reasons. The additives are considered not irritant to skin or eyes and not dermal sensitisers but a risk by inhalation. The Panel concluded that the additives are efficacious as nutritional additives and as flavouring compounds.
- Published
- 2022
16. Safety of the fermentation product of Aspergillus oryzae NRRL 458 (Amaferm®) as a feed additive for dairy cows (Biozyme Inc.)
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Bampidis, V., Azimonti, G., de Lourdes Bastos, M., Christensen, H., Dusemund, B., Fašmon Durjava, M., Kouba, M., López-Alonso, M., López Puente, S., Marcon, F., Mayo, B., Pechová, A., Petkova, M., Ramos, F., Sanz, Y., Edoardo Villa, R., Woutersen, R., Dierick, N., Prieto Maradona, M., Galobart, J., Pettenati, E., and Anguita, M.
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renewal ,Settore VET/07 - Farmacologia e Tossicologia Veterinaria ,Veterinary (miscellaneous) ,Amaferm ,Animal Science and Zoology ,Parasitology ,dairy cows ,Plant Science ,digestibility enhancers ,zootechnical additives ,Microbiology ,Food Science - Abstract
Amaferm® is a fermentation product produced by Aspergillus oryzae NRRL 458, containing alpha-amylase and cellulase enzyme activities, authorised for use as a feed additive for dairy cows. In 2016, the applicant requested for the renewal of the authorisation and the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion at that regard in 2020. In that opinion, the Panel could not confirm the previously drawn conclusions (EFSA, 2006) regarding the safety of the production strain, and consequently could not confirm the safety of the additive for the target species and consumers. In the current submission, the applicant provided supplementary information that allowed the Panel to conclude on the identity of the production strain, redefine the specifications of the additive, and finally to conclude on its safety. Therefore, the new data provided permit to conclude that Amaferm® complies with the conditions of the authorisation. However, the Panel noted that there is the need to change the specification and description of the cellulase and amylase units in the authorisation act. The data provided in the previous (EFSA FEEDAP Panel, 2020) and the current assessments support that Amaferm® remains safe under the approved conditions for target species, consumers and the environment. The additive is non-irritant to skin and eyes, or a dermal sensitiser but should be considered a potential respiratory sensitiser.
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- 2022
17. Safety and efficacy of a feed additive consisting of an essential oil from the flowers of Cananga odorata (Lam.) Hook.f. & Thomson (ylang ylang oil) for use in all animal species (FEFANA asbl)
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Bampidis, V., Azimonti, G., Bastos, M.D.L., Christensen, H., Fašmon Durjava, M., Kouba, M., López-Alonso, M., López Puente, S., Marcon, F., Mayo, B., Pechová, A., Petkova, M., Ramos, F., Sanz, Y., Villa, R.E., Woutersen, R., Brantom, P., Chesson, A., Westendorf, J., Manini, P., Pizzo, F., and Dusemund, B.
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safety ,Settore VET/07 - Farmacologia e Tossicologia Veterinaria ,Cananga odorata (Lam.) ,sensory additives ,Veterinary (miscellaneous) ,component‐based approach ,Plant Science ,Microbiology ,Ylang ylang oil ,essential oil ,flavouring compounds ,estragole ,β‐caryophyllene ,Animal Science and Zoology ,Parasitology ,Food Science - Published
- 2022
18. Safety and efficacy of a feed additive consisting of astaxanthin-rich Phaffia rhodozyma for salmon and trout (Igene Biotechnology, Inc.)
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Bampidis, V., Azimonti, G., Bastos, M.D.L., Christensen, H., Dusemund, B., Fašmon Durjava, M., Kouba, M., López-Alonso, M., López Puente, S., Marcon, F., Mayo, B., Pechová, A., Petkova, M., Ramos, F., Sanz, Y., Villa, R.E., Woutersen, R., Galobart, J., Holcznecht, O., and Vettori, M.V.
- Subjects
safety ,Settore VET/07 - Farmacologia e Tossicologia Veterinaria ,trout ,Veterinary (miscellaneous) ,efficacy ,salmon ,Plant Science ,sensory additive ,Phaffia rhodozyma ,astaxanthin ,colourant ,Microbiology ,Animal Science and Zoology ,Parasitology ,Food Science - Abstract
Following a request from the European Commission, the FEEDAP Panel was asked to deliver a scientific opinion on the safety and efficacy of astaxanthin (ATX)-rich Phaffia rhodozyma. The additive, belonging to the category ‘sensory additives’ and the functional group ‘substances which, when fed to animals, add colours to food of animal origin’ is intended to be used in feed for salmon and trout from an age of six months onwards up to a maximum content of 100 mg ATX/kg complete feed. The product is produced by the telemorph of Phaffia rhodozyma, Xanthophyllomyces dendrorhous, and it is declared to contain 995 g dried inactivated biomass and 5 g ascorbic acid per kg additive. The main active principle of the additive is ATX; however, the FEEDAP Panel noted that some other carotenoids are also present in lower quantities. The minimum ATX concentration is specified to be 5,000 mg per kg additive. The yeast Xanthophyllomyces dendrorhous is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment; therefore, the use of the production strain in the production of the additive would not raise any safety concern for the target species, the consumers of products from animals fed the additive and the environment. In the absence of a tolerance study with the additive, the FEEDAP Panel cannot conclude on the safety for the target species. In the absence of residue and toxicity data of ATX, no final conclusions on the safety for the consumer can be drawn. The FEEDAP Panel concluded that the additive is irritant to skin and eyes, and a skin and respiratory sensitiser, although exposure by inhalation is likely low. The FEEDAP Panel considers that ATX from the biomass does not pose a significant additional risk to the environment compared with other natural sources of ATX. In absence of adequate evidence, no conclusion can be made on the efficacy of the additive.
- Published
- 2022
19. Assessment of the feed additive consisting of Lentilactobacillus buchneri (formerly Lactobacillus buchneri) DSM 12856 for all animal species for the renewal of its authorisation (Lactosan GmbH & Co KG)
- Author
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Bampidis, V., Azimonti, G., Bastos, M.D.L., Christensen, H., Dusemund, B., Fašmon Durjava, M., Kouba, M., López-Alonso, M., López Puente, S., Marcon, F., Mayo, B., Pechová, A., Petkova, M., Ramos, F., Sanz, Y., Villa, R.E., Woutersen, R., Galobart, J., Vettori, M.V., and Brozzi, R.
- Subjects
renewal ,safety ,Settore VET/07 - Farmacologia e Tossicologia Veterinaria ,Lentilactobacillus buchneri DSM 12856 ,QPS ,efficacy ,silage additive ,technological additive ,Veterinary (miscellaneous) ,Plant Science ,Microbiology ,Animal Science and Zoology ,Parasitology ,Food Science - 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 Lentilactobacillus buchneri (formerly Lactobacillus buchneri) DSM 12856 as a technological additive for use in forage for all animal species. The additive aims at improving the production of silage and is authorised for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no evidence to lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety L. buchneri DSM 12856 is not irritant to skin and eyes but is considered a skin and respiratory sensitiser. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
- Published
- 2022
20. Safety and efficacy of a feed additive consisting of Bacillus velezensis NITE BP-01844 (BA-KING®) for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding and all avian species for fattening, or rearing to slaughter or point of lay including non-food producing species (Toa Biopharma Co., Ltd.)
- Author
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Bampidis, V., Azimonti, G., Bastos, M.D.L., Christensen, H., Dusemund, B., Kouba, M., Fašmon Durjava, M., López-Alonso, M., López Puente, S., Marcon, F., Mayo, B., Pechová, A., Petkova, M., Ramos, F., Sanz, Y., Villa, R.E., Woutersen, R., Brantom, P., Maradona, M.P., Anguita, M., Galobart, J., Pettenati, E., and Revez, J.
- Subjects
safety ,Settore VET/07 - Farmacologia e Tossicologia Veterinaria ,Bacillus velezensis NITE BP-01844 ,gut flora stabilisers ,Bacillus velezensis NITE BP‐01844 ,Veterinary (miscellaneous) ,efficacy ,BA-KING ,Plant Science ,Microbiology ,QPS ,zootechnical additive ,BA‐KING® ,Animal Science and Zoology ,Parasitology ,Food Science - 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 safety and efficacy of BA-KING® Bacillus velezensis when used as a feed additive for chickens for fattening, turkeys for fattening, chickens reared for laying, turkeys reared for breeding and all avian species for fattening, or rearing to slaughter or point of lay including non-food producing species. The product under assessment is based on viable spores of a strain identified as B. velezensis, which is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agent was established, and it does not harbour acquired antimicrobial resistance genes, lacks toxigenic potential and does not have the capacity to produce aminoglycosides. Following the QPS approach to safety assessment, B. velezensis NITE BP-01844 is presumed safe for the target species, consumers of products derived from animals fed the additive and the environment. Since no concerns are expected from the other components of the additive, BA-KING® is also considered safe for the target species, consumers of products derived from animals fed the additive and the environment. BA-KING® is not irritant to skin but is potentially irritant to eyes. In addition, should be considered a skin and respiratory sensitiser. The Panel is not in the position to conclude on the efficacy of BA-KING® for the target species.
- Published
- 2022
21. Safety and efficacy of a feed additive consisting of Propionibacterium freudenreichii DSM 33189 and Lentilactobacillus buchneri (formerly Lactobacillus buchneri) DSM 12856 for all animal species (Lactosan GmbH & Co.KG.)
- Author
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Bampidis, V., Azimonti, G., Bastos, M.D.L., Christensen, H., Dusemund, B., Fašmon Durjava, M., Kouba, M., López-Alonso, M., López Puente, S., Marcon, F., Mayo, B., Pechová, A., Petkova, M., Ramos, F., Sanz, Y., Villa, R.E., Woutersen, R., Brozzi, R., Galobart, J., Innocenti, M., and Revez, J.
- Subjects
safety ,Settore VET/07 - Farmacologia e Tossicologia Veterinaria ,silage additive ,Veterinary (miscellaneous) ,efficacy ,Lentilactobacillus buchneri (formerly Lactobacillus buchneri) DSM 12856 ,Propionibacterium freudenreichii DSM 33189 ,QPS ,technological additive ,Plant Science ,Microbiology ,Animal Science and Zoology ,Parasitology ,Food Science - 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 safety and efficacy of an additive consisting of Propionibacterium freudenreichii DSM 33189 and Lentilactobacillus buchneri (formerly Lactobacillus buchneri) DSM 12856 as a technological additive for all animal species. The additive is intended to improve the production of silage at a proposed application rate of 1 × 108 colony-forming units (CFU)/kg fresh material. The bacterial species P. freudenreichii and L. buchneri are considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to assessment. As the identity of the strains has been clearly established and no acquired antimicrobial resistance determinants of concern were detected, the use of the strains as a silage additive is considered safe for livestock species, for consumers and for the environment. The additive is not irritant for eyes or skin but should be considered a respiratory sensitiser. In the absence of data, the FEEDAP Panel could not conclude on the potential of the additive to be a skin sensitiser. The additive at the proposed application rate of 1 × 108 CFU/kg fresh plant material showed the potential to improve the aerobic stability silage with dry matter content ranging from 30% to 70%.
- Published
- 2022
22. Presence of endoparasites in the Greek buffalo (Bubalus bubalis) from Northern Greece
- Author
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FOUNTA, A., PAPADOPOULOS, E., CHLIOUNAKIS, S., BAMPIDIS, V. A., and PAPAZAHARIADOU, M.
- Subjects
Greek buffalo ,παράσιτα ,Ελληνικός βούβαλος ,Northern Greece ,parasites ,Βόρειος Ελλάδα - Abstract
Σκοπός της παρούσας έρευνας ήταν η διερεύνηση της παρουσίας παρασίτων σε δείγματα κοπράνων βουβάλων, της φυλής του Ελληνικού βουβάλου (Bubalus bubalis), που εκτρέφονται σε περιοχές της Περιφερειακής Ενότητας Σερρών στη Βόρεια Ελλάδα. Κατά το χρονικό διάστημα Φεβρουάριος – Οκτώβριος 2014, εξετάσθηκαν δείγματα κοπράνων από 110 βουβάλους της φυλής του Ελληνικού βουβάλου (Bubalus bubalis), από 9 εκτροφές που βρίσκονται σε αγροτικούς οικισμούς περιμετρικά της λίμνης Κερκίνης, με σκοπό την ανεύρεση αναπαραγωγικών στοιχείων παρασίτων (αυγών, προνυμφών, κύστεων και ωοκύστεων). Κατά την εξέταση των 110 δειγμάτων κοπράνων, τα 102 (92,73%) βρέθηκαν μολυσμένα με αναπαραγωγικά στοιχεία παρασίτων. Συγκεκριμένα, τα παράσιτα που βρέθηκαν ήταν: Eimeria spp. (40%), Entamoeba bovis (16,36%), Paramphistomum cervi (10%), Fasciola hepatica (16,36%), Dicrocoelium dendriticum (28,18%), Moniezia benedeni (27,27%), Toxocara vitulorum (11,82%), Στρογγυλοειδή (γαστρεντερικά νηματώδη) (31,82%) και πνευμονικά παράσιτα (28,18%). Στην παρούσα έρευνα γίνεται η πρώτη αναφορά της ανεύρεσης πνευμονικών παρασίτων στους βουβάλους, στην Ελλάδα., This study was conducted in order to determine the presence of parasitic infections of the Greek buffalo (Bubalus bubalis) in the Prefecture of Serres, Northern Greece. During the period from February to October 2014, faecal samples from 110 buffaloes of the Greek buffalo breed (Bubalus bubalis), from 9 farms located in proximity to Lake Kerkini, in the Prefecture of Serres, Northern Greece, were examined, in order to find reproductive elements of parasites. Out of 110 faecal samples examined, 102 (92.73%) were found infected with reproductive elements (eggs, larvae, cysts and oocysts) of parasites. Specifically, the parasites found were: Eimeria spp. (40%), Entamoeba bovis (16.36%), Paramphistomum cervi (10%), Fasciola hepatica (16.36%), Dicrocoelium dendriticum (28.18%), Moniezia benedeni (27.27%), Toxocara vitulorum (11.82%), Strongylida (gastrointestinal nematodes) (31.82%) and lungworms (28.18%). The present study appears to be the first report of the detection of lungworms in buffaloes, in Greece.
- Published
- 2018
23. Rare earth elements (REE) as feed additives in animal nutrition.
- Author
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Flachowsky, G., primary, Bampidis, V., additional, Zhao GuangYong, Zhao GuangYong, additional, Grün, M., additional, and Meyer, U., additional
- Published
- 2019
- Full Text
- View/download PDF
24. Scientific Opinion on the safety and efficacy of L-methionine produced by Escherichia coli (KCCM 11252P) and Escherichia coli (KCCM 11340P) for all animal species
- Author
-
Sejrsen K., Hogstrand C., Rychen G., Aquilina G. Bampidis V., Bastos M. L., Costa L. G., Flachowsky G., Gralak M. A., Leng L., López Puente S., MARTELLI, GIOVANNA, Mayo B., Ramos F., Renshaw D., Saarela M., Van Beelen P., Wallace R. J., Westendorf J., Sejrsen K., Hogstrand C., Rychen G., Aquilina G. Bampidis V., Bastos M.L., Costa L.G., Flachowsky G., Gralak M.A., Leng L., López Puente S., Martelli G., Mayo B., Ramos F., Renshaw D., Saarela M., Van Beelen P., Wallace R.J., and Westendorf J.
- Subjects
NUTRITIONAL ADDITIVE ,safey ,Veterinary (miscellaneous) ,Animal Science and Zoology ,Parasitology ,Plant Science ,L-methionine ,Microbiology ,Food Science - Abstract
L-Methionine, feed grade, is a feed additive produced by two genetically modified Escherichia coli strains. Neither the production strains nor their recombinant DNA were detected in the final product; thus, no safety concerns are associated with the genetic modification of the production strains. The L-methionine produced by such E. coli strains is safe for the target animals when used as a feed additive to meet their requirements. The FEEDAP Panel has concerns over the safety of L-methionine for the target species when administered via water for drinking since any additional supply of an essential amino acid would disturb the balanced amino acid profile of complete diets. There are no safety concerns for the consumer associated with the use of L-methionine in animal nutrition. The additive L-methionine was demonstrated to be without irritant or dermal sensitising properties. Although no data on dusting potential were provided, the FEEDAP Panel considers it unlikely that the user will be exposed to significant amounts of L-methionine by inhalation. L-Methionine is a natural constituent of plants and animals. Its use in animal nutrition does not represent a risk to the environment. The additive L-methionine is considered an efficacious source of the amino acid L-methionine for all animal species.
- Published
- 2013
25. Scientific Opinion on the safety and efficacy of L-valine produced by Corynebacterium glutamicum (KCCM 80058) for all animal species, based on a dossier submitted by CJ Europe GmbH
- Author
-
Sejrsen K., Hogstrand C., Rychen G., Aquilina G., Bampidis V., Bastos M. L., Costa L. G., Flachowsky G., Gralak M. A., Leng L., López Puente S., MARTELLI, GIOVANNA, Mayo B., Ramos F., Renshaw D., Saarela M., Van Beelen P., Wallace R. J., Westendorf J., Sejrsen K., Hogstrand C., Rychen G., Aquilina G., Bampidis V., Bastos M.L., Costa L.G., Flachowsky G., Gralak M.A., Leng L., López Puente S., Martelli G., Mayo B., Ramos F., Renshaw D., Saarela M., Van Beelen P., Wallace R.J., and Westendorf J.
- Subjects
L-valine ,Veterinary (miscellaneous) ,SAFETY ,nutritional additive ,Animal Science and Zoology ,Parasitology ,Plant Science ,Microbiology ,Food Science - Abstract
L-Valine is a feed additive produced by a genetically modified strain of Corynebacterium glutamicum. Neither the production strain nor its recombinant DNA was found in the final product. The final product does not raise any safety concern with regard to the genetic modifications. L-Valine is safe for all target animals when added in appropriate amounts to diets. However, the FEEDAP Panel has concerns over the safety of L-valine for target species when administered via water for drinking since any additional supply of an essential amino acid would disturb the balanced amino acid pattern of complete diets. When used in animal nutrition, L-valine will be incorporated into the protein of the body of the target animal, and any potential excess will be metabolised and excreted. Considering the high purity of the product under assessment, and the lack of toxicological effects at likely use levels, no risks are expected for the consumer from the use L-valine as a feed additive. The L-valine produced by such strain of C. glutamicum has been shown not to be an irritant or a dermal sensitiser. The results of an acute inhalation study performed at high concentration show no evidence of significant acute toxicity by this route. Exposure of users by inhalation cannot be excluded. L-Valine is a natural constituent of plants and animals. Its use in animal nutrition does not represent a risk to the environment. L-Valine is efficacious as a supplemented amino acid to maintain or restore the adequate balance of amino acids for animal nutrition. A response in ruminants requires some degree of protection of L-valine from ruminal degradation.
- Published
- 2013
26. The Effect of Buffalo Meat on Composition, Instrumental and Sensory Characteristics of Traditional Greek Sausages
- Author
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Petridis, D., primary, Zotos, A., additional, Skapetas, B., additional, and Bampidis, V. A., additional
- Published
- 2015
- Full Text
- View/download PDF
27. Nutrient Content of Rabbit Meat as Compared to Chicken, Beef and Pork Meat
- Author
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Nistor, E, primary, Bampidis, V, additional, P, N, additional, cal, cal, additional, Pentea, M, additional, Tozer, J, additional, and Prundeanu, H, additional
- Published
- 2013
- Full Text
- View/download PDF
28. CYTOGENETIC STUDIES IN THE GREEK BUFALLO (BUBALUS BUBALIS).
- Author
-
Nicolae, Ioana, Lymperopoulos, A., Nistor, E., Christodoulou, V., Bampidis, V. A., and Vidmichi, D. M.
- Subjects
CYTOGENETICS ,WATER buffalo ,KARYOTYPES ,REPRODUCTION - Abstract
The main purpose of this work was to describe the karyotype of the Greek buffalo. Cytogenetic studies were carried out on a group of 42 Greek buffaloes (21 females and 21 males) reared in 5 Greek farms. The collected blood samples arrived to Romanian cytogenetic laboratory in the same day and two types of cell cultures were performed: normal cultures and cultures with addition of analogue bases during the last hours of incubation to get improved R-banding patterns and SCEs test. Slides from both cultures were stained with acridine orange or giemsa. The methaphase plates were studied under a Nikon microscope, captured with a CCD camera and were processed by specific image software. The RBA-banding karyotype for male (2n=50,XY) and female (2n=50,XX) have been done. The present study revealed that 21 males and 20 females had normal karyotype and one female was found with chromosomal instability, showing frequent mono- and bi-chromatidic breakages on autosomes and heterosomes. For each investigated animal the cytogenetic analysis bulletin has been delivered. [ABSTRACT FROM AUTHOR]
- Published
- 2015
29. Effect of Dried Oregano Leaves Versus Neomycin in Treating Newborn Calves with Colibacillosis
- Author
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Bampidis, V. A., primary, Christodoulou, V., additional, Florou‐Paneri, P., additional, and Christaki, E., additional
- Published
- 2006
- Full Text
- View/download PDF
30. Safety and efficacy of a feed additive consisting of butylated hydroxytoluene (BHT) for all animal species (Katyon Technologies Limited)
- Author
-
Vasileios, Bampidis, Giovanna, Azimonti, Maria de Lourdes, Bastos, Henrik, Christensen, Birgit, Dusemund, Mojca, Fašmon Durjava, Maryline, Kouba, Marta, López-Alonso, Secundino, López Puente, Francesca, Marcon, Baltasar, Mayo, Alena, Pechová, Mariana, Petkova, Fernando, Ramos, Yolanda, Sanz, Roberto Edoardo, Villa, Ruud, Woutersen, Antonio, Finizio, Ivana, Teodorovic, Gabriele, Aquilina, Georges, Bories, Jurgen, Gropp, Carlo, Nebbia, Matteo, Innocenti, Bampidis, V, Azimonti, G, Bastos, M, Christensen, H, Dusemund, B, Fašmon Durjava, M, Kouba, M, López-Alonso, M, López Puente, S, Marcon, F, Mayo, B, Pechová, A, Petkova, M, Ramos, F, Sanz, Y, Villa, R, Woutersen, R, Finizio, A, Teodorovic, I, Aquilina, G, Bories, G, Gropp, J, Nebbia, C, and Innocenti, M
- Subjects
safety ,BHT ,Butylated hydroxytoluene ,antioxidant ,Veterinary (miscellaneous) ,efficacy ,Animal Science and Zoology ,Parasitology ,technological additive ,Plant Science ,all animal specie ,Microbiology ,Food Science - 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 safety and efficacy of butylated hydroxytoluene (BHT) as a feed additive for all animal species. The additive BHT is considered safe for chickens for fattening and weaned piglets at the maximum proposed concentration of 150 mg/kg complete feed. This conclusion is extended to chickens reared for laying and extrapolated to pigs for fattening. In the absence of data, no conclusion on the safety for the other target species could be drawn. The exposure of the consumer to BHT from tissues and products of animals fed the additive ranged from 1% to 3% of the acceptable daily intake (ADI). The FEEDAP Panel concluded that the use of BHT as a feed additive at the proposed conditions of use is of no concern for the safety of the consumers. Exposure of the user to BHT via inhalation is likely; however, the Panel is not in the position to conclude on the potential inhalation toxicity of the additive. BHT is a skin and eye irritant, no conclusions can be drawn on the potential of the additive to be a skin sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the safety of BHT for the environment. The additive BHT is considered an efficacious antioxidant in feedingstuffs for all animal species.
- Published
- 2022
31. Safety and efficacy of a feed additive consisting of butylated hydroxytoluene (BHT) for all animal species (Lanxess Deutschland GmbH)
- Author
-
Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Mojca Fasmon Durjava, Maryline Kouba, Marta Lopez, Alonso, Secundino Lopez Puente, Francesca Marcon, Baltasar Mayo, Alena Pechova, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa, Ruud Woutersen, Antonio Finizio, Ivana Teodorovic, Gabriele Aquilina, Georges Bories, Jurgen Gropp, Carlo Nebbia, Matteo Innocenti, Bampidis, V, Azimonti, G, de Lourdes Bastos, M, Christensen, H, Dusemund, B, Fasmon Durjava, M, Kouba, M, Lopez, M, Alonso, Lopez Puente, S, Marcon, F, Mayo, B, Pechova, A, Petkova, M, Ramos, F, Sanz, Y, Edoardo Villa, R, Woutersen, R, Finizio, A, Teodorovic, I, Aquilina, G, Bories, G, Gropp, J, Nebbia, C, and Innocenti, M
- Subjects
safety ,BHT ,Butylated hydroxytoluene ,antioxidant ,Veterinary (miscellaneous) ,efficacy ,Animal Science and Zoology ,Parasitology ,Plant Science ,technological additive ,all animal specie ,Microbiology ,Food Science - 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 safety and efficacy of butylated hydroxytoluene (BHT) as a feed additive for all animal species. The additive BHT is considered safe for chickens for fattening and weaned piglets at the maximum proposed concentration of 150 mg/kg complete feed. This conclusion is extended to chickens reared for laying and extrapolated to pigs for fattening. In the absence of data, no conclusion on the safety for the other target species could be drawn. The exposure of the consumer to BHT from tissues and products of animals fed the additive ranged from 1% to 3% of the acceptable daily intake (ADI). The FEEDAP Panel concluded that the use of BHT as a feed additive at the proposed conditions of use is of no concern for the safety of the consumers. Exposure of the user to BHT via inhalation is likely; however, the Panel is not in the position to conclude on the potential inhalation toxicity of the additive. BHT is a skin and eye irritant, no conclusions can be drawn on the potential of the additive to be a skin sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the safety of BHT for the environment. The additive BHT is considered an efficacious antioxidant in feedingstuffs for all animal species.
- Published
- 2022
32. Safety and efficacy of a feed additive consisting of ethoxyquin (6-ethoxy-1,2-dihydro-2,2,4-trimethylquinoline) for all animal species (FEFANA asbl)
- Author
-
Vasileios, Bampidis, Giovanna, Azimonti, Maria de Lourdes, Bastos, Henrik, Christensen, Birgit, Dusemund, Mojca, Fašmon Durjava, Maryline, Kouba, Marta, López-Alonso, Secundino, López Puente, Francesca, Marcon, Baltasar, Mayo, Alena, Pechová, Mariana, Petkova, Fernando, Ramos, Yolanda, Sanz, Roberto Edoardo, Villa, Ruud, Woutersen, Antonio, Finizio, Ivana, Teodorovic, Gabriele, Aquilina, Georges, Bories, Jurgen, Gropp, Carlo, Nebbia, Jordi, Tarrés-Call, Matteo, Innocenti, Bampidis, V, Azimonti, G, Bastos, M, Christensen, H, Dusemund, B, Fašmon Durjava, M, Kouba, M, López‐alonso, M, López Puente, S, Marcon, F, Mayo, B, Pechová, A, Petkova, M, Ramos, F, Sanz, Y, Villa, R, Woutersen, R, Finizio, A, Teodorovic, I, Aquilina, G, Bories, G, Gropp, J, Nebbia, C, Tarrés‐call, J, and Innocenti, M
- Subjects
ethoxyquin ,safety ,p-phenetidine ,antioxidant ,Veterinary (miscellaneous) ,genotoxicity ,toxicity ,Animal Science and Zoology ,Parasitology ,Plant Science ,Microbiology ,ethoxyquin quinone imine ,Food Science - Abstract
Ethoxyquin is synthetised from p-phenetidine, a possible mutagen, which remains in the additive as an impurity at concentrations of < 2.5 mg/kg additive. Ethoxyquin is considered safe for all animal species at the proposed inclusion level of 50 mg/kg complete feed. However, owing the presence of p-phenetidine, no safe level of the additive in feed for long-living and reproductive animals could be identified. The FEEDAP Panel derived a health-based guidance value of 0.006 mg ethoxyquin dimer (EQDM)/kg bw per day and applied it to the sum of ethoxyquin and its transformation products. A maximum total concentration of 50 mg ethoxyquin/kg complete feed for all animal species, except dairy ruminants, would not pose a risk for the consumer. However, in the absence of data on p-phenetidine residues in tissues and products of animal origin, no conclusion on the safety for the consumer could be drawn. The conclusions on consumer safety assume that the maximum total concentration of 50 mg EQ/kg feed is expressed as the sum of EQ, EQDM, EQI and DHEQ. Exposure of the unprotected user to p-phenetidine via inhalation should be minimised. No safety concerns for groundwater are expected. It is not possible to conclude on the safety of EQ for the terrestrial compartment. A risk for the aquatic compartment cannot be excluded when ethoxyquin is used in terrestrial animals. Unacceptable risk is not expected for freshwater sediment-dwelling organisms. A risk of secondary poisoning via the terrestrial food chain is not expected, whereas a risk via the aquatic food chain cannot be excluded. No concerns for aquatic organisms are expected for ethoxyquin used in fish farmed in land-based system, a risk cannot be excluded for marine sediment dwelling organisms when ethoxyquin is used in sea-cages. Ethoxyquin is considered efficacious in the range 25–50 mg/kg complete feed.
- Published
- 2022
33. Safety of a feed additive consisting of semduramicin sodium (Aviax 5%) for chickens for fattening (Phibro Animal Health s.a.)
- Author
-
Vasileios, Bampidis, Giovanna, Azimonti, Maria de Lourdes, Bastos, Henrik, Christensen, Birgit, Dusemund, Mojca, Fašmon Durjava, Maryline, Kouba, Marta, López-Alonso, Secundino, López Puente, Francesca, Marcon, Baltasar, Mayo, Alena, Pechová, Mariana, Petkova, Fernando, Ramos, Yolanda, Sanz, Roberto Edoardo, Villa, Ruud, Woutersen, Georges, Bories, Pier Sandro, Cocconcelli, Antonio, Finizio, Jürgen, Gropp, Guido, Rychen, Ivana, Teodorovic, Rosella, Brozzi, Orsolya, Holczknecht, Elisa, Pettenati, Joana, Revez, Maria Vittoria, Vettori, Bampidis, V, Azimonti, G, Bastos, M, Christensen, H, Dusemund, B, Fasmon Durjava, M, Kouba, M, Lopez-Alonso, M, Lopez Puente, S, Marcon, F, Mayo, B, Pechova, A, Petkova, M, Ramos, F, Sanz, Y, Villa, R, Woutersen, R, Bories, G, Cocconcelli, P, Finizio, A, Gropp, J, Rychen, G, Teodorovic, I, Brozzi, R, Holczknecht, O, Pettenati, E, Revez, J, and Vettori, M
- Subjects
safety ,Veterinary (miscellaneous) ,chickens for fattening ,Animal Science and Zoology ,Parasitology ,coccidiostats and histomonostat ,Plant Science ,Microbiology ,semduramicin sodium ,Food Science - Abstract
Following a request from the European Commission, the Panel on Additives and Products or substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the safety of the coccidiostat Aviax 5% (semduramicin sodium) when used in feed for chickens for fattening. In a previous assessment, the FEEDAP Panel could not conclude on the taxonomical identification of the production strain at species level and on the absence of genetic determinants for antimicrobial resistance. In addition, the Panel could not conclude on the safety for the target animals and could not set maximum residue limits to protect consumers. Regarding the safety for the environment, although the use of the additive was considered safe for the terrestrial compartment, a risk for the aquatic compartment and for groundwater pollution could not be excluded. Based on the new data provided, the FEEDAP Panel concludes that there are no safety concerns for the target animals, consumer, user and environment regarding the production strain of semduramicin sodium. Based on the results in the tolerance trial, the FEEDAP Panel concludes that the additive is safe for chickens for fattening up to the maximum recommended level (25 mg/kg complete feed), but no margin of safety can be established. The use of semduramicin sodium at a maximum level of 25 mg/kg complete feed for chickens for fattening is safe for consumers with no withdrawal time. Based on the new data provided and the current requirements for environmental risk assessment, the use of semduramicin sodium from Aviax 5% in feed for chickens for fattening up to 25 mg/kg complete feed does not pose a risk for groundwater nor for aquatic and sediment compartments, while a risk for the terrestrial compartment cannot be excluded. The bioaccumulation and the risk for secondary poisoning are considered to be low.
- Published
- 2022
34. Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Bacillus subtilis LMG S‐27588 (Beltherm MP/ML) for laying hens, minor poultry species and all avian species (Puratos NV)
- Author
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Yolanda Sanz, Fernando Ramos, Efsa Panel on Additives, Roberto Edoardo Villa, Montserrat Anguita, Giovanna Martelli, Birgit Dusemund, Noël Dierick, Alena Pechová, Mojca Fašmon Durjava, Ruud Woutersen, Henrik Christensen, Marta López-Alonso, Jaume Galobart, Lieve Herman, Mariana Petkova, Maria de Lourdes Bastos, Maryline Kouba, Baltasar Mayo, Secundino López Puente, Vasileios Bampidis, Francesca Marcon, Giovanna Azimonti, Bampidis V., Azimonti G., Bastos M.D.L., Christensen H., Dusemund B., Fasmon Durjava M., Kouba M., Lopez-Alonso M., Lopez Puente S., Marcon F., Mayo B., Pechova A., Petkova M., Ramos F., Sanz Y., Villa R.E., Woutersen R., Dierick N., Herman L., Martelli G., Galobart J., and Anguita M.
- Subjects
safety ,Veterinary (miscellaneous) ,Feed additive ,efficacy ,TP1-1185 ,Plant Science ,Bacillus subtilis ,Microbiology ,Anim2953 ,TX341-641 ,Food science ,digestibility enhancers ,Beltherm ,xylanase ,biology ,Nutrition. Foods and food supply ,Chemistry ,Chemical technology ,Endo 1 4 β xylanase ,biology.organism_classification ,zootechnical additives ,Scientific Opinion ,Xylanase ,Animal Science and Zoology ,Parasitology ,digestibility enhancer ,Food Science - Abstract
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an endo-1,4-β-xylanase (Beltherm MP/ML), produced by a genetically-modified Bacillus subtilis strain, as a zootechnical additive for laying hens, minor poultry species and all avian species. The additive is authorised for use in feed for poultry species for fattening or reared for laying/breeding, weaned piglets, pigs for fattening and minor porcine species for fattening. The safety and efficacy of the additive for those species have been evaluated previously by the EFSA Panelon Additives and Products or Substances used in Animal Feed (FEEDAP Panel). The current application is for an extension of use of the additive. No viable cells were detected in the additive, but the data provided to support the absence of DNA in the additive was not sufficient to conclude on the absence of recombinant DNA in the additive. However, the Panelconcluded that no safety concerns would arise from the presence of DNA from the production strain in the additive. In the current assessment, the FEEDAP Panelconcluded that the additive is safe for all avian species at the recommended level of 100 ADXU/kg feed. Similarly, the FEEDAP Panelconcluded that Beltherm MP/ML is safe for the consumer and the environment. Concerning the user safety, the FEEDAP Panelconcluded that the additive is not toxic by inhalation or irritant for skin or eyes, but it is considered a potential dermal and a respiratory sensitiser. In a previous opinion, the efficacy of the additive in poultry species for fattening was shown. However, owing to the insufficient data submitted in previous and current assessments, the Panelcould not conclude on the efficacy of the product for the target species for which the application was made.
- Published
- 2021
35. Maximum levels of cross-contamination for 24 antimicrobial active substances in non-target feed. Part 9: Polymyxins: colistin
- Author
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EFSA Panel on Biological Hazards (BIOHAZ), Koutsoumanis, Konstantinos, Allende, Ana, Alvarez-Ordóñez, Avelino, Bolton, Declan, Bover-Cid, Sara, Chemaly, Marianne, Davies, Robert, De Cesare, Alessandra, Herman, Lieve, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Suffredini, Elisabetta, Andersson, Dan I., Bampidis, Vasileios, Bengtsson-Palme, Johan, Bouchard, Damien, Ferran, Aude, Kouba, Maryline, López Puente, Secundino, López-Alonso, Marta, Nielsen, Søren Saxmose, Pechová, Alena, Petkova, Mariana, Girault, Sebastien, Broglia, Alessandro, Guerra, Beatriz, Innocenti, Matteo Lorenzo, Liébana, Ernesto, López-Gálvez, Gloria, Manini, Paola, Stella, Pietro, Peixe, Luisa, Indústries Alimentàries, Funcionalitat i Seguretat Alimentària, Koutsoumanis K., Allende A., Alvarez-Ordoñez A., Bolton D., Bover-Cid S., Chemaly M., Davies R., De Cesare A., Herman L., Hilbert F., Lindqvist R., Nauta M., Ru G., Simmons M., Skandamis P., Suffredini E., Andersson D.I., Bampidis V., Bengtsson-Palme J., Bouchard D., Ferran A., Kouba M., Lopez Puente S., Lopez-Alonso M., Nielsen S.S., Pechova A., Petkova M., Girault S., Broglia A., Guerra B., Innocenti M.L., Liebana E., Lopez-Galvez G., Manini P., Stella P., and Peixe L.
- Subjects
663/664 ,medicine.drug_class ,Veterinary (miscellaneous) ,Polymyxin ,Growth promotion ,TP1-1185 ,Plant Science ,Biology ,Microbiology ,Non target ,Antibiotic resistance ,growth promotion ,medicine ,TX341-641 ,antimicrobial resistance ,colistin ,yield increase ,Animal health ,Nutrition. Foods and food supply ,business.industry ,Chemical technology ,sub-inhibitory concentration ,sub‐inhibitory concentration ,Contamination ,Feed Antimicrobial Resistance Selection Concentration (FARSC) ,Antimicrobial ,food-producing animal ,Biotechnology ,Colistin ,Animal Science and Zoology ,Parasitology ,business ,Food Science ,medicine.drug - Abstract
The specific concentrations of colistin in non-target feed for food-producing animals, below which there would not be an effect on the emergence of, and/or selection for, resistance in bacteria relevant for human and animal health, as well as the specific antimicrobial concentrations in feed which have an effect in terms of growth promotion/increased yield were assessed by EFSA in collaboration with EMA. Details of the methodology used for this assessment, associated data gaps and uncertainties, are presented in a separate document. To address antimicrobial resistance, the Feed Antimicrobial Resistance Selection Concentration (FARSC) model developed specifically for the assessment was applied. However, due to the lack of data on the parameters required to calculate the FARSC, it was not possible to conclude the assessment until further experimental data become available. To address growth promotion, data from scientific publications obtained from an extensive literature review were used. Levels of colistin in feed that showed to have an effect on growth promotion/increased yield were reported. It was recommended to carry out studies to generate the data that are required to fill the gaps which prevented the calculation of the FARSC for these antimicrobials. info:eu-repo/semantics/publishedVersion
- Published
- 2021
36. Maximum levels of cross-contamination for 24 antimicrobial active substances in non-target feed. Part 13: Diaminopyrimidines: trimethoprim
- Author
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EFSA Panel on Biological Hazards (BIOHAZ), Koutsoumanis, Konstantinos, Allende, Ana, Alvarez-Ordóñez, Avelino, Bolton, Declan, Bover-Cid, Sara, Chemaly, Marianne, Davies, Robert, De Cesare, Alessandra, Herman, Lieve, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Suffredini, Elisabetta, Andersson, Dan I., Bampidis, Vasileios, Bengtsson-Palme, Johan, Bouchard, Damien, Ferran, Aude, Kouba, Maryline, López Puente, Secundino, López-Alonso, Marta, Nielsen, Søren Saxmose, Pechová, Alena, Petkova, Mariana, Girault, Sebastien, Broglia, Alessandro, Guerra, Beatriz, Innocenti, Matteo Lorenzo, Liébana, Ernesto, López-Gálvez, Gloria, Manini, Paola, Stella, Pietro, Peixe, Luisa, Indústries Alimentàries, Funcionalitat i Seguretat Alimentària, Koutsoumanis K., Allende A., Alvarez-Ordoñez A., Bolton D., Bover-Cid S., Chemaly M., Davies R., De Cesare A., Herman L., Hilbert F., Lindqvist R., Nauta M., Ru G., Simmons M., Skandamis P., Suffredini E., Andersson D.I., Bampidis V., Bengtsson-Palme J., Bouchard D., Ferran A., Kouba M., Lopez Puente S., Lopez-Alonso M., Nielsen S.S., Pechova A., Petkova M., Girault S., Broglia A., Guerra B., Innocenti M.L., Liebana E., Lopez-Galvez G., Manini P., Stella P., and Peixe L.
- Subjects
Complete data ,663/664 ,Veterinary (miscellaneous) ,Growth promotion ,TP1-1185 ,Plant Science ,Biology ,Microbiology ,Trimethoprim ,Non target ,Antibiotic resistance ,growth promotion ,medicine ,TX341-641 ,antimicrobial resistance ,yield increase ,Animal health ,Nutrition. Foods and food supply ,business.industry ,Chemical technology ,sub-inhibitory concentration ,food-producing animals ,Biol5012 ,food‐producing animals ,sub‐inhibitory concentration ,Contamination ,Feed Antimicrobial Resistance Selection Concentration (FARSC) ,Antimicrobial ,food-producing animal ,Biotechnology ,Scientific Opinion ,Animal Science and Zoology ,Parasitology ,business ,Food Science ,medicine.drug - Abstract
The specific concentrations of trimethoprim in non-target feed for food-producing animals below which there would not be an effect on the emergence of, and/or selection for, resistance in bacteria relevant for human and animal health, as well as the specific antimicrobial concentrations in feed which have an effect in terms of growth promotion/increased yield were assessed by EFSA in collaboration with EMA. Details of the methodology used for this assessment, associated data gaps and uncertainties, are presented in a separate document. To address antimicrobial resistance, the Feed Antimicrobial Resistance Selection Concentration (FARSC) model developed specifically for the assessment was applied. The FARSC for trimethoprim was estimated. Uncertainties and data gaps associated to the levels reported were addressed. To address growth promotion, data from scientific publications obtained from an extensive literature review were used. No suitable data for the assessment were available. It was recommended to perform further studies to supply more diverse and complete data related to the requirements for calculation of the FARSC for trimethoprim. info:eu-repo/semantics/publishedVersion
- Published
- 2021
37. Maximum levels of cross‐contamination for 24 antimicrobial active substances in non‐target feed. Part 12: Tetracyclines: tetracycline, chlortetracycline, oxytetracycline, and doxycycline
- Author
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EFSA Panel on Biological Hazards (BIOHAZ), Koutsoumanis, Konstantinos, Allende, Ana, Alvarez-Ordóñez, Avelino, Bolton, Declan, Bover-Cid, Sara, Chemaly, Marianne, Davies, Robert, De Cesare, Alessandra, Herman, Lieve, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Suffredini, Elisabetta, Andersson, Dan I, Bampidis, Vasileios, Bengtsson-Palme, Johan, Bouchard, Damien, Ferran, Aude, Kouba, Maryline, López Puente, Secundino, López-Alonso, Marta, Nielsen, Søren Saxmose, Pechová, Alena, Petkova, Mariana, Girault, Sebastien, Broglia, Alessandro, Guerra, Beatriz, Innocenti, Matteo Lorenzo, Liébana, Ernesto, López-Gálvez, Gloria, Manini, Paola, Stella, Pietro, Peixe, Luisa, Indústries Alimentàries, Funcionalitat i Seguretat Alimentària, Koutsoumanis K., Allende A., Alvarez-Ordonez A., Bolton D., Bover-Cid S., Chemaly M., Davies R., De Cesare A., Herman L., Hilbert F., Lindqvist R., Nauta M., Ru G., Simmons M., Skandamis P., Suffredini E., Andersson D.I., Bampidis V., Bengtsson-Palme J., Bouchard D., Ferran A., Kouba M., Lopez Puente S., Lopez-Alonso M., Nielsen S.S., Pechova A., Petkova M., Girault S., Broglia A., Guerra B., Innocenti M.L., Liebana E., Lopez-Galvez G., Manini P., Stella P., and Peixe L.
- Subjects
Chlortetracycline ,663/664 ,Tetracycline ,Veterinary (miscellaneous) ,Growth promotion ,TP1-1185 ,Plant Science ,Oxytetracycline ,Biology ,Microbiology ,Antibiotic resistance ,growth promotion ,medicine ,TX341-641 ,antimicrobial resistance ,Food science ,chlortetracycline ,tetracycline ,Doxycycline ,doxycycline ,Nutrition. Foods and food supply ,Chemical technology ,food-producing animals ,Contamination ,Antimicrobial ,food-producing animal ,Animal Science and Zoology ,Parasitology ,oxytetracycline ,Food Science ,medicine.drug - Abstract
The specific concentrations of tetracycline, chlortetracycline, oxytetracycline and doxycycline in non-target feed for food-producing animals, below which there would not be an effect on the emergence of, and/or selection for, resistance in bacteria relevant for human and animal health, as well as the specific antimicrobial concentrations in feed which have an effect in terms of growth promotion/increased yield were assessed by EFSA in collaboration with EMA. Details of the methodology used for this assessment, associated data gaps and uncertainties are presented in a separate document. To address antimicrobial resistance, the Feed Antimicrobial Resistance Selection Concentration (FARSC) model developed specifically for the assessment was applied. The FARSC for these four tetracyclines was estimated. To address growth promotion, data from scientific publications obtained from an extensive literature review were used. Levels in feed that showed to have an effect on growth promotion/increased yield were reported for tetracycline, chlortetracycline, oxytetracycline, whilst for doxycycline no suitable data for the assessment were available. Uncertainties and data gaps associated with the levels reported were addressed. It was recommended to perform further studies to supply more diverse and complete data related to the requirements for calculation of the FARSC for these antimicrobials. info:eu-repo/semantics/publishedVersion
- Published
- 2021
38. Maximum levels of cross‐contamination for 24 antimicrobial active substances in non‐target feed. Part 10: Quinolones: flumequine and oxolinic acid
- Author
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EFSA Panel on Biological Hazards (BIOHAZ), Koutsoumanis, Konstantinos, Allende, Ana, Alvarez-Ordóñez, Avelino, Bolton, Declan, Bover-Cid, Sara, Chemaly, Marianne, Davies, Robert, De Cesare, Alessandra, Herman, Lieve, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Suffredini, Elisabetta, Andersson, Dan I, Bampidis, Vasileios, Bengtsson-Palme, Johan, Bouchard, Damien, Ferran, Aude, Kouba, Maryline, López Puente, Secundino, López-Alonso, Marta, Nielsen, Søren Saxmose, Pechová, Alena, Petkova, Mariana, Girault, Sebastien, Broglia, Alessandro, Guerra, Beatriz, Innocenti, Matteo Lorenzo, Liébana, Ernesto, López-Gálvez, Gloria, Manini, Paola, Stella, Pietro, Peixe, Luisa, Koutsoumanis K., Allende A., Alvarez-Ordoñez A., Bolton D., Bover-Cid S., Chemaly M., Davies R., De Cesare A., Herman L., Hilbert F., Lindqvist R., Nauta M., Ru G., Simmons M., Skandamis P., Suffredini E., Andersson D.I., Bampidis V., Bengtsson-Palme J., Bouchard D., Ferran A., Kouba M., Lopez Puente S., Lopez-Alonso M., Nielsen S.S., Pechova A., Petkova M., Girault S., Broglia A., Guerra B., Innocenti M.L., Liebana E., Lopez-Galvez G., Manini P., Stella P., Peixe L., Indústries Alimentàries, and Funcionalitat i Seguretat Alimentària
- Subjects
663/664 ,Veterinary (miscellaneous) ,Growth promotion ,flumequine ,TP1-1185 ,Plant Science ,Microbiology ,Non target ,Antibiotic resistance ,growth promotion ,oxolinic acid ,Oxolinic acid ,medicine ,TX341-641 ,Food science ,antimicrobial resistance ,Food8822 ,yield increase ,Animal health ,Nutrition. Foods and food supply ,Chemical technology ,sub-inhibitory concentration ,food-producing animals ,food‐producing animals ,Contamination ,sub‐inhibitory concentration ,Antimicrobial ,food-producing animal ,Scientific Opinion ,Flumequine ,Environmental science ,Animal Science and Zoology ,Parasitology ,Food Science ,medicine.drug - Abstract
The specific concentrations of flumequine and oxolinic acid in non-target feed for food-producing animals, below which there would not be an effect on the emergence of, and/or selection for, resistance in bacteria relevant for human and animal health, as well as the specific antimicrobial concentrations in feed which have an effect in terms of growth promotion/increased yield were assessed by EFSA in collaboration with EMA. Details of the methodology used for this assessment, associated data gaps and uncertainties, are presented in a separate document. To address antimicrobial resistance, the Feed Antimicrobial Resistance Selection Concentration (FARSC) model developed specifically for the assessment was applied. However, due to the lack of data on the parameters required to calculate the FARSC, it was not possible to conclude the assessment until further experimental data are available. To address growth promotion, data from scientific publications obtained from an extensive literature review were used. No suitable data for the assessment were available. It was recommended to carry out studies to generate the data that are required to fill the gaps which prevented the calculation of the FARSC for these antimicrobials. info:eu-repo/semantics/publishedVersion
- Published
- 2021
39. Maximum levels of cross‐contamination for 24 antimicrobial active substances in non‐target feed. Part 4: β‐Lactams: amoxicillin and penicillin V
- Author
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EFSA Panel on Biological Hazards (BIOHAZ), Koutsoumanis, Konstantinos, Allende, Ana, Alvarez-Ordóñez, Avelino, Bolton, Declan, Bover-Cid, Sara, Chemaly, Marianne, Davies, Robert, De Cesare, Alessandra, Herman, Lieve, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Suffredini, Elisabetta, Andersson, Dan I, Bampidis, Vasileios, Bengtsson-Palme, Johan, Bouchard, Damien, Ferran, Aude, Kouba, Maryline, López Puente, Secundino, López-Alonso, Marta, Nielsen, Søren Saxmose, Pechová, Alena, Petkova, Mariana, Girault, Sebastien, Broglia, Alessandro, Guerra, Beatriz, Innocenti, Matteo Lorenzo, Liébana, Ernesto, López-Gálvez, Gloria, Manini, Paola, Stella, Pietro, Peixe, Luisa, Indústries Alimentàries, Funcionalitat i Seguretat Alimentària, Koutso111umanis K., Allende A., Alvarez-Ordonez A., Bolton D., Bover-Cid S., Chemaly M., Davies R., De Cesare A., Herman L., Hilbert F., Lindqvist R., Nauta M., Ru G., Simmons M., Skandamis P., Suffredini E., Andersson D.I., Bampidis V., Bengtsson-Palme J., Bouchard D., Ferran A., Kouba M., Lopez Puente S., Lopez-Alonso M., Nielsen S.S., Pechova A., Petkova M., Girault S., Broglia A., Guerra B., Innocenti M.L., Liebana E., Lopez-Galvez G., Manini P., Stella P., and Peixe L.
- Subjects
663/664 ,Veterinary (miscellaneous) ,Growth promotion ,TP1-1185 ,Plant Science ,Biology ,Microbiology ,Antibiotic resistance ,Non target ,growth promotion ,β lactams ,medicine ,TX341-641 ,antimicrobial resistance ,Food science ,yield increase ,amoxicillin ,Nutrition. Foods and food supply ,sub-inhibitory concentration ,Chemical technology ,food-producing animals ,Biol5012 ,food‐producing animals ,sub‐inhibitory concentration ,Contamination ,Amoxicillin ,penicillin V ,Antimicrobial ,food-producing animal ,Penicillin ,Scientific Opinion ,Animal Science and Zoology ,Parasitology ,Food Science ,medicine.drug - Abstract
The specific concentrations of amoxicillin and penicillin V in non-target feed for food-producing animals, below which there would not be an effect on the emergence of, and/or selection for, resistance in bacteria relevant for human and animal health, as well as the specific antimicrobial concentrations in feed which have an effect in terms of growth promotion/increased yield were assessed by EFSA in collaboration with EMA. Details of the methodology used for this assessment, associated data gaps and uncertainties, are presented in a separate document. To address antimicrobial resistance, the Feed Antimicrobial Resistance Selection Concentration (FARSC) model developed specifically for the assessment was applied. However, due to the lack of data on the parameters required to calculate the FARSC, it was not possible to conclude the assessment until further experimental data become available. To address growth promotion, data from scientific publications obtained from an extensive literature review were used. Levels in feed that showed to have an effect on growth promotion/increased yield were reported for amoxicillin, whilst for penicillin V no suitable data for the assessment were available. It was recommended to carry out studies to generate the data that are required to fill the gaps which prevented the calculation of the FARSC for these two antimicrobials. info:eu-repo/semantics/publishedVersion
- Published
- 2021
40. Maximum levels of cross‐contamination for 24 antimicrobial active substances in non‐target feed. Part 6: Macrolides: tilmicosin, tylosin and tylvalosin
- Author
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EFSA Panel on Biological Hazards (BIOHAZ), Koutsoumanis, Konstantinos, Allende, Ana, Alvarez-Ordóñez, Avelino, Bolton, Declan, Bover-Cid, Sara, Chemaly, Marianne, Davies, Robert, De Cesare, Alessandra, Herman, Lieve, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Suffredini, Elisabetta, Andersson, Dan I, Bampidis, Vasileios, Bengtsson-Palme, Johan, Bouchard, Damien, Ferran, Aude, Kouba, Maryline, López Puente, Secundino, López-Alonso, Marta, Nielsen, Søren Saxmose, Pechová, Alena, Petkova, Mariana, Girault, Sebastien, Broglia, Alessandro, Guerra, Beatriz, Innocenti, Matteo Lorenzo, Liébana, Ernesto, López-Gálvez, Gloria, Manini, Paola, Stella, Pietro, Peixe, Luisa, Koutsoumanis K., Allende A., Alvarez-Ordoñez A., Bolton D., Bover-Cid S., Chemaly M., Davies R., De Cesare A., Herman L., Hilbert F., Lindqvist R., Nauta M., Ru G., Simmons M., Skandamis P., Suffredini E., Andersson D.I., Bampidis V., Bengtsson-Palme J., Bouchard D., Ferran A., Kouba M., Lopez Puente S., Lopez-Alonso M., Nielsen S.S., Pechova A., Petkova M., Girault S., Broglia A., Guerra B., Innocenti M.L., Liebana E., Lopez-Galvez G., Manini P., Stella P., Peixe L., Indústries Alimentàries, and Funcionalitat i Seguretat Alimentària
- Subjects
663/664 ,Veterinary (miscellaneous) ,Growth promotion ,TP1-1185 ,Plant Science ,Tylosin ,Biology ,tilmicosin ,Microbiology ,chemistry.chemical_compound ,Antibiotic resistance ,Non target ,growth promotion ,TX341-641 ,antimicrobial resistance ,Food science ,Tilmicosin ,yield increase ,tylosin ,Nutrition. Foods and food supply ,Chemical technology ,food-producing animals ,tylvalosin ,Contamination ,Antimicrobial ,food-producing animal ,chemistry ,Animal Science and Zoology ,Parasitology ,Tylvalosin ,Food Science - Abstract
The specific concentrations of tilmicosin, tylosin and tylvalosin in non-target feed for food-producing animals, below which there would not be an effect on the emergence of, and/or selection for, resistance in bacteria relevant for human and animal health, as well as the specific antimicrobial concentrations in feed which have an effect in terms of growth promotion/increased yield, were assessed by EFSA in collaboration with EMA. Details of the methodology used for this assessment, associated data gaps and uncertainties, are presented in a separate document. To address antimicrobial resistance, the Feed Antimicrobial Resistance Selection Concentration (FARSC) model developed specifically for the assessment was applied. However, due to the lack of data on the parameters required to calculate the FARSC, it was not possible to conclude the assessment until further experimental data become available. To address growth promotion, data from scientific publications obtained from an extensive literature review were used. Levels in feed that showed to have an effect on growth promotion/increased yield were reported for tilmicosin and tylosin, whilst for tylvalosin no suitable data for the assessment were available. It was recommended to carry out studies to generate the data that are required to fill the gaps which prevented the calculation of the FARSC for these three antimicrobials. info:eu-repo/semantics/publishedVersion
- Published
- 2021
41. Maximum levels of cross‐contamination for 24 antimicrobial active substances in non‐target feed. Part 7: Amphenicols: florfenicol and thiamphenicol
- Author
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EFSA Panel on Biological Hazards (BIOHAZ), Konstantinos Koutsoumanis, Ana Allende, Avelino Alvarez‐Ordóñez, Declan Bolton, Sara Bover‐Cid, Marianne Chemaly, Robert Davies, Alessandra De Cesare, Lieve Herman, Friederike Hilbert, Roland Lindqvist, Maarten Nauta, Giuseppe Ru, Marion Simmons, Panagiotis Skandamis, Elisabetta Suffredini, Dan I Andersson, Vasileios Bampidis, Johan Bengtsson‐Palme, Damien Bouchard, Aude Ferran, Maryline Kouba, Secundino López Puente, Marta López‐Alonso, Søren Saxmose Nielsen, Alena Pechová, Mariana Petkova, Sebastien Girault, Alessandro Broglia, Beatriz Guerra, Matteo Lorenzo Innocenti, Ernesto Liébana, Gloria López‐Gálvez, Paola Manini, Pietro Stella, Luisa Peixe, Indústries Alimentàries, Qualitat i Tecnologia Alimentària, Koutsoumanis K., Allende A., Alvarez-Ordonez A., Bolton D., Bover-Cid S., Chemaly M., Davies R., De Cesare A., Herman L., Hilbert F., Lindqvist R., Nauta M., Ru G., Simmons M., Skandamis P., Suffredini E., Andersson D.I., Bampidis V., Bengtsson-Palme J., Bouchard D., Ferran A., Kouba M., Lopez Puente S., Lopez-Alonso M., Nielsen S.S., Pechova A., Petkova M., Girault S., Broglia A., Guerra B., Innocenti M.L., Liebana E., Lopez-Galvez G., Manini P., Stella P., and Peixe L.
- Subjects
Florfenicol ,663/664 ,florfenicol ,medicine.drug_class ,Veterinary (miscellaneous) ,Growth promotion ,Plant Science ,TP1-1185 ,Microbiology ,chemistry.chemical_compound ,Non target ,Antibiotic resistance ,growth promotion ,medicine ,TX341-641 ,Food science ,antimicrobial resistance ,yield increase ,thiamphenicol ,Nutrition. Foods and food supply ,sub-inhibitory concentration ,Chemical technology ,Biol5012 ,food‐producing animals ,food-producing animals ,Contamination ,sub‐inhibitory concentration ,Thiamphenicol ,Antimicrobial ,food-producing animal ,Scientific Opinion ,chemistry ,Environmental science ,Animal Science and Zoology ,Parasitology ,Amphenicols ,Food Science ,medicine.drug - Abstract
The specific concentrations of florfenicol and thiamphenicol in non-target feed for food-producing animals, below which there would not be an effect on the emergence of, and/or selection for, resistance in bacteria relevant for human and animal health, as well as the specific antimicrobial concentrations in feed which have an effect in terms of growth promotion/increased yield, were assessed by EFSA in collaboration with EMA. Details of the methodology used for this assessment, associated data gaps and uncertainties, are presented in a separate document. To address antimicrobial resistance, the Feed Antimicrobial Resistance Selection Concentration (FARSC) model developed specifically for the assessment was applied. The FARSC for florfenicol was estimated. However, due to the lack of data, the calculation of the FARSC for thiamphenicol was not possible until further experimental data become available. To address growth promotion, data from scientific publications obtained from an extensive literature review were used. Levels in feed that showed to have an effect on growth promotion/increased yield were reported for florfenicol, whilst for thiamphenicol no suitable data for the assessment were available. Uncertainties and data gaps associated to the levels reported were addressed. For florfenicol, it was recommended to perform further studies to supply more diverse and complete data related to the requirements for calculation of the FARSC, whereas for thiamphenicol, the recommendation was to generate the data required to fill the gaps which prevented the FARSC calculation. info:eu-repo/semantics/publishedVersion
- Published
- 2021
42. Maximum levels of cross‐contamination for 24 antimicrobial active substances in non‐target feed. Part 8: Pleuromutilins: tiamulin and valnemulin
- Author
-
EFSA Panel on Biological Hazards (BIOHAZ), Konstantinos Koutsoumanis, Ana Allende, Avelino Alvarez‐Ordóñez, Declan Bolton, Sara Bover‐Cid, Marianne Chemaly, Robert Davies, Alessandra De Cesare, Lieve Herman, Friederike Hilbert, Roland Lindqvist, Maarten Nauta, Giuseppe Ru, Marion Simmons, Panagiotis Skandamis, Elisabetta Suffredini, Dan I Andersson, Vasileios Bampidis, Johan Bengtsson‐Palme, Damien Bouchard, Aude Ferran, Maryline Kouba, Secundino López Puente, Marta López‐Alonso, Søren Saxmose Nielsen, Alena Pechová, Mariana Petkova, Sebastien Girault, Alessandro Broglia, Beatriz Guerra, Matteo Lorenzo Innocenti, Ernesto Liébana, Gloria López‐Gálvez, Paola Manini, Pietro Stella, Luisa Peixe, Koutsoumanis K., Allende A., Alvarez-Ordoñez A., Bolton D., Bover-Cid S., Chemaly M., Davies R., De Cesare A., Herman L., Hilbert F., Lindqvist R., Nauta M., Ru G., Simmons M., Skandamis P., Suffredini E., Andersson D.I., Bampidis V., Bengtsson-Palme J., Bouchard D., Ferran A., Kouba M., Lopez Puente S., Lopez-Alonso M., Nielsen S.S., Pechova A., Petkova M., Girault S., Broglia A., Guerra B., Innocenti M.L., Liebana E., Lopez-Galvez G., Manini P., Stella P., Peixe L., Indústries Alimentàries, and Funcionalitat i Seguretat Alimentària
- Subjects
663/664 ,tiamulin ,Veterinary (miscellaneous) ,Tiamulin ,Growth promotion ,Plant Science ,TP1-1185 ,Microbiology ,chemistry.chemical_compound ,Non target ,Antibiotic resistance ,growth promotion ,medicine ,TX341-641 ,valnemulin ,antimicrobial resistance ,yield increase ,Animal health ,business.industry ,Nutrition. Foods and food supply ,sub-inhibitory concentration ,Chemical technology ,food-producing animals ,Contamination ,sub‐inhibitory concentration ,Valnemulin ,Antimicrobial ,food-producing animal ,Biotechnology ,chemistry ,Environmental science ,Animal Science and Zoology ,Parasitology ,business ,Food Science ,medicine.drug - Abstract
The specific concentrations of tiamulin and valnemulin in non-target feed for food-producing animals, below which there would not be an effect on the emergence of, and/or selection for, resistance in bacteria relevant for human and animal health, as well as the specific antimicrobial concentrations in feed which have an effect in terms of growth promotion/increased yield were assessed by EFSA in collaboration with EMA. Details of the methodology used for this assessment, associated data gaps and uncertainties, are presented in a separate document. To address antimicrobial resistance, the Feed Antimicrobial Resistance Selection Concentration (FARSC) model developed specifically for the assessment was applied. However, due to the lack of data on the parameters required to calculate the FARSC, it was not possible to conclude the assessment until further experimental data become available. To address growth promotion, data from scientific publications obtained from an extensive literature review were used. Levels in feed that showed to have an effect on growth promotion/increased yield were reported for tiamulin, while for valnemulin no suitable data for the assessment were available. It was recommended to carry out studies to generate the data that are required to fill the gaps which prevented the calculation of the FARSC for these two antimicrobials. info:eu-repo/semantics/publishedVersion
- Published
- 2021
43. Maximum levels of cross‐contamination for 24 antimicrobial active substances in non‐target feed. Part 11: Sulfonamides
- Author
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EFSA Panel on Biological Hazards (BIOHAZ), Koutsoumanis, Konstantinos, Allende, Ana, Alvarez-Ordóñez, Avelino, Bolton, Declan, Bover-Cid, Sara, Chemaly, Marianne, Davies, Robert, De Cesare, Alessandra, Herman, Lieve, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Suffredini, Elisabetta, Andersson, Dan I., Bampidis, Vasileios, Bengtsson-Palme, Johan, Bouchard, Damien, Ferran, Aude, Kouba, Maryline, López Puente, Secundino, López-Alonso, Marta, Nielsen, Søren Saxmose, Pechová, Alena, Petkova, Mariana, Girault, Sebastien, Broglia, Alessandro, Guerra, Beatriz, Innocenti, Matteo Lorenzo, Liébana, Ernesto, López-Gálvez, Gloria, Manini, Paola, Stella, Pietro, Peixe, Luisa, Koutsoumanis K., Allende A., Alvarez-Ordoñez A., Bolton D., Bover-Cid S., Chemaly M., Davies R., De Cesare A., Herman L., Hilbert F., Lindqvist R., Nauta M., Ru G., Simmons M., Skandamis P., Suffredini E., Andersson D.I., Bampidis V., Bengtsson-Palme J., Bouchard D., Ferran A., Kouba M., Lopez Puente S., Lopez-Alonso M., Nielsen S.S., Pechova A., Petkova M., Girault S., Broglia A., Guerra B., Innocenti M.L., Liebana E., Lopez-Galvez G., Manini P., Stella P., Peixe L., Indústries Alimentàries, and Funcionalitat i Seguretat Alimentària
- Subjects
Sulfamerazine ,663/664 ,Veterinary (miscellaneous) ,Growth promotion ,TP1-1185 ,Plant Science ,Sulfonamide ,Microbiology ,Antibiotic resistance ,Non target ,growth promotion ,medicine ,TX341-641 ,antimicrobial resistance ,Food science ,yield increase ,Sulfonamides ,Animal health ,Nutrition. Foods and food supply ,Chemical technology ,sub-inhibitory concentration ,food‐producing animals ,food-producing animals ,sub‐inhibitory concentration ,Contamination ,Antimicrobial ,food-producing animal ,Sulfathiazole ,Environmental science ,Animal Science and Zoology ,Parasitology ,Food Science ,medicine.drug - Abstract
The specific concentrations of sulfonamides in non-target feed for food-producing animals, below which there would not be an effect on the emergence of, and/or selection for, resistance in bacteria relevant for human and animal health, as well as the specific antimicrobial concentrations in feed which have an effect in terms of growth promotion/increased yield were assessed by EFSA in collaboration with EMA. Details of the methodology used for this assessment, associated data gaps and uncertainties, are presented in a separate document. To address antimicrobial resistance, the Feed Antimicrobial Resistance Selection Concentration (FARSC) model developed specifically for the assessment was applied. However, due to the lack of data on the parameters required to calculate the FARSC, it was not possible to conclude the assessment until further experimental data are available. To address growth promotion, data from scientific publications obtained from an extensive literature review were used. Levels in feed that showed to have an effect on growth promotion/increased yield were identified for three sulfonamides: sulfamethazine, sulfathiazole and sulfamerazine. It was recommended to carry out studies to generate the data that are required to fill the gaps which prevented the calculation of the FARSC for these antimicrobials. info:eu-repo/semantics/publishedVersion
- Published
- 2021
44. Safety and efficacy of a feed additive consisting of disodium 5’‐guanylate produced with Corynebacterium stationis KCCM 10530 and Escherichia coli K‐12 KFCC 11067 for all animal species (CJ Europe GmbH)
- Author
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Birgit Dusemund, Noël Dierick, Secundino López Puente, Roberto Edoardo Villa, Mariana Petkova, Ruud Woutersen, Giovanna Azimonti, Jaume Galobart, Paola Manini, Efsa Panel on Additives, Baltasar Mayo, Fernando Ramos, Marta López-Alonso, Henrik Christensen, Mojca Fašmon Durjava, Yolanda Sanz, Jordi Tarrés-Call, Montserrat Anguita, Alena Pechová, Elisa Pettenati, Francesca Marcon, Vasileios Bampidis, Maria de Lourdes Bastos, Maryline Kouba, Giovanna Martelli, Bampidis V., Azimonti G., Bastos M.D.L., Christensen H., Dusemund B., Fasmon Durjava M., Kouba M., Lopez-Alonso M., Lopez Puente S., Marcon F., Mayo B., Pechova A., Petkova M., Ramos F., Sanz Y., Villa R.E., Woutersen R., Dierick N., Martelli G., Galobart J., Manini P., Pettenati E., Tarres-Call J., and Anguita M.
- Subjects
safety ,Veterinary (miscellaneous) ,Feed additive ,efficacy ,Plant Science ,TP1-1185 ,medicine.disease_cause ,Microbiology ,flavouring compounds ,Corynebacterium stationis ,all animal species ,medicine ,disodium 5’‐guanylate ,TX341-641 ,Food science ,Animal species ,Escherichia coli ,disodium 5’-guanylate ,Sensory ,Chemistry ,Nutrition. Foods and food supply ,Chemical technology ,all animal specie ,flavouring compound ,Animal Science and Zoology ,Parasitology ,Food Science - Abstract
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of disodium 5’-guanylate produced by fermentation with Corynebacterium stationis KCCM 10530 and Escherichia coli K-12 KFCC 11067 when used as a sensory additive (flavouring compound) in feed and water for drinking for all animal species. The additive does not raise safety concerns under the proposed conditions of use for the target species, consumers the users and the environment. The Panelon Additives and Products or Substances used in Animal Feed (FEEDAP) expressed reservations on the use of the additive in water for drinking due to concerns on its impact on hygienic conditions of the water. The Panelconcluded that the additive is efficacious to contribute to the flavour of feed.
- Published
- 2021
45. Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced by Bacillus subtilis LMG S‐15136 (Belfeed B MP/ML) for sows in order to have benefits in piglets and for all porcine species (Beldem, a division of Puratos NV)
- Author
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Henrik Christensen, Giovanna Martelli, Ruud Woutersen, Maria de Lourdes Bastos, Maryline Kouba, Birgit Dusemund, Noël Dierick, Roberto Edoardo Villa, Montserrat Anguita, Efsa Panel on Additives, Secundino López Puente, Fernando Ramos, Baltasar Mayo, Mojca Fašmon Durjava, Yolanda Sanz, Alena Pechová, Joana Revez, Jaume Galobart, Giovanna Azimonti, Mariana Petkova, Marta López-Alonso, Francesca Marcon, Vasileios Bampidis, Bampidis V., Azimonti G., Bastos M.D.L., Christensen H., Dusemund B., Durjava M.F., Kouba M., Lopez-Alonso M., Lopez Puente S., Marcon F., Mayo B., Pechova A., Petkova M., Ramos F., Sanz Y., Villa R.E., Woutersen R., Dierick N., Martelli G., Galobart J., Anguita M., and Revez J.
- Subjects
safety ,Veterinary (miscellaneous) ,Feed additive ,efficacy ,sows ,Plant Science ,Bacillus subtilis ,TP1-1185 ,Microbiology ,Porcine species ,sow ,TX341-641 ,Food science ,digestibility enhancers ,xylanase ,biology ,Chemistry ,Nutrition. Foods and food supply ,Chemical technology ,Endo 1 4 β xylanase ,biology.organism_classification ,zootechnical additives ,Scientific Opinion ,Xylanase ,Animal Science and Zoology ,Parasitology ,digestibility enhancer ,Food Science - Abstract
Following a request from the European Commission, the Panelon Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Belfeed B MP/ML as a feed additive for sows in order to have benefits in piglets. The additive is to be used in to sows in order to have benefits in piglets and to all porcine species at any developmental stage at 10 IU/kg feed. This additive consists of endo-1,4-β-xylanase produced by a genetically modified strain of Bacillus subtilis (LMG S-15136). In a previous opinion, the FEEDAP Panelcould not conclude on the safety of the additive for the users regarding the potential of the additive as dermal sensitiser and on the efficacy of the additive when added to feed for sows in order to have benefits in piglets. In the absence of new information, the FEEDAP Panelretained its previous conclusion that the additive is not irritant to skin or eyes but should be considered a respiratory sensitiser. No conclusions could be drawn on its potential to be a dermal sensitiser. The applicant provided new efficacy data and complementary information regarding a previous study. Based on the previously assessed data and the newly submitted ones, the Panelconcludes that although the additive has a potential to be efficacious as a zootechnical additive in sows during the lactation period at the level of 10 IU/kg feed, the data are considered not sufficient to conclude on a beneficial effect on the performance of the litters.
- Published
- 2021
46. Safety and efficacy of the additive consisting of muramidase produced by Trichoderma reesei DSM 32338 (Balancius™) for use in weaned piglets (DSM Nutritional products Ltd)
- Author
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Miguel Prieto Maradona, Maria de Lourdes Bastos, Efsa Panel on Additives, Maryline Kouba, Secundino López Puente, Ruud Woutersen, Fernando Ramos, Maria Saarela, Henrik Christensen, Francesca Marcon, Birgit Dusemund, Elisa Pettenati, Roberto Edoardo Villa, Noël Dierick, Giovanna Martelli, Mojca Fašmon Durjava, Baltasar Mayo, Vasileios Bampidis, Jaume Galobart, Giovanna Azimonti, Montserrat Anguita, Yolanda Sanz, Alena Pechová, Boet Glandorf, Pier Sandro Cocconcelli, Marta López-Alonso, Lieve Herman, Mariana Petkova, Bampidis V., Azimonti G., Bastos M.D.L., Christensen H., Dusemund B., Fasmon Durjava M., Kouba M., Lopez-Alonso M., Lopez Puente S., Marcon F., Mayo B., Pechova A., Petkova M., Ramos F., Sanz Y., Villa R.E., Woutersen R., Cocconcelli P.S., Dierick N.A., Herman L., Glandorf B., Martelli G., Maradona M.P., Saarela M., Galobart J., Pettenati E., and Anguita M.
- Subjects
safety ,Balancius™ ,biology ,Nutrition. Foods and food supply ,Veterinary (miscellaneous) ,Chemical technology ,Nutritional products ,efficacy ,Plant Science ,TP1-1185 ,muramidase ,biology.organism_classification ,weaned piglet ,Microbiology ,zootechnical additives ,Scientific Opinion ,Weaned piglets ,Animal Science and Zoology ,Parasitology ,weaned piglets ,TX341-641 ,Food science ,Muramidase ,Trichoderma reesei ,Food Science - Abstract
Following a request from the European Commission, the Panelon Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of muramidase produced by Trichoderma reesei DSM 32338 (Balancius™) as a feed additive for weaned piglets. The additive has been previously assessed by the FEEDAP Panelin the context of other applications, and in the current assessment the applicant requests for an extension of use. Based on the data available in a sub-chronic oral toxicity study, the Panelconcluded that the additive is safe for weaned piglets at the maximum recommended level of 65,000 LSU(F)/kg feed. The additive is safe for the consumers and the environment but should be considered a potential respiratory sensitiser. The Panelcould not conclude on the potential of the additive for skin/eye irritancy and skin sensitisation. The additive has the potential to be efficacious as a zootechnical additive for weaned piglets at the dose of 50,000 LSU(F)/kg feed.
- Published
- 2021
47. Safety and efficacy of a feed additive consisting of Saccharomyces cerevisiae MUCL 39885 (Biosprint®) for cats and dogs (Prosol S.p.A.)
- Author
-
Montserrat Anguita, Yolanda Sanz, Maria de Lourdes Bastos, Maryline Kouba, Marta López-Alonso, Alena Pechová, Ruud Woutersen, Birgit Dusemund, Elisa Pettenati, Jordi Tarrés-Call, Fabiola Pizzo, Baltasar Mayo, Giovanna Martelli, Jaume Galobart, Mariana Petkova, Fernando Ramos, Efsa Panel on Additives, Roberto Edoardo Villa, Paola Manini, Giovanna Azimonti, Francesca Marcon, Henrik Christensen, Vasileios Bampidis, Secundino López Puente, Mojca Fašmon Durjava, Bampidis V., Azimonti G., Bastos M.D.L., Christensen H., Dusemund B., Fasmon Durjava M., Kouba M., Lopez-Alonso M., Lopez Puente S., Marcon F., Mayo B., Pechova A., Petkova M., Ramos F., Sanz Y., Villa R.E., Woutersen R., Martelli G., Anguita M., Galobart J., Manini P., Tarres-Call J., Pettenati E., and Pizzo F.
- Subjects
dogs ,Veterinary (miscellaneous) ,Feed additive ,Saccharomyces cerevisiae ,cat ,Plant Science ,TP1-1185 ,® ,Safety status ,Microbiology ,QPS ,Anim2953 ,Animal science ,Biosprint® ,TX341-641 ,renewal ,CATS ,biology ,Nutrition. Foods and food supply ,Chemical technology ,cats ,biology.organism_classification ,Scientific Opinion ,zootechnical additive ,dog ,Animal Science and Zoology ,Parasitology ,Biosprint ,Food Science - Abstract
The additive Biosprint® contains viable cells of Saccharomyces cerevisiae MUCL 39885 and is authorised as a feed additive in sows, dairy cows, horses, piglets (weaned), cattle for fattening, minor ruminants for fattening and minor ruminants for dairy products. The applicant has requested to extend the use of the additive to cats and dogs at a minimum inclusion level of 7 × 1010 CFU/kg of complete feed. S. cerevisiae is considered by EFSA to have qualified presumption of safety status and consequently is considered safe for the target species. The additive is considered as a potential skin and eye irritant and a skin and respiratory sensitiser. Based on the results on efficacy studies provided, the FEEDAP Panel concludes that Biosprint® is efficacious when used in feeds for dogs. However, the FEEDAP Panel considered that the biological relevance of the magnitude of the effect detected is questionable. Based on the trial available, the FEEDAP Panel was unable to conclude on the efficacy of the additive when administered to cats.
- Published
- 2021
48. Safety and efficacy of a feed additive consisting on the bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097 infecting Salmonella Gallinarum B/00111 (Bafasal®) for all avian species (Proteon Pharmaceuticals S.A.)
- Author
-
Henrik Christensen, Montserrat Anguita, Baltasar Mayo, Matteo Lorenzo Innocenti, Ruud Woutersen, Vasileios Bampidis, Maria Saarela, Efsa Panel on Additives, Luca Tosti, Alena Pechová, Pier Sandro Cocconcelli, Joana Revez, Birgit Dusemund, Mojca Fašmon Durjava, Secundino López Puente, Noël Dierick, Boet Glandorf, Jaume Galobart, Francesca Marcon, Elisa Pettenati, Rosella Brozzi, Giovanna Azimonti, Miguel Prieto Maradona, Yolanda Sanz, Marta López-Alonso, Lieve Herman, Kettil Svensson, Mariana Petkova, Paul Brantom, Roberto Edoardo Villa, Fernando Ramos, Giovanna Martelli, Maria de Lourdes Bastos, Maryline Kouba, Bampidis V., Azimonti G., Bastos M.D.L., Christensen H., Dusemund B., Kouba M., Durjava M.F., Lopez-Alonso M., Lopez Puente S., Marcon F., Mayo B., Pechova A., Petkova M., Ramos F., Sanz Y., Villa R.E., Woutersen R., Cocconcelli P.S., Glandorf B., Herman L., Prieto Maradona M., Saarela M., Dierick N., Martelli G., Brantom P., Tosti L., Svensson K., Anguita M., Galobart J., Innocenti M., Pettenati E., Revez J., and Brozzi R.
- Subjects
safety ,bacteriophages ,Veterinary (miscellaneous) ,Feed additive ,efficacy ,Salmonella enterica ser. Gallinarum B/00111 ,avian species ,TP1-1185 ,Plant Science ,Biology ,® ,Salmonella Gallinarum ,Microbiology ,Anim2953 ,bacteriophage ,TX341-641 ,Food science ,Nutrition. Foods and food supply ,Chemical technology ,Bafasal® ,Bafasal ,avian specie ,Scientific Opinion ,Zootechnical additive ,Animal Science and Zoology ,Parasitology ,Food Science - Abstract
Following a request from the European Commission, the Panelon Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the feed additive consisting of four bacteriophages infecting Salmonella Gallinarum B/00111 (PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097, trade name: Bafasal®) when used as a zootechnical additive in water for drinking and liquid complementary feed for all avian species. The effects sought are the reduction of the Salmonella spp. carriage in chickens for fattening, the improvement of their performance, or both. The host strain harbours an acquired antimicrobial resistance gene. No viable cells or DNA from the host organism were found in the additive. The four phages proved to be strictly lytic and to have a machinery allowing to package a unit-length of the viral genome. The manufacturing process excludes the presence of remnants from the propagation process in the final additive. Consequently, no concerns are expected from the nature and manufacture of the product. Considering this and the results of the tolerance study with chickens for fattening, the Panelconcluded that Bafasal® is safe for all avian species. Considering the nature and manufacturing process of the additive, Bafasal® is not expected to pose a risk for consumers. The results of the subchronic oral toxicity study and genotoxicity studies provided support this conclusion. Exposure of users via inhalation is expected to be low, but Bafasal® should be considered a respiratory sensitiser. No conclusions were drawn on the irritancy of Bafasal® to skin and eyes or on its dermal sensitisation potential due to lack of data. Considering the nature and manufacturing process of the additive, Bafasal® is safe for the environment. The Panelwas not in the position to conclude on the efficacy of Bafasal® for any avian species due to insufficient data.
- Published
- 2021
49. Maximum levels of cross-contamination for 24 antimicrobial active substances in non-target feed. Part 5: Lincosamides: lincomycin
- Author
-
EFSA Panel on Biological Hazards (BIOHAZ), Koutsoumanis, Konstantinos, Allende, Ana, Alvarez-Ordóñez, Avelino, Bolton, Declan, Bover-Cid, Sara, Chemaly, Marianne, Davies, Robert, De Cesare, Alessandra, Herman, Lieve, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Suffredini, Elisabetta, Andersson, Dan I, Bampidis, Vasileios, Bengtsson-Palme, Johan, Bouchard, Damien, Ferran, Aude, Kouba, Maryline, López Puente, Secundino, López-Alonso, Marta, Nielsen, Søren Saxmose, Pechová, Alena, Petkova, Mariana, Girault, Sebastien, Broglia, Alessandro, Guerra, Beatriz, Innocenti, Matteo Lorenzo, Liébana, Ernesto, López-Gálvez, Gloria, Manini, Paola, Stella, Pietro, Peixe, Luisa, Indústries Alimentàries, Funcionalitat i Seguretat Alimentària, Koutsoumanis K., Allende A., Alvarez-Ordonez A., Bolton D., Bover-Cid S., Chemaly M., Davies R., De Cesare A., Herman L., Hilbert F., Lindqvist R., Nauta M., Ru G., Simmons M., Skandamis P., Suffredini E., Andersson D.I., Bampidis V., Bengtsson-Palme J., Bouchard D., Ferran A., Kouba M., Lopez Puente S., Lopez-Alonso M., Nielsen S.S., Pechova A., Petkova M., Girault S., Broglia A., Guerra B., Innocenti M.L., Liebana E., Lopez-Galvez G., Manini P., Stella P., and Peixe L.
- Subjects
663/664 ,medicine.drug_class ,Veterinary (miscellaneous) ,Growth promotion ,Plant Science ,TP1-1185 ,Biology ,Microbiology ,Antibiotic resistance ,Non target ,growth promotion ,medicine ,TX341-641 ,Food science ,antimicrobial resistance ,yield increase ,Lincosamides ,Animal health ,Nutrition. Foods and food supply ,sub-inhibitory concentration ,Chemical technology ,Biol5012 ,food‐producing animals ,food-producing animals ,Contamination ,sub‐inhibitory concentration ,Antimicrobial ,Feed Antimicrobial Resistance Selection Concentration (FARSC) ,food-producing animal ,Lincomycin ,Scientific Opinion ,Animal Science and Zoology ,Parasitology ,lincomycin ,Food Science ,medicine.drug - Abstract
The specific concentrations of lincomycin in non-target feed for food-producing animals, below which there would not be an effect on the emergence of, and/or selection for, resistance in bacteria relevant for human and animal health, as well as the specific antimicrobial concentrations in feed which have an effect in terms of growth promotion/increased yield were assessed by EFSA in collaboration with EMA. Details of the methodology used for this assessment, associated data gaps and uncertainties, are presented in a separate document. To address antimicrobial resistance, the Feed Antimicrobial Resistance Selection Concentration (FARSC) model developed specifically for the assessment was applied. However, due to the lack of data on the parameters required to calculate the FARSC, it was not possible to conclude the assessment until further experimental data become available. To address growth promotion, data from scientific publications obtained from an extensive literature review were used. Levels of lincomycin in feed that showed to have an effect on growth promotion/increased yield were reported. It was recommended to carry out studies to generate the data that are required to fill the gaps which prevented the calculation of the FARSC for lincomycin. info:eu-repo/semantics/publishedVersion
- Published
- 2021
50. Maximum levels of cross-contamination for 24 antimicrobial active substances in non-target feed. Part 2: Aminoglycosides/aminocyclitols: apramycin, paromomycin, neomycin and spectinomycin
- Author
-
EFSA Panel on Biological Hazards (BIOHAZ), Allende, Ana, Koutsoumanis, Konstantinos, Alvarez-Ordóñez, Avelino, Bolton, Declan, Bover-Cid, Sara, Chemaly, Marianne, Davies, Robert, De Cesare, Alessandra, Herman, Lieve, Hilbert, Friederike, Lindqvist, Roland, Nauta, Maarten, Ru, Giuseppe, Simmons, Marion, Skandamis, Panagiotis, Suffredini, Elisabetta, Andersson, Dan I, Bampidis, Vasileios, Bengtsson-Palme, Johan, Bouchard, Damien, Ferran, Aude, Kouba, Maryline, López Puente, Secundino, López-Alonso, Marta, Nielsen, Søren Saxmose, Pechová, Alena, Petkova, Mariana, Girault, Sebastien, Broglia, Alessandro, Guerra, Beatriz, Innocenti, Matteo Lorenzo, Liébana, Ernesto, López-Gálvez, Gloria, Manini, Paola, Stella, Pietro, Peixe, Luisa, Allende A., Koutsoumanis K., Alvarez-Ordoñez A., Bolton D., Bover-Cid S., Chemaly M., Davies R., De Cesare A., Herman L., Hilbert F., Lindqvist R., Nauta M., Ru G., Simmons M., Skandamis P., Suffredini E., Andersson D.I., Bampidis V., Bengtsson-Palme J., Bouchard D., Ferran A., Kouba M., Lopez Puente S., Lopez-Alonso M., Nielsen S.S., Pechova A., Petkova M., Girault S., Broglia A., Guerra B., Innocenti M.L., Liebana E., Lopez-Galvez G., Manini P., Stella P., Peixe L., Indústries Alimentàries, and Funcionalitat i Seguretat Alimentària
- Subjects
Spectinomycin ,663/664 ,spectinomycin ,Veterinary (miscellaneous) ,Growth promotion ,Paromomycin ,TP1-1185 ,Plant Science ,Biology ,Apramycin ,Microbiology ,Antibiotic resistance ,growth promotion ,medicine ,TX341-641 ,Food science ,antimicrobial resistance ,Nutrition. Foods and food supply ,Chemical technology ,neomycin ,food-producing animals ,Neomycin ,Contamination ,Antimicrobial ,food-producing animal ,Animal Science and Zoology ,Parasitology ,paromomycin ,Food Science ,medicine.drug ,apramycin - Abstract
The specific concentrations of apramycin, paromomycin, neomycin and spectinomycin in non-target feed for food-producing animals, below which there would not be an effect on the emergence of, and/or selection for, resistance in bacteria relevant for human and animal health, as well as the specific antimicrobial concentrations in feed which have an effect in terms of growth promotion/increased yield, were assessed by EFSA in collaboration with EMA. Details of the methodology used for this assessment, associated data gaps and uncertainties, are presented in a separate document. To address antimicrobial resistance, the Feed Antimicrobial Resistance Selection Concentration (FARSC) model developed specifically for the assessment was applied. However, due to the lack of data on the parameters required to calculate the FARSC for these antimicrobials, it was not possible to conclude the assessment until further experimental data become available. To address growth promotion, data from scientific publications obtained from an extensive literature review were used. Levels in feed that showed to have an effect on growth promotion/increased yield were reported for apramycin and neomycin, whilst for paromomycin and spectinomycin, no suitable data for the assessment were available. It was recommended to carry out studies to generate the data that are required to fill the gaps which prevented the calculation of the FARSC for these four antimicrobials. info:eu-repo/semantics/publishedVersion
- Published
- 2021
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