EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Montserrat Anguita, Matteo L. Innocenti, Jaume Galobart, Rosella Brozzi, Rafaella Christodoulou
{"title":"对所有用于育肥、产蛋/繁殖和观赏鸟类的家禽（Biochem Zusatzstoffe Handels- und productionges）饲料添加剂（含有Weizmannia faecalis DSM 32016 （TechnoSpore50®））的授权条款修改申请进行评估。mbH)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Montserrat Anguita, Matteo L. Innocenti, Jaume Galobart, Rosella Brozzi, Rafaella Christodoulou","doi":"10.2903/j.efsa.2025.9548","DOIUrl":null,"url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the additive consisting of <i>Weizmannia faecalis</i> DSM 32016 (TechnoSpore50®) as a zootechnical feed additive, for all poultry species for fattening, reared for breeding and laying and ornamental birds. The additive is already authorised for use in feed and water for drinking for the above-mentioned species. With this application, the company requested the modification of the current authorisations as regards the simultaneous use of the additive with the coccidiostats amprolium and narasin+nicarbazin. The FEEDAP Panel concluded that the proposed modification in the conditions of the authorisation would not modify the conclusions previously drawn regarding the safety of TechnoSpore50® for target species, consumers and the environment. Regarding user safety, the additive is not a skin/eye irritant but should be considered as a skin and respiratory sensitiser and inhalation and dermal exposure is considered a risk. In a former opinion, the compatibility of TechnoSpore50® with narasin+nicarbazin could not be established in an in vivo trial since the difference in colony counts of non-heat-treated caecal samples from the control group receiving only the additive and the respective treatment group receiving the additive and the coccidiostat was above 0.5 log. The applicant supplied a new in vivo trial suggesting that the microbiological method applied underestimated the counts of non-heat-treated samples since spores of <i>W. faecalis</i> DSM 32016 require a thermal treatment to germinate. Based on these findings, the Panel reconsidered the results of the in vivo trial formerly submitted and concluded that TechnoSpore50® is compatible to narasin+nicarbazin at the proposed conditions of use. TechnoSpore50® was found to be compatible with amprolium in an in vitro test.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 7","pages":""},"PeriodicalIF":3.3000,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9548","citationCount":"0","resultStr":"{\"title\":\"Assessment of the application for modification of the terms of the authorisation of the feed additive consisting of Weizmannia faecalis DSM 32016 (TechnoSpore50®) for all poultry species for fattening, reared for laying/breeding and ornamental birds (Biochem Zusatzstoffe Handels- und Produktionsges. mbH)\",\"authors\":\"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Montserrat Anguita, Matteo L. Innocenti, Jaume Galobart, Rosella Brozzi, Rafaella Christodoulou\",\"doi\":\"10.2903/j.efsa.2025.9548\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the additive consisting of <i>Weizmannia faecalis</i> DSM 32016 (TechnoSpore50®) as a zootechnical feed additive, for all poultry species for fattening, reared for breeding and laying and ornamental birds. The additive is already authorised for use in feed and water for drinking for the above-mentioned species. With this application, the company requested the modification of the current authorisations as regards the simultaneous use of the additive with the coccidiostats amprolium and narasin+nicarbazin. The FEEDAP Panel concluded that the proposed modification in the conditions of the authorisation would not modify the conclusions previously drawn regarding the safety of TechnoSpore50® for target species, consumers and the environment. Regarding user safety, the additive is not a skin/eye irritant but should be considered as a skin and respiratory sensitiser and inhalation and dermal exposure is considered a risk. In a former opinion, the compatibility of TechnoSpore50® with narasin+nicarbazin could not be established in an in vivo trial since the difference in colony counts of non-heat-treated caecal samples from the control group receiving only the additive and the respective treatment group receiving the additive and the coccidiostat was above 0.5 log. The applicant supplied a new in vivo trial suggesting that the microbiological method applied underestimated the counts of non-heat-treated samples since spores of <i>W. faecalis</i> DSM 32016 require a thermal treatment to germinate. Based on these findings, the Panel reconsidered the results of the in vivo trial formerly submitted and concluded that TechnoSpore50® is compatible to narasin+nicarbazin at the proposed conditions of use. TechnoSpore50® was found to be compatible with amprolium in an in vitro test.</p>\",\"PeriodicalId\":11657,\"journal\":{\"name\":\"EFSA Journal\",\"volume\":\"23 7\",\"pages\":\"\"},\"PeriodicalIF\":3.3000,\"publicationDate\":\"2025-07-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9548\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"EFSA Journal\",\"FirstCategoryId\":\"97\",\"ListUrlMain\":\"https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2025.9548\",\"RegionNum\":3,\"RegionCategory\":\"农林科学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"FOOD SCIENCE & TECHNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"EFSA Journal","FirstCategoryId":"97","ListUrlMain":"https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2025.9548","RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"FOOD SCIENCE & TECHNOLOGY","Score":null,"Total":0}
Assessment of the application for modification of the terms of the authorisation of the feed additive consisting of Weizmannia faecalis DSM 32016 (TechnoSpore50®) for all poultry species for fattening, reared for laying/breeding and ornamental birds (Biochem Zusatzstoffe Handels- und Produktionsges. mbH)
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the additive consisting of Weizmannia faecalis DSM 32016 (TechnoSpore50®) as a zootechnical feed additive, for all poultry species for fattening, reared for breeding and laying and ornamental birds. The additive is already authorised for use in feed and water for drinking for the above-mentioned species. With this application, the company requested the modification of the current authorisations as regards the simultaneous use of the additive with the coccidiostats amprolium and narasin+nicarbazin. The FEEDAP Panel concluded that the proposed modification in the conditions of the authorisation would not modify the conclusions previously drawn regarding the safety of TechnoSpore50® for target species, consumers and the environment. Regarding user safety, the additive is not a skin/eye irritant but should be considered as a skin and respiratory sensitiser and inhalation and dermal exposure is considered a risk. In a former opinion, the compatibility of TechnoSpore50® with narasin+nicarbazin could not be established in an in vivo trial since the difference in colony counts of non-heat-treated caecal samples from the control group receiving only the additive and the respective treatment group receiving the additive and the coccidiostat was above 0.5 log. The applicant supplied a new in vivo trial suggesting that the microbiological method applied underestimated the counts of non-heat-treated samples since spores of W. faecalis DSM 32016 require a thermal treatment to germinate. Based on these findings, the Panel reconsidered the results of the in vivo trial formerly submitted and concluded that TechnoSpore50® is compatible to narasin+nicarbazin at the proposed conditions of use. TechnoSpore50® was found to be compatible with amprolium in an in vitro test.
期刊介绍：
The EFSA Journal covers methods of risk assessment, reports on data collected, and risk assessments in the individual areas of plant health, plant protection products and their residues, genetically modified organisms, additives and products or substances used in animal feed, animal health and welfare, biological hazards including BSE/TSE, contaminants in the food chain, food contact materials, enzymes, flavourings and processing aids, food additives and nutrient sources added to food, dietetic products, nutrition and allergies.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
