EFSA JournalPub Date : 2025-06-06DOI: 10.2903/j.efsa.2025.9461
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, Jaume Galobart, Matteo L. Innocenti, Alberto Navarro-Villa, Maria Vittoria Vettori
{"title":"Efficacy of a feed additive consisting of tartrazine for its use in baits for freshwater fish (GIFAP)","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, Jaume Galobart, Matteo L. Innocenti, Alberto Navarro-Villa, Maria Vittoria Vettori","doi":"10.2903/j.efsa.2025.9461","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9461","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of tartrazine. Tartrazine is intended to be used as a sensory additive (functional group: (a) colourants: (i) substances that add or restore colour in feedingstuffs) in baits for freshwater fish up to a maximum content of 30 mg/kg in complementary feed. Tartrazine is intended to be incorporated in fishing baits in order to colour them and attract fish in freshwater (ponds, rivers), for both recreational and competitive fishing. The additive is not intended for use in aquaculture. The characterisation of the additive, its safety and its efficacy were evaluated in a previous opinion of the Panel. In that opinion, the Panel concluded that the use of tartrazine in the preparation of baits for freshwater fish under the proposed conditions of use (maximum use level of 30 mg/kg complementary feed) is of no concern for the target animals. The use of tartrazine as a feed additive under the proposed conditions of use is considered safe for the consumer and the environment. Regarding the user safety, the additive should be considered a dermal and respiratory sensitiser. Inhalation and dermal exposure are considered a risk. The FEEDAP Panel could not conclude on the irritation potential of the additive. Finally, in the previous opinion, the Panel concluded that in absence of data no conclusion could be reached on the efficacy of tartrazine in freshwater fish baits. Based on the new data submitted by the applicant, the Panel concluded that tartrazine has the potential to be efficacious in colouring fishing baits under the proposed conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9461","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144219984","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EFSA JournalPub Date : 2025-06-06DOI: 10.2903/j.efsa.2025.9464
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, Jaume Galobart, Orsolya Holczknecht, Matteo L. Innocenti, Fabiola Pizzo, Jordi Tarrés-Call, Maria Vittoria Vettori, Alberto Navarro-Villa
{"title":"Assessment of the feed additives consisting of potassium iodide and calcium iodate anhydrous for all animal species for the renewal of their authorisation (AJAY EUROPE SARL)","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, Jaume Galobart, Orsolya Holczknecht, Matteo L. Innocenti, Fabiola Pizzo, Jordi Tarrés-Call, Maria Vittoria Vettori, Alberto Navarro-Villa","doi":"10.2903/j.efsa.2025.9464","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9464","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of potassium iodide (3b201) and calcium iodate anhydrous (3b202) as nutritional additives (functional group: compounds of trace elements) for all species and categories. The additives are currently authorised for use in all animal species. The applicant has provided evidence that both additives, potassium iodide and calcium iodate anhydrous, comply with the conditions of the authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) confirms that the use of potassium iodide and calcium iodate anhydrous under the current authorised conditions of use are safe for the target species and the environment. Due to the lack of adequate deposition data to assess the consumer exposure, the FEEDAP Panel is not in the position to conclude on the safety for the consumer. With regard to the safety of users, potassium iodide is not an eye irritant, but calcium iodate anhydrous is. The additives potassium iodide and calcium iodate anhydrous should be considered skin and respiratory sensitisers. Inhalation and dermal exposure are considered a risk. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9464","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144219983","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EFSA JournalPub Date : 2025-06-05DOI: 10.2903/j.efsa.2025.9469
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, Jaume Galobart, Maria Vittoria Vettori, Alberto Navarro-Villa
{"title":"Efficacy of a feed additive consisting of a copper(II)-betaine complex for all animal species (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, Jaume Galobart, Maria Vittoria Vettori, Alberto Navarro-Villa","doi":"10.2903/j.efsa.2025.9469","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9469","url":null,"abstract":"<p>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 copper(II)-betaine complex as a nutritional feed additive for all species and categories. In a previous opinion, the FEEDAP Panel characterised the feed additive and concluded that it is safe for the target animals, consumers, and the environment when used up to the maximum authorised levels of copper in the diets. With regard to the safety of users, the additive is considered irritant to the eyes and a skin and respiratory sensitiser. In the current submission, the applicant provided a new efficacy study in chickens for fattening to support the efficacy of the additive. The data submitted provided evidence that the additive is a bioavailable source of copper and thus, the FEEDAP Panel concludes that the additive is efficacious as a source of copper for all animal species.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9469","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144214052","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EFSA JournalPub Date : 2025-06-05DOI: 10.2903/j.efsa.2025.9468
EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Dominique Turck, Montaña Cámara, Torsten Bohn, Jacqueline Castenmiller, Stefaan De Henauw, Ángeles Jos, Alexandre Maciuk, Inge Mangelsdorf, Breige McNulty, Androniki Naska, Kristina Pentieva, Alfonso Siani, Frank Thies, Margarita Aguilera-Gómez, Francesco Cubadda, Thomas Frenzel, Marina Heinonen, Helle Katrine Knutsen, Harry J. McArdle, Monika Neuhäuser-Berthold, Morten Poulsen, Miguel Prieto Maradona, Josef Rudolf Schlatter, Alexandros Siskos, Henk van Loveren, Salvatore Multari, Annamaria Rossi, Karen Ildico Hirsch-Ernst
{"title":"Safety of D-allulose as a novel food pursuant to Regulation (EU) 2015/2283","authors":"EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA), Dominique Turck, Montaña Cámara, Torsten Bohn, Jacqueline Castenmiller, Stefaan De Henauw, Ángeles Jos, Alexandre Maciuk, Inge Mangelsdorf, Breige McNulty, Androniki Naska, Kristina Pentieva, Alfonso Siani, Frank Thies, Margarita Aguilera-Gómez, Francesco Cubadda, Thomas Frenzel, Marina Heinonen, Helle Katrine Knutsen, Harry J. McArdle, Monika Neuhäuser-Berthold, Morten Poulsen, Miguel Prieto Maradona, Josef Rudolf Schlatter, Alexandros Siskos, Henk van Loveren, Salvatore Multari, Annamaria Rossi, Karen Ildico Hirsch-Ernst","doi":"10.2903/j.efsa.2025.9468","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9468","url":null,"abstract":"<p>Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on D-allulose as a novel food (NF) pursuant to Regulation (EU) 2015/2283. During the risk assessment, the Panel identified a number of data gaps, which needed to be addressed by the applicant. Therefore, an EFSA request for additional information was sent to the applicant. The requested data concerned the identity, the production process, proposed uses and use levels, genotoxicity and human data of the NF. Despite being contacted several times, the applicant did not reply to EFSA's requests for additional data. Based on the available data, the Panel concludes that the safety of the NF, i.e. D-allulose, cannot be established.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 6","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9468","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144214051","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EFSA JournalPub Date : 2025-05-28DOI: 10.2903/j.efsa.2025.9453
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, Lieve Herman, Montserrat Anguita, Nicole Bozzi Cionci, Matteo L. Innocenti, Jordi Tarrés-Call
{"title":"Safety and efficacy of a feed additive consisting of l-arginine produced with Corynebacterium glutamicum KCCM 80393 for all animal species (Daesang Europe BV)","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, Lieve Herman, Montserrat Anguita, Nicole Bozzi Cionci, Matteo L. Innocenti, Jordi Tarrés-Call","doi":"10.2903/j.efsa.2025.9453","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9453","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of <span>l</span>-arginine produced with a genetically modified strain of <i>Corynebacterium glutamicum</i> (KCCM 80393) when used as a nutritional additive in feed and water for drinking for all animal species and categories. The Panel concluded that the product under assessment does not give rise to any safety concern with regard to the genetic modification of the production strain. No DNA of the production strain was detected in the final product. <span>l</span>-Arginine produced by fermentation with <i>C. glutamicum</i> KCCM 80393 is safe for the target species when supplemented in appropriate amounts to the diet according to the nutritional needs of the target species. The FEEDAP Panel has concerns on the use of <span>l</span>-arginine in water for drinking. The use of <span>l</span>-arginine produced by fermentation with <i>C. glutamicum</i> KCCM 80393 in animal nutrition is considered safe for the consumers and for the environment. Regarding the user safety, in the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be irritant to skin and/or eyes, or to be a dermal or respiratory sensitiser. The additive <span>l</span>-arginine produced by fermentation with <i>C. glutamicum</i> KCCM 80393 is regarded as an efficacious source of the essential amino acid <span>l</span>-arginine for non-ruminant nutrition. For the supplemental <span>l</span>-arginine to be as efficacious in ruminants as in non-ruminant species, it requires protection against degradation in the rumen.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9453","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144148323","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EFSA JournalPub Date : 2025-05-28DOI: 10.2903/j.efsa.2025.9435
EFSA Panel on Biological Hazards (BIOHAZ), Ana Allende, Avelino Alvarez-Ordóñez, Valeria Bortolaia, Sara Bover-Cid, Alessandra De Cesare, Wietske Dohmen, Laurent Guillier, Lieve Maria Herman, Liesbeth Jacxsens, Lapo Mughini-Gras, Maarten Nauta, Jakob Ottoson, Luisa Peixe, Fernando Perez-Rodriguez, Panagiotis Skandamis, Elisabetta Suffredini, Olivier Andreoletti, Vincent Béringue, John Griffin, Marion Simmons, Kamela Kryemadhi, Barbara Lanfranchi, Angel Ortiz-Pelaez, Romolo Nonno
{"title":"Effect of incineration, co-incineration and combustion on TSE hazards in category 1 animal by-products","authors":"EFSA Panel on Biological Hazards (BIOHAZ), Ana Allende, Avelino Alvarez-Ordóñez, Valeria Bortolaia, Sara Bover-Cid, Alessandra De Cesare, Wietske Dohmen, Laurent Guillier, Lieve Maria Herman, Liesbeth Jacxsens, Lapo Mughini-Gras, Maarten Nauta, Jakob Ottoson, Luisa Peixe, Fernando Perez-Rodriguez, Panagiotis Skandamis, Elisabetta Suffredini, Olivier Andreoletti, Vincent Béringue, John Griffin, Marion Simmons, Kamela Kryemadhi, Barbara Lanfranchi, Angel Ortiz-Pelaez, Romolo Nonno","doi":"10.2903/j.efsa.2025.9435","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9435","url":null,"abstract":"<p>The European Commission requested EFSA to assess the effect of incineration, co-incineration and combustion of Category 1 animal by-products (ABP) on the BSE/TSE hazards in ash resulting from these treatments. The presence of residual TSE hazards is assessed by detection of prion infectivity or seeding activity. TSE agents or prions are challenging to inactivate completely using heat-based methods. Different TSE strains exhibit varying degrees of thermoresistance. Based on available studies at temperatures 120–134°C, the C-BSE strain is more thermoresistant than other evaluated strains. The vast majority of Category 1 ABP is rendered into ‘meat and bone meal’ prior to incineration/co-incineration/combustion. Scenarios involving co-incineration for cement production do not need to be considered because all ash is incorporated into the cement. It is not possible to generalise the time/temperature combinations to which Category 1 ABP are subjected across all processes. Due to the challenges in precisely measuring the temperature and residence time in industrial systems, and the wide range of system designs and operating conditions, it can only be assumed that Category 1 ABP are exposed to at least the legal requirements as determined by the conditions of the gas produced or injected into the process: 850°C for 2 s or 1100°C for 0.2 s. The limited sensitivity of the method used in a study involving C-BSE at 1000°C for 20 min prevented a conclusive exclusion of residual C-BSE prions.. Therefore, it is not possible to exclude – with high certainty (> 99%) – the presence of residual BSE/TSE hazards in ash produced from the incineration, co-incineration or combustion of Category 1 ABP. It is recommended to generate data on the actual reduction of infectivity in ‘meat and bone meal’ spiked with thermoresistant TSE field strains after treatment with the time/temperature combinations required by the legislation or specific industry processes.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9435","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144148290","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EFSA JournalPub Date : 2025-05-28DOI: 10.2903/j.efsa.2025.9457
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, Jaume Galobart, Matteo L. Innocenti, Jordi Ortuño, Fabiola Pizzo, Rosella Brozzi
{"title":"Assessment of the feed additive consisting of Bacillus velezensis ATCC PTA-6737 (PB6) for the renewal of its authorisation for laying hens and minor poultry species for laying (4b1823) and its extension of use to other laying/breeding birds (Kemin Europa n.v.)","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, Jaume Galobart, Matteo L. Innocenti, Jordi Ortuño, Fabiola Pizzo, Rosella Brozzi","doi":"10.2903/j.efsa.2025.9457","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9457","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a feed additive consisting of <i>Bacillus velezensis</i> ATCC PTA-6737 (PB6) as a zootechnical feed additive. With the current application, the applicant is seeking the renewal of the authorisation for laying hens and minor poultry species for laying. In addition, the applicant is seeking the modification of the terms of the existing authorisation to obtain the authorisation of a more concentrated form of the additive (from 1 × 10<sup>10</sup> to 8 × 10<sup>10</sup> colony forming units (CFU)) and the authorisation of the additive for other birds kept for egg production or breeding. The evidence provided showed that the additive complies with the new specifications and the current terms of the authorisation. The FEEDAP Panel concludes that the additive is safe for laying hens, birds kept for egg production or breeding, the consumer and the environment. Regarding safety for the user, the additive is not irritant to the skin and eyes but should be considered a skin and respiratory sensitiser and inhalation and dermal exposure is considered a risk. The additive has the potential to be efficacious in other birds kept for egg production or breeding at the minimum inclusion level of 1 × 10<sup>8</sup> CFU/kg complete feed.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9457","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144148291","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EFSA JournalPub Date : 2025-05-26DOI: 10.2903/j.efsa.2025.9459
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, Noël Dierick, Montserrat Anguita, Matteo L. Innocenti, Jordi Ortuño
{"title":"Efficacy of a feed additive consisting of Enterococcus faecium DSM 33761, Pediococcus acidilactici DSM 33758, Bifidobacterium animalis DSM 16284, Limosilactobacillus reuteri DSM 33751, Ligilactobacillus salivarius DSM 16351 (Biomin® C5) as a zootechnical additive for poultry for fattening and reared for laying/breeding (Biomin GmbH)","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, Noël Dierick, Montserrat Anguita, Matteo L. Innocenti, Jordi Ortuño","doi":"10.2903/j.efsa.2025.9459","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9459","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of Biomin® C5, which consists of a preparation containing viable cells of <i>Enterococcus faecium</i> DSM 33761, <i>Pediococcus acidilactici</i> DSM 33758, <i>Bifidobacterium animalis</i> DSM 16284, <i>Limosilactobacillus reuteri</i> DSM 33751 and <i>Ligilactobacillus salivarius</i> DSM 16351, as a zootechnical feed additive (functional group: gut flora stabilisers). The additive is intended to be used for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or reared for laying/breeding at a use level of 1 × 10<sup>8</sup> CFU/kg complete feed or 5 × 10<sup>7</sup> CFU/L in water for drinking. In a previous assessment, the FEEDAP Panel concluded that the additive is safe for the target species, consumers and the environment but could not conclude on its efficacy due to insufficient data. The applicant provided three long-term trials in chickens for fattening to address the data gaps in the efficacy assessment. Based on the results of the trials in the previous and current applications, the FEEDAP Panel concluded that Biomin® C5 has the potential to be efficacious when supplemented either in the feed or water of chickens for fattening, and the conclusion was extrapolated to all poultry for fattening and reared for laying/breeding.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9459","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144135766","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EFSA JournalPub Date : 2025-05-26DOI: 10.2903/j.efsa.2025.9455
European Food Safety Authority (EFSA)
{"title":"Statement on the maximum residue level for propamocarb in lettuces","authors":"European Food Safety Authority (EFSA)","doi":"10.2903/j.efsa.2025.9455","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9455","url":null,"abstract":"<p>In accordance with Article 43 of Regulation (EC) No 396/2005, EFSA received a mandate from the European Commission to provide a statement on the maximum residue level (MRL) of propamocarb in lettuces. EFSA was mandated to identify a safe fall-back MRL in lettuces since, for the current MRL of 40 mg/kg, acute consumer intake concerns could not be excluded. After an ad hoc data call, some Member States reported several potential fall-back good agricultural practices (GAPs) and submitted residue trial data to support the fall-back MRL options. An appropriate fall-back MRL value of 30 mg/kg was identified by EFSA. EFSA concluded that the short-term and long-term intake of residues of propamocarb in lettuces (resulting from the fall-back GAPs considered in the present statement) and of residues in other commodities of food and animal origin is unlikely to present a risk to consumer health.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9455","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144135812","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
EFSA JournalPub Date : 2025-05-23DOI: 10.2903/j.efsa.2025.9470
EFSA Panel on Nutrition, Novel Foods and Food allergens (NDA), Dominique Turck, Torsten Bohn, Montaña Cámara, Jacqueline Castenmiller, Stefaan de Henauw, Karen-Ildico Hirsch-Ernst, Angeles Jos, Alexandre Maciuk, Inge Mangelsdorf, Breige McNulty, Androniki Naska, Kristina Pentieva, Frank Thies, Ines Drenjančević, Ionut Craciun, Thibault Fiolet, Alfonso Siani
{"title":"Phenolic compounds naturally present in olive oil and lowering of blood LDL-cholesterol and systolic blood pressure, therefore reducing the risk of coronary heart disease: Evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006","authors":"EFSA Panel on Nutrition, Novel Foods and Food allergens (NDA), Dominique Turck, Torsten Bohn, Montaña Cámara, Jacqueline Castenmiller, Stefaan de Henauw, Karen-Ildico Hirsch-Ernst, Angeles Jos, Alexandre Maciuk, Inge Mangelsdorf, Breige McNulty, Androniki Naska, Kristina Pentieva, Frank Thies, Ines Drenjančević, Ionut Craciun, Thibault Fiolet, Alfonso Siani","doi":"10.2903/j.efsa.2025.9470","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9470","url":null,"abstract":"<p>Following an application from QvExtra! Internacional pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Spain, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to phenolic compounds naturally present in olive oil and lowering of blood LDL-cholesterol (LDL-c) and systolic blood pressure (SBP), therefore reducing the risk of coronary heart disease (CHD). The scope of the application was proposed to fall under a health claim referring to disease risk reduction. The Panel considers that the food/constituent, phenolic compounds naturally present in olive oil, is sufficiently characterised, and that lowering of blood LDL-c and SBP are beneficial effects by reducing the risk of CHD. The applicant identified seven pertinent human intervention studies investigating the effect of olive oil polyphenols on LDL-c and/or SBP. In weighing the evidence with regard to blood LDL-c, the Panel considered that, although one human intervention study in hypercholesteraemic individuals showed a reduction in LDL-c following daily consumption of olive oil polyphenols for 3 weeks, these results are not supported by other studies. The Panel also considered that no evidence was available for the sustainability of the effect over longer periods of time (e.g. ≥ 8 weeks), or for a plausible mechanism of action. In weighing the evidence with regard to SBP, the Panel took into account that, although some evidence for a plausible mechanism by which phenolic compounds in olive oil could exert the claimed effect has been provided, the studies submitted did not show an effect of olive oil polyphenols on SBP. The Panel concludes that a cause-and-effect relationship has not been established between the consumption of phenolic compounds naturally present in olive oil and the reduction of blood LDL-c or SBP.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9470","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144117876","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}