EFSA Journal最新文献

{"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),&nbsp;Roberto Edoardo Villa,&nbsp;Giovanna Azimonti,&nbsp;Eleftherios Bonos,&nbsp;Henrik Christensen,&nbsp;Mojca Durjava,&nbsp;Birgit Dusemund,&nbsp;Ronette Gehring,&nbsp;Boet Glandorf,&nbsp;Maryline Kouba,&nbsp;Marta López-Alonso,&nbsp;Francesca Marcon,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Ilen Röhe,&nbsp;Katerina Theodoridou,&nbsp;Lieve Herman,&nbsp;Montserrat Anguita,&nbsp;Nicole Bozzi Cionci,&nbsp;Matteo L. Innocenti,&nbsp;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}

{"title":"Effect of incineration, co-incineration and combustion on TSE hazards in category 1 animal by-products","authors":"EFSA Panel on Biological Hazards (BIOHAZ),&nbsp;Ana Allende,&nbsp;Avelino Alvarez-Ordóñez,&nbsp;Valeria Bortolaia,&nbsp;Sara Bover-Cid,&nbsp;Alessandra De Cesare,&nbsp;Wietske Dohmen,&nbsp;Laurent Guillier,&nbsp;Lieve Maria Herman,&nbsp;Liesbeth Jacxsens,&nbsp;Lapo Mughini-Gras,&nbsp;Maarten Nauta,&nbsp;Jakob Ottoson,&nbsp;Luisa Peixe,&nbsp;Fernando Perez-Rodriguez,&nbsp;Panagiotis Skandamis,&nbsp;Elisabetta Suffredini,&nbsp;Olivier Andreoletti,&nbsp;Vincent Béringue,&nbsp;John Griffin,&nbsp;Marion Simmons,&nbsp;Kamela Kryemadhi,&nbsp;Barbara Lanfranchi,&nbsp;Angel Ortiz-Pelaez,&nbsp;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 (&gt; 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}

{"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),&nbsp;Roberto Edoardo Villa,&nbsp;Giovanna Azimonti,&nbsp;Eleftherios Bonos,&nbsp;Henrik Christensen,&nbsp;Mojca Durjava,&nbsp;Birgit Dusemund,&nbsp;Ronette Gehring,&nbsp;Boet Glandorf,&nbsp;Maryline Kouba,&nbsp;Marta López-Alonso,&nbsp;Francesca Marcon,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Ilen Röhe,&nbsp;Katerina Theodoridou,&nbsp;Montserrat Anguita,&nbsp;Jaume Galobart,&nbsp;Matteo L. Innocenti,&nbsp;Jordi Ortuño,&nbsp;Fabiola Pizzo,&nbsp;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 × 10¹⁰ to 8 × 10¹⁰ 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 × 10⁸ 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}

{"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),&nbsp;Roberto Edoardo Villa,&nbsp;Giovanna Azimonti,&nbsp;Eleftherios Bonos,&nbsp;Henrik Christensen,&nbsp;Mojca Durjava,&nbsp;Birgit Dusemund,&nbsp;Ronette Gehring,&nbsp;Boet Glandorf,&nbsp;Maryline Kouba,&nbsp;Marta López-Alonso,&nbsp;Francesca Marcon,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Ilen Röhe,&nbsp;Katerina Theodoridou,&nbsp;Noël Dierick,&nbsp;Montserrat Anguita,&nbsp;Matteo L. Innocenti,&nbsp;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 × 10⁸ CFU/kg complete feed or 5 × 10⁷ 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}

{"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}

{"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),&nbsp;Dominique Turck,&nbsp;Torsten Bohn,&nbsp;Montaña Cámara,&nbsp;Jacqueline Castenmiller,&nbsp;Stefaan de Henauw,&nbsp;Karen-Ildico Hirsch-Ernst,&nbsp;Angeles Jos,&nbsp;Alexandre Maciuk,&nbsp;Inge Mangelsdorf,&nbsp;Breige McNulty,&nbsp;Androniki Naska,&nbsp;Kristina Pentieva,&nbsp;Frank Thies,&nbsp;Ines Drenjančević,&nbsp;Ionut Craciun,&nbsp;Thibault Fiolet,&nbsp;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}

{"title":"Epidemiological analysis of African swine fever in the European Union during 2024","authors":"European Food Safety Authority (EFSA),&nbsp;Karl Ståhl,&nbsp;Anette Ella Boklund,&nbsp;Tomasz Podgórski,&nbsp;Timothée Vergne,&nbsp;Roxani Aminalragia-Giamini,&nbsp;José Cortiñas Abrahantes,&nbsp;Stella Papaleo,&nbsp;Lina Mur","doi":"10.2903/j.efsa.2025.9436","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9436","url":null,"abstract":"<p>During 2024, the number of EU Member States affected by African swine fever (ASF) decreased from 14 to 13, with Sweden regaining freedom and no new Member State becoming infected. ASF outbreaks in domestic pigs in the EU declined by 83% compared to 2023, primarily due to fewer outbreaks in Croatia and Romania, although Romania notified 66% of the 333 outbreaks in the EU. Most outbreaks (78%) occurred in establishments with fewer than 100 pigs. However, an increase in outbreaks in establishments with more than 100 pigs was observed in Italy and Poland. Like previous years, there was a clear seasonality for domestic pig outbreaks, with 51% of them notified between July and September. Most of the outbreaks in domestic pigs were detected through passive surveillance based on clinical suspicion (79.4%), while fewer outbreaks were detected through enhanced passive surveillance involving systematic testing of dead pigs (14.2%) and 6.4% through tracing contacts after outbreak detection. In wild boar, the number of outbreaks notified has remained stable since 2022 (between 7000 and 8000) with a less clear seasonality than for domestic pigs, and a winter peak observed only in Hungary, Italy, Poland and Slovakia. Overall, 29% of the 23,919 wild boar carcasses found during passive surveillance activities tested positive for ASFv by PCR, representing 70.4% of the wild boar outbreaks in the EU. In contrast, around 0.4% of the 412,753 hunted wild boar tested positive by PCR, representing 28.4% of the wild boar outbreaks. While the use of serological tests performed in wild boar decreased, the number of PCR tests remained stable. Despite the reduction in the number of outbreaks in domestic pigs, the total size of the restricted zones III in the EU remained stable, with a slight increase in restricted zones II + III in 2024.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9436","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085053","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}

{"title":"Safety evaluation of the food enzyme pullulanase from the non-genetically modified Klebsiella pneumoniae strain AE-PUL","authors":"EFSA Panel on Food Enzymes (FEZ),&nbsp;Holger Zorn,&nbsp;José Manuel Barat Baviera,&nbsp;Claudia Bolognesi,&nbsp;Francesco Catania,&nbsp;Gabriele Gadermaier,&nbsp;Ralf Greiner,&nbsp;Baltasar Mayo,&nbsp;Alicja Mortensen,&nbsp;Yrjö Henrik Roos,&nbsp;Marize L. M. Solano,&nbsp;Monika Sramkova,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Silvia Peluso,&nbsp;Magdalena Andryszkiewicz,&nbsp;Daniele Cavanna,&nbsp;Ana Criado,&nbsp;Cristina Fernàndez-Fraguas,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9332","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9332","url":null,"abstract":"<p>The food enzyme pullulanase (pullulan 6-α-glucanohydrolase, EC 3.2.1.41) is produced by Amano Enzymes Inc. with the non-genetically modified <i>Klebsiella pneumoniae</i> strain AE-PUL, a known human pathogen. The food enzyme is free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in 10 food manufacturing processes. Since residual amounts of food enzyme—total organic solids (TOS) are removed in two processes, dietary exposure was calculated only for the remaining eight food manufacturing processes. It was estimated to be up to 0.075 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 0 124 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, results in a margin of exposure of at least 1653. A search for the homology of the amino acid sequence of the pullulanase to known allergens was made and matches with two food allergens were found. The Panel considered that a risk of allergic reactions upon dietary exposure to this food enzyme cannot be excluded. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns under the intended conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9332","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085247","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}

{"title":"Safety evaluation of the food enzyme 4-α-glucanotransferase from the genetically modified Bacillus amyloliquefaciens strain MAS","authors":"EFSA Panel on Food Enzymes (FEZ),&nbsp;Holger Zorn,&nbsp;José Manuel Barat Baviera,&nbsp;Claudia Bolognesi,&nbsp;Francesco Catania,&nbsp;Gabriele Gadermaier,&nbsp;Ralf Greiner,&nbsp;Baltasar Mayo,&nbsp;Alicja Mortensen,&nbsp;Yrjö Henrik Roos,&nbsp;Marize L. M. Solano,&nbsp;Monika Sramkova,&nbsp;Henk Van Loveren,&nbsp;Laurence Vernis,&nbsp;Simone Lunardi,&nbsp;Magdalena Andryszkiewicz,&nbsp;Giulio Di Piazza,&nbsp;Natalia Kovalkovicova,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2025.9420","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9420","url":null,"abstract":"<p>The food enzyme 4-α-glucanotransferase (1,4-α-<span>d</span>-glucan:1,4-α-<span>d</span>-glucan 4-α-<span>d</span>-glycosyltransferase; EC2.4.1.25) is produced with the genetically modified <i>Bacillus amyloliquefaciens</i> strain MAS by Koninklijke Cooperatie Avebe U.A. The production strain contains multiple copies of known antimicrobial resistance genes. However, based on the absence of viable cells and DNA from the production organism in the food enzyme, this is not considered to be a risk. The food enzyme is intended to be used in the production of enzymatically treated starch. Dietary exposure to the food enzyme total organic solids (TOS) was estimated to be up to 0.012 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not indicate a safety concern. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 1000 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 83,333. A search for homology of the amino acid sequence of the 4-α-glucanotransferase to known allergens was made and no match was found. The Panel considered that a risk of allergic reactions upon dietary exposure cannot be excluded, but that the likelihood is low. Based on the data provided, the Panel concluded that this food enzyme does not give rise to safety concerns, under the intended conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9420","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085246","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}

{"title":"Safety of the proposed amendment of the specifications of the food additive E960c(i) or E960c(ii)","authors":"EFSA Panel on Food Additives and Flavourings (FAF),&nbsp;Laurence Castle,&nbsp;Monica Andreassen,&nbsp;Gabriele Aquilina,&nbsp;Maria Lourdes Bastos,&nbsp;Polly Boon,&nbsp;Biagio Fallico,&nbsp;Reginald FitzGerald,&nbsp;Maria Jose Frutos Fernandez,&nbsp;Bettina Grasl-Kraupp,&nbsp;Ursula Gundert-Remy,&nbsp;Rainer Gürtler,&nbsp;Eric Houdeau,&nbsp;Marcin Kurek,&nbsp;Henriqueta Louro,&nbsp;Patricia Morales,&nbsp;Sabina Passamonti,&nbsp;José Manuel Barat Baviera,&nbsp;Gisela Degen,&nbsp;David Gott,&nbsp;Lieve Herman,&nbsp;Jean-Charles Leblanc,&nbsp;Peter Moldeus,&nbsp;Ine Waalkens-Berendsen,&nbsp;Detlef Wölfle,&nbsp;Civitella Consuelo,&nbsp;Borana Dino,&nbsp;Simone Lunardi,&nbsp;Agnieszka Mech,&nbsp;Salvatore Multari,&nbsp;Camilla Smeraldi,&nbsp;Alexandra Tard,&nbsp;Laura Ruggeri","doi":"10.2903/j.efsa.2025.9396","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9396","url":null,"abstract":"<p>The EFSA Panel on Food Additives and Flavourings (FAF Panel) provides a scientific opinion on the safety of the proposed amendment of the EU specifications of Rebaudioside M produced via enzyme-catalysed bioconversion (E960c(i) or E 960c(ii)), to include a different microorganism strain in the definition. Rebaudioside M is produced via enzymatic bioconversion from Stevia leaf extract, using the genetically modified yeast strain <i>K. phaffii</i> CGMCC 7539. The final product is composed mostly of rebaudioside M (&gt; 97%) and a mixture of rebaudiosides A, B and D at various concentrations. The Panel considered that the proposed amendment of the specifications is justified with respect to the inclusion of a new microorganism strain, taking into account that the manufacturing process and the submitted analytical data are already covered by the parameters listed in the existing EU specifications for E 960c(i) and E 960c(ii). The Panel considered that it is in the remit of the risk managers to decide whether the proposed changes in the specifications should result in an amendment of the already existing EU specifications of E960c(i) or E960c(ii). Viable cells and DNA from the production strain are not present in the final product; hence, the manufacturing process does not raise a safety concern. The Panel considered that the proposed food additive has the same physicochemical characteristics of E 960c(i) or E 960c(ii); therefore, the biological and toxicological data considered in previous evaluations will also apply to the safety assessment of Rebaudioside M produced from <i>K. phaffii</i> CGMCC 7539. The Panel concluded that there is no safety concern with respect to the proposed amendment to the EU specifications of E 960c(i) or E 960c(ii) related to the use of the new genetically modified strain <i>K. phaffii</i> CGMCC 7539 in the manufacturing process of the food additive Rebaudioside M produced via enzyme-catalysed bioconversion.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 5","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9396","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143944655","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}