EFSA Journal最新文献

{"title":"Statement on the confirmatory data following the Article 12 MRL review for triclopyr","authors":"European Food Safety Authority (EFSA)","doi":"10.2903/j.efsa.2024.9176","DOIUrl":"https://doi.org/10.2903/j.efsa.2024.9176","url":null,"abstract":"<p>In accordance with Article 31 of Regulation (EC) No 178/2002, EFSA received a mandate from the European Commission to issue a scientific statement concerning the confirmatory data following the review of the existing maximum residue levels (MRLs) under Article 12 of Regulation (EC) No 396/2005 for triclopyr. Although the required application in support to the confirmatory data following the MRL review was not submitted within deadline, some information identified as unavailable in the MRL review has been made available to EFSA in the context of other applications submitted under different regulatory processes. Based on the assessment of the available data, EFSA concluded that the tentative MRL for apples, pears and peaches is confirmed. The tentative MRLs for grapefruits, oranges, lemons, mandarins, apricots and rice are not fully supported by data. Risk manager may consider the alternative MRL of 0.07 mg/kg for oranges, lemons, mandarins and the lowering to the specific limit of quantification (LOQ) for grapefruits, apricots and rice. An update of the consumer risk assessment for triclopyr was performed and it did not indicate any potential consumer health risks. The statement was circulated to Member States for consultation via a written procedure before finalisation.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"22 12","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.9176","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142868936","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 and efficacy of a feed additive consisting of Lactiplantibacillus plantarum NCIMB 30148 for all animal species (Genus Breeding Ltd.)","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;Natalia Alija-Novo,&nbsp;Montserrat Anguita,&nbsp;Nicole Bozzi Cionci,&nbsp;Matteo L. Innocenti,&nbsp;Fabiola Pizzo,&nbsp;Jordi Tarrés-Call,&nbsp;Piera Valeri,&nbsp;Yolanda García-Cazorla","doi":"10.2903/j.efsa.2024.9143","DOIUrl":"https://doi.org/10.2903/j.efsa.2024.9143","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 <i>Lactiplantibacillus plantarum</i> NCIMB 30148 as a technological additive to improve ensiling of fresh plant material. The additive is intended for use in all fresh material for all animal species at a proposed minimum concentration of 1 × 10⁹ colony forming units (CFU)/kg fresh plant material. The bacterial species <i>L. plantarum</i> is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strain was established, and no antimicrobial resistance genes of concern were detected. Therefore, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of the strain as a silage additive is considered safe for all the animal species, for consumers of products from animals fed with the treated silage and for the environment. Regarding user safety, the additive should be considered as a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. The additive is not a skin irritant, but the Panel cannot conclude on the eye irritation potential of the additive. The FEEDAP Panel concluded that the addition of <i>L. plantarum</i> NCIMB 30148 at a minimum level of 1 × 10⁹ CFU/kg fresh plant material has the potential to improve the production of silage from fresh material.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"22 12","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.9143","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142861784","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 and efficacy of a feed additive consisting of an essential oil derived from the leaves of Salvia officinalis L. (sage oil) for use in all animal species (FEFANA asbl)","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;Maria de Lourdes Bastos,&nbsp;Paul Brantom,&nbsp;Andrew Chesson,&nbsp;Josef Schlatter,&nbsp;Johannes Westendorf,&nbsp;Paola Manini","doi":"10.2903/j.efsa.2024.9135","DOIUrl":"https://doi.org/10.2903/j.efsa.2024.9135","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 an essential oil from the leaves of <i>Salvia officinalis</i> L. (sage oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that sage oil is considered safe up to the maximum proposed use levels in complete feed of 20 mg/kg for ornamental fish. For the other species, the calculated safe concentrations in complete feed were 3 mg/kg for chickens for fattening and turkeys for fattening, 4 mg/kg for laying hens and rabbits, 5 mg/kg for piglets, 6 mg/kg for pigs for fattening, 7 mg/kg for sows and dairy cows, 11 mg/kg for veal calves (milk replacers) and salmonids, 10 mg/kg for cattle for fattening, sheep/goats and horses, 12 mg/kg for dogs and 2 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 2 mg/kg complete feed. The FEEDAP Panel considered that the use of sage oil in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. The use of sage oil in animal feed under the proposed conditions of use is safe for the consumer and the environment. Regarding user safety, sage oil should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. Since the oil of the leaves of <i>S. officinalis</i> is recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"22 12","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.9135","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142851445","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 Lactiplantibacillus plantarum NCIMB 40027 for all animal species for the renewal of its authorisation (Volac International ltd)","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;Nicole Bozzi Cionci,&nbsp;Rosella Brozzi,&nbsp;Yolanda García-Cazorla,&nbsp;Matteo L. Innocenti,&nbsp;Joana Revez,&nbsp;Jordi Tarrés-Call,&nbsp;Piera Valeri,&nbsp;Joana P. Firmino","doi":"10.2903/j.efsa.2024.9145","DOIUrl":"https://doi.org/10.2903/j.efsa.2024.9145","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of the authorisation of <i>Lactiplantibacillus plantarum</i> NCIMB 40027 as a technological additive (functional group: silage additives) for use in fresh material for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing terms of the authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for all animal species, consumers, and the environment. Regarding user safety, the FEEDAP Panel reiterates its previous conclusion that the additive is not irritant to skin or eyes. However, it should be considered as a skin and respiratory sensitiser, and any exposure through the skin and respiratory tract is 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":"22 12","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.9145","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142851452","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 and efficacy of a feed additive consisting of Lactiplantibacillus plantarum NCIMB 41028 for all animal species (Genus Breeding Ltd.)","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;Natalia Alija-Novo,&nbsp;Montserrat Anguita,&nbsp;Nicole Bozzi Cionci,&nbsp;Matteo L. Innocenti,&nbsp;Fabiola Pizzo,&nbsp;Jordi Tarrés-Call,&nbsp;Piera Valeri,&nbsp;Yolanda García-Cazorla","doi":"10.2903/j.efsa.2024.9142","DOIUrl":"https://doi.org/10.2903/j.efsa.2024.9142","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 <i>Lactiplantibacillus plantarum</i> NCIMB 41028 as a technological additive to improve ensiling of fresh plant material. The additive is intended for use in all fresh material for all animal species at a proposed minimum concentration of 1 × 10⁹ colony forming units (CFU)/kg fresh plant material. The bacterial species <i>L. plantarum</i> is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strain was established, and no antimicrobial resistance genes of concern were detected. Therefore, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of the strain as a silage additive is considered safe for all the animal species, for consumers of products from animals fed with the treated silage and for the environment. Regarding user safety, the additive should be considered as a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. The additive is not a skin irritant, but the Panel cannot conclude on the eye irritation potential of the additive. The FEEDAP Panel concluded that the addition of <i>L. plantarum</i> NCIMB 41028 at a minimum level of 1 × 10⁹ CFU/kg fresh plant material has the potential to improve the production of silage from fresh material.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"22 12","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.9142","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142861770","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":"Revised dietary exposure assessment of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus oryzae strain NZYM-FL","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;Daniele Cavanna,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2024.9165","DOIUrl":"https://doi.org/10.2903/j.efsa.2024.9165","url":null,"abstract":"<p>The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with the genetically modified <i>Aspergillus oryzae</i> strain NZYM-FL by Novozymes A/S. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that, under the intended conditions of use, this food enzyme did not give rise to safety concerns. Due to the implementation of a new methodology to estimate the dietary exposure to food enzymes in 2016, the European Commission requested EFSA to revise the exposure assessment of this food enzyme by using this new methodology. In this assessment, EFSA realigned the intended uses of this food enzyme to two food manufacturing processes and recalculated the dietary exposure. As the food enzyme-total organic solids (TOS) are removed in one food manufacturing process, the dietary exposure to the food enzyme-TOS was estimated only for the remaining process. It was calculated to be up to 0.492 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (340 mg TOS/kg bw per day, the mid-dose tested), the Panel derived a margin of exposure of at least 691. Based on the revised exposure estimate, the margin of exposure calculated thereof and the previous evaluation, 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":"22 12","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.9165","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142851518","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":"Revised dietary exposure assessment of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus oryzae strain NZYM-AL","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;Daniele Cavanna,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2024.9166","DOIUrl":"https://doi.org/10.2903/j.efsa.2024.9166","url":null,"abstract":"<p>The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with the genetically modified <i>Aspergillus oryzae</i> strain NZYM-AL by Novozymes A/S. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that, under the intended conditions of use, this food enzyme did not give rise to safety concerns. Due to the implementation of a new methodology to estimate the dietary exposure to food enzymes in 2016, the European Commission requested EFSA to revise the exposure assessment of this food enzyme by using this new methodology. In this assessment, EFSA realigned the intended uses of this food enzyme to four food manufacturing processes. The dietary exposure was calculated to be up to 0.089 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (49.1 mg TOS/kg bw per day, the lowest dose tested), the Panel derived a margin of exposure of at least 552. Based on the revised exposure estimate, the margin of exposure calculated thereof and the previous evaluation, 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":"22 12","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.9166","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142851519","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":"Setting of residue definitions and toxicological reference values for ethiprole","authors":"EFSA (European Food Safety Authority),&nbsp;Giulia Bellisai,&nbsp;Giovanni Bernasconi,&nbsp;Marco Binaglia,&nbsp;Luis Carrasco Cabrera,&nbsp;Irene Castellan,&nbsp;Anna Federica Castoldi,&nbsp;Arianna Chiusolo,&nbsp;Federica Crivellente,&nbsp;Monica Del Aguila,&nbsp;Lucien Ferreira,&nbsp;Luna Greco,&nbsp;Frederique Istace,&nbsp;Samira Jarrah,&nbsp;Anna Lanzoni,&nbsp;Renata Leuschner,&nbsp;Iris Mangas,&nbsp;Andrea Mioč,&nbsp;Stefanie Nave,&nbsp;Martina Panzarea,&nbsp;Juan Manuel Parra Morte,&nbsp;Hermine Reich,&nbsp;Silvia Ruocco,&nbsp;Alessia Pia Scarlato,&nbsp;Andrea Simonati,&nbsp;Marta Szot,&nbsp;Andrea Terron,&nbsp;Anne Theobald,&nbsp;Manuela Tiramani,&nbsp;Alessia Verani,&nbsp;Elena Zioga","doi":"10.2903/j.efsa.2024.9129","DOIUrl":"10.2903/j.efsa.2024.9129","url":null,"abstract":"<p>In accordance with Article 6 of Regulation (EC) No 396/2005, the original evaluating Member State (EMS), the United Kingdom, received an application from Bayer CropScience to set an import tolerance for the non-approved active substance ethiprole in rice. In the framework of the assessment process, the application was re-allocated to the Netherlands and the purpose of the application was changed to only set European residue definitions and toxicological reference values for the active substance ethiprole. Based on the assessment of the available toxicological data, an acceptable daily intake of 0.002 mg/kg bw per day and an acute reference dose of 0.005 mg/kg bw were derived. The data submitted in support of the request were found to be sufficient to derive residue definitions in primary crops and in processed commodities. The residue definition for enforcement was derived as ‘ethiprole’. Adequate analytical methods for enforcement are available to control the residues of ethiprole in dry commodities at the validated LOQ of 0.002 mg/kg. A residue definition for risk assessment was derived as the ‘sum of ethiprole, ethiprole-sulfone (RPA097973) and ethiprole-amide (RPA112916), expressed as ethiprole’. This residue definition is applicable for foliar treatment in all primary crops, for both foliar and soil treatments in cereals crops, and is also valid for processed commodities.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"22 12","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11653028/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142853540","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 β-fructofuranosidase from the non-genetically modified Saccharomyces cerevisiae strain CNCM I-3399","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;Andrew Chesson,&nbsp;Lieve Herman,&nbsp;Jaime Aguilera,&nbsp;Magdalena Andryszkiewicz,&nbsp;Daniele Cavanna,&nbsp;Giulio di Piazza,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2024.9128","DOIUrl":"10.2903/j.efsa.2024.9128","url":null,"abstract":"<p>The food enzyme β-fructofuranosidase (β-<span>d</span>-fructofuranoside fructohydrolase; EC 3.2.1.26) is produced with the non-genetically modified <i>Saccharomyces cerevisiae</i> strain CNCM I-3399 by Kerry Ingredients &amp; Flavours Ltd. The production strain qualifies for the qualified presumption of safety (QPS) approach for risk assessment. The food enzyme is intended to be used in four food manufacturing processes. Exposure was estimated to be up to 2.485 mg total organic solids/kg body weight (bw) per day in European populations. As the production strain qualifies for QPS, and in the absence of other concerns, the Panel considered that toxicological studies were not needed for the safety assessment of this food enzyme. A search for homology of the amino acid sequence of the food enzyme to known allergens was made and one match with a tomato allergen was found. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in tomato allergic individuals, cannot be excluded, but 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":"22 12","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11653026/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142853538","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":"Revised dietary exposure assessment of the food enzyme triacylglycerol lipase from the genetically modified Aspergillus oryzae strain NZYM-LH","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;Daniele Cavanna,&nbsp;Yi Liu","doi":"10.2903/j.efsa.2024.9164","DOIUrl":"10.2903/j.efsa.2024.9164","url":null,"abstract":"<p>The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase, EC 3.1.1.3) is produced with the genetically modified <i>Aspergillus oryzae</i> strain NZYM-LH by Novozymes A/S. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that, under the intended conditions of use, this food enzyme did not give rise to safety concerns. Due to the implementation of a new methodology to estimate the dietary exposure to food enzymes in 2016, the European Commission requested EFSA to revise the exposure assessment of this food enzyme by using this new methodology. In this assessment, EFSA realigned the intended uses of this food enzyme to two food manufacturing processes and recalculated the dietary exposure. Dietary exposure to the food enzyme-TOS was calculated to be up to 0.284 mg TOS/kg body weight (bw) per day in European populations. When combined with the no observed adverse effect level previously reported (1080 mg TOS/kg bw per day, the highest dose tested), the Panel derived a margin of exposure of at least 3803. Based on the revised exposure estimate, the margin of exposure calculated thereof and the previous evaluation, 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":"22 12","pages":""},"PeriodicalIF":3.3,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11650022/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142846207","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}