Pub Date : 2024-07-05DOI: 10.2903/j.efsa.2024.8866
EFSA Scientific Committee, Simon More, Vasileios Bampidis, Diane Benford, Claude Bragard, Antonio Hernandez-Jerez, Susanne Hougaard Bennekou, Konstantinos Koutsoumanis, Claude Lambré, Kyriaki Machera, Wim Mennes, Ewen Mullins, Soren Saxmose Nielsen, Josef Schlatter, Dieter Schrenk, Dominique Turck, Maged Younes, Tony Fletcher, Matthias Greiner, Evangelia Ntzani, Neil Pearce, Marco Vinceti, Martine Vrijheid, Marios Georgiadis, Andrea Gervelmeyer, Thorhallur I. Halldorsson
EFSA requested its Scientific Committee to prepare a guidance document on appraising and integrating evidence from epidemiological studies for use in EFSA's scientific assessments. The guidance document provides an introduction to epidemiological studies and illustrates the typical biases, which may be present in different epidemiological study designs. It then describes key epidemiological concepts relevant for evidence appraisal. This includes brief explanations for measures of association, exposure assessment, statistical inference, systematic error and effect modification. The guidance then describes the concept of external validity and the principles of appraising epidemiological studies. The customisation of the study appraisal process is explained including tailoring of tools for assessing the risk of bias (RoB). Several examples of appraising experimental and observational studies using a RoB tool are annexed to the document to illustrate the application of the approach. The latter part of this guidance focuses on different steps of evidence integration, first within and then across different streams of evidence. With respect to risk characterisation, the guidance considers how evidence from human epidemiological studies can be used in dose–response modelling with several different options being presented. Finally, the guidance addresses the application of uncertainty factors in risk characterisation when using evidence from human epidemiological studies.
欧洲食物安全局要求其科学委员会编写一份关于评估和整合流行病学研究证据的指导文件,用于欧洲食物安全局的科学评估。该指导文件介绍了流行病学研究,并说明了不同流行病学研究设计中可能存在的典型偏差。然后介绍了与证据评估相关的主要流行病学概念。其中包括对关联测量、暴露评估、统计推论、系统误差和效应修正的简要解释。然后,指南介绍了外部有效性的概念和流行病学研究的评估原则。对研究评估流程的定制进行了说明,包括评估偏倚风险 (RoB) 的定制工具。本文件附有使用 RoB 工具评估实验研究和观察性研究的几个实例,以说明该方法的应用。本指南的后半部分侧重于证据整合的不同步骤,首先是证据流内部的整合,然后是不同证据流之间的整合。在风险特征描述方面,指南考虑了如何将人类流行病学研究的证据用于剂量-反应模型,并提出了几种不同的方案。最后,指南讨论了在使用人类流行病学研究证据时,如何在风险特征描述中应用不确定性因素。
{"title":"Scientific Committee guidance on appraising and integrating evidence from epidemiological studies for use in EFSA's scientific assessments","authors":"EFSA Scientific Committee, Simon More, Vasileios Bampidis, Diane Benford, Claude Bragard, Antonio Hernandez-Jerez, Susanne Hougaard Bennekou, Konstantinos Koutsoumanis, Claude Lambré, Kyriaki Machera, Wim Mennes, Ewen Mullins, Soren Saxmose Nielsen, Josef Schlatter, Dieter Schrenk, Dominique Turck, Maged Younes, Tony Fletcher, Matthias Greiner, Evangelia Ntzani, Neil Pearce, Marco Vinceti, Martine Vrijheid, Marios Georgiadis, Andrea Gervelmeyer, Thorhallur I. Halldorsson","doi":"10.2903/j.efsa.2024.8866","DOIUrl":"https://doi.org/10.2903/j.efsa.2024.8866","url":null,"abstract":"<p>EFSA requested its Scientific Committee to prepare a guidance document on appraising and integrating evidence from epidemiological studies for use in EFSA's scientific assessments. The guidance document provides an introduction to epidemiological studies and illustrates the typical biases, which may be present in different epidemiological study designs. It then describes key epidemiological concepts relevant for evidence appraisal. This includes brief explanations for measures of association, exposure assessment, statistical inference, systematic error and effect modification. The guidance then describes the concept of external validity and the principles of appraising epidemiological studies. The customisation of the study appraisal process is explained including tailoring of tools for assessing the risk of bias (RoB). Several examples of appraising experimental and observational studies using a RoB tool are annexed to the document to illustrate the application of the approach. The latter part of this guidance focuses on different steps of evidence integration, first within and then across different streams of evidence. With respect to risk characterisation, the guidance considers how evidence from human epidemiological studies can be used in dose–response modelling with several different options being presented. Finally, the guidance addresses the application of uncertainty factors in risk characterisation when using evidence from human epidemiological studies.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.8866","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141537025","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}
Pub Date : 2024-07-05DOI: 10.2903/j.efsa.2024.8832
EFSA Panel on Plant Health (PLH), Claude Bragard, Paola Baptista, Elisavet Chatzivassiliou, Francesco Di Serio, Paolo Gonthier, Josep Anton Jaques Miret, Annemarie Fejer Justesen, Alan MacLeod, Christer Sven Magnusson, Juan A. Navas-Cortes, Stephen Parnell, Roel Potting, Philippe Lucien Reignault, Emilio Stefani, Antonio Vicent Civera, Wopke van der Werf, Jonathan Yuen, Lucia Zappalà, Hans-Hermann Thulke, Antoon Loomans, Eugen H. Christoph, Matteo Crotta, Alex Gobbi, Dejana Golic, Andrea Maiorano, Anastasia Terzidou, Panagiotis Milonas
Following a request from the European Commission, the EFSA Panel on Plant Health performed a quantitative risk assessment for the EU of Phlyctinus callosus (Coleoptera: Curculionidae), a polyphagous pest occurring in Australia, New Zealand and South Africa. The current risk assessment focused on potential pathways for entry, the climatic conditions allowing establishment, the expected spread capacity and the impact considering a time horizon of 10 years (2023–2032). The Panel identified the import of apples, cut flowers and table grapes as the most relevant entry pathways. Over the next 10 years, an annual median estimate of approximately 49.5 (90% certainty range, CR, ranging from 4.0 to 881.2) potential P. callosus founder populations are expected. When the probability of establishment is considered and climatic indicators are used to define the areas in the EU where establishment is possible, the model estimated a median of 1 founder population every 1.3 years (90% CR: 1 every 30.8 years to 23.3 per year) in the scenario where the areas are defined by the union of all the climatic indicators and 1 founder population every 11.9 years (90% CR: 1 every 256.6 years to 2.5 per year) in the scenario where establishment is possible only in the areas defined by the climatic indicator of minimum soil temperature. The estimated number of founder populations per year is mostly driven by the probability of establishment in the rural areas, infestation rate in table grapes and the probability of transfer to a suitable host in the rural area. The risk of entry for cut flowers and apples is substantially lower than the risk from the table grapes. If such founder populations were to establish, P. callosus is estimated to spread by natural dispersal and common agricultural practices at a rate of 15.5 m/year (90% CR 5.1–46.8 m/year) after a lag phase of 4.0 years (90% CR 1.3–8.7 years). The impact, expressed as percentage loss of the production directly attributable to P. callosus in the areas where establishment is possible and assuming farmers do not apply specific control measures was estimated at 0.5% (90% CR 0.01%–2.8%) for cut flowers/foliage, 5.2% (90% CR 2.2%–11.7%) for apples and 2% (90% CR 1.3%–5.2%) for table grapes. Options for risk reduction are discussed, but their effectiveness is not quantified.
{"title":"Risk assessment of Phlyctinus callosus for the EU","authors":"EFSA Panel on Plant Health (PLH), Claude Bragard, Paola Baptista, Elisavet Chatzivassiliou, Francesco Di Serio, Paolo Gonthier, Josep Anton Jaques Miret, Annemarie Fejer Justesen, Alan MacLeod, Christer Sven Magnusson, Juan A. Navas-Cortes, Stephen Parnell, Roel Potting, Philippe Lucien Reignault, Emilio Stefani, Antonio Vicent Civera, Wopke van der Werf, Jonathan Yuen, Lucia Zappalà, Hans-Hermann Thulke, Antoon Loomans, Eugen H. Christoph, Matteo Crotta, Alex Gobbi, Dejana Golic, Andrea Maiorano, Anastasia Terzidou, Panagiotis Milonas","doi":"10.2903/j.efsa.2024.8832","DOIUrl":"https://doi.org/10.2903/j.efsa.2024.8832","url":null,"abstract":"<p>Following a request from the European Commission, the EFSA Panel on Plant Health performed a quantitative risk assessment for the EU of <i>Phlyctinus callosus</i> (Coleoptera: Curculionidae), a polyphagous pest occurring in Australia, New Zealand and South Africa. The current risk assessment focused on potential pathways for entry, the climatic conditions allowing establishment, the expected spread capacity and the impact considering a time horizon of 10 years (2023–2032). The Panel identified the import of apples, cut flowers and table grapes as the most relevant entry pathways. Over the next 10 years, an annual median estimate of approximately 49.5 (90% certainty range, CR, ranging from 4.0 to 881.2) potential <i>P. callosus</i> founder populations are expected. When the probability of establishment is considered and climatic indicators are used to define the areas in the EU where establishment is possible, the model estimated a median of 1 founder population every 1.3 years (90% CR: 1 every 30.8 years to 23.3 per year) in the scenario where the areas are defined by the union of all the climatic indicators and 1 founder population every 11.9 years (90% CR: 1 every 256.6 years to 2.5 per year) in the scenario where establishment is possible only in the areas defined by the climatic indicator of minimum soil temperature. The estimated number of founder populations per year is mostly driven by the probability of establishment in the rural areas, infestation rate in table grapes and the probability of transfer to a suitable host in the rural area. The risk of entry for cut flowers and apples is substantially lower than the risk from the table grapes. If such founder populations were to establish, <i>P. callosus</i> is estimated to spread by natural dispersal and common agricultural practices at a rate of 15.5 m/year (90% CR 5.1–46.8 m/year) after a lag phase of 4.0 years (90% CR 1.3–8.7 years). The impact, expressed as percentage loss of the production directly attributable to <i>P. callosus</i> in the areas where establishment is possible and assuming farmers do not apply specific control measures was estimated at 0.5% (90% CR 0.01%–2.8%) for cut flowers/foliage, 5.2% (90% CR 2.2%–11.7%) for apples and 2% (90% CR 1.3%–5.2%) for table grapes. Options for risk reduction are discussed, but their effectiveness is not quantified.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.8832","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141537026","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}
Pub Date : 2024-07-05DOI: 10.2903/j.efsa.2024.8877
EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), Claude Lambré, José Manuel Barat Baviera, Claudia Bolognesi, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Inger-Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis, Holger Zorn, Boet Glandorf, Lieve Herman, Yrjö Roos, Jaime Aguilera, Magdalena Andryskiewicz, Daniele Cavanna, Natália Kovalkovičová, Yi Liu, Rita Ferreira de Sousa, Andrew Chesson
The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is produced with the non-genetically modified Penicillium caseifulvum strain AE-LRF by Amano Enzyme Inc. The food enzyme was free from viable cells of the production organism. It is intended to be used in four food manufacturing processes. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.013 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 69 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 5308. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. However, the Panel noted that traces of ■■■■■, used in the manufacture of the triacylglycerol lipase, may be found in the food enzyme. The Panel considered that the risk of allergic reactions upon dietary exposure could not be excluded, particularly in individuals sensitised to fish. 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.
{"title":"Safety evaluation of the food enzyme triacylglycerol lipase from the non-genetically modified Penicillium caseifulvum strain AE-LRF","authors":"EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), Claude Lambré, José Manuel Barat Baviera, Claudia Bolognesi, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Inger-Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis, Holger Zorn, Boet Glandorf, Lieve Herman, Yrjö Roos, Jaime Aguilera, Magdalena Andryskiewicz, Daniele Cavanna, Natália Kovalkovičová, Yi Liu, Rita Ferreira de Sousa, Andrew Chesson","doi":"10.2903/j.efsa.2024.8877","DOIUrl":"https://doi.org/10.2903/j.efsa.2024.8877","url":null,"abstract":"<p>The food enzyme triacylglycerol lipase (triacylglycerol acylhydrolase; EC 3.1.1.3) is produced with the non-genetically modified <i>Penicillium caseifulvum</i> strain AE-LRF by Amano Enzyme Inc. The food enzyme was free from viable cells of the production organism. It is intended to be used in four food manufacturing processes. Dietary exposure to the food enzyme–total organic solids (TOS) was estimated to be up to 0.013 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 69 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 5308. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. However, the Panel noted that traces of ■■■■■, used in the manufacture of the triacylglycerol lipase, may be found in the food enzyme. The Panel considered that the risk of allergic reactions upon dietary exposure could not be excluded, particularly in individuals sensitised to fish. 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":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.8877","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141537022","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}
Pub Date : 2024-07-05DOI: 10.2903/j.efsa.2024.8860
European Food Safety Authority (EFSA), Fernando Álvarez, Maria Arena, Domenica Auteri, Sofia Batista Leite, Marco Binaglia, Anna Federica Castoldi, Arianna Chiusolo, Angelo Colagiorgi, Mathilde Colas, Federica Crivellente, Chloe De Lentdecker, Isabella De Magistris, Mark Egsmose, Gabriella Fait, Franco Ferilli, German Giner Santonja, Varvara Gouliarmou, Katrin Halling, Laia Herrero Nogareda, Alessio Ippolito, Frederique Istace, Samira Jarrah, Dimitra Kardassi, Aude Kienzler, Anna Lanzoni, Roberto Lava, Renata Leuschner, Alberto Linguadoca, Jochem Louisse, Christopher Lythgo, Oriol Magrans, Iris Mangas, Galini Mavriou, Andrea Mioč, Ileana Miron, Tunde Molnar, Laura Padovani, Vincenzo Padricello, Martina Panzarea, Juan Manuel Parra Morte, Simone Rizzuto, Anamarija Romac, Agnès Rortais, Miguel Santos, Rositsa Serafimova, Rachel Sharp, Csaba Szentes, Andrea Terron, Anne Theobald, Manuela Tiramani, Giorgia Vianello, Laura Villamar-Bouza
The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Belgium, and co-rapporteur Member State, Austria, for the pesticide active substance lenacil are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of lenacil as a herbicide on sugar and fodder beet (field use). The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.
{"title":"Peer review of the pesticide risk assessment of the active substance lenacil","authors":"European Food Safety Authority (EFSA), Fernando Álvarez, Maria Arena, Domenica Auteri, Sofia Batista Leite, Marco Binaglia, Anna Federica Castoldi, Arianna Chiusolo, Angelo Colagiorgi, Mathilde Colas, Federica Crivellente, Chloe De Lentdecker, Isabella De Magistris, Mark Egsmose, Gabriella Fait, Franco Ferilli, German Giner Santonja, Varvara Gouliarmou, Katrin Halling, Laia Herrero Nogareda, Alessio Ippolito, Frederique Istace, Samira Jarrah, Dimitra Kardassi, Aude Kienzler, Anna Lanzoni, Roberto Lava, Renata Leuschner, Alberto Linguadoca, Jochem Louisse, Christopher Lythgo, Oriol Magrans, Iris Mangas, Galini Mavriou, Andrea Mioč, Ileana Miron, Tunde Molnar, Laura Padovani, Vincenzo Padricello, Martina Panzarea, Juan Manuel Parra Morte, Simone Rizzuto, Anamarija Romac, Agnès Rortais, Miguel Santos, Rositsa Serafimova, Rachel Sharp, Csaba Szentes, Andrea Terron, Anne Theobald, Manuela Tiramani, Giorgia Vianello, Laura Villamar-Bouza","doi":"10.2903/j.efsa.2024.8860","DOIUrl":"https://doi.org/10.2903/j.efsa.2024.8860","url":null,"abstract":"<p>The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Belgium, and co-rapporteur Member State, Austria, for the pesticide active substance lenacil are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of lenacil as a herbicide on sugar and fodder beet (field use). The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.8860","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141537023","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}
Pub Date : 2024-07-04DOI: 10.2903/j.efsa.2024.8868
EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), Claude Lambré, José Manuel Barat Baviera, Claudia Bolognesi, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Inger-Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis, Holger Zorn, Yrjö Roos, Daniele Cavanna, Yi Liu, Giulio di Piazza, Andrew Chesson
The food enzyme bacillolysin (EC 3.4.24.28) is produced with the non-genetically modified Bacillus amyloliquefaciens strain AE-NP by Amano Enzyme Inc. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in thirteen food manufacturing processes. Subsequently, the applicant requested to extend its use to two additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of fifteen food manufacturing processes. As the food enzyme–total organic solids (TOS) are removed in two food manufacturing processes, the dietary exposure to the food enzyme–TOS was estimated only for the remaining thirteen processes. Dietary exposure was calculated to be up to 35.251 mg TOS/kg body weight per day in European populations. Based on the data provided for the previous evaluation and the revised dietary exposure in the present evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.
{"title":"Safety evaluation of an extension of use of the food enzyme bacillolysin from the non-genetically modified Bacillus amyloliquefaciens strain AE-NP","authors":"EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), Claude Lambré, José Manuel Barat Baviera, Claudia Bolognesi, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Inger-Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis, Holger Zorn, Yrjö Roos, Daniele Cavanna, Yi Liu, Giulio di Piazza, Andrew Chesson","doi":"10.2903/j.efsa.2024.8868","DOIUrl":"10.2903/j.efsa.2024.8868","url":null,"abstract":"<p>The food enzyme bacillolysin (EC 3.4.24.28) is produced with the non-genetically modified <i>Bacillus amyloliquefaciens</i> strain AE-NP by Amano Enzyme Inc. A safety evaluation of this food enzyme was made previously, in which EFSA concluded that this food enzyme did not give rise to safety concerns when used in thirteen food manufacturing processes. Subsequently, the applicant requested to extend its use to two additional processes. In this assessment, EFSA updated the safety evaluation of this food enzyme when used in a total of fifteen food manufacturing processes. As the food enzyme–total organic solids (TOS) are removed in two food manufacturing processes, the dietary exposure to the food enzyme–TOS was estimated only for the remaining thirteen processes. Dietary exposure was calculated to be up to 35.251 mg TOS/kg body weight per day in European populations. Based on the data provided for the previous evaluation and the revised dietary exposure in the present evaluation, the Panel concluded that this food enzyme does not give rise to safety concerns under the revised intended conditions of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11222869/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141534018","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}
Pub Date : 2024-07-04DOI: 10.2903/j.efsa.2024.8878
EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), Claude Lambré, José Manuel Barat Baviera, Claudia Bolognesi, Andrew Chesson, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Inger-Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis, Holger Zorn, Vincent Dudler, Maria Rosaria Milana, Constantine Papaspyrides, Maria de Fatima Poças, Alexandros Lioupis, Daniele Comandella, Elisa Savini, Evgenia Lampi
The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Fucine Film (EU register number RECYC322), which uses the Reifenhäuser technology. The input material consists of hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post-consumer PET containers, including no more than 5% PET from non-food consumer applications. The flakes are extruded under vacuum into sheets. The recycled sheets are intended to be used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, excluded drinking water and beverages, for long-term storage at room temperature, with or without hotfill. Based on the limited data available, the Panel concluded that the information submitted to EFSA was inadequate to demonstrate that the recycling process Fucine Film is able to reduce potential unknown contamination of the input PET flakes to a concentration that does not pose a risk to human health.
欧洲食品安全局食品接触材料、酶和加工助剂专家小组(CEP)对采用 Reifenhäuser 技术的回收工艺 Fucine Film(欧盟注册号 RECYC322)的安全性进行了评估。输入材料包括经热苛性碱洗涤和干燥的聚对苯二甲酸乙二酯(PET)薄片,主要来自收集的消费后 PET 容器,其中不超过 5% 的 PET 来自非食品消费应用。片材在真空条件下挤压成板材。再生片材用于制造与各类食品接触的材料和物品,不包括饮用水和饮料,可在室温下长期储存,带或不带热灌装。根据现有的有限数据,专家小组得出结论认为,提交给欧洲食品安全局的信息不足以证明 Fucine Film 再循环工艺能够将输入 PET 片材的潜在未知污染降低到不会对人类健康构成风险的浓度。
{"title":"Safety assessment of the process Fucine Film, based on the Reifenhäuser technology, used to recycle post-consumer PET into food contact materials","authors":"EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), Claude Lambré, José Manuel Barat Baviera, Claudia Bolognesi, Andrew Chesson, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Inger-Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis, Holger Zorn, Vincent Dudler, Maria Rosaria Milana, Constantine Papaspyrides, Maria de Fatima Poças, Alexandros Lioupis, Daniele Comandella, Elisa Savini, Evgenia Lampi","doi":"10.2903/j.efsa.2024.8878","DOIUrl":"10.2903/j.efsa.2024.8878","url":null,"abstract":"<p>The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP) assessed the safety of the recycling process Fucine Film (EU register number RECYC322), which uses the Reifenhäuser technology. The input material consists of hot caustic washed and dried poly(ethylene terephthalate) (PET) flakes mainly originating from collected post-consumer PET containers, including no more than 5% PET from non-food consumer applications. The flakes are extruded under vacuum into sheets. The recycled sheets are intended to be used at up to 100% for the manufacture of materials and articles for contact with all types of foodstuffs, excluded drinking water and beverages, for long-term storage at room temperature, with or without hotfill. Based on the limited data available, the Panel concluded that the information submitted to EFSA was inadequate to demonstrate that the recycling process Fucine Film is able to reduce potential unknown contamination of the input PET flakes to a concentration that does not pose a risk to human health.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11222897/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141534017","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}
Pub Date : 2024-07-04DOI: 10.2903/j.efsa.2024.8873
EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), Claude Lambré, José Manuel Barat Baviera, Claudia Bolognesi, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Inger-Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis, Holger Zorn, Yrjö Roos, Jaime Aguilera, Magdalena Andryszkiewicz, Daniele Cavanna, Silvia Peluso, Rita Ferreira de Sousa, Francesco Pesce, Yi Liu, Andrew Chesson
The food enzyme subtilisin (EC 3.4.21.62) is produced with the non-genetically modified Bacillus paralicheniformis strain AP-01 by Nagase (Europa) GmbH. It was considered free from viable cells of the production organism. The food enzyme is intended to be used in five food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in one process, dietary exposure was calculated only for the remaining four food manufacturing processes. It was estimated to be up to 0.875 mg TOS/kg body weight per day in European populations. The production strain of the food enzyme has the capacity to produce bacitracin and thus failed to meet the requirements of the Qualified Presumption of Safety approach. Bacitracin was detected in the industrial fermentation medium but not in the food enzyme itself. However, the limit of detection of the analytical method used for bacitracin was not sufficient to exclude the possible presence of bacitracin at a level representing a risk for the development of antimicrobial resistant bacteria. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and twenty-eight matches with respiratory allergens, one match with a contact allergen and two matches with food allergens (melon and pomegranate) were found. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to melon or pomegranate, cannot be excluded, but would not exceed the risk of consuming melon or pomegranate. Based on the data provided, the Panel could not exclude the presence of bacitracin, a medically important antimicrobial, and consequently the safety of this food enzyme could not be established.
{"title":"Safety evaluation of the food enzyme subtilisin from the non-genetically modified Bacillus paralicheniformis strain AP-01","authors":"EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), Claude Lambré, José Manuel Barat Baviera, Claudia Bolognesi, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Inger-Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis, Holger Zorn, Yrjö Roos, Jaime Aguilera, Magdalena Andryszkiewicz, Daniele Cavanna, Silvia Peluso, Rita Ferreira de Sousa, Francesco Pesce, Yi Liu, Andrew Chesson","doi":"10.2903/j.efsa.2024.8873","DOIUrl":"10.2903/j.efsa.2024.8873","url":null,"abstract":"<p>The food enzyme subtilisin (EC 3.4.21.62) is produced with the non-genetically modified <i>Bacillus paralicheniformis</i> strain AP-01 by Nagase (Europa) GmbH. It was considered free from viable cells of the production organism. The food enzyme is intended to be used in five food manufacturing processes. Since residual amounts of food enzyme-total organic solids (TOS) are removed in one process, dietary exposure was calculated only for the remaining four food manufacturing processes. It was estimated to be up to 0.875 mg TOS/kg body weight per day in European populations. The production strain of the food enzyme has the capacity to produce bacitracin and thus failed to meet the requirements of the Qualified Presumption of Safety approach. Bacitracin was detected in the industrial fermentation medium but not in the food enzyme itself. However, the limit of detection of the analytical method used for bacitracin was not sufficient to exclude the possible presence of bacitracin at a level representing a risk for the development of antimicrobial resistant bacteria. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and twenty-eight matches with respiratory allergens, one match with a contact allergen and two matches with food allergens (melon and pomegranate) were found. The Panel considered that the risk of allergic reactions upon dietary exposure to this food enzyme, particularly in individuals sensitised to melon or pomegranate, cannot be excluded, but would not exceed the risk of consuming melon or pomegranate. Based on the data provided, the Panel could not exclude the presence of bacitracin, a medically important antimicrobial, and consequently the safety of this food enzyme could not be established.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11222870/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141534019","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}
Pub Date : 2024-07-04DOI: 10.2903/j.efsa.2024.8861
EFSA Panel on Nutrition, Novel Foods and Food allergens (NDA), Dominique Turck, Torsten Bohn, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch-Ernst, Helle Katrine Knutsen, Alexandre Maciuk, Inge Mangelsdorf, Harry J. McArdle, Androniki Naska, Kristina Pentieva, Frank Thies, Sophia Tsabouri, Marco Vinceti, Jean-Louis Bresson, Thibault Fiolet, Alfonso Siani
Following an application from Egde Pharma Sp. z o.o, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Poland, 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 citicoline and memory. The Panel considers that the food, citicoline (cytidine 5-diphosphocholine, CDP-Choline) inner salt, is sufficiently characterised. Improvement, maintenance or reduced loss of memory is a beneficial physiological effect for middle-aged or elderly adults encountering age-associated subjective memory impairment. The applicant identified three pertinent human intervention studies in healthy individuals that investigated the effect of citicoline on memory. In weighing the evidence, the Panel took into account that only one randomised controlled trial in healthy participants showed a beneficial effect of citicoline on episodic memory when consumed at doses of 500 mg/day for 12 weeks, whereas this effect has not been observed in another study using citicoline at doses of 1 g/day for 3 months or supported by data obtained in patients with dementia using doses of 1 g/day for 12 weeks and 12 months. No convincing evidence of a plausible mechanism by which citicoline or any of its components (in addition to their endogenous synthesis) could exert an effect on memory in humans has been provided. The Panel concludes that a cause-and-effect relationship has not been established between the consumption of citicoline (CDP-Choline) inner salt and improvement, maintenance or reduced loss of memory in middle-aged or elderly adults encountering age-associated subjective memory impairment.
{"title":"‘Citicoline’ and support of the memory function: Evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006","authors":"EFSA Panel on Nutrition, Novel Foods and Food allergens (NDA), Dominique Turck, Torsten Bohn, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch-Ernst, Helle Katrine Knutsen, Alexandre Maciuk, Inge Mangelsdorf, Harry J. McArdle, Androniki Naska, Kristina Pentieva, Frank Thies, Sophia Tsabouri, Marco Vinceti, Jean-Louis Bresson, Thibault Fiolet, Alfonso Siani","doi":"10.2903/j.efsa.2024.8861","DOIUrl":"10.2903/j.efsa.2024.8861","url":null,"abstract":"<p>Following an application from Egde Pharma Sp. z o.o, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Poland, 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 citicoline and memory. The Panel considers that the food, citicoline (cytidine 5-diphosphocholine, CDP-Choline) inner salt, is sufficiently characterised. Improvement, maintenance or reduced loss of memory is a beneficial physiological effect for middle-aged or elderly adults encountering age-associated subjective memory impairment. The applicant identified three pertinent human intervention studies in healthy individuals that investigated the effect of citicoline on memory. In weighing the evidence, the Panel took into account that only one randomised controlled trial in healthy participants showed a beneficial effect of citicoline on episodic memory when consumed at doses of 500 mg/day for 12 weeks, whereas this effect has not been observed in another study using citicoline at doses of 1 g/day for 3 months or supported by data obtained in patients with dementia using doses of 1 g/day for 12 weeks and 12 months. No convincing evidence of a plausible mechanism by which citicoline or any of its components (in addition to their endogenous synthesis) could exert an effect on memory in humans has been provided. The Panel concludes that a cause-and-effect relationship has not been established between the consumption of citicoline (CDP-Choline) inner salt and improvement, maintenance or reduced loss of memory in middle-aged or elderly adults encountering age-associated subjective memory impairment.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11222871/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141533992","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}
Pub Date : 2024-07-04DOI: 10.2903/j.efsa.2024.8862
EFSA Panel on Nutrition, Novel Foods and Food allergens (NDA), Dominique Turck, Torsten Bohn, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch-Ernst, Helle Katrine Knutsen, Alexandre Maciuk, Inge Mangelsdorf, Harry J. McArdle, Androniki Naska, Kristina Pentieva, Frank Thies, Sophia Tsabouri, Marco Vinceti, Jean-Louis Bresson, Thibault Fiolet, Alfonso Siani
Following an application from Cárnicas Joselito S.A. pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Spain, the 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 ‘Joselito ham increases antioxidant substances in the body, reduces blood pressure and plasma triglycerides, decreases oxidative stress and prevents effect in diseases related to the cardiovascular and intestinal systems’. The scope of the application was proposed to fall under a health claim referring to disease risk reduction. The food constituent that is the subject of the health claim is Joselito, an Iberian ham characterised by a high content of oleic acid. The Panel considers that the food is sufficiently characterised. The Panel considers that lowering of LDL-cholesterol concentration and blood pressure is a beneficial effect by decreasing the risk of coronary heart disease. Upon a request from EFSA, the applicant identified one human intervention study as being pertinent to the claim. However, due to methodological limitations, the Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panel notes that no human intervention studies from which conclusions could be drawn for the scientific substantiation of the claim were provided by the applicant. The Panel concludes that a cause and effect relationship has not been established between the intake of Joselito® ham and the reduction of LDL-cholesterol concentration or blood pressure.
{"title":"Joselito® and lowering of LDL-cholesterol concentration, blood pressure, and reduction of coronary heart disease risk: 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, Jacqueline Castenmiller, Stefaan De Henauw, Karen Ildico Hirsch-Ernst, Helle Katrine Knutsen, Alexandre Maciuk, Inge Mangelsdorf, Harry J. McArdle, Androniki Naska, Kristina Pentieva, Frank Thies, Sophia Tsabouri, Marco Vinceti, Jean-Louis Bresson, Thibault Fiolet, Alfonso Siani","doi":"10.2903/j.efsa.2024.8862","DOIUrl":"10.2903/j.efsa.2024.8862","url":null,"abstract":"<p>Following an application from Cárnicas Joselito S.A. pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Spain, the 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 ‘<i>Joselito ham increases antioxidant substances in the body, reduces blood pressure and plasma triglycerides, decreases oxidative stress and prevents effect in diseases related to the cardiovascular and intestinal systems</i>’. The scope of the application was proposed to fall under a health claim referring to disease risk reduction. The food constituent that is the subject of the health claim is Joselito, an Iberian ham characterised by a high content of oleic acid. The Panel considers that the food is sufficiently characterised. The Panel considers that lowering of LDL-cholesterol concentration and blood pressure is a beneficial effect by decreasing the risk of coronary heart disease. Upon a request from EFSA, the applicant identified one human intervention study as being pertinent to the claim. However, due to methodological limitations, the Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim. The Panel notes that no human intervention studies from which conclusions could be drawn for the scientific substantiation of the claim were provided by the applicant. The Panel concludes that a cause and effect relationship has not been established between the intake of Joselito® ham and the reduction of LDL-cholesterol concentration or blood pressure.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11222867/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141533993","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}
Pub Date : 2024-07-04DOI: 10.2903/j.efsa.2024.8872
EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), Vittorio Silano, José Manuel Barat Baviera, Claudia Bolognesi, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Claude Lambré, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Inger-Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis, Holger Zorn, Boet Glandorf, Lieve Herman, Yrjö Roos, Magdalena Andryszkiewicz, Yi Liu, Simone Lunardi, Elsa Nielsen, Karin Norby, Andrew Chesson
The food enzyme β-glucosidase (β-D-glucoside glucohydrolase; EC 3.2.1.21) is produced with the non-genetically modified Penicillium guanacastense strain AE-GLY by Amano Enzyme Inc. The food enzyme is intended to be used in four food manufacturing processes. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 4.054 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise 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 943 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 233. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that the risk of allergic reactions by dietary exposure 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.
{"title":"Safety evaluation of the food enzyme β-glucosidase from the non-genetically modified Penicillium guanacastense strain AE-GLY","authors":"EFSA Panel on Food Contact Materials, Enzymes and Processing Aids (CEP), Vittorio Silano, José Manuel Barat Baviera, Claudia Bolognesi, Pier Sandro Cocconcelli, Riccardo Crebelli, David Michael Gott, Konrad Grob, Claude Lambré, Evgenia Lampi, Marcel Mengelers, Alicja Mortensen, Gilles Rivière, Inger-Lise Steffensen, Christina Tlustos, Henk Van Loveren, Laurence Vernis, Holger Zorn, Boet Glandorf, Lieve Herman, Yrjö Roos, Magdalena Andryszkiewicz, Yi Liu, Simone Lunardi, Elsa Nielsen, Karin Norby, Andrew Chesson","doi":"10.2903/j.efsa.2024.8872","DOIUrl":"10.2903/j.efsa.2024.8872","url":null,"abstract":"<p>The food enzyme β-glucosidase (β-D-glucoside glucohydrolase; EC 3.2.1.21) is produced with the non-genetically modified <i>Penicillium guanacastense</i> strain AE-GLY by Amano Enzyme Inc. The food enzyme is intended to be used in four food manufacturing processes. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 4.054 mg TOS/kg body weight (bw) per day in European populations. Genotoxicity tests did not raise 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 943 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 233. A search for the similarity of the amino acid sequence of the food enzyme to known allergens was made and no match was found. The Panel considered that the risk of allergic reactions by dietary exposure 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":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11222868/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141534020","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}