Pub Date : 2024-07-16DOI: 10.2903/j.efsa.2024.8883
EFSA Panel on Biological Hazards (BIOHAZ), Konstantinos Koutsoumanis, Ana Allende, Declan Bolton, Sara Bover-Cid, Marianne Chemaly, Alessandra De Cesare, Lieve Herman, Friederike Hilbert, Roland Lindqvist, Maarten Nauta, Romolo Nonno, Luisa Peixe, Giuseppe Ru, Marion Simmons, Panagiotis Skandamis, Elisabetta Suffredini, Amie Adkin, Olivier Andreoletti, John Griffin, Barbara Lanfranchi, Angel Ortiz-Pelaez, Avelino Alvarez Ordonez
The European Commission requested an estimation of the BSE risk (C-, L- and H-BSE) from gelatine and collagen derived from ovine, caprine or bovine bones, and produced in accordance with Regulation (EC) No 853/2004, or Regulation (EC) No 1069/2009 and its implementing Regulation (EU) No 142/2011. A quantitative risk assessment was developed to estimate the BSE infectivity, measured in cattle oral infectious dose 50 (CoID50), in a small size batch of gelatine including one BSE-infected bovine or ovine animal at the clinical stage. The model was built on a scenario where all ruminant bones could be used for the production of gelatine and high-infectivity tissues remained attached to the skull (brain) and vertebral column (spinal cord). The risk and exposure pathways defined for humans and animals, respectively, were identified. Exposure routes other than oral via food and feed were considered and discussed but not assessed quantitatively. Other aspects were also considered as integrating evidence, like the epidemiological situation of the disease, the species barrier, the susceptibility of species to BSE and the assumption of an exponential dose–response relationship to determine the probability of BSE infection in ruminants. Exposure to infectivity in humans cannot be directly translated to risk of disease because the transmission barrier has not yet been quantified, although it is considered to be substantial, i.e. much greater amounts of infectivity would be needed to successfully infect a human and greater in the oral than in the parenteral route of exposure. The probability that no new case of BSE in the cattle or small ruminant population would be generated through oral exposure to gelatine made of ruminant bones is 99%–100% (almost certain) This conclusion is based on the current state of knowledge, the epidemiological situation of the disease and the current practices, and is also valid for collagen.
欧盟委员会要求对根据 (EC) No 853/2004 号法规或 (EC) No 1069/2009 号法规及其实施细则 (EU) No 142/2011 生产的明胶和胶原蛋白的疯牛病风险(C 型、L 型和 H 型疯牛病)进行评估,这些明胶和胶原蛋白来自绵羊、山羊或牛的骨骼。我们开发了一种定量风险评估方法,用于估算小批量明胶(包括临床阶段感染 BSE 的一头牛或一头绵羊)的 BSE 感染率(以牛口服感染剂量 50 (CoID50) 计)。该模型是在所有反刍动物骨骼都可用于生产明胶,高感染性组织仍附着在头骨(大脑)和脊椎骨(脊髓)上的情况下建立的。确定了分别针对人类和动物的风险和接触途径。除通过食物和饲料口服外,还考虑并讨论了其他暴露途径,但未进行定量评估。作为综合证据,还考虑了其他方面,如疾病的流行病学情况、物种屏障、物种对疯牛病的易感性,以及假设指数剂量-反应关系来确定反刍动物感染疯牛病的概率。人类的感染率不能直接转化为疾病风险,因为传播障碍尚未量化,尽管人们认为传播障碍很大,即成功感染人类所需的感染率要高得多,而且口服途径的感染率要高于肠道外接触途径。通过口服反刍动物骨骼制成的明胶不会在牛或小型反刍动物中产生新的疯牛病病例的可能性为 99%-100%(几乎肯定)。
{"title":"BSE risk posed by ruminant collagen and gelatine derived from bones","authors":"EFSA Panel on Biological Hazards (BIOHAZ), Konstantinos Koutsoumanis, Ana Allende, Declan Bolton, Sara Bover-Cid, Marianne Chemaly, Alessandra De Cesare, Lieve Herman, Friederike Hilbert, Roland Lindqvist, Maarten Nauta, Romolo Nonno, Luisa Peixe, Giuseppe Ru, Marion Simmons, Panagiotis Skandamis, Elisabetta Suffredini, Amie Adkin, Olivier Andreoletti, John Griffin, Barbara Lanfranchi, Angel Ortiz-Pelaez, Avelino Alvarez Ordonez","doi":"10.2903/j.efsa.2024.8883","DOIUrl":"10.2903/j.efsa.2024.8883","url":null,"abstract":"<p>The European Commission requested an estimation of the BSE risk (C-, L- and H-BSE) from gelatine and collagen derived from ovine, caprine or bovine bones, and produced in accordance with Regulation (EC) No 853/2004, or Regulation (EC) No 1069/2009 and its implementing Regulation (EU) No 142/2011. A quantitative risk assessment was developed to estimate the BSE infectivity, measured in cattle oral infectious dose 50 (CoID<sub>50</sub>), in a small size batch of gelatine including one BSE-infected bovine or ovine animal at the clinical stage. The model was built on a scenario where all ruminant bones could be used for the production of gelatine and high-infectivity tissues remained attached to the skull (brain) and vertebral column (spinal cord). The risk and exposure pathways defined for humans and animals, respectively, were identified. Exposure routes other than oral via food and feed were considered and discussed but not assessed quantitatively. Other aspects were also considered as integrating evidence, like the epidemiological situation of the disease, the species barrier, the susceptibility of species to BSE and the assumption of an exponential dose–response relationship to determine the probability of BSE infection in ruminants. Exposure to infectivity in humans cannot be directly translated to risk of disease because the transmission barrier has not yet been quantified, although it is considered to be substantial, i.e. much greater amounts of infectivity would be needed to successfully infect a human and greater in the oral than in the parenteral route of exposure. The probability that no new case of BSE in the cattle or small ruminant population would be generated through oral exposure to gelatine made of ruminant bones is 99%–100% (almost certain) This conclusion is based on the current state of knowledge, the epidemiological situation of the disease and the current practices, and is also valid for collagen.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11249823/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141626248","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 : 2024-07-16DOI: 10.2903/j.efsa.2024.8875
EFSA Scientific Committee, Simon John More, Diane Benford, Susanne Hougaard Bennekou, Vasileios Bampidis, Claude Bragard, Thorhallur Ingi Halldorsson, Antonio F. Hernández-Jerez, Kostas Koutsoumanis, Claude Lambré, Kyriaki Machera, Ewen Mullins, Søren Saxmose Nielsen, Josef Schlatter, Dieter Schrenk, Dominique Turck, Androniki Naska, Morten Poulsen, Jukka Ranta, Salomon Sand, Heather Wallace, Maria Bastaki, Djien Liem, Anthony Smith, Ermolaos Ververis, Giorgia Zamariola, Maged Younes
The EFSA Scientific Committee has updated its 2010 Guidance on risk–benefit assessment (RBA) of foods. The update addresses methodological developments and regulatory needs. While it retains the stepwise RBA approach, it provides additional methods for complex assessments, such as multiple chemical hazards and all relevant health effects impacting different population subgroups. The updated guidance includes approaches for systematic identification, prioritisation and selection of hazardous and beneficial food components. It also offers updates relevant to characterising adverse and beneficial effects, such as measures of effect size and dose–response modelling. The guidance expands options for characterising risks and benefits, incorporating variability, uncertainty, severity categorisation and ranking of different (beneficial or adverse) effects. The impact of different types of health effects is assessed qualitatively or quantitatively, depending on the problem formulation, scope of the RBA question and data availability. The integration of risks and benefits often involves value-based judgements and should ideally be performed with the risk–benefit manager. Metrics such as Disability-Adjusted Life Years (DALYs) and Quality-Adjusted Life Years (QALYs) can be used. Additional approaches are presented, such as probability of all relevant effects and/or effects of given severities and their integration using severity weight functions. The update includes practical guidance on reporting results, interpreting outcomes and communicating the outcome of an RBA, considering consumer perspectives and responses to advice.
{"title":"Guidance on risk–benefit assessment of foods","authors":"EFSA Scientific Committee, Simon John More, Diane Benford, Susanne Hougaard Bennekou, Vasileios Bampidis, Claude Bragard, Thorhallur Ingi Halldorsson, Antonio F. Hernández-Jerez, Kostas Koutsoumanis, Claude Lambré, Kyriaki Machera, Ewen Mullins, Søren Saxmose Nielsen, Josef Schlatter, Dieter Schrenk, Dominique Turck, Androniki Naska, Morten Poulsen, Jukka Ranta, Salomon Sand, Heather Wallace, Maria Bastaki, Djien Liem, Anthony Smith, Ermolaos Ververis, Giorgia Zamariola, Maged Younes","doi":"10.2903/j.efsa.2024.8875","DOIUrl":"10.2903/j.efsa.2024.8875","url":null,"abstract":"<p>The EFSA Scientific Committee has updated its 2010 Guidance on risk–benefit assessment (RBA) of foods. The update addresses methodological developments and regulatory needs. While it retains the stepwise RBA approach, it provides additional methods for complex assessments, such as multiple chemical hazards and all relevant health effects impacting different population subgroups. The updated guidance includes approaches for systematic identification, prioritisation and selection of hazardous and beneficial food components. It also offers updates relevant to characterising adverse and beneficial effects, such as measures of effect size and dose–response modelling. The guidance expands options for characterising risks and benefits, incorporating variability, uncertainty, severity categorisation and ranking of different (beneficial or adverse) effects. The impact of different types of health effects is assessed qualitatively or quantitatively, depending on the problem formulation, scope of the RBA question and data availability. The integration of risks and benefits often involves value-based judgements and should ideally be performed with the risk–benefit manager. Metrics such as Disability-Adjusted Life Years (DALYs) and Quality-Adjusted Life Years (QALYs) can be used. Additional approaches are presented, such as probability of all relevant effects and/or effects of given severities and their integration using severity weight functions. The update includes practical guidance on reporting results, interpreting outcomes and communicating the outcome of an RBA, considering consumer perspectives and responses to advice.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11250173/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141626327","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 : 2024-07-15DOI: 10.2903/j.efsa.2024.8898
European Food Safety Authority (EFSA), Vincenzo Cavalieri, Elisa Fasanelli, Davide Gibin, Alicia Gutierrez Linares, Pierfederico La Notte, Luca Pasinato, Alice Delbianco
This scientific report provides an update of the Xylella spp. host plant database, aiming to provide information and scientific support to risk assessors, risk managers and researchers dealing with Xylella spp. Upon a mandate of the European Commission, EFSA created and regularly updates a database of host plant species of Xylella spp. The current mandate covers the period 2021–2026. This report is related to the 10th version of the database published in Zenodo in the EFSA Knowledge Junction community, covering literature published from 1 July 2023 up to 31 December 2023, and recent Europhyt outbreak notifications. Informative data have been extracted from 39 selected publications. Sixteen new host plants, five genera and one family were identified and added to the database. They were naturally infected by X. fastidiosa subsp. fastidiosa or unknown either in Portugal or the United States. No additional data were retrieved for X. taiwanensis, and no additional multilocus sequence types (STs) were identified worldwide. New information on the tolerant/resistant response of plant species to X. fastidiosa infection were added to the database. The Xylella spp. host plant species were listed in different categories based on the number and type of detection methods applied for each finding. The overall number of Xylella spp. host plants determined with at least two different detection methods or positive with one method either by sequencing or pure culture isolation (category A), reaches now 451 plant species, 204 genera and 70 families. Such numbers rise to 712 plant species, 312 genera and 89 families if considered regardless of the detection methods applied (category E).
{"title":"Update of the Xylella spp. host plant database – Systematic literature search up to 31 December 2023","authors":"European Food Safety Authority (EFSA), Vincenzo Cavalieri, Elisa Fasanelli, Davide Gibin, Alicia Gutierrez Linares, Pierfederico La Notte, Luca Pasinato, Alice Delbianco","doi":"10.2903/j.efsa.2024.8898","DOIUrl":"10.2903/j.efsa.2024.8898","url":null,"abstract":"<p>This scientific report provides an update of the <i>Xylella</i> spp. host plant database, aiming to provide information and scientific support to risk assessors, risk managers and researchers dealing with <i>Xylella</i> spp. Upon a mandate of the European Commission, EFSA created and regularly updates a database of host plant species of <i>Xylella</i> spp. The current mandate covers the period 2021–2026. This report is related to the 10th version of the database published in Zenodo in the EFSA Knowledge Junction community, covering literature published from 1 July 2023 up to 31 December 2023, and recent Europhyt outbreak notifications. Informative data have been extracted from 39 selected publications. Sixteen new host plants, five genera and one family were identified and added to the database. They were naturally infected by <i>X. fastidiosa</i> subsp. <i>fastidiosa</i> or unknown either in Portugal or the United States. No additional data were retrieved for <i>X. taiwanensis</i>, and no additional multilocus sequence types (STs) were identified worldwide. New information on the tolerant/resistant response of plant species to <i>X. fastidiosa</i> infection were added to the database. The Xylella spp. host plant species were listed in different categories based on the number and type of detection methods applied for each finding. The overall number of Xylella spp. host plants determined with at least two different detection methods or positive with one method either by sequencing or pure culture isolation (category A), reaches now 451 plant species, 204 genera and 70 families. Such numbers rise to 712 plant species, 312 genera and 89 families if considered regardless of the detection methods applied (category E).</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11247332/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141619649","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 : 2024-07-15DOI: 10.2903/j.efsa.2024.8859
EFSA Panel on Contaminants in the Food Chain (CONTAM), Dieter Schrenk, Margherita Bignami, Laurent Bodin, James Kevin Chipman, Jesús del Mazo, Bettina Grasl-Kraupp, Christer Hogstrand, Laurentius (Ron) Hoogenboom, Jean-Charles Leblanc, Carlo Stefano Nebbia, Elsa Nielsen, Evangelia Ntzani, Annette Petersen, Salomon Sand, Tanja Schwerdtle, Heather Wallace, Diane Benford, Andy Hart, Henri Schroeder, Martin Rose, Martine Vrijheid, Eirini Kouloura, Luisa Ramos Bordajandi, Francesca Riolo, Christiane Vleminckx
The European Commission asked EFSA to update its 2011 risk assessment on tetrabromobisphenol A (TBBPA) and five derivatives in food. Neurotoxicity and carcinogenicity were considered as the critical effects of TBBPA in rodent studies. The available evidence indicates that the carcinogenicity of TBBPA occurs via non-genotoxic mechanisms. Taking into account the new data, the CONTAM Panel considered it appropriate to set a tolerable daily intake (TDI). Based on decreased interest in social interaction in male mice, a lowest observed adverse effect level (LOAEL) of 0.2 mg/kg body weight (bw) per day was identified and selected as the reference point for the risk characterisation. Applying the default uncertainty factor of 100 for inter- and intraspecies variability, and a factor of 3 to extrapolate from the LOAEL to NOAEL, a TDI for TBBPA of 0.7 μg/kg bw per day was established. Around 2100 analytical results for TBBPA in food were used to estimate dietary exposure for the European population. The most important contributors to the chronic dietary LB exposure to TBBPA were fish and seafood, meat and meat products and milk and dairy products. The exposure estimates to TBBPA were all below the TDI, including those estimated for breastfed and formula-fed infants. Accounting for the uncertainties affecting the assessment, the CONTAM Panel concluded with 90%–95% certainty that the current dietary exposure to TBBPA does not raise a health concern for any of the population groups considered. There were insufficient data on the toxicity of any of the TBBPA derivatives to derive reference points, or to allow a comparison with TBBPA that would support assignment to an assessment group for the purposes of combined risk assessment.
欧盟委员会要求欧洲食品安全局更新其 2011 年对食品中四溴双酚 A(TBBPA)和五种衍生物的风险评估。在啮齿动物研究中,神经毒性和致癌性被认为是四溴双酚 A 的关键影响。现有证据表明,三溴双酚 A 的致癌性是通过非遗传毒性机制产生的。考虑到新的数据,康坦姆小组认为设定每日可容忍摄入量(TDI)是适当的。根据雄性小鼠对社会交往兴趣下降的情况,确定了最低观测不良效应水平(LOAEL)为每天 0.2 毫克/千克体重(bw),并将其选定为风险特征描述的参考点。根据种间和种内变异性的默认不确定系数 100,以及从最低观测不良效应水平外推至无观测不良效应水平的系数 3,确定了每天 0.7 微克/千克体重的三溴双酚 A TDI。约 2100 项针对食品中四溴双酚 A 的分析结果被用于估算欧洲人口的膳食暴露量。鱼类和海产品、肉类和肉制品以及奶类和奶制品是造成长期膳食中溴化联苯醚暴露量的最主要因素。三溴双酚 A 的估计暴露量都低于 TDI,包括母乳喂养和配方奶喂养婴儿的估计暴露量。考虑到影响评估的不确定性,康坦姆小组以90%-95%的确定性得出结论,认为目前从膳食中摄入的三溴双酚A不会对所考虑的任何人群造成健康问题。没有足够的数据说明任何一种三溴双酚A衍生物的毒性,因此无法得出参考点,也无法与三溴双酚A进行比较,从而支持为综合风险评估目的将其归入一个评估组。
{"title":"Update of the scientific opinion on tetrabromobisphenol A (TBBPA) and its derivatives in food","authors":"EFSA Panel on Contaminants in the Food Chain (CONTAM), Dieter Schrenk, Margherita Bignami, Laurent Bodin, James Kevin Chipman, Jesús del Mazo, Bettina Grasl-Kraupp, Christer Hogstrand, Laurentius (Ron) Hoogenboom, Jean-Charles Leblanc, Carlo Stefano Nebbia, Elsa Nielsen, Evangelia Ntzani, Annette Petersen, Salomon Sand, Tanja Schwerdtle, Heather Wallace, Diane Benford, Andy Hart, Henri Schroeder, Martin Rose, Martine Vrijheid, Eirini Kouloura, Luisa Ramos Bordajandi, Francesca Riolo, Christiane Vleminckx","doi":"10.2903/j.efsa.2024.8859","DOIUrl":"10.2903/j.efsa.2024.8859","url":null,"abstract":"<p>The European Commission asked EFSA to update its 2011 risk assessment on tetrabromobisphenol A (TBBPA) and five derivatives in food. Neurotoxicity and carcinogenicity were considered as the critical effects of TBBPA in rodent studies. The available evidence indicates that the carcinogenicity of TBBPA occurs via non-genotoxic mechanisms. Taking into account the new data, the CONTAM Panel considered it appropriate to set a tolerable daily intake (TDI). Based on decreased interest in social interaction in male mice, a lowest observed adverse effect level (LOAEL) of 0.2 mg/kg body weight (bw) per day was identified and selected as the reference point for the risk characterisation. Applying the default uncertainty factor of 100 for inter- and intraspecies variability, and a factor of 3 to extrapolate from the LOAEL to NOAEL, a TDI for TBBPA of 0.7 μg/kg bw per day was established. Around 2100 analytical results for TBBPA in food were used to estimate dietary exposure for the European population. The most important contributors to the chronic dietary LB exposure to TBBPA were fish and seafood, meat and meat products and milk and dairy products. The exposure estimates to TBBPA were all below the TDI, including those estimated for breastfed and formula-fed infants. Accounting for the uncertainties affecting the assessment, the CONTAM Panel concluded with 90%–95% certainty that the current dietary exposure to TBBPA does not raise a health concern for any of the population groups considered. There were insufficient data on the toxicity of any of the TBBPA derivatives to derive reference points, or to allow a comparison with TBBPA that would support assignment to an assessment group for the purposes of combined risk assessment.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11247339/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141619650","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 : 2024-07-15DOI: 10.2903/j.efsa.2024.8874
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, Lieve Herman, Jaime Aguilera, Magdalena Andryszkiewicz, Daniele Cavanna, Cristina Fernàndez-Fraguas, Yi Liu, Sandra Rainieri, Yrjö Roos, Andrew Chesson
The food enzyme asparaginase (l-asparagine amidohydrolase; EC 3.5.1.1) is produced with the genetically modified Aspergillus niger strain ASP by DSM Food Specialties B.V. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in the prevention of acrylamide formation in foods and in the processing of yeast and yeast products. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.792 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 at the highest dose tested of 1038 mg TOS/kg bw per day, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 1311. 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 upon 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 asparaginase from the genetically modified Aspergillus niger strain ASP","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, Lieve Herman, Jaime Aguilera, Magdalena Andryszkiewicz, Daniele Cavanna, Cristina Fernàndez-Fraguas, Yi Liu, Sandra Rainieri, Yrjö Roos, Andrew Chesson","doi":"10.2903/j.efsa.2024.8874","DOIUrl":"10.2903/j.efsa.2024.8874","url":null,"abstract":"<p>The food enzyme asparaginase (<span>l</span>-asparagine amidohydrolase; EC 3.5.1.1) is produced with the genetically modified <i>Aspergillus niger</i> strain ASP by DSM Food Specialties B.V. The genetic modifications do not give rise to safety concerns. The food enzyme was considered free from viable cells of the production organism and its DNA. The food enzyme is intended to be used in the prevention of acrylamide formation in foods and in the processing of yeast and yeast products. Dietary exposure to the food enzyme-total organic solids (TOS) was estimated to be up to 0.792 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 at the highest dose tested of 1038 mg TOS/kg bw per day, which when compared with the estimated dietary exposure, resulted in a margin of exposure of at least 1311. 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 upon 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":"2024-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11247330/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141619648","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 : 2024-07-15DOI: 10.2903/j.efsa.2024.8854
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Maryline Kouba, Marta López-Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Roberto Edoardo Villa, Ruud Woutersen, Boet Glandorf, Luca Tosti, Montserrat Anguita, Matteo Lorenzo Innocenti, Jordi Tarrés-Call, Elisa Pettenati
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of endo-1,4-beta-xylanase (produced with Trichoderma reesei MUCL 49755), endo-1,3(4)-beta-glucanase (produced with T. reesei MUCL 49754) and polygalacturonase (produced with Aspergillus fijiensis CBS 589.94) (AveMix® 02 CS/ AveMix® 02 CS L) as a zootechnical feed additive for weaned and suckling piglets. The additive is already authorised for use with weaned piglets. This scientific opinion concerns the request for the renewal of the authorisation of the additive for weaned piglets and the extension of use to suckling piglets. The applicant provided evidence that the additive currently in the market complies with the conditions of the authorisation. There was no new evidence that would lead the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) to reconsider its previous conclusions that the additive is safe for weaned piglets, the consumer and the environment under the authorised conditions of use. This conclusion applied also to the new target species (suckling piglets) for which a request for an extension of use was made. The additive in both formulations (powder and liquid) is not irritant to skin or eyes but should be considered a dermal and respiratory sensitiser. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation for weaned piglets. The Panel concluded that the additive is efficacious in suckling piglets at 2140 XU, 1230 BGU and 46 PGLU/kg complete feed.
应欧盟委员会的请求,欧洲食品安全局被要求就由内-1,4-beta-木聚糖酶(由毛霉菌 MUCL 49755 生产)、内-1,3(4)-beta-葡聚糖酶(由毛霉菌 MUCL 49754 生产)和聚半乳糖醛酸酶(由斐济曲霉菌 CBS 589.94 生产)组成的饲料添加剂(AveMix® 02 CS/ AveMix® 02 CS L)的安全性和功效提出科学意见。作为断奶仔猪和哺乳仔猪的动物技术饲料添加剂,AveMix® 02 CS/ AveMix® 02 CS L 可添加内-1,3(4-beta-葡聚糖酶(由 T. reesei MUCL 49754 生产)和聚半乳糖醛酸酶(由 Aspergillus fijiensis CBS 589.94 生产)。该添加剂已获准用于断奶仔猪。本科学意见涉及该添加剂用于断奶仔猪的授权续展申请,以及将使用范围扩大到哺乳仔猪的申请。申请人提供的证据表明,目前市场上销售的添加剂符合授权条件。没有新的证据导致添加剂和动物饲料中使用的产品或物质专家小组(FEEDAP)重新考虑其先前的结论,即在授权使用条件下,该添加剂对断奶仔猪、消费者和环境是安全的。这一结论也适用于新的目标物种(哺乳仔猪),该物种已申请延长使用期限。两种配方(粉末和液体)中的添加剂对皮肤和眼睛均无刺激性,但应视为皮肤和呼吸道致敏物质。在延长断奶仔猪使用许可的情况下,没有必要评估该添加剂的功效。专家小组的结论是,该添加剂对哺乳仔猪有效,每公斤全价饲料中的剂量为 2140 XU、1230 BGU 和 46 PGLU。
{"title":"Assessment of the feed additive consisting of endo-1,4-beta-xylanase (produced with Trichoderma reesei MUCL 49755), endo-1,3(4)-beta-glucanase (produced with T. reesei MUCL 49754) and polygalacturonase (produced with Aspergillus fijiensis CBS 589.94) (AveMix® 02 CS) for weaned piglets for the renewal of its authorisation and for its extension of use to suckling piglets (AVEVE BV)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Maryline Kouba, Marta López-Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Roberto Edoardo Villa, Ruud Woutersen, Boet Glandorf, Luca Tosti, Montserrat Anguita, Matteo Lorenzo Innocenti, Jordi Tarrés-Call, Elisa Pettenati","doi":"10.2903/j.efsa.2024.8854","DOIUrl":"10.2903/j.efsa.2024.8854","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 the feed additive consisting of endo-1,4-beta-xylanase (produced with <i>Trichoderma reesei</i> MUCL 49755), endo-1,3(4)-beta-glucanase (produced with <i>T. reesei</i> MUCL 49754) and polygalacturonase (produced with <i>Aspergillus fijiensis</i> CBS 589.94) (AveMix® 02 CS/ AveMix® 02 CS L) as a zootechnical feed additive for weaned and suckling piglets. The additive is already authorised for use with weaned piglets. This scientific opinion concerns the request for the renewal of the authorisation of the additive for weaned piglets and the extension of use to suckling piglets. The applicant provided evidence that the additive currently in the market complies with the conditions of the authorisation. There was no new evidence that would lead the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) to reconsider its previous conclusions that the additive is safe for weaned piglets, the consumer and the environment under the authorised conditions of use. This conclusion applied also to the new target species (suckling piglets) for which a request for an extension of use was made. The additive in both formulations (powder and liquid) is not irritant to skin or eyes but should be considered a dermal and respiratory sensitiser. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation for weaned piglets. The Panel concluded that the additive is efficacious in suckling piglets at 2140 XU, 1230 BGU and 46 PGLU/kg complete feed.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11247329/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141619646","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 : 2024-07-15DOI: 10.2903/j.efsa.2024.8852
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Maryline Kouba, Marta López-Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Roberto Edoardo Villa, Ruud Woutersen, Paul Brantom, Boet Glandorf, Montserrat Anguita, Matteo Lorenzo Innocenti, Jordi Tarrés-Call, Elisa Pettenati
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of endo-1,4-beta-xylanase (produced with Trichoderma reesei MUCL 49755) and endo-1,3(4)-beta-glucanase (produced with T. reesei MUCL 49754) (AveMix® XG 10/AveMix® XG 10 L) as a zootechnical feed additive for weaned and suckling piglets. The additive is already authorised for use in weaned piglets. This scientific opinion concerns the request for the renewal of the authorisation of the additive for weaned piglets and the extension of use to suckling piglets. The applicant declared a change in the carrier material used in AveMix® XG 10 from soybean meal to calcium carbonate + wheat flour or calcium carbonate + sepiolite. The applicant provided evidence that the additive AveMix® XG 10 with calcium carbonate + wheat flour and AveMix® XG 10 L comply with the conditions of the authorisation. The EFSA Panel on Additives and Products or Substances used in Animal FEED (FEEDAP) noted that no data were submitted to support compliance of the formulation of AveMix® XG 10 with calcium carbonate + sepiolite with the conditions of the authorisation. The FEEDAP Panel concluded that both formulations of the additive (powder and liquid) remain safe for the target species, consumers and the environment, and that the extension of use to suckling piglets would not affect these conclusions. AveMix® XG 10 formulated with calcium carbonate + sepiolite and AveMix® XG 10 L are not irritant to skin and eyes. No conclusions on the irritation potential of AveMix® XG 10 formulated with calcium carbonate + wheat flour could be drawn. The additive in all its formulations is considered a respiratory and skin sensitiser. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation for weaned piglets. The Panel concluded that the additive is efficacious in suckling piglets at 4000 XU and 900 BGU/kg complete feed.
{"title":"Assessment of the feed additive consisting of endo-1,4-beta-xylanase (produced with Trichoderma reesei MUCL 49755) and endo-1,3(4)-beta-glucanase (produced with T. reesei MUCL 49754) (AveMix® XG 10) for weaned piglets for the renewal of its authorisation and for its extension of use to suckling piglets (AVEVE BV)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Maryline Kouba, Marta López-Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Roberto Edoardo Villa, Ruud Woutersen, Paul Brantom, Boet Glandorf, Montserrat Anguita, Matteo Lorenzo Innocenti, Jordi Tarrés-Call, Elisa Pettenati","doi":"10.2903/j.efsa.2024.8852","DOIUrl":"10.2903/j.efsa.2024.8852","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 the feed additive consisting of endo-1,4-beta-xylanase (produced with <i>Trichoderma reesei</i> MUCL 49755) and endo-1,3(4)-beta-glucanase (produced with <i>T. reesei</i> MUCL 49754) (AveMix® XG 10/AveMix® XG 10 L) as a zootechnical feed additive for weaned and suckling piglets. The additive is already authorised for use in weaned piglets. This scientific opinion concerns the request for the renewal of the authorisation of the additive for weaned piglets and the extension of use to suckling piglets. The applicant declared a change in the carrier material used in AveMix® XG 10 from soybean meal to calcium carbonate + wheat flour or calcium carbonate + sepiolite. The applicant provided evidence that the additive AveMix® XG 10 with calcium carbonate + wheat flour and AveMix® XG 10 L comply with the conditions of the authorisation. The EFSA Panel on Additives and Products or Substances used in Animal FEED (FEEDAP) noted that no data were submitted to support compliance of the formulation of AveMix® XG 10 with calcium carbonate + sepiolite with the conditions of the authorisation. The FEEDAP Panel concluded that both formulations of the additive (powder and liquid) remain safe for the target species, consumers and the environment, and that the extension of use to suckling piglets would not affect these conclusions. AveMix® XG 10 formulated with calcium carbonate + sepiolite and AveMix® XG 10 L are not irritant to skin and eyes. No conclusions on the irritation potential of AveMix® XG 10 formulated with calcium carbonate + wheat flour could be drawn. The additive in all its formulations is considered a respiratory and skin sensitiser. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation for weaned piglets. The Panel concluded that the additive is efficacious in suckling piglets at 4000 XU and 900 BGU/kg complete feed.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11247333/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141619647","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 : 2024-07-12DOI: 10.2903/j.efsa.2024.8846
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Maryline Kouba, Marta López-Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Roberto Edoardo Villa, Ruud Woutersen, Paul Brantom, Miguel Prieto, Montserrat Anguita, Jaume Galobart, Matteo L. Innocenti, Jordi Ortuño, Elisa Pettenati, Fabiola Pizzo, Rosella Brozzi
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the alpha-amylase (Ronozyme® HiStarch CT/L) produced with a genetically modified strain of Bacillus licheniformis (DSM 34315) as a zootechnical feed additive for chickens for fattening, turkeys for fattening and minor growing poultry species. The additive is available in two forms, a coated thermotolerant granulate formulation and a liquid formulation. The production strain and its DNA were not detected in an intermediate concentrated product representative of the final formulations. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the final product did not trigger safety concerns with regard to the genetic modification. The Panel concluded that Ronozyme® HiStarch CT/L is safe for chickens for fattening, turkeys for fattening and minor growing poultry species at the recommended inclusion level of 80 KNU/kg complete feed. The use of Ronozyme® HiStarch CT/L in animal nutrition under the proposed conditions of use is safe for the consumers and the environment. The additive in any form was shown to be non-irritant to the skin and the solid form was shown to be non-irritant to the eyes. No conclusions could be drawn on the potential of the liquid form to be irritant to the eyes or on the potential of both forms of the additive to be dermal sensitisers due to lack of data. Owing to the proteinaceous nature of the active substance, the additive in either form was considered to be a respiratory sensitiser and any exposure by inhalation is considered a risk. In the absence of data, the Panel was not in the position to conclude on the efficacy of Ronozyme® HiStarch CT/L for chickens for fattening, turkeys for fattening and minor growing poultry species.
{"title":"Safety and efficacy of a feed additive consisting of alpha-amylase (produced with Bacillus licheniformis DSM 34315) (Ronozyme® HiStarch) for chickens for fattening, turkeys for fattening and minor growing poultry species (DSM Nutritional Products Ltd)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Maryline Kouba, Marta López-Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Roberto Edoardo Villa, Ruud Woutersen, Paul Brantom, Miguel Prieto, Montserrat Anguita, Jaume Galobart, Matteo L. Innocenti, Jordi Ortuño, Elisa Pettenati, Fabiola Pizzo, Rosella Brozzi","doi":"10.2903/j.efsa.2024.8846","DOIUrl":"https://doi.org/10.2903/j.efsa.2024.8846","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 the alpha-amylase (Ronozyme® HiStarch CT/L) produced with a genetically modified strain of <i>Bacillus licheniformis</i> (DSM 34315) as a zootechnical feed additive for chickens for fattening, turkeys for fattening and minor growing poultry species. The additive is available in two forms, a coated thermotolerant granulate formulation and a liquid formulation. The production strain and its DNA were not detected in an intermediate concentrated product representative of the final formulations. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the final product did not trigger safety concerns with regard to the genetic modification. The Panel concluded that Ronozyme® HiStarch CT/L is safe for chickens for fattening, turkeys for fattening and minor growing poultry species at the recommended inclusion level of 80 KNU/kg complete feed. The use of Ronozyme® HiStarch CT/L in animal nutrition under the proposed conditions of use is safe for the consumers and the environment. The additive in any form was shown to be non-irritant to the skin and the solid form was shown to be non-irritant to the eyes. No conclusions could be drawn on the potential of the liquid form to be irritant to the eyes or on the potential of both forms of the additive to be dermal sensitisers due to lack of data. Owing to the proteinaceous nature of the active substance, the additive in either form was considered to be a respiratory sensitiser and any exposure by inhalation is considered a risk. In the absence of data, the Panel was not in the position to conclude on the efficacy of Ronozyme® HiStarch CT/L for chickens for fattening, turkeys for fattening and minor growing poultry species.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.8846","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141597187","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 : 2024-07-12DOI: 10.2903/j.efsa.2024.p220702
{"title":"Plain Language Summary of the use of high expansion foam for stunning and killing pigs and poultry","authors":"","doi":"10.2903/j.efsa.2024.p220702","DOIUrl":"https://doi.org/10.2903/j.efsa.2024.p220702","url":null,"abstract":"","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.p220702","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141597184","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 : 2024-07-12DOI: 10.2903/j.efsa.2024.8855
EFSA Panel on Animal Health and Welfare (AHAW), Søren Saxmose Nielsen, Julio Alvarez, Dominique Joseph Bicout, Paolo Calistri, Elisabetta Canali, Julian Ashley Drewe, Bruno Garin-Bastuji, Jose Luis Gonzales Rojas, Christian Gortázar, Mette S. Herskin, Miguel Ángel Miranda Chueca, Barbara Padalino, Helen Clare Roberts, Hans Spoolder, Karl Stahl, Antonio Velarde, Christoph Winckler, Arvo Viltrop, Jessica Martin, Mohan Raj, Alexei Vyssotski, Yves Van der Stede, Marika Vitali, Aikaterini Manakidou, Virginie Michel
The EFSA Panel on Animal Health and Welfare (AHAW) was asked to deliver a scientific opinion on the use of high-expansion foam for stunning and killing pigs and poultry. A dossier was provided by the applicant as the basis for an assessment of the extent to which the method is able to provide a level of animal welfare at least equivalent to that ensured by the currently allowed methods for pigs and poultry. According to legislation, to be approved in the EU, new stunning methods must ensure (1) the absence of pain, distress or suffering until the onset of unconsciousness, and (2) that the animal remains unconscious until death. An ad hoc Working Group set up by EFSA performed the assessment as follows: (1) The data provided were checked against the criteria laid down in the EFSA Guidance (EFSA, 2018), and was found to partially fulfil those criteria; (2) extensive literature search; (3) data extraction for quantitative assessment; (4) qualitative exercise based on non-formal expert elicitation. The assessment led to conclude that it is more likely than not (certainty > 50%–100%) that high-expansion foam for stunning and killing pigs and poultry, named NEFS in container (Nitrogen Expansion Foam Stunning in container), provides a level of welfare at least equivalent to one or more of the currently allowed methods listed in Annex I of Council Regulation (EC) No 1099/2009. The overall assessment of EFSA is valid only under the technical conditions described in this Opinion for laying hens, broiler chickens of all age and pigs weighing 15–41 kg in situations other than slaughter. The overall assessment of EFSA is that NEFS can be suitable for depopulation using containers for pig and poultry farms respecting the technical conditions and the categories and types of animals defined in this Scientific Opinion.
{"title":"The use of high expansion foam for stunning and killing pigs and poultry","authors":"EFSA Panel on Animal Health and Welfare (AHAW), Søren Saxmose Nielsen, Julio Alvarez, Dominique Joseph Bicout, Paolo Calistri, Elisabetta Canali, Julian Ashley Drewe, Bruno Garin-Bastuji, Jose Luis Gonzales Rojas, Christian Gortázar, Mette S. Herskin, Miguel Ángel Miranda Chueca, Barbara Padalino, Helen Clare Roberts, Hans Spoolder, Karl Stahl, Antonio Velarde, Christoph Winckler, Arvo Viltrop, Jessica Martin, Mohan Raj, Alexei Vyssotski, Yves Van der Stede, Marika Vitali, Aikaterini Manakidou, Virginie Michel","doi":"10.2903/j.efsa.2024.8855","DOIUrl":"https://doi.org/10.2903/j.efsa.2024.8855","url":null,"abstract":"<p>The EFSA Panel on Animal Health and Welfare (AHAW) was asked to deliver a scientific opinion on the use of high-expansion foam for stunning and killing pigs and poultry. A dossier was provided by the applicant as the basis for an assessment of the extent to which the method is able to provide a level of animal welfare at least equivalent to that ensured by the currently allowed methods for pigs and poultry. According to legislation, to be approved in the EU, new stunning methods must ensure (1) the absence of pain, distress or suffering until the onset of unconsciousness, and (2) that the animal remains unconscious until death. An ad hoc Working Group set up by EFSA performed the assessment as follows: (1) The data provided were checked against the criteria laid down in the EFSA Guidance (EFSA, 2018), and was found to partially fulfil those criteria; (2) extensive literature search; (3) data extraction for quantitative assessment; (4) qualitative exercise based on non-formal expert elicitation. The assessment led to conclude that it is more likely than not (certainty > 50%–100%) that high-expansion foam for stunning and killing pigs and poultry, named NEFS in container (Nitrogen Expansion Foam Stunning in container), provides a level of welfare at least equivalent to one or more of the currently allowed methods listed in Annex I of Council Regulation (EC) No 1099/2009. The overall assessment of EFSA is valid only under the technical conditions described in this Opinion for laying hens, broiler chickens of all age and pigs weighing 15–41 kg in situations other than slaughter. The overall assessment of EFSA is that NEFS can be suitable for depopulation using containers for pig and poultry farms respecting the technical conditions and the categories and types of animals defined in this Scientific Opinion.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":null,"pages":null},"PeriodicalIF":3.3,"publicationDate":"2024-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2024.8855","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141596993","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}