EFSA Supporting Publications最新文献

{"title":"Updates to the wild bird abundance and movement models for the early warning system for avian influenza in the EU","authors":"Juan Gallego-Zamorano,&nbsp;Jacob Davies,&nbsp;Roos Reinartz,&nbsp;Rob Robinson,&nbsp;Gabriel Gargallo,&nbsp;Céline Faverjon,&nbsp;Henk Sierdsema,&nbsp;Julia Stahl","doi":"10.2903/sp.efsa.2024.EN-9000","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-9000","url":null,"abstract":"<p>Highly pathogenic avian influenza (HPAI) viruses pose a significant threat to both poultry and wild bird populations. Migratory wild birds play a key role in the intercontinental spread of avian influenza (AI), introducing the virus into poultry populations. In response to frequent AI outbreaks in Europe, the European Food Safety Authority (EFSA), at the request of the European Commission (EC), produces quarterly and annual epidemiological reports to monitor and analyse AI trends. A key component of this surveillance includes the integration of outbreak data from Member States and contributions from non-governmental ornithological organisations like the European Bird Census Council (EBCC) and the European Union for Bird Ringing (EURING) together in a predictive spatio-temporal risk assessment model. Previous data integration and modelling efforts led to the development of an early warning system for predicting HPAI outbreaks accessible through a publicly available online user interface: the Bird Flu Radar. This report presents an improvement of the system by expanding the species coverage and refining the existing base models behind the epidemiological model. Specifically, this report details the exploration to incorporate 12 additional wild bird species into the models, and the changes made to the base models predicting the distribution and movements of wild birds. We demonstrate the improvements respecting the existing base models while at the same time enhancing the effectiveness in predicting HPAI outbreaks and possibly mitigating negative effects in Europe by providing more accurate predictions to different stakeholders.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 10","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-9000","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142429191","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mock Assessment: Acute prospective cumulative risk assessment","authors":"Laurine Lucas,&nbsp;Pierre L'Yvonnet,&nbsp;Alexandra Mienné,&nbsp;Xavier Sarda","doi":"10.2903/sp.efsa.2024.EN-9014","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-9014","url":null,"abstract":"<p>This Mock assessment is a part of the Framework Partnership Agreement between ANSES and EFSA with the help of RIVM to investigate the feasibility of a tiered approach proposed by EFSA for prospective acute cumulative risk assessment (CRA). Three tiers address successively a need for prospective CRA (Tier 0), the safety of the MRL (Tier I) and the safety of the intended GAP (Tier II). ANSES tested this approach with an application for change of MRL for the active substance tefluthrin (with acute effects on functional alterations of the motor division) on carrot based on a new intended use. For each tier, the Margin of Exposure (MOE) was calculated for 9 populations with MCRA software using input data provided by EFSA. At P99.9 of exposure, all the adjusted MOET at Tier I and Tier II of all populations were below the threshold of 100. Different settings were tested (IESTI equation, consumption data, adjustment for uncertainties, cycle of monitoring data…). With respect to Tier I, the trigger value of 1000 for the MOE_{Tier 0} is pragmatic. In the vast majority of cases, when the MOE_{Tier 0} is above 1000, the MOET_{Tier I} would be above 100. With respect to Tier II, a MOE_{Tier 0} higher than 1000 ensures a MOET_{Tier II} above 100. Tier I could be considered a good first estimate for a prospective CRA with conservative parameters for the foreground. Two routes were tested to account for uncertainties. One was not possible. The second resulted in a new median multiplicative factor (MF)_{exposure*toxicology} of 2.82 that differs significantly from the value of 5.13 found in the retrospective assessment. Despite the simplifications envisaged, the uncertainty analysis seems difficult to be implemented on a routine basis and it might be useful to define criteria to identify cases where an uncertainty analysis is really needed.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 9","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-9014","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142316882","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A proposal for the development of a feed consumption database using a standardised feed classification system","authors":"L. Pinotti,&nbsp;G. Pastorelli,&nbsp;G. Varese,&nbsp;F. Cheli,&nbsp;C. Di Lorenzo,&nbsp;S. Montanelli,&nbsp;C. Landolfi,&nbsp;G. Mangano,&nbsp;C. Gazerro,&nbsp;V. Perricone,&nbsp;M. Ottoboni,&nbsp;A. Moradei,&nbsp;R. Abbate,&nbsp;A. Luciano,&nbsp;F. Mercogliano","doi":"10.2903/sp.efsa.2024.EN-9036","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-9036","url":null,"abstract":"<p>There is currently no comprehensive feed consumption database using a harmonised feed classification system. This means there is a lack of accurate information on the individual amount of feed consumed daily by farmed and companion animals. Such a database would support exposure assessments of feed. This report provides a complete overview of the main feed databases, their structure, and how feed materials are classified. It highlights their limits and potential and reports any differences from FoodEx2. A proposal for future updates of FoodEx2 and the development of a comprehensive feed consumption model database is provided. The proposed model database is based on three information areas represented by three Excel sheets. These represent Animal, Feed, and Consumption, allowing the determination of animal dietary exposure. A proof of concept of the developed model database was carried out by performing two case studies focused on genetically modified feed and feed contaminants. For genetically modified feed, a reduced animal dietary exposure was obtained compared to estimations reported in the scientific opinions and obtained using Excel calculators proposed by EFSA. For the contaminants in feed, differences were limited, resulting in slightly higher or lower exposure values. Weaknesses and possible mitigations are also addressed, and recommendations are made for a comprehensive feed consumption database. These include recommendations establishing an EU classification system in which the main features and items reported in the European Catalogue of Feed Materials are harmonised with FoodEx2. It is also recommended that real-life animal consumption data are collected by the feed industry, animal nutritionists, breeders, and farmers, along with the collaboration of stakeholders.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 9","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-9036","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142316883","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mock assessment: Chronic prospective cumulative risk assessment","authors":"Laurine Lucas,&nbsp;Pierre L'Yvonnet,&nbsp;Alexandra Mienné,&nbsp;Xavier Sarda","doi":"10.2903/sp.efsa.2024.EN-9013","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-9013","url":null,"abstract":"<p>This Mock assessment is a part of the Framework Partnership Agreement between ANSES and EFSA with the help of RIVM to investigate the feasibility of a tiered approach proposed by EFSA for prospective chronic cumulative risk assessment (CRA). Three tiers address successively (i) a need for prospective CRA (Tier 0) using a deterministic approach to estimate the foreground exposure based on IEDI equation, (ii) a first estimation of prospective CRA (Tier I) using a probabilistic approach to estimate the background exposure at P99.9 and a deterministic approach to estimate the foreground exposure at mean or P97.5 consumption and (iii) a second estimation of prospective CRA (Tier II) using a probabilistic approach to estimate the background and foreground exposure at P99.9. ANSES tested this approach with an MRL application for the active substance fenamidone (with chronic effects on the thyroid) on lettuce, based on a new intended use currently under assessment at national level. For each Tier, the Margin of Exposure (MOE) was calculated for 9 populations with MCRA software using input data provided by EFSA and settings according to EFSA protocol. Different combinations of settings were tested as part of sensitivity analyses (consumption data, adjustment for additional uncertainties, cycle of monitoring data, etc.) and were used as the basis for discussion of different open points (trigger value in Tier 0, use frequency for the focal combination in tier II, ad hoc uncertainty analysis to account for additional uncertainties, etc.) to be addressed before prospective CRA could be implemented as a routine exercise. Finally, based on these discussions, recommendations were made to consolidate the approach for chronic prospective CRA.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 9","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-9013","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142316881","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Data collection, hazard characterisation and establishment of cumulative assessment groups of pesticides for specific effects on the thyroid: 2024 update","authors":"Francesca Metruccio,&nbsp;Ilaria Castelli,&nbsp;Alessandra Baroni,&nbsp;Martina Marazzini,&nbsp;Teresa Mammone,&nbsp;Luca Tosti","doi":"10.2903/sp.efsa.2024.EN-9012","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-9012","url":null,"abstract":"<p>This report evaluates the thyroid-related effects of various active substances and metabolites, categorizing them into Cumulative Assessment Groups (CAGs) based on indicators of hypothyroidism and C-cell effects. 21 active substances and six metabolites were scrutinized resulting in 18 substances and three metabolites for hypothyroidism (CAG-TCF) and two substances for C-cell hypertrophy, hyperplasia, and neoplasia (CAG-TCP). Detailed NOAEL and LOAEL values were derived for each substance, highlighting differences between current findings and previous assessments. The analysis reveals uncertainties due to variations in data quality and study durations. Overall, the report provides a comprehensive hazard characterization of substances affecting thyroid function, contributing to cumulative risk assessment update for effects on the thyroid.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 9","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-9012","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142313311","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Outcome of the stakeholder consultation on the reasoned opinions for azocyclotin, bifenthrin, chlorfenapyr, cyhexatin, diazinon, dicofol, endosulfan, fenarimol, fenpropathrin and profenofos","authors":"European Food Safety Authority (EFSA)","doi":"10.2903/sp.efsa.2024.EN-9002","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-9002","url":null,"abstract":"<p>In accordance with Article 43 of Regulation (EC) No 396/2005, the European Commission has requested the European Food Safety Authority (EFSA) to organise a stakeholder consultation on the reasoned opinions for the following active substances, non-approved for use as plant protection products in the European Union: azocyclotin, bifenthrin, chlorfenapyr, cyhexatin, diazinon, dicofol, endosulfan, fenarimol, fenpropathrin and profenofos. This technical report presents the outcome of the consultation, an appraisal of the data received and a conclusion on whether a reconsideration of the previous assessments will be needed based on the additional data collected.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 9","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-9002","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142313310","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Proposal for a qualification system for New Approach Methodologies (NAMs) in the food and feed sector: example of implementation for nanomaterial risk assessment","authors":"Andrea Haase,&nbsp;João Barroso,&nbsp;Alessia Bogni,&nbsp;Susanne Bremer-Hoffmann,&nbsp;Valerie Fessard,&nbsp;Arno C. Gutleb,&nbsp;Jan Mast,&nbsp;Emily McVey,&nbsp;Birgit Mertens,&nbsp;Agnes G. Oomen,&nbsp;Vera Ritz,&nbsp;Tommaso Serchi,&nbsp;Katherina Siewert,&nbsp;Deborah Stanco,&nbsp;Shirin M. Usmani,&nbsp;Eveline Verleysen,&nbsp;Olimpia Vincentini,&nbsp;Meike van der Zande,&nbsp;Francesco Cubadda","doi":"10.2903/sp.efsa.2024.EN-9008","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-9008","url":null,"abstract":"<p>Plenty of new approach methodologies (NAMs) for risk assessment have been developed but only some are included in OECD Test Guidelines (TGs) for regulatory implementation. Nevertheless, NAMs are increasingly applied, e.g. for nanomaterial (NM) risk assessments. The EFSA Guidance on NM risk assessment suggests that NAM-derived data concerning degradation/dissolution (in relevant biofluids), intestinal uptake/crossing, genotoxicity, cytotoxicity, oxidative stress, (pro-)inflammatory potential and barrier integrity, for many of which no OECD TGs exist, have to be evaluated first. Consequently, NM risk assessments involve data from non-guideline studies, requiring time-consuming and challenging case-by-case evaluations. Establishing an OECD TG is a formal process aiming for international use according to the Mutual Acceptance of Data (MAD). However, not every promising NAM can be prioritised for OECD TGs. A qualification, based on an expert opinion, may enable an efficient use of adequate NAMs for a specific context-of-use. Furthermore, it supports the optimisation of promising NAMs for regulatory applications. Existing qualification systems operate in the context of e.g., drug development tools (FDA) and research and development into pharmaceuticals (EMA). The NAMS4NANO consortium was tasked to propose a generic framework for a qualification system for chemical risk assessment in the food and feed sector to speed up the regulatory use of NAMs. Here we describe our proposal including the process and evaluation criteria. A detailed test method description, preferably as standard operating procedures (SOPs), describing the set-up of the NAM including its application and evaluation phase is crucial. Furthermore, the scientific validity, i.e. its reliability and relevance for the context-of-use, needs to be demonstrated, for which we suggest a less rigorous process compared to OECD TGs. We propose to initially establish a qualification system for NM risk assessment, aligned with the EFSA framework. This document is an interim version to stipulate a broader discussion among experts and stakeholders.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 9","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-9008","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142244983","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Review of New Approach Methodologies for Application in Risk Assessment of Nanoparticles in the Food and Feed Sector: Status and Challenges","authors":"Shirin M. Usmani,&nbsp;Susanne Bremer-Hoffmann,&nbsp;Karlien Cheyns,&nbsp;Francesco Cubadda,&nbsp;Verónica I. Dumit,&nbsp;Sylvia E. Escher,&nbsp;Valerie Fessard,&nbsp;Arno C. Gutleb,&nbsp;Thibaut Léger,&nbsp;Yuk-Chien Liu,&nbsp;Jan Mast,&nbsp;Emily McVey,&nbsp;Birgit Mertens,&nbsp;Daniela Montalvo,&nbsp;Agnes G. Oomen,&nbsp;Vera Ritz,&nbsp;Tommaso Serchi,&nbsp;Holger Sieg,&nbsp;Katherina Siewert,&nbsp;Deborah Stanco,&nbsp;Eveline Verleysen,&nbsp;Olimpia Vincentini,&nbsp;Calvin W. S. Yeo,&nbsp;Dingyi Yu,&nbsp;Meike van der Zande,&nbsp;Andrea Haase","doi":"10.2903/sp.efsa.2024.EN-8826","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-8826","url":null,"abstract":"<p>New Approach Methodologies (NAMs), broadly understood to include <i>in silico</i>, <i>in chemico</i>, <i>in vitro</i> and <i>ex vivo</i> methods, show great potential in advancing risk assessment albeit their regulatory implementation is lagging. The EFSA Guidance on risk assessment of nanomaterials (EFSA Guidance on Nano-RA) suggests nano-specific risk assessment is best achieved through Integrated Approaches to Testing and Assessment (IATAs) with NAMs as the first choice to generate new information. Integrating NAMs in risk assessment promises several advantages such as a better human focus, more detailed insights into molecular mechanisms and a higher efficacy. However, applying NAMs to NMs also poses considerable challenges such as issues related to dispersion stability, dosimetry, agglomeration, dissolution, transformations or assay interferences. Significant efforts are being undertaken by standardisation organisations and research projects to establish various NAMs for NMs. Here a thorough review is provided covering NAMs that will be potentially useful for risk assessment of NMs in the food and feed sector. It follows the structure of the EFSA Guidance on Nano-RA and expands it, where needed, to support decision-making in selection of NAMs for NM risk assessment. The review begins with an overview on nano-specific NAM-frameworks, followed by a description of individual NAMs including those relevant to NM physicochemical characterisation, exposure and hazard assessment covering toxicodynamics and toxicokinetics. The focus is on NAMs concerning NM degradation/dissolution, genotoxicity, cytotoxicity, oxidative stress, (pro-)inflammation, and barrier integrity as those are important endpoints for initial screening according to the EFSA framework. As a result, in total 267 individual nano-relevant NAMs, mostly “not validated” (with a few notable exceptions), were included in this review. Validation notwithstanding, NAMs could already prove relevant and reliable for risk assessment of NMs, especially in integrated approaches.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 9","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-8826","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142244982","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Technical Report on the need for re-evaluation of the safety of hexane used as an extraction solvent in the production of foodstuffs and food ingredients","authors":"European Food Safety Authority (EFSA),&nbsp;Daniele Comandella,&nbsp;Margherita Bignami,&nbsp;Peter Fürst,&nbsp;Konrad Grob,&nbsp;Marcel Mengelers,&nbsp;Claudia Cascio,&nbsp;Kyriaki Xiftou,&nbsp;Cristina Croera,&nbsp;Claude Lambré","doi":"10.2903/sp.efsa.2024.EN-9001","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-9001","url":null,"abstract":"<p>Hexane (called ‘technical hexane’ in this report) is authorised for use as an extraction solvent in the production of foodstuffs and food ingredients under Directive 2009/32/EC. Following a request from the European Commission, EFSA assessed the need for a re-evaluation of its safety, which was addressed by the Scientific Committee on Food (SCF) in 1996. To this end, EFSA focused on the composition of technical hexane, its established and potential toxicological adverse effects and the potential exposure of consumers. Technical hexane is defined in the Directive as ‘a commercial product consisting essentially of acyclic saturated hydrocarbons containing six carbon atoms and distilling between 64°C and 70°C’. Specifications, including the identity and fraction of constituents, are not defined. n-Hexane is reported to be the main constituent. Impurities may be of concern, as they may be transferred to the extracted food, depending on their physicochemical properties and the extraction procedure. An exposure assessment based on regulatory limits showed that the exposure of infants, toddlers and other children may be higher than that considered by the SCF. Regarding genotoxicity, EFSA reiterated the absence of concern. The information provided by the 90-day study in rats considered by the SCF was no longer considered sufficient to adequately conclude on the safety of technical hexane. Moreover, as n-hexane is absorbed in humans, additional toxicity studies exploring more end points may be needed. A scoping literature search showed that recent toxicological information on the safety of technical hexane is available, although its relevance was not appraised during this activity. EFSA concluded that there is a need for a re-evaluation of the safety of the use of technical hexane as an extraction solvent in the production of foodstuffs and food ingredients.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 9","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-9001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142230971","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Scientific and technical assistance report on the evaluation of human-identical milk oligosaccharides (HiMOs) as novel foods","authors":"European Food Safety Authority (EFSA),&nbsp;Dominique Turck,&nbsp;Paolo Colombo,&nbsp;Estefanía Noriega Fernández,&nbsp;Pablo Rodríguez Fernández,&nbsp;Helle Katrine Knutsen","doi":"10.2903/sp.efsa.2024.EN-8994","DOIUrl":"https://doi.org/10.2903/sp.efsa.2024.EN-8994","url":null,"abstract":"<p>EFSA was asked by the European Commission to provide scientific and technical assistance on the evaluation of human-identical milk oligosaccharides (HiMOs) as novel foods (NFs). In recent years, the number of authorisations of HiMOs as NFs has markedly increased, which may lead to situations of multiple concurrent uses. Since the safety assessment of HiMOs is based on the comparison with the ‘natural’ intake of human milk oligosaccharides (HMOs), i.e. the HMO intake from human milk in exclusively breastfed infants, a scoping literature review was outsourced to update the database of mean concentrations of single and total HMOs in human milk, and relevant HMO intakes were thus updated. It is noted that in infants up to 16 weeks of age exclusively fed with infant formula, when adding all the assessed HiMOs at their highest maximum use levels across production methods, the resulting highest daily intakes of single HiMOs and the sum of HiMOs are within the natural HMO intake range. These intakes were also estimated (DietEx) for the most exposed population groups (i.e., infants and young children) considering the highest maximum use levels in those food categories with the highest contribution to the overall HiMO intake (i.e., infant and follow-on formulae, ready-to-eat meals, yoghurt and cow milk). The resulting highest P95 daily HiMO intakes were unlikely to be higher than the highest mean daily HMO intakes. However, any possible higher intake would not necessarily imply a safety concern since such natural intake estimates represent an upper end of average natural intakes. It can be concluded that currently there are no safety concerns resulting from the authorised or assessed HiMO intakes from their concurrent combined uses. Nonetheless, in consideration of the increased interest in the use of HiMOs as NFs, a simplified but realistic approach for the intake assessment is proposed in the case of new HiMOs or extensions of use of already authorised HiMOs.</p>","PeriodicalId":100395,"journal":{"name":"EFSA Supporting Publications","volume":"21 9","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/sp.efsa.2024.EN-8994","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142123207","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}