EFSA Journal最新文献

{"title":"Safety and efficacy of a feed additive consisting of protease and Bacillus velezensis NRRL B-50508, B. velezensis NRRL B-50509 and B. subtilis NRRL B-50510 (Syncra® SWI 201 TPT) for pigs for fattening and other growing porcine species (Danisco (UK) ltd.)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP),&nbsp;Roberto Edoardo Villa,&nbsp;Giovanna Azimonti,&nbsp;Eleftherios Bonos,&nbsp;Henrik Christensen,&nbsp;Mojca Durjava,&nbsp;Birgit Dusemund,&nbsp;Ronette Gehring,&nbsp;Boet Glandorf,&nbsp;Maryline Kouba,&nbsp;Marta López-Alonso,&nbsp;Francesca Marcon,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Ilen Röhe,&nbsp;Katerina Theodoridou,&nbsp;Vasileios Bampidis,&nbsp;Ruud Woutersen,&nbsp;Montserrat Anguita,&nbsp;Jaume Galobart,&nbsp;Matteo L. Innocenti,&nbsp;Jordi Ortuño Casanova,&nbsp;Elisa Pettenati,&nbsp;Rosella Brozzi","doi":"10.2903/j.efsa.2025.9265","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9265","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a product consisting of the protease produced with the genetically modified strain <i>Bacillus subtilis</i> CBS 148232, and viable spores of <i>Bacillus velezensis</i> NRRL B-50508, <i>B. velezensis</i> NRRL B-50509 and <i>B. subtilis</i> NRRL B-50510 (Syncra® SWI 201 TPT) as a zootechnical feed additive for pigs for fattening and other growing porcine species. The FEEDAP Panel concludes that the use of the active agents <i>B. velezensis</i> NRRL B-50508, <i>B. velezensis</i> NRRL B-50509 and <i>B. subtilis</i> NRRL B-50510 in animal nutrition is safe for the target species, consumers and the environment. Similarly, the Panel concluded that the use of <i>B. subtilis</i> CBS 148232 as a production strain of the protease present in the final product does not raise safety concerns. No viable cells and no DNA of this strain were detected in the intermediate concentrates used to formulate the final additive. Based on the results obtained in a tolerance trial in weaned piglets, the FEEDAP Panel concluded that Syncra® SWI 201 TPT is safe for pigs for fattening and other growing porcine species at the proposed conditions of use. Syncra® SWI 201 TPT is not irritant to the eyes or the skin but should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. The additive does not raise safety concerns for the environment. Syncra® SWI 201 TPT has the potential to be efficacious when supplemented in the feed of pigs for fattening and other minor porcine species at the same physiological stage at 5000 protease units (U)/kg and 1.5 × 10⁸ colony forming units (CFU)/kg complete feed.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9265","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143497406","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of the feed additives calcium d-pantothenate and d-panthenol for all animal species for the renewal of their authorisation (DSM Nutritional products Ltd)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP),&nbsp;Roberto Edoardo Villa,&nbsp;Giovanna Azimonti,&nbsp;Eleftherios Bonos,&nbsp;Henrik Christensen,&nbsp;Mojca Durjava,&nbsp;Birgit Dusemund,&nbsp;Ronette Gehring,&nbsp;Boet Glandorf,&nbsp;Maryline Kouba,&nbsp;Marta López-Alonso,&nbsp;Francesca Marcon,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Ilen Röhe,&nbsp;Katerina Theodoridou,&nbsp;Jaume Galobart,&nbsp;Orsolya Holczknecht,&nbsp;Fabiola Pizzo,&nbsp;Anita Radovnikovic,&nbsp;Maria Vittoria Vettori,&nbsp;Angelica Amaduzzi","doi":"10.2903/j.efsa.2025.9252","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9252","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 calcium <span>d</span>-pantothenate and <span>d</span>-panthenol for the renewal of its authorisation. Calcium <span>d</span>-pantothenate and <span>d</span>-panthenol are currently authorised as nutritional feed additives for all animal species and categories. The FEEDAP Panel concluded that the use of calcium <span>d</span>-pantothenate and <span>d</span>-panthenol as feed additive in animal nutrition under the conditions of use is of no concern for the safety of the target species, the consumer and the environment. Calcium <span>d</span>-pantothenate is not irritant to skin and eyes and is not a dermal sensitiser. <span>d</span>-panthenol is considered to be a skin and eye irritant and a dermal and respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of this renewal of the authorisation.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9252","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143497073","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Update of the Xylella spp. host plant database – Systematic literature search up to 30 June 2024","authors":"European Food Safety Authority (EFSA),&nbsp;Vincenzo Cavalieri,&nbsp;Elisa Fasanelli,&nbsp;Giandomenico Furnari,&nbsp;Davide Gibin,&nbsp;Alicia Gutierrez Linares,&nbsp;Pierfederico La Notte,&nbsp;Luca Pasinato,&nbsp;Giuseppe Stancanelli,&nbsp;Alice Delbianco","doi":"10.2903/j.efsa.2025.9241","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9241","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 11th version of the database published in Zenodo in the EFSA Knowledge Junction community, covering literature published from 1 January 2024 up to 30 June 2024, and recent Europhyt outbreak notifications. Informative data have been extracted from 27 selected publications. One new host plant (<i>Quercus orocantabrica</i>) was identified and added to the database. It was naturally infected by <i>X. fastidiosa</i> subsp. <i>fastidiosa</i> in Portugal. No additional data were retrieved for <i>X. taiwanensis</i>, and no additional multilocus sequence tipes (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 <i>Xylella</i> 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 <i>Xylella</i> spp. host plants determined with at least two different detection methods or positive with one method (between sequencing and pure culture isolation (category A), reaches now 452 plant species, 204 genera and 70 families. Such numbers rise to 713 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":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9241","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143481592","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Commodity risk assessment of Taxus baccata plants from the UK","authors":"EFSA Panel on Plant Health (PLH),&nbsp;Antonio Vicent Civera,&nbsp;Paula Baptista,&nbsp;Anna Berlin,&nbsp;Elisavet Chatzivassiliou,&nbsp;Jaime Cubero,&nbsp;Nik Cunniffe,&nbsp;Eduardo de la Peña,&nbsp;Nicolas Desneux,&nbsp;Francesco Di Serio,&nbsp;Anna Filipiak,&nbsp;Beata Hasiów-Jaroszewska,&nbsp;Hervé Jactel,&nbsp;Blanca Landa,&nbsp;Lara Maistrello,&nbsp;David Makowski,&nbsp;Panagiotis Milonas,&nbsp;Nikos Papadopoulos,&nbsp;Roel Potting,&nbsp;Hanna Susi,&nbsp;Dirk Jan van Der Gaag,&nbsp;Andrea Battisti,&nbsp;Claude Bragard,&nbsp;Christer Sven Magnusson,&nbsp;Hugo Mas,&nbsp;Daniel Rigling,&nbsp;Massimo Faccoli,&nbsp;Alžběta Mikulová,&nbsp;Fabio Stergulc,&nbsp;Olaf Mosbach-Schulz,&nbsp;Franz Streissl,&nbsp;Paolo Gonthier","doi":"10.2903/j.efsa.2025.9277","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9277","url":null,"abstract":"<p>The European Commission requested the EFSA Panel on Plant Health to prepare and deliver risk assessments for commodities listed in Commission Implementing Regulation (EU) 2018/2019 as ‘High risk plants, plant products and other objects’. This Scientific Opinion covers plant health risks posed by plants of <i>Taxus baccata</i> imported from the United Kingdom (UK) as: (a) bundles of 2-year-old bare root plants (whips), (b) 2- to 7-year-old bare root plants, either exported as single plants or in bundles, (c) 2-year-old cell grown plants exported in bundles, and (d) 3- to 15-year-old plants in pots. The assessment was performed considering the available scientific information, including the technical information provided by the UK. All pests associated with the commodity were evaluated against specific criteria for their relevance for this opinion. One EU quarantine pest, <i>Phytophthora ramorum</i> (non-EU isolates) fulfilled all relevant criteria and was selected for further evaluation. For the selected pest, the risk mitigation measures implemented in the technical dossier from the UK were evaluated taking into account the possible limiting factors. An expert judgement was given on the likelihood of pest freedom taking into consideration the risk mitigation measures acting on the pest, including uncertainties associated with the assessment. The fact that <i>T. baccata</i> is an evergreen plant on which <i>P. ramorum</i> can cause foliar infection was considered a critical element in the risk assessment. In addition, the age of the plants was considered, reasoning that older trees are more likely to be infected mainly due to longer exposure time and larger size. The degree of pest freedom slightly differs between bare root plants (including whips) and plants in pots (including cell grown plants), with plants in pots being less likely pest free. The Expert Knowledge Elicitation (EKE) indicated with 95% certainty that between 9699 and 10,000 3- to 15-year-old plants in pots and bundles of 2-year-old cell grown plants per 10,000 will be free from <i>P. ramorum</i> (non-EU isolates).</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9277","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143475765","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Modification of the existing maximum residue levels for oxathiapiprolin in various crops","authors":"European Food Safety Authority (EFSA),&nbsp;Giulia Bellisai,&nbsp;Giovanni Bernasconi,&nbsp;Luis Carrasco Cabrera,&nbsp;Irene Castellan,&nbsp;Monica del Aguila,&nbsp;Lucien Ferreira,&nbsp;Luna Greco,&nbsp;Samira Jarrah,&nbsp;Renata Leuschner,&nbsp;Andrea Mioč,&nbsp;Stefanie Nave,&nbsp;Hermine Reich,&nbsp;Silvia Ruocco,&nbsp;Alessia Pia Scarlato,&nbsp;Andrea Simonati,&nbsp;Marta Szot,&nbsp;Anne Theobald,&nbsp;Manuela Tiramani,&nbsp;Alessia Verani,&nbsp;Elena Zioga","doi":"10.2903/j.efsa.2025.9273","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9273","url":null,"abstract":"<p>In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRLs) for the active substance oxathiapiprolin in Brussels sprouts, kales, watercresses, herbs and edible flowers (excluding basil and edible flowers). The data submitted in support of the request were found to be sufficient to derive MRL proposals for all the crops under assessment. The potential carry-over of residues into honey from the relevant intended uses on mellifluous crops is covered by the existing MRL in honey. Adequate analytical methods for enforcement are available to control the residues of oxathiapiprolin in plant matrices and in honey matrix at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the long-term intake of residues resulting from the intended and authorised uses of oxathiapiprolin according to the reported agricultural practices, and of residues expected in honey, is unlikely to present a risk to consumer health.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9273","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143456103","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Peer review of the pesticide risk assessment of the active substance clomazone","authors":"European Food Safety Authority (EFSA),&nbsp;Fernando Álvarez,&nbsp;Maria Arena,&nbsp;Domenica Auteri,&nbsp;Sofia Batista Leite,&nbsp;Marco Binaglia,&nbsp;Anna Federica Castoldi,&nbsp;Arianna Chiusolo,&nbsp;Angelo Colagiorgi,&nbsp;Mathilde Colas,&nbsp;Federica Crivellente,&nbsp;Chloe De Lentdecker,&nbsp;Isabella De Magistris,&nbsp;Mark Egsmose,&nbsp;Gabriella Fait,&nbsp;Franco Ferilli,&nbsp;Monica Fittipaldi Broussarad,&nbsp;German Giner Santonja,&nbsp;Varvara Gouliarmou,&nbsp;Katrin Halling,&nbsp;Alessio Ippolito,&nbsp;Frederique Istace,&nbsp;Samira Jarrah,&nbsp;Dimitra Kardassi,&nbsp;Aude Kienzler,&nbsp;Anna Lanzoni,&nbsp;Roberto Lava,&nbsp;Renata Leuschner,&nbsp;Alberto Linguadoca,&nbsp;Jochem Louisse,&nbsp;Christopher Lythgo,&nbsp;Oriol Magrans,&nbsp;Iris Mangas,&nbsp;Andrea Mioč,&nbsp;Ileana Miron,&nbsp;Tunde Molnar,&nbsp;Laura Padovani,&nbsp;Vincenzo Padricello,&nbsp;Martina Panzarea,&nbsp;Juan Manuel Parra Morte,&nbsp;Alexandra Piti,&nbsp;Simone Rizzuto,&nbsp;Agnès Rortais,&nbsp;Miguel Santos,&nbsp;Rositsa Serafimova,&nbsp;Rachel Sharp,&nbsp;Csaba Szentes,&nbsp;Andrea Terron,&nbsp;Anne Theobald,&nbsp;Manuela Tiramani,&nbsp;Giorgia Vianello,&nbsp;Laura Villamar-Bouza","doi":"10.2903/j.efsa.2025.9206","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9206","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, Denmark, and co-rapporteur Member State, Germany, for the pesticide active substance clomazone 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 clomazone as a herbicide on potato and spring/winter oilseed rape. 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 identified.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9206","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143456081","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Peer review of the pesticide risk assessment of the active substance daminozide","authors":"European Food Safety Authority (EFSA),&nbsp;Fernando Álvarez,&nbsp;Maria Arena,&nbsp;Domenica Auteri,&nbsp;Sofia Batista Leite,&nbsp;Marco Binaglia,&nbsp;Anna Federica Castoldi,&nbsp;Arianna Chiusolo,&nbsp;Angelo Colagiorgi,&nbsp;Mathilde Colas,&nbsp;Federica Crivellente,&nbsp;Chloe De Lentdecker,&nbsp;Isabella De Magistris,&nbsp;Mark Egsmose,&nbsp;Gabriella Fait,&nbsp;Franco Ferilli,&nbsp;Monica Fittipaldi Broussarad,&nbsp;German Giner Santonja,&nbsp;Varvara Gouliarmou,&nbsp;Katrin Halling,&nbsp;Alessio Ippolito,&nbsp;Frederique Istace,&nbsp;Samira Jarrah,&nbsp;Dimitra Kardassi,&nbsp;Aude Kienzler,&nbsp;Anna Lanzoni,&nbsp;Roberto Lava,&nbsp;Renata Leuschner,&nbsp;Alberto Linguadoca,&nbsp;Jochem Louisse,&nbsp;Christopher Lythgo,&nbsp;Oriol Magrans,&nbsp;Iris Mangas,&nbsp;Andrea Mioč,&nbsp;Ileana Miron,&nbsp;Tunde Molnar,&nbsp;Laura Padovani,&nbsp;Vincenzo Padricello,&nbsp;Martina Panzarea,&nbsp;Juan Manuel Parra Morte,&nbsp;Alexandra Piti,&nbsp;Simone Rizzuto,&nbsp;Anamarija Romac,&nbsp;Agnès Rortais,&nbsp;Miguel Santos,&nbsp;Rositsa Serafimova,&nbsp;Rachel Sharp,&nbsp;Csaba Szentes,&nbsp;Andrea Terron,&nbsp;Anne Theobald,&nbsp;Manuela Tiramani,&nbsp;Giorgia Vianello,&nbsp;Laura Villamar-Bouza","doi":"10.2903/j.efsa.2025.9210","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9210","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 Czech Republic and co-rapporteur Member State Hungary for the pesticide active substance daminozide 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 daminozide as a plant growth regulator in ornamentals (field and greenhouse). 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 identified.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9210","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143456082","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Review of the methodology used for the assessment of the short-term (acute) dietary exposure to pesticide residues in food (IESTI methodology)","authors":"European Food Safety Authority (EFSA)","doi":"10.2903/j.efsa.2025.9233","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9233","url":null,"abstract":"<p>In accordance with the mandate under Article 43 of Regulation (EC) No 396/2005, EFSA reviewed the methodology used for the assessment of the short-term dietary exposure to pesticide residues currently used in the EU (also known as international estimated short-term intake (IESTI) methodology) and elaborated three alternative options for exposure calculations that would address some of the weak points of the current methodology. For more than 400 pesticide/commodity combinations, comparative calculations were performed using the current IESTI methodology and the proposed alternative calculation algorithms. This impact assessment illustrated that the food commodities currently falling under IESTI case 1, 2a, 2b and 3, respectively, would be affected to a different extent if the IESTI methodology is replaced as proposed in the alternative calculation options. In addition, EFSA performed a probabilistic exposure calculation based on monitoring data for 62 pesticides present in food products that are the main components of the diet of EU citizens. These calculations can give an indication whether the legal limits (maximum residue levels, MRLs), which have been set after they passed the acute risk assessment using the IESTI methodology, are sufficiently protective for European consumers. The calculations identified that for the majority of pesticide/population subgroups, the probability of an exposure above the acute reference dose (ARfD) was negligible. However, for a few cases, the probability of an exposure above the ARfD could not be ruled out. Nevertheless, given the conservative assumptions used in the probabilistic calculations and the absence of data to refine the exposure estimates, the current maximum residue levels (MRLs) for the selected pesticides are considered to offer a good protection for European consumers. Overall, the probabilistic exposure calculations should support further discussions at risk management level whether the level of conservatism of the revised methodology needs to increase compared with the current IESTI methodology.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9233","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143456104","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of the feed additive consisting of choline chloride for all animal species for the renewal of its authorisation (Andrés Pintaluba S.A., Taminco B.V., Balchem Italia S.r.l.)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP),&nbsp;Roberto Edoardo Villa,&nbsp;Giovanna Azimonti,&nbsp;Eleftherios Bonos,&nbsp;Henrik Christensen,&nbsp;Mojca Durjava,&nbsp;Birgit Dusemund,&nbsp;Ronette Gehring,&nbsp;Boet Glandorf,&nbsp;Maryline Kouba,&nbsp;Marta López-Alonso,&nbsp;Francesca Marcon,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Ilen Röhe,&nbsp;Katerina Theodoridou,&nbsp;Montserrat Anguita,&nbsp;Jaume Galobart,&nbsp;Matteo L. Innocenti,&nbsp;Jordi Tarrés-Call,&nbsp;Joana P. Firmino","doi":"10.2903/j.efsa.2025.9264","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9264","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of choline chloride as a nutritional additive for all animal species. The additive is already authorised for use in all animal species (3a890). The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of the feed additive in animal nutrition under the proposed conditions of use remains safe for the target species, the consumers and the environment. Regarding user safety, the FEEDAP Panel concluded that the active substance choline chloride should be considered as a potential skin and respiratory sensitiser; therefore, any exposure via skin or respiratory tract is considered a risk. Although aqueous solutions of up to 70% choline chloride are considered non-irritant to eyes, no conclusion can be reached on the eye irritation potential for more concentrated forms. These conclusions would apply, in principle, to any preparations produced with the active substance. The present application for renewal of the authorisation does not include any modification proposal that would have an impact on the efficacy of the additive and therefore there is no need for re-assessing the efficacy.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9264","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143447014","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"农林科学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of the feed additive consisting of canthaxanthin (Carophyll® Red 10%) for breeder hens for the renewal of its authorisation (DSM Nutritional Products Ltd.)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP),&nbsp;Roberto Edoardo Villa,&nbsp;Giovanna Azimonti,&nbsp;Eleftherios Bonos,&nbsp;Henrik Christensen,&nbsp;Mojca Durjava,&nbsp;Birgit Dusemund,&nbsp;Ronette Gehring,&nbsp;Boet Glandorf,&nbsp;Maryline Kouba,&nbsp;Marta López-Alonso,&nbsp;Francesca Marcon,&nbsp;Carlo Nebbia,&nbsp;Alena Pechová,&nbsp;Miguel Prieto-Maradona,&nbsp;Ilen Röhe,&nbsp;Katerina Theodoridou,&nbsp;Jaume Galobart,&nbsp;Orsolya Holczknecht,&nbsp;Alberto Navarro-Villa,&nbsp;Fabiola Pizzo,&nbsp;Maria Vittoria Vettori","doi":"10.2903/j.efsa.2025.9253","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9253","url":null,"abstract":"<p>Following a request from the European Commission, the EFSA was asked to deliver a scientific opinion on the renewal of the feed additive consisting of canthaxanthin (Carophyll® Red 10%) for breeder hens and to modify the additive specifications by substituting ethoxyquin by 4.4% butylated hydroxytoluene (BHT) and increasing the limit for dichloromethane to 80 mg/kg. The additive complies with the conditions of the authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) notes that the proposed modifications for the additive are considered to be of no concern. The Panel concluded that CAROPHYLL®Red 10% remains safe for the target species and the consumer under the current authorised conditions of use for CAROPHYLL® Red 10%. The Panel noted that the current maximum residue limits (MRLs) set in the different authorisations for canthaxanthin may not be protective enough for the consumer when considering combined exposure by all possible routes. CAROPHYLL® Red 10% should be considered to be irritant to skin and eyes and the respiratory tract and to be a skin sensitiser; any exposure is considered a risk. In the absence of data, the Panel could not conclude whether the additive CAROPHYLL® Red 10% remains safe for the environment under the current conditions of the authorisation. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9253","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143447013","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}