EFSA JournalPub Date : 2025-02-14DOI: 10.2903/j.efsa.2025.9271
European Food Safety Authority (EFSA)
{"title":"Statement on the update of maximum residue levels (MRLs) for copper compounds in light of the EFSA scientific opinion on the re-evaluation of the health-based guidance values (HBGVs) and exposure assessment from all sources","authors":"European Food Safety Authority (EFSA)","doi":"10.2903/j.efsa.2025.9271","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9271","url":null,"abstract":"<p>In compliance with Article 43 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) reviewed the maximum residue levels (MRLs) for copper compounds in light of the EFSA Scientific Committee opinion on the re-evaluation of the health-based guidance values (HBGVs) and exposure assessment from all sources. Based on the exposure calculations performed according to three different scenarios, the updated occurrence data and the residues from the new intended uses are not expected to have an impact on the chronic exposure calculations conducted under the framework of the EFSA Scientific Committee assessment. Therefore, the conclusions of the previous assessment by EFSA Scientific Committee are still valid. Since the current copper exposure is expected to cover all sources of copper, including the uses of copper as plant protection products (PPPs), it can be concluded that the authorised PPP uses for copper compounds and the new intended PPP uses present no health risk for the population, including children. Due to copper being also a micronutrient and ubiquitous in the environment, as requested in the mandate, the dietary risk assessment was performed following a different approach than the standard methodology for the dietary risk assessment of pesticide residues in the framework of setting and reviewing MRLs under Regulation (EC) No 396/2005 and in the peer review of pesticides under Regulation (EU) No 1107/2009. Therefore, all MRL proposals are suggested for further consideration by risk managers.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9271","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143404593","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}
EFSA JournalPub Date : 2025-02-14DOI: 10.2903/j.efsa.2025.9221
EFSA Panel on Food Enzymes (FEZ), Holger Zorn, José Manuel Barat Baviera, Claudia Bolognesi, Francesco Catania, Gabriele Gadermaier, Ralf Greiner, Baltasar Mayo, Alicja Mortensen, Yrjö Henrik Roos, Marize L. M. Solano, Monika Sramkova, Henk Van Loveren, Laurence Vernis, Magdalena Andryszkiewicz, Ana Gomes, Natalia Kovalkovicova, Yi Liu
{"title":"Safety evaluation of the food enzyme cyclomaltodextrin glucanotransferase from the non-genetically modified Anoxybacillus caldiproteolyticus strain AE-KCGT","authors":"EFSA Panel on Food Enzymes (FEZ), Holger Zorn, José Manuel Barat Baviera, Claudia Bolognesi, Francesco Catania, Gabriele Gadermaier, Ralf Greiner, Baltasar Mayo, Alicja Mortensen, Yrjö Henrik Roos, Marize L. M. Solano, Monika Sramkova, Henk Van Loveren, Laurence Vernis, Magdalena Andryszkiewicz, Ana Gomes, Natalia Kovalkovicova, Yi Liu","doi":"10.2903/j.efsa.2025.9221","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9221","url":null,"abstract":"<p>The food enzyme cyclomaltodextrin glucanotransferase ((1–4)-α-<span>d</span>-glucan 4-α-<span>d</span>-[(1–4)- α-<span>d</span>-glucano]-transferase; EC 2.4.1.19) is produced with the non-genetically modified <i>Anoxybacillus caldiproteolyticus</i> strain AE-KCGT by Amano Enzyme Inc. The food enzyme is free from viable cells of the production organism. It is intended to be used in two food manufacturing processes. The dietary exposure was estimated to be up to 20.27 mg total organic solids (TOS)/kg bw per day in European populations. Genotoxicity tests did not raise safety concerns. The systemic toxicity was assessed by means of a repeated dose 90-day oral toxicity study in rats. The Panel identified a no observed adverse effect level of 2246 mg TOS/kg bw per day, the highest dose tested, which when compared with the estimated dietary exposure, resulted in a margin of exposure (MoE) of at least 141 for infants, 111 for toddlers, 154 for children, 362 for adolescents, 508 for adults and 713 for the elderly. A search for the homology of the amino acid sequence of the cyclomaltodextrin glucanotransferase to known allergens was made and matches with three respiratory allergens were found. The Panel considered that a risk of allergic reactions upon dietary exposure to the food enzyme 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 for adolescents, adults and the elderly. The MoE is insufficient to exclude safety concerns for infants, toddlers and children.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9221","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143404592","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}
EFSA JournalPub Date : 2025-02-13DOI: 10.2903/j.efsa.2025.9249
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Baltasar Mayo, Nicole Bozzi Cionci, Rosella Brozzi, Jaume Galobart, Orsolya Holczknecht, Paola Manini, Piera Valeri, Maria Vittoria Vettori, Fabiola Pizzo
{"title":"Safety and efficacy of feed additives consisting of vitamin B2 (98%) and vitamin B2 (80%) produced with Bacillus subtilis CGMCC 7.449 for all animal species (Chifeng Pharmaceutical Co., Ltd.)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Baltasar Mayo, Nicole Bozzi Cionci, Rosella Brozzi, Jaume Galobart, Orsolya Holczknecht, Paola Manini, Piera Valeri, Maria Vittoria Vettori, Fabiola Pizzo","doi":"10.2903/j.efsa.2025.9249","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9249","url":null,"abstract":"<p>Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of EFSA was asked to deliver a scientific opinion on the safety and efficacy of vitamin B<sub>2</sub> 98% and vitamin B<sub>2</sub> 80% in the form of riboflavin produced by fermentation with a genetically modified strain of <i>Bacillus subtilis</i> (CGMCC 7.449) as nutritional feed additives for all animal species. Viable cells and DNA of the production strain were not detected in the final products and therefore, the use of <i>B. subtilis</i> CGMCC 7.449 to produce vitamin B<sub>2</sub> does not raise safety concerns. The use of vitamin 98% and 80% produced with <i>B. subtilis</i> CGMCC 7.449 in animal nutrition does not represent a safety concern for the target species, consumers and for the environment. The additives are not dermal nor eye irritants but are dermal and respiratory sensitisers. Inhalation and dermal exposure are considered a risk. The additives under assessment are effective in covering the animals' requirements of vitamin B<sub>2</sub> when administered via feed.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9249","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143397175","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}
EFSA JournalPub Date : 2025-02-13DOI: 10.2903/j.efsa.2025.9248
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Montserrat Anguita, Nicole Bozzi Cionci, Matteo L. Innocenti, Joana Revez
{"title":"Assessment of the feed additive consisting of Lactiplantibacillus plantarum DSM 16627 for all animal species for the renewal of its authorisation (Microferm Ltd.)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Montserrat Anguita, Nicole Bozzi Cionci, Matteo L. Innocenti, Joana Revez","doi":"10.2903/j.efsa.2025.9248","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9248","url":null,"abstract":"<p>Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of the authorisation of a preparation <i>Lactiplantibacillus plantarum</i> DSM 16627 as a technological additive to improve ensiling of fresh plant material for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There was no new evidence that would lead the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) to reconsider its previous conclusions for all animal species, consumers and the environment, for which the additive is considered to remain safe. Regarding the user safety, the additive is a preparation containing a microorganism and therefore should be considered a skin and respiratory sensitiser, and any exposure through the skin and respiratory tract is considered a risk. In the absence of data, no conclusion could be drawn on the eye irritation potential of the additive. There is no need for assessing the efficacy of the additive in the context of renewal of the authorisation.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9248","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143397134","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}
EFSA JournalPub Date : 2025-02-12DOI: 10.2903/j.efsa.2025.9250
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Kettil Svensson, Luca Tosti, Jaume Galobart, Orsolya Holczknecht, Maria Vittoria Vettori, Fabiola Pizzo
{"title":"Assessment of the feed additive consisting of biotin for all animal species for the renewal of its authorisation (ADISSEO, DSM Nutritional Products Ltd., NHU Europe GmbH)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Kettil Svensson, Luca Tosti, Jaume Galobart, Orsolya Holczknecht, Maria Vittoria Vettori, Fabiola Pizzo","doi":"10.2903/j.efsa.2025.9250","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9250","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 biotin as a nutritional feed additive for all animal species. The applicants provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions regarding the safety of the additive. The FEEDAP Panel concluded that biotin remains safe for all animal species, consumers and environment under the authorised conditions of use. Regarding the user safety, the Panel concluded that biotin is not irritant to skin or eyes and is not a dermal sensitiser. Exposure to the additive by inhalation is likely. 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":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9250","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143389275","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}
EFSA JournalPub Date : 2025-02-12DOI: 10.2903/j.efsa.2025.9251
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Montserrat Anguita, Nicole Bozzi Cionci, Matteo L. Innocenti, Elisa Pettenati, Jordi Tarres-Call, Joana P. Firmino
{"title":"Assessment of the feed additive consisting of l-valine produced by fermentation with Corynebacterium glutamicum KCCM 80058 for all animal species for the renewal of its authorisation (CJ Europe GmbH)","authors":"EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López-Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto-Maradona, Ilen Röhe, Katerina Theodoridou, Montserrat Anguita, Nicole Bozzi Cionci, Matteo L. Innocenti, Elisa Pettenati, Jordi Tarres-Call, Joana P. Firmino","doi":"10.2903/j.efsa.2025.9251","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9251","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 <span>l</span>-valine produced by fermentation with a genetically modified strain of <i>Corynebacterium glutamicum</i> KCCM 80058 as a nutritional feed additive for all animal species. The additive is authorised for use in all animal species (3c370). The applicant has 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 remains safe for the target species, consumers and the environment. As regards the safety for the user, <span>l</span>-valine produced by <i>C. glutamicum</i> KCCM 80058 is not an irritant to skin or eyes nor a skin sensitiser. 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":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9251","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143389277","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}
EFSA JournalPub Date : 2025-02-11DOI: 10.2903/j.efsa.2025.9232
European Food Safety Authority (EFSA), Giulia Bellisai, Giovanni Bernasconi, Luis Carrasco Cabrera, Irene Castellan, Monica del Aguila, Lucien Ferreira, Luna Greco, Samira Jarrah, Renata Leuschner, Andrea Mioč, Stefanie Nave, Hermine Reich, Silvia Ruocco, Alessia Pia Scarlato, Andrea Simonati, Marta Szot, Anne Theobald, Manuela Tiramani, Alessia Verani, Elena Zioga
{"title":"Modification of the existing maximum residue levels for potassium phosphonates in apricots and cherries","authors":"European Food Safety Authority (EFSA), Giulia Bellisai, Giovanni Bernasconi, Luis Carrasco Cabrera, Irene Castellan, Monica del Aguila, Lucien Ferreira, Luna Greco, Samira Jarrah, Renata Leuschner, Andrea Mioč, Stefanie Nave, Hermine Reich, Silvia Ruocco, Alessia Pia Scarlato, Andrea Simonati, Marta Szot, Anne Theobald, Manuela Tiramani, Alessia Verani, Elena Zioga","doi":"10.2903/j.efsa.2025.9232","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9232","url":null,"abstract":"<p>In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Fitosanitarios de Bajo Riesgo AIE submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRLs) for the active substance potassium phosphonates in apricots and cherries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the crops under assessment. Adequate analytical methods for enforcement are available to control the residues of potassium phosphonates in accordance with the residue definition ‘phosphonic acid and its salts expressed as phosphonic acid’ on commodities under consideration at the validated limit of quantification (LOQ) of 0.1 mg/kg. Based on the risk assessment results, EFSA concluded that the long-term intake of residues resulting from the use of potassium phosphonates according to the reported agricultural practices is unlikely to present a risk to consumer health. The risk assessment shall be regarded as indicative because some MRL proposals derived by EFSA in the framework of the MRL review according to Articles 12 and 43 of Regulation (EC) No 396/2005 require further consideration by risk managers.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9232","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143380620","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}
EFSA JournalPub Date : 2025-02-10DOI: 10.2903/j.efsa.2025.9104
EFSA Panel on Food Contact Materials (FCM), Claude Lambré, Riccardo Crebelli, Maria da Silva, Konrad Grob, Evgenia Lampi, Maria Rosaria Milana, Marja Pronk, Mario Ščetar, Georgios Theodoridis, Els Van Hoeck, Nadia Waegeneers, Claudia Bolognesi, Ronan Cariou, Laurence Castle, Emma Di Consiglio, Roland Franz, Detlef Wölfle, Zainab Al Harraq, Eric Barthélémy, Daniele Comandella, Julia Fontán Vela, Blanka Halamoda, Gilles Rivière
{"title":"Update of the safety assessment of N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amines (FCM No 19) and N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amine hydrochlorides (FCM No 20) for their use in plastic materials and articles intended to come into contact with food","authors":"EFSA Panel on Food Contact Materials (FCM), Claude Lambré, Riccardo Crebelli, Maria da Silva, Konrad Grob, Evgenia Lampi, Maria Rosaria Milana, Marja Pronk, Mario Ščetar, Georgios Theodoridis, Els Van Hoeck, Nadia Waegeneers, Claudia Bolognesi, Ronan Cariou, Laurence Castle, Emma Di Consiglio, Roland Franz, Detlef Wölfle, Zainab Al Harraq, Eric Barthélémy, Daniele Comandella, Julia Fontán Vela, Blanka Halamoda, Gilles Rivière","doi":"10.2903/j.efsa.2025.9104","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9104","url":null,"abstract":"<p>The European Commission asked EFSA to review whether the authorisation of N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amine (FCM No 19) and N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amine hydrochlorides (FCM No 20) is still in accordance with Regulation (EC) No 1935/2004, as provided for in Article 12(3). The FCM Panel concluded that some uses of the substance N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amine (FCM No 19) are not in accordance with this Regulation, since the migration is likely to exceed the current SML(T) of 1.2 mg/kg food under certain conditions of use. Based on the provided data, the FCM Panel concluded that the FCM substance No 19, N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amine, is not of safety concern for the consumer if (i) the substance is used at up to 0.1% w/w as polymer production aid and as processing aid to manufacture polyolefin materials and articles of thickness up to 1 mm that are intended for contact with all types of food except infant foods. This exception for infant foods and the restriction for maximum thickness do not apply to caps of bottles; (ii) the migration does not exceed 5 mg/kg food; (iii) the source of the alkyl group is either from hydrogenated vegetable oil or synthetic from ethylene oligomers with a high degree of linear structure and (iv) the impurities do not exceed 5% w/w. As they bear unsaturation, PFAEO-coco, PFAEO-oleyl, PFAEO-HT, PFAEO-T and PFAO-C18 do not fall within the scope of the FCM substance No 19. The information related to these substances was only considered supportive for FCM substance No 19. If they were intended to be used to manufacture FCMs, a proper application following the EFSA Guidance documents should be submitted. No uses of the FCM substance No 20, N,N-bis(2-hydroxyethyl)alkyl(C8-C18)amine hydrochlorides, were claimed and no information was provided to support that the current authorisation is in accordance with the Regulation (EC) No 1935/2004.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9104","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143380880","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}
EFSA JournalPub Date : 2025-02-10DOI: 10.2903/j.efsa.2025.9227
EFSA Panel on Food Enzymes (FEZ), Holger Zorn, José Manuel Barat Baviera, Claudia Bolognesi, Francesco Catania, Gabriele Gadermaier, Ralf Greiner, Baltasar Mayo, Alicja Mortensen, Yrjö Henrik Roos, Marize L. M. Solano, Monika Sramkova, Henk Van Loveren, Laurence Vernis, Roos Anna de Nijs, Daniele Cavanna, Yi Liu
{"title":"Safety evaluation of an extension of use of the food enzyme acylglycerol lipase from the genetically modified Penicillium sp. strain AE-LGS","authors":"EFSA Panel on Food Enzymes (FEZ), Holger Zorn, José Manuel Barat Baviera, Claudia Bolognesi, Francesco Catania, Gabriele Gadermaier, Ralf Greiner, Baltasar Mayo, Alicja Mortensen, Yrjö Henrik Roos, Marize L. M. Solano, Monika Sramkova, Henk Van Loveren, Laurence Vernis, Roos Anna de Nijs, Daniele Cavanna, Yi Liu","doi":"10.2903/j.efsa.2025.9227","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9227","url":null,"abstract":"<p>The food enzyme acylglycerol lipase (glycerol-ester acylhydrolase, EC 3.1.1.23) is produced with the genetically modified <i>Penicillium</i> sp. strain AE-LGS by Amano Enzyme Inc. A safety evaluation of this food enzyme was made previously, in which the Panel could not complete the safety assessment due to insufficient data to characterise the production strain and the composition of the food enzyme. In the current application, the applicant requested to extend the use of the food enzyme to include two additional food manufacturing processes. For the same reasons as stated in the previous assessment, the Panel could not complete the evaluation of the extension of use.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9227","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143380881","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}
EFSA JournalPub Date : 2025-02-06DOI: 10.2903/j.efsa.2025.9209
European Food Safety Authority (EFSA), Fernando Álvarez, Maria Arena, Domenica Auteri, Sofia Batista Leite, Marco Binaglia, Anna Federica Castoldi, Arianna Chiusolo, Angelo Colagiorgi, Mathilde Colas, Federica Crivellente, Chloe De Lentdecker, Isabella De Magistris, Mark Egsmose, Gabriella Fait, Franco Ferilli, Monica Fittipaldi Broussarad, German Giner Santonja, Varvara Gouliarmou, Katrin Halling, Alessio Ippolito, Frederique Istace, Samira Jarrah, Dimitra Kardassi, Aude Kienzler, Anna Lanzoni, Roberto Lava, Renata Leuschner, Alberto Linguadoca, Jochem Louisse, Christopher Lythgo, Oriol Magrans, Iris Mangas, Silvia Mazzega, Andrea Mioč, Ileana Miron, Tunde Molnar, Laura Padovani, Vincenzo Padricello, Martina Panzarea, Juan Manuel Parra Morte, Alexandra Piti, Simone Rizzuto, Anamarija Romac, Agnès Rortais, Miguel Santos, Rositsa Serafimova, Rachel Sharp, Csaba Szentes, Andrea Terron, Anne Theobald, Manuela Tiramani, Giorgia Vianello, Laura Villamar-Bouza
{"title":"Peer review of the pesticide risk assessment of the active substance cyprodinil","authors":"European Food Safety Authority (EFSA), Fernando Álvarez, Maria Arena, Domenica Auteri, Sofia Batista Leite, Marco Binaglia, Anna Federica Castoldi, Arianna Chiusolo, Angelo Colagiorgi, Mathilde Colas, Federica Crivellente, Chloe De Lentdecker, Isabella De Magistris, Mark Egsmose, Gabriella Fait, Franco Ferilli, Monica Fittipaldi Broussarad, German Giner Santonja, Varvara Gouliarmou, Katrin Halling, Alessio Ippolito, Frederique Istace, Samira Jarrah, Dimitra Kardassi, Aude Kienzler, Anna Lanzoni, Roberto Lava, Renata Leuschner, Alberto Linguadoca, Jochem Louisse, Christopher Lythgo, Oriol Magrans, Iris Mangas, Silvia Mazzega, Andrea Mioč, Ileana Miron, Tunde Molnar, Laura Padovani, Vincenzo Padricello, Martina Panzarea, Juan Manuel Parra Morte, Alexandra Piti, Simone Rizzuto, Anamarija Romac, Agnès Rortais, Miguel Santos, Rositsa Serafimova, Rachel Sharp, Csaba Szentes, Andrea Terron, Anne Theobald, Manuela Tiramani, Giorgia Vianello, Laura Villamar-Bouza","doi":"10.2903/j.efsa.2025.9209","DOIUrl":"https://doi.org/10.2903/j.efsa.2025.9209","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 France and co-rapporteur Member State Bulgaria for the pesticide active substance cyprodinil 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 cyprodinil as a fungicide on apples and barley. The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified.</p>","PeriodicalId":11657,"journal":{"name":"EFSA Journal","volume":"23 2","pages":""},"PeriodicalIF":3.3,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2025.9209","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143248696","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}