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Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles

Following a mandate from the European Commission, EFSA has developed a Guidance on Technical Requirements (Guidance on Particle‐TR), defining the criteria for assessing the presence of a fraction of small particles, and setting out information requirements for applications in the regulated food and...

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Autores principales: More, Simon, Bampidis, Vasileios, Benford, Diane, Bragard, Claude, Halldorsson, Thorhallur, Hernández‐Jerez, Antonio, Bennekou, Susanne Hougaard, Koutsoumanis, Kostas, Lambré, Claude, Machera, Kyriaki, Naegeli, Hanspeter, Nielsen, Søren, Schlatter, Josef, Schrenk, Dieter, Silano (deceased), Vittorio, Turck, Dominique, Younes, Maged, Castenmiller, Jacqueline, Chaudhry, Qasim, Cubadda, Francesco, Franz, Roland, Gott, David, Mast, Jan, Mortensen, Alicja, Oomen, Agnes G., Weigel, Stefan, Barthelemy, Eric, Rincon, Ana, Tarazona, Jose, Schoonjans, Reinhilde
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8331058/
https://www.ncbi.nlm.nih.gov/pubmed/34377191
http://dx.doi.org/10.2903/j.efsa.2021.6769
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author More, Simon
Bampidis, Vasileios
Benford, Diane
Bragard, Claude
Halldorsson, Thorhallur
Hernández‐Jerez, Antonio
Bennekou, Susanne Hougaard
Koutsoumanis, Kostas
Lambré, Claude
Machera, Kyriaki
Naegeli, Hanspeter
Nielsen, Søren
Schlatter, Josef
Schrenk, Dieter
Silano (deceased), Vittorio
Turck, Dominique
Younes, Maged
Castenmiller, Jacqueline
Chaudhry, Qasim
Cubadda, Francesco
Franz, Roland
Gott, David
Mast, Jan
Mortensen, Alicja
Oomen, Agnes G.
Weigel, Stefan
Barthelemy, Eric
Rincon, Ana
Tarazona, Jose
Schoonjans, Reinhilde
author_facet More, Simon
Bampidis, Vasileios
Benford, Diane
Bragard, Claude
Halldorsson, Thorhallur
Hernández‐Jerez, Antonio
Bennekou, Susanne Hougaard
Koutsoumanis, Kostas
Lambré, Claude
Machera, Kyriaki
Naegeli, Hanspeter
Nielsen, Søren
Schlatter, Josef
Schrenk, Dieter
Silano (deceased), Vittorio
Turck, Dominique
Younes, Maged
Castenmiller, Jacqueline
Chaudhry, Qasim
Cubadda, Francesco
Franz, Roland
Gott, David
Mast, Jan
Mortensen, Alicja
Oomen, Agnes G.
Weigel, Stefan
Barthelemy, Eric
Rincon, Ana
Tarazona, Jose
Schoonjans, Reinhilde
collection PubMed
description Following a mandate from the European Commission, EFSA has developed a Guidance on Technical Requirements (Guidance on Particle‐TR), defining the criteria for assessing the presence of a fraction of small particles, and setting out information requirements for applications in the regulated food and feed product areas (e.g. novel food, food/feed additives, food contact materials and pesticides). These requirements apply to particles requiring specific assessment at the nanoscale in conventional materials that do not meet the definition of engineered nanomaterial as set out in the Novel Food Regulation (EU) 2015/2283. The guidance outlines appraisal criteria grouped in three sections, to confirm whether or not the conventional risk assessment should be complemented with nanospecific considerations. The first group addresses solubility and dissolution rate as key physicochemical properties to assess whether consumers will be exposed to particles. The second group establishes the information requirements for assessing whether the conventional material contains a fraction or consists of small particles, and its characterisation. The third group describes the information to be presented for existing safety studies to demonstrate that the fraction of small particles, including particles at the nanoscale, has been properly evaluated. In addition, in order to guide the appraisal of existing safety studies, recommendations for closing the data gaps while minimising the need for conducting new animal studies are provided. This Guidance on Particle‐TR complements the Guidance on risk assessment of nanomaterials to be applied in the food and feed chain, human and animal health updated by the EFSA Scientific Committee as co‐published with this Guidance. Applicants are advised to consult both guidance documents before conducting new studies.
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spelling pubmed-83310582021-08-09 Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles More, Simon Bampidis, Vasileios Benford, Diane Bragard, Claude Halldorsson, Thorhallur Hernández‐Jerez, Antonio Bennekou, Susanne Hougaard Koutsoumanis, Kostas Lambré, Claude Machera, Kyriaki Naegeli, Hanspeter Nielsen, Søren Schlatter, Josef Schrenk, Dieter Silano (deceased), Vittorio Turck, Dominique Younes, Maged Castenmiller, Jacqueline Chaudhry, Qasim Cubadda, Francesco Franz, Roland Gott, David Mast, Jan Mortensen, Alicja Oomen, Agnes G. Weigel, Stefan Barthelemy, Eric Rincon, Ana Tarazona, Jose Schoonjans, Reinhilde EFSA J Guidance Following a mandate from the European Commission, EFSA has developed a Guidance on Technical Requirements (Guidance on Particle‐TR), defining the criteria for assessing the presence of a fraction of small particles, and setting out information requirements for applications in the regulated food and feed product areas (e.g. novel food, food/feed additives, food contact materials and pesticides). These requirements apply to particles requiring specific assessment at the nanoscale in conventional materials that do not meet the definition of engineered nanomaterial as set out in the Novel Food Regulation (EU) 2015/2283. The guidance outlines appraisal criteria grouped in three sections, to confirm whether or not the conventional risk assessment should be complemented with nanospecific considerations. The first group addresses solubility and dissolution rate as key physicochemical properties to assess whether consumers will be exposed to particles. The second group establishes the information requirements for assessing whether the conventional material contains a fraction or consists of small particles, and its characterisation. The third group describes the information to be presented for existing safety studies to demonstrate that the fraction of small particles, including particles at the nanoscale, has been properly evaluated. In addition, in order to guide the appraisal of existing safety studies, recommendations for closing the data gaps while minimising the need for conducting new animal studies are provided. This Guidance on Particle‐TR complements the Guidance on risk assessment of nanomaterials to be applied in the food and feed chain, human and animal health updated by the EFSA Scientific Committee as co‐published with this Guidance. Applicants are advised to consult both guidance documents before conducting new studies. John Wiley and Sons Inc. 2021-08-03 /pmc/articles/PMC8331058/ /pubmed/34377191 http://dx.doi.org/10.2903/j.efsa.2021.6769 Text en © 2021 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. https://creativecommons.org/licenses/by-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nd/4.0/ (https://creativecommons.org/licenses/by-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made.
spellingShingle Guidance
More, Simon
Bampidis, Vasileios
Benford, Diane
Bragard, Claude
Halldorsson, Thorhallur
Hernández‐Jerez, Antonio
Bennekou, Susanne Hougaard
Koutsoumanis, Kostas
Lambré, Claude
Machera, Kyriaki
Naegeli, Hanspeter
Nielsen, Søren
Schlatter, Josef
Schrenk, Dieter
Silano (deceased), Vittorio
Turck, Dominique
Younes, Maged
Castenmiller, Jacqueline
Chaudhry, Qasim
Cubadda, Francesco
Franz, Roland
Gott, David
Mast, Jan
Mortensen, Alicja
Oomen, Agnes G.
Weigel, Stefan
Barthelemy, Eric
Rincon, Ana
Tarazona, Jose
Schoonjans, Reinhilde
Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles
title Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles
title_full Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles
title_fullStr Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles
title_full_unstemmed Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles
title_short Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles
title_sort guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles
topic Guidance
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8331058/
https://www.ncbi.nlm.nih.gov/pubmed/34377191
http://dx.doi.org/10.2903/j.efsa.2021.6769
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