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

Research output: Contribution to journal › Journal article › Research

Standard

Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles. / EFSA Scientific Committee; 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.

In: EFSA Journal, Vol. 19, No. 8, e06769, 2021, p. 1-48.

Research output: Contribution to journal › Journal article › Research

Harvard

EFSA Scientific Committee, More, S, Bampidis, V, Benford, D, Bragard, C, Halldorsson, T, Hernández-Jerez, A, Bennekou, SH, Koutsoumanis, K, Lambré, C, Machera, K, Naegeli, H, Nielsen, S, Schlatter, J, Schrenk, D, Silano (deceased), V, Turck, D, Younes, M, Castenmiller, J, Chaudhry, Q, Cubadda, F, Franz, R, Gott, D, Mast, J, Mortensen, A, Oomen, AG, Weigel, S, Barthelemy, E, Rincon, A, Tarazona, J & Schoonjans, R 2021, 'Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles', EFSA Journal, vol. 19, no. 8, e06769, pp. 1-48. https://doi.org/10.2903/j.efsa.2021.6769

APA

EFSA Scientific Committee, More, S., Bampidis, V., Benford, D., Bragard, C., Halldorsson, T., Hernández-Jerez, A., Bennekou, S. H., Koutsoumanis, K., Lambré, C., Machera, K., Naegeli, H., Nielsen, S., Schlatter, J., Schrenk, D., Silano (deceased), V., Turck, D., Younes, M., Castenmiller, J., ... Schoonjans, R. (2021). Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles. EFSA Journal, 19(8), 1-48. [e06769]. https://doi.org/10.2903/j.efsa.2021.6769

Vancouver

EFSA Scientific Committee, More S, Bampidis V, Benford D, Bragard C, Halldorsson T et al. Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles. EFSA Journal. 2021;19(8):1-48. e06769. https://doi.org/10.2903/j.efsa.2021.6769

Author

EFSA Scientific Committee ; 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. In: EFSA Journal. 2021 ; Vol. 19, No. 8. pp. 1-48.

Bibtex

@article{a7b6c7e24758405a95c35591b55c8694,
title = "Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles",
abstract = "Abstract 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.",
keywords = "nanomaterial, nanofraction, solubility, dissolution/degradation rate, sample dispersion protocol, electron microscopy, particle size distribution",
author = "{EFSA Scientific Committee} and Simon More and Vasileios Bampidis and Diane Benford and Claude Bragard and Thorhallur Halldorsson and Antonio Hern{\'a}ndez-Jerez and Bennekou, {Susanne Hougaard} and Kostas Koutsoumanis and Claude Lambr{\'e} and Kyriaki Machera and Hanspeter Naegeli and S{\o}ren Nielsen and Josef Schlatter and Dieter Schrenk and {Silano (deceased)}, Vittorio and Dominique Turck and Maged Younes and Jacqueline Castenmiller and Qasim Chaudhry and Francesco Cubadda and Roland Franz and David Gott and Jan Mast and Alicja Mortensen and Oomen, {Agnes G.} and Stefan Weigel and Eric Barthelemy and Ana Rincon and Jose Tarazona and Reinhilde Schoonjans",
year = "2021",
doi = "10.2903/j.efsa.2021.6769",
language = "English",
volume = "19",
pages = "1--48",
journal = "E F S A Journal",
issn = "1831-4732",
publisher = "European Food Safety Authority (E F S A)",
number = "8",

}

RIS

TY - JOUR

T1 - Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles

AU - EFSA Scientific Committee, null

AU - More, Simon

AU - Bampidis, Vasileios

AU - Benford, Diane

AU - Bragard, Claude

AU - Halldorsson, Thorhallur

AU - Hernández-Jerez, Antonio

AU - Bennekou, Susanne Hougaard

AU - Koutsoumanis, Kostas

AU - Lambré, Claude

AU - Machera, Kyriaki

AU - Naegeli, Hanspeter

AU - Nielsen, Søren

AU - Schlatter, Josef

AU - Schrenk, Dieter

AU - Silano (deceased), Vittorio

AU - Turck, Dominique

AU - Younes, Maged

AU - Castenmiller, Jacqueline

AU - Chaudhry, Qasim

AU - Cubadda, Francesco

AU - Franz, Roland

AU - Gott, David

AU - Mast, Jan

AU - Mortensen, Alicja

AU - Oomen, Agnes G.

AU - Weigel, Stefan

AU - Barthelemy, Eric

AU - Rincon, Ana

AU - Tarazona, Jose

AU - Schoonjans, Reinhilde

PY - 2021

Y1 - 2021

N2 - Abstract 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.

AB - Abstract 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.

KW - nanomaterial

KW - nanofraction

KW - solubility

KW - dissolution/degradation rate

KW - sample dispersion protocol

KW - electron microscopy

KW - particle size distribution

U2 - 10.2903/j.efsa.2021.6769

DO - 10.2903/j.efsa.2021.6769

M3 - Journal article

C2 - 34377191

VL - 19

SP - 1

EP - 48

JO - E F S A Journal

JF - E F S A Journal

SN - 1831-4732

IS - 8

M1 - e06769

ER -

ID: 275765607