RT Journal Article
T1 Guidance on technical requirements for regulated food and feed product applications to establish the presence of small particles including nanoparticles.
A1 EFSA Scientific Committee, 
A1 More, Simon
A1 Bampidis, Vasileios
A1 Benford, Diane
A1 Bragard, Claude
A1 Halldorsson, Thorhallur
A1 Hernández-Jerez, Antonio
A1 Bennekou, Susanne Hougaard
A1 Koutsoumanis, Kostas
A1 Lambré, Claude
A1 Machera, Kyriaki
A1 Naegeli, Hanspeter
A1 Nielsen, Søren
A1 Schlatter, Josef
A1 Schrenk, Dieter
A1 Silano Deceased, Vittorio
A1 Turck, Dominique
A1 Younes, Maged
A1 Castenmiller, Jacqueline
A1 Chaudhry, Qasim
A1 Cubadda, Francesco
A1 Franz, Roland
A1 Gott, David
A1 Mast, Jan
A1 Mortensen, Alicja
A1 Oomen, Agnes G
A1 Weigel, Stefan
A1 Barthelemy, Eric
A1 Rincon, Ana
A1 Tarazona, Jose
A1 Schoonjans, Reinhilde
K1 dissolution/degradation rate
K1 electron microscopy
K1 nanofraction
K1 nanomaterial
K1 particle size distribution
K1 sample dispersion protocol
K1 solubility
AB 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.
YR 2021
FD 2021-08-03
LK https://hdl.handle.net/10668/26741
UL https://hdl.handle.net/10668/26741
LA en
DS RISalud
RD Apr 10, 2025