Proposal for a qualification system for New Approach Methodologies (NAMs) in the food and feed sector: example of implementation for nanomaterial risk assessment
EFSA Supporting Publications,
Год журнала:
2024,
Номер
21(9)
Опубликована: Сен. 1, 2024
Abstract
Plenty
of
new
approach
methodologies
(NAMs)
for
risk
assessment
have
been
developed
but
only
some
are
included
in
OECD
Test
Guidelines
(TGs)
regulatory
implementation.
Nevertheless,
NAMs
increasingly
applied,
e.g.
nanomaterial
(NM)
assessments.
The
EFSA
Guidance
on
NM
suggests
that
NAM‐derived
data
concerning
degradation/dissolution
(in
relevant
biofluids),
intestinal
uptake/crossing,
genotoxicity,
cytotoxicity,
oxidative
stress,
(pro‐)inflammatory
potential
and
barrier
integrity,
many
which
no
TGs
exist,
to
be
evaluated
first.
Consequently,
assessments
involve
from
non‐guideline
studies,
requiring
time‐consuming
challenging
case‐by‐case
evaluations.
Establishing
an
TG
is
a
formal
process
aiming
international
use
according
the
Mutual
Acceptance
Data
(MAD).
However,
not
every
promising
NAM
can
prioritised
TGs.
A
qualification,
based
expert
opinion,
may
enable
efficient
adequate
specific
context‐of‐use.
Furthermore,
it
supports
optimisation
applications.
Existing
qualification
systems
operate
context
e.g.,
drug
development
tools
(FDA)
research
into
pharmaceuticals
(EMA).
NAMS4NANO
consortium
was
tasked
propose
generic
framework
system
chemical
food
feed
sector
speed
up
NAMs.
Here
we
describe
our
proposal
including
evaluation
criteria.
detailed
test
method
description,
preferably
as
standard
operating
procedures
(SOPs),
describing
set‐up
its
application
phase
crucial.
scientific
validity,
i.e.
reliability
relevance
context‐of‐use,
needs
demonstrated,
suggest
less
rigorous
compared
We
initially
establish
assessment,
aligned
with
framework.
This
document
interim
version
stipulate
broader
discussion
among
experts
stakeholders.
Язык: Английский
Silver Accumulation and Ionomic Profile Alterations in Pigs: Evaluation of Silver Nanoparticles as Feed Supplements and Potential Human Exposure
ACS Agricultural Science & Technology,
Год журнала:
2025,
Номер
unknown
Опубликована: Фев. 25, 2025
The
antimicrobial
properties
of
silver
nanoparticles
(AgNPs)
in
animal
feed
have
drawn
increasing
attention
as
a
potential
alternative
to
antibiotics.
However,
concerns
about
bioaccumulation
and
possible
effects
on
mineral
homeostasis
require
thorough
evaluation.
This
study
investigates
the
Ag
various
tissues
ionomic
alterations
pigs
fed
AgNPs
complexed
with
carbohydrates
(AgNPs@Carb).
Silver
concentrations
were
measured
tissues,
such
liver,
kidney,
spleen,
heart,
cecal
contents,
at
different
time
points
following
withdrawal
nanoparticle-supplemented
diet.
Principal
component
analysis
(PCA)
assessed
18
elements
across
10
tissues.
Results
indicate
that
primarily
accumulates
liver
varying
clearance
rates
estimated
daily
intake
(EDI)
for
human
consumption
was
evaluated,
revealing
low
values
all
suggests
exposure
through
edible
from
animals
supplemented
is
minimal
does
not
pose
an
immediate
health
risk.
Significant
changes
also
observed
profiles,
suggesting
disrupt
trace
element
homeostasis.
These
findings
underscore
importance
understanding
both
biodistribution
their
long-term
impact
consumers.
Язык: Английский
Recent Innovations in Metal-Based Nanoparticles for Food Packaging: A Focus on Safety and Environmental Impact
Applied Food Research,
Год журнала:
2025,
Номер
unknown, С. 100860 - 100860
Опубликована: Апрель 1, 2025
Язык: Английский
Hazard screening of colloidal silica nanomaterials with varying degrees of silane surface functionalization: a safe-by-design case study
Particle and Fibre Toxicology,
Год журнала:
2025,
Номер
22(1)
Опубликована: Май 26, 2025
The
Safe
and
Sustainable
by
Design
(SSbD)
concept
facilitates
the
design
of
safer
more
sustainable
chemicals
materials
is
a
crucial
approach
towards
reaching
goals
set
out
in
European
Green
Deal.
It
critical
that
suitable
guidance
provided
on
how
to
use
new
methodologies
(NAMs)
fill
hazard
data
gaps
for
nanomaterials
(NMs)
facilitate
SSbD
decisions.
Here,
we
showcase
nano-specific
vitro
case
study.
five
colloidal
silica
nanoforms
(SiO2-NFs)
under
investigation
this
study
are
surface
modified
with
varying
amounts
glycerolpropyl-organosilane
groups.
In
study,
simple
yet
comprehensive
test
battery
along
thorough
particle
characterization
investigate
effect
silanization
toxicity
inform
Cytotoxic,
pro-inflammatory
oxidative
stress
responses
A549,
dTHP-1,
BEAS-2B
cells
after
exposure
SiO2-NFs
submerged
at
air-liquid
interface
(ALI)
decreased
increasing
silane
modification.
None
showed
reactivity
or
haemolytic
potential.
Deposition
assessment
using
inductively
coupled
plasma
-
optical
emission
spectrometry
(ICP-OES)
revealed
modification
settling.
two
highest
amount
did
not
reach
setting,
they
were
therefore
only
tested
ALI.
Identical
dose-response
curves
observed
both
testing
ALI
without
low/intermediate
functionalization,
again
showing
decrease
effects
functionalization.
We
show
assays
provide
valuable
information
decision
making.
cytotoxic,
can
be
reduced
deposition
efficiency
however,
highlights
behaviour
cell
culture
medium
should
always
performed
testing.
required
reduce
important
future
production
nano-enabled
products.
Exposure,
functionality,
sustainability
remain
investigated
draw
full
conclusions.
Язык: Английский
Monte Carlo Simulation of Pesticide Toxicity for Rainbow Trout (Oncorhynchus mykiss) Using New Criteria of Predictive Potential
Journal of Xenobiotics,
Год журнала:
2025,
Номер
15(3), С. 82 - 82
Опубликована: Июнь 1, 2025
Background:
The
toxicity
of
pesticides
for
fish
in
general
and
Rainbow
Trout
(Oncorhynchus
mykiss)
particular
is
an
important
ecological
indicator
required
by
regulations,
it
implies
the
use
a
large
number
fish.
animals
needed
would
be
even
higher
to
evaluate
metabolites
pesticide
impurities.
Considering
ethical
issues,
costs,
necessary
resources,
silico
models
often
proposed.
Aim
study:
We
explore
advanced
Monte
Carlo
methods
obtain
improved
results
testing
acute
toxicity.
Several
versions
stochastic
simulation
Trout,
carried
out
using
CORAL
software,
were
studied.
set
substances
was
split
into
four
subsets:
active
training,
passive
calibration,
validation.
Modeling
repeated
five
times
enable
better
statistical
evaluation.
To
improve
predictive
potential
models,
index
ideality
correlation
(IIC),
intensity
(CII),
coefficient
conformism
prediction
(CCCP)
applied.
Main
novelty:
most
suitable
observed
case
CCCP-based
optimization
SMILES-based
descriptors,
achieving
R2
0.88
on
validation
set,
all
random
splits,
demonstrating
consistent
robust
modeling
performance.
relationship
information
systems
related
QSAR
new
ideas
discussed,
assigning
key
role
fundamental
concepts
like
mass
energy.
study
mentioned
criteria
during
conducted
computer
experiments
showed
that
though
they
are
aimed
at
improving
potential,
their
values
do
not
correlate,
except
CII
CCCP.
This
means
that,
general,
impact
considered
has
different
nature,
least
mykiss).
applicability
domain
model
specific
pesticides;
software
identifies
outliers
looking
rare
molecular
fragments.
Язык: Английский
The Use of Core-Shell Nanoparticles in Photovoltaics
Photonics,
Год журнала:
2025,
Номер
12(6), С. 555 - 555
Опубликована: Май 31, 2025
The
field
of
photovoltaics
(PV)
continually
seeks
innovative
materials
solutions
to
enhance
the
efficiency
and
stability
their
standard
devices.
Core-shell
nanoparticles
have
emerged
as
a
promising
new
technology
with
unique
structural
attributes
widely
tunable
properties.
This
paper
reviews
use
plasmonic
core-shell
in
PV
applications
through
various
experimental
validations.
We
describe
advancements
design
control
over
properties
highlight
integration
into
solar
cells,
based
on
ability
finely
tune
optical,
electronic,
chemical
also
discuss
results
for
organic,
perovskite,
dye-sensitized
where
been
successfully
deployed.
Additionally,
we
identify
gaps
current
research,
such
need
scalable
synthesis
methods
long-term
assessments,
will
point
out
developments
at
frontier
that
field.
Язык: Английский
Regulatory practices on the genotoxicity testing of nanomaterials and outlook for the future
Regulatory Toxicology and Pharmacology,
Год журнала:
2025,
Номер
unknown, С. 105881 - 105881
Опубликована: Июнь 1, 2025
Язык: Английский
Overview of Computational Toxicology Methods Applied in Drug and Green Chemical Discovery
Journal of Xenobiotics,
Год журнала:
2024,
Номер
14(4), С. 1901 - 1918
Опубликована: Дек. 4, 2024
In
the
field
of
computational
chemistry,
computer
models
are
quickly
and
cheaply
constructed
to
predict
toxicology
hazards
results,
with
no
need
for
test
material
or
animals
as
these
predictions
often
based
on
physicochemical
properties
chemical
structures.
Multiple
methodologies
employed
support
in
silico
assessments
machine
learning
(ML)
deep
(DL).
This
review
introduces
development
toxicology,
focusing
ML
DL
emphasizing
their
importance
toxicology.
A
fine
balance
between
target
potency,
selectivity,
absorption,
distribution,
metabolism,
excretion,
toxicity
(ADMET)
clinical
safety
should
be
achieved
discover
a
potential
new
drug.
It
is
advantageous
perform
virtual
early
possible
drug
processes,
even
before
molecule
synthesized.
Currently,
there
numerous
commercially
available
free
web-based
programs
prediction,
which
can
used
construct
various
predictive
models.
The
key
features
QSAR
method
also
outlined,
selection
appropriate
descriptors
prerequisite
robust
predictions.
addition,
examples
open-source
tools
applied
prediction
included,
well
application
different
methods
design
environmental
Язык: Английский