HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 275/38
EN
Official Journal of the European Union
20.10.2011
RECOMMENDATIONS
COMMISSION RECOMMENDATION
of 18 October 2011
on the definition of nanomaterial
(Text with EEA relevance)
(2011/696/EU)
THE EUROPEAN COMMISSION,
regard to hazard or risk. This definition, based only on
the size of a material, covers natural, incidental or manu
factured materials.
Having regard to the Treaty on the Functioning of the European
Union, and in particular Article 292 thereof,
(5) The
definition
of
the
term
‘nanomaterial’
should
be
based
on available scientific knowledge.
Whereas:
(6) Measuring
size
and
size
distributions
in
nanomaterials
is
(1) The
Commission
Communication
of
7
June
2005
challenging in many cases and different measurement
‘Nanosciences and nanotechnologies: An action plan for
methods may not provide comparable results.
Europe 2005-2009’ ( 1 ) defines a series of articulated and
Harmonised measurement methods must be developed
interconnected actions for the immediate implementation
with a view to ensuring that the application of the defi
of a safe, integrated and responsible approach for nanos
nition leads to consistent results across materials and
ciences and nanotechnologies.
over time. Until harmonised measurement methods are
available, best available alternative methods should be
applied.
(2) The
Commission,
in
line
with
the
commitments
made
in
the Action Plan, carefully reviewed relevant Union legis
lation with a view to determine the applicability of the
(7) The
European
Commission
Joint
Research
Centre
existing regulations to the potential risks of nano
Reference Report ‘Considerations on a Definition of
materials. The result of the review was contained in the
Nanomaterial for Regulatory purposes’ (
Commission Communication of 17 June 2008 ‘Regu

4 ) suggests that
a definition of nanomaterials should address particulate
latory aspects of nanomaterials’ ( 2 ). The Communication
nanomaterials, be broadly applicable in Union legislation
concluded that the term ‘nanomaterials’ is not mentioned
and be in line with other approaches worldwide. Size
specifically in Union legislation but that existing legis
should be the only defining property which necessitates
lation in principle covers the potential health, safety
a clear definition of the nanoscale limits.
and environmental risks in relation to nanomaterials.
(3) The
European
Parliament
in
its
resolution
of
24
April (8) The
Commission
mandated
the
Scientific
Committee
on
2009 on regulatory aspects of nanomaterials (
Emerging and Newly Identified Health Risks (SCENIHR)

3 ) called,
inter alia, for the introduction of a comprehensive
to provide scientific input on elements to consider when
science-based definition of nanomaterials in Union legis
developing a definition of the term ‘nanomaterial’ for
lation.
regulatory purposes. The opinion ‘Scientific basis for
the definition of the term “Nanomaterial” ’ was subject
to a public consultation in 2010. In its opinion of
8 December 2010 ( 5 ), SCENIHR concluded that size is
(4) The
definition
in
this
Recommendation
should
be
used
as
universally applicable to nanomaterials and the most
a reference for determining whether a material should be
suitable measurand. A defined size range would facilitate
considered as a ‘nanomaterial’ for legislative and policy
a uniform interpretation. The lower limit was proposed
purposes in the Union. The definition of the term ‘nano
at 1 nm. An upper limit of 100 nm is commonly used
material’ in Union legislation should be based solely on
by general consensus, but there is no scientific evidence
the size of the constituent particles of a material, without
to support the appropriateness of this value. The use of a
( 1 ) COM(2005) 243 final.
( 4 ) EUR 24403 EN, June 2010.
( 2 ) COM(2008) 366 final.
( 5 ) http://ec.europa.eu/health/scientific_committees/emerging/docs/
( 3 ) P6_TA(2009) 0328.
scenihr_o_032.pdf

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EN
20.10.2011 Official
Journal
of
the
European
Union L
275/39
single upper limit value might be too limiting for the
(12) Agglomerated
or
aggregated
particles
may
exhibit
the
classification of nanomaterials and a differentiated
same properties as the unbound particles. Moreover,
approach might be more appropriate. For regulatory
there can be cases during the life-cycle of a nanomaterial
purposes, the number size distribution should also be
where the particles are released from the agglomerates or
considered using the mean size and the standard
aggregates. The definition in this Recommendation
deviation of the size to refine the definition. The size
should therefore also include particles in agglomerates
distribution of a material should be presented as size
or aggregates whenever the constituent particles are in
distribution based on the number concentration (i.e.
the size range 1 nm-100 nm.
the number of objects within a given size range
divided by the number of objects in total) and not on
the mass fraction of nanoscale particles in the nano
material as a small mass fraction may contain the
largest number of particles. SCENIHR identified certain
(13) At present it is possible to measure the specific surface
specific cases where the application of the definition can
area by volume for dry solid materials or powders with
be facilitated by using the volume specific surface area as
the nitrogen adsorption method (‘BET-method’). In those
proxy to determine if a material falls within the defined
cases the specific surface area can be used as a proxy to
nano size range.
identify a potential nanomaterial. New scientific
knowledge may expand the possibility to use this and
other methods to other types of materials in the future.
There can be a discrepancy between the measurement of
the specific surface area and the number size distribution
(9) The
International
Organisation
for
Standardisation
defines the term ‘nanomaterial’ as ‘material with any
from one material to another. Therefore it should be
external dimensions in the nanoscale or having internal
specified that results for number size distribution
structure or surface structure in the nanoscale’. The term
should prevail and it should not be possible to use the
‘nanoscale’ is defined as size range from approximately
specific surface area to demonstrate that a material is not
1 nm to 100 nm (
a nanomaterial.

1 ).
(10) The
number
size
distribution
should
cover
for
the
fact
(14) Technological development and scientific progress
that nanomaterials most typically consist of many
continue with great speed. The definition including
particles present in different sizes in a particular
descriptors should therefore be subject to a review by
distribution. Without specifying the number size
December 2014 to ensure that it corresponds to the
distribution, it would be difficult to determine if a
needs. In particular, the review should assess whether
specific material complies with the definition where
the number size distribution threshold of 50 % should
some particles are below 100 nm while others are not.
be increased or decreased and whether to include
This approach is in line with the opinion of SCENIHR
materials with internal structure or surface structure in
that the particle distribution of a material should be
the nanoscale such as complex nano-component nano
presented as the distribution based on the number
materials including nano-porous and nano-composite
concentration (i.e. the particle number).
materials that are used in some sectors.
(11) There
is
no
unequivocal
scientific
basis
to
suggest
a
specific value for the size distribution below which
(15) Guidance
and
standardised
measurement
methods
as
well
materials containing particles in the size range 1 nm-
as knowledge about typical concentrations of nanopar
100 nm are not expected to exhibit properties specific
ticles in representative sets of materials should be
to nanomaterials. The scientific advice was to use a stat
developed where feasible and reliable to facilitate the
istical approach based on standard deviation with a
application of the definition in a specific legislative
threshold value of 0,15
%. Given the widespread
context.
occurrence of materials that would be covered by such
a threshold and the need to tailor the scope of the defi
nition for use in a regulatory context, the threshold
should be higher. A nanomaterial as defined in this
(16) The
definition
set
out
in
this
Recommendation
should
recommendation should consist for 50 % or more of
not prejudge nor reflect the scope of application of any
particles having a size between 1
nm-100 nm. In
piece of Union legislation or of any provisions
accordance with SCENIHR’s advice, even a small
potentially establishing additional requirements for
number of particles in the range between 1
nm-
those materials, including those relating to risk
100 nm may in certain cases justify a targeted
management. It may in some cases be necessary to
assessment. However, it would be misleading to
exclude certain materials from the scope of application
categorise such materials as nanomaterials. Nevertheless
of specific legislation or legislative provisions even if they
there may be specific legislative cases where concerns for
fall within the definition. It may likewise be necessary to
the environment, health, safety or competitiveness
include additional materials, such as some materials with
warrant the application of a threshold below 50 %.
a size smaller than 1 nm or greater than 100 nm in the
scope of application of specific legislation or legislative
( 1 ) http://cdb.iso.org
provisions suited for a nanomaterial.

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L 275/40
EN
Official Journal of the European Union
20.10.2011
(17) Given the special circumstances prevailing in the phar
(b) ‘agglomerate’ means a collection of weakly bound
maceutical sector and the specialised nano-structured
particles or aggregates where the resulting external
systems already in use, the definition in this Recommen
surface area is similar to the sum of the surface areas
dation should not prejudice the use of the term ‘nano’
of the individual components;
when defining certain pharmaceuticals and medical
devices,
(c) ‘aggregate’ means a particle comprising of strongly
bound or fused particles.
HAS ADOPTED THIS RECOMMENDATION
1. Member States, the Union agencies and economic operators
5. Where technically feasible and requested in specific legis
are invited to use the following definition of the term ‘nano
lation, compliance with the definition in point 2 may be
material’ in the adoption and implementation of legislation
determined on the basis of the specific surface area by
and policy and research programmes concerning products of
volume. A material should be considered as falling under
nanotechnologies.
the definition in point 2 where the specific surface area by
volume of the material is greater than 60 m 2 /cm 3 . However,
a material which, based on its number size distribution, is a
2. ‘Nanomaterial’ means a natural, incidental or manufactured
nanomaterial should be considered as complying with the
material containing particles, in an unbound state or as an
definition in point 2 even if the material has a specific
aggregate or as an agglomerate and where, for 50 % or more
surface area lower than 60 m 2 /cm 3 .
of the particles in the number size distribution, one or more
external dimensions is in the size range 1 nm-100 nm.
6. By December 2014, the definition set out in points 1 to 5
In specific cases and where warranted by concerns for the
will be reviewed in the light of experience and of scientific
environment, health, safety or competitiveness the number
and technological developments. The review should
size distribution threshold of 50 % may be replaced by a
particularly focus on whether the number size distribution
threshold between 1 and 50 %.
threshold of 50 % should be increased or decreased.
3. By derogation from point 2, fullerenes, graphene flakes and
7. This Recommendation is addressed to the Member States,
single wall carbon nanotubes with one or more external
Union agencies and economic operators.
dimensions below 1 nm should be considered as nano
materials.
Done at Brussels, 18 October 2011.
4. For the purposes of point 2, ‘particle’, ‘agglomerate’ and
‘aggregate’ are defined as follows:
For the Commission
(a) ‘particle’ means a minute piece of matter with defined
Janez POTONIK
physical boundaries;
Member of the Commission

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