kSIST-TS FprCEN/TS 18401:2026

SLOVENSKI STANDARD
01-november-2026
Kratek priročnik za uvedbo ustreznega sistema upravljanja tveganj za zdravje in
varnost za nanoobjekte ter njihove agregate in aglomerate (NOAA)
Quick start guide for deploying a relevant health and safety risk management for nano-
objects and their aggregates and agglomerates (NOAA)
Nanotechnologien - Kurzanleitung zur Einführung eines relevanten Gesundheits- und
Sicherheitsrisikomanagementsystems für Nanotechnologien
Nanotechnologies - Guide de démarrage rapide pour le déploiement d’une gestion
pertinente des risques en termes de santé et sécurité
Ta slovenski standard je istoveten z: FprCEN/TS 18401
ICS:
07.120 Nanotehnologije Nanotechnologies
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

FINAL DRAFT
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
September 2026
ICS
English Version
Quick start guide for deploying a relevant health and
safety risk management for nano-objects and their
aggregates and agglomerates (NOAA)
Nanotechnologies - Guide de démarrage rapide pour le Nanotechnologien - Kurzanleitung zur Einführung
déploiement d'une gestion pertinente des risques en eines relevanten Gesundheits- und
termes de santé et sécurité Sicherheitsrisikomanagementsystems für
Nanotechnologien
This draft Technical Specification is submitted to CEN members for Vote. It has been drawn up by the Technical Committee
CEN/TC 352.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

Warning : This document is not a Technical Specification. It is distributed for review and comments. It is subject to change
without notice and shall not be referred to as a Technical Specification.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprCEN/TS 18401:2026 E
worldwide for CEN national Members.

Contents Page
European Foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Identification of NOAA and cases of applicability of the methodology. 6
4.1 General. 6
4.2 Manufactured NOAA used in the process . 9
4.3 Incidental or natural NOAA . 9
5 Risk assessment and management methodology . 10
Annex A (normative) Simplified hazard band chart . 15
Annex B (informative) Case study . 18
Bibliography . 21
European Foreword
This document (FprCEN/TS 18401:2026) has been prepared by Technical Committee CEN/TC 352
“Nanotechnologies”, the secretariat of which is held by AFNOR.
This document is currently submitted to the Vote on TS.
Introduction
Today, industrial hygiene and occupational health professionals are aware of the potential risks from
exposure to nano-objects. For example, the penetration of these particles deep into the pulmonary alveoli
and the possibility of systemic transfer (among others) is a particular source of concern.
However, for those unfamiliar with the risks of nanomaterials, integrating identified risks into chemical
risk management can be challenging due to the existence of multiple definitions, guidance documents,
reference documents and standards, as well as blurred boundaries. Like for other chemicals, risk
management of nano-objects requires the application of the general methodology of chemical risk
prevention. The reader is invited to study these methodologies in order to effectively apply the approach
presented in this document.
This document is applicable to manufactured materials that contain nano-objects such as nanoparticles,
nanofibres, nanotubes, nanowires and nanoplates as well as their aggregates and agglomerates (NOAA).
The term “NOAA”, as used in ISO 80004-1 and ISO/TS 12901-1, applies to such materials either in their
original form or incorporated in other materials or preparations from which they could be released
during their life cycle, including downstream activities as well as disposal.
The incomplete understanding of NOAA-related risks and of the best approaches to manage them is a
significant obstacle to the deployment of nanotechnologies and innovation. This quick start guide
explains NOAA-related risks in simple terms and demonstrates that the management of these is within
the reach of industrial hygiene professionals. Nevertheless, the NOAA-related risks remain a complex
issue, and, compliance with specific national legislation will also be relevant.
The objective is to help the reader to build a first approach in terms of identification, risk assessment,
risk mitigation and control methodology. References to relevant documents and tools are provided.
1 Scope
This document provides a quick start guide to structure the approach to be taken by health and safety
professionals when they need to manage the occupational health and safety risks of manufactured nano-
objects and their aggregates and agglomerates greater than 100 nm (NOAA). All routes of exposure are
taken into account: inhalation, dermal or ingestion.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://www.electropedia.org/.
3.1
agglomerate
collection of weakly or medium strongly bound particles where the resulting external surface area is
similar to the sum of the surface areas of the individual components
Note 1 to entry: The forces holding an agglomerate together are weak forces, for example, van der Waals forces or
simple physical entanglement.
Note 2 to entry: Agglomerates are also termed secondary particles and the original source particles are termed
primary particles.
[SOURCE:ISO 80004-1:2023, 3.2.4]
3.2
aggregate
particle comprising strongly bonded or fused particles where the resulting external surface area is
significantly smaller than the sum of surface areas of the individual components
Note 1 to entry: The forces holding an aggregate together are strong forces, for example, covalent or ionic bonds, or
those resulting from sintering or complex physical entanglement.
Note 2 to entry: Aggregates are also termed secondary particles and the original source particles are termed
primary particles.
[SOURCE:ISO 80004-1:2023, 3.2.5]
3.3
nano-object
discrete piece of material with one, two or three external dimensions in the nanoscale
[SOURCE:ISO 80004-1:2023, 3.1.5]
3.4
nanoscale
length range approximately from 1 nm to 100 nm
[SOURCE:ISO 80004-1:2023, 3.1.1]
3.5
NOAA
nano-objects and their aggregates and agglomerates
Note 1 to entry: NOAA include structures with one, two or three external dimensions in the nanoscale, which can be
spheres, fibres, tubes and others as primary structures. NOAA can consist of individual primary structures in the
nanoscale and aggregated or agglomerated structures, including those with sizes larger than 100 nm.
[SOURCE: ISO 80004-1: 2023, 3.2.6]
4 Identification of NOAA and cases of applicability of the methodology
4.1 General
Figure 1 presents a flowchart that illustrates a simplified approach to identify NOAA and the way to apply
the proposed methodology. Additional details on the content of each box of the flow-chart are available
at the end of the section.
Figure 1 – Flow-chart on NOAA identification and applicability of the methodology
Sources for identification of NOAA: The approach starts by identifying the presence of NOAA and any
associated risks. Identification is mainly carried out on documents using different sources of information:
— SDS (Safety Data Sheet): when it exists. Information on the content of nanoparticles or
nanostructures or simply the string “nano” in the text will be searched for. The term used may also
be "ultrafine" (e.g. ultrafine TiO ). REACH legislation (Annex II) requires users to be informed of the
presence of nanoforms in SDS. However, in case that the substance contains some nanoparticles but
their fraction stays below the threshold of 50 % by number, the SDS might only reflect information
for the ‘conventional’ substance. Therefore, consulting the SDS does not always provide information
on the presence of NOAA, even if the products contain NOAA.
— Questions to the supplier: If the industrial hygiene officer evaluates that the substance / product
could contain NOAAs, but the supplier has not mentioned this, they should be contacted to discuss
about the potential presence of NOAAs, noting that their information may be difficult to obtain,
especially if the supply chain is long. If the presence is known or likely, additional information should
be requested, especially for hazard assessment combined with a literature search on the hazard
properties of the nanoform.
— REACH nanoform / national registry: check if the substance is registered as a nanoform under
REACH. Ask if any of the suppliers in the supply chain have made a declaration to a national reporting
system (for example R-nano in France).
— Material specifications or Technical data sheets: Information on the content of nanoparticles or
nanostructure or simply the string "nano" in the text can be searched for. Another often used term is
"ultrafine" (e.g. ultrafine TiO ). Be careful not to interpret the stated particle sizes as justifying the
absence of nano-objects as frequently the stated particle size reflects the size of agglomerates or
fragments of materials, which consist of nano-objects.
— Field observation: Certain processes, such as combustion, can release substances that generate NOAA
as by-products, including fumes and smoke. Visible smoke can contain substantial amounts of NOAA.
However, NOAA generated incidentally is generally exempt from the information requirements
under REACH.
— Technical literature: Consult the technical literature if the product is not known to contain NOAA,
particularly by its chemical composition or the particular properties attributed to it. For example,
TiO used for its photocatalytic or UV shielding properties is composed mostly of NOAA. The main
important substances containing NOAA in terms of tonnage are carbon black, synthetic silica,
alumina, titanium dioxide and calcium carbonate (source: French registry R-nano). The European
Union Observatory for Nanomaterials and the DANA database (https://www.nanoobjects.info/en/)
can help to identify products containing NOAA, frequently encountered chemical compositions, their
functionalities and common applications.
— Characterization: If the above approaches do not provide information on the presence of NOAAs in
the substance or product under consideration, laboratory characterization may be necessary. In this
case, state-of-the-art methods should be employed, which typically involve combining multiple
analytical techniques. Commonly used techniques are: electron microscopy, BET, single particle ICP-
MS, and DLS. If the NOAA is incorporated in a product or complex mixture, extraction of the NOAA
may be required, which can be a challenging step.
Origin of NOAA: It can be difficult to clearly define if NOAA are manufactured or incidental, and a
distinction can be made according to the origin and function of the NOAA. Manufactured NOAA are
produced or used in a process, and thus have a function either as a raw material or incorporated in a
material or product.
4.2 Manufactured NOAA used in the process
It is recommended to take into account the intermittent operations, maintenance or incidents. In
particular, it is necessary to conduct risk analysis.
Powders / airborne materials: These are the forms of greatest concern with respect to inhalation risk.
However dermal or ingestion exposure should be taken into account.
NOAA incorporated in a solid: These products present a low possibility for inhalation exposure except,
except in situations where particles are released into the air due to mechanical stress or work (machining,
cutting, drilling, sanding.), or by crumbling, wear and tear, normal use, weathering or ageing.
Potential dermal or ingestion exposure should be taken into account.
NOAA dispersed in a liquid: such products present a low possibility for inhalation exposure except that
particles can be emitted into the air following drying, spraying, fogging or boiling.
Potential dermal or ingestion exposure should be considered.
If inhalation exposure is expected: Methodology of this standard to be applied: this situation
requires the application of specific risk management methodology described in this document. If several
routes are relevant (dermal or ingestion in addition to inhalation), the methodology should be applied to
each route.
If inhalation exposure is not expected: Methodology of this standard is only applicable to potential
dermal/ingestion exposure and for labelling/disposal: If a potential dermal or ingestion exposure
exists, the specific risk management methodology described in this document is applicable.
For labelling/disposal, see parts concerned in the paragraph "Actions related to exposure control" below
in the methodology.
4.3 Incidental or natural NOAA
Even if non-manufactured NOAA are outside the scope of this document, the reader should be aware that
NOAA are sometimes unintentionally present at the workplace.
Hence the reader should be rigorous in identifying potential exposure, in particular by measurement with
real-time counters, which are very sensitive to background nanoparticles. The latter are mostly of organic
composition and frequently have nothing in common with the NOAA generated by processes. It is
therefore crucial in the proper application of this document to make a clear distinction between the two
origins at this stage. Sampling and observation by electron microscopy with EDX detector allow this
distinction to be made and remain the basis for the identification of the NOAA character of the particles.
Incidentally produced dust/ fumes: The reader should be aware that incidental NOAA, such as those
emitted into the air by diesel combustion or welding, may also be present in the working environment.
Incidentally produced dust / fumes can come from process related activities but also from other human
sources (e.g emission from vehicles, heating, printers,…)
Natural Background: These are NOAA present in the environment independently of process emissions.
NOAA are present in the air and have been for a long time (standard values are several tens of thousands
of particles per cm ). They can be emitted by for example forest fires, volcanoes.
When NOAA originate from natural background or incidentally produced dust/fumes, the methodology
of this document is not applicable, but could be a source of information. The reader is encouraged to
consult general air quality guides.
5 Risk assessment and management methodology
A flow-chart is presented as a support of the approach. Each box of the flowchart is then described in the
text that follows.
Figure 2 — Risk Assessment and Risk Management Methodology Flow-chart
General information: The purpose of risk management is to evaluate whether the risk existing in a
specific workplace environment exceeds the organization’s acceptable level of risk. By doing so, it
provides decision makers with information on the need to further strengthen risk management
approaches (except from ISO/TR 12885:2018).
Hazard band classification: The person in charge of the risk assessment should identify the NOAA
hazard band based on the available knowledge. Ideally, a precise exposure limit value would be available,
but there are only few such values and, at the time of writing, no regulatory ones for NOAA.
Additional exposure assessment values (e.g. derived no effect level) can be chosen.
The hazard banding approach usually consists of 3 to 5 bands depending on the approach used (see
Annex A). If there is insufficient knowledge to assign a hazard band or a target limit value, a suitable
containment search approach (partial, dynamic or total) can be considered. Independently of the precise
identification of the hazard, the choice of a containment approach may be made as a precautionary
measure.
Assignment of a hazard band or target limit value: If a hazard-band classification system is already in
use within the entity, it is recommended to follow it and position the NOAA studied in it.
If no classification system is used or if it is considered unsuitable, the person in charge of the risk
assessment shall choose an approach among the following 2 levels of complexity:
— Level 1: Use of the simplified hazard band approach presented in Annex A.
It proposes a hazard classification of the most common nanomaterials, i.e. the main ones in terms of
quantity: carbon black, synthetic amorphous silica, calcium carbonate, titanium dioxide and
aluminium oxides.
It proposes a simple distinction between insoluble particles with low toxicity, soluble particles with
moderate toxicity and fibrous forms.
— 2nd level: Use of the full hazard band approach described in ISO/TS 12901-2:2014.
Exposure assessment: Two approaches can be used to assess exposure: qualitative assessment or
measurement.
Qualitative assessment is based on the use of a reference system to classify exposure levels, such as the
exposure bands described in ISO/TS 12901-2:2014.
Given the challenges in measuring exposure to NOAA, starting with the relevant metrics (measurands) to
be used, the qualitative approach will be mainly applied when using containment (partial, dynamic or
total).
For example, this approach can be used with low amount (less than 1 grams), low toxicity NOAA
manipulated in a properly functioning laboratory fume hood.
It should be noted that under certain circumstances the use of the exposure band approach described in
ISO/TS 12901-2:2014 will, in most industrial settings, lead towards containment, which might not be
feasible for the activity.
NOAA exposure measurement has evolved a lot in recent years and the publication of EN 17058:2018
“Workplace exposure - Assessment of exposure by inhalation of nano-objects and their aggregates and
agglomerates” and EN 16966:2018 “Measurement of exposure by inhalation of nano-objects and their
aggregates and agglomerates - Metrics to be used such as number concentration, surface area
concentration and mass concentration” now provides a framework. The principle for exposure
assessments is based on the use of two categories of apparatus: real-time apparatus (but which does not
differentiate the type of particles), and sampling apparatus for laboratory analysis (which gives the
information on a delayed basis). Today, generations of easy-to-use instruments are available on the
market for both categories.
Regarding dermal exposure assessment, the framework is provided in ISO/TS 21623:2017 Workplace
exposure — Assessment of dermal exposure to nano-objects and their aggregates and agglomerates
(NOAA).
It highlights that:
• skin contamination is frequent,
• skin penetration is limited but possible under certain conditions,
• the condition of the skin barrier is a key factor (intact or damaged skin)
• inadvertent (hand to mouth) ingestion is a potential route,
a progressive, documented approach enables appropriate risk management.
Correspondence / coherence with limit values Risk is defined as the combination of hazard and
exposure. However, assessing risks can be challenging when either the hazard or exposure is not well
understood, which is common for NOAA. To assess risk and judge the need for action, it is therefore
important to use benchmarks in the process. Benchmarks are company-specific and depend on the
chemical agent under consideration and the exposure situation.
The benchmarks proposed in the methodology are as follows:
— When a hazard band is assigned, the exposure levels shall be within the range of the associated
exposure limit value.
— When a specific limit value is chosen, exposure levels shall be below this value.
NOTE: if a regulatory exposure limit value exists or an exposure threshold value is commonly accepted as the state
of the art, such a value is the upper threshold (benchmark) for exposure.
Assignment of an adequate type of containment (total or partial under expert validation): In this
approach, uncertainty about the hazard is considered high and the person in charge of the risk
assessment shall define the type of containment appropriate to the situation. Containment can be partial,
dynamic or total. The objective is to limit exposures to a negligible level, which is evaluated in relation to
the highest toxicity that the person in charge of the risk assessment can anticipate for the NOAA
considered.
As this judgment may be subjective, the approach shall be supervised by an NOAA risk management
expert. If the state of exposure knowledge is so low that a critical hazard cannot be avoided, total
containment shall be used.
A first approach for ventilation management and design can be found in the following documents:
Controlling airborne contaminants at work: A guide to local exhaust ventilation (LEV)
https://www.hse.gov.uk/pubns/books/hsg258.htm
TRGS (Technical Rules for Hazardous Substances) 527 Activities with nanomaterials, German Committee
on Hazardous Substances, 2020, www.baua.de
NIOSH: Current Strategies for Engineering Controls in Nanomaterial Production and Downstream
Handling Processes
DHHS (NIOSH) Publication 2014-102 The focus of this document is to identify and describe strategies for
the engineering control of worker exposure during the production or use of engineered
The Exposure Control Efficacy Library (ECEL v3.0) is an online tool which provides information on the
effectiveness of different types of occupational and environmental Risk Management Measures (RMM).
The tool helps in the safe use of substances based on quantitative exposures and exposure reduction by
RMMs.
Equipment performance assessment: When a choice of containment is made, it is necessary to check
the good performance of the equipment, w
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