ISO/DTS 12901-2.2
(Main)Nanotechnologies — Occupational risk management applied to engineered nanomaterials — Part 2: Use of the control banding approach
Nanotechnologies — Occupational risk management applied to engineered nanomaterials — Part 2: Use of the control banding approach
Nanotechnologies — Gestion du risque professionnel appliquée aux nanomatériaux manufacturés — Partie 2: Utilisation de l’approche par gestion graduée des risques
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ISO/DTS 12901-2
ISO/TC 229
Nanotechnologies — Occupational
Secretariat: BSI
risk management applied to
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engineered nanomaterials —
2025-03-18
Part 2:
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Use of the control banding approach
Nanotechnologies — Gestion du risque professionnel appliquée
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Partie 2: Utilisation de l'approche par bandes de dangers
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ISO/DTS 12901-2:2025(en) © ISO 2025
FINAL DRAFT
ISO/DTS 12901-2:2025(en)
Technical
Specification
ISO/DTS 12901-2
ISO/TC 229
Nanotechnologies — Occupational
Secretariat: BSI
risk management applied to
Voting begins on:
engineered nanomaterials —
2025-03-18
Part 2:
Voting terminates on:
2025-05-13
Use of the control banding approach
Nanotechnologies — Gestion du risque professionnel appliquée
aux nanomatériaux manufacturés —
Partie 2: Utilisation de l'approche par bandes de dangers
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
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© ISO 2025
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ii
ISO/DTS 12901-2:2025(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols and abbreviated terms. 1
5 General framework for control banding . 2
5.1 General .2
5.2 Information gathering and data recording .3
5.3 Hazard banding . . .3
5.4 Exposure banding .3
5.5 Control banding .3
5.5.1 Proactive implementation of control banding .3
5.5.2 Retroactive implementation approach: evaluation of control banding and risk
banding .4
5.6 Review and data recording.4
6 Information gathering . 4
6.1 Characterization .4
6.1.1 General .4
6.1.2 Information and identification .4
6.1.3 Physicochemical properties and characterization .5
6.1.4 Toxicological data .5
6.2 Exposure characterization .6
6.2.1 General exposure characterization elements .6
6.2.2 Physical form .6
6.2.3 Amount .7
6.2.4 Potential for dust generation .7
6.2.5 Quantitative exposure measurements .7
6.3 Characterization of control measures .7
6.3.1 General .7
6.3.2 Reduction of emission . .7
6.3.3 Reduction of transmission . .7
6.3.4 Reduction of immission .7
6.3.5 Workplace area and personal exposure monitoring data .8
7 Control banding implementation . 8
7.1 Preliminary remarks .8
7.2 Hazard band setting .8
7.2.1 Hazard categorization of chemicals and general hazard banding process for
bulk materials .8
7.2.2 Allocation to a hazard band . . .10
7.3 Exposure band setting.14
7.3.1 Preliminary remarks .14
7.3.2 Synthesis, production and manufacturing .14
7.3.3 Material dispersed in a solid matrix . 15
7.3.4 Material in suspension in a liquid .16
7.3.5 Material in powder form .16
7.3.6 Option for modifying the process to reduce exposure levels .17
7.4 Control band setting and control strategies .17
7.5 Evaluation of controls .18
7.6 Retroactive approach — Risk banding .19
8 Performance, review and continual improvement .21
8.1 General .21
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ISO/DTS 12901-2:2025(en)
8.2 Objectives and performance . 22
8.3 Data recording . 22
8.4 Management review . 22
Annex A (informative) Health hazard class according to GHS .23
Annex B (informative) Nanomaterial risk assessment (NaRA) .24
Annex C (Informative) Modified occupational hazard band (OHB) .26
Bibliography .29
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ISO/DTS 12901-2:2025(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 229, Nanotechnologies.
This second edition cancels and replaces the first edition (ISO/TS 12901-2:2014) which has been technically
revised.
The main changes are as follows:
— revision of examples in the annexes, including The Control Banding Nano Tools NaRA, GoodNanoGuide
and OHB, and replacement of Annex B;
— revision of links to websites;
— addition of sources for all NOAA hazard characterization inventories.
A list of all parts in the ISO/TS 12901 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
v
ISO/DTS 12901-2:2025(en)
Introduction
Nano-objects, and their aggregates and agglomerates greater than 100 nm (NOAA), can exhibit properties,
including toxicological properties which are different from those of non-nanoscale (bulk) material.
Therefore, current occupational exposure limits (OELs), which are mostly established for bulk materials can
be inappropriate for NOAA. The control banding approach can be used as a first approach to controlling
workplace exposure to NOAA.
NOTE: Regulatory specifications can apply regarding NOAA.
Control banding is a pragmatic approach which can be used for the control of workplace exposure to
possibly hazardous agents with unknown or uncertain toxicological properties and for which quantitative
exposure estimations are lacking. The ultimate purpose of control banding is to control exposure to prevent
any possible adverse effects on workers’ health. It can complement the traditional quantitative methods
based on air sampling and analysis with reference to OELs when they exist. It can provide an alternative
risk assessment and risk management process, by grouping occupational settings in categories presenting
similarities of either hazards or exposure, or both, while incorporating professional judgment and
monitoring. This process applies a range of control techniques (such as general ventilation or containment)
to a specific chemical, considering its range (or band) of hazard and the range (or band) of exposure.
In general, control banding is based on the idea that while workers can be exposed to a diversity of chemicals,
implying a diversity in risks, the number of common approaches to risk control is limited. These approaches
are grouped into levels based on how much protection the approach offers (with “stringent” controls being
the most protective). The greater the potential for harm, the greater the levels of protection needed for
exposure control.
Control banding was originally developed by the pharmaceutical industry as a way to safely work with new
chemicals that had little or no toxicity information. These new chemicals were classified into “bands” based
on the toxicity of analogous and better-known chemicals and were linked to anticipated safe work practices,
[1]
taking into consideration exposure assessments. Each band was then aligned with a control scheme.
Following this concept, the Health and Safety Executive in the UK has developed a user-friendly scheme
[2]
called COSHH Essentials , primarily for the benefit of small- and medium-sized enterprises that potentially
do not benefit from the expertise of a resident occupational hygienist. The Department of Occupational
Safety and Health Malaysia published the Nanomaterial Risk Assessment (NaRA) based on Reference [2].
Similar schemes are used in the practical guidance given by the German Federal Institute for Occupational
[4] 1) [5]
Safety and Health. The Stoffenmanager® tool represents a further development, combining a hazard
banding scheme similar to that of COSHH Essentials and an exposure banding scheme based on an exposure
process model, which was customized to allow non-expert users to understand and use the model.
Control banding applies to issues related to occupational health in the development, manufacturing and use
of NOAA under normal or reasonably predictable conditions, including maintenance and cleaning operations
but excluding incidental or accidental situations.
Control banding is not intended to apply to the fields of safety management, environment or transportation;
it is considered as only one part of a comprehensive risk management process.
Control banding can be particularly useful for the risk assessment and management of nanomaterials, given
the level of uncertainty in work-related potential health risks from NOAA. It can be used for risk management
in a proactive manner and in a retroactive manner. In the proactive manner existing control measures, if
any, are not used as input variables in the potential exposure banding while in a retroactive manner existing
control measures are used as input variables. Both approaches are described in this document. While
control banding appears, in theory, to be appropriate for nanoscale materials exposure control, very few
comprehensive tools are currently available for ongoing nanotechnology operations. A conceptual control
[6]
banding model was presented by Maynard offering the same four control approaches as COSHH. A slightly
[7]
different approach, called “control banding nanotool”, was presented by Paik et al. This approach takes
into account existing knowledge of NOAA toxicology and uses the control banding framework proposed in
1) The Stoffenmanager® tool is an example of a suitable product available commercially. This information is given for
the convenience of users of this document and does not constitute an endorsement by ISO of this product. Equivalent
products may be used if they can be shown to lead to the same results.
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ISO/DTS 12901-2:2025(en)
earlier publications. However, the ranges of values used in the “control banding nanotool” correspond to
those ranges that one would expect in small-scale research type operations (less than one gram) and are
possibly not appropriate for larger scale uses. In the meantime, several other specific control banding tools
[8]-[11]
have been published to control inhalation exposure to engineered nanomaterials for larger scale uses.
All these tools define hazard bands and exposure bands for inhalation exposure and combine these in a two-
dimensional matrix, resulting in a score for risk control (proactive approach).
In 2009, the National Institute for Occupational Safety and Health (in the United States, published a review
and analysis of existing toolkits for control banding without any recommendation for implementation in
[12]
the United States. An occupational exposure banding process was later described as a starting point
[13]
to inform risk management decisions when an OEL is unavailable. This process uses hazard-based
data to identify the overall hazard potential and the associated airborne concentration range for chemical
substances. It also describes special categories of aerosols, including nanoscale particles. An occupational
exposure banding approach can inform risk management and control decisions. Although it is not itself
a control banding approach, the use of occupational exposure bands as control ranges is consistent with
common applications of control banding.
[14]
Schneider et al. developed a conceptual model for assessment of inhalation exposure to engineered
nanomaterials, suggesting a general framework for future exposure models. This framework follows the
2)
same structure as the conceptual model for inhalation exposure used in the Stoffenmanager® tool and
[5],[14]
the Advanced REACH Tool (ART) . Based on this conceptual framework, a control banding tool called
[14]
Stoffenmanager Nano® was developed, encompassing both the proactive approach and retroactive (risk
banding) approach.
Reference [15] proposed a new approach for the handling of powders and nanomaterials. This method is
very practical and has been widely used by several cosmetic manufacturers. However, industry data are
limited to cosmetic ingredients.
The toxicological approach proposed by the cosmetics industry in France considers highest acute toxicity
and CMRS at the same level. The exposure model is applicable to powders leaning on usual descriptors that
have been translated into observable data, which makes the methodology user-friendly for field operators
(see details in Annex C).
In addition, the French agency for food, environmental and occupational health and safety has developed a
control banding tool specifically for nanomaterials, which is described in Reference [16].
[17]
Furthermore, the European Commission published non-binding guidance entitled that includes a control
banding approach. The purpose of it is to assist employers, health and safety practitioners and workers in
fulfilling their regulatory obligations, whenever exposure to manufactured nanomaterials (MNMs) or use of
nanotechnology in a professional capacity can likely take place, with the ultimate aim of ensuring adequate
protection of workers’ health and safety. The guidance provides an overview of the issues surrounding the
safe use of MNMs in the workplace, sets out the broad outlines of preventive action and provides a practical
tool for complying with specific aspects of workers’ safety, such as risk assessment and risk management.
[17]
This can be valuable if an in-depth technical understanding of the issues involved is missing.
In 2021, the Organisation for Economic Co-operation and Development (OECD) embarked on a systematic
review of the most representative control banding tools available for nanomaterials. The resulting inventory
provided information on both regulatory and non-regulatory tools to assess occupational exposure to
MNMs (NOAA) and included an applicability assessment for occupational exposure to NOAA. The project
was divided into occupational and consumer scopes:
— part I involved a compilation of tools and models;
— part II focused on the performance of tools and models for occupational exposure;
— part III presented the results for consumer exposure tools and models;
[18]
Finally, 32 models and tools were assessed using a common case for each tool.
2) The Stoffenmanager® tool is an example of a suitable product available commercially. This information is given for
the convenience of users of this document and does not constitute an endorsement by ISO of this product. Equivalent
products may be used if they can be shown to lead to the same results.
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ISO/DTS 12901-2:2025(en)
The biggest challenge in developing any control banding approach for NOAA is to decide which parameters
are to be considered, what criteria are relevant to assign a nano-object to a control band, and what
operational control strategies are to be implemented at different operational levels.
This document is focused on intentionally produced NOAA that consist of nano-objects such as nanoparticles,
nanopowders, nanofibres, nanotubes, nanowires, as well as aggregates and agglomerates of the same. As used
in this document, the term “NOAA” applies to such components, whether in their original form or incorporated
in materials or preparations from which they can be released during their lifecycle. However, as for many other
industrial processes, nanotechnological processes can generate by-products in the form of unintentionally
produced NOAA which can be linked to health and safety issues that must be addressed as well.
This document proposes recommendations for controlling and managing occupational risk based on a control
banding approach specifically designed for NOAA. It is the responsibility of manufacturers and importers to
determine whether a material of concern contains NOAA, and to provide relevant information in safety data
sheets (SDS) and labels. Employers can use this information to identify hazards and implement appropriate
controls. This document does not intend to give recommendations on this decision-making process.
It is emphasized that the control banding method applied to manufactured NOAA requires assumptions to
be formulated on information that is desirable but unavailable. Thus, the user of the control banding tool
must have proven skills in chemical risk prevention and, more specifically, in risk issues known to be related
to that type of material. The successful implementation of this approach involves solid expertise combined
with a capacity for critical evaluation of potential occupational exposures and training to use control
banding tools to ensure appropriate control measures and an adequately conservative approach.
The approach using CB Tools for NOAA includes the methodology of the sector where it is intended to be
used. NOAA is used in industries where the process is frequently used and limited characterization is known
but the characterization of adverse events secondary to NOAA use are well described and can be considered
to implement a light approach of CB Tools for industry, even if the hazard is not completely identified
and thus not well known. If the NOAA is not frequently used but there is a possibility to characterize it
physicochemical and biologically, there will be the need to use a more complex and academic CB Tool.
In parallel to the approach described in this document, a full hazard assessment considers all substance-
related hazards, including explosive risk and environmental hazards.
NOTE Explosive dust clouds can be generated from most organic materials, many metals and even some non-
metallic inorganic materials. The primary factor influencing the ignition sensitivity and explosive violence of a dust
cloud is the particle size or specific surface area (i.e. the total surface area per unit volume or unit mass of the dust)
and the particle composition. As the particle size decreases, the specific surface area increases. The general trend
is for the violence of the dust explosion and the ease of ignition to increase as the particle size decreases, though for
many dusts this trend begins to level out at particle sizes in the order of tens of micrometres (µm). However, no lower
particle size limit has been established below which dust explosions cannot occur and many nanoparticle types have
the potential to cause explosions.
viii
FINAL DRAFT Technical Specification ISO/DTS 12901-2:2025(en)
Nanotechnologies — Occupational risk management applied
to engineered nanomaterials —
Part 2:
Use of the control banding approach
1 Scope
This document describes the use of a control banding approach for controlling the risks associated with
occupational exposures to nano-objects and their aggregates and agglomerates greater than 100 nm (NOAA),
even if knowledge regarding their toxicity and quantitative exposure estimations is limited or lacking.
This document applies to inhalation control, for which the control banding tool is specifically designed.
NOTE Some guidance for skin and eye protection is given in ISO/TS 12901-1.
This document does not apply to materials of biological origin.
This document is intended to help businesses and others, including research organizations engaged in the
manufacturing, processing, or handling of NOAA, by providing an easy-to-understand, pragmatic approach
to controlling occupational exposures.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 80004-1 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/
4 Symbols and abbreviated terms
CMRS carcinogenicity, mutagenicity, reproductive toxicity or sensitization
COSHH control of substances hazardous to health
DLS dynamic light scattering
EB exposure banding
GHS globally harmonized system of classification and labelling of chemicals
SDS safety data sheet
MNMs manufactured nanomaterials
ISO/DTS 12901-2:2025(en)
NOAA nano-objects, and their aggregates and agglomerates greater than 100 nm
OEL occupational exposure limit
PPE personal protective equipment
SEM scanning electron microscopy
STOP substitution, technical measures, organizational measures, personal protective equipment
TEM transmission electron microscopy
5 General framework for control banding
5.1 General
The control banding tool described in this document applies to NOAA and materials containing NOAA. This
control banding tool can only be considered as one part, though an integral part, of an overall system for
health and safety risk management. It necessitates input data, irrespective of the phase of the NOAA life cycle,
such as information collected at the place of work through observation of actual work by an occupational
hygienist with solid expertise and training to use control banding tools as well as the enunciation of hazards
and the best toxicology data available.
The foundation of this approach is the hazard identification process, which is based on:
— current knowledge of the specific NOAA (toxicology or health effect data; physical and chemical
properties);
— assessment of potential worker exposure.
The hazard and exposure information are combined to determine an appropriate level of control (such as
general ventilation, local exhaust, or containment).
This approach is based on the view that the engineering control techniques for nanoparticle exposure can
build on the knowledge and experience from current exposure control to aerosols. This knowledge and
control have already been applied to aerosols containing ultrafine particles (e.g. welding fumes, carbon
black or viruses). Effective techniques can be obtained by adapting and redesigning current technology. This
applies to techniques for general ventilation, local and process ventilation, containments, enclosures and
filtration.
The control banding approach allows shifting from exposure assessment to exposure control and vice versa.
Thus, it can be performed either in a proactive way or in a retroactive way. The proactive way is based on
anticipated exposures and uses basic factors mitigating exposure potential. The retroactive way (or risk
banding approach) is based on a risk assessment that takes more exposure mitigating factors into account,
including control measures actually implemented or to be implemented. In both cases, hazard banding is a
common step. The general structure of the process is shown in Figure 1 and includes the following elements:
— information gathering;
— assignment of the NOAA to a hazard band: hazard banding;
— description of potential exposure characteristics: exposure banding;
— definition of recommended work environments and handling practices: control banding;
— evaluation of the control strategy or risk banding.
ISO/DTS 12901-2:2025(en)
Figure 1 — Control banding process
5.2 Information gathering and data recording
The methodology presented in this document is information-driven; it does not implicitly assume the
presence of risk or hazard in any material. Where there is little or no information to guide decisions on
the potential for a particular hazard or exposure, reasonable worst-case assumptions should be used along
with management practices appropriate for those options. The methodology is also designed to encourage
replacing assumptions with real information and refining management practices accordingly.
Input data must be obtained prior to implementing control banding. Especially considering NOAA for which
no health-based limit values can be established, it is important to document substances being used, control
measures taken, working conditions and possibly exposure measurements, given that these factors are not
always easy to determine with complete certainty, and that they depend on the extent to which the hazard is
known and on the accuracy of the methods used for exposure assessment.
All input data should be documented and traceable through an appropriate documentation management system.
5.3 Hazard banding
Hazard banding consists in assigning a hazard band to NOAA on the basis of a comprehensive evaluation of
all available data on this material, taking into account parameters such as toxicity, in vivo biopersistence and
factors influencing the ability of particles to reach the respiratory tract, their ability to deposit in various
regions of the respiratory tract, and their ability to elicit biological responses. These factors can be related
to physical and chemical properties such as surface area, surface chemistry, shape, particle size, etc.
5.4 Exposure banding
Exposure banding consists of assigning an exposure scenario (a set of conditions under which exposure can
occur) at a workplace or a workstation to an exposure band on the basis of a comprehensive evaluation of all
available data of the exposure scenario under consideration, e.g. physical form of NOAA, amount of NOAA,
dust generation potential of processes and actual exposure measurement data.
5.5 Control banding
5.5.1 Proactive implementation of control banding
Control banding can be used for risk control management in a proactive manner. In that case, recommended
work environments and handling practices may be defined on the basis of hazard banding as well as of
ISO/DTS 12901-2:2025(en)
fundamental factors mitigating anticipated exposure potential, e.g. propensity of the material to become
airborne, the type of process and amounts of material being handled.
Such an approach is used to determine the control measures appropriate for the operation being assessed
but not to determine an actual level of risk, as the existing control measures, if any, are not used as an input
variable in the exposure banding process.
5.5.2 Retroactive implementation approach: evaluation of control banding and risk banding
In a retroactive approach, control banding may be used either to evaluate the controls recommended as
outputs of the proactive approach or for risk assessment on its own.
In that case, both hazard and actual exposure must be characterized in order to define a risk level. The
major difference with the proactive use of control banding is that exposure mitigating factors (such as
implemented control measures) are taken into account using an exposure algorithm.
The approach then includes the following elements:
— assignment of the NOAA to a hazard band;
— exposure banding;
— overview of risks based on risk banding as a result of hazard and exposure banding;
— iterative examination of control measures until the risk is reduced to an acceptable level;
— design of an action plan based on the chosen specific control scenario.
Such an approach may be used to determine the actual risk level using the existing control measures as
an input variable. In this respect, the retroactive approach can be considered as a means for periodic re-
evaluation of the proactive approach.
5.6 Review and data recording
In the review and adapt step, a system of periodic and as-needed reviews should be implemented to ensure
that the information, evaluations, decisions and actions of the previous steps are kept up-to-date. Reviews
should be performed when new information has been generated or has emerged. The adequacy of the
risk management process for the material or the application at hand should be re-assessed. It should be
questioned whether the current risk evaluation must be revised in light of the new information and, if so,
whether the current risk management practices must be changed as well.
6 Information gathering
6.1 Characterization
6.1.1 General
The lists of characteristics and endpoints given in 6.1.2 to 6.1.4 should be taken into account when assessing
the human health hazards of NOAA. Addressing this data set should lead to the development of dossiers
describing basic characterization parameters and available mammalian toxicity information. These
endpoints are based upon the list proposed by the OECD testing program for a set of MNMs for human health
[20]
and environmental safety. It can be considered as a starting point when assessing the human health
hazards of NOAA. Epidemiological data, when available, should also be taken into account.
6.1.2 Information and identification
The following information should be taken into consideration:
— NOAA name;
ISO/DTS 12901-2:2025(en)
— CAS number;
— structural formula and molecular structure;
— composition of NOAA being tested;
— basic morphology;
— description of surface chemistry;
— method of production.
6.1.3 Physicochemical properties and characterization
The following information should be taken into consideration:
— agglomeration and aggregation;
— solubility (e.g. in water or biologically relevant fluids);
— crystalline phase;
— dustiness;
— crystallite size;
— representative TEM picture(s);
— particle size distribution;
— specific surface area;
— surface chemistry (where appropriate);
— catalytic or photocatalytic activity;
— pour density;
— porosity;
— octanol-water partition coefficient, where relevant;
— redox potential;
— radical formation potential;
— other relevant information (where available).
Although some of the above characteristics can be unavailable, and very few of these characteristics will
actually be taken into account in the control banding process, NOAA’s characteristics should be documented
and recorded as accurately as possible (including reference to size and measurement conditions). This
is necessary in the case of possible future medical issues. When utilizing characteristics relating to non-
nanoscale materials, it should be taken into account that these characteristics can differ significantly from
those for the material in the nanoscale.
6.1.4 Toxicological data
The following information should be taken into consideration:
— pharmacokinetics (absorption, distribution, metabolism, elimination);
— acute toxicity;
— repeated dose toxicity;
ISO/DTS 12901-2:2025(en)
— chronic toxicity;
— reproductive toxicity;
— developmental toxicity;
— genetic toxicity;
— experience with human exposure;
— epidemiological data;
— other relevant test data.
Although some of the above data can be unavailable, and some of these data are not necessarily taken into
account in the control banding process, NOAA’s toxicological data should be documented and recorded as
accurately as possible.
A list of hazard indications is presented in Annex A.
6.2 Exposure characterization
6.2.1 General exposure characterization elements
The main goal of exposure characterization is to provide a summary and a synthesis of available exposure
information. General exposure characterization includes the following elements:
a) a statement of purpose, scope, level of detail, as well as the approach used in the exposure
characterization;
b) estimates of exposure for each relevant pathway, both for individuals and populations (e.g. groups of
workers);
c) an evaluation of the overall quality of the assessment and the degree of confidence in the exposure
estimates and, in the conclusions, drawn, including sources and the extent of uncertainty (see
ISO/TS 12901-1);
d) in this control banding approach, the critical elements of exposure characterization, which are necessary
to determine the exposure band include:
— the physical form of NOAA;
— the amount of NOAA;
— the determination of dust generation potential during the processes;
— the actual exposure measurement data.
6.2.2 Physical form
The actual stage in the NOAA’s life cycle is an important parameter to consider as it can influence the
potenti
...
ISO/DTS 12901-2:2024(E)
ISO/TC 229/WG 3
Secretariat: BSI
Date: 2025-03-04
Nanotechnologies — Occupational risk management applied to
engineered nanomaterials —
Part 2:
Use of the control banding approach
Nanotechnologies — Gestion du risque professionnel appliquée aux nanomatériaux manufacturés — —
Partie 2: Utilisation de l'approche par bandes de dangers
ISO/DTS 12901-2:2024(E:(en)
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO
at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
EmailE-mail: copyright@iso.org
Website: www.iso.orgwww.iso.org
Published in Switzerland
ii
ISO/DTS 12901-2:2024(E:(en)
Contents
Foreword . iv
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols and abbreviated terms . 1
5 General framework for control banding . 2
5.1 General . 2
5.2 Information gathering and data recording . 3
5.3 Hazard banding . 3
5.4 Exposure banding . 4
5.5 Control banding . 4
5.6 Review and data recording . 4
6 Information gathering . 5
6.1 Characterization . 5
6.2 Exposure characterization . 7
6.3 Characterization of control measures . 8
7 Control banding implementation . 8
7.1 Preliminary remarks . 8
7.2 Hazard band setting . 9
7.3 Exposure band setting . 16
7.4 Control band setting and control strategies . 22
7.5 Evaluation of controls . 23
7.6 Retroactive approach — Risk banding . 25
8 Performance, review and continual improvement . 27
8.1 General . 27
8.2 Objectives and performance . 27
8.3 Data recording . 28
8.4 Management review . 28
Annex A (informative) Health hazard class according to GHS . 29
Annex B (informative) Nanomaterial risk assessment (NaRA) . 30
Annex C (Informative) Modified occupational hazard band (OHB) . 33
Bibliography . 37
iii
ISO/DTS 12901-2:2024(E:(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of
ISO documentsdocument should be noted. This document was drafted in accordance with the editorial rules
of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawnISO draws attention to the possibility that some of the elementsimplementation of this
document may beinvolve the subjectuse of (a) patent(s). ISO takes no position concerning the evidence,
validity or applicability of any claimed patent rights in respect thereof. As of the date of publication of this
document, ISO had not received notice of (a) patent(s) which may be required to implement this document.
However, implementers are cautioned that this may not represent the latest information, which may be
obtained from the patent database available at www.iso.org/patents. ISO shall not be held responsible for
identifying any or all such patent rights. Details of any patent rights identified during the development of the
document will be in the Introduction and/or on the ISO list of patent declarations received (see ).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
The committee responsible for this This document iswas prepared by Technical Committee ISO/TC 229,
Nanotechnologies.
This second edition cancels and replaces the first edition (ISO/TS 12901-2:20122014) which has been
technically revised.
The main changes are as follows:
— revision of examples in the annexes, including The Control Banding Nano Tools NaRA, GoodNanoGuide
and OHB were added as examples in the annexes. The Stoffenmanager Tool was removed as an annex, and
replacement of Annex Badded as a reference.;
- Websites that no longer are working were removed
— Additionalrevision of links to websites;
— addition of sources for sullall NOAA hazard characterization inventories were added DANA 4.0 and OECD.
ISO/TS 12901 consists of the following parts, under the general title Nanotechnologies— Occupational risk
management applied to engineered nanomaterials:
— — Part 1: Principles and approaches
— Part 2: Use of the control banding approach
iv
ISO/DTS 12901-2:2024(E:(en)
A list of all parts in the ISO/TS 12901 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
v
ISO/DTS 12901-2:2024(E:(en)
Introduction
According to the current state of knowledge, nanoNano-objects, and their aggregates and agglomerates
greater than 100 nm (NOAA)), can exhibit properties, including toxicological properties, which are different
from those of non-nanoscale (bulk) material. Therefore, current occupational exposure limits (OELs), which
are mostly established for bulk materials can be inappropriate for NOAA. In the absence of relevant regulatory
specifications for NOAA, theThe control banding approach can be used as a first approach to controlling
workplace exposure to NOAA.
NOTE: Regulatory specifications can apply regarding NOAA.
Control banding is a pragmatic approach which can be used for the control of workplace exposure to possibly
hazardous agents with unknown or uncertain toxicological properties and for which quantitative exposure
estimations are lacking. The ultimate purpose of control banding is to control exposure to prevent any possible
adverse effects on workers’ health. It can complement the traditional quantitative methods based on air
sampling and analysis with reference to OELs when they exist. It can provide an alternative risk assessment
and risk management process, by grouping occupational settings in categories presenting similarities of either
hazards and/or exposure, or both, while incorporating professional judgment and monitoring. This process
applies a range of control techniques (such as general ventilation or containment) to a specific chemical,
considering its range (or band) of hazard and the range (or band) of exposure.
In general, control banding is based on the idea that while workers can be exposed to a diversity of chemicals,
implying a diversity in risks, the number of common approaches to risk control is limited. These approaches
are grouped into levels based on how much protection the approach offers (with “stringent” controls being
the most protective). The greater the potential for harm, the greater the levels of protection needed for
exposure control.
Control banding was originally developed by the pharmaceutical industry as a way to safely work with new
chemicals that had little or no toxicity information. These new chemicals were classified into “bands” based
on the toxicity of analogous and better-known chemicals and were linked to anticipated safe work practices,
[1 [1]]
taking into consideration exposure assessments. Each band was then aligned with a control scheme. .
Following this concept, the Health and Safety Executive (HSE) in the UK has developed a user-friendly scheme
[2 [2]]
called COSHH Essentials , , primarily for the benefit of small- and medium-sized enterprises that potentially
do not benefit from the expertise of a resident occupational hygienist. The Department of Occupational Safety
and Health Malaysia published the Nanomaterial Risk Assessment (NaRA) based on Reference [2COSHHs
[3]
Essential and GoodNanoGuide (see details in Annex B).]. Similar schemes are used in the practical guidance
[4 [4]] [5]
given by the German Federal Institute for Occupational Safety and Health. . The Stoffenmanager Tool ®
1) [5 ]
tool represents a further development, , combining a hazard banding scheme similar to that of COSHH
Essentials and an exposure banding scheme based on an exposure process model, which was customized to
allow non-expert users to understand and use the model.
Control banding applies to issues related to occupational health in the development, manufacturing and use
of NOAA under normal or reasonably predictable conditions, including maintenance and cleaning operations
but excluding incidental or accidental situations.
Control banding is not intended to apply to the fields of safety management, environment or transportation;
it is considered as only one part of a comprehensive risk management process.
1)
The Stoffenmanager® tool is an example of a suitable product available commercially. This information is given for the
convenience of users of this document and does not constitute an endorsement by ISO of this product. Equivalent
products may be used if they can be shown to lead to the same results.
vi
ISO/DTS 12901-2:2024(E:(en)
Control banding can be particularly useful for the risk assessment and management of nanomaterials, given
the level of uncertainty in work-related potential health risks from NOAA. It maycan be used for risk
management in a proactive manner and in a retroactive manner. In the proactive manner existing control
measures, if any, are not used as input variables in the potential exposure banding while in a retroactive
manner existing control measures are used as input variables. Both approaches are described in this
document. While control banding appears, in theory, to be appropriate for nanoscale materials exposure
control, very few comprehensive tools are currently available for ongoing nanotechnology operations. A
[6[6]]
conceptual control banding model was presented by Maynard offering the same four control approaches
as COSHH. A slightly different approach, called “Control Banding Nanotoolcontrol banding nanotool”, was
[7 [7]]
presented by Paik et al. . This approach takes into account existing knowledge of NOAA toxicology and uses
the control banding framework proposed in earlier publications. However, the ranges of values used in the
“Control Banding Nanotoolcontrol banding nanotool” correspond to those ranges that one would expect in
small-scale research type operations (less than one gram) and might are possibly not seem appropriate for
larger scale uses. In the meantime, several other specific control banding tools have been published to control
[8]-[11 [8, 9, 10, 11]]
inhalation exposure to engineered nanomaterials for larger scale uses. . All these tools define
hazard bands and exposure bands for inhalation exposure and combine these in a two-dimensional matrix,
resulting in a score for risk control (proactive approach).
In 2009, NIOSHthe National Institute for Occupational Safety and Health (in the United States, published a
review and analysis of existing toolkits for control banding without any recommendation for implementation
[12 [12]]
in the United States. . An Occupational Exposure Bandingoccupational exposure banding process was
later described as a starting point to inform risk management decisions when an Occupational Exposure
[13 [13]]
LimitOEL is unavailable. not available. This process uses hazard-based data to identify the overall hazard
potential and the associated airborne concentration range for chemical substances. It also describes special
categories of aerosols, including nanoscale particles. An occupational exposure banding approach can inform
risk management and control decisions. Although it is not itself a control banding approach, the use of
occupational exposure bands as control ranges is consistent with common applications of control banding.
[14 [14] ]
Schneider et al. . have developed a conceptual model for assessment of inhalation exposure to engineered
nanomaterials, suggesting a general framework for future exposure models. This framework follows the same
2)
structure as the conceptual model for inhalation exposure used in the Stoffenmanager Tool® tool and the
[5],[14 [5, 14]]
Advanced REACH Tool (ART) ). . Based on this conceptual framework, a control banding tool called
[14 [14]]
“Stoffenmanager Nano” has been® was developed, , encompassing both the proactive approach and
retroactive (risk banding) approach.
[15]
Reference [15Gridelet et. al. ] proposed a new approach for the handling of powders and nanomaterials.
This method is very practical and has been widely used by several cosmetic manufacturers. However, industry
data are limited to cosmetic ingredients.
The toxicological approach proposed by the cosmetics industry in France considers highest acute toxicity and
CMRCMRS at the same level. The exposure model is applicable to powders leaning on usual descriptors that
have been translated into observable data, which makes the methodology user-friendly for field operators
(see details in Annex CAnnex C).).
In addition, the French agency for food, environmental and occupational health and safety (ANSES) has
developed a control banding tool specifically for nanomaterials, which is described in Reference [16the report
[16]
“Development of a specific control banding tool for nanomaterials” .].
[17
Furthermore, the European Commission published a non-binding guidance entitled ‘Working safely with
]
manufactured nanomaterials’ that includes a control banding approach. The purpose of it is to assist
employers, health and safety practitioners and workers in fulfilling their regulatory obligations, whenever
2)
The Stoffenmanager® tool is an example of a suitable product available commercially. This information is given for the
convenience of users of this document and does not constitute an endorsement by ISO of this product. Equivalent
products may be used if they can be shown to lead to the same results.
vii
ISO/DTS 12901-2:2024(E:(en)
exposure to manufactured nanomaterials (MNMs) or use of nanotechnology in a professional capacity
couldcan likely take place, with the ultimate aim of ensuring adequate protection of workers’ health and safety.
The Guidanceguidance provides an overview of the issues surrounding the safe use of MNMs in the workplace,
sets out the broad outlines of preventive action and provides a practical tool for complying with specific
aspects of ensuring workers’ safety, such as risk assessment and risk management. This can be particularly
[17
valuable if an in-depth technical understanding of the issues involved is missing. , and may assist in ensuring
[17]]
compliance with the Occupational Safety and Health legislation when dealing with MNMs.
In 2021, the Organisation for Economic Co-operation and Development (OECD) embarked on a systematic
review of the most representative control banding tools available for nanomaterials. The resulting inventory
provided information on both regulatory and non-regulatory tools to assess occupational exposure to
manufactured nanomaterialsMNMs (NOAA) and included an applicability assessment for occupational
exposure to NOAA. The project was divided into occupational and consumer scopes. Part I involved a
compilation of tools and models, part II focused on the performance of tools and models for occupational
exposure, and part III presented the results for consumer exposure tools and models. Finally, 32 models and
[18]
tools were assessed using a common case for each tool. :
— part I involved a compilation of tools and models;
— part II focused on the performance of tools and models for occupational exposure;
— part III presented the results for consumer exposure tools and models;
[18]
Finally, 32 models and tools were assessed using a common case for each tool.
The biggest challenge in developing any control banding approach for NOAA is to decide which parameters
are to be considered and, what criteria are relevant to assign a nano-object to a control band, and what
operational control strategies oughtare to be implemented at different operational levels.
This document is focused on intentionally produced NOAA that consist of nano-objects such as nanoparticles,
nanopowders, nanofibres, nanotubes, nanowires, as well as aggregates and agglomerates of the same. As used
in this document, the term “NOAA” applies to such components, whether in their original form or incorporated
in materials or preparations from which they couldcan be released during their lifecycle. However, as for many
other industrial processes, nanotechnological processes can generate by-products in the form of
unintentionally produced NOAA which mightcan be linked to health and safety issues that need tomust be
addressed as well.
This document proposes guidelinesrecommendations for controlling and managing occupational risk based
on a control banding approach specifically designed for NOAA. It is the responsibility of manufacturers and
importers to determine whether a material of concern contains NOAA, and to provide relevant information in
safety data sheets (SDS) and labels, in compliance with any national or international existing regulation.
Employers can use this information to identify hazards and implement appropriate controls. This document
does not intend to give recommendations on this decision-making process.
It is emphasized that the control banding method applied to manufactured NOAA requires assumptions to be
formulated on information that is desirable but unavailable. Thus, the user of the control banding tool needs
tomust have proven skills in chemical risk prevention and, more specifically, in risk issues known to be related
to that type of material. The successful implementation of this approach requiresinvolves solid expertise
combined with a capacity for critical evaluation of potential occupational exposures and training to use control
banding tools to ensure appropriate control measures and an adequately conservative approach.
The approach using CB Tools for NOAA includes the methodology of the sector where it is intended to be used.
NOAA is used in industries where the process is frequently used and limited characterization is known but the
characterization of adverse events secondary to NOAA use are well described and can be considered to
implement a light approach of CBToolsCB Tools for industry, even if the hazard is not completely identified
viii
ISO/DTS 12901-2:2024(E:(en)
and thus not well known. If the NOAA is not frequently used but there is a possibility to characterize it
physicochemical and biologically, there will be the need to use a more complex and academic CBToolCB Tool.
In parallel to the approach described in this document, a full hazard assessment is advisable to
considerconsiders all substance-related hazards, including explosive risk (see NOTE 1), and environmental
hazards.
Note NOTE Explosive dust clouds can be generated from most organic materials, many metals and even some non-
metallic inorganic materials. The primary factor influencing the ignition sensitivity and explosive violence of a dust cloud
is the particle size or specific surface area (i.e. the total surface area per unit volume or unit mass of the dust) and the
particle composition. As the particle size decreases, the specific surface area increases. The general trend is for the
violence of the dust explosion and the ease of ignition to increase as the particle size decreases, though for many dusts
this trend begins to level out at particle sizes ofin the order of tens of micrometres (µm). However, no lower particle size
limit has been established below which dust explosions cannot occur and it has to be considered that many nanoparticle
types have the potential to cause explosions.
ix
ISO/DTS 12901-2:2024(E:(en)
Nanotechnologies — Occupational risk management applied to
engineered nanomaterials —
Part 2:
Use of the control banding approach
1 Scope
This document describes the use of a control banding approach for controlling the risks associated with
occupational exposures to nano-objects and their aggregates and agglomerates greater than 100 nm (NOAA),
even if knowledge regarding their toxicity and quantitative exposure estimations is limited or lacking.
The ultimate purpose of control banding isThis document applies to control exposure to prevent any possible
adverse effects on workers’ health. Theinhalation control, for which the control banding tool described here
is specifically designed for inhalation control. .
[19]
NOTE Some guidance for skin and eye protection is given in ISO/TS 12901--1. .
This document does not apply to materials of biological origin.
This document is intended to help businesses and others, including research organizations engaged in the
manufacturing, processing, or handling of NOAA, by providing an easy-to-understand, pragmatic approach to
controlling occupational exposures.
2 Materials of biological originNormative references
There are outside the scope ofno normative references in this document.
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO/TS 27687 and ISO 80004-1,
Nanotechnologies – Vocabulary – Part 1: Core vocabulary are used throughout this document 80004-1 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/
4 Symbols and abbreviated terms
CMRS carcinogenicity, mutagenicity, reproductive toxicity or sensitization
COSHH control of substances hazardous to health
DLS dynamic light scattering
EB exposure banding
GHS Globally Harmonized Systemglobally harmonized system of classification and labelling of
chemicals
SDS safety data sheet
ISO/DTS 12901-2:2024(E:(en)
MNMs manufactured nanomaterials
NOAA nano-objects, and their aggregates and agglomerates greater than 100 nm
OEL occupational exposure limit
PPE personal protective equipment
SEM scanning electron microscopy
STOP substitution, technical measures, organizational measures, personal protective equipment
TEM transmission electron microscopy
5 General framework for control banding applied to NOAA
5.1 General
The control banding tool described in this document applies to NOAA and materials containing NOAA. It is
important to note that thisThis control banding tool can only be considered as one part, though an integral
part, of an overall system for health and safety risk management. It requiresnecessitates input data,
irrespective of the phase of the NOAA life cycle, such as information collected at the place of work through
observation of actual work by an occupational hygienist with solid expertise and training to use control
banding tools as well as the enunciation of hazards and the best toxicology data available.
The foundationsfoundation of this approach areis the hazard identification process, which is based on the :
— current knowledge of the specific NOAA (toxicology or health effect data; physical and chemical
properties) and the );
— assessment of potential worker exposure.
The hazard and exposure information are combined to determine an appropriate level of control (such as
general ventilation, local exhaust, or containment).
This approach is based on the view that the engineering control techniques for nanoparticle exposure can
build on the knowledge and experience from current exposure control to aerosols. This knowledge and control
have already been applied to aerosols containing ultrafine particles (e.g. welding fumes, carbon black or
viruses). Effective techniques can be obtained by adapting and redesigning current technology. This applies
to techniques for general ventilation, local and process ventilation, containments, enclosures and filtration.
The control banding approach allows shifting from exposure assessment to exposure control and vice versa.
Thus, it can be performed either in a proactive way, or in a retroactive way. The proactive way is based on
anticipated exposures and usinguses basic factors mitigating exposure potential, or in a. The retroactive way
(or risk banding approach),) is based on a risk assessment that will taketakes more exposure mitigating
factors into account, including control measures actually implemented or to be implemented. In both cases,
hazard banding is a common step. The general structure of the process is presentedshown in Figure 1Figure 1
and includes the following elements:
— — information gathering;
— — assignment of the NOAA to a hazard band: hazard banding;
— — description of potential exposure characteristics: exposure banding;
— — definition of recommended work environments and handling practices: control banding;
— — evaluation of the control strategy or risk banding.
ISO/DTS 12901-2:2024(E:(en)
—
Figure 1 — Control banding process
5.2 Information gathering and data recording
The methodology presented in this document is information-driven; it does not implicitly assume the presence
of risk or hazard in any material. Where there is little or no information to guide decisions on the potential for
a particular hazard or exposure, “reasonable worst-case assumptions” should be used along with management
practices appropriate for those options. The methodology is also designed to encourage replacing
assumptions with real information and refining management practices accordingly.
Input data are pre-required in ordermust be obtained prior to implementimplementing control banding.
Especially considering NOAA for which no health-based limit values can be established, it is important to
document substances being used, control measures taken, working conditions and possibly exposure
measurements, given that these factors are not always easy to determine with complete certainty, and that
they depend on the extent to which the hazard is known and on the accuracy of the methods used for exposure
assessment.
All input data should be documented and traceable through an appropriate documentation management
system.
5.3 Hazard banding
Hazard banding consists in assigning a hazard band to NOAA on the basis of a comprehensive evaluation of all
available data on this material, taking into account parameters such as toxicity, in vivo biopersistence and
ISO/DTS 12901-2:2024(E:(en)
factors influencing the ability of particles to reach the respiratory tract, their ability to deposit in various
regions of the respiratory tract, and their ability to elicit biological responses. These factors can be related to
physical and chemical properties such as surface area, surface chemistry, shape, particle size, etc.
5.4 Exposure banding
Exposure banding consists of assigning an exposure scenario (a set of conditions under which exposure
maycan occur) at a workplace or a workstation to an exposure band on the basis of a comprehensive
evaluation of all available data of the exposure scenario under consideration, e.g. physical form of NOAA,
amount of NOAA, dust generation potential of processes and actual exposure measurement data.
5.5 Control banding
5.5.1 Proactive implementation of control banding
Control banding can be used for risk control management in a proactive manner. In that case, recommended
work environments and handling practices may be defined on the basis of hazard banding as well as of
fundamental factors mitigating anticipated exposure potential, e.g. propensity of the material to become
airborne, the type of process and amounts of material being handled.
Such an approach is used to determine the control measures appropriate for the operation being assessed but
not to determine an actual level of risk, as the existing control measures, if any, are not used as an input
variable in the exposure banding process.
5.5.2 Retroactive implementation approach: evaluation of control banding and risk banding
In a retroactive approach, control banding may be used either to evaluate the controls recommended as
outputs of the proactive approach or for risk assessment on its own.
In that case, both hazard and actual exposure need tomust be characterized in order to define a risk level. The
major difference with the proactive use of control banding is that exposure mitigating factors (such as
implemented control measures) are taken into account using an exposure algorithm.
The approach then includes the following elements:
— — assignment of the NOAA to a hazard band;
— — exposure banding;
— — overview of risks based on risk banding as a result of hazard and exposure banding;
— — iterative examination of control measures until the risk is reduced to an acceptable level;
— — design of an action plan based on the chosen specific control scenario.
Such an approach may be used to determine the actual risk level using the existing control measures as an
input variable. In this respect, the retroactive approach can be considered as a means for periodic
reevaluationre-evaluation of the proactive approach.
5.6 Review and data recording
In this “the review and adapt” step, a system of periodic and as-needed reviews should be implemented to
ensure that the information, evaluations, decisions and actions of the previous steps are kept up-to-date.
Reviews should be performed when new information has been generated or has emerged. The adequacy of
the risk management process for the material or the application at hand should be reassessedre-assessed. It
ISO/DTS 12901-2:2024(E:(en)
should be questioned whether the current risk evaluation needs tomust be revised in light of the new
information and, if so, whether the current risk management practices need tomust be changed as well.
6 Information gathering
6.1 NOAA characterization
6.1 Characterization
6.1.1 General
The lists of characteristics and endpoints given in 6.1.25.1.2 to 6.1.45.1.4 should be taken into account when
assessing the human health hazards of NOAA. Addressing this data set should lead to the development of
dossiers describing basic characterization parameters and available mammalian toxicity information. These
endpoints are based upon the list proposed by the OECD testing program for a set of manufactured
[20 [20]]
nanomaterialsMNMs for human health and environmental safety. . It can be considered as a starting point
when assessing the human health hazards of NOAA. Epidemiological data, when available, should also be taken
into account.
6.1.2 NOAA information Information and identification
— The following information should be taken into consideration:
— NOAA name;
— — CAS Numbernumber;
— — structural formula/ and molecular structure;
— — composition of NOAA being tested;
— — basic morphology;
— — description of surface chemistry;
— — method of production.
6.1.3 Physicochemical properties and NOAA characterization
— The following information should be taken into consideration:
— agglomeration/ and aggregation;
— — solubility (e.g. in water or biologically relevant fluids));
— — crystalline phase;
— — dustiness;
— — crystallite size;
— — representative TEM picture(s));
— — particle size distribution;
— — specific surface area;
ISO/DTS 12901-2:2024(E:(en)
— — surface chemistry (where appropriate));
— — catalytic or photocatalytic activity;
— — pour density;
— — porosity;
— — octanol-water partition coefficient, where relevant;
— — redox potential;
— — radical formation potential;
— — other relevant information (where available)).
Although some of the above characteristics can be unavailable, and very few of these characteristics will
actually be taken into account in the control banding process, NOAA’s characteristics should be documented
and recorded as accurately as possible (including reference to size and measurement conditions). This will be
neededis necessary in the case of possible future medical issues. When utilizing characteristics relating to non-
nanoscale materials, it should be taken into account that these characteristics can differ significantly from
those for the material in the nanoscale.
6.1.4 NOAA toxicologicalToxicological data
— The following information should be taken into consideration:
— pharmacokinetics (absorption, distribution, metabolism, elimination));
— — acute toxicity;
— — repeated dose toxicity;
— — chronic toxicity;
— — reproductive toxicity;
— — developmental toxicity;
— — genetic toxicity;
— — experience with human exposure;
— — epidemiological data;
— — other relevant test data.
Although some of the above data can be unavailable, and some of these data are not necessarily taken into
account in the control banding process, NOAA’s toxicological data should be documented and recorded as
accurately as possible.
A list of hazard indications is presented in Annex AAnnex A.
ISO/DTS 12901-2:2024(E:(en)
6.2 Exposure characterization
6.2.1 General exposure characterization elements
The main goal of exposure characterization is to provide a summary and a synthesis of available exposure
information. General exposure characterization includes the following elements:
a) a) a statement of purpose, scope, level of detail, as well as the approach used in the exposure
characterization;
b) b) estimates of exposure for each relevant pathway, both for individuals and populations (e.g. groups of
workers);
c) c) an evaluation of the overall quality of the assessment and the degree of confidence in the exposure
estimates and, in the conclusions, drawn, including sources and the extent of uncertainty (see
ISO/TS 12901--1);
d) d) in this control banding approach, the critical elements of exposure characterization, which are
necessary to determine the exposure band include:
— — the physical form of NOAA,;
— — the amount of NOAA,;
— — the determination of dust generation potential during the processes,;
— — the actual exposure measurement data.
6.2.2 Physical form
The actual stage in the NOAA’s life cycle is an important parameter to consider as it can influence the potential
for worker exposure and thus the selection of risk control parameters.
NOAA can be in different forms, as produced (e.g. as a powder), or as used (e.g. embedded in a solid matrix or
attached to a substrate), suspended in a gas or in a liquid; or as waste. Each of these different stages will have
its own exposure pattern.
Thus, the NOAA’s physical form (i.e. exposure availability) should be characterized throughout the product
lifecycle. This information is critical for the appropriate and safe handling of the material.
6.2.3 Amount of NOAA
The amounts of nanomaterial processed or manufactured in the workplace is one of the most important
determinants of exposure. The presence of large amounts of NOAA in the workplace increases the potential
for the generation of a higher concentration in the air and, therefore, can lead to higher exposures.
6.2.4 Potential for dust generation
Workplace processes, such as spraying, packaging, maintenance activities and dumping can lead to generation
of airborne particles. As a consequence, it is important to analyse the details of the operator’s activities and
process operations must be analysed in order to estimate the potency of the process to release NOAA into the
workplace air. This implies performing an inventory of operators’ tasks, including start and stop operations,
process steps, etc.
ISO/DTS 12901-2:2024(E:(en)
6.2.5 Quantitative exposure measurements
Actual exposure measurements, when feasible, represent the best information for the selection of the
appropriate exposure band. Therefore, they should be encouraged and when both personal sampling and area
measurements are available, the preference should be given to individual exposure measurements. The
results should be taken into account when determining the corresponding exposure band. ISO/TS 12901--1
provides information on available measurement equipment, possible measurement strategies and results
interpretations.
6.3 Characterization of control measures
6.3.1 General
Exposure control measures implemented in the workplace should be characterized. They can lower exposures
by reducing emission, transmission and immission.
6.3.2 Reduction of emission
The reduction of NOAA emission from the source can be achieved in several ways such as handling NOAA in
suspension into a liquid or dispersed into a paste or a solid matrix rather than in the form of dry powders;
avoiding high energy processes or any activity likely to release free NOAA in the workplaces.
6.3.3 Reduction of transmission
Reduction of transmission from the source towards the worker is possible in several ways. Two generic
control measures are:
— — local control, e.g. either containment and/or local exhaust ventilation, or both;
— — general ventilation, e.g. natural or mechanical ventilation.
6.3.4 Reduction of immission
The reduction of immission has three generic control measures:
— — personal enclosure/ and separating the worker from the source, e.g. a ventilated cabin,;
— — segregation of the source from the worker, i.e. isolation of sources from the work environment in a
separate room without direct containment of the source itself,;
— — use of personal protective equipment.
6.3.5 Workplace area and personal exposure monitoring data
When feasible, actual exposure measurements provide important information on the effectiveness of controls
and workers protection level.
7 Control banding implementation
7.1 Preliminary remarks
Whatever the approach, control banding implementation should be consistent with the hierarchy of controls
(and the so-called STOP principle): substitution, technical measures, organizational measures and personal
protective equipment (PPE) the last one used as the last resort when previous measures do not provide
adequate control.
ISO/DTS 12901-2:2024(E:(en)
Control banding should incorporate general industrial hygiene good practices. In the case when control
measures recommended by the nano-s
...
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Technical
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risk management applied to
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Part 2:
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ii
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols and abbreviated terms. 2
5 General framework for control banding . 2
5.1 General .2
5.2 Information gathering and data recording .3
5.3 Hazard banding . . .3
5.4 Exposure banding .4
5.5 Control banding .4
5.5.1 Proactive implementation of control banding .4
5.5.2 Retroactive implementation approach: evaluation of control banding and risk
banding .4
5.6 Review and data recording.4
6 Information gathering . 5
6.1 Characterization .5
6.1.1 General .5
6.1.2 Information and identification .5
6.1.3 Physicochemical properties and characterization .5
6.1.4 Toxicological data .6
6.2 Exposure characterization .6
6.2.1 General exposure characterization elements .6
6.2.2 Physical form .7
6.2.3 Amount .7
6.2.4 Potential for dust generation .7
6.2.5 Quantitative exposure measurements .7
6.3 Characterization of control measures .7
6.3.1 General .7
6.3.2 Reduction of emission . .7
6.3.3 Reduction of transmission . .8
6.3.4 Reduction of immission .8
6.3.5 Workplace area and personal exposure monitoring data .8
7 Control banding implementation . 8
7.1 Preliminary remarks .8
7.2 Hazard band setting .8
7.2.1 Hazard categorization of chemicals and general hazard banding process for
bulk materials .8
7.2.2 Allocation to a hazard band . . .11
7.3 Exposure band setting.14
7.3.1 Preliminary remarks .14
7.3.2 Synthesis, production and manufacturing . 15
7.3.3 Material dispersed in a solid matrix .16
7.3.4 Material in suspension in a liquid .17
7.3.5 Material in powder form .17
7.3.6 Option for modifying the process to reduce exposure levels .18
7.4 Control band setting and control strategies .18
7.5 Evaluation of controls .19
7.6 Retroactive approach — Risk banding . 20
8 Performance, review and continual improvement .22
8.1 General . 22
iii
8.2 Objectives and performance . 23
8.3 Data recording . 23
8.4 Management review . 23
Annex A (informative) Health hazard class according to GHS .24
Annex B (informative) Nanomaterial risk assessment (NaRA) .25
Annex C (informative) Modified occupational hazard band (OHB) .27
Bibliography .30
iv
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 229, Nanotechnologies.
This second edition cancels and replaces the first edition (ISO/TS 12901-2:2014) which has been technically
revised.
The main changes are as follows:
— revision of examples in the annexes, including The Control Banding Nano Tools NaRA, GoodNanoGuide
and OHB, and replacement of Annex B;
— revision of links to websites;
— addition of sources for all NOAA hazard characterization inventories.
A list of all parts in the ISO/TS 12901 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
v
Introduction
Nano-objects, and their aggregates and agglomerates greater than 100 nm (NOAA), can exhibit properties,
including toxicological properties which are different from those of non-nanoscale (bulk) material.
Therefore, current occupational exposure limits (OELs), which are mostly established for bulk materials can
be inappropriate for NOAA. The control banding approach can be used as a first approach to controlling
workplace exposure to NOAA.
NOTE Regulatory specifications can apply regarding NOAA.
Control banding is a pragmatic approach which can be used for the control of workplace exposure to
possibly hazardous agents with unknown or uncertain toxicological properties and for which quantitative
exposure estimations are lacking. The ultimate purpose of control banding is to control exposure to prevent
any possible adverse effects on workers’ health. It can complement the traditional quantitative methods
based on air sampling and analysis with reference to OELs when they exist. It can provide an alternative
risk assessment and risk management process, by grouping occupational settings in categories presenting
similarities of either hazards or exposure, or both, while incorporating professional judgment and
monitoring. This process applies a range of control techniques (such as general ventilation or containment)
to a specific chemical, considering its range (or band) of hazard and the range (or band) of exposure.
In general, control banding is based on the idea that while workers can be exposed to a diversity of chemicals,
implying a diversity in risks, the number of common approaches to risk control is limited. These approaches
are grouped into levels based on how much protection the approach offers (with “stringent” controls being
the most protective). The greater the potential for harm, the greater the levels of protection needed for
exposure control.
Control banding was originally developed by the pharmaceutical industry as a way to safely work with new
chemicals that had little or no toxicity information. These new chemicals were classified into “bands” based
on the toxicity of analogous and better-known chemicals and were linked to anticipated safe work practices,
[1]
taking into consideration exposure assessments. Each band was then aligned with a control scheme.
Following this concept, the Health and Safety Executive in the UK has developed a user-friendly scheme called
[2]
"COSHH Essentials", primarily for the benefit of small- and medium-sized enterprises that potentially do
not benefit from the expertise of a resident occupational hygienist. The Department of Occupational Safety
and Health Malaysia published the Nanomaterial Risk Assessment (NaRA) based on Reference [3]. Similar
schemes are used in the practical guidance given by the German Federal Institute for Occupational Safety
[4] 1) [5]
and Health . The Stoffenmanager® tool represents a further development, combining a hazard banding
scheme similar to that of "COSHH Essentials" and an exposure banding scheme based on an exposure process
model, which was customized to allow non-expert users to understand and use the model.
Control banding applies to issues related to occupational health in the development, manufacturing and use
of NOAA under normal or reasonably predictable conditions, including maintenance and cleaning operations
but excluding incidental or accidental situations.
Control banding is not intended to apply to the fields of safety management, environment or transportation;
it is considered as only one part of a comprehensive risk management process.
Control banding can be particularly useful for the risk assessment and management of nanomaterials, given
the level of uncertainty in work-related potential health risks from NOAA. It can be used for risk management
in a proactive manner and in a retroactive manner. In the proactive manner existing control measures, if
any, are not used as input variables in the potential exposure banding while in a retroactive manner existing
control measures are used as input variables. Both approaches are described in this document. While
control banding appears, in theory, to be appropriate for nanoscale materials exposure control, very few
comprehensive tools are currently available for ongoing nanotechnology operations. A conceptual control
banding model was presented in Reference [6], offering the same four control approaches as the control of
substances hazardous to health (COSHH). A slightly different approach, called “control banding nanotool”,
was presented in Reference [7]. This approach takes into account existing knowledge of NOAA toxicology
1) The Stoffenmanager® tool is an example of a suitable product available commercially. This information is given for
the convenience of users of this document and does not constitute an endorsement by ISO of this product. Equivalent
products may be used if they can be shown to lead to the same results.
vi
and uses the control banding framework proposed in earlier publications. However, the ranges of values
used in the “control banding nanotool” correspond to those ranges that one would expect in small-scale
research type operations (less than one gram) and are possibly not appropriate for larger scale uses. In the
meantime, several other specific control banding tools have been published to control inhalation exposure
[ ],[ ],[ ],[ ],[ ]
to engineered nanomaterials for larger scale uses. 8 9 10 11 12 All these tools define hazard bands and
exposure bands for inhalation exposure and combine these in a two-dimensional matrix, resulting in a score
for risk control (proactive approach).
In 2009, the National Institute for Occupational Safety and Health (in the United States, published a review
and analysis of existing toolkits for control banding without any recommendation for implementation in
[13]
the United States. An occupational exposure banding process was later described as a starting point
[14]
to inform risk management decisions when an OEL is unavailable. This process uses hazard-based
data to identify the overall hazard potential and the associated airborne concentration range for chemical
substances. It also describes special categories of aerosols, including nanoscale particles. An occupational
exposure banding approach can inform risk management and control decisions. Although it is not itself
a control banding approach, the use of occupational exposure bands as control ranges is consistent with
common applications of control banding.
Reference [15] developed a conceptual model for assessment of inhalation exposure to engineered
nanomaterials, suggesting a general framework for future exposure models. This framework follows
the same structure as the conceptual model for inhalation exposure used in the Stoffenmanager® tool
and the Advanced REACH Tool (ART). Based on this conceptual framework, a control banding tool called
Stoffenmanager Nano® was developed, encompassing both the proactive approach and the retroactive (risk
banding) approach.
Reference [16] proposed a new approach for the handling of powders and nanomaterials. This method is
very practical and has been widely used by several cosmetic manufacturers. However, industry data are
limited to cosmetic ingredients.
The toxicological approach proposed by the cosmetics industry in France considers highest acute toxicity
and CMRS at the same level. The exposure model is applicable to powders leaning on usual descriptors that
have been translated into observable data, which makes the methodology user-friendly for field operators
(see Annex C).
In addition, the French agency for food, environmental and occupational health and safety has developed a
control banding tool specifically for nanomaterials, which is described in Reference [17].
[18]
Furthermore, the European Commission published non-binding guidance entitled that includes a control
banding approach. The purpose of it is to assist employers, health and safety practitioners and workers in
fulfilling their regulatory obligations, whenever exposure to manufactured nanomaterials (MNMs) or use of
nanotechnology in a professional capacity can likely take place, with the ultimate aim of ensuring adequate
protection of workers’ health and safety. The guidance provides an overview of the issues surrounding the
safe use of MNMs in the workplace, sets out the broad outlines of preventive action and provides a practical
tool for complying with specific aspects of workers’ safety, such as risk assessment and risk management.
[18]
This can be valuable if an in-depth technical understanding of the issues involved is missing.
In 2021, the Organisation for Economic Co-operation and Development (OECD) embarked on a systematic
review of the most representative control banding tools available for nanomaterials. The resulting inventory
provided information on both regulatory and non-regulatory tools to assess occupational exposure to
MNMs (NOAA) and included an applicability assessment for occupational exposure to NOAA. The project
was divided into occupational and consumer scopes.
— Part I involved a compilation of tools and models for occupational and consumer exposure to nanomaterials
and further evaluation of their applicability.
— Part II focused on the performance testing results of tools and models for occupational exposure.
— Part III presented the performance testing results for consumer exposure tools and models.
[19]
Finally, 32 models and tools were assessed.
vii
The biggest challenge in developing any control banding approach for NOAA is to decide which parameters
are to be considered, what criteria are relevant to assign a nano-object to a control band, and what
operational control strategies are to be implemented at different operational levels.
This document is focused on intentionally produced NOAA that consist of nano-objects such as nanoparticles,
nanopowders, nanofibres, nanotubes, nanowires, as well as aggregates and agglomerates of the same. As used
in this document, the term “NOAA” applies to such components, whether in their original form or incorporated
in materials or preparations from which they can be released during their lifecycle. However, as for many other
industrial processes, nanotechnological processes can generate by-products in the form of unintentionally
produced NOAA which can be linked to health and safety issues that must be addressed as well.
This document proposes recommendations for controlling and managing occupational risk based on a control
banding approach specifically designed for NOAA. It is the responsibility of manufacturers and importers to
determine whether a material of concern contains NOAA, and to provide relevant information in safety data
sheets (SDS) and labels. Employers can use this information to identify hazards and implement appropriate
controls. This document does not intend to give recommendations on this decision-making process.
It is emphasized that the control banding method applied to manufactured NOAA requires assumptions to
be formulated on information that is desirable but unavailable. Thus, the user of the control banding tool
must have proven skills in chemical risk prevention and, more specifically, in risk issues known to be related
to that type of material. The successful implementation of this approach involves solid expertise combined
with a capacity for critical evaluation of potential occupational exposures and training to use control
banding tools to ensure appropriate control measures and an adequately conservative approach.
The approach using CB Tools for NOAA includes the methodology of the sector where it is intended to be
used. NOAA is used in industries where the process is frequently used and limited characterization is known
but the characterization of adverse events secondary to NOAA use are well described and can be considered
to implement a light approach of CB Tools for industry, even if the hazard is not completely identified
and thus not well known. If the NOAA is not frequently used but there is a possibility to characterize it
physicochemical and biologically, there will be the need to use a more complex and academic CB Tool.
In parallel to the approach described in this document, a full hazard assessment considers all substance-
related hazards, including explosive risk and environmental hazards.
NOTE Explosive dust clouds can be generated from most organic materials, many metals and even some non-
metallic inorganic materials. The primary factor influencing the ignition sensitivity and explosive violence of a dust
cloud is the particle size or specific surface area (i.e. the total surface area per unit volume or unit mass of the dust)
and the particle composition. As the particle size decreases, the specific surface area increases. The general trend
is for the violence of the dust explosion and the ease of ignition to increase as the particle size decreases, though for
many dusts this trend begins to level out at particle sizes in the order of tens of micrometres (µm). However, no lower
particle size limit has been established below which dust explosions cannot occur and many nanoparticle types have
the potential to cause explosions.
viii
FINAL DRAFT Technical Specification ISO/DTS 12901-2.2:2025(en)
Nanotechnologies — Occupational risk management applied
to engineered nanomaterials —
Part 2:
Use of the control banding approach
1 Scope
This document establishes and gives guidance on the use of a control banding approach for controlling the
risks associated with occupational exposures to nano-objects and their aggregates and agglomerates greater
than 100 nm (NOAA), even if knowledge regarding their toxicity and quantitative exposure estimations is
limited or lacking.
This document applies to inhalation control, for which the control banding tool is specifically designed.
NOTE Some guidance for skin and eye protection is given in ISO/TS 12901-1.
This document does not apply to materials of biological origin.
This document is intended to help businesses and others, including research organizations engaged in the
manufacturing, processing, or handling of NOAA, by providing an easy-to-understand, pragmatic approach
to controlling occupational exposures.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 80004-1, Nanotechnologies – Vocabulary — Part 1: Core vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 80004-1 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/
4 Symbols and abbreviated terms
CMRS carcinogenicity, mutagenicity, reproductive toxicity or sensitization
COSHH control of substances hazardous to health
DLS dynamic light scattering
EB exposure banding
GHS globally harmonized system of classification and labelling of chemicals
SDS safety data sheet
MNMs manufactured nanomaterials
NOAA nano-objects, and their aggregates and agglomerates greater than 100 nm
OEL occupational exposure limit
PPE personal protective equipment
SEM scanning electron microscopy
STOP substitution, technical measures, organizational measures, personal protective equipment
TEM transmission electron microscopy
5 General framework for control banding
5.1 General
The control banding tool described in this document applies to NOAA and materials containing NOAA. This
control banding tool can only be considered as one part, though an integral part, of an overall system for
health and safety risk management. It necessitates input data, irrespective of the phase of the NOAA life cycle,
such as information collected at the place of work through observation of actual work by an occupational
hygienist with solid expertise and training to use control banding tools as well as the enunciation of hazards
and the best toxicology data available.
The foundation of this approach is the risk identification process, which is based on:
— current knowledge of the specific NOAA (toxicology or health effect data; physical and chemical
properties);
— assessment of potential worker exposure.
The hazard and exposure information are combined to determine an appropriate level of control (such as
general ventilation, local exhaust, or containment).
This approach is based on the view that the engineering control techniques for nanoparticle exposure can
build on the knowledge and experience from current exposure control to aerosols. This knowledge and
control have already been applied to aerosols containing ultrafine particles (e.g. welding fumes, carbon
black or viruses). Effective techniques can be obtained by adapting and redesigning current technology. This
applies to techniques for general ventilation, local and process ventilation, containments, enclosures and
filtration.
The control banding approach allows shifting from exposure assessment to exposure control and vice versa.
Thus, it can be performed either in a proactive way or in a retroactive way. The proactive way is based on
anticipated exposures and uses basic factors mitigating exposure potential. The retroactive way (or risk
banding approach) is based on a risk assessment that takes more exposure mitigating factors into account,
including control measures actually implemented or to be implemented. In both cases, hazard banding is a
common step. The general structure of the process is shown in Figure 1 and includes the following elements:
— information gathering;
— assignment of the NOAA to a hazard band: hazard banding;
— description of potential exposure characteristics: exposure banding;
— definition of recommended work environments and handling practices: control banding;
— evaluation of the control strategy or risk banding.
Figure 1 — Control banding process
5.2 Information gathering and data recording
The methodology presented in this document is information-driven; it does not implicitly assume the
presence of risk or hazard in any material. Where there is little or no information to guide decisions on
the potential for a particular hazard or exposure, reasonable worst-case assumptions should be used along
with management practices appropriate for those options. The methodology is also designed to encourage
replacing assumptions with real information and refining management practices accordingly.
Input data must be obtained prior to implementing control banding. Especially considering NOAA for which
no health-based limit values can be established, it is important to document substances being used, control
measures taken, working conditions and possibly exposure measurements, given that these factors are not
always easy to determine with complete certainty, and that they depend on the extent to which the hazard is
known and on the accuracy of the methods used for exposure assessment.
All input data should be documented and traceable through an appropriate documentation management system.
5.3 Hazard banding
Hazard banding consists in assigning a hazard band to NOAA on the basis of a comprehensive evaluation of
all available data on this material, taking into account parameters such as toxicity, in vivo biopersistence and
factors influencing the ability of particles to reach the respiratory tract, their ability to deposit in various
regions of the respiratory tract, and their ability to elicit biological responses. These factors can be related
to physical and chemical properties such as surface area, surface chemistry, shape, particle size, etc.
5.4 Exposure banding
Exposure banding consists of assigning an exposure scenario (a set of conditions under which exposure can
occur) at a workplace or a workstation to an exposure band on the basis of a comprehensive evaluation of all
available data of the exposure scenario under consideration, e.g. physical form of NOAA, amount of NOAA,
dust generation potential of processes and actual exposure measurement data.
5.5 Control banding
5.5.1 Proactive implementation of control banding
Control banding can be used for risk control management in a proactive manner. In that case, recommended
work environments and handling practices may be defined on the basis of hazard banding as well as of
fundamental factors mitigating anticipated exposure potential, e.g. propensity of the material to become
airborne, the type of process and amounts of material being handled.
Such an approach is used to determine the control measures appropriate for the operation being assessed
but not to determine an actual level of risk, as the existing control measures, if any, are not used as an input
variable in the exposure banding process.
5.5.2 Retroactive implementation approach: evaluation of control banding and risk banding
In a retroactive approach, control banding may be used either to evaluate the controls recommended as
outputs of the proactive approach or for risk assessment on its own.
In that case, both hazard and actual exposure must be characterized in order to define a risk level. The
major difference with the proactive use of control banding is that exposure mitigating factors (such as
implemented control measures) are taken into account using an exposure algorithm.
The approach then includes the following elements:
— assignment of the NOAA to a hazard band;
— exposure banding;
— overview of risks based on risk banding as a result of hazard and exposure banding;
— iterative examination of control measures until the risk is reduced to an acceptable level;
— design of an action plan based on the chosen specific control scenario.
Such an approach may be used to determine the actual risk level using the existing control measures as
an input variable. In this respect, the retroactive approach can be considered as a means for periodic re-
evaluation of the proactive approach.
5.6 Review and data recording
In the review and adapt step, a system of periodic and as-needed reviews should be implemented to ensure
that the information, evaluations, decisions and actions of the previous steps are kept up-to-date. Reviews
should be performed when new information has been generated or has emerged. The adequacy of the
risk management process for the material or the application at hand should be re-assessed. It should be
questioned whether the current risk evaluation must be revised in light of the new information and, if so,
whether the current risk management practices must be changed as well.
6 Information gathering
6.1 Characterization
6.1.1 General
The lists of characteristics and endpoints given in 6.1.2 to 6.1.4 should be taken into account when assessing
the human health hazards of NOAA. Addressing this data set should lead to the development of dossiers
describing basic characterization parameters and available mammalian toxicity information. These
endpoints are based upon the list proposed by the OECD testing program for a set of MNMs for human health
[20]
and environmental safety. It can be considered as a starting point when assessing the human health
hazards of NOAA. Epidemiological data, when available, should also be taken into account.
6.1.2 Information and identification
The following information should be taken into consideration:
— NOAA name;
— CAS number;
— structural formula and molecular structure;
— composition of NOAA being tested;
— basic morphology;
— description of surface chemistry;
— method of production.
6.1.3 Physicochemical properties and characterization
The following information should be taken into consideration:
— agglomeration and aggregation;
— solubility (e.g. in water or biologically relevant fluids);
— crystalline phase;
— dustiness;
— crystallite size;
— representative TEM picture(s);
— particle size distribution;
— specific surface area;
— surface chemistry (where appropriate);
— catalytic or photocatalytic activity;
— pour density;
— porosity;
— octanol-water partition coefficient, where relevant;
— redox potential;
— radical formation potential;
— other relevant information (where available).
Although some of the above characteristics can be unavailable, and very few of these characteristics
will be taken into account in the control banding process, NOAA’s characteristics should be documented
and recorded as accurately as possible (including reference to size and measurement conditions). This
is necessary in the case of possible future medical issues. When utilizing characteristics relating to non-
nanoscale materials, it should be taken into account that these characteristics can differ significantly from
those for the material in the nanoscale.
6.1.4 Toxicological data
The following information should be taken into consideration:
— pharmacokinetics (absorption, distribution, metabolism, elimination);
— acute toxicity;
— repeated dose toxicity;
— chronic toxicity;
— reproductive toxicity;
— developmental toxicity;
— genetic toxicity;
— experience with human exposure;
— epidemiological data;
— other relevant test data.
Although some of the above data can be unavailable, and some of these data are not necessarily taken into
account in the control banding process, NOAA’s toxicological data should be documented and recorded as
accurately as possible.
A list of hazard indications is presented in Annex A.
6.2 Exposure characterization
6.2.1 General exposure characterization elements
The main goal of exposure characterization is to provide a summary and a synthesis of available exposure
information. General exposure characterization includes the following elements:
a) a statement of purpose, scope, level of detail, as well as the approach used in the exposure
characterization;
b) estimates of exposure for each relevant pathway, both for individuals and populations (e.g. groups of
workers);
c) an evaluation of the overall quality of the assessment and the degree of confidence in the exposure
estimates and, in the conclusions, drawn, including sources and the extent of uncertainty (see
ISO/TS 12901-1);
d) in this control banding approach, the critical elements of exposure characterization, which are necessary
to determine the exposure band include:
— the physical form of NOAA;
...
ISO/TC 229
Secretariat: BSI
Date: 2025-09-1910-17
Nanotechnologies — Occupational risk management applied to
engineered nanomaterials —
Part 2:
Use of the control banding approach
Nanotechnologies — Gestion du risque professionnel appliquée aux nanomatériaux manufacturés —
Partie 2: Utilisation de l'approche par bandes de dangers
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO
at the address below or ISO’s member body in the country of the requester.
ISO copyright office
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Published in Switzerland
ii
Contents
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Symbols and abbreviated terms . 1
5 General framework for control banding . 2
5.1 General . 2
5.2 Information gathering and data recording . 3
5.3 Hazard banding . 4
5.4 Exposure banding . 4
5.5 Control banding . 4
5.6 Review and data recording . 5
6 Information gathering . 5
6.1 Characterization . 5
6.2 Exposure characterization . 7
6.3 Characterization of control measures . 8
7 Control banding implementation . 8
7.1 Preliminary remarks . 8
7.2 Hazard band setting . 9
7.3 Exposure band setting . 16
7.4 Control band setting and control strategies . 21
7.5 Evaluation of controls . 22
7.6 Retroactive approach — Risk banding . 23
8 Performance, review and continual improvement . 26
8.1 General . 26
8.2 Objectives and performance . 26
8.3 Data recording . 26
8.4 Management review . 27
Annex A (informative) Health hazard class according to GHS . 28
Annex B (informative) Nanomaterial risk assessment (NaRA) . 29
Annex C (informative) Modified occupational hazard band (OHB) . 33
Bibliography . 36
iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of
ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 229, Nanotechnologies.
This second edition cancels and replaces the first edition (ISO/TS 12901-2:2014) which has been technically
revised.
The main changes are as follows:
— revision of examples in the annexes, including The Control Banding Nano Tools NaRA, GoodNanoGuide
and OHB, and replacement of Annex B;;
— revision of links to websites;
— addition of sources for all NOAA hazard characterization inventories.
A list of all parts in the ISO/TS 12901 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
Introduction
Nano-objects, and their aggregates and agglomerates greater than 100 nm (NOAA), can exhibit properties,
including toxicological properties which are different from those of non-nanoscale (bulk) material. Therefore,
current occupational exposure limits (OELs), which are mostly established for bulk materials can be
inappropriate for NOAA. The control banding approach can be used as a first approach to controlling
workplace exposure to NOAA.
NOTE: Regulatory specifications can apply regarding NOAA.
Control banding is a pragmatic approach which can be used for the control of workplace exposure to possibly
hazardous agents with unknown or uncertain toxicological properties and for which quantitative exposure
estimations are lacking. The ultimate purpose of control banding is to control exposure to prevent any possible
adverse effects on workers’ health. It can complement the traditional quantitative methods based on air
sampling and analysis with reference to OELs when they exist. It can provide an alternative risk assessment
and risk management process, by grouping occupational settings in categories presenting similarities of either
hazards or exposure, or both, while incorporating professional judgment and monitoring. This process applies
a range of control techniques (such as general ventilation or containment) to a specific chemical, considering
its range (or band) of hazard and the range (or band) of exposure.
In general, control banding is based on the idea that while workers can be exposed to a diversity of chemicals,
implying a diversity in risks, the number of common approaches to risk control is limited. These approaches
are grouped into levels based on how much protection the approach offers (with “stringent” controls being
the most protective). The greater the potential for harm, the greater the levels of protection needed for
exposure control.
Control banding was originally developed by the pharmaceutical industry as a way to safely work with new
chemicals that had little or no toxicity information. These new chemicals were classified into “bands” based
on the toxicity of analogous and better-known chemicals and were linked to anticipated safe work practices,
[1] [ ]
taking into consideration exposure assessments. Each band was then aligned with a control scheme. . 1
Following this concept, the Health and Safety Executive in the UK has developed a user-friendly scheme called
[2] [ ]
"COSHH Essentials, ", 2 primarily for the benefit of small- and medium-sized enterprises that potentially do
not benefit from the expertise of a resident occupational hygienist. The Department of Occupational Safety
[3]
and Health Malaysia published the Nanomaterial Risk Assessment (NaRA) based on Reference. [3]. Similar
schemes are used in the practical guidance given by the German Federal Institute for Occupational Safety and
[4][ ] 1) [ ]
Health. 4 . The Stoffenmanager® tool represents a further development,[5], 5 combining a hazard banding
scheme similar to that of "COSHH Essentials" and an exposure banding scheme based on an exposure process
model, which was customized to allow non-expert users to understand and use the model.
Control banding applies to issues related to occupational health in the development, manufacturing and use
of NOAA under normal or reasonably predictable conditions, including maintenance and cleaning operations
but excluding incidental or accidental situations.
Control banding is not intended to apply to the fields of safety management, environment or transportation;
it is considered as only one part of a comprehensive risk management process.
Control banding can be particularly useful for the risk assessment and management of nanomaterials, given
the level of uncertainty in work-related potential health risks from NOAA. It can be used for risk management
in a proactive manner and in a retroactive manner. In the proactive manner existing control measures, if any,
are not used as input variables in the potential exposure banding while in a retroactive manner existing
control measures are used as input variables. Both approaches are described in this document. While control
1)
The Stoffenmanager® tool is an example of a suitable product available commercially. This information is given for
the convenience of users of this document and does not constitute an endorsement by ISO of this product. Equivalent
products may be used if they can be shown to lead to the same results.
v
banding appears, in theory, to be appropriate for nanoscale materials exposure control, very few
comprehensive tools are currently available for ongoing nanotechnology operations. A conceptual control
banding model was presented by Maynard [6]in Reference [6], offering the same four control approaches as
the control of substances hazardous to health (COSHH.). A slightly different approach, called “control banding
nanotool”, was presented by Paik et al. [7]in Reference [7]. This approach takes into account existing
knowledge of NOAA toxicology and uses the control banding framework proposed in earlier publications.
However, the ranges of values used in the “control banding nanotool” correspond to those ranges that one
would expect in small-scale research type operations (less than one gram) and are possibly not appropriate
for larger scale uses. In the meantime, several other specific control banding tools have been published to
control inhalation exposure to engineered nanomaterials for larger scale uses. [8], [9], [10], [11],
[ ],[ ],[ ],[ ],[ ]
[12]. 8 9 10 11 12 All these tools define hazard bands and exposure bands for inhalation exposure and
combine these in a two-dimensional matrix, resulting in a score for risk control (proactive approach).
In 2009, the National Institute for Occupational Safety and Health (in the United States, published a review
and analysis of existing toolkits for control banding without any recommendation for implementation in the
[ ]
United States. [13]. 13 An occupational exposure banding process was later described as a starting point to
[ ]
inform risk management decisions when an OEL is unavailable. [14]. 14 This process uses hazard-based data
to identify the overall hazard potential and the associated airborne concentration range for chemical
substances. It also describes special categories of aerosols, including nanoscale particles. An occupational
exposure banding approach can inform risk management and control decisions. Although it is not itself a
control banding approach, the use of occupational exposure bands as control ranges is consistent with
common applications of control banding.
Schneider et al. [15]Reference [15] developed a conceptual model for assessment of inhalation exposure to
engineered nanomaterials, suggesting a general framework for future exposure models. This framework
follows the same structure as the conceptual model for inhalation exposure used in the Stoffenmanager® tool
and the Advanced REACH Tool (ART). Based on this conceptual framework, a control banding tool called
Stoffenmanager Nano® was developed, encompassing both the proactive approach and the retroactive (risk
banding) approach.
Reference [16][16] proposed a new approach for the handling of powders and nanomaterials. This method is
very practical and has been widely used by several cosmetic manufacturers. However, industry data are
limited to cosmetic ingredients.
The toxicological approach proposed by the cosmetics industry in France considers highest acute toxicity and
CMRS at the same level. The exposure model is applicable to powders leaning on usual descriptors that have
been translated into observable data, which makes the methodology user-friendly for field operators (see
details in ).).
Annex C
In addition, the French agency for food, environmental and occupational health and safety has developed a
control banding tool specifically for nanomaterials, which is described in Reference. [17] [17].
[ ]
Furthermore, the European Commission published non-binding guidance entitled [18] 18 that includes a
control banding approach. The purpose of it is to assist employers, health and safety practitioners and workers
in fulfilling their regulatory obligations, whenever exposure to manufactured nanomaterials (MNMs) or use
of nanotechnology in a professional capacity can likely take place, with the ultimate aim of ensuring adequate
protection of workers’ health and safety. The guidance provides an overview of the issues surrounding the
safe use of MNMs in the workplace, sets out the broad outlines of preventive action and provides a practical
tool for complying with specific aspects of workers’ safety, such as risk assessment and risk management. This
[ ]
can be valuable if an in-depth technical understanding of the issues involved is missing. [18]. 18
In 2021, the Organisation for Economic Co-operation and Development (OECD) embarked on a systematic
review of the most representative control banding tools available for nanomaterials. The resulting inventory
provided information on both regulatory and non-regulatory tools to assess occupational exposure to MNMs
vi
(NOAA) and included an applicability assessment for occupational exposure to NOAA. The project was divided
into occupational and consumer scopes:.
— partPart I involved a compilation of tools and models for occupational and consumer exposure to
nanomaterials and further evaluation of their applicability;.
— partPart II focused on the performance testing results of tools and models for occupational exposure; .
— partPart III presented the performance testing results for consumer exposure tools and models; .
[ ]
Finally, 32 models and tools were assessed. [19]. 19
The biggest challenge in developing any control banding approach for NOAA is to decide which parameters
are to be considered, what criteria are relevant to assign a nano-object to a control band, and what operational
control strategies are to be implemented at different operational levels.
This document is focused on intentionally produced NOAA that consist of nano-objects such as nanoparticles,
nanopowders, nanofibres, nanotubes, nanowires, as well as aggregates and agglomerates of the same. As used
in this document, the term “NOAA” applies to such components, whether in their original form or incorporated
in materials or preparations from which they can be released during their lifecycle. However, as for many
other industrial processes, nanotechnological processes can generate by-products in the form of
unintentionally produced NOAA which can be linked to health and safety issues that must be addressed as
well.
This document proposes recommendations for controlling and managing occupational risk based on a control
banding approach specifically designed for NOAA. It is the responsibility of manufacturers and importers to
determine whether a material of concern contains NOAA, and to provide relevant information in safety data
sheets (SDS) and labels. Employers can use this information to identify hazards and implement appropriate
controls. This document does not intend to give recommendations on this decision-making process.
It is emphasized that the control banding method applied to manufactured NOAA requires assumptions to be
formulated on information that is desirable but unavailable. Thus, the user of the control banding tool must
have proven skills in chemical risk prevention and, more specifically, in risk issues known to be related to that
type of material. The successful implementation of this approach involves solid expertise combined with a
capacity for critical evaluation of potential occupational exposures and training to use control banding tools
to ensure appropriate control measures and an adequately conservative approach.
The approach using CB Tools for NOAA includes the methodology of the sector where it is intended to be used.
NOAA is used in industries where the process is frequently used and limited characterization is known but the
characterization of adverse events secondary to NOAA use are well described and can be considered to
implement a light approach of CB Tools for industry, even if the hazard is not completely identified and thus
not well known. If the NOAA is not frequently used but there is a possibility to characterize it physicochemical
and biologically, there will be the need to use a more complex and academic CB Tool.
In parallel to the approach described in this document, a full hazard assessment considers all substance-
related hazards, including explosive risk and environmental hazards.
NOTE Explosive dust clouds can be generated from most organic materials, many metals and even some non-
metallic inorganic materials. The primary factor influencing the ignition sensitivity and explosive violence of a dust cloud
is the particle size or specific surface area (i.e. the total surface area per unit volume or unit mass of the dust) and the
particle composition. As the particle size decreases, the specific surface area increases. The general trend is for the
violence of the dust explosion and the ease of ignition to increase as the particle size decreases, though for many dusts
this trend begins to level out at particle sizes in the order of tens of micrometres (µm). However, no lower particle size
limit has been established below which dust explosions cannot occur and many nanoparticle types have the potential to
cause explosions.
vii
Nanotechnologies — Occupational risk management applied to
engineered nanomaterials —
Part 2:
Use of the control banding approach
1 Scope
This document describesestablishes and gives guidance on the use of a control banding approach for
controlling the risks associated with occupational exposures to nano-objects and their aggregates and
agglomerates greater than 100 nm (NOAA), even if knowledge regarding their toxicity and quantitative
exposure estimations is limited or lacking.
This document applies to inhalation control, for which the control banding tool is specifically designed.
NOTE Some guidance for skin and eye protection is given in ISO/TS 12901-1.
This document does not apply to materials of biological origin.
This document is intended to help businesses and others, including research organizations engaged in the
manufacturing, processing, or handling of NOAA, by providing an easy-to-understand, pragmatic approach to
controlling occupational exposures.
2 Normative references
There are no normative references in this document.
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 80004-1, Nanotechnologies – Vocabulary — Part 1: Core vocabulary
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 80004-1 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/
4 Symbols and abbreviated terms
CMRS carcinogenicity, mutagenicity, reproductive toxicity or sensitization
COSHH control of substances hazardous to health
DLS dynamic light scattering
EB exposure banding
GHS globally harmonized system of classification and labelling of chemicals
SDS safety data sheet
MNMs manufactured nanomaterials
NOAA nano-objects, and their aggregates and agglomerates greater than 100 nm
OEL occupational exposure limit
PPE personal protective equipment
SEM scanning electron microscopy
STOP substitution, technical measures, organizational measures, personal protective equipment
TEM transmission electron microscopy
5 General framework for control banding
5.1 General
The control banding tool described in this document applies to NOAA and materials containing NOAA. This
control banding tool can only be considered as one part, though an integral part, of an overall system for health
and safety risk management. It necessitates input data, irrespective of the phase of the NOAA life cycle, such
as information collected at the place of work through observation of actual work by an occupational hygienist
with solid expertise and training to use control banding tools as well as the enunciation of hazards and the
best toxicology data available.
The foundation of this approach is the risk identification process, which is based on:
— current knowledge of the specific NOAA (toxicology or health effect data; physical and chemical
properties);
— assessment of potential worker exposure.
The hazard and exposure information are combined to determine an appropriate level of control (such as
general ventilation, local exhaust, or containment).
This approach is based on the view that the engineering control techniques for nanoparticle exposure can
build on the knowledge and experience from current exposure control to aerosols. This knowledge and control
have already been applied to aerosols containing ultrafine particles (e.g. welding fumes, carbon black or
viruses). Effective techniques can be obtained by adapting and redesigning current technology. This applies
to techniques for general ventilation, local and process ventilation, containments, enclosures and filtration.
The control banding approach allows shifting from exposure assessment to exposure control and vice versa.
Thus, it can be performed either in a proactive way or in a retroactive way. The proactive way is based on
anticipated exposures and uses basic factors mitigating exposure potential. The retroactive way (or risk
banding approach) is based on a risk assessment that takes more exposure mitigating factors into account,
including control measures actually implemented or to be implemented. In both cases, hazard banding is a
common step. The general structure of the process is shown in Figure 1 and includes the following elements:
— information gathering;
— assignment of the NOAA to a hazard band: hazard banding;
— description of potential exposure characteristics: exposure banding;
— definition of recommended work environments and handling practices: control banding;
— evaluation of the control strategy or risk banding.
Figure 1 — Control banding process
5.2 Information gathering and data recording
The methodology presented in this document is information-driven; it does not implicitly assume the presence
of risk or hazard in any material. Where there is little or no information to guide decisions on the potential for
a particular hazard or exposure, reasonable worst-case assumptions should be used along with management
practices appropriate for those options. The methodology is also designed to encourage replacing
assumptions with real information and refining management practices accordingly.
Input data must be obtained prior to implementing control banding. Especially considering NOAA for which
no health-based limit values can be established, it is important to document substances being used, control
measures taken, working conditions and possibly exposure measurements, given that these factors are not
always easy to determine with complete certainty, and that they depend on the extent to which the hazard is
known and on the accuracy of the methods used for exposure assessment.
All input data should be documented and traceable through an appropriate documentation management
system.
5.3 Hazard banding
Hazard banding consists in assigning a hazard band to NOAA on the basis of a comprehensive evaluation of all
available data on this material, taking into account parameters such as toxicity, in vivo biopersistence and
factors influencing the ability of particles to reach the respiratory tract, their ability to deposit in various
regions of the respiratory tract, and their ability to elicit biological responses. These factors can be related to
physical and chemical properties such as surface area, surface chemistry, shape, particle size, etc.
5.4 Exposure banding
Exposure banding consists of assigning an exposure scenario (a set of conditions under which exposure can
occur) at a workplace or a workstation to an exposure band on the basis of a comprehensive evaluation of all
available data of the exposure scenario under consideration, e.g. physical form of NOAA, amount of NOAA, dust
generation potential of processes and actual exposure measurement data.
5.5 Control banding
5.5.1 Proactive implementation of control banding
Control banding can be used for risk control management in a proactive manner. In that case, recommended
work environments and handling practices may be defined on the basis of hazard banding as well as of
fundamental factors mitigating anticipated exposure potential, e.g. propensity of the material to become
airborne, the type of process and amounts of material being handled.
Such an approach is used to determine the control measures appropriate for the operation being assessed but
not to determine an actual level of risk, as the existing control measures, if any, are not used as an input
variable in the exposure banding process.
5.5.2 Retroactive implementation approach: evaluation of control banding and risk banding
In a retroactive approach, control banding may be used either to evaluate the controls recommended as
outputs of the proactive approach or for risk assessment on its own.
In that case, both hazard and actual exposure must be characterized in order to define a risk level. The major
difference with the proactive use of control banding is that exposure mitigating factors (such as implemented
control measures) are taken into account using an exposure algorithm.
The approach then includes the following elements:
— assignment of the NOAA to a hazard band;
— exposure banding;
— overview of risks based on risk banding as a result of hazard and exposure banding;
— iterative examination of control measures until the risk is reduced to an acceptable level;
— design of an action plan based on the chosen specific control scenario.
Such an approach may be used to determine the actual risk level using the existing control measures as an
input variable. In this respect, the retroactive approach can be considered as a means for periodic re-
evaluation of the proactive approach.
5.6 Review and data recording
In the review and adapt step, a system of periodic and as-needed reviews should be implemented to ensure
that the information, evaluations, decisions and actions of the previous steps are kept up-to-date. Reviews
should be performed when new information has been generated or has emerged. The adequacy of the risk
management process for the material or the application at hand should be re-assessed. It should be questioned
whether the current risk evaluation must be revised in light of the new information and, if so, whether the
current risk management practices must be changed as well.
6 Information gathering
6.1 Characterization
6.1.1 General
The lists of characteristics and endpoints given in 6.1.2 to 6.1.4 should be taken into account when assessing
the human health hazards of NOAA. Addressing this data set should lead to the development of dossiers
describing basic characterization parameters and available mammalian toxicity information. These endpoints
are based upon the list proposed by the OECD testing program for a set of MNMs for human health and
[ ]
environmental safety. [20]. 20 It can be considered as a starting point when assessing the human health
hazards of NOAA. Epidemiological data, when available, should also be taken into account.
6.1.2 Information and identification
The following information should be taken into consideration:
— NOAA name;
— CAS number;
— structural formula and molecular structure;
— composition of NOAA being tested;
— basic morphology;
— description of surface chemistry;
— method of production.
6.1.3 Physicochemical properties and characterization
The following information should be taken into consideration:
— agglomeration and aggregation;
— solubility (e.g. in water or biologically relevant fluids);
— crystalline phase;
— dustiness;
— crystallite size;
— representative TEM picture(s);
— particle size distribution;
— specific surface area;
— surface chemistry (where appropriate);
— catalytic or photocatalytic activity;
— pour density;
— porosity;
— octanol-water partition coefficient, where relevant;
— redox potential;
— radical formation potential;
— other relevant information (where available).
Although some of the above characteristics can be unavailable, and very few of these characteristics will
actually be taken into account in the control banding process, NOAA’s characteristics should be documented
and recorded as accurately as possible (including reference to size and measurement conditions). This is
necessary in the case of possible future medical issues. When utilizing characteristics relating to non-
nanoscale materials, it should be taken into account that these characteristics can differ significantly from
those for the material in the nanoscale.
6.1.4 Toxicological data
The following information should be taken into consideration:
— pharmacokinetics (absorption, distribution, metabolism, elimination);
— acute toxicity;
— repeated dose toxicity;
— chronic toxicity;
— reproductive toxicity;
— developmental toxicity;
— genetic toxicity;
— experience with human exposure;
— epidemiological data;
— other relevant test data.
Although some of the above data can be unavailable, and some of these data are not necessarily taken into
account in the control banding process, NOAA’s toxicological data should be documented and recorded as
accurately as possible.
A list of hazard indications is presented in Annex A.
6.2 Exposure characterization
6.2.1 General exposure characterization elements
The main goal of exposure characterization is to provide a summary and a synthesis of available exposure
information. General exposure characterization includes the following elements:
a) a statement of purpose, scope, level of detail, as well as the approach used in the exposure
characterization;
b) estimates of exposure for each relevant pathway, both for individuals and populations (e.g. groups of
workers);
c) an evaluation of the overall quality of the assessment and the degree of confidence in the exposure
estimates and, in the conclusions, drawn, including sources and the extent of uncertainty (see
ISO/TS 12901-1);
d) in this control banding approach, the critical elements of exposure characterization, which are necessary
to determine the exposure band include:
— the physical form of NOAA;
— the amount of NOAA;
— the determination of dust generation potential during the processes;
— the actual exposure measurement data.
6.2.2 Physical form
The actual stage in the NOAA’s life cycle is an important parameter to consider as it can influence the potential
for worker exposure and thus the selection of risk control parameters.
NOAA can be in different forms, as produced (e.g. as a powder), or as used (e.g. embedded in a solid matrix or
attached to a substrate), suspended in a gas or in a liquid; or as waste. Each of these different stages will have
its own exposure pattern.
Thus, the NOAA’s physical form (i.e. exposure availability) should be characterized throughout the product
lifecycle. This information is critical for the appropriate and safe handling of the material.
6.2.3 Amount
The amounts of nanomaterial processed or manufactured in the workplace is one of the most important
determinants of exposure. The presence of large amounts of NOAA in the workplace increases the potential
for the generation of a higher concentration in the air and, therefore, can lead to higher exposures.
6.2.4 Potential for dust generation
Workplace processes, such as spraying, packaging, maintenance activities and dumping can lead to generation
of airborne particles. As a consequence, the details of the operator’s activities and process operations must be
analysed in order to estimate the potency of the process to release NOAA into the workplace air. This implies
performing an inventory of operators’ tasks, including start and stop operations, process steps, etc.
6.2.5 Quantitative exposure measurements
Actual exposure measurements, when feasible, represent the best information for the selection of the
appropriate exposure band. Therefore, they should be encouraged and when both personal sampling and area
measurements are available, the preference should be given to individual exposure measurements. The
results should be taken into account when determining the corresponding exposure band. ISO/TS 12901-1
provides information on available measurement equipment, possible measurement strategies and results
interpretations.
6.3 Characterization of control measures
6.3.1 General
Exposure control measures implemented in the workplace should be characterized. They can lower exposures
by reducing emission, transmission and immission.
6.3.2 Reduction of emission
The reduction of NOAA emission from the source can be achieved in several ways such as handling NOAA in
suspension into a liquid or dispersed into a paste or a solid matrix rather than in the form of dry powders;
avoiding high energy processes or any activity likely to release free NOAA in the workplaces.
6.3.3 Reduction of transmission
Reduction of transmission from the source towards the worker is possible in several ways. Two generic
control measures are:
— local control, e.g. either containment or local exhaust ventilation, or both;
— general ventilation, e.g. natural or mechanical ventilation.
6.3.4 Reduction of immission
The reduction of immission has three generic control measures:
— personal enclosure and separating the worker from the source, e.g. a ventilated cabin;
— segregation of the source from the worker, i.e. isolation of sources from the work environment in a
separate room without direct containment of the source itself;
— use of personal protective equipment.
6.3.5 Workplace area and personal exposure monitoring data
When feasible, actual exposure measurements provide important information on the effectiveness of controls
and workers protection level.
7 Control banding implementation
7.1 Preliminary remarks
Whatever the approach, control banding implementation should be consistent with the hierarchy of controls
(and the STOP principle): substitution, technical measures, organizational measures and personal protective
equipment (PPE) the last one used as the last resort when previous measures do not provide adequate control.
Control banding should incorporate general industrial hygiene good practices. In the case when control
measures recommended by the nano-specific control banding differ from other industrial hygiene
considerations, then the more stringent control measures should be applied.
As mentioned above, control banding can be used in two different ways, a proactive approach and a
retroactive, evaluation or risk banding approach. Both approaches are described in this document. They
present a first common step which is the hazard banding process.
7.2 Hazard band setting
7.2.1 Hazard categorization of chemicals and general hazard banding process for bulk materials
Hazard bands are defined, for a specific chemical, according to the severity level of the hazard resulting from
the analysis of the available information as evaluated by knowledgeable and experienced professionals. This
information can relate to various criteria for toxicity, described or suspected, in the literature or technical
documentation (labelling, product classification).
NOTE A knowledgeable and experienced professional is an individual who will properly perform a specific job. This
person utilizes a combination of knowledge, skills and behaviour to improve performance.
[ ]
The approach presented in the International Labour Organization Control Banding Toolkit [21] 21 is to group
chemicals into one of five inhalation hazard groups (A to E) according to the increasing severity described in
the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) hazard classification
[ ]
applicable to the chemical (see in Table 1 and ). [22]Annex A). 22 The OEL related to 8 hours of exposure is
[ ][ ][ ][ ][ ]
based on NIOSH, OSHA and OECD definitions [23] [24] [25] [26] [27]. 23 24 25 26 27. The dose ranges given
[ ]
in this table correspond to the criteria set for classification under GHS.[22]. 22 Hazard band allocation can
vary depending on national statutory provisions.
The hazard group allocation table according to the GHS health classes are listed in Table 1.
Table 1 — Hazard group allocation
Category A Category B Category C Category D Category E
No
significant Slight hazard Moderate Serious Severe
risk to Slightly toxic hazard hazard hazard
health
OEL dust mg/m
1 to 10 0,1 to 1 0,01 to 0,1 < 0,01
(8-h time-weighted average)
Acute toxicity Acute toxicity Acute toxicity Acute toxicity
Acute toxicity Low
Category 4 Category 3 Category 2 Category 1
a
LD50 oral route mg/kg > 2 000 300 to 2 000 50 to 300 5 to 50 < 5
a
LD50 dermal route mg/kg > 2 000 1 000 to 2 000 200 to 1 000 50 to 200 < 50
b
LC50 inhalation 4H (mg/l)
> 20 000 2 500 to 500 to 2 500 100 to 500 < 100
Gases
20 000
> 20 2 to 10 0,5 to 2 < 0,5
Vapours
10 to 20
> 5 0,5 to 1 0,05 to 0,5 < 0,05
Aerosols/particles
1 to 5
c
STOT SE 3;
Severity of acute
c c
STOT SE 2 STOT SE 1- -
(life-threatening) effects
-
...
PROJET FINAL
Spécification
technique
ISO/TC 229
Nanotechnologies — Gestion du
Secrétariat: BSI
risque professionnel appliquée aux
Début de vote:
nanomatériaux manufacturés —
2025-10-31
Partie 2:
Vote clos le:
2025-12-26
Utilisation de l’approche par
gestion graduée des risques
Nanotechnologies — Occupational risk management applied to
engineered nanomaterials —
Part 2: Use of the control banding approach
LES DESTINATAIRES DU PRÉSENT PROJET SONT
INVITÉS À PRÉSENTER, AVEC LEURS OBSERVATIONS,
NOTIFICATION DES DROITS DE PROPRIÉTÉ DONT ILS
AURAIENT ÉVENTUELLEMENT CONNAISSANCE ET À
FOURNIR UNE DOCUMENTATION EXPLICATIVE.
OUTRE LE FAIT D’ÊTRE EXAMINÉS POUR
ÉTABLIR S’ILS SONT ACCEPTABLES À DES FINS
INDUSTRIELLES, TECHNOLOGIQUES ET COM-MERCIALES,
AINSI QUE DU POINT DE VUE DES UTILISATEURS, LES
PROJETS DE NORMES
INTERNATIONALES DOIVENT PARFOIS ÊTRE CONSIDÉRÉS
DU POINT DE VUE DE LEUR POSSI BILITÉ DE DEVENIR DES
NORMES POUVANT
SERVIR DE RÉFÉRENCE DANS LA RÉGLEMENTATION
NATIONALE.
Numéro de référence
Spécification
technique
ISO/TS 12901-2
Deuxième édition
Nanotechnologies — Gestion du
risque professionnel appliquée aux
nanomatériaux manufacturés —
Partie 2:
Utilisation de l’approche par
gestion graduée des risques
Nanotechnologies — Occupational risk management applied to
engineered nanomaterials —
Part 2: Use of the control banding approach
DOCUMENT PROTÉGÉ PAR COPYRIGHT
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ii
Sommaire Page
Avant-propos .v
Introduction .vi
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Symboles et abréviations . 2
5 Cadre conceptuel de gestion graduée des risques . 2
5.1 Généralités .2
5.2 Collecte d’informations et enregistrement des données .3
5.3 Gestion graduée des dangers .4
5.4 Gestion graduée des expositions .4
5.5 Gestion graduée des risques .4
5.5.1 Mise en œuvre proactive de la gestion graduée des risques .4
5.5.2 Approche par mise en œuvre rétroactive: évaluation de la gestion graduée des
risques .4
5.6 Revue et enregistrement des données .5
6 Collecte d’informations. 5
6.1 Caractérisation .5
6.1.1 Généralités .5
6.1.2 Informations et identification .5
6.1.3 Propriétés physicochimiques et caractérisation .5
6.1.4 Données toxicologiques . .6
6.2 Caractérisation des expositions .7
6.2.1 Éléments de caractérisation générale des expositions .7
6.2.2 Forme physique .7
6.2.3 Quantité .7
6.2.4 Potentiel de production de poussières .7
6.2.5 Mesurages quantitatifs des expositions .8
6.3 Caractérisation des moyens de maîtrise .8
6.3.1 Généralités .8
6.3.2 Réduction de l’émission .8
6.3.3 Réduction de la transmission.8
6.3.4 Réduction de l’immission . .8
6.3.5 Données de surveillance de lieu de travail et d’exposition individuelle .8
7 Mise en œuvre de la gestion graduée des risques . 8
7.1 Remarques préliminaires .8
7.2 Attribution de bandes de danger.9
7.2.1 Catégorisation des dangers liés aux produits chimiques et processus général de
gestion graduée des dangers pour les matériaux en masse .9
7.2.2 Attribution à une bande de danger .11
7.3 Attribution de bandes d’exposition . 15
7.3.1 Remarques préliminaires . 15
7.3.2 Synthèse, production et fabrication .16
7.3.3 Matériau dispersé dans une matrice solide .17
7.3.4 Matériaux en suspension dans un liquide . .18
7.3.5 Matériau sous forme de poudre .19
7.3.6 Possibilité de modification du processus pour réduire les niveaux d’exposition .19
7.4 Définition des bandes de risque et stratégie de maîtrise des risques .19
7.5 Évaluation des moyens de maîtrise . 20
7.6 Approche rétroactive — Gestion graduée des risques .21
8 Performance, revue et amélioration continue .23
8.1 Généralités . 23
iii
8.2 Objectifs et performances .24
8.3 Enregistrement des données .24
8.4 Revue de direction .24
Annexe A (informative) Classe de danger pour la santé conformément au SGH .25
Annexe B (informative) Évaluation des risques liés aux nanomatériaux (NaRA) .26
Annexe C (informative) Bande de danger professionnel modifiée (OHB) .29
Bibliographie .32
iv
Avant-propos
L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes nationaux
de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est en général
confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude a le droit de faire
partie du comité technique créé à cet effet. Les organisations internationales, gouvernementales et non
gouvernementales, en liaison avec l’ISO participent également aux travaux. L’ISO collabore étroitement avec
la Commission électrotechnique internationale (IEC) en ce qui concerne la normalisation électrotechnique.
Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont
décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier, de prendre note des différents
critères d’approbation requis pour les différents types de documents ISO. Le présent document
a été rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2
(voir www.iso.org/directives).
L’ISO attire l’attention sur le fait que la mise en application du présent document peut entraîner l’utilisation
d’un ou de plusieurs brevets. L’ISO ne prend pas position quant à la preuve, à la validité et à l’applicabilité de
tout droit de brevet revendiqué à cet égard. À la date de publication du présent document, l’ISO n’avait pas
reçu notification qu’un ou plusieurs brevets pouvaient être nécessaires à sa mise en application. Toutefois,
il y a lieu d’avertir les responsables de la mise en application du présent document que des informations
plus récentes sont susceptibles de figurer dans la base de données de brevets, disponible à l’adresse
www.iso.org/brevets. L’ISO ne saurait être tenue pour responsable de ne pas avoir identifié de tels droits de
propriété et averti de leur existence.
Les appellations commerciales éventuellement mentionnées dans le présent document sont données pour
information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un engagement.
Pour une explication de la nature volontaire des normes, la signification des termes et expressions
spécifiques de l’ISO liés à l’évaluation de la conformité, ou pour toute information au sujet de l’adhésion de
l’ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles techniques au
commerce (OTC), voir www.iso.org/avant-propos.
Le présent document a été élaboré par le comité technique ISO/TC 229, Nanotechnologies.
Cette deuxième édition annule et remplace la première édition (ISO/TS 12901-2:2014), qui a fait l’objet d’une
révision technique.
Les principales modifications sont les suivantes:
— révision des exemples dans les annexes, y compris les outils de gestion graduée des risques NaRA,
le GoodNanoGuide et les bandes de danger professionnel (OHB, Occupational Hazard Band,), ainsi que
remplacement de l’Annexe B;
— révision des liens vers les sites Web;
— ajout de sources pour tous les inventaires de caractérisation des dangers liés aux NOAA.
Une liste de toutes les parties de la série ISO/TS 12901 se trouve sur le site web de l’ISO.
Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent
document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes se
trouve à l’adresse www.iso.org/fr/members.html.
v
Introduction
Les nano-objets, et leurs agrégats et agglomérats de plus de 100 nm (NOAA) peuvent présenter des propriétés,
y compris des propriétés toxicologiques, différentes de celles de matériaux (en masse) à une échelle plus
grande que l’échelle nanométrique. Par conséquent, les valeurs limites d’exposition professionnelle (VLEP),
établies dans la plupart des cas pour des matériaux en masse, peuvent s’avérer inappropriées pour les NOAA.
L’approche de gestion graduée des risques peut être utilisée en tant que première approche pour contrôler
l’exposition aux NOAA sur les lieux de travail.
NOTE Des spécifications réglementaires peuvent s’appliquer aux NOAA.
L’approche par gestion graduée des risques est une approche pragmatique qui peut être utilisée pour le
contrôle de l’exposition sur les lieux de travail à des agents potentiellement dangereux ayant des propriétés
toxicologiques incertaines et pour lesquels il n’existe pas d’estimations quantitatives d’exposition.
L’objectif final de la gestion graduée des risques est de maîtriser l’exposition afin de prévenir d’éventuels
effets nocifs pour la santé du personnel. Cette approche peut être utilisée en complément des méthodes
quantitatives classiques basées sur le prélèvement et l’analyse de l’air en se référant aux valeurs limites
d’exposition professionnelle (VLEP) lorsqu’elles existent. Elle peut fournir une méthode alternative
d’évaluation du risque et de gestion du risque, par regroupement des milieux professionnels en catégories
présentant des similarités en termes d’exposition et/ou de dangers, et par intégration d’un jugement
professionnel et de moyens de surveillance. Ce processus applique une gamme de techniques de contrôle
(par exemple, ventilation ou confinement) à une substance chimique spécifique, en tenant compte de ses
dangers intrinsèques (ou bande de danger) et du niveau d’exposition (ou bande d’exposition).
En général, la gestion graduée des risques est fondée sur l’idée selon laquelle le nombre d’approches
communes pour la maîtrise des risques est limité, bien que le personnel puisse être exposé à une grande
variété de produits chimiques impliquant un large éventail de risques. Ces approches sont regroupées
en niveaux basés sur le degré de protection procuré par l’approche (les moyens de maîtrise «rigoureux»
étant ceux qui assurent une protection maximale). Plus le dommage potentiel est élevé et plus les niveaux de
protection nécessaire pour le contrôle de l’exposition sont élevés.
La gestion graduée des risques avait été initialement développée par l’industrie pharmaceutique comme une
méthode de travail en toute sécurité avec de nouveaux produits chimiques pour lesquels peu d’informations
sur la toxicité étaient disponibles. Ces nouveaux produits chimiques ont été classés en «bandes» sur
la base de la toxicité de produits chimiques analogues et mieux connus, puis associés à des pratiques de
travail sûres, tenant compte d’une évaluation des expositions. Chaque bande a été ensuite associée à un
[1]
programme de contrôle . Suivant ce concept, l’organisme britannique HSE (Health and Safety Executive)
[2]
a élaboré un programme convivial appelé «COSHH Essentials » , s’adressant principalement aux petites
et moyennes entreprises susceptibles de ne pas bénéficier de l’expertise d’un hygiéniste du travail en poste
dans l’entreprise. Le ministère malaisien de la Sécurité et de la santé au travail a publié l’évaluation des
risques liés aux nanomatériaux (Nanomaterial Risk Assessment, NaRA) en se fondant sur la Référence [3].
Des programmes similaires sont utilisés dans le guide pratique fourni par l’Institut fédéral allemand chargé
[4] 1) [5]
de la santé et de la sécurité au travail. L’outil Stoffenmanager® représente un autre développement ,
combinant une approche par gestion graduée des dangers semblable à celle de «COSHH Essentials» et une
approche de gestion graduée des expositions fondée sur un modèle de processus d’exposition, qui a été
adapté de manière à permettre à des utilisateurs non spécialisés de comprendre et d’utiliser le modèle.
La gestion graduée des risques s’applique aux problèmes relatifs à la santé du travail dans le développement,
la fabrication et l’utilisation de NOAA dans des conditions normales ou raisonnablement prévisibles,
y compris les opérations d’entretien et de nettoyage, à l’exclusion des situations accidentelles ou incidentelles.
La gestion graduée des risques n’est pas destinée à s’appliquer aux domaines du management de la sécurité,
de l’environnement ou des transports; elle est considérée seulement comme une partie d’un processus de
management du risque compréhensible. ®
1) L’outil Stoffenmanager est un exemple de produit adapté disponible dans le commerce. Cette information est donnée
à l’intention des utilisateurs du présent document et ne signifie nullement que l’ISO approuve l’emploi du produit ainsi
désigné. Des produits équivalents peuvent être utilisés s’il est démontré qu’ils aboutissent aux mêmes résultats.
vi
L’approche par gestion graduée des risques peut être particulièrement utile pour l’évaluation et la gestion des
risques des nanomatériaux, compte tenu de l’incertitude liée aux risques professionnels potentiels présentés
par les NOAA. L’approche par gestion graduée des risques peut être utilisée pour la gestion des risques selon
une approche proactive et selon une approche rétroactive. Dans l’approche proactive, les moyens de maîtrise,
si existants, ne sont pas utilisés comme des variables d’entrée dans la gestion graduée des expositions
potentielles, alors que dans l’approche rétroactive, ils le sont. Les deux approches sont décrites dans le
présent document. Bien que la gestion graduée des risques semble, en théorie, appropriée pour le contrôle
de l’exposition aux matériaux à l’échelle nanométrique, un très faible nombre d’outils sont actuellement
disponibles pour les opérations en cours dans le domaine des nanotechnologies. Un modèle conceptuel
de gestion graduée des risques a été présenté à la Référence [6]; ce modèle proposant les quatre mêmes
approches de contrôle que le contrôle des substances dangereuses pour la santé (COSSH). Une approche
légèrement différente, appelée «Control Banding Nanotool» (nano-outil de gestion graduée des risques), a
été présentée à la Référence [7].Cette approche tient compte des connaissances existantes concernant la
toxicologie des NOAA et utilise le cadre de la gestion graduée des risques proposé dans des publications
antérieures. Toutefois, les gammes de valeurs utilisées dans le «Control Banding Nanotool» (nano-outil de
gestion graduée des risques) correspondent aux gammes attendues dans les opérations du type recherche
à petite échelle (moins d’un gramme) et ne sont probablement pas appropriées pour des utilisations à plus
grande échelle. Entre-temps, des publications ont fait état de plusieurs autres outils de gestion graduée des
risques spécifiques destinés à contrôler l’exposition par inhalation aux nanomatériaux manufacturés pour
[8] [9] [10] [11] [12]
des utilisations à plus grande échelle , , , , Tous ces outils définissent des bandes de danger et des
bandes d’expositions pour l’exposition par inhalation et les combinent en une matrice bidimensionnelle,
permettant d’obtenir une notation (score) pour la maîtrise des risques (approche proactive).
En 2009, le National Institute for Occupational Safety and Health (Institut national pour la sécurité et la
santé au travail des États-Unis) a publié une étude et une analyse des outils existants pour la gestion graduée
[13]
des risques, sans toutefois formuler de recommandations quant à leur mise en œuvre aux États-Unis .
Un processus de gestion graduée des expositions professionnelles a ensuite été décrit comme un point de
[14]
départ pour éclairer les décisions en matière de gestion des risques lorsqu’aucune VLEP n’est disponible .
Ce processus emploie les données fondées sur les dangers pour déterminer le danger potentiel global et
la fourchette de concentration dans l’air associée pour les substances chimiques. Il décrit également les
catégories spécifiques d’aérosol, en incluant les particules à l’échelle nanométrique. Une approche de gestion
graduée des expositions professionnelles permet d’éclairer les décisions en matière de gestion et de maîtrise
des risques. Bien qu’il ne s’agisse pas d’une approche de gestion graduée des risques en soi, l’utilisation de la
gestion graduée des expositions professionnelles en tant que bandes d’exposition est en cohérence avec les
applications conventionnelles de gestion graduée des risques.
La Référence [15] met en évidence l’élaboration d’un modèle conceptuel pour l’évaluation de l’exposition par
inhalation aux nanomatériaux manufacturés, suggérant un cadre général pour des modèles d’expositions
ultérieurs. Ce cadre conceptuel suit la même structure que le modèle conceptuel pour l’évaluation de
l’exposition par inhalation employé dans l’outil Stoffenmanager® et dans l’Advanced REACH Tool (ART).
En se fondant sur ce cadre conceptuel, un outil de gestion graduée des risques dénommé Stoffenmanager
Nano® englobant l’approche proactive et l’approche rétroactive (gestion graduée) a été développé.
La Référence [16] a suggéré une nouvelle approche relative à la manipulation des poudres et des
nanomatériaux. Cette méthode est très pratique et a été grandement utilisée par plusieurs fabricants de
cosmétiques. Cependant, les données de l’industrie se limitent aux ingrédients cosmétiques.
L’approche toxicologique proposée par l’industrie cosmétique en France prend en considération la toxicité
aiguë à un niveau supérieur à celui retenu pour les CMR-S. Le modèle d’exposition est applicable aux
poudres reposant sur des descripteurs classiques qui ont été traduits en données observables, ce qui rend la
méthodologie facile à utiliser pour les opérateurs sur le terrain (voir l’Annexe C).
En outre, l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (ANSES)
a développé, en France, un outil de gestion graduée des risques spécifiques aux nanomatériaux, qui est décrit
à la Référence [17].
[18]
En outre, la Commission européenne a publié des recommandations non contraignantes qui comprennent
une approche de gestion graduée des risques. L’objectif est d’aider les employeurs, les professionnels de
la santé et de la sécurité et les travailleurs à remplir leurs obligations réglementaires, chaque fois qu’une
exposition à des nanomatériaux manufacturés ou que l’utilisation de nanotechnologies dans le cadre
vii
professionnel est susceptible de se produire, dans le but ultime d’assurer une protection adéquate de la
santé et de la sécurité des travailleurs. Les recommandations fournissent une vue d’ensemble des questions
relatives à l’utilisation sécurisée des nanomatériaux manufacturés, présentent les grandes lignes des actions
préventives et fournissent un outil pratique afin de se conformer à des aspects spécifiques de la sécurité des
travailleurs, tels que l’appréciation du risque et la gestion des risques. Cela peut s’avérer utile en l’absence
[18]
d’une compréhension technique approfondie des questions en jeu .
En 2021, l’Organisation de coopération et de développement économiques (OCDE) a entrepris un examen
systématique des outils de gestion graduée des risques les plus représentatifs disponibles pour les
nanomatériaux. L’inventaire qui en a résulté a fourni des informations sur les outils réglementaires et non
réglementaires permettant d’évaluer l’exposition professionnelle aux nanomatériaux manufacturés (NOAA)
et comprenait une évaluation de l’applicabilité pour l’exposition professionnelle aux NOAA. Le projet a été
divisé en deux domaines d’application: professionnel et consommateurs.
— La Partie I comprenait une compilation d’outils et de modèles pour l’exposition professionnelle et des
consommateurs aux nanomatériaux, ainsi qu’une évaluation approfondie de leur applicabilité.
— La Partie II était axée sur les résultats d’essais de performance des outils et modèles pour l’exposition
professionnelle.
— La Partie III présentait les résultats d’essais de performance des outils et modèles pour l’exposition des
consommateurs.
[19]
Enfin, 32 modèles et outils ont été évalués .
Le plus grand défi à relever lors de l’élaboration de toute approche par gestion graduée des risques
concernant les NOAA réside dans le choix des paramètres devant être pris en compte et des critères devant
être considérés comme pertinents pour affecter un nano-objet à une bande de risque, ainsi que des stratégies
de contrôle opérationnel qui doivent être mises en œuvre à différents niveaux opérationnels.
Le présent document s’intéresse tout particulièrement aux NOAA produits volontairement et composés
de nano-objets tels que des nanoparticules, des nanopoudres, des nanofibres, des nanotubes, des nanofils,
ainsi que d’agrégats et d’agglomérats de ceux-ci. Tel qu’utilisé dans le présent document, le terme «NOAA»
s’applique à de tels composants, qu’ils existent sous leur forme d’origine ou qu’ils soient incorporés
dans des matériaux ou préparations à partir desquels ils pourraient être libérés au cours de leur cycle
de vie. Cependant, comme c’est le cas pour de nombreux autres processus industriels, les processus
nanotechnologiques peuvent engendrer des sous-produits se présentant sous la forme de NOAA produits
involontairement et pouvant être liés à des questions de santé et de sécurité qui doivent être également
abordées.
Le présent document propose des recommandations relatives au contrôle et à la gestion des risques
professionnels en s’appuyant sur une approche par gestion graduée des risques spécifiquement conçue pour
les NOAA. Il incombe aux fabricants et aux importateurs de déterminer si un matériau d’intérêt contient ou
non des NOAA et de fournir des informations dans les fiches de données de sécurité (FDS) et les étiquettes.
Les employeurs peuvent utiliser ces informations pour identifier les dangers et mettre en œuvre les moyens
de maîtrise appropriés. Le présent document n’est pas destiné à donner des recommandations concernant ce
processus décisionnel.
L’accent est mis sur le fait que la méthode de gestion graduée des risques appliquée aux NOAA manufacturés
exige que des hypothèses soient formulées concernant les informations souhaitées, mais non disponibles.
De ce fait, l’utilisateur de l’outil de gestion graduée des risques doit disposer de compétences prouvées dans
la prévention des risques chimiques et plus particulièrement dans la prévention des risques connus comme
étant liés à ce type de matériau. Le succès de la mise en œuvre de cette approche implique une expertise
confirmée associée à une capacité d’évaluation critique des expositions professionnelles potentielles et à une
formation sur l’utilisation des outils de gestion graduée des risques afin d’assurer des moyens de maîtrise
appropriés et une approche prudente adéquate.
L’approche employant CB Tools pour les NOAA inclut la méthodologie du secteur dans lequel elle est destinée
à être utilisée. Les NOAA sont employés dans les industries où le processus est fréquemment utilisé et où
la caractérisation est limitée, mais où la caractérisation des événements indésirables secondaires liés à
l’utilisation des NOAA est bien décrite et peut être considérée comme une approche simplifiée des CB Tools
viii
pour l’industrie, même si le danger n’est pas complètement identifié et donc mal connu. Si les NOAA ne
sont pas utilisés fréquemment, mais qu’il existe une possibilité de les caractériser aussi bien sur le plan
physicochimique que biologique, il est alors nécessaire d’utiliser un CB Tool plus complexe et théorique.
Parallèlement à l’approche décrite dans le présent document, une évaluation exhaustive des risques
prend en compte tous les dangers liés aux substances, y compris le risque d’explosion et les dangers pour
l’environnement.
NOTE Des nuages de poussières explosives peuvent être produits par la plupart des matériaux organiques, par de
nombreux métaux et même par certains matériaux inorganiques non métalliques. La taille des particules ou la surface
spécifique (c’est-à-dire la surface totale par unité de volume ou par unité de masse de la poussière) et la composition
de la poussière constituent les principaux facteurs ayant une influence sur la sensibilité à l’inflammation et sur la
violence d’explosion d’un nuage de poussière. La surface spécifique augmente lorsque la taille des particules diminue.
La tendance générale est que la violence d’explosion de poussière et la facilité d’inflammation augmentent lorsque
la taille des particules diminue, bien que, pour bon nombre de poussières, cette tendance commence à se stabiliser
pour des tailles de particules de l’ordre de quelques dizaines de microns (µm). Toutefois, aucune limite inférieure de
taille de particules n’a été établie en dessous de laquelle les explosions de poussières ne peuvent pas avoir lieu et de
nombreux types de nanoparticules sont capables de provoquer des explosions.
ix
PROJET FINAL Spécification technique ISO/DTS 12901-2.2:2025(fr)
Nanotechnologies — Gestion du risque professionnel
appliquée aux nanomatériaux manufacturés —
Partie 2:
Utilisation de l’approche par gestion graduée des risques
1 Domaine d’application
L’objectif du présent document est d’établir et de fournir des recommandations relatives à l’utilisation
d’une approche par gestion graduée des risques pour maîtriser les risques associés aux expositions
professionnelles aux nano-objets, et leurs agrégats et agglomérats de plus de 100 nm (NOAA) ayant des
propriétés toxicologiques incertaines et pour lesquels il n’existe pas d’estimations quantitatives d’exposition.
Le présent document s’applique au contrôle des expositions par inhalation, pour lesquelles l’outil de gestion
graduée des risques a été spécifiquement conçu.
NOTE Quelques recommandations concernant la protection de la peau et des yeux sont données dans
l’ISO/TS 12901-1.
Le présent document ne s’applique pas aux matériaux d’origine biologique.
Le présent document est destiné à aider les entreprises et autres acteurs, y compris les organismes de
recherche impliqués dans la fabrication, le traitement ou la manipulation de NOAA, en leur proposant une
approche pragmatique et facile à comprendre pour le contrôle des expositions professionnelles.
2 Références normatives
Les documents suivants sont cités dans le texte de sorte qu’ils constituent, pour tout ou partie de leur
contenu, des exigences du présent document. Pour les références datées, seule l’édition citée s’applique. Pour
les références non datées, la dernière édition du document de référence s’applique (y compris les éventuels
amendements).
ISO 80004-1, Nanotechnologies — Vocabulaire — Partie 1: Vocabulaire "cœur"
3 Termes et définitions
Pour les besoins du présent document, les termes et les définitions de l’ISO 80004-1 s’appliquent.
L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en normalisation,
consultables aux adresses suivantes:
— ISO Online browsing platform: disponible à l’adresse https:// www .iso .org/ obp
— IEC Electropedia: disponible à l’adresse https:// www .electropedia .org/
4 Symboles et abréviations
CMR-S propriétés carcinogènes, mutagènes, reprotoxiques ou sensibilisantes (Carcinogenicity, Mutage-
nicity, Reproductive toxicity or Sensitization)
COSHH contrôle des substances dangereuses pour la santé (Control Of Substances Hazardous to Health)
DLS diffusion dynamique de la lumière (Dynamic Light Scattering)
EB gestion graduée des expositions (Exposure Banding)
SGH Système Général Harmonisé de classification et d’étiquetage des produits chimiques
FDS Fiche de Données de Sécurité
MNM nanomatériaux manufacturés (Manufactured NanoMaterials)
NOAA Nano-Objets et leurs Agrégats et Agglomérats supérieurs à 100 nm
VLEP Limite d’Exposition Professionnelle
EPI Équipement de Protection Individuelle
MEB Microscopie Électronique à Balayage
STOP Substitution, mesures Techniques, mesures Organisationnelles, équipements de Protection
individuelle
MET Microscopie Électronique à Transmission
5 Cadre conceptuel de gestion graduée des risques
5.1 Généralités
L’outil de gestion graduée des risques décrit dans le présent document s’applique aux NOAA et aux matériaux
contenant des NOAA. Cet outil de gestion graduée des risques ne peut être considéré que comme une partie
distincte, bien qu’il fasse partie intégrante d’un système global pour la gestion des risques pour la santé et
la sécurité. Cet outil nécessite des données d’entrée, indépendamment de la phase du cycle de vie des NOAA,
telles que des informations recueillies sur le lieu de travail grâce à l’observation du travail réel effectuée par
un hygiéniste du travail disposant d’une expertise confirmée et formé pour l’utilisation des outils de gestion
graduée des risques ainsi que pour l’identification des dangers et des meilleures données toxicologiques
disponibles.
Cette approche est fondée sur le processus d’identification des risques qui repose sur:
— les connaissances actuelles des NOAA spécifiques (données toxicologiques ou d’effets sur la santé;
propriétés physiques et chimiques);
— l’évaluation de l’exposition potentielle des travailleurs.
Les informations relatives aux dangers et celles relatives à l’exposition sont combinées pour déterminer un
niveau de risques approprié (par exemple, ventilation générale, système d’évacuation locale, ou confinement).
Cette approche est basée sur l’avis selon lequel le développement de techniques de contrôle d’ingénierie pour
l’exposition aux nanoparticules peut s’appuyer sur les connaissances et l’expérience acquises concernant
la maîtrise de l’exposition aux aérosols. Ces connaissances et cette maîtrise ont déjà été appliquées à des
aérosols contenant des particules ultrafines (par exemple, fumées de soudage, noir de carbone ou virus).
Des techniques efficaces peuvent être obtenues en adaptant et en révisant la conception de la technologie
actuelle. Cela s’applique aux techniques relatives à la ventilation générale, à la ventilation locale, aux
confinements, aux enceintes et à la filtration.
L’approche par gestion graduée des risques permet de passer de l’évaluation de l’exposition au contrôle
de l’exposition et réciproquement. Ainsi, elle peut être réalisée soit de manière proactive, soit de manière
rétroactive. La méthode proactive est basée sur les expositions anticipées et utilise des facteurs de base
atténuant le potentiel d’exposition. La méthode rétroactive (ou approche de gestion graduée des risques)
repose sur une évaluation des risques qui prend davantage en compte les facteurs d’atténuation de
l’exposition, y compris les moyens de maîtrise effectivement mis en œuvre ou à mettre en œuvre. Dans les
deux cas, la gestion graduée des dangers est une étape commune. La structure générale du processus est
présentée à la Figure 1 et comprend les éléments suivants:
— collecte d’informations;
— affectation des NOAA à une bande de danger: gestion graduée des dangers;
— description des caractéristiques d’exposition potentielle: gestion graduée des expositions;
— définition des environnements de travail recommandés et des pratiques de manipulation: gestion
graduée des risques;
— évaluation de la stratégie de contrôle ou de la gestion graduée des risques.
Figure 1 — Processus de gestion graduée des risques
5.2 Collecte d’informations et enregistrement des données
La méthodologie présentée dans le présent document s’appuie sur les informations disponibles; elle ne
présume pas implicitement la présence de risque ou de danger dans un matériau. Lorsque les informations
disponibles pour guider les décisions concernant la présence potentielle d’une exposition ou d’un danger
particulier sont rares ou inexistantes, il convient d’utiliser des «hypothèses raisonnables des cas les plus
défavorables» en même temps que des pratiques de gestion appropriées pour ces options. La méthodologie
est également destinée à inciter à remplacer des hypothèses par des informations réelles et à affiner les
pratiques de gestion en conséquence.
Les données d’entrée doivent être obtenues avant la mise en œuvre de la gestion graduée des risques. Surtout
en ce qui concerne les NOAA pour lesquels il n’est pas possible d’établir des valeurs limites basées sur la
santé, il est important de documenter les substances utilisées, les moyens de maîtrise adoptés, les conditions
de travail et éventuellement les mesurages de l’exposition, sachant que ces facteurs ne sont pas toujours
faciles à déterminer avec une certitude totale et qu’ils dépendent du degré auquel le danger est connu et de
l’exactitude des méthodes utilisées pour l’évaluation de l’exposition.
Il convient que toutes les données d’entrée soient documentées et que leur traçabilité soit assurée au moyen
d’un système approprié de gestion de la documentation.
5.3 Gestion graduée des dangers
La gestion graduée des dangers consiste à affecter une bande de danger à un NOAA sur la base d’une
évaluation exhaustive de toutes les données disponibles concernant ce matériau, en tenant compte de
paramètres tels que la toxicité, la biopersistance in vivo et de paramètres influençant l’aptitude des
particules à atteindre l’appareil respiratoire, leur aptitude à se déposer dans diverses régions de l’appareil
respiratoire, ainsi que leur aptitude à induire des réponses biologiques. Ces facteurs peuvent être liés à des
propriétés physiques et chimiques telles que la surface spécifique, la chimie de surface, la forme, la taille des
particules, etc.
5.4 Gestion graduée des expositions
La gestion graduée des expositions consiste à affecter, à une bande d’exposition, un scénario d’exposition
(un ensemble de conditions dans lesquelles une exposition peut avoir lieu) sur un lieu de travail ou un
poste de travail, en s’appuyant sur une évaluation exhaustive de toutes les données disponibles du scénario
d’exposition considéré, par exemple forme physique des NOAA, quantité de NOAA, potentiel de production
de poussière des processus et données réelles de mesurage de l’exposition.
5.5 Gestion graduée des risques
5.5.1 Mise en œuvre proactive de la gestion graduée des risques
La gestion graduée des risques peut être utilisée pour maîtriser les risques de manière proactive. Dans ce
cas, les environnements de travail et les pratiques de manipulation peuvent être déterminés en s’appuyant
sur une gestion graduée des dangers ainsi que sur des facteurs fondamentaux d’atténuation du potentiel
d’exposition estimé, par exemple, la propension du matériau à se trouver en suspension dans l’air, le type de
processus et les quantités de matériaux manipulés.
Cette approche permet de déterminer les moyens de maîtrise appropriés pour l’opération faisant l’objet de
l’évaluation; elle n’est pas employée pour déterminer un niveau réel de risque, car les moyens de maîtrise
existants, si disponibles, ne sont pas utilisés comme une variable d’entrée dans le processus de gestion
graduée des expositions.
5.5.2 Approch
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