Guidance on the protection of thehealth and safety of workers from thepotential risks related tonanomaterials at work

Guidance for employers andhealth and safety practitioners

Employment, Social Affairs & Inclusion
Guidance on the protection of the health and safety of workers fromthe potential risks related to nanomaterials at work
Guidance for employers and health and safety practitioners

This programme is implemented by the European Commission. It was established tofinancially support the implementation of the objectives of the European Union in theemployment, social affairs and equal opportunities area, and thereby contribute to theachievement of the Europe 2020 Strategy goals in these fields.
The seven-year Programme targets all stakeholders who can help shape thedevelopment of appropriate and effective employment and social legislation andpolicies, across the EU-27, EFTA-EEA and EU candidate and pre-candidate countries.
For more information see: http://ec.europa.eu/progress
PROGRESS mission is to strengthen the EU contribution in support of Member States'
commitment. PROGRESS will be instrumental in:• providing analysis and policy advice on PROGRESS policy areas;• monitoring and reporting on the implementation of EU legislation and policies in
PROGRESS policy areas;• promoting policy transfer, learning and support among Member States on EU
objectives and priorities; and• relaying the views of the stakeholders and society at large.

The development of this document has been led by Risk & Policy Analysts Ltd, UK withassistance from IVAM Research and Consultancy on Sustainability, UvA Amsterdam,
NL and Denehurst Chemical Safety Ltd., UK and Cranfield University, UK.

Document completed in June 2013.
Reproduction is authorised provided the source is acknowledged.
Acknowledgments
This Guidance draws on a number of existing information sources and the advice ofEuropean organisations and experts which was provided continuously during its
development. This assistance is gratefully acknowledged.

November 20142

Employment, Social Affairs & Inclusion
Guidance on the protection of the health and safety of workers fromthe potential risks related to nanomaterials at work
Guidance for employers and health and safety practitioners

Table of Contents
1

Introduction .................................................................................................... 6
1.1
About this Guide ........................................... Error! Bookmark not defined.
2
Structure of this Guidance and reference to Directive 98/24/EC .......................... 10
3
Terminology and Definitions ............................................................................ 11
3.1
What are nanomaterials ........................................................................... 11
4
Risk Assessment and Management Process ....................................................... 15
4.1
Step 1 – Identification of the manufactured nanomaterials (MNMs) ............... 16
4.2
Step 2 – Hazard assessment ..................................................................... 17
4.2.1
General risk considerations ................................................................. 17
4.2.2
Categorising level of concern – shape and solubility ............................... 21
4.2.3
Categorising level of concern – dustiness and flammability ..................... 23
4.3
Step 3 – Exposure Assessment ................................................................. 24
4.4
Step 4 – Categorisation of Risk (Control Banding) ....................................... 28
4.5
Step 5 – Detailed Risk Assessment ............................................................ 29
4.6
Step 6 – Risk Management ....................................................................... 32
4.6.1
General principles, hierarchy of controls and Risk Management Measures . 32
4.6.2
Risk Level 1 ...................................................................................... 37
4.6.3
Risk Level 2 ...................................................................................... 37
4.6.4
Risk Level 3 ...................................................................................... 38
4.6.5
Risk Level 4 ...................................................................................... 38
4.6.6
Information, Instruction and Training................................................... 39
4.6.7
Medical Surveillance .......................................................................... 40
4.7
Step 7 – Review ...................................................................................... 41
5
References ......................................................... Error! Bookmark not defined.
Annex I - Concerns Over Hazards and Risks of Nanomaterials ................................... 45
Annex II - Further guidance on the industrial use of nanomaterials ............................ 49
Annex III - Examples of applications of MNMs ......................................................... 56
Annex IV - Legislation Applicable to Nanomaterials .................................................. 58
Annex V - Challenges in monitoring exposure to nanomaterials ................................. 62

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Guidance on the protection of the health and safety of workers fromthe potential risks related to nanomaterials at work
Guidance for employers and health and safety practitioners

List of Abbreviationsµm

Micrometre

BAuA

Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (Germany) Federal
Institute for Occupational Safety and Health

CAD

Chemical Agents Directive 98/24/EC

CLP

Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of
Substances and Mixtures

CMD

Carcinogens and Mutagens Directive 2004/37/EC

CMR

Carcinogen, mutagen and/or reprotoxic substance

CNT

Carbon nanotubes

CSA

Chemical Safety Assessment

CSR

Chemical Safety Report (detailing a Chemical Safety Assessment), as set
out by Article 14 of REACH

DNEL

Derived No Effect Level

EC

European Commission

EU

European Union of twenty-eight Member States

GBP

Granular bio-durable particles without known significant specific toxicity

HARN

High Aspect Ratio Nanoparticles

HEPA

High-efficiency particulate air

HSE

Health and Safety Executive

IARC

International Agency for Research on Cancer

ISOInternational Organisation for Standardisation

LEV

Local Exhaust Ventilation

MNM

Manufactured Nanomaterial; i.e. a nanomaterial which has been
deliberately manufactured rather than a nanomaterial which is naturally
occurring or arises as an unintended consequence of human activities

MS

Member States

MWCNT

Multi wall carbon nanotube

NIOSH

National Institute for Occupational Safety and Healthnm

Nanometre

NM

Nanomaterial,withreferencetoCommission
Recommendation
2011/696/EU on the Definition of Nanomaterial, unless otherwise stated

OEL

Occupational Exposure Limit value
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Employment, Social Affairs & Inclusion
Guidance on the protection of the health and safety of workers fromthe potential risks related to nanomaterials at work
Guidance for employers and health and safety practitioners

OSH

Occupational Safety and Health

PGNP

Process Generated Nano Particle;
intentionally during a process

PM

Particulate Matter

PPE

Personal Protective Equipment

PSLT

Poorly Soluble Low-Toxicity particles

REACH

Regulation (EC) No. 1907/2006 concerning the Registration, Evaluation,
Authorisation and Restriction of Chemicals

REL

Recommended Exposure Limits

RMM

Risk Management Measure

SME

Small and Medium-sized Enterprise
Recommendation 2003/361/EC)

SWCNT

Single wall carbon nanotube

TWA

Time-weighted average

UFP

Ultrafine particle

WHO

World Health Organisation

a

nano

(as

particledefinedgenerated

by

non-

Commission

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Employment, Social Affairs & Inclusion
Guidance on the protection of the health and safety of workers fromthe potential risks related to nanomaterials at work
Guidance for employers and health and safety practitioners

1.

Introduction and background

The purpose of this Guidance is to assist employers, health and safety practitioners
and workers in fulfilling their regulatory obligations, namely those under the provisionsof Framework Directive 89/391/EEC and the Chemical Agents Directive 98/24/EEC(CAD), whenever exposure to MNMs or use of nanotechnology in a professional
capacity is known or likely to take place, with the ultimate aim of ensuring adequate
protection of workers’ health and safety.
This guidance is provided for general use in occupational settings1 within the EU in
which nanotechnology is used. It does not replace any specific requirements or
guidance that may exist at national level, which should be also considered. Also, itshould be recognised that nanotechnology is developing fast. Consequently, whendrafting this guidance, choices were made with regard to concepts, terminology andmethodology which may not be followed elsewhere. Consideration may be given to
introducing changes to this Guidance in the future, in the light of relevant
developments.
New information, relevant to the protection of workers' health and safety, may
become available after the publication of this guidance. It will be important for
employers to take any such new information into account when deciding on the mostappropriate approaches to risk assessment and risk management at individual
workplaces.
This document has been produced for the European Commission as part of a study
Service Contract to evaluate the scope and requirements of possible modifications of
relevant EU Safety & Health at Work legislation and to elaborate a guidance document
to accommodate corresponding risks/concerns (Contract number: VC/2011/0521).
This Guidance document offers 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 may be of particular value to those who
may not have an in-depth technical understanding of the issues involved, and may
assist in ensuring compliance with the Occupational Safety and Health (OSH)
legislation when dealing with MNMs. In particular, this Guidance should assist in
1

More general information on nanomaterials is available at the following website of
the European Commission:
http://ec.europa.eu/health/scientific_committees/opinions_layman/nanomaterials/en/i
ndex.htm#il1
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Guidance on the protection of the health and safety of workers fromthe potential risks related to nanomaterials at work
Guidance for employers and health and safety practitioners

addressing any specific risks or concerns about nanomaterials and thus help ensurethat they are adequately controlled at the workplace.
Importantly, the procedures and measures suggested by this Guidance are intended tobe applied in addition to, and not instead of, the risk assessment procedures and risk
management measures normally implemented within the workplace when dealing withchemical agents, in compliance with the provisions of the Chemical Agents Directive
98/24/EC (CAD). Hence, any suggested measures should be implemented
without prejudice to any stricter measures already in place or required byrelevant legislation. For example, when the bulk form of the manufactured
nanomaterial has been classified as a carcinogen or mutagen (CM)2, all appropriate
measures according to the occupational legislation for working with substances with
CM properties should be applied, namely the Carcinogens and Mutagens Directive
2004/37/EEC (CMD), Directive 92/85/EEC on pregnant workers and workers who haverecently given birth or are breastfeeding, and Directive 94/33/EC on the protection ofyoung people at work.
It must be noted that whenever a MNM is within the scope of CAD, a Risk
Assessment should be carried out (Article 4 of CAD). The scope of CAD isdetermined by either meeting the criteria for classification as hazardous laid down inRegulation (EC) No. 1272/2008 (CLP) or when a MNM presents a risk to workers’
health and safety, according to Article 2(b) (iii) of CAD.
A MNM may have specific characteristics that could result in the material showing
special performance properties of value to industry. At the same time, these special
properties may also result in a distinctive 'hazard profile', which may be different foreach MNM of the same chemistry. As such, the potential risks from the use of a MNM
should be assessed on a case-by-case basis. To date, large gaps exist in scientificunderstanding of the potential health hazards that could be posed by MNMs. Even for
those MNMs which have been relatively well examined, the data generated cannot, or
can only to a limited extent, be compared to those for substances in bulk form, since
suitable characterisation of samples is often lacking or inadequate3. However, it isforeseen that the extensive research programmes being conducted worldwide, forexample under the EU Research Programmes (FP7 and Horizon 2020) and the OECD’s
Sponsorship Programme4, as well as REACH dossier updates and evaluations5 , will2

CM = Carcinogenic, Mutagenic substance, according to the CLP Regulation (EC) No
1272/2008.

3

UBA et al (2013): Nanomaterials and REACH, Background Paper on the Positionof German Competent Authorities, Umwelt Bundes Amt. Available at:
http://www.bfr.bund.de/cm/349/nanomaterials-and-reach.pdf, p.6.
A further twelve MNMs (Fullerenes C60, SWCNTs, MWCNTs, Iron nanoparticles,
Cerium oxide, Zinc oxide, Dendrimers, Nanoclays and Gold nanoparticles, as well as
Silver nanoparticles, Titanium dioxide and Silicon dioxide) are currently being
tested and evaluated for 59 defined endpoints relevant to environmental safety andhuman health. Source: http://www.oecd.org/science/nanosafety/

4

5Currently, three substances in nano-form (silicon dioxide, silver and titanium
dioxide) are planned to undergo the Substance Evaluation process under REACH.
Source: http://echa.europa.eu/regulations/reach/evaluation/substanceevaluation/community-rolling-action-planNovember 20147

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Guidance for employers and health and safety practitioners

provide specific toxicological and ecotoxicological data for some of the most widelyused MNMs. Consequently, because of the present degree of uncertainty, this
Guidance approaches the issues relating to the safe use of nanomaterials in theworkplace in a precautionary manner.

Recourse to the precautionary principle presupposes:• identification of potentially negative effects resulting from a phenomenon,
product or procedure;•a scientific evaluation of the risk which because of the insufficiency of thedata, their inconclusive or imprecise nature, makes it impossible to determinewith sufficient certainty the risk in question.
European Commission (2000): Communication on the precautionary principle

At present, the validity of the methods used to assess the health effects ofnanomaterials is under debate. The OECD is working on amending existing anddeveloping new test guidelines and guidance documents to assess the hazard potentialof nanomaterials. However, the application to nanomaterials of the OECD test
guidelines developed for general chemicals has resulted in identification of potential
negative effects of MNM justifying recourse to the precautionary principle (a brief
review of the evidence raised by toxicological studies is provided in Annex I).
It must be highlighted that inhalation exposure is of the greatest concern
with regard to the effects of particulate nanomaterials on occupational
health, and special attention is being given to studying impacts on the respiratory
system and the cardio-vascular system. Dermal exposure is also of importance.
However, healthy skin has a better barrier function when compared to the respiratory
tract although this barrier function could be limited by skin lesions, strong mechanicalstrain or small nanoparticles (<5 to 10 nm) (EU-OSHA, 2009). Exposure byingestion is of lower concern within the workplace; following good personal
hygiene and basic safety practice rules (such as washing hands with soap
and water before breaks and at the end of the workday, not wearing personal
protective clothing outside of work areas and not taking them home forcleaning) should avoid any oral uptake.
Given the level of uncertainty, the risk assessment proposed in this Guidance places astrong focus on consideration of exposure while still trying to prioritise attention
towards those MNMs for which specific health concerns have been raised. Hence, thecategorisation of the extent of control needed is based on the physicochemical
characteristics of the MNMs and the level of exposure for each task of the work
process, directing the user to relevant sources of information and suggesting the levelof control corresponding to the potential risk and the degree of associated uncertainty.
Given the current lack of specific information related to the nanoform of the chemicals

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Guidance on the protection of the health and safety of workers fromthe potential risks related to nanomaterials at work
Guidance for employers and health and safety practitioners

on Safety Data Sheets, the proposed categorisation draws on information about thosephysicochemical characteristics that should be readily available to the suppliers of thechemicals. It should be noted that, according to Articles 31 and 32 of the (EC)Regulation No. 1907/2006 (REACH), it is the duty of the supplier to communicate
down the supply chain “any other available and relevant information about thesubstance that is necessary to enable appropriate risk management measures to be
identified and applied…” (Art. 32(1)(d)). Consequently, any downstream user, in order
to comply with the CAD and carry out a risk assessment to identify the appropriate
RMMs, can ask for further information (free of charge6) from the supplier about atleast the size and shape of the particles of the substance/mixture and its solubility
characteristics. Comprehensive toxicological research has shown without any
reasonable doubt that the inhalation of biopersistent/poorly soluble particles can have
harmful effects on the respiratory system under certain exposure conditions and thatsome types of fibre-shaped nanomaterials might have toxicological characteristics
similar to asbestos7 (EU OSHA, 2009).
Although the focus of this Guidance is on MNMs, some of the risk management
measures suggested could contribute to minimising exposure to naturally occurring
nanomaterials and incidental nanomaterials (also known as process-generated
nanoparticles – PGNPs). Simultaneous exposure to MNMs and to PGNPs may occur inmany workplaces and it is advised to take all potential sources of nanoparticles(i.e., the total exposure load) into account when undertaking a workplace risk
assessment to define the necessary risk management practices.
It should also be noted that several authoritative European and non-European bodies(e.g. ISO and NIOSH) have previously published guidance on the safe use of
nanomaterials, including in some instances guidance specific to particular MNMs or
specific use scenarios. Users of this Guidance document are advised to also consider
these additional other sources of information, as appropriate (see Annex II).
Importantly, the present Guidance should be regarded as a ‘living document’ which
represents the knowledge of nanomaterials and understanding of health and safetyissues pertaining to them at the time of writing (June 2014). It may be revised asnecessary in the light of new developments. Anyone using this Guide should ensurethat they keep up-to-date with this rapidly developing field of knowledge, for example
by monitoring the websites listed in Annex II of this Guide. They should also be awareof the need to review their risk assessments for nanomaterials often, in order to takeadvantage of the latest scientific and medical understanding and, subsequently, toconsider whether risk management practices require any amendment.

6

Article 32(2) of the REACH Regulation.

7

EU-OSHA (2009):
Workplace exposure to nanoparticles, European Risk
Observatory Literature Review, the European Agency for Safety and Health at Work
(EU-OSHA),
available
from
the
EU-OSHAInternetsite:
http://osha.europa.eu/en/publications/literature_reviews/workplace_exposure_to_n
anoparticles
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Guidance on the protection of the health and safety of workers fromthe potential risks related to nanomaterials at work
Guidance for employers and health and safety practitioners

2.

Structure of this Guidance and reference to Directive 98/24/EC

Section 3 provides an introduction to the terminology used in this Guidance, while
Section 4 summarises the suggested risk assessment and risk management
procedures. Table 2.1 sets out the correspondence between the contents of this
Guidance document and the provisions of the Chemical Agents Directive 98/24/EC(CAD)8.
Table 2.1: Contents of this Guidance and their correspondence with the CAD
SectionReference in CAD
4.1 Step 1 – Identification of the MNMs
Article 4(1) “…determine whether any hazardous
chemical agents are present at the workplace”
4.2 Step 2 – Hazard Assessment
Article 4(1) “(…) assess any risk to the safety andhealth of workers arising from the presence of
those chemical agents, taking into consideration…”
4.3 Step 3 – Exposure Assessment
Article 4(2) “The risk assessment shall be
documented in a suitable form according tonational law and practice…”
Article4(3)“Certainactivities
withintheundertaking
orestablishment,suchas
maintenance, in respect of which it
is foreseeable that there is a potential forsignificant exposure, or which may result indeleterious effects to safety and health for otherreasons, even after all technicalmeasures have been taken, shall be included in theriskassessment”
4.4 Step 4 – Characterisation of Risk Article 4(2) “The risk assessment (…)may include(Control Banding)a justification by the employer that the nature andextent of the risks related to chemical agents makea further detailed risk assessment unnecessary”
4.5 Step 5 – Detailed Risk Assessment
Article 6(4) “Unless the employer clearly
demonstrates by other means of evaluation that(…) adequate prevention and protection have beenachieved, the employer shall carry out on a regularbasis, and when any change occurs in the
8

Full text available at:
http://eur-lex.europa.eu/legalcontent/EN/TXT/PDF/?uri=CELEX:31998L0024&from=EN
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Guidance for employers and health and safety practitioners

4.6 Step 6 – Risk Management
4.7 Information, instruction and training
4.8 Medical Surveillance

4.9 Step 7 – Review

3.

conditions which may affect workers' exposure tochemical agents, such measurements of chemical
agents which may present a risk to worker's healthat the workplace as are necessary, in particular in
relation to the occupational exposure limit values”
Articles 5 General principles for prevention of risks(…)
Article 6 Specific protection and prevention
measures
Article 7 Arrangements to deal with accidents,
incidents and emergencies
Article 8 Information and training for workers
Article 10 Health surveillance
Article 11 Consultation and participation ofworkers
Article 4(2) “The risk assessment shall be kept
up-to-date, particularly if there have beensignificant changes which could render it out-ofdate…”
Article (5) “In the case of a new activity involving
hazardous chemical agents, work shall only
commence after an assessment of the risk of that
activity has been made and any preventive
measures identified have been implemented”

Terminology and Definitions

What are nanomaterials
In order for the user to correctly interpret this Guidance, an introduction to therelevant terminology on nanotechnology is provided here.
Many definitions have been discussed by international organisations, national
authorities and scientific committees.
For an extensive review of the working
definitions at national and international level, please consult the JRC Reference Report(JRC, 2010).
For the purpose of this Guidance, the European Commission’s currently
recommended definition9 (provided in Box 1) has been used.

9

Availableat:
http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:275:0038:0040:EN:PDF
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Guidance for employers and health and safety practitioners

Box 1: Definition of a nanomaterial
A natural, incidental or manufactured material containing particles, in an unboundstate or as an aggregate or as an agglomerate and where, for 50 % or more of theparticles in the number size distribution, one or more external dimensions is in thesize range 1 nm - 100 nm.
In specific cases and where warranted by concerns for the environment, health,safety or competitiveness the number size distribution threshold of 50 % may bereplaced by a threshold between 1 and 50 %.
By derogation [from the above], fullerenes, graphene flakes and single wall carbon
nanotubes with one or more external dimensions below 1 nm should be considered as
nanomaterials.
Within this definition of nanomaterials, the terms "particle", "agglomerate" and"aggregate" are defined as follows:"Particle" means a minute piece of matter with defined physical boundaries;"Agglomerate" means a collection of weakly bound particles or aggregates where theresulting external surface area is similar to the sum of the surface areas of theindividual components;"Aggregate" means a particle comprising strongly bound or fused particles.
Where technically feasible and requested in specific legislation, compliance with thedefinition [of a nanomaterial] may be determined on the basis of the specific surface
area by volume. A material should be considered as falling under the definition where
the specific surface area by volume of the material is greater than 60 m 2/cm3.
However, a material which, based on its number size distribution, is a nanomaterial
should be considered as complying with the definition even if the material has a
specific surface area lower than 60 m2/cm3.
European Commission, Recommendation 2011/696/EU.
A review (1st step before a possible revision) of this definition is due by December
2014.

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Guidance on the protection of the health and safety of workers fromthe potential risks related to nanomaterials at work
Guidance for employers and health and safety practitioners

Nanotechnology has been identified as a key enabling technology (KET) providing thebasis for further innovation and new products10. Products using nanotechnology are
increasingly finding application within European industries. As a result, the potential
risks arising from the use of nanomaterials may be present in many different sectors
and work activities. Annex III provides a non-exhaustive list of the main applicationsof some of the most used MNMs.
The intrinsic properties (physicochemical and toxicological) of chemical agents (andthus of nanomaterials) constitute the hazards which have the potential to cause harm(hence needing to be assessed – hazard assessment), while the way they are used orare present in the workplace (exposure) determines the likelihood that the potential
for harm will be attained (hence the need for an exposure assessment). Further
clarification on the applicability of the CAD to nanomaterials is provided in Annex IV.
Although this Guidance attempts to provide concise and easily understandable
information for a non-specialised audience, the use of some technical words andconcepts is unavoidable when dealing with nanotechnology. In order to clarify suchterms, their definitions have been provided below. Some of these are consistent withthe terminology as elaborated and used by other organisations11 and in any caseconsistent with the current EC recommended definition of nanomaterials.
Nanoscale is the size range from approximately 1 nm to 100 nm (NOTE 1: Properties
that are not extrapolations from a larger size will typically, but not exclusively, be
exhibited in this size range. NOTE 2: The lower limit in this definition (approximately 1nm) has no physical significance but is introduced to avoid single and small groups of
atoms from being designated as nano-objects or elements of nanostructures, whichmight be implied by the absence of a lower limit) (BSI, 2007).
Nano-object is a discrete piece of material with one or more external dimensions in
the nanoscale (NOTE: This is a generic term for all nanoscale objects) (BSI, 2007).
10

http://ec.europa.eu/enterprise/sectors/ict/key_technologies/kets_high_level_g
roup_en.htm
11

e.g. the British Standard Institution (BSI) in the Publicly Available Specification(PAS) on the terminology for nanomaterials and the International Standard
Organisation, in particular the Technical Committee 229, in the Technical
Specifications for the terminology to be used in the nanotechnology field, mostimportantly:
 ISO/TS 27687:2008 “Nanotechnologies – Terminology and definitions for nanoobjects – Nanoparticle, nanofibre and nanoplate”;
 ISO/TS 80004-1:2010 "Nanotechnologies - Vocabulary - Part 1: Core terms";
and ISO/TS 80004-3:2010 "Nanotechnologies - Vocabulary - Part 3: Carbon nanoobjects".
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Guidance for employers and health and safety practitioners

Nanoparticle is a nano-object with all three external dimensions in the nanoscale(NOTE: If the length of the longest and the shortest axes of the nano-object differ
significantly (typically by more than three times) the terms nanorod or nanoplate areintended to be used instead of the term nanoparticle) (BSI, 2007).
Nanopowder is a mass of dry nanoparticles (BSI, 2007).
Ultrafine particles (UFPs) make up the smallest fraction of ambient particulatematter (PM) and are defined as airborne particles with a diameter in the nanoscale(HEI, 2013). In this Guidance, the term “ultrafine particles” is used when referring tonaturally-occurring nanomaterials.
Process-generated nanoparticles (PGNPs) or incidental nanomaterials, areparticles generated incidentally during work activities, e.g. by electrical machines,
heating, welding and combustion processes.
Nanofibre is a nano-object with two similar external dimensions in the nanoscale andthe third dimension significantly larger. A nanofibre can be flexible or rigid. The twosimilar external dimensions are considered to differ in size by less than three times
and the significantly larger external dimension is considered to differ from the othertwo by more than three times. The largest external dimension is not necessarily in thenanoscale (ISO/TS 27687:2008). If the nanofibre has a length greater than 5 µm, awidth less than 3 µm and a length to width ratio (aspect ratio) greater than 3:1, it
meets the WHO criteria and, within this Guidance, is called a WHO nanofibre.
High Aspect Ratio Nanoparticles (known as HARNs) are particles with one or two
dimensions in the nanoscale that are much smaller than the others (HSE, 2013).
Besides nanofibres, nanoplatelets (that present only one dimension in the nanoscale)
are considered HARNs.

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Guidance for employers and health and safety practitioners

4.

Risk Assessment and Management Process

The employers’ obligations for ensuring the protection of the health and safety ofworkers from the risks related to hazardous chemical agents at work are set out in
Section II of the CAD. As for any chemical, it is the duty of employers to carry out a
Risk Assessment whenever MNMs are handled during work activities. Figure 4.1
shows the various steps involved in risk prevention when working with MNMs. Eachstep is detailed in the sections that follow. The risk assessment and the efficacy of theimplemented risk management measures must be reviewed periodically and before
any changes are made to either the chemical agents being used or working conditions(in compliance with CAD Article 4(5)).

Figure 4.1: Diagram for Risk Assessment

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Guidance for employers and health and safety practitioners

4.1

Step 1 – Identification of the MNMs

Article 4(1) of the CAD first requires employers to determine whether any hazardous
chemical agents are present at the workplace. In addition, employers that are
uncertain about the presence of MNMs in the workplace should check theinventories of substances used or supplied to verify whether any are identified as
MNMs or may contain MNMs.
Primary sources of information are the Safety data sheets (SDS) accompanying thesubstances/mixtures used in the workplace. Although, according to article 31 of the
REACH Regulation, their provision is mandatory only for those substances andmixtures that are classified under the CLP Regulation or meet the criteria set out inAnnex XIII of the REACH Regulation as being classified as persistent, bioaccumulative
and toxic or very persistent and very bioaccumulative, it is commonly the practice ofthe chemical industry to provide a SDS for non-classified substances/mixtures as well.
If a SDS is not needed (no classification according to CLP) and not supplied
information may be found online from other suppliers; the quality of this information
may need checking. More information can be found on the ECHA website12. In
particular, information about the form of the substance or the presence of MNMs in a
mixture might be found in the following sections of a SDS:

1. Identification of the substance/mixture and of the company/undertaking;
3. Composition/information on ingredients;
9. Physical and chemical properties.
Where
there
is
uncertainty,
employers
shouldcontact
thesuppliers/manufacturers of the substances/mixtures to specifically request
the necessary information.

12

http://echa.europa.eu/information-on-chemicals/registered-substances
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4.2

Step 2 – Hazard assessment

4.2.1 General risk considerations
If MNMs are present in the workplace, the employer shall then assess any risks tothe safety and health of workers. Table 4.1 (reproduced and adapted from EC,
200413) summarises the risks to be assessed under the CAD and provides a nonexhaustive list of risk factors related to the presence of hazardous chemical agents.
Some risk factors to which particular attention should be paid during the risk
assessment of MNMs have been highlighted in bold.

Table 4.1: Risks arising from the presence of MNMs
Risk
Some risk factors
Risks due to inhalation
 Toxicity of the MNMof the Physicochemical characteristics of the MNM
agent Environmental concentration
 Exposure time
 Particularly sensitive workers
 Inappropriate selection and/or use of RPE
Risks due to absorption
 Location and extent of the contact with the skinthrough Toxicity of the MNM agent via the skin
the skin Duration and frequency of contact
 Particularly sensitive workers
 Inappropriate selection and/or use of PPE
Risks due to contact
 Inappropriate selection and/or use of PPEwith the skin or eyes
 Inappropriate work procedure Incorrect transfer procedure
Risks due to ingestion
 Toxicity of the MNM Potential toxicity of the MNM Incorrect personal hygiene habits Possibility of eating, drinking or smoking in the workplace Particularly sensitive workers
Risks of fire and/or
 Physical state (ultrafine dust)
explosion Pressure/temperature13

EC (2004): Practical Guidelines of a non-Binding Nature on the Protection of the
Health and Safety of Workers from the Risks Related to Chemical Agents at Work.
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Guidance for employers and health and safety practitioners

Table 4.1: Risks arising from the presence of MNMs
Risk
Some risk factors
 Flammability/calorific value
 Airborne concentration
 Sources of ignition
Risks due to hazardous
 Chemical reactivity and instability of hazardous chemical agents
chemical reactions
 Inadequate cooling systems
 Unreliable system for controlling key variables in the reaction(pressure, temperature and flow control)
Risks arising from Corrosion of materials and installations
installations which may Deficient or non-existent facilities for controlling leaks and spills
have(retaining trays, protection against mechanical impacts)
consequences on the Deficient or non-existent preventive maintenancehealth andsafety of workers
To determine the capacity of chemical agents (and thus of MNMs) present in theworkplace to cause risk, the hazardous properties of these agents and the exposure,i.e. the way in which they are used or are present, must be known. Normally,
information on the hazardous properties of chemical agents present in the workplace
can be obtained from:
Labels (pictograms);
Safety data sheets;European Commission recommendations;

Occupational exposure limit values; and

Other sources (peer reviewed data, scientific literature, relevant databases, etc.).

Currently, specific information on the physicochemical characteristics of MNMs is notreported in SDS. Moreover, toxicological and ecotoxicological data specific to MNMs
may be lacking. Different international organisations (such as the OECD) are working
on adapting existing or developing new standardised testing methodologies fornanomaterials and are in the process of generating further relevant information forsome widely used MNMs. In the meantime, simplified risk assessment procedures
have been developed to overcome these shortcomings.
Several lists of physicochemical parameters for the characterisation of nanomaterials
have been proposed and the way they influence the toxicological profile of MNMs isbeing discussed. However, some hazardous properties are known from the macromaterial form, for example highly reactive materials can be expected to cause toxic
effects if they are inhaled or absorbed into the body, as these types of properties are
known to be significant factors in the toxicity of macro form materials. Similarly, if themacro form of a substance is classified as a carcinogen, mutagen or
reproductive toxin (CMR), as a sensitiser, or for another significant toxicity,then it should be assumed that the nanoform will also show these properties
unless proven otherwise. Although, presently, it is still uncertain which parameters
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Employment, Social Affairs & Inclusion
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Guidance for employers and health and safety practitioners

represent the best predictive value for toxicity, there is growing evidence that fornanomaterials a high aspect ratio and poor solubility might lead to negative effects onhuman health.
As detailed in Annex I, most concerns regarding MNMs have centred on the possible
consequences of inhalation exposure, as nanoparticles may be carried deep into thelungs and there are concerns that they may have the ability to elicit acute or chronic
inflammatory responses.
Particular care is suggested when considering the risks that may be posed bynanoparticles possessing certain physical aspect characteristics. In particular,
attention has focused on the so called “High Aspect Ratio Nanoparticles” (HARNs)
because of suggested similarities in their physical characteristics to materials known tobe hazardous, such as asbestos or some man-made mineral fibres. Poland andDonaldson14 suggested that HARNs may be retained in the pleural cavity for long
periods of time15 if they show the additional characteristics:
Thinner than 3 µm

Longer than 10-20 µm

Biopersistent, andWhich do not dissolve/break into shorter fibres16

As for nanofibres, concerns have been raised over nanoplatelets (considered HARNs)
and their aerodynamic behaviour which might result in them penetrating deep within
the lung (HSE, 2013).
Water solubility is another factor that may influence toxicity. In order to overcome thelack of specific data on biopersistence of MNMs, water solubility is used in this
Guidance as a proxy for possible biopersistence. See more detailed explanations on
this parameter under section 4.2.2 of this document.

14

http://www.safenano.org/KnowledgeBase/CurrentAwareness/FeatureArticles/M
urphyHARNpaper.aspx
http://www.particleandfibretoxicology.com/content/7/1/5/abstract
15

Mechanism known as “frustrated phagocytosis”, the incomplete engulfment of aparticle by a cell, leading to failure to remove the particle form the body and a riskof cell damage and release of harmful endogenous substances into the body.

16

The hazards characteristics of HARNs with a length below 5 µm are (probably) the same as for granular particles.
However, as the length distributions of samples of HARNs usually exhibit wide variations, a sample with a median lengthof 1.5 µm could still contain a considerable number of individual HARNs with a length > 5 µm.

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Employment, Social Affairs & Inclusion
Guidance on the protection of the health and safety of workers fromthe potential risks related to nanomaterials at work
Guidance for employers and health and safety practitioners

In order to comply with CAD Article 4(1), the employer should obtain additional
information needed for the risk assessment from the supplier or from otherreadily available sources and, as a minimum, this should include informationon the size and shape of the particles of the substance/mixture and its
solubility and/or biopersistence characteristics. It must be noted that “thegreater the differences between the physical and chemical characteristics of one
material and another, even though they may have the same chemical composition, themore likely it is that hazard data for one material will not provide a suitable basis toassess the hazards of another” (HSE, 2013). For example, carbon nanotubes do nothave identical inherent properties and not all of them have caused equal high concern
for possible effects on human health.
Forms which do not differ significantly in terms of their physicochemical characteristics
can be regarded as comparable. To date, however, it is not possible to determine what
degree of variation is acceptable for each individual parameter (UBA et al, 2013).
It should be noted that Article 4(1) of CAD states that the employer shall obtain fromthe supplier additional information on the hazardous properties of a substance, when it
is needed for the risk assessment, and Article 8.3 lays down that Member States may
take measures to ensure that this information can be obtained. On the other hand,according to Articles 31 and 32 of REACH, suppliers of substances and mixtures
have a duty to pass on any available information needed for a downstream
user to carry out a risk assessment. In the absence of specific toxicologicalinformation on MNMs, employers therefore have the right to ask, free of charge, forrelevant physicochemical information sufficient to allow at least a partial
characterisation of the MNMs and of their potential hazard profile (see table 4.2).
If the information available is not sufficient for the characterisation of the MNM inorder to carry out the simplified risk assessment detailed in this Guidance, theemployer should adopt a reasonable worst case scenario approach, taking
account of the available evidence and in the light of the precautionary
principle.
Table 4.2 presents the data that should be gathered, as a minimum, to allow the
simplified Risk Assessment procedure proposed in this Guidance to be carried out.
Table 4.2: Characterisation data
Minimum Information
Chemical name and product name
Manufacturer/supplier company name
CAS Number and EC Number
Chemical Formula/Chemical Structure
Intended Purpose of the MNM
Physical Hazard Classification of the bulk form*

Health Hazard Classification of the bulk form*
Environmental Classification of the bulk form*
Appearance

Material example for Minimum Information
e.g. Nanosilver
If you are the manufacturer, please insert the name ofyour company
e.g. CAS Number 7440-22-4, EC Number 231-131-3
e.g. Age.g. the MNM increase the protection against
weathering
Hazard Class and Category Code(s) (e.g. Expl. 1.1)
and/or text defining the appropriate Hazard
Statements
e.g. Acute Tox. 1 or H300
e.g. Aquatic Acute 1 or H059
Physical state, granulometry and specific surface area
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Guidance for employers and health and safety practitioners

Table 4.2: Characterisation data
Surface Composition

If the MNM is modified, functionalised or coated with achemical, please seek expert advice
e.g. particulate or fibrous, rigid or flexible

Geometry/Shape, rigidity
Number Particle Size Distribution
Water solubility
e.g. 45 mg/l
Dustiness
Flammability
Notes:*Please consider that if the bulk form of the nanomaterials you handle have been classified under the
CLP Regulation (EC) No 1272/2008, you should apply, as a minimum, the Risk Management Measuresrequired by the relevant legislation and indicated on the Safety Data Sheet.

4.2.2 Categorising level of concern – shape and solubility
A categorisation rating for the level of concern relating to the possible effects of MNMs
on workers’ health based on the geometry/shape and persistence/water solubility
characteristics is proposed below in Table 4.3. For proper categorisation, a thoroughunderstanding of these concepts is important.
Table 4.3: Concern Categorisation
Concern Category
Characteristics of the MNMHighConcern
Medium-High
Concern

Medium-Low
Concern
Low
Concern

Poorly soluble or insoluble (water solubility <100 mg/l) WHO
nanofibres
Poorly soluble or insoluble (water solubility <100 mg/l)
nanoparticles with specific toxicity and poorly soluble orinsoluble HARNs other than poorly soluble or insoluble WHO
nanofibres
Poorly soluble or insoluble nanomaterials with no specifictoxicity
Soluble nanomaterials

MNM
1

MNM
…

☐

☐

☐

☐

☐

☐

☐

☐

Shape - ISO defines the shape of particles on the basis of the number of dimensions
in the nanoscale. A nanoplate is a particle with only one dimension in the nanoscale, ananofibre is a particle with two dimensions in the nanoscale and the third dimension
significant larger, while a nanoparticle is a particle with all three dimensions in thenanoscale. A hollow nanofibre is called a nanotube, a flexible nanofibre is called ananowire and a rigid nanofibre is called a nanorod. Figure 4.2 provides a schematic
representation of the types of nanomaterials based on shape.

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Guidance for employers and health and safety practitioners

Figure 4.2 Schematic representation of types of nanomaterials based on
shape
Persistence – Persistence is primarily used in a risk assessment context to definechemicals or materials which are retained in the body or in the environment beyond adefined amount of time. A persistent material is a material poorly soluble/insoluble
and resistant to breakdown into smaller structures and molecules. For example, withrespect to fibrous materials, the term biopersistence can be defined as the ability toresist removal from the lungs by natural mechanisms like dissolution. In this case, themeasure used is the half-life, i.e. the time needed for 50% of the fibres to be removed
from the lungs. Macrophages play an important role in the clearance of short fibres byphagocytosis. However, for long, rigid and poorly soluble fibres, the process ofphagocytosis is hampered because the fibre cannot be “swallowed” completely by themacrophage.
Water Solubility – Water solubility (usually expressed in mg/l) is the highest amountof a substance that can be dissolved in a specific volume of water. The solubility of thebulk form may differ significantly from the solubility of the nano-size form. The
threshold of 100 mg/l is usually indicated to distinguish between soluble and poorly
soluble/insoluble (nano)materials. In order to overcome the lack of specific data
about the biopersistence of MNMs, water solubility is used in this Guidance as a proxyfor biopersistence. In terms of solubility only, poorly soluble or insoluble
nanomaterials are considered of concern; soluble nanomaterials (with a watersolubility above 100 mg/l) are considered of no concern. However, in some cases, amaterial may show a poor solubility in water but a good solubility in biological media
as, for example, cobalt which is insoluble in water but soluble in serum.
With the possible exception of amorphous silica, all the nanomaterials currently
produced in high volume17 are poorly soluble/insoluble.

17

For example: amorphous silica, silver, titanium dioxide, fullerenes C60, SWCNTs,
MWCNTs, iron nanoparticles, aluminium oxide, cerium oxide, zinc oxide, nanoclays
and gold nanoparticles).
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Guidance for employers and health and safety practitioners

Concern categories18
High concern - poorly soluble or insoluble nanofibres are of the highest concern:
toxicological studies demonstrated that long fibres retained in the pleural cavity cancause persistent inflammation and might lead to long-term health effects such as
fibrosis and lung cancer. Although evidence of toxic effects has been identified for rigid
fibres longer than 10-20 µm, all the fibres with a length of more than 5 µm (fibres
meeting the WHO criteria), regardless of their rigidity, should be considered of highconcern, since “fluffy” nanofibres might be tangled together and behave as rigid fibres
within the body. Some types of CNTs match these characteristics and should be
regarded as of high concern.
Medium-high concern - Poorly soluble or insoluble (with water solubility of less than
100 mg/l) nanoparticles with specific toxicity and poorly soluble/insoluble High Aspect
Ratio Nanoparticles other than poorly soluble or insoluble WHO nanofibres should be
regarded as of medium-high concern. This category encompasses those nanomaterials
with toxic properties and those nanomaterials for which the macroform of thesubstance possesses toxic properties and there are no data showing that the nanoform
does not present the same properties. Moreover, those poorly soluble or insoluble
HARNs that are not included in the high concern category (nanoplatelets, nanofibres
with a length of less than 5 µm) should be considered of medium-high concern due totheir ability to penetrate deep into the lungs which may result in inflammatory
reactions. Examples of medium-high concern nanomaterials include nanosilver, gold
nanoparticles and zinc oxide nanoparticles.
Medium-low concern - Poorly soluble or insoluble nanomaterials with no specifictoxicity and that do not present a high aspect ratio are of medium-low concern: these
MNMs do not present specific toxic properties beyond those owned by the substance.
Examples are carbon black and titanium dioxide.
Low concern – All nanomaterials with a water solubility above 100 mg/l should be
regarded as of low concern with regard to nano-specific toxicological effects. Due totheir solubility, the nanoparticle should not be retained into the body for a period longenough to cause nano-specific adverse health effects. Examples of MNMs in thiscategory are: sodium chloride nanoparticles, lipid-nanoparticles, flour nanoparticles,
sucrose-nanoparticles and amorphous silica.

4.2.3 Categorising level of concern – dustiness and flammability
Dustiness – Dustiness may be defined as the propensity of a solid to form airborne
dust when mechanically processed. Table 4.4 reproduces for the convenience of the
Guidance user, the dustiness bands proposed in ECHA (2012)19.

18

The categories of concern are defined at present drawing essentially on the likely
impact that the nanoform of a substance may have; in specific cases the same effects
may be caused by the substance in non-nanoform.
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Guidance on the protection of the health and safety of workers fromthe potential risks related to nanomaterials at work
Guidance for employers and health and safety practitioners

Table 4.4: Dustiness bands
Band
DustinessHigh
Fine, light powders. When used, dust clouds canbe seen to form and remain airborne for several
minutes. For example: cement, titanium dioxide,
photocopier toner
MediumCrystalline, granular solids. When used, dust isseen, but it settles quickly. Dust is seen on thesurface after use. For example: soap powder,sugar granules
Low
Pellet-like, non-friable solids. Little evidence of any
dust observed during use. For example: PVC
pellets, waxes
Flammability – flammability is a concept related to the easiness of a substance toignite or sustain a combustion reaction. By and large, nanoscale metal powders areeasily ignitable, while carbon nanomaterials are not (safe work Australia, 2013)20.
Fully oxidised materials, such as silicon dioxide, cerium dioxide and zinc oxide do not
ignite or sustain a combustion reaction.

4.3

Step 3 – Exposure Assessment

A key part of any risk assessment is a thorough understanding of the exposure
potential for workers.
For each MNM, routine workplace activities and other foreseeable events (e.g.
accidental spills or other equipment failure scenarios) which may potentially result in
the release of the MNM and subsequent exposure of workers should be defined. A listof generic activities21 which may apply to the life-cycle of each MNM is presented
below:

19

Material Receipt, Unpacking and Delivery;Laboratory Operations;

Manufacturing and Finishing;

ECHA (2012):
Guidance on information requirements and chemical safetyassessment, Chapter R.14: Occupational exposure estimation, version 2.1 –November 2012.
20
safe work australia (2013): Safety Hazards of Engineered Nanomaterials,
Information
sheet,
availableat:
http://www.safeworkaustralia.gov.au/sites/SWA/about/Publications/Documents/76
2/Safety-hazards-engineered-nanomaterials.pdf
21This list is proposed in goodnanoguide.org, available at Internet site:
http://www.goodnanoguide.org/Assess+Potential+Exposures
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Guidance for employers and health and safety practitioners



Cleaning and Maintenance;

Storage, Packaging and Shipping;

Waste Management;

Reasonable Foreseeable Emergencies.

For each work activity involving the manufactured nanomaterial, as appropriate, you
should ask the following questions22:
What are the tasks where the workers are exposed to MNMs?

Is the material dusty or the process likely to generate dusts or aerosols of MNMs?



Does the process include cutting, shearing, grinding, abrasion, or other mechanicalrelease of MNMs or materials containing MNMs?



What is the physical state of the MNMs in each stage of the work process? (i.e.
Dry powder / suspension or liquid / embedded or bound in other materials)

What are the potential routes of human exposure? (e.g., inhalation, dermal
absorption)What is the chance of exposure occurring? Consider not just exposures during
normal routine working but also possible accidental releases and maintenance.

How often is exposure likely to occur, for example continuously over a working
shift, intermittently, rarely?

For the convenience of users of this Guidance, Table 4.5 provides a list of possible
work activities involving the handling of MNMs. The table should be modified
accordingly if necessary and used for the recording of information relevant for the
Exposure Assessment.
Emissions of dust/mist/haze may have already been prevented by risk management
measures (RMMs) introduced to reduce risks of other (non-nano) chemical agents. In
this case, the efficacy of these RMMs in minimising workers’ exposure to MNMs shouldbe verified. The information sheets provided with the installed equipment/personal
protective equipment might report on their efficacy for the different forms of the

22

These questions were proposed in CSIRO (2012): Safe handling and use of Carbon
NanoTubes, prepared for Safe Work Australia, and adapted accordingly.
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Guidance for employers and health and safety practitioners

chemical agents. If this information is not available, the employer should ask the
supplier of the equipment or seek expert advice.

Table 4.5: Activities involving potential exposure to MNMs
Name of the MNM(s): ......................................................................
Activity
AmountDust
Duration(kg, l)emission (minute(yes/no)s)
Manufacturing of the MNM
Reception and storageof the MNM
Transport in the facility(fork truck, manual , etc.)
Operating machines
Handling (opening vessels,
valves, seals, emptying sacks,
brushing, spraying…)
Machining (drilling,abrasion, polishing...)Filtering/separation
Sampling (quality
control)
Filling/packaging of end
product
Cleaning andmaintenanceof equipment
Cleaning working area
(e.g. floor, walls, etc.)
Transport outside(container byroad/sea/air…)
On-site treatment ofwasteCollection of waste
Removal of waste
Emergencies
Other activities…

Frequency(times per
d/w/m)

No and ID
of workers

Based on the information collected in Tables 4.4 and 4.5, Table 4.6 shows the
exposure categorisation according to the characteristics of work activities and thedustiness of the substance/mixture. The exposure assessment should be carried out
for each identified MNM for each work activity.
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Employment, Social Affairs & Inclusion
Guidance on the protection of the health and safety of workers fromthe potential risks related to nanomaterials at work
Guidance for employers and health and safety practitioners

It is worth remembering that, in order to comply with Article 4(2) of the CAD, all theinformation gathered for the Risk Assessment should be “documented in asuitable form according to national law and practice…”.

Table 4.6: Work activity exposure assessment
Name of the MNM(s): ......................................................................
Level of exposure
Description

High

Medium High

Medium Low

Low

Free/unbound MNMs, dustiness high band,
likely emission of MNMs
Tasks that are likely to produce airborne MNMs:• Manufacture of MNMs — e.g. synthesis, “top-down” process• MNM handling in dry state or powder form, e.g.
sampling, weighing and measuring, scraping,packing and opening of bags
• Spraying of a solution containing MNMs
• Cleaning and maintenance of equipment
Possible Emission of MNMs (friable or brittle
matrix), dustiness medium band:• Dry blending of MNMs into a matrix (e.g.
polymer)• Processing of solid substances in the nanoform
or solid mixtures containing MNMs through, e.g.
weave, knit, twist, cut, grind, scrape, etc.
• Cutting/grinding a matrix containing MNMs ifthey can be released from the matrix
Emission of MNMs anticipated as very low,
dustiness low band:• Extruding and manipulating matrixes containing
MNMs (e.g. paints or polymers)• Processing, shaping, moulding of matrixes
containing MNMs
• Cutting/grinding a matrix containing MNMs if
release is unlikely• Solutions containing MNMs are mixed or agitated• MNMs in articles or in fully cured coating on
surfaces of articles
Unlikely emission of MNMs:

Activity
1

Activi
ty
…

☐

☐

☐

☐

☐

☐

☐

☐

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Employment, Social Affairs & Inclusion
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Guidance for employers and health and safety practitioners• Painting, coating (excluding spraying)packaging of extruded product• MNMs are embedded in a matrix andmachining•

4.4

or
no

Step 4 – Categorisation of Risk (Control Banding)

The simplified risk assessment procedures presented in this Guidance have beendeveloped to assist employers in determining the need for implementing control
measures. This section is a general description of the control banding concept and how
it could be applied to the risk assessment in the particular case of exposure tonanomaterials.
Some Member States have developed national guidance documents to address thisissue (see references in Annex II) and, as mentioned in Section 1, employers should
follow any existing national requirements.
The procedure presented in this Guidance is used to determine the risk management
measures appropriate for the work activity being assessed. Table 4.7 shows the four
potential levels of risk identified by combining the information gathered from thehealth concern categorisation and from the level of exposure determined for each
MNM and work activity. According to the level of risk determined, some technicalsolutions are provided in the following sections.
Table 4.7: Control Banding: Risk Level = Concern Category x Level of
Exposure
Level of Exposure
Concern Category
Low
MediumMediumHigh
low
high
Low
1
1
2
2
Medium-low
12
2
3
Medium-high
2
2
3
4
High
3
3
4
4
For Risk Level 1 and 2, where the level of exposure is low, medium low and/or thelevel of concern over the potential hazard of the MNMs is low, medium low, it isconsidered that adequate prevention and protection can be achieved by implementing
standard risk management measures and without the need for additional periodic
exposure measurements, as provided by article 6(4) of the CAD. It is left to thejudgement of employers to determine whether following this approach will be
sufficiently protective of workers’ health.
For Risk Level 1 and 2: Section 4.6 provides an overview of the hierarchy of controls
and of the risk management measures advisable for the different risk level.
For Risk Level 3 and 4, before implementing any RMMs (presented in Section 4.6), adetailed Risk Assessment should be carried out (as detailed in Section 4.5).
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Guidance for employers and health and safety practitioners

The higher the risk level obtained, the more stringent risk management measures
should be taken. In case of uncertainty on the outcome of the control banding
approach, a detailed risk assessment, normally including airborne concentration
measurements, is needed (see section 4.5). For the higher risks levels 3 and 4 it isadvisable to carry out a detailed assessment as a general rule.
According to the Risk Level identified, Table 4.8 can be used to record the appropriate
Control Level by MNM and work activity.
Table 4.8: Record of the appropriate level of control
Control level
2
3

No.

MNM

Activity1…………………………….

…………………………………………….

□

□

□

□

2

…………………………….

…………………………………………….

□

□

□

□

3

…………………………….

…………………………………………….

□

□

□

□

4

etc.

etc.

□

□

□

□

4.5

1

4

Step 5 – Detailed Risk Assessment

It is an important principle of occupational health and safety practice to assess
potential exposure quantitatively and to verify the adequacy of engineering controls.
Particularly in the case of hazardous substances (irrespective of whether they are in
nano- or macro-form), regular monitoring of the correct functioning of engineering
controls is necessary.
This may be complemented by periodic exposure measurements where suitablesampling and analytical methodologies exist, taking into account any NMN-specificOELs.
In the case of MNMs with no health hazard classifications and for which no European
or Member State occupational exposure limits (OELs) have been established, it may bethat the manufacturer has established a nano-specific derived no-effect level (DNEL)
value in accordance with the REACH regulation (though this would be likely only if thesubstance had a market volume of >10 tonnes/annum and it is classified according toCLP). In this case, the REACH exposure scenario, attached to the Safety Data Sheet,provides information on Risk Management Measures and Operational Conditions.
For certain nanomaterials, industry and research have suggested either specific OELs
or DNELs (these are summarized in Table 4.9 below). Some companies and research
institutes have also proposed an OEL for multiwall carbon nanotubes (MWCNTs)(Bayer, Nanocyl and NIOSH); while DNELs were calculated in an experimental study
by Stone et al. (2009) applying the DNEL methodology with the prescribed
assessment factors to MWCNTs, fullerenes, Ag and TiO2. A threshold value for Carbon
Nanotubes has also been set in Switzerland in 2011 by the Swiss National Accident
Insurance Fund at 0.01 fibres/ml (SECO, 2012).
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Guidance for employers and health and safety practitioners

Even where no MNM-specific OELs have been defined, consideration may still be given
to establishing an exposure monitoring programme (either for ambient air levels in theworkplace or for concentration levels in worker’s breathing zones using personal
sampling devices), where this is judged to be prudent as a precautionary measure.
This may be particularly appropriate in the case of MNM falling within the twocategories of highest concern. Where there are no obvious criteria against which tojudge the acceptability of exposure, it should be noted that some organisations havesuggested that – in the absence of OEL or DNEL values – a pragmatic approach would
be to compare the extent of nanomaterial exposure against nominal, non-healthbased, benchmark values. Examples of such benchmark-based approaches include
that of the IFA23 and, in the Netherlands, the use of nano reference values (NRV 24).
In any event, as a minimum, it will be necessary to ensure compliance withany existing generic threshold limit values, such as general dust limit-values
for alveolar and respirable dust fractions, irrespective of the sources
contributing to these fractions (be they MNM or process generated orincidental particles). The output of such monitoring would assess theappropriateness of the control measures introduced to ensure worker safety withrespect to nanoparticle exposure since the nano-fraction of airborne particles will be
included in the respirable particle fraction.

23

24

IFA (2009): Criteria for assessment of the effectiveness of protective measures,Institut für Arbeitsschutz der Deutschen Gesetzlichen Unfall versicherung (IFA),
available
from
the
IFA
Internetsite(http://www.dguv.de/ifa/en/fac/nanopartikel/beurteilungsmassstaebe/index.jsp).
See FNV, VNO, NCW,CNV (2011) Guidance working safely with nanomaterials and products, the guidefor employers and employees, published by Dutch Ministry of Social Affairs and Employment.
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Guidance for employers and health and safety practitioners

Table 4.9: Suggested RELs and DNELs at March 2013
Substance
REL µg/m3
DNEL
µg/m3
MWCNT
Long
term
50
exposure
CNT and CNF
8-hr TWA
1
Fullerenes
Chronic
270
inhalation
DNEL
98
Ag (18-19nm)
TiO2 (10(REL)-100nm)10hr/day,
40hr/week

300

Reference
Pauluhn, 2009
25 26;
NIOSH 201327
Stone
et
al
2009 28
Stone
et
al
2009
NIOSH 2011 29

Undertaking a robust monitoring program on nanoparticles or nanofibres is, however,challenging: at the time of writing, no official occupational exposure limits (OELs)
specific to nanomaterials have been set at EU level, sampling and measurement
methods are being researched and simple methods for practical monitoring of
exposure in commercial enterprises do not exist yet (see Annex V). Under suchcircumstances, it is generally advisable to focus on applying the principles ofgood occupational hygiene and take all practicable measures to prevent orcontrol exposure in accordance with Section 4.6.
Where exposure measurements are undertaken the results should inform theimplementation of the risk management measures as suggested in the following
Section.

25

Pauluhn J (2009): Multi-walled Carbon Nanotubes (Baytubes®): Approach for Derivation of Occupational
Exposure Limit, Regulatory Toxicology and Pharmacology, DOI: 10.1016/j.yrtph.2009.12.012

26

http://apps.echa.europa.eu/registered/data/dossiers/DISS-b281d1a0-c6d8-5dcfe044-00144f67d031/DISS-b281d1a0-c6d8-5dcf-e044-00144f67d031_DISSb281d1a0-c6d8-5dcf-e044-00144f67d031.html

27

NIOSH (2013): Occupational Exposure to Carbon Nanotubes and Nanofibers,
Current Intelligence Bulletin 65, Department of Helath and Human Services,Centers for Disease Control and Prevention, National Institute for Occupational
Safety and Health.

28

Stone V et al (2009): ENRHES 2009, Engineered Nanoparticles: Review of Healthand Environmental Safety, Edinburgh Napier University. Available at:
http://www.temas.ch/Impart/ImpartProj.nsf/7903C02E1083D0C3C12576CC003DD
7DE/$FILE/ENRHES+Review.pdf?OpenElement&enetarea=03

29

NIOSH 2011, Occupational Exposure to Titanium Dioxide, Current Intelligence Bulletin 63, April 2011.
http://www.cdc.gov/niosh/docs/2011-160/pdfs/2011-160.pdf
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4.6

Step 6 – Risk Management

4.6.1 General
Measuresprinciples,

hierarchyofcontrols

and

Risk

Management

Some national guidances have evaluated and recommended Risk Management
Measures (see annex II).
The general principles for preventing risks associated with hazardous chemical agentsare set out in articles 6(1) and (2) of Occupational Health and Safety Framework
Directive 89/391/EEC and in article 5 of the CAD (reported in Box 2) can also be fully
applied to the risk management of MNMs. Currently, the identified risk of MNMs
depends on the hazardous properties of the MNM combined with the possibility of
inhalation by workers. When the MNMs used or handled within the workplace cannot
be substituted with other less hazardous chemical agents or be provided in a different
form which is not subject to inhalation (e.g. pellets), the risk must be reduced byapplying prevention or protection measures. A simple strategy is, for example,
handling MNMs in liquid media or binding them in solid media.
“Applying these principles involves integrating the basic aspects of prevention into thework organisation and, in general, using logic and common sense in work involving
hazardous chemical agents” (EC, 2004).
Their applicability to MNMs is further
explained below in box 2.

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Box 2: General principles for prevention of risks associated with hazardous
chemical agents (article 5 of the CAD)
Risks to the health and safety of workers at work involving hazardous chemical
agents shall be eliminated or reduced to a minimum by: the design and organisation of systems of work at the workplace,

the provision of suitable equipment for work with chemical agents andmaintenance procedures which ensure the health and safety of workers at work,

reducing to a minimum the number of workers exposed or likely to be exposed,

reducing to a minimum the duration and intensity of exposure,

appropriate hygiene measures, reducing the quantity of chemical agents present
at the workplace to the minimum required for the type of work concerned,

suitable working procedures including arrangements for the safe handling,storage and transport within the workplace of hazardous chemical agents andwaste containing such chemical agents.

In applying the principles, the well-established hierarchy of controls (presented inTable 4.10) should be followed. A suitable combination of the risk control measuressuggested in the following paragraphs should be adopted by employers to ensure thesafe handling of MNMs.
Table 4.10: Hierarchy of Controls
Eliminate /SubstituteThe risks posed by a MNM can be eliminated by either avoiding its
use or replacing it by a less hazardous agent, taking account of itsconditions of use.
MNMs (or its bulk form) which are classified as carcinogens ormutagens should be considered as a priority for substitution.

Modifyprocess

Change the process to reduce the extent of concern by, forexample:• Handling MNMs in liquid media or binding MNMs in solid media• Reducing the amount of MNMs handled, on any given occasion or• Changing work procedures so as to minimise the exposure

IsolateEncloseor

Engineering
Control

All operations which involve the likely release of MNMs into the air
are performed in contained installations or in facilities that can be
operated remotely from a protected area
All processes where there is the potential for creating dusts oraerosols of MNMs are carried out in areas with efficient local exhaust
ventilation. Wet cutting is recommended for cutting solid articles
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Table 4.10: Hierarchy of Controls
containing MNMs

Administrativ
e Control

Working procedures are developed for the safe handling of MNMs
and job rotation programmes to minimise individual exposure are
implemented. Workers potentially exposed to MNMs are consulted
and informed about the results of the Risk Assessment and training
courses about the control measures implemented are provided. An
Emergency Management Plan should be established.

Personal
Protective
Equipment(PPE)

PPE is a last resort control measure or a supplemental option to help
support higher levels of exposure control. PPE may include
respiratory protection devices, dermal protection and eye
protection.

Design and organisation of systems of work
In designing the work processes, risks arising from the handling of dry ultrafine
particles should be considered along with technological and economic aspects.
Provision of suitable equipment for work with MNMs and maintenanceprocedures which ensure the health and safety of workers at work
All workplaces must comply with the minimum ventilation requirements laid down in
Directive 89/654/EEC, more precisely:“5. Ventilation of enclosed workplaces
5.1. Steps shall be taken to see to it that there is sufficient fresh air in enclosed
workplaces, having regard to the working methods used and the physicaldemands placed on the workers. If a forced ventilation system is used, it shallbe maintained in working order.
Any breakdown must be indicated by a control system where this is necessary
for workers' health.
5.2. If air-conditioning or mechanical ventilation installations are used, theymust operate in such a way that workers are not exposed to draughts whichcause discomfort.
Any deposit or dirt likely to create an immediate danger to the health ofworkers by polluting the atmosphere must be removed without delay”.
The aim in designing ventilation controls should be to ensure adequate control of thepoint of exposure for all work activities which involve risk of exposure to freenanoparticles, including packing for disposal.

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The appropriateness of enclosure filtration systems will vary depending on the natureof the nanomaterial being handled. Thus, for CNTs and HARNs which show
biopersistence, exhaust air should be filtered using a HEPA filter class H14. However,ductless HEPA-filtered safety cabinets and HEPA-filtered microbiological safetycabinets may be adequate for procedures involving only small quantities (e.g. <1gram of CNTs). For nanomaterials which do not pose a specific health hazard, HEPA
filters of at least H13 should be used. However, other hood types (e.g. capturing,receiving hoods or down draught benches) may be suitable for cutting, sawing or
polishing of composite nanomaterials. Where enclosure is impractical, Local Extraction
Ventilation (LEV) systems should be designed to enclose the process as much as
possible.
Moreover, it is important to give careful consideration to the nature of any personal
protective equipment (PPE) employed. For many nanomaterials, it will be acceptable
to use laboratory coats or coveralls made from polyester/cotton or cotton in situations
where exposure may occur. Where the clothing is intended to be reusable, there is anadditional need to consider what laundering practices are appropriate. In particular,
washing outside the work premises should not be allowed in order to preclude risk of
secondary exposure.
However, for high concern MNMs, it is recommended to use protective clothing madeof materials such as polyethylene textiles since there is evidence suggesting that these
MNMs may permeate through some intact disposable overall materials and, by
implication, could pass through woven reusable materials. For the high concern MNMs,
the use of wool, cotton, poly-cotton or knitted materials is not recommended.
When selecting gloves, it should be noted that material thickness is a major
determinant of the protection provided. However, it is also essential to consider what
other substances (e.g. solvents) may be present within the workplace environment. If
it appears that latex is the safest choice, it is important to only use low-protein
powder-free gloves. Although for some nanomaterials, use of suitable disposable
single-use gloves manufactured to an appropriate standard may be acceptable. In thecase of high concern MNMs, it is recommended that at least two layers of gloves areworn.
The use of eye protection is also recommended. As a minimum, close fitting safety
glasses should be used for all nanomaterials.
Respiratory protective equipment should only be used when all other reasonably
practicable measures have been taken but have not, in themselves, achieved anadequate level of control. If used with other measures (i.e. as a secondary
precaution), disposable and half-masks should have an appropriate assigned
protection factor (APF). If a high performance mask is going to be worn for long
periods, the use of powered air flow designs should be considered. All workers
required to wear RPE should undergo face-piece fit testing and training to ensure
correct fitting and proper use.
Reducing to a minimum the number of workers exposed or likely to be
exposedThis organisational measure aims to lower the collective risk involved in working with
MNMs. However, it does not lower the individual risk. Work activities can be organised
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in order to minimise the number of workers exposed to MNMs by segregating the work
areas from the rest of the workplace and restricting access to those areas.
Reducing to a minimum the duration and intensity of exposure
In working with MNMs, particular care should be taken to minimise inhalation. This canbe achieved in two ways: by lowering the environmental concentration (e.g. throughthe installation of ventilation systems) and by minimising the exposure time to MNMs.
Often, exposure can be lowered by acting cautiously when performing simple routine
manual operations, such as opening bags, cleaning equipment by compressed air, etc.
Appropriate hygiene measures
It is particularly important that a high level of cleanliness is maintained in a workplace
where nanomaterials are present since their small size enables them to enter easily
and spread through the air where, depending on their tendency to form agglomerates,
they may remain for considerable periods. For example, airborne non-agglomerated
nanoparticles will behave much like gases and show rapid diffusion over long distances
as well as very slow sedimentation rates. For this reason, engineering and operational
control systems should seek to limit opportunities for emission or accumulation of
airborne nanoparticles in the work environment. In addition, if a spillage ofnanomaterials occurs, it is important NOT to use a brush, compressed air or astandard vacuum cleaner for cleaning up. Removal should be achieved through use of
a commercial HEPA-filtered vacuum cleaner dedicated to this purpose alone. The filter
should be regularly changed under controlled conditions to ensure containment of thecontents, which should be disposed of as hazardous waste. The vacuum cleaner itself
will also need to be treated as hazardous waste at the end of its life cycle. Lastly, thearea of spillage and any potentially contaminated equipment should be subject to wetwiping.
Reducing the quantity of MNMs present at the workplace to the minimum
required for the type of work concerned
Minimising the quantity of MNMs used or handled in each work activity leads to an
efficient reduction of the intensity of exposure and, consequently, of the magnitude of
the risk.
Suitable working procedures including arrangements for cleaning andmaintenance operations and for the safe handling, storage and transport
within the workplace of MNMs and waste containing MNMs
Cleaning of work premises and maintenance of machinery used for the processing of
MNMs should be carried out by trained workers with suitable personal protective
equipment. Wet cleaning or the use of an industrial vacuum cleaner for dust class H isadvised. When cleaning, applying a strong jet of water should be avoided, in order tominimise the possibility of suspension of dust. Cleaning with compressed air should
be avoided.
The correct design of the working procedures can prevent unnecessary exposure. The
handling, storage and transport of MNMs should be carried out by trained workers
only.
Moreover, disposal of waste contaminated with nanomaterials should adopt a
precautionary approach, unless there are known to be no potential hazards orconcerns posed by the material. Otherwise, the waste should be double-bagged or
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Guidance for employers and health and safety practitioners

doubly-contained in labelled and sealed containers and disposed of as hazardous
waste (preferably using incineration).
Emergency procedures in case of accidental release
In the event of a spillage of dry nanopowders or in any extraordinary situations thatmight result in a high exposure to MNMs, all the persons in the work premises shouldbe evacuated. The accident zone should be restricted and re-entered only once the
MNMs have settled; since a certain load of airborne MNMs should be expected in any
case, suitable PPE (such as a dust-proof suit type 5, gloves and respirator with P3
filter) should be worn during the cleaning operation.
Table 4.11 (at the end of this Section) can be used for recording the RMMs to be
implemented.

4.6.2 Risk Level 1
In general, in these situations, the risk to the health and safety of workers may be
regarded as slight within the meaning of Article 5(4) of the CAD. In addition, if theapplication of the general principles for prevention is sufficient to reduce this risk,
Article 5(4) of the Directive establishes that the provisions of Articles 6, 7 and 10 do
not need to be applied. Normally, such situations can be controlled through theuse of general ventilation.

4.6.3 Risk Level 2

In the following situations, specific prevention measures should be implemented,
in addition to what is required for risk level 1 situations:where the emission of medium-high concern MNMs is anticipated as very low or
unlikely;
where the emission of medium-low concern MNMs is probable or very low; orwhere low concern MNMs are likely to be emitted.

For risk level 2, engineering control measures such as local extraction might suffice inminimising the exposure and associated risk.
In situations leading to a risk level 2 according to table 4.7, specific prevention
measures should be implemented, in addition to what is required for risk level 1
situations. Engineering control measures such as local exhaust ventilation might
suffice in minimising the exposure and associated risk.

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Guidance for employers and health and safety practitioners

4.6.4 Risk Level 3
In the following situations, closed systems or containment must be used. A
detailed Risk Assessment, informed by exposure measurements, should be
carried out with the assistance of an expert:

where MNMs of high concern are used but their emission is expected to be verylow;where the emission of MNMs of medium-high concern is probable due to their
dustiness and the characteristics of the work activities; or

where poorly soluble/insoluble nanomaterials with no specific toxicity are likely
to be emitted.

The optimum combination of engineering control measures, administrative control
measures and the adoption of personal protective equipment by the workers
potentially exposed to the MNMs should be selected and implemented for theminimisation of the exposure.
In situations leading to a risk level 3 according to table 4.7, closed systems orcontainment must be used and their efficiency ensured by checking regularly theirperformance (this may be done by measuring key variables of the functioning of thecontrol systems and/or by measuring airborne concentrations of the MNM).
The optimum combination of engineering control measures, administrative control
measures and the adoption of personal protective equipment by the workers
potentially exposed to the MNMs should be selected and implemented to minimise
exposure.

4.6.5 Risk Level 4
In the following situations, it is essential that measures specifically designed forthe processes in question are adopted:

where MNMs have given rise to significant concerns over their potential impacts
on human health on the basis of the evidence gathered by research (namely
poorly soluble/insoluble WHO nanofibres) and where it is likely or probable thatemissions will occur during the work activities resulting in a high level of
exposure of the workers; and / or

where MNMs have given rise to a medium-high concern (namely poorly
soluble/insoluble nanoparticles with specific toxicity and poorly soluble/insoluble
HARNs other than those encompassed in concern category 1) and the MNMs
easily could be released into the atmosphere.

In situations leading to a risk level 4 according to table 4.7, it is essential thatmeasures specifically designed for the processes are adopted.
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Measurements within the facilities should be carried out in order to quantitatively
evaluate exposures. Although Occupational Exposure Limits for nanomaterials
have not been established yet, for a few specific MNMs industry and research havesuggested either specific OELs or DNELs. Such values might be used by employers as
thresholds over which additional RMMs should be implemented. A detailed Risk
Assessment (as for Section 4.5) and periodic exposure measurements should be
carried out in order to determine which RMMs need to be implemented and to verify
their effectiveness.
As a reminder and according to table 4.10, when the application of the Control
Banding results in Risk level 4, according to the hierarchy of control, employers should
consider as a first step the possibility of substituting the MNM (following an approachsimilar to that set out in the CMD for carcinogens and mutagens in the workplace). If
substitution is not possible, employers should consider how to modify processes inorder to minimise the potential emission of nanoparticles, e.g. avoiding working withdry nanopowders (dispersing the MNM in liquid media, binding it into solid matrices or,if the MNM is already in a liquid, avoiding procedures that might lead to the formationof aerosols).
If substitution/modification of working procedures is not possible or not sufficient for
the reduction of MNM emissions, employers should consider containment of thoseworking procedures and the design / introduction of closed systems.
If containment is technically not possible, consider the instalment of suitableengineering control equipment, the adoption of administrative control measures andthe provision of suitable personal protective equipment, as presented in the previous
subsection.

4.6.6 Information, Instruction and Training
Particular attention should be given to training all employees who may be exposed tonanomaterials, so that they understand the potential health concerns regarding thesematerials as well as the importance of taking all necessary precautions to avoid or
minimise exposure. This training should include clear explanation of what control
measures should be used for particular work activities or in particular parts of theworkplace. In addition, each employee should be aware of his/her responsibility toreport any defects or weaknesses in the control measures. Workers should also be
encouraged to report any problems and to suggest improvements. Employers should
also provide adequate supervision, particularly to new or inexperienced workers.
As a minimum, training on the safe handling of nanomaterials should include
instruction on:
 the risks in relation to physicochemical hazards (e.g. fire and explosion);
 the potential nature of health concerns;

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 the proper use of protective equipment (e.g. wearing appropriate personal
protection equipment before handling nanomaterials) and the need to maintainsuch equipment; and the need to comply with all operational procedures enacted to ensure
protection.
The selection of appropriate hazard labelling and pictograms should be informed by anunderstanding of the potential hazard posed by the nanomaterials used in theworkplace. In the absence of definitive information, a precautionary approach isrecommended. However, currently there is no EU-wide recognised workplace
sign/pictogram that advises specifically on the presence of nanomaterials.
Nonetheless, some organisations have developed unofficial pictograms intended todenote the presence of nanomaterials, for example, in relation to the use of a yellow
warning triangle format. The use of clearly understandable pictograms may provide a
visual indication of the presence of nanomaterials. Irrespective of considerations toemploy such unofficial pictograms, it is important to ensure that all appropriate official
risk and safety phrases and warning pictograms are in place and that the workforce
has access to all relevant information on actual or potential hazards or safety risks.

4.6.7 Health Surveillance
Article 2(f) of CAD defines the basis for monitoring the state of health of individual
workers if they are exposed to specific chemical agents. Article 10 mandates the useof such monitoring where the following conditions are simultaneously met: the worker’s exposure to a hazardous chemical agent is such that an
identifiable disease or adverse effect on health may be associated with that
exposure;
 there is a likelihood that the disease or effect may occur under the conditionsof the worker’s work; and the surveillance technique is such as to be of low risk to the worker.
The actual nature of the health surveillance that should be undertaken is defined on
the basis of the risk assessment (Article 4) and will thus vary depending on the natureof the MNM to which the worker is exposed. Various techniques may be employedincluding: the conduct of medical examination, use of health questionnaires orinterviews, or clinical pathology investigation.
In the case of MNMs, current scientific uncertainty has given rise to concerns that their
physicochemical properties may pose a risk to worker health which, as yet, is poorly
characterised. Hence, it is debatable whether, based on current knowledge, specificmedical surveillance investigations are appropriate for potentially exposed workers.

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Guidance for employers and health and safety practitioners

The health surveillance undertaken should reflect the national practices andrequirements. At a minimum, it is suggested that records are kept of all those working
with nanomaterials, as would be the case for other substances of concern.

4.7

Step 7 – Review

The risk assessment and the efficacy of the implemented risk management measures
must be reviewed periodically and before any changes in the chemical agents orworking conditions (in compliance with CAD Article 4(5)). However, the review process
is subject to the same limitations of detailed risk assessment.

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Table 4.11 Risk Management plan
Tasks
MNM
MNM
Control
Band
Physicalstate

Engineering
Controls

Administrative and
PPE
Controls

Officer
responsibleforimplementa
tion

Planneddate formeasurebeing inoperationMaterial
Receipt,
Unpacking andDeliveryLaboratoryOperations
Manufact
uring andFinishing
Cleaning
and
Maintena
nce
Storage,
PackagingandShipping
Waste
Management
ReasonableForeseen
Emergenc
ies
Other

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5.

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Guidance for employers and health and safety practitioners

INRS (2012): Valeurs limites d’exposition professionnelle aux agents chimiques en
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Annex I – Concerns over Hazards and Risks of Nanomaterials

Why do MNMs need to be treated as special case?
The reason why MNMs are of such interest and offer such potentially significant
benefits to society is that they often have very different properties to the same
substances on the macro scale – they may be more reactive, have increased strength,etc. However, these same differences also mean that they may also be more readily
absorbed into biological systems and that their hazards may be different from those of
their larger forms.
“From a toxicological point of view nanomaterials of poor solubility in biological fluids
are of special importance, because they maintain their nanostructure after contact
with the human body. Nanomaterials that are enclosed in an insoluble matrix are ofminor importance, but may become relevant as soon as they are released by e.g.
mechanical forces”. It should be noted that “most of currently relevant nanomaterials
occur in a solid aggregate state and have a (very) low solubility” (EU-OSHA, 2009).

Concerns over the Possible Hazards of Nanomaterials
Although the potential effects of nanomaterials on human health can vary from thoseof the chemical agents in macro-forms due to their specific physicochemical
characteristics, the possible mechanisms for the generation of harm remain the same:the causation can be direct, through contact, or indirect, through the production ofsome form of energy which can have an adverse effect on human health. In the firstcase, exposure might result in an “acute effect”, when the harm becomes apparent
rapidly or even immediately after contact, or in a “chronic effect”, when the harm
appears in the long term, normally due to repeated exposure over time. Moreover,
the term “local effect” is used if the harm becomes apparent at the point of contact;“systematic effect” denotes harm that appears in any point of the body regardless ofthe place where the contact occurred, normally following a process of absorption anddistribution through the body (EC, 2004). “The smallness of nanomaterials can lead toan increased potential to cross barriers in living organisms which increases thenumber of organs that can be affected” (EU-OSHA, 2009). Nanomaterials could also
cause harm by fire or explosion.
Extensive research campaigns are being conducted for the understanding of thepossible hazards of nanomaterials; “Not all nanomaterials are hazardous, not all
nanomaterials are equally hazardous and there can be considerable variation in
toxicity between nanomaterials with a similar chemical composition, because of their
physicochemical characteristics” (HSE, 2013). This section summarises the findings ofthe literature review on the workplace exposure to nanoparticles (EU-OSHA, 2009)
commissioned by the European Agency for Safety and Health at Work and conductedby members of different OSH national institutes, namely: Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (BAuA, project leader),Germany;

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 Institut National de Recherche et de Sécurité pour la prévention des accidents
du travail et des maladies professionnelles (INRS), France;
 Centralny Instytut Ochrony Pracy - Państwowy Instytut Badawczy (CIOP-PIB),
Poland; Instituto Nacional de Seguridad e Higiene en el Trabajo (INSHT), Spain.
Methods for the assessment of health effects are usually divided in four groups:• Epidemiology/occupational medicine;•

In vivo methods with animals;•

In vitro methods;•

Methods for the determination of physicochemical properties.

The OECD Working Party on Manufactured Nanomaterials (WPMN) is scrutinising theadequacy of the current test guidelines to deliver results for hazard classification of
nanomaterials and is preparing new standardised testing procedures with a particularcare on the sample preparation and dosimetry.

Concerns over Physical Hazards
There is a wide consensus on the lack of knowledge and the need for further researchon the safety risks that might be posed by nanopowders.
When handling nanopowders, particular attention should be paid to the catalytic
effects and the risk of fire or explosion. Moreover, in some specific work activities,
other possible hazards should be considered, for example:
 during the generation of a plasma via the use of high currents, hazard ofelectrocution might be increased; during work activities with possible leaks of inert protective gases there might
be an asphyxiation hazard.
Due to their greater surface area, nanoparticles can be easily charged electrostatically,
thus increasing the risk of ignition and the violence of an explosion. Furthermore, due
to their size, they might remain airborne for long periods of time, thus increasing thepossibility of creating potentially explosive dust clouds.
The Nanosafe2 project30 ranked various carbon black powders, aluminium
nanoparticles of different sizes and carbon nanotubes in terms of their flammability
and explosivity: on a scale from 0 to 3, where 0 is “no explosion”, 1 corresponds to“weak explosion”, 2 to “strong explosion” and 3 to “very strong explosion”, carbon
30

http://www.nanosafe.org/
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black and carbon nanotubes are in the dust explosion class 1 “weak explosion”, whilealuminium nanopowders, depending on the particle size, were ranked in the highest
classes 2 and 3, from “strong explosion” to “very strong explosion”.

Concerns over Health Hazards
Epidemiological studies were mainly conducted on the effects of carbon black, one the
MNMs that has been used for many decades. However, the International Agency for
Research on Cancer (IARC) evaluates carbon black as possibly carcinogenic to humans(Group 2B), as there is sufficient evidence in experimental animals but inadequate
evidence in human epidemiological studies31. Moreover, it is not certain whether
workers were exposed to carbon black at nanoscale or micro-scale. This same
uncertainty also undermines epidemiological studies on nano-titanium dioxide.
According to HEI (2013), a growing number of epidemiological studies have been
conducted over the last ten – fifteen years on the human health effects of ultrafine
particles (naturally-occurring nanoparticles). However, the evidence of adverse effects
from short-term exposure to ambient UFPs on acute mortality and morbidity from
respiratory and cardiovascular diseases is suggestive rather than conclusive. Due tounderlying deficiencies in exposure data, it is not possible to conclude (or exclude)that UFPs alone account substantially for the adverse effects associated with otherambient pollutants such as PM2.5. No epidemiological studies of long-term exposures
to UFPs have been conducted so far.
Due to the uncertain reliability of in-vitro methods to assess the health effects ofnanomaterials and the limited and inconclusive epidemiological evidence, in-vivo
studies provide most of the data on which the current concerns have been built.
Short and mid-term duration animal studies have provided evidence of toxic effects tothe lung (inflammation, cytotoxicity and tissue damage) of different types of MNMs
(e.g. carbon black, titanium dioxide, carbon nanotubes, C 60-fullerenes and amorphoussilicon dioxide). However, there is conflicting evidence on the higher potency ofnanomaterials compared to micro-sized particles. Markers of inflammation in thebrain were observed in rats following inhalation exposure to nano-manganese. Somepreliminary studies detected effects similar to those of asbestos for specificmodification of carbon nanotubes. Several types of nanomaterials have shown thecapacity of systemic distribution in the organism; however, the toxicologicalimplications of the availability of MNMs in further organs were not sufficiently
classified.
Animal studies of long-term duration raised evidence on lung toxicity following
inhalation exposure to nano-carbon black and nano-titanium dioxide and lung tumours
were evoked in rats. The intratracheal instillation of different types of MNMs (namely
carbon black, aluminium oxide, aluminium silicate, titanium dioxide, and amorphoussilicon dioxide) has induced tumours and a higher potency of nanomaterials compared
to micro sized particles have been observed. “However, there are insufficient data to
confirm the health consequences of long-term repeated exposure” (HSE, 2013).

31

http://monographs.iarc.fr/ENG/Monographs/PDFs/93-carbonblack.pdf
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The US National Institute for Occupational Safety and Health (NIOSH) has determined,
in light of the results of in-vivo studies, that exposure to ultrafine TiO2 should beconsidered a potential occupational carcinogen, acting “through a secondary
genotoxicity mechanism that is not specific to TiO2 but primarily related to particle sizeand surface area”. Moreover, “the higher mass-based potency of ultrafine TiO2
compared to micro sized TiO2 is associated with the greater surface area of ultrafine
particles for a given mass”. This has led to the setting of different Recommended
airborne Exposure Limits of 2.4 mg/m 3 for fine (micro sized) TiO2 and 0.3 mg/m3 forultrafine (nano sized) TiO2 (including manufactured nano-TiO2), as time-weighted
average (TWA) concentrations for up to 10 hours per day during a 40-hour work
week. Importantly, NIOSH concluded that the adverse effects of inhaling TiO2 may not
be material-specific but appear to be due to a generic effect of poorly soluble lowtoxicity (PSLT) particles in the lungs at sufficiently high exposure. While NIOSH
concludes that there is insufficient evidence to classify fine TiO 2 as a potential
occupational carcinogen, NIOSH is concerned about the potential carcinogenicity ofultrafine and engineered nanoscale TiO2 if workers are exposed at the current massbased exposure limits for respirable or total mass fractions of TiO 2. NIOSH
recommends controlling exposures as low as possible, below the RELs” (NIOSH,
2011).

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Annex II – Further Guidance on the Use of Nanomaterials
Readers are advised that, while the following guidance materials may be considered tobe representative of the documents available at the time of collation, this listingshould be viewed as not exhaustive. Also, in some cases the approaches suggested by
the guidance documents may not be compatible or consistent and their inclusion inthis listing should not be regarded as suggesting they necessarily constitute ‘bestpractice’ within the context of the European Union. It should appreciated also that thedevelopment of understanding in relation to the health and safety issues relating to
the manufacture and use in industry of nanomaterials is a rapidly developing area andthat revised or additional guidance materials are frequently being published by various
bodies. Therefore, users are advised to check for the latest available information that
may be available, rather than rely on the sources identified below.
In addition to the listed sources, it should be the International Organization forStandardization (ISO) publishes a series of standards and guidance materials(available
topurchase;
topicsmaybeviewedvia
Internetsite:
http://www.iso.org/iso/home.html).
Furthermore, the Organisation for Economic Co-operation and Development (OECD)
also publish on the topic of the safe use of nanomaterials in the workplace (the latest
versions are freely accessible via Internet site:
http://www.oecd.org/env/ehs/nanosafety/publicationsintheseriesonthesafetyofmanufa
cturednanomaterials.htm

Guidance published in European States
Austria
AGES (undated): Österreichisches NanoInformationsPortal "nanoinformation".
Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH., Austria.
Available at Internet site http://nanoinformation.at/arbeitswelt.html.
AUVA (undated):
Merkblatt M 310 Nanotechnologien - Arbeits- undGesundheitsschutz.
Allgemeine Unfallversicherungsanstalt, Austria.
Available at
Internetsite
http://www.auva.at/portal27/portal/auvaportal/start/startWindow?action=2&p_menui
d=15&p_tabid=1
Bundesministerium für Arbeit (2010): Leitfaden für das Risikomanagement beim
Umgang mit Nanomaterialien am Arbeitsplatz. Bundesministerium für Arbeit, Soziales
und Konsumentenschutz, Zentral-Arbeitsinspektorat, Wien, Austria.
Denmark

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Depa (2011): NanoRiskCat (NRC) - A Conceptual Decision Support Tool for
Nanomaterials. Danish Environmental Protection Agency (DEPA), Denmark. Available
at Internet site
http://www.mst.dk/Publikationer/Publications/2011/12/978-8792779-11-3.htm
FranceANSES (2008): Development of a specific Control Banding Tool for Nanomaterials.
French Agency for Food, Environmental and Occupational Health & Safety, France.
Available at Internet site http://www.anses.fr/fr
INRS (undated): Nanomaterials: definitions, toxicological risk, characterisation ofoccupational exposure and prevention measures. Institut national de recherche et desécurité,France.
Available
atInternetsite :
http://en.inrs.fr/inrspub/inrs01.nsf/IntranetObjectaccesParReference/Breve%20Occupational%20Risks%20Associated%20to%20Nanomaterials%20EN/$File/print.html
INRS (2012): Recommendations for characterizing potential emissions and exposure
to aerosols released from nanomaterials in workplace operations. Institut national derecherche et de sécurité, France. Available at Internet site http://www.hst.fr/inrspub/inrs01.nsf/IntranetObject-accesParReference/HST_ND%202355/$File/ND2355.pdf
INRS (2012): Nanomaterials. Risk prevention in laboratories. Institut national derecherche et de sécurité, France. Available at Internet site
http://www.inrs.fr/accueil/dms/inrs/CataloguePapier/ED/TI-ED-6115/ed6115.pdf
INRS (2011): Nanomaterials. Air filtration and protection of employees. Institut
national de recherche et de sécurité, France. Available at Internet site
http://www.inrs.fr/accueil/dms/inrs/CataloguePapier/ED/TI-ED-138/ed138.pdf
Germany
BAuA/VCI (2012): Empfehlung für die Gefährdungsbeurteilung bei Tätigkeiten mit
Nanomaterialien am Arbeitsplatz. Bundesanstalt für Arbeitsschutz und Arbeitsmedizin(BAuA) / Verband der Chemischen Industrie e.V. (VCI), Germany. Available at
Internet site: http://www.baua.de/de/Publikationen/Fachbeitraege/Gd4.html
BGI/GUV(2011):
SicheresArbeiteninLaboratorien
Grundlagen
undHandlungshilfen.
BG Rohstoffe und chemische Industrie. Arbeitskreis Laboratorien, Fachausschuss
Chemie, DGUV & Ausschuss für Gefahrstoffe. Available at Internet site:
http://bgi850-0.vur.jedermann.de/index.jsp.
BMAS (2013): Hergestellte Nanomaterialien. Bekanntmachungen zu Gefahrstoffen(BekGS 527). Bundesministerium für Arbeit und Soziales. Available at Internet site:
http://www.baua.de/en/Topics-from-A-to-Z/HazardousSubstances/TRGS/pdf/Announcement-527.pdf?__blob=publicationFile&v=3
Deutscher Verband Nanotechnologie e. V. (DV Nano):
Infoportal: Alles rund um "Nano"
Instrumente zur Bewertung von Nanomaterialien und -produkten
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DGUV:
BGI/GUV-I 5149 Nanomaterialien am Arbeitsplatz (PDF-Datei, 1 MB)
Tätigkeiten mit Nanomaterialien - Arbeitshilfe für Betriebsärzte
DGUV-Arbeitskreis Laboratorien:
Nanomaterialien im Labor - Hilfestellungen für den Umgang (2012) (PDF-Datei, 6 MB)
Hans-Böckler-Stiftung:Bedeutung von Nanomaterialien beim Recycling von Abfällen (2012)
Hessen-Nanotech:
Informationsplattform Nano-Sicherheit
Supplement "Innovationsfördernde Good-Practice-Ansätze zum verantwortlichen
Umgang mit Nanomaterialien"
Sichere Verwendung von Nanomaterialien in der Lack- und Farbenbranche - Ein
Betriebsleitfaden
Industriegewerkschaft Bergbau, Chemie, Energie (IG BCE):
Nanomaterialien - Herausforderung für den Arbeits- und Gesundheitsschutz
Institut für Arbeitsschutz der DGUV (IFA):
Ultrafeine Aerosole und Nanopartikel am Arbeitsplatz
Länderausschuss für Arbeitsschutz und Sicherheitstechnik (LASI):
Nanomaterialien: Schutz von Beschäftigten am Arbeitsplatz
Landesanstalt für Umwelt, Messungen und Naturschutz Baden-Württemberg(LUBW)
http://www.lubw.baden-wuerttemberg.de/servlet/is/208954/
Verband der Chemischen Industrie e.V. (VCI):
https://www.vci.de/Themen/Chemikaliensicherheit/Nanomaterialien/Seiten/Listenseite.asp
Verband der deutschen Lack- und Druckfarbenindustrie e. V.:
http://www.lackindustrie.de/Publikation/TechnischeVeroeffentlichungen/Documents/Leitfaden%20zum%20Umgang%20mit%20Nanoobjek
ten%20am%20Arbeitsplatz.pdf
Italy
INAIL (2011): Exposure to engineered nanomaterials and occupational health andsafety effects. Department of Occupational Medicine, Italian National Institute for
Occupational Safety and Prevention, Italy.
Available at Internet site:www.ispesl.it/nanotecnologie/documenti/WB_NANO_network.pdf.
The Netherlands
Delft University of Technology (TU Delft):
Nanosafety Guidelines
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Dutch Ministry of Social Affairs and Employment:
Guidance working safely with nanomaterials and nanoproducts, the guide for
employers and employees (PDF-Datei, 654 KB)
Stoffenmanager Nano Modul
Rijksinstituut voor Volksgezondheid en Milieu (RIVM):
Nanotechnology Workplace
Provisional nano-reference values: Applicability of the concept and of publishedmethods
Social and Economic Council of the Netherlands (SER):
Advisory report "Nanoparticles in the Workplace: Health and Safety Precautions"SwedenArbetsmiljöverket (2011): Carbon nanotubes - Exposure, toxicology and protective
measures in the work environment. Arbetsmiljöverket, Sweden. Available at Internet
site: www.av.se/publikationer/rapporter/
Switzerland
Bundesamt für Gesundheit (BAG):
http://www.bag.admin.ch/nanotechnologie
Bundesamt für Gesundheit (BAG) und Bundesamt für Umwelt (BAFU):
Vorsorgeraster synthetische Nanomaterialien
Innovationsgesellschaft mbH St. Gallen und TÜV SÜD:
CENARIOS® - Zertifizierbares Risikomanagement- und Monitoringsystem für die
Nanotechnologie - Faktenblatt (PDF-Datei, 271 KB)
Interessengemeinschaft Detailhandel Schweiz (IG DHS) in Zusammenarbeit
mit der Innovationsgesellschaft:
Code of Conduct Nanotechnologien
Schweizerische Unfallversicherungsanstalt (SUVA):
http://www.suva.ch/startseite-suva/praevention-suva/arbeit-suva/branchen-undthemen-filter-suva/nanopartikel-arbeitsplaetzen-suva.htm
Grenzwerte am Arbeitsplatz 2014
Factsheet "Nanopartikel und ultrafeine Partikel am Arbeitsplatz" (2012) (PDF-Datei,
101 KB)
Staatssekretariat für Wirtschaft (SECO):
http://www.bag.admin.ch/nanotechnologie/12171/12176/index.html?lang=de
Textilverband Schweiz (TVS) und Eidgenössische Materialprüfungs- undForschungsanstalt (Empa):
Projekt "NanoSafe Textiles"
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Leitfaden nano textiles
Nanomaterialien in Textilien - Umwelt-, Gesundheits- und Sicherheits-AspekteUK
HSE (2013): Using Nanomaterials at work. Health and Safety Executive, UK.
Available at Internet site: http://www.hse.gov.uk/nanotechnology/publications.htm.
Other Guidance published by European Organisations
ATI (2007): ATI Code of Practice – Nanoparticles – April 2007. Advanced Technology
Institute, University of Surrey, UK.
BASF AG. (undated): Nanotechnologie: Sicherheit und Verantwortung. BASF AG.
Available
atInternetsite
http://www.basf.com/group/corporate/nanotechnology/de/microsites/nanotechnology/
safety/index
Cefic (2012): Responsible Production and Use of Nanomaterials: Implementing
Responsible Care® 2nd Edition. European Chemical Industry Council. Available at
Internetsite
http://www.cefic.org/SearchResults/?q=nano#gsc.tab=0&gsc.q=nano&gsc.page=1
Institut für Technikfolgen-(2012):
Nanomaterialien und Aspekte desArbeitnehmerInnenschutzes – Eine Übersicht (Jänner 2012).Institut für TechnikfolgenAbschätzung der Österreichischen Akademie der Wissenschaften, Austria. Available at
Internet site http://nanotrust.ac.at/dossiers_sum.html#029.
Observatory NANO (2010): Guide to Responsible Nano-business.
nanotechnologies for the benefit of business, customers, and society.
Internet site: http://www.observatorynano.eu/project/document/3736/

How to use
Available at

PACTE (2008): Code of Conduct for the Production and Use of Carbon Nanotubes.
Producers Association of Carbon nanoTubes in Europe (PACTE), Cefic. Available at
Internet site: http://www.cefic.org/About-us/How-Cefic-is-organised/Fine-Specialityand-Consumer-Chemicals/Producer-Association-of-Carbon-Nanotubes-in-EuropePACTE
Industries Council of Occupational Health and Safety (2011): Nanoparticles in
the Working Environment. Inspiration for laboratories. Nanoparticles in the working
environment. Revised edition. Branchearbejdsmiljørådet for Undervisningog Forskning
and Industriens Branchearbejdsmiljøråd, Denmark. Available at Internet site:
http://www.ibar.dk
IUTA/BAuA/BG RCI/IFA/TUD (2011): Tiered Approach to an Exposure
Measurement and Assessment of Nanoscale Aerosols Released from Engineered
Nanomaterials in Workplace Operations. Produced by (in alphabetical order): Air
Quality and Sustainable Nanotechnology, Institute of Energy and Environmental
Technology e.V. (IUTA); Federal Institute for Occupational Safety and Health (BAuA);
German Social Accident Insurance Institution for the Raw Materials and Chemical
Industry (BG RCI); German Chemical Industry Association (VCI); Institute for
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Occupational Safety and Health of the DGUV (IFA); Research Group Mechanical
Process Engineering, Institute of Process Engineering and Environmental Technology,
Technical University Dresden (TUD. Available at:
http://www.safenano.org/KnowledgeBase/CurrentAwareness/ArticleView/tabid/168/Ar
ticleId/111/Tiered-Approach-to-Exposure-Measurement-and-Assessment-ofNanoscale-Aerosols.aspx
TUD/ IUTA/ BG RC/ BAuA/ IFA/ VCI (2012): "Ein mehrstufiger Ansatz zur
Expositionsermittlung und -bewertung nanoskaliger Aerosole, die aus synthetischen
Nanomaterialien in die Luft am Arbeitsplatz freigesetzt werden". Institut fürVerfahrenstechnik und Umwelttechnik, Technische Universität Dresden, Bereich
Luftreinhaltung & Nachhaltige Nanotechnologie, Institut für Energie- undUmwelttechnik e.V., Berufsgenossenschaft Rohstoffe und chemische Industrie,
Bundesanstalt für Arbeitsschutz und Arbeitsmedizin, Institut für Arbeitsschutz der
DGUV and Verband der Chemischen Industrie e.V., Germany.Available at Internet site
UKNSPG (2012): Guidance "Working Safely with Nanomaterials in Research &Development" (2012). UK Nano Safety Partnership Group. Available at Internet site
http://www.safenano.org/UKNanosafetyPartnership.aspx

Guidance published by Non-European Organisations
CNCHE (2012): Nano toolkit - Working Safely with Engineered Nanomaterials in
Academic Research Settings. California Nano safety Consortium of Higher Education,
USA, Available at Internet site http://www.cein.ucla.edu/resources_safety.html
Dupont/Environmental Defense Fund (undated): NANO Risk Framework.
Available at Internet site http://www.nanoriskframework.com/
ICON (undated): The Good Nano Guide. International Council on Nanotechnology.
Available at Internet site http://icon.rice.edu/projects.cfm?doc_id=12207
IRSST (2009): Best Practices Guide to Synthetic Nanoparticle Risk Management (R599). Institut de recherche Robert-Sauvé en santé et en sécurité du travail, Quebec,
Canada. Available at Internet site : http://www.irsst.qc.ca/en/-irsst-publication-bestpractices-guide-to-synthetic-nanoparticle-risk-management-r-599.html
NanoSafe Australia (2007): Current OHS best practices for the Australian
Nanotechnology industry - A Position Paper by the NanoSafe Australia Network. RMIT
University,
Melbourne,
Australia.
Available
atInternetsite:
http://www.rmit.edu.au/nanosafe
NIEHS (2012): Filling the Knowledge Gaps for Safe Nanotechnology in the Workplace(2012), National Institute of Environmental Health Sciences, USA.
Available at:
http://www.cdc.gov/niosh/docs/2013-101
NIOSH (2012): General Safe Practices for Working with Engineered Nanomaterials in
Research Laboratories. National Institute for Occupational Safety and Health (NIOSH),
USA. Available at Internet site: http://www.cdc.gov/niosh/docs/2012-147

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NSRC (2008):
Approach to Nanomaterial ES&H. Nanoscale Science ResearchCenters,
DepartmentofEnergy,USA.
Available
atInternetsite:
http://science.energy.gov/bes/suf/user-facilities/nanoscale-science-research-centers
OTA (undated):
OTA Technology Guidance Document "Nanotechnology Considerations for Safe Development", Massachusetts Office of Technical Assistance(OTA), USA. Available at Internet site: http://www.mass.gov/eea/ota
Safe Work Australia (2012): Safe handling and use of carbon nanotubes. Safe
Work
Australia.
Available
atInternetsite:
http://www.safeworkaustralia.gov.au/sites/swa/about/publications/pages/safehandling-nanotubes

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Annex III – Examples of applications of MNMs
Non-exhaustive list of applications for the most commonly used MNMs.
Table III-a: Main Application Areas of nanomaterials
MNM
Main Application Areas
Nano-silver

Nano-silver is currently the most commonly used nano-object in a wide
range of consumer products. It is used in cosmetics and personal careproducts, food and health-food, antimicrobial paints and coatings,
hygienic surfaces and packaging materials, medical applications etc.

Carbon black

Carbon black has been produced at industrial scale in high tonnage
volumes for many years, and has many applications including tyre
manufacturing and dye/pigment manufacture
Because of the high tensile strength, the main use of CNTs is in
structural materials, such as ceramic and polymer composites,
conducting composites for the aerospace, automotive and electronics
industries, and in adhesives such as epoxy resin. A major area of CNT
application is in the electronics sector

Carbonnanotubes

Fumed(amorphous)silicaFumed amorphous silica has been produced in high tonnage volumes formany years, and is widely used for a variety of applications. These
include paints and coatings, polishing microelectronic devices, foodcontact surfaces and food packaging applications. Porous silica is also
used in nano-filtration of water and beverages. Amorphous silica isbelieved to be used in food applications, such as in clearing of beers andwines, and as a free flowing agent in powdered soups (and in
condiments)

Nano-titanium Nano-titanium dioxide is produced in high tonnage volumes for main
dioxideuses in paints and coatings (as a UV absorber to help prevent UV
degradation), cosmetics (in sunscreens to prevent UV damage to skin),and packaging applications
Zinc oxide

Zinc oxide is currently produced in small but growing tonnage volumes.
It is mainly used in cosmetics and personal care products, but otherapplications such as antimicrobial packaging have also emerged recently

Nanoclays

Nanoclays are used for a variety of applications. The nanoclay mineralmost commonly used is montmorillonite (also termed as bentonite),
which is a natural clay obtained from volcanic ash/rocks. Nanoclays
have a natural nano-scaled layer structure and are often organicallymodified to bind to polymer matrices to develop improved materials,
such as composites with enhanced gas-barrier properties for foodpackaging

Nano-ceriumoxide

Nano-sized cerium oxide is used as a secondary fuel catalyst in diesel.
The application is claimed to reduce fuel consumption and particulate
emissionsNano-ironZero-valent nano-iron is finding an increasing use in water treatment
and for the remediation of contaminated soils. Nano-iron is used in thetreatment of contaminated waters, e.g. groundwater, where it is claimed
to decontaminate water by breaking down organic pollutants and killing
microbial pathogens
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Table III-a: Main Application Areas of nanomaterials
MNM

Main Application Areas

Organic
nanomaterials

A wide range of organic nanomaterials is available, or under researchand development (R&D), for uses mainly in cosmetics, food andmedicine sectors. Examples of possible uses for organic nanotechnology
include vitamins, antioxidants, colours, flavours, preservatives, active
ingredients for cosmetics and therapeutics, detergents etc. The main
tenet behind the development of nano-sized organic substances is thegreater uptake, absorption and bioavailability of bioactive substances inthe body, compared to conventional bulk equivalents

Other

Other nanomaterials that are produced at an increasing commercial
scale include metal and metal oxides of aluminium, copper, tin,
zirconium, metal nitrides (e.g. titanium nitride), alkaline earth metals(calcium, magnesium), non-metals (selenium).
Quantum dots – composed of metal (oxide), or semiconductor materials
with novel electronic, optical, magnetic and catalytic properties are alsofinding increasing applications in medical imaging and diagnostics andsecurity printing. The production of quantum dots, however, may not behigh-tonnage at present
Source: Milieu & RPA (2010)

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Annex IV – Legislation Applicable to Nanomaterials
MNMs are not covered by specific regulations but rather are subject to the same EU
and national legislation that ensures the safe handling of conventional chemicals andmixtures. There is a wide consensus that the Chemical Agents Directive 98/24/EC is
the most relevant legislative act to comply with in order to ensure the safe handling of
MNMs in the workplace.
It should be noted that nanomaterials are not explicitly included in or excluded fromthe scope of the Directive, but the “safeguard” subpara (Art. 2(b)(iii)) makes it clearthat the general objective covers them in principle and the CAD applies provided thatthe hazard is known.
The key aspect is indeed the identification of the hazard. While it is true that “hazard
identification” is the first step of a risk assessment, nevertheless the identification of a“chemical hazard” (where the identification of a hazard potentially posed by NMs
requires a similar level of knowledge) partially relies on information passed by the
supplier of the substances or mixtures through the safety data sheets accompanying
them. However, the lack of safety data sheets accompanying MNMs or the lack of
specific information on MNMs in the safety data sheet of the bulk form of the material
does not mean that MNMs cannot be identified or regarded as hazardous: as explainedby the Practical Guidelines developed by the European Commission to comply with Art.
12(2) of the CAD32: “chemical agents in the workplace may pose risks to the health orsafety of workers on account of: (…) the manner in which they are present in theworkplace (e.g.: inert solid in the form of a breathable powder)” (EC, 2004, p.13).
Moreover, in paragraph 1.1.2, the same document explains that “…any substancewhich has an exposure limit value must be regarded as a hazardous substance. This is
the case with particles of insoluble materials which are not classifiable as dangerous tohealth”.
At the pan-European level, currently there are no general exposure limits for dusts;
only certain OELs referring to specific substance dusts. However, in many Member
States there are general (default) limit values for dusts based on respirable orinhalable size criteria. As illustrative examples:

32

33

•

In France33, les Valeurs limites d’exposition professionnelle are set at 10 mg/m3
for the inhalable fraction and 5 mg/m3 for the respirable fraction.

•

In Germany34allgemeiner Staubgrenzwert (general dust limit values) have been
set up for alveolengängige Fraktion (respirable fraction) at 3 mg/m 3 and for
einatembare fraction (inhalable fraction) at 10 mg/m3;

EC (2004b): Practical Guidelines of a non-binding nature on the protection of the health and safety ofworkers from the risks related to chemical agents at work, Dok. 2261-00-00-EN final. Available at
Internetsite:
https://osha.europa.eu/fop/netherlands/nl/fop/netherlands/nl/legislation/PDFdownl
oads/2261-EN.pdf
INRS (2012): Valeurs limites d’exposition professionnelle aux agents chimiques en France, ED 984 AideMémoire Technique.
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Guidance for employers and health and safety practitioners•

In the UK35, the COSHH definition of a substance hazardous to health includes
dust of any kind when present at a concentration in air equal to or greater than
10 mg/m3 8-hour TWA of inhalable dust or 4 mg/m3 8-hour TWA of respirable
dust;

Consequently, whenever nanomaterials are present in the workplace, they are subject
to the CAD provisions. In this case, the main obligations on employers are:•to carry out risk assessments pertaining to chemical agents and their relatedrisks. These should be carried out by obtaining the necessary “additional
information […] from the supplier or from other readily available sources”.
These risk assessments need to be documented and kept up-to-date (Article4);•

to prevent chemical risk, meaning that such risks are “eliminated or reduced toa minimum”. The ways in which this should be achieved are laid out in Articles
5 and 6 and consist of, in order of priority:-

substituting hazardous agents or processes by less hazardous ones;-

designing work processes and controls to eliminate or minimise therelease of hazardous chemical agents;-

applying collective protection measures (e.g. ventilation);-

applying personal protection measures;•to have emergency provisions in place to deal with accidents, incidents andemergencies (Article 7); and•to provide information and training for workers pertaining to the results of therisk assessment carried out; the identity, risks and occupational exposure limit
values and legislative provisions of the chemical agents used in theirworkplace; and the appropriate precautions and actions to be taken (Article 8).

The CAD also re-states the OSHD obligation of employers to provide for “consultation andparticipation of workers and/or their representatives […] on the matters covered by this Directive”. In
addition to the above, there are prohibitions on four chemical agents listed in Annex
III.
A non-exhaustive list of acts and regulations supplementing the CAD which apply
within the European Union is provided below:
34

35

BAuA (2012): TRGS 900 – Technische Regeln für Gefahrstoffe – Arbeitsplatzgrenzwerte, GMBI 2012 S.
715-716 Nr.40.
HSE (2011): EH40/2005 Workplace exposure limits containing the list of workplace exposure limits foruse with the Control of Substances Hazardous to Health Regulations (as amended), Crown copyright.
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Guidance for employers and health and safety practitioners

 Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures
to encourage improvements in the safety and health of workers at work; The ATEX Directive 99/92/EC (also known as 'ATEX 137' or the 'ATEX
Workplace Directive') - requires employers to meet requirements for theprotection of workers potentially at risk from explosive atmospheres;
 Directive 2004/37/EC of the European Parliament and of the Council of 29 April
2004 on the protection of workers from the risks related to exposure tocarcinogens or mutagens at work (Sixth individual Directive within the meaningof Article 16(1) of Council Directive 89/391/EEC) (codified version) (Text with
EEA relevance); Council Directive 92/85/EEC of 19 October 1992 on the introduction of
measures to encourage improvements in the safety and health at work ofpregnant workers and workers who have recently given birth or arebreastfeeding (tenth individual Directive within the meaning of Article 16 (1) of
Directive 89/391/EEC); Council Directive 94/33/EC of 22 June 1994 on the protection of young people
at work; Council Directive 89/656/EEC of 30 November 1989 on the minimum healthand safety requirements for the use by workers of personal protective
equipment at the workplace (third individual directive within the meaning of
Article 16 (1) of Directive 89/391/EEC).

All of these worker protection laws require that employers identify hazards and carryout a risk assessment so that the potential risks identified can be eliminated or
reduced as far as is practicable.
Other regulations which apply to chemicals placed on the market include: The REACH Regulation (EC) No 1907/2006 – requiring manufacturers andimporters to gather information on the properties of their chemical substances
which will allow their safe handling. When reviewing data provided as part of aregistration under REACH, one should be aware that in many cases much of thedata provided in the registration dossier will have been generated for the bulk
form of the substance. As previously mentioned, it is duty of the supplier(according to Articles 31 and 32 of the REACH Regulation) to communicate
down the supply chain “any other available and relevant information about thesubstance that is necessary to enable appropriate risk management measures
to be identified and applied including specific conditions resulting from theapplication of Section 3 of Annex XI” (Art. 32(1)(d)). Subsequently, any
downstream user, in order to comply with the CAD and carry out a risk
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Guidance for employers and health and safety practitioners

assessment to identify the appropriate RMMs, can ask for further information(free of charge36) of the supplier about, at least, the size of the particles of thesubstance/mixture and its solubility/biopersistence characteristics, since
comprehensive toxicological research has shown without any reasonable doubtthat the inhalation of any biopersistent/poorly soluble particles can have
harmful effects on the respiratory system; The CLP Regulation (EC) No 1272/2008 - requires that chemical substancesand mixtures placed on the market are appropriately classified for their
possible hazardous effects and labelled and packaged accordingly. In light ofArticles 5(1), 6(1), 8(1)(2)(6) and 9(5), “manufacturers, importers anddownstream users shall consider the forms or physical states in which thesubstance or mixture is placed on the market and in which it can be reasonably
expected to be used”. Companies are expected to make use of the relevant
available information created, e.g. under REACH, and conduct additional testing
where required for physicochemical properties. Tests should therefore be
carried out on representative samples of the substance or mixture as it isplaced on the market. As explained in EC (2009), “a substance with different
particle sizes or forms can have different classifications, as is the case for e.g.
nickel and nickel powder (particle diameter <1 mm). If substances areproduced/imported both at nanoscale and as bulk, a separate classification andlabelling may be required if the available data on the intrinsic properties
indicates a difference in hazard class between the nanoform and ones the bulk
form”;
 The Cosmetics Regulation No 1223/2009 - requires that cosmetic products
containing nanomaterials shall be notified to the Commission, providing
physical and chemical properties of the nanomaterial, the quantity intended to
be placed on the market, its toxicological profile, the safety data and theforeseeable exposure conditions. Furthermore, it requires all ingredients in theform of nanomaterials to be clearly labelled and followed by the word “nano”;
 The Biocides Regulation No 528/2012 - requires that, where nanomaterials areused in biocidal products, the risk to human health, animal health and theenvironment shall be assessed separately and the ingredients in nano-form
clearly labelled as nanomaterials;
 The Food Information to Consumers Regulation No 1169/2011 - requires that
all ingredients present in the form of MNMs shall be labelled as nanomaterials.

This Guidance document should be read in conjunction with the available guidance oncomplying with these regulations.

36

Article 32(2) of the REACH Regulation.
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Guidance for employers and health and safety practitioners

Annex V – Challenges in Monitoring Exposure to Nanomaterials
The challenges in monitoring exposure to nanoparticles may be illustrated by thecurrent lack of consensus as to what constitutes the most appropriate metric to
describe MNM exposure. For bulk forms of substances, a mass-based measurement isgenerally employed (except in the case of fibres where a number-based metric isused); however, scientific evidence suggests that particle (or fibre) number or surface
area based measures may be of more relevance when considering NMs. Consequently,
the gravimetric measurement methods usually employed for airborne monitoring are
not ideal, and so number-based methods are generally regarded as also being
necessary. There exist a number of techniques and associated instrumentation which
may be of value for establishing exposure levels for nanoparticles (see Table V-a).
However, it should be emphasised that these have generally been developed forresearch applications, rather than routine workplace monitoring. Furthermore, it
should be noted that the available measurements methods for NMs are susceptible tospatial and temporal variability and have yet to be validated at the EU level.
Table V-a: Examples of monitoring instrumentation that may be applied for
MNM exposure measurements
DeviceCapable ofNotemeasuring(metric)
Size-selective
Mass
Cascade impactors can offer a cut point of 1
static sampler
around 100 nm
Size-selective
Mass
Subjecttotechnical
limitations
andpersonal sampler
potentially complex analysis.
Mass may also be derived by sizedistribution measurements
Tapered Element Mass
Sensitive and offering real-time monitoring
Oscillating
Microbalance(TOEM)SMPS
Mass;
Data output interpretable in terms of mass
Number;concentration and number concentration or,(Surface area)
in some circumstances, surface area
ELPI
Mass;
Offers real time monitoring.
Number;Data output interpretable in terms of mass
Surface area
concentration, number concentration or
surface area
CPC
NumberOffers real time monitoring.
Requirescustomisation
tooperatespecifically at nano-range
OpticalParticle Number
Limitations to particle size range they are
Countersuitable for
Diffusion Charger
Surface area
Offers real time monitoring.
Not all instruments of this type are suitableand even then requires customisation
Source: Adapted from Aitken et al (2011)
The situation is further complicated by the technical difficulties in attempting todifferentiate between MNMs and background sources of nano-scale particles (which
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Guidance for employers and health and safety practitioners

may be carried into the workplace in ambient air or generated as a result of processes
undertaken within the workplace). In this respect, it should be appreciated that urban
air typically contains between 10,000 to 40,000 particles per cm³ while in industrial
settings, additional nano or ultrafine-particles may arise from the operation of heating
units, fork lift trucks, vacuum cleaners and as exhaust from engines, as well asprocess-related activities such as cutting, grinding and polishing. All these various
sources will contribute to the total load in air of particles with diameters <100 nm. In
this respect, where an air monitoring program is being considered, it may be helpful
as a first step to measure the extent of nano-particulate dusts present in theworkplace as ‘background’ pollutants before beginning MNM-based operations. Thisway, any results obtained with regard to MNMs can be placed into context against
background exposures.
Further insights into the technical approaches to monitoring exposure to nano-forms
and the associated challenges may be gained from a range of published sources,
including:
Aitken et al. (2011): Specific Advice on Exposure Assessment and Hazard/Risk
Characterisation for Nanomaterials under REACH (RIP-oN 3) – Final Project Report.
Document reference RNC/RIP-oN3/FPR/1/FINAL.
HSE (undated): When to monitor. Health and Safety Executive, available at
http://www.hse.gov.uk/nanotechnology/when-to-monitor.htm
INRS (2009): Nanomaterials. Definitions, toxicological risk, characterisation ofoccupational exposure and prevention measures. L’Institut national de recherché et desecurité.
IUTA/BAuA/BG RCI/IFA/TUD (2011): Tiered Approach to an Exposure
Measurement and Assessment of Nanoscale Aerosols Released from Engineered
Nanomaterials in Workplace Operations. Produced by (in alphabetical order): Air
Quality and Sustainable Nanotechnology, Institute of Energy and Environmental
Technology e.V. (IUTA); Federal Institute for Occupational Safety and Health (BAuA);
German Social Accident Insurance Institution for the Raw Materials and Chemical
Industry (BG RCI); German Chemical Industry Association (VCI); Institute for
Occupational Safety and Health of the DGUV (IFA); Research Group Mechanical
Process Engineering, Institute of Process Engineering and Environmental Technology,
Technical University Dresden (TUD. Available at:
http://www.safenano.org/KnowledgeBase/CurrentAwareness/ArticleView/tabid/168/Ar
ticleId/111/Tiered-Approach-to-Exposure-Measurement-and-Assessment-ofNanoscale-Aerosols.aspx
Ostiguy C et al (2009): REPORT R-599. Best Practices Guide to Synthetic
Nanoparticle Risk Management. IRSST, Quebec.
Safe work Australia (2009): Engineered Nanomaterials: Evidence on
Effectiveness of Workplace Controls to Prevent Exposure, Safe work Australia.

the

VCI (2008): Responsible Production and Use of Nanomaterials.
Institute for
Occupational Safety and Health of the DGUV (IFA) Research Group Mechanical Process
Engineering, Verband der Cgmischen Industrie e V., Germany.
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