SIST-TS CEN/TS 17275:2019

SLOVENSKI STANDARD
kSIST-TS FprCEN/TS 17275:2018
01-september-2018
Nanotehnologija - Smernice za ravnanje z odpadki in njihovo odstranjevanje pri
proizvodnji in predelavi proizvedenih nanopredmetov
Nanotechnologies - Guidelines for the management and disposal of waste from the
manufacturing and processing of manufactured nano-objects
Nanotechnologien - Leitfaden für die Handhabung und Entsorgung des Abfalls von
hergestellten und verarbeiteten Nano-Objekten
Nanotechnologies - Lignes directrices pour la gestion et le traitement des déchets issus
de la fabrication et la transformation des nano-objets manufacturés
Ta slovenski standard je istoveten z: FprCEN/TS 17275
ICS:
07.120 Nanotehnologije Nanotechnologies
13.030.01 Odpadki na splošno Wastes in general
kSIST-TS FprCEN/TS 17275:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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kSIST-TS FprCEN/TS 17275:2018

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kSIST-TS FprCEN/TS 17275:2018


FINAL DRAFT
TECHNICAL SPECIFICATION
FprCEN/TS 17275
SPÉCIFICATION TECHNIQUE

TECHNISCHE SPEZIFIKATION

June 2018
ICS 07.120
English Version

Nanotechnologies - Guidelines for the management and
disposal of waste from the manufacturing and processing
of manufactured nano-objects
Nanotechnologies - Lignes directrices pour la gestion Nanotechnologien - Leitfaden für die Handhabung und
et le traitement des déchets issus de la fabrication et la Entsorgung des Abfalls von hergestellten und
transformation des nano-objets manufacturés verarbeiteten Nano-Objekten


This draft Technical Specification is submitted to CEN members for Vote. It has been drawn up by the Technical Committee
CEN/TC 352.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

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


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprCEN/TS 17275:2018 E
worldwide for CEN national Members.

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Contents Page
European foreword . 4
Introduction . 5
1 Scope . 8
2 Normative references . 8
3 Terms and definitions . 8
4 Abbreviations .14
5 Regulatory framework .15
6 General environmental and waste management .15
7 Risk assessment and management .19
8 Waste tracking .19
9 Classification of waste .20
10 Pre-disposal procedures of WMP-MNOs by companies producing and processing
MNOs .23
11 Transport and storage of WMP-MNOs .26
12 Selection of disposal and treatment routes for WMP-MNOs .28
13 Management of WMP-MNOs during waste disposal .37
14 Accident management plan .43
Annex A (informative) European legislation including the treaty, relevant for waste .46
A.1 European waste related legislation .46
A.2 Packaging Labelling (CLP) .48
A.3 Regulation (EU) No 528/2012 Biocidal products .49
A.4 REACH Regulation (EC) No 1907/2006 .49
A.5 Directive 1999/92/EC Explosive atmospheres .49
A.6 Other regulations not referenced in the document: .49
A.7 National legislation.50
A.8 International treaty .50
Annex B (informative) Tools for source reduction of production waste .51
B.1 General .51
B.2 Organizational waste prevention approaches .51
B.2.1 Strategic planning .51
B.2.2 Implementation of a waste prevention programme .52
B.2.3 Good housekeeping .53
B.3 Technical and science-based source reduction approaches .54
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Annex C (informative) CLP hazard classes and categories . 56
C.1 General . 56
Annex D (informative) Indication of applicability of 850 ˚C and 1 100 ˚C incineration
processes for MNOs . 58
Bibliography . 60

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European foreword
This document (FprCEN/TS 17275:2018) has been prepared by Technical Committee CEN/TC 352
“Nanotechnologies”, the secretariat of which is held by AFNOR.
This document is currently submitted to the Vote on TS.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association.
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Introduction
Innovation in nanotechnology is linked with commercial developments that use nanomaterials to deliver
new products or services to the market. In recent years, nanotechnology has moved from the research
laboratory to the manufacturing plant and into consumer products. Manufactured nano-objects (MNOs)
can be incorporated in products to enhance their performance and create new properties. In the process
of making such products, using them or disposing them at the end of their life, MNOs may be released and
come in contact with humans and the environment. As of yet, MNO producers and the scientific
community do not have a complete understanding of whether nanomaterials, particularly MNOs pose a
risk to the health of workers, consumers and the environment. It is thought that some MNOs may pose a
hazard to human health and the environment.
Nanomaterials include nano-objects and nanostructured materials. Nano-objects may be naturally
occurring, incidental [CEN ISO/TS 80004-1:2015, 2.10], engineered or manufactured
[CEN ISO/TS 80004-1:2015, 2.9]. In general, naturally occurring and incidental nano-objects are emitted
into the atmosphere by natural process or as a by-product of a process (for example welding fume,
combustion fume). Engineered nano-objects (ENOs) or MNOs, a very specific class of nanomaterials, are
sometimes incorporated in products to achieve new or enhanced / improved properties, which are only
attainable with nanotechnology. In some cases, they may be substituted for highly toxic substances, may
lead to waste reduction, or may extend the longevity of a product.
MNOs may have distinct physicochemical properties as a result of their nanoscale formulation. Thus, they
may exhibit hazards and risks to human health and to the environment distinct from those presented by
non-nanoscale materials. There is therefore a need for specific guidance on the assessment and
management of the human health and environmental hazards and risks associated with the management
and disposal of waste from the manufacturing and processing of manufactured nano-objects
(WMP-MNOs).
The manufacturing of MNOs and their incorporation in products may involve multi-stage processes,
including primary synthesis, precipitation, sorting, chemical or physical separation and purification, as
well as incorporation in intermediate products.
Each process in the manufacturing chain may generate process wastes, residues and diffuse release of
MNOs or their aggregates and agglomerates. Process wastes may result from:
— making more or buying more than necessary (for example overproduction, large batches or excess
items that remain in stock);
— making batches that are not at the correct specification or requirements of the customer; and
— making batches with expired specifications or requirements.
Diffuse release means the (unintended) release of chemicals to air, groundwater and soil, which occur in
a diffuse way due to processes such as migration or dispersing, and which should be avoided. Diffuse
emissions can be controlled via, for example, waste collection and adequate waste treatment, where
MNOs will be either eliminated or accumulated in a controlled system.
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In general, WMP-MNOs are expected to be in a powder form, in a liquid suspension and /or contaminated
items. Nano-objects resulting from the manufacturing and processing of MNOs can be classified in two
categories:
— nano-objects having the same physical and chemical identity as the final intended nano-object
production batch, which are generated during manufacturing and processing;
— nano-objects being production residues or being the result of a non-conformed batch production
(production refuse). Their physico-chemical characteristics may be known, partially known or
unknown due to unintended transformation processes.
Powder-form and liquid WMP-MNOs can be composed purely of nano-objects and non-nanoscale
particles.
The industry involved in nanotechnology and nanomaterials is a linear network as illustrated in Figure 1.
It involves organizations ranging from raw material producers (suppliers of MNOs), modifiers (producers
of semi-products obtained by modifying the composition or the surface of MNOs), to formulators and
users of nanomaterials (who incorporate MNOs or semi-products in finished products, resulting in
nanostructured materials or nanocomposites).

Figure 1 — Overview of the nanotechnology and nanomaterials industry
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Disposal routes for non-nanoscale materials are well known and well-regulated in all EU member states
by national and the EU directives. It is not the intention of this document to lead on this. This document
serves as a guideline to the safe waste management of WMP-MNOs and provides guidelines for all waste
management activities from the manufacturing and processing of MNOs as illustrated in Figure 1 by the
dotted lines.
This Technical Specification (TS) aims to provide guidance for all waste management activities associated
with the manufacturing and processing of MNOs including the management of process waste, residues
and diffuse emissions of MNOs and takes into account the uncertainties in this emerging technology and
the potential for human and environmental exposure.
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1 Scope
This document provides guidelines for all waste management activities from the manufacturing and
processing of manufactured nano-objects.
The guidelines apply to all actors in the waste management chain, namely MNO manufacturers, MNO
modifiers, as well as waste disposal companies and carriers and consignees of WMP-MNOs.
This document does not intend to provide guidelines on the management and disposal of
nanocomposites, waste derived from consumer products containing nano-objects or waste containing
only naturally occurring or incidental nano-objects. Also excluded from the scope are any waste from
non-nanoscale materials resulting from the manufacturing and processing of MNOs.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
• IEC Electropedia: available at http://www.electropedia.org/
• ISO Online browsing platform: available at http://www.iso.org/obp
3.1 Nanotechnologies general terms
3.1.1
engineered nano-object
nano-object (3.1.6) designed for specific purpose or function
[SOURCE: CEN ISO/TS 80004-2:2017, 4.1]
3.1.2
incidental nano-object
nano-object (3.1.6) generated as an unintentional by-product of a process
Note 1 to entry: The process includes manufacturing, biotechnological or other processes.
[SOURCE: CEN ISO/TS 80004-2:2017, 4.3]
3.1.3
manufactured nano-object
nano-object (3.1.6) intentionally produced to have selected properties or composition
[SOURCE: CEN ISO/TS 80004-2:2017, 4.2]
3.1.4
nanocomposite
solid comprising a mixture of two or more phase-separated materials, one or more
being nanophase (2.12 of CEN ISO/TS 80004-1:2015)
Note 1 to entry: Gaseous nanophases are excluded [they are covered by nanoporous material (3.4 of
CEN ISO/TS 80004-1:2015)].
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Note 2 to entry: Materials with nanoscale (3.1.7) phases formed by precipitation alone are not considered to be
nanocomposite materials.
[SOURCE: CEN ISO/TS 80004-4:2011, 3.2]
3.1.5
nanomaterial
material with any external dimension in the nanoscale (3.1.7) or having internal structure or surface
structure in the nanoscale
Note 1 to entry: This generic term is inclusive of nano-object (3.1.6) and nanostructured material (3.1.8).
Note 2 to entry: See also definitions 2.8 to 2.10 of CEN ISO/TS 80004-1:2015.
[SOURCE: CEN ISO/TS 80004-1:2015, 2.4]
3.1.6
nano-object
discrete piece of material with one, two or three external dimensions in the nanoscale (3.1.7)
Note 1 to entry: The second and third external dimensions are orthogonal to the first dimension and to each other.
[SOURCE: CEN ISO/TS 80004-1:2015, 2.5]
3.1.7
nanoscale
length range approximately from 1 nm to 100 nm
Note 1 to entry: Properties that are not extrapolations from larger sizes are predominantly exhibited in this length
range.
[SOURCE: CEN ISO/TS 80004-1:2015, 2.1]
3.1.8
nanostructured material
material having internal nanostructure (3.1.9) or surface nanostructure
Note 1 to entry: This definition does not exclude the possibility for a nano-object (3.1.6) to have internal structure
or surface structure. If external dimension(s) are in the nanoscale (3.1.7), the term nano-object is recommended.
[SOURCE: CEN ISO/TS 80004-1:2015, 2.7]
3.1.9
nanostructure
composition of inter-related constituent parts in which one or more of those parts is a nanoscale (3.1.7)
region
Note 1 to entry: A region is defined by a boundary representing a discontinuity in properties.
[SOURCE: CEN ISO/TS 80004-1:2015, 2.6]
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3.2 Waste general terms
3.2.1
ash
solid residue of effectively complete combustion
[SOURCE: ISO 29464:2017, 3.2.20]
3.2.2
flue gas
gaseous product of combustion including excess air and particulate matter in form of aerosols
Note 1 to entry: Adapted from EN ISO 13705:2012, 3.1.31.
3.2.3
groundwater
water which is being held in, and can usually be recovered from, an underground formation
[SOURCE: ISO 6107-1:2004, 41]
3.2.4
intermediate products
output from a unit process that is input to other unit processes that require further transformation within
the system
[SOURCE: EN ISO 14050:2010, 6.2.1]
3.2.5
landfill
waste disposal site for the deposit of waste on to or into land under controlled or regulated conditions
[SOURCE: ISO 15270:2008, 3.18]
3.2.6
leachate
liquid that has percolated through solid wastes
[SOURCE: ISO/TR 14685:2001, 2.29]
3.2.7
contaminant
pollutant
substance (solid, liquid or gas) that negatively affects the intended use of a fluid
[SOURCE: ISO 29464:2017, 3.1.8]
3.2.8
residue
material left over from consumption or a process
[SOURCE: ISO 6707-1:2017, 3.8.12]
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3.2.9
sedimentation
process of settling and deposition, under the influence of gravity, of suspended matter carried by water
or wastewater
[SOURCE: ISO 6107-1:2004, 62]
3.2.10
sewage
domestic wastewater
water-borne wastes of a community
[SOURCE: ISO 6107-1:2004, 65]
3.2.11
sludge
accumulated settled solids separated from various types of water as a result of natural or artificial
processes
[SOURCE: ISO 6107-1:2004, 67]
3.2.12
surface water
water which flows over, or rests on, the surface of a land mass
[SOURCE: ISO 6107-1:2004, 74]
3.2.13
waste
substances or objects with the holder intends or is required to dispose of
Note 1 to entry: This definition is taken from the Basel Convention on the Control of Transboundary Movements of
Hazardous Wastes and Their Disposal (22 March 1989), but is not confined in this International Standard to
hazardous waste.
[SOURCE: EN ISO 14040:2006, 3.35]
unneeded or useless matter which is to be discarded
[SOURCE: ISO 18309:2014, 3.6]
3.2.14
waste treatment
chemical or physical processing, or both, of waste for interim or ultimate disposal
Note 1 to entry: Adapted from ISO 12749-3:2015, 3.7.12.
3.2.15
waste management
all administrative and operational activities involved in the handling, pretreatment, treatment,
conditioning, transport, material storage, and disposal of waste
Note 1 to entry: Adapted from ISO 12749-3:2015, 3.7.7.
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3.3 Waste management terms
3.3.1
consignor
party which, by contract with a carrier, consigns or sends goods with the carrier, or has them conveyed
by him
[SOURCE: ISO/TS 24533:2012, 2.13]
3.3.2
carrier
person or organization, which owns and/or operates a transport means, engaged in the transportation
of passengers or property by land, rail, air or water
[SOURCE: ISO/TS 24533:2012, 2.7]
3.4 Waste treatment terms
3.4.1
aerobic condition
descriptive of a condition in which dissolved oxygen is present
[SOURCE: ISO 6107-1:2004, 5]
3.4.2
anaerobic condition
descriptive of a condition in which dissolved oxygen, nitrate and nitrite are absent
[SOURCE: ISO 6107-1:2004, 6]
3.4.3
centrifugation
partial removal of water from wastewater sludge by centrifugal force
[SOURCE: ISO 6107-1:2004, 11]
3.4.4
chemical treatment
process involving the addition of chemicals to achieve a specific result
[SOURCE: ISO 6107-1:2004, 12]
3.4.5
chemical coagulation
process of adding a chemical (the coagulant) which causes the destabilization and aggregation of
dispersed colloidal material into flocs
[SOURCE: ISO 6107-1:2004, 13]
3.4.6
filtration
treatment process whereby water is passed through a porous layer of material in order to remove
particulate matter
[SOURCE: ISO 6107-1:2004, 36]
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3.4.7
flocculation
formation of large separable particles by aggregation of small particles; the process is usually assisted by
mechanical, physical, chemical or biological means
[SOURCE: ISO 6107-1:2004, 38]
3.4.8
flotation
raising of suspended matter in water to the surface, for example by the entrainment of a gas on the
suspended matter
[SOURCE: ISO 6107-1:2004, 39]
3.4.9
incineration
controlled burning of waste products or other combustible materials in an incinerator or similar
apparatus
[SOURCE: ISO 16165:2013, 2.11.1]
3.4.10
incinerator
device constructed for the purpose of disposing of materials through thermal oxidation
[SOURCE: ISO 16165:2013, 2.11.2]
3.4.11
reverse osmosis
flow of water through a membrane from a more concentrated to a less concentrated solution, as a result
of applying pressure to the more concentrated solution in excess of the normal osmotic pressure
[SOURCE: ISO 6107-1:2004, 61]
3.4.12
sedimentation
process of settling and deposition, under the influence of gravity, of suspended matter carried by water
or wastewater
[SOURCE: ISO 6107-1:2004, 62]
3.5 Waste analysis terms
3.5.1
electrokinetic potential
zeta potential
difference in electric potential between that at the slipping plane and that of the bulk liquid
Note 1 to entry: Electrokinetic potential is expressed in volts.
[SOURCE: ISO 13099-1:2012, 2.1.8]
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3.6 Health and safety general terms
3.6.1
harm
injury or damage to the health of people, or damage to property or the environment
[SOURCE: ISO/IEC Guide 51:2014, 3.1]
3.6.2
risk
combination of the probability of occurrence of harm and the severity of that harm
Note 1 to entry: The probability of occurrence includes the exposure to a hazardous situation (3.4), the occurrence
of a hazardous event (3.3) and the possibility to avoid or limit the harm.
[SOURCE: ISO/IEC Guide 51:2014, 3.9]
3.6.3
safety
freedom from risk (3.6.2) which is not tolerable
[SOURCE: ISO/IEC Guide 51:2014, 3.14]
3.6.4
tolerable risk
level of risk (3.6.2) that is accepted in a given context based on the current values of society
Note 1 to entry: For the purposes of this Guide, the terms “acceptable risk” and “tolerable risk” are considered to
be synonymous.
[SOURCE: ISO/IEC Guide 51:2014, 3.15]
4 Abbreviations
For the purposes of this document, the following abbreviations apply.
APF Assigned Protection Factor
BAT Best Available Techniques
BEP Best Environmental Practice
BFs Bag Filters
BOD Biochemical Oxygen Demand
BREF Best Available Techniques Reference Document
CLP Classification Labelling and Packaging
CMTR carcinogens, mutagens, teratogens and reproductive toxicants
CNTs Carbon Nanotubes
COD Chemical Oxygen Demand
EMAS Eco-Management and Audit Scheme
EMS Environmental Management Systems
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ENO Engineered Nano-Object
ESPs Electrostatic precipitators
EWC European Waste Catalogue
FFP Filtering Face Piece
FGC Flue Gas Conditioning
HDPE High-Density Polyethylene
IBC Intermediate Bulk Container
MNO Manufactured Nano-Object
MWCNT Multi Wall Carbon Nanotubes
NOAA nano-objects, and their agglomerates and aggregates greater than 100nm
PPE Personal Protective Equipment
PM Particulate matter
(Q)SAr Quantitative Structure–Activity relationship
R&D Research and Development
RPE Respiratory Protective Equipment
STOT Specific target organ toxicity
STW Sewage Treatment Works
WAC Waste Acceptance Criteria
WFD Waste Framework Directive
WI Waste Incineration
WMP-MNO Waste from the Manufacturing and Processing of Manufactured Nano-Objects
5 Regulatory framework
This clause aims to provide guidelines for manufacturers or modifiers of MNOs, companies handling
WMP-MNOs during transport or storage and companies pre-treating or treating WMP-MNOs.
There is currently no regulatory provision specific to the waste management of nanomaterials and MNOs
in Europe but other regulatory frameworks apply. Nanomaterials in general and MNOs in particular are
part of chemicals regulation and waste management leading to compliance requirement under all existing
regulations. Annex A provides a map of the regulatory framework and inform the reader of the main
European relevant regulations.
6 General environmental and waste management
6.1 General
This clause is predominantly aimed at proving guidelines to manufacturers or modifiers of MNOs.
6.2 General environmental management
The adoption of environmental management systems (EMS) has been proven to ensure improved
practices and outcomes with regards to ensuring the safety of workers and the environment across all
lifecycle stages of products.
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The most widely used EMSs in Europe are the Regulation (EC) No 1221/2009 of the European Parliament
and of the Council of 25 November 2009 on the voluntary participation by organisations in a Community
eco-management and audit scheme (EMAS) [1] and EN ISO 14001:2015 [2]. EMAS references ISO
standards, which provides an environmental management framework and guidelines for
implementation.
Risk assessment and risk management underpin sound environmental management and further details
are provided in Clause 7.
Waste management forms a sub-activity of environmental management and should therefore ideally be
considered within the context of an overarching EMS.
Best Available Techniques (BAT) Reference Document (BREF) and Best Environmental Practice (BEP)
for waste treatment of chemical substances are relevant and can provide useful guidance for the
reduction of MNOs release in waste streams (for example Best Available Techniques (BAT) Reference
Document for Waste Treatment. Industrial Emissions Directive 2010/75/EU (Integrated Pollution
1
Prevention and Control): Final Draft (October 2017) [3]).
6.3 General principles for management of WMP-MNOs
In addition to the general waste management principles described in 6.1, the following specific principles
apply:
1) all waste emerging from the manufacturing and processing of MNOs should be treated in accordance
with the waste management hierarchy. Generation of waste should therefore be prevented at each
production and processing stage of MNOs to ensure overall waste minimization;
2) there is no regulatory framework specific to WMP-MNOs in Europe, but other regulatory frameworks
apply on chemical substances and on waste management. These legal requirements must be
complied with;
3) it is the responsibility of the producer of the waste material to take reasonable steps to evaluate the
potential hazards associated with the MNO, to know how to manage associated risks in the handling,
use, storage and eventual waste management of the production or processing facility;
4) in the absence of sufficient knowledge of the specific hazards of the MNO(s), the MNO(s) should
always be classified at least as hazardous as the non-nanoscale fo
...