CEN/TS 16937:2016

SLOVENSKI STANDARD
01-september-2016
Nanotehnologija - Navodila za odgovoren razvoj nanotehnologije
Nanotechnologies - Guidance for the responsible development of nanotechnologies
Nanotechnologien - Leitfaden zur verantwortungsvollen Entwicklung von
Nanotechnologien
Nanotechnologies - Guide pour le développement responsable des nanotechnologies
Ta slovenski standard je istoveten z: CEN/TS 16937:2016
ICS:
07.120 Nanotehnologije Nanotechnologies
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

CEN/TS 16937
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
May 2016
TECHNISCHE SPEZIFIKATION
ICS 07.030
English Version
Nanotechnologies - Guidance for the responsible
development of nanotechnologies
Nanotechnologies - Guide pour le développement Nanotechnologien - Leitfaden zur
responsable des nanotechnologies verantwortungsvollen Entwicklung von
Nanotechnologien
This Technical Specification (CEN/TS) was approved by CEN on 22 March 2016 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.

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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 16937:2016 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Introduction . 4
1 Scope . 5
2 Normative references . 5
3 Terms and definitions . 5
4 Methodology . 8
4.1 General . 8
4.2 Board Accountability . 8
4.3 Stakeholder Involvement . 8
4.4 Worker Health and Safety . 8
4.5 Benefits to and Risks for Public Health, Safety and the Environment . 9
4.6 Wider Social and Ethical implications and impacts . 11
4.7 Engagement with Business Partners. 11
4.8 Transparency and Disclosure . 11
Bibliography . 12

European foreword
This document (CEN/TS 16937:2016) has been prepared by Technical Committee CEN/TC 352
“Nanotechnologies”, the secretariat of which is held by AFNOR.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to announce this Technical Specification: 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, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Introduction
Nanotechnology-related development brings novel functionalities to materials, and new applications.
They have been accompanied by a societal demand to assess their effects, given the lack of (reliable)
information related to this novel area. While assessing risks, benefits, lack of (reliable) information, or
ambiguity, is not specific to this field, the question of responsible development, including societal and
ethical aspects, is often raised in the context of nanotechnologies. As the technology matures, lack of
(reliable) information should be reduced and the risks associated with the use of such technology
should be minimised. Ambiguity may arise in presence of contradictory scientific results and diversity
of opinions, and should as far as possible be reduced over time. Making appropriate decisions regarding
policy, strategy, human health and the environment, safety or communication in nanotechnology is
therefore a task that most small, medium and large organisations involved in this field face today.
It is therefore clear that making the right decisions in an open, transparent and balanced manner is
critical for industry to continue to develop nanotechnologies responsibly.
Organisations working in the nanotechnology area should ensure to develop and implement an
appropriate set of norms with the same approach for all products or services of the organization.
To ensure the responsible development of nanotechnologies, this Technical Specification (TS) provides
a guidance to communication and interaction with relevant stakeholders. It describes the process that
an organization or group of organisations may choose to follow to ensure accountability, transparency,
safety (for workers, consumers, and for the environment) and clear communication.
The approach proposes to compare benefits and risks of nanotechnology activities, and seeks to
encourage the implementation of preventive or corrective actions before commercialisation (such as
design modification).
This Technical Specification can be used by organisations working in nanotechnology supply chains,
academia, policy makers and non-governmental organisations (NGOs). This Technical Specification may
also be used by the organisations providing services to the industry such as consulting, finance or
insurance companies.
This Technical Specification provides guidance that does not supersede or substitute for any applicable
legal requirements.
1 Scope
This Technical Specification provides a guidance for the responsible development of nanotechnologies
taking into account:
— Board Accountability;
— Stakeholder Involvement;
— Worker Health and Safety;
— Benefits to and Risks for Public Health, Safety and the Environment;
— Wider Social and Ethical Implications and Impacts;
— Engagement with Business Partners;
— Transparency and Disclosure.
NOTE 1 This Technical Specification contributes to social responsibility as defined in ISO 26000:2010.
NOTE 2 Nanotechnology activities include industrial production, R&D, services, and marketing of products.
This Technical Specification neither covers labelling and advertising aspects nor is it intended for
certification purposes, nor does it imply any legally binding agreements.
This Technical Specification intends to cover nanotechnology activities involving manufactured
nanomaterials, and where relevant incidental nanomaterials.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
CEN ISO/TS 80004-1:2015, Nanotechnologies – Vocabulary – Part 1: Core terms (ISO/TS 80004-1:2015)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in CEN ISO/TS 80004-1:2015 and
the following apply.
3.1
ambiguity
plurality of legitimate viewpoints, multiple values and perspectives for both conducting and evaluating
the science and information used for decision-making, for the interpretation of decision outcomes and
justifying judgements about their tolerability and acceptability
3.2
benefit
positive impact(s) to stakeholders such as consumers, citizens or companies, related to the
nanotechnology activity
Note 1 to entry: Environmental aspects are included.
3.3
consumer
individual member of the general public purchasing or using property, products or services for private
purposes
[SOURCE: ISO 26000:2010, 2.2]
3.4
incidental nanomaterials
nanomaterial (3.6) generated as an unintentional by-product of a process
Note 1 to entry: The process includes manufacturing, bio-technological or other processes.
Note 2 to entry: See “ultrafine particle” in ISO/TR 27628:2007, 2.21.
[SOURCE: CEN ISO/TS 80004-1:2015, 2.10]
3.5
manufactured nanomaterial
nanomaterial (3.6) intentionally produced to have selected properties or composition
[SOURCE: CEN ISO/TS 80004-1:2015, 2.9]
3.6
nanomaterial
material with any external dimension in the nanoscale (3.7) or having internal structure or surface
structure in the nanoscale
Note 1 to entry: This generic term is inclusive of nano-object (CEN ISO/TS 80004-1:2015, 2.5) and
nanostructured material (CEN ISO/TS 80004-1:2015, 2.7).
Note 2 to entry: See also engineered nanomaterial (CEN ISO/TS 80004-1:2015, 2.8), manufactured
nanomaterial (3.5) and incidental nanomaterial (3.4).
[SOURCE: CEN ISO/TS 80004-1:2015, 2.4]
3.7
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]
3.8
nanotechnology
application of scientific knowledge to manipulate and control matter predominantly in the nanoscale
(3.7) to make use of size- and structure-dependent properties and phenomena distinct from those
associated with individual atoms or molecules or extrapolation from larger sizes of the same material
Note 1 to entry: Manipulation and control includes material synthesis.
[SOURCE: CEN ISO/TS 80004-1:2015, 2.3]
3.9
organization
entity or group of people and facilities with an arrangement of responsibilities, authorities and
relationships and identifiable objectives
Note 1 to entry: For the purposes of this International Standard (ISO 26000:2010, 2.12), organization does not
include government acting in its sovereign role to create and enforce law, exercise judicial authority, carry out its
duty to establish policy in the public interest or honour the international obligations of the state.
Note 2 to entry: Clarity on the meaning of small and medium-sized organizations (SMOs) is provided in
ISO 26000:2010, 3.3.
[SOURCE: ISO 26000:2010, 2.12]
3.10
product
any goods or service
[SOURCE: EN ISO 14040:2006, 3.9, modified – deletion of Notes 1 to 3]
3.11
professional user
user with recognized competence to select and use products appropriate to its profession, without
direct supervision, but not necessarily having control over which products are purchased for use in its
workplace
3.12
risk
effect of uncertainty on objectives
Note 1 to entry: An effect is a deviation from the expected —, positive and/or negative.
Note 2 to entry: Objectives can have different aspects (such as financial, health and safety, and environmental
goals) and can apply at different levels (such as strategic, organization-wide, project, product and process).
Note 3 to entry: Risk is often characterized by reference to potential events (ISO Guide 73:2009, 3.5.1.3) and
consequences (ISO Guide 73:2009, 3.6.1.3) or a combination of these.
Note 4 to entry: Risk is often expressed in terms of a combination of the consequences of an event (including
changes in circumstances) and the associated likelihood (ISO Guide 73:2009, 3.6.1.1) of occurrence.
Note 5 to entry: Uncertainty is the state, even partial, of deficiency of information related to, understanding or
knowledge of, an event, its consequence or its likelihood
Note 6 to entry: In the context of this Technical Specification, risks are related to negative effects, and benefits
(3.2) are related to positive effects. Nanotechnology risk evaluation and manag
...