CEN/TS 16937:2016

Nanotechnologies - Guidance for the responsible development of nanotechnologies

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.

Nanotechnologien - Leitfaden zur verantwortungsvollen Entwicklung von Nanotechnologien

Die vorliegende Technische Spezifikation gibt Leitlinien für die verantwortungsvolle Entwicklung von Nanotechnologien unter Berücksichtigung von Folgendem:
   Verantwortlichkeit des Vorstands;
   Einbeziehung von Stakeholdern;
   Gesundheitsschutz und Arbeitssicherheit von Arbeitnehmern;
   Vorteile und Risiken für die öffentliche Gesundheit, Sicherheit und Umwelt;
   umfassendere soziale und ethische Auswirkungen und Einflüsse;
   Beteiligung von Geschäftspartnern;
   Transparenz und Offenlegung.
ANMERKUNG 1   Diese Technische Spezifikation trägt zur gesellschaftlichen Verantwortung bei, wie in ISO 26000:2010 festgelegt.
ANMERKUNG 2   Die Nanotechnologieaktivitäten umfassen die industrielle Herstellung, Forschung und Entwicklung, Dienstleistungen und Vermarktung von Produkten.
Diese Technische Spezifikation deckt weder Aspekte der Kennzeichnung und Werbung ab, noch ist sie für Zertifizierungszwecke vorgesehen und enthält keine rechtsverbindlichen Vereinbarungen.
Diese Technische Spezifikation soll Nanotechnologieaktivitäten unter Einbeziehung industriell hergestellter Nanomaterialien und gegebenenfalls unbeabsichtigter Nanomaterialien abdecken.

Nanotechnologies - Guide pour le développement responsable des nanotechnologies

La présente Spécification technique fournit un guide pour le développement responsable des nanotechnologies tenant compte :
-   de la responsabilité du conseil d'administration ;
-   de l'implication des parties prenantes ;
-   de la santé et de la sécurité des travailleurs ;
-   des bénéfices et des risques pour la santé publique, la sécurité et l'environnement ;
-   des conséquences et des impacts éthiques et sociaux plus étendus ;
-   de l'engagement vis-à-vis des partenaires commerciaux ;
-   de la transparence et de la communication.
NOTE 1   La présente Spécification technique contribue à la responsabilité sociétale telle que définie dans l'ISO 26000:2010.
NOTE 2   Les activités liées aux nanotechnologies comprennent la production industrielle, les activités de recherche et développement, les services et la commercialisation des produits.
La présente Spécification technique ne traite pas des aspects liés à l'étiquetage et à la publicité ; elle n'est pas non plus destinée à des fins de certification et n'implique aucun accord juridiquement contraignant.
La présente Spécification technique vise à couvrir les activités liées aux nanotechnologies impliquant des nanomatériaux manufacturés et, le cas échéant, des nanomatériaux « incidentels ».

Nanotehnologija - Navodila za odgovoren razvoj nanotehnologije

Ta tehnična specifikacija podaja smernice za odgovoren razvoj nanotehnologij ob upoštevanju naslednjih točk:
– odgovornost vodstvenega odbora;
– vključenost deležnikov;
– zdravje in varnost delavcev;
– koristi in tveganja za javno zdravje, varnost in okolje;
– širše družbene in etične posledice ter vplivi;
– sodelovanje s poslovnimi partnerji;
– preglednost in razkritje.
OPOMBA 1: ta tehnična specifikacija prispeva k družbeni odgovornosti, kot je opredeljeno v standardu ISO 26000:2010.
OPOMBA 2: področja dejavnosti nanotehnologije vključujejo industrijsko proizvodnjo, raziskovanje in razvoj, storitve in trženje proizvodov.
Ta tehnična specifikacija ne zajema vidikov označevanja in oglaševanja, ni predvidena za namene certificiranja in ne označuje pravno zavezujočega sporazuma.
Ta tehnična specifikacija zajema področja dejavnosti nanotehnologije, ki vključujejo namensko in (kjer je to ustrezno) slučajno proizvedene nanomateriale.

General Information

• Status: Published
• Publication Date: 24-May-2016
• ICS: 03.100.02 - Governance and ethics
• ICS: 07.030 - Physics. Chemistry
• ICS: 07.120 - Nanotechnologies
• Technical Committee: CEN/TC 352 - Nanotechnologies
• Drafting Committee: CEN/TC 352/WG 1 - Measurement, characterization and performance evaluation
• Current Stage: 9093 - Decision to confirm - Review Enquiry
• Start Date: 06-Jan-2020
• Completion Date: 14-Apr-2025
• Ref Project: SIST-TS CEN/TS 16937:2016 - Nanotechnologies - Guidance for the responsible development of nanotechnologies

Overview

CEN/TS 16937:2016 - "Nanotechnologies - Guidance for the responsible development of nanotechnologies" - is a CEN Technical Specification offering practical guidance for organizations involved in nanotechnology activities. It focuses on responsible development of manufactured and, where relevant, incidental nanomaterials across R&D, industrial production, services and marketing. The document is advisory (not a certification or legally binding standard) and complements social responsibility guidance such as ISO 26000:2010.

Key Topics

The Technical Specification structures a responsible-development methodology into seven core areas:

• Board Accountability - assign management-level responsibility for nanotechnology strategy, assessment and oversight.
• Stakeholder Involvement - identify and engage stakeholders (workers, customers, NGOs, academia, regulators) in multilateral dialogue and decision-making.
• Worker Health and Safety - apply up-to-date occupational health and safety practices, document risk assessments and transparently report incidents.
• Benefits and Risks for Public Health, Safety and the Environment - perform early-stage risk/benefit assessments (preferably at design phase) and consider preventive or corrective measures prior to commercialization.
• Wider Social and Ethical Implications - consider societal impacts, ambiguity in scientific evidence, and ethical concerns during development.
• Engagement with Business Partners - align supply-chain partners on responsible practices and share expectations across the value chain.
• Transparency and Disclosure - communicate decisions, assessment methods and outcomes openly to stakeholders while respecting privacy and legal constraints.

Important clarifications: the TS does not cover labelling or advertising and is not intended for certification or legal enforcement.

Applications

CEN/TS 16937:2016 is practical for:

• Corporate governance bodies and CSR/EHS managers establishing nanotechnology policies.
• R&D and product design teams integrating early-stage risk/benefit analyses to reduce downstream hazards.
• Health & safety officers implementing worker protection and incident reporting for nanomaterial handling.
• Supply-chain managers and procurement aligning business partners on responsible practices.
• Policy makers, NGOs, academics, insurers and investors evaluating organizational approaches to nanotechnology governance and transparency.
  Typical uses include risk assessment planning, stakeholder engagement frameworks, transparency and disclosure policies, and due-diligence processes before commercialization.

Related Standards

The TS references and complements existing guidance:

• CEN ISO/TS 80004-1:2015 (Nanotechnologies - Vocabulary)
• ISO 26000:2010 (Social responsibility)
• ISO 31000 (Risk management) and sector-specific guidance such as ISO/TR 13121 and ISO/TS 12901 series for nanotechnology risk evaluation and management.

CEN/TS 16937:2016 is a practical, stakeholder-focused framework to help organizations manage safety, ethical and societal aspects of nanotechnologies while improving transparency and trust.

Standards Content (Sample)

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 management is further described in
ISO/TR 13121:2011 and ISO/TS 12901-1:2012 and ISO/TS 12901-2:2014.
[SOURCE: ISO Guide 73:2009, 1.1, modified – addition of a new Note 6 to entry]
3.13
stakeholder
individual or group that has an interest in any decision or activity of an organization (3.9)
[SOURCE: ISO 26000:2010, 2.20]
4 Methodology
4.1 General
The methodology is composed of seven sections addressed in the scope. Following this Technical
Specification only partially may make it more difficult to demonstrate to other stakeholders the
fundamental principles in a responsible development such as accountability, transparency, safety
(workers, consumers safety and environmental safety) and communication. The user of this Technical
Specification is therefore advised to implement the responsible methodology in its entirety (all seven
sections) as described below.
Due to issues of translation to other languages (e.g. French or German) it is important to remind the
user that neither “accountability” nor the “responsibility” are to be understood as legal obligations in
the context of this Technical Specification.
4.2 Board Accountability
The user of this Technical Specification should ensure appropriate accountability at management level.
Appropriate staff should be assigned in the organization to deal with accountability in guiding and
managing the development in nanotechnology.
The appointed staff should consider, understand, assess and minimize any adverse human health,
environmental and safety, societal and ethical issues associated with the organization’s involvement
with nanotechnology activities.
4.3 Stakeholder Involvement
The user of the Technical Specification should identify the concerned stakeholders and proactively
engage with them. The engagement should be more than just information dissemination and should
provide a platform for a multilateral dialogue.
Stakeholders may (not exclusively) involve workers, customers (business-to-business and end-
consumers), shareholders, suppliers, non-governmental organisations (NGOs), civil society
organisations, academics, consumer bodies, trade unions, national governments, international
governing bodies and the general public.
The user of the Technical Specification should be able to demonstrate how stakeholder views have been
considered. As agreement with all stakeholders is not always possible the organization should be able
to justify the decisions taken in the case of lack of agreement.
The user should define with stakeholders how they will be involved. Indeed stakeholders might be
involved under different perspectives, like but not limited to understanding and advising on the
function of the product, identifying alternatives, defining metrics to assess the risks and the benefits,
understanding and resolving lack of (reliable) information and ambiguities (for instance regarding the
risk assessment).
The user of the Technical Specification and the stakeholders initially engaged in the process should
decide in common at an initial stage whether the situation needs to include additional stakeholders.
More emphasis on the involvement of stakeholders, and a diversity of stakeholders is relevant in
situations where risks or benefits are particularly complex, where there is a significant lack of (reliable)
information, and especially if there is ambiguity.
4.4 Worker Health and Safety
The organization should ensure high standards of occupational health and safety for its workers. The
arrangements for the protection and safety of workers shall satisfy all regulatory requirements imposed
by regulators. Such requirements shall be met before using this Technical Specification and should be
considered as a minimum set of requirements.
CEN
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