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Pas 00130-2007

PAS 00130-2007

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0% found this document useful (0 votes)
103 views26 pages

Pas 00130-2007

PAS 00130-2007

Uploaded by

Ivan Ttofimchuk
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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BS PAS 130 (2007) (English): Guidance on the


labelling of manufactured nanoparticles and
products containing manufactured nanoparticles

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MAGNACARTA( 1297)
PAS 130:2007

PUBLICLY AVAILABLE SPECIFICATION

Guidance on the labelling


of manufactured
nanoparticles and
products containing
manufactured
nanoparticles
ICS 71.100.99

NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW


PAS 130:2007

Publishing and copyright information


The BSI copyright notice displayed in this document indicates when the
document was last issued.

© BSI 2007

ISBN 978 0 580 61315 9

Publication history
First published December 2007

Amendments issued since publication


Amd. no. Date Text affected
PAS 130:2007

Contents
Foreword iii
0 Introduction 1
1 Scope 3
2 Terms and definitions 4
3 Use of the term “nano” 5
4 What should be labelled? 5
5 Content of labels for PCMNPs for consumer use 6
6 Content of labels for PCMNPs or MNPs for professional use 8
7 Content of labels for PCMNPs or MNPs for
business-to-business use 10
8 Label statements 11
9 Characterization and hazards 11
10 Form of labels 12
11 Uncertainty and change 12
12 Links 12
Annexes
Annex A (informative) Possible application areas for MNPs 13
Annex B (informative) Examples of MNPs, chemical substances and
uses 14
Annex C (informative) Possible activities for which labelling might be
relevant 14
Annex D (informative) Examples of MNP characteristics 15
Annex E (informative) Other bodies relevant to labelling 16
Bibliography 17

Summary of pages
This document comprises a front cover, an inside front cover,
pages i to iv, pages 1 to 17 and a back cover.

© BSI 2007 • i
PAS 130:2007

ii • © BSI 2007 This page deliberately left blank


PAS 130:2007

Foreword
Publishing information
This Publicly Available Specification (PAS) has been commissioned by
the UK Department for Innovation, Universities and Skills (DIUS) and
developed through the British Standards Institution. It came into effect
on 31 December 2007.
Acknowledgement is given to the following organizations that were
involved in the development of this terminology:
• Association of British Healthcare Industries (ABHI);
• BSI Consumer and Public Interest Committee;
• Cosmetic Toiletry and Perfumery Association (CTPA) Ltd;
• Food and Drink Federation (FDF);
• IonBond Ltd;
• Nanotechnology Industries Association;
• Neville Craddock Associates;
• Oxonica;
• Quintiles Consulting Europe;
• Soil Association;
• University of Surrey.
BSI retains ownership and copyright of this PAS. BSI reserves the right
to withdraw or amend this PAS on receipt of authoritative advice that it
is appropriate to do so. This PAS will be reviewed at intervals not
exceeding two years, and any amendments arising from the review will
be published as an amended PAS and publicized in Update Standards.
This PAS is not to be regarded as a British Standard. It will be withdrawn
upon publication of its content in, or as, a British Standard.
The PAS process enables a specification to be rapidly developed in
order to fulfil an immediate need in industry. A PAS may be considered
for further development as a British Standard, or constitute part of the
UK input into the development of a European or International Standard.

Relationship with other publications


This PAS is issued as part of a suite of nanotechnology PASs:
PAS 131, Terminology for medical, health and personal care
applications of nanotechnologies;
PAS 132, Terminology for the bio-nano interface;
PAS 133, Terminology for nanoscale measurement and
instrumentation;
PAS 134, Terminology for carbon nanostructures;
PAS 135, Terminology for nanofabrication;
PAS 136, Terminology for nanomaterials.

© BSI 2007 • iii


PAS 130:2007

In selecting a title for this PAS, consideration was given to the need to
make the document accessible to a wide range of users, many of whom
might be unfamiliar with the latest thinking on terminology for
nanotechnologies. Whilst “nanoparticle” has now been defined as
“nano-object with all three external dimensions in the nanoscale”
(PAS 136, Terminology for nanomaterials), colloquial use of the term
includes all nanoscale objects, including nanotubes and nanofibres, and
that is the sense in which the term “manufactured nanoparticle” is used
in this PAS (see 2.3 below).

Contractual and legal considerations


This publication does not purport to include all the necessary provisions
of a contract. Users are responsible for its correct application.
Compliance with a Publicly Available Specification cannot
confer immunity from legal obligations.

iv • © BSI 2007
PAS 130:2007

0 Introduction
0.1 Background
Nanotechnology is an enabling technology founded on harnessing the
novel properties of materials with nanoscale dimensions or structures.
At the end of 2007, there were over 500 “nanotechnology-based
consumer products” in the marketplace worldwide and this number is
rapidly increasing. Industrial applications are also developing quickly
[A Nanotechnology Consumer Products Inventory, 2007 [1]].
The Royal Society and the Royal Academy of Engineering Report (2004)
states: “We recommend that the ingredients list of consumer products
should identify the fact that manufactured nanoparticulate material has
been added. There is an additional case in favour of labelling based on
a desire for transparency of information about consumer products.”
[Nanoscience and nanotechnologies: opportunities and
uncertainties, 2004 [2]].
This PAS builds on these recommendations by providing guidance for
both suppliers and users of manufactured nanoparticles (MNPs) and
products containing manufactured nanoparticles (PCMNPs). Currently,
there is no generic labelling requirement for either MNPs or PCMNPs,
or other regulation specific to the nanoscale properties of
nanomaterials.1) It is generally agreed that nanotechnology brings
opportunities for new industrial and consumer applications as well as
concerns about possible adverse effects on health and the environment.
This means that the use of nanotechnology presents manufacturers,
retailers and consumers with new opportunities, potential risks, and
responsibilities, all at the same time. The potential risks associated with
the use of MNPs in consumer products are not well understood.
Labelling and specifications are important tools for addressing these
new conditions. Product specifications enable businesses to reliably
select or avoid ingredients based on their nanoscale properties, to meet
general regulatory requirements and other essential conditions of
business such as insurance contracts. Appropriate consumer product
labelling is necessary to identify ingredients in nanoparticle form and to
inform consumers of their presence in final products.
Labelling should take into consideration the level of knowledge and
understanding of those who are intended to read the label, in order to
avoid any misinterpretation that could lead to confusion and misuse of
products.
Openness and transparency should accompany the responsible
introduction of new technologies to the marketplace. Labelling, as part
of this approach, helps consumers to make informed choices and should
facilitate traceability and the monitoring of health and environmental
impacts.
A common approach to labelling for this area could also help to avoid
confusing or inappropriate use of the term “nano”.

1) There are sectoral labelling and safety requirements that may be relevant to
nanotechnology.

© BSI 2007 • 1
PAS 130:2007

0.2 Purpose of this guidance


The purpose of this guidance, is
• to promote a standardized approach to labelling;
• to ensure that users of MNPs and PCMNPs can correctly identify
the MNP contents for the purposes of making informed decisions
in selection, purchase, distribution, handling, use and disposal;
• to inform regulatory authorities and assist healthcare
professionals, technicians, health and safety officers and others to
make informed decisions in relation to matters of occupational,
consumer, public and environmental health and safety;
• to standardize the use of the term “nano” in labels;
• to provide guidance on the use of other specific terms in these
labels.
For a list of possible application areas for MNPs, see Annex A.

0.3 Conceptual framework

0.3.1 Context
This guidance is set within the context of general risk governance
concepts such as transparency, upstream public engagement, the
precautionary principle, life cycle approach and traceability, which are
briefly considered in 0.3.2 to 0.3.6.

0.3.2 Transparency
Transparency enables accountability and the freedom and availability of
information, putting an onus on the provider to supply information
sufficient to allow users to make informed choices.

0.3.3 Upstream public engagement


The concept of upstream public engagement is the assumption that, in
general, it is right and beneficial for the public to be informed about and
engaged with new developments at the earliest possible stage. Thus it
puts the onus on scientific, engineering, commercial and regulatory
developers to initiate such engagement as far as possible.

0.3.4 Precautionary principle


The precautionary principle is the concept that lack of scientific
evidence of risk should not prevent appropriate precautionary actions
being taken. These should be proportionate, non-discriminatory, and
consistent with previous action, considering both costs and benefits and
be subject to review.
NOTE See European Commission, Communication on the Precautionary
Principle 2 February, 2000 – COM (2000) 1 final [3].

2 • © BSI 2007
PAS 130:2007

0.3.5 Life-cycle approach


This approach encourages manufacturers, distributors and others to
promote the safe and responsible use of nanoparticles across entire
sourcing, production, supply and disposal chains [Proceedings of the
Workshop on Nanotechnology and Life Cycle Assessment, 2007 [4]].

0.3.6 Traceability
Traceability is the system that enables products and their ingredients to
be identified retrospectively at any stage in the life-cycle. Labelling is
one source of information that facilitates this, e.g. contact information
for the producer and precise identification data such as designation,
model, production batch, serial number and/or date of manufacture.
NOTE Traceability is essential if circumstances arise after a product
has been placed on the market that require the producer to take action to
withdraw, recall or issue warning notices to consumers. Producers have a
responsibility as well as a financial incentive to take measures in advance
to limit such action to just those products affected, by uniquely identifying
products and batches.

1 Scope
This Publicly Available Specification (PAS) provides guidance on the
format and content of voluntary labels for manufactured nanoparticles
and products or substances containing manufactured nanoparticles.
This PAS also provides guidance on the use of the term “nano” in
product labelling.
This PAS does not substitute for labelling that is required by law, but
provides guidance on additional labelling.
This (voluntary) guidance is designed for use by businesses and other
organizations involved in the manufacture, distribution, supply,
handling, use and disposal of manufactured nanoparticles (MNPs) or
products containing MNPs (PCMNPs) and/or products exhibiting
nano-enabled effects.
Nanoparticulates in the liquid state, e.g. “nano” emulsions, are not
included in the scope of this PAS, unless encapsulated in a solid or gel
shell. Despite this exclusion, manufacturers of products containing
nanoparticulates in the liquid phase might find the guidance in this
PAS helpful.
This guidance does not apply to nanoparticles that are produced by
natural processes (e.g. volcanic) and which are not subjected to further
processing. Nanoparticles that are incidental (e.g. diesel combustion
and similar environmental contaminants) are also outside the scope of
this guidance.
Reference is made to the appropriate labelling of products producing
nano-enabled effects, whether or not these are produced with the use
of MNPs.

© BSI 2007 • 3
PAS 130:2007

2 Terms and definitions


For the purpose of this PAS, the following terms and definitions apply.

2.1 label
written, printed or graphic information provided on the product, its
container or packaging

2.2 labelling
information about a product provided by its manufacturer or supplier
NOTE Such information can relate, among other things, to contents,
identification, technical application, storage, transport or use.

2.3 manufactured nanoparticle (MNP)


solid entity with size from approximately 1 nm to 100 nm in at least two
dimensions that has been produced by a manufacturing process
NOTE 1 This definition includes processed nanoparticles.
NOTE 2 For examples of MNPs and their characteristics, see Annexes B
and D.
NOTE 3 The lower limit in this definition (approximately 1 nm) has no
physical significance but is introduced to avoid single and small groups
of atoms from being designated as nanoparticles, which might otherwise
be implied by the absence of a lower limit.
NOTE 4 The upper limit of approximately 100 nm does not imply that
particles with larger dimensions might not be of significance from a health
or environmental point of view.

2.4 nano-enabled effect


effect which is enabled by the use of a nanomaterial or nanostructure
NOTE 1 Examples of nano-enabled effects are non-wetting surfaces
produced using “lotus leaf” type nanostructured surfaces, enhanced
solubility of nanoparticles of a material with otherwise low solubility, and
“transparent” metal oxide based sunscreens containing non-light-
scattering nanoparticles of, for example, titanium dioxide.
NOTE 2 The presence of a nano-enabled effect does not necessarily
require the presence of a nanomaterial in the product used to produce it.
For example, a polymer which spontaneously self assembles to form a
nanostructured, non-wetting film is not necessarily itself a nanomaterial
prior to its application to the surface being treated.

2.5 product containing manufactured nanoparticles (PCMNP)


any product in which MNPs are intentionally added, mixed, attached,
embedded or suspended
NOTE For examples of application areas for MNPs, see Annex A. For
examples of MNPs and their uses, see Annex B.

2.6 processed nanoparticles


naturally occurring nanoparticles that are processed in some way prior
to supply to a customer or inclusion in a product
NOTE Such processing could include chemical, e.g. functionalization;
physical, e.g. thermal treatment; or mechanical, e.g. high shear rate
mixing. Processing that is intended to concentrate the number density of
nanoparticles is also included.

2.7 consumer products


products intended to be, or likely to be, used by consumers

4 • © BSI 2007
PAS 130:2007

2.8 products or substances for professional use


products or substances supplied to a party with recognized competence
to select and use them appropriately

2.9 products or substances for business to business use


goods supplied by one commercial entity to another commercial entity
for further processing, incorporation into other products or for resale
with or without repackaging

3 Use of the term “nano”


It is recommended that the term “nano” should only be used on a
product label if the product does in fact contain manufactured
nanoscale entities or produces a nano-enabled effect (see 2.4).
For products producing a nano-enabled effect, it is recommended that
a description is included of how the effect is achieved (e.g. “The
self-cleaning is achieved by the active liquid ingredient in this material
drying to form a nano-structured film that displays the lotus-leaf
effect.”)

4 What should be labelled?


Labelling is recommended for:
• MNPs.
• PCMNPs, except where the nanoparticle component of the product
is intimately bound and could not be released under reasonable
and foreseeable conditions of use or disposal.
• PCMNPs which are components of complex systems (e.g. a
vehicle, mobile phone or game console), which could be expected
to release MNPs under reasonable and foreseeable conditions of
use or disposal.
• By-products, where MNPs, generated as by-products, are present
in MNPs and PCMNPs and might affect the technical properties of
the product or pose a risk to health or the environment.
NOTE 1 Examples of MNPs and their uses are given in Annexes A and B.
NOTE 2 For examples of possible activities for which labelling might be
relevant, see Annex C.

© BSI 2007 • 5
PAS 130:2007

5 Content of labels for PCMNPs for


consumer use
5.1 General
This guidance provides recommendations for labelling to be provided
for PCMNPs that is additional to that required by any legal obligation or
known risks of the product (whether due to use of MNPs or to other
features of the product).
Depending on the nature of the product and how it is distributed and
used, it might be necessary to present some information, additionally,
in media other than labels on the product or packaging.
Products likely to be used by consumers within the European Union are
required to conform to the General Product Safety Directive (GPSD).
Consumer products should not be sold with known irreducible risks
inherent in their use unless consumers are provided with appropriate
information (i.e. warnings and/or instructions) enabling them to assess
the risks and protect themselves from harm.

5.2 Information required for purchase


All relevant information should be provided to enable consumers to
make an informed choice between products before purchase, without
opening any retail packaging.
It is recommended that labels on any of the following goods should
include a statement (in the form of the most appropriate of the
examples listed in 8.1) so that it is visible and legible prior to sale to
consumers expecting to find it:
a) Containers of MNPs;
b) Products (or their packaging) containing or comprising MNPs;
c) Products (or their packaging) using nano-enabled effects;
d) Products that use the prefix “nano” in promotional or descriptive
information (however, see Clause 3).
Typically this should be on the outside of retail packaging, together with
(and no less prominent than) such information as a list of ingredients,
technical specification, claims of intellectual property or indications of
compliance with specific standards.

5.3 Information required for use (instructions for


use)
Consumers using PCMNPs for the first time may not be prepared for any
greater effectiveness, efficiency, capability or other difference
compared to similar non-MNP products. Consumers should therefore be
informed or reminded in the instructions for use of different effects, if
it is necessary to have a different expectation (for example in the case
of a powder that is substantially more readily dispersible, a racquet with
greater elasticity, a skateboard or ski with less friction or an abrasive
that should be used more sparingly). It may also be helpful to repeat this
kind of advice on a label that has to be removed from the product in
order to use it.

6 • © BSI 2007
PAS 130:2007

If any different handling, maintenance, cleaning, storage or disposal of


the product is advised as a consequence of nanoparticle content (i.e.
that differs from normal practice or advice for similar non-MNP
products), this should be advised in instructions and, wherever possible,
on labels permanently attached to the product itself, or where that is
impractical, on packaging in which the product is intended to be kept
by the consumer. In the event that this is not possible, such information
should be combined with accompanying instructions for use, which
should be prominently headed: “IMPORTANT. KEEP FOR FUTURE
REFERENCE”.
Labelling should similarly be provided, if, as a consequence of
nanoparticle content, any difference is advised in normal first aid or
other medical treatment when compared with existing non-MNP
products. This would be relevant in the event of accidental
contamination or injury or in respect of action to be taken in the event
of any other unintended emergency (e.g. exposure to extreme heat or
fire).
The above instructions should be integrated with other information
required for use on labels and/or other media and be prepared and
presented in accordance with BS EN 62079:2001, or comparable
published guidance to best current practice on preparing instructions
for use of consumer products.

5.4 Information required after purchase


Information should be provided to maximize and simplify the
traceability of PCMNPs that are likely to be used by consumers. As a
minimum, wherever possible, the following information should be given
in such a way that it is visible and easily readable by consumers
expecting to find it, on labels permanently attached to the product itself
or (where that is impractical) on packaging in which the product is
intended to be kept by the consumer:
a) name, address and contact details of the producer; and
b) identification data that can be used to trace the product back as
precisely as is reasonably practicable or necessary to its date of
manufacture, raw material supplier, and/or quality inspection
checks; e.g. data such as commercial designation, model/version
and (as appropriate) a production batch, serial number or date of
manufacture.
It is recommended that where customer service departments exist in
more than one country, the telephone numbers for all countries in which
the product is likely to be sold and/or used are listed in accompanying
documents or instructions for use, which should be prominently
headed: “IMPORTANT. KEEP FOR FUTURE REFERENCE”.

© BSI 2007 • 7
PAS 130:2007

6 Content of labels for PCMNPs or


MNPs for professional use
6.1 General
The labelling of products that are likely to be used only by professional
users should meet the same user needs and follow the same information
structure as required for consumer products, (particularly in respect of
their ability to be identified and traced), but with allowance for the
greater level of common knowledge of hazards, competence in skilled
procedures, familiarity with generic terminology and ready access to
appropriate handling equipment that may be presumed to be available
to those professionals.
NOTE 1 Unlike consumers, professional users can be expected to possess
and use the knowledge and skills appropriate to their profession when
selecting and using specialist products, without direct supervision, but
they may not have control over which products are purchased for use in
their workplace. They may also be handling small quantities of a large
range of types of products or substances for a variety of successive tasks.
Products that are intended for professional use, but which it is foreseen
may also be used by consumers, should be labelled according to 5.2 and
5.3 and (if it is foreseen that they might be directly purchased by some
consumers) also according to 5.4.
NOTE 2 Although there is no umbrella legislation giving common
information requirements for products that are not used by consumers, for
every product sector there are likely to be some specific legal
requirements, transportation rules or health and safety at work guidance
to specify minimum information that is to appear on labels on each
product, unit or container. Moreover, the General Product Safety Directive
2001/95 2) (GPSD) [5] and Product Liability Directive 1985/374 3) [6]
specify that, producers owe a duty of care to foreseeable users of their
products, whether they are consumers, professionals or employees without
relevant expertise.

6.2 Information required for purchase


Product-specific information that a professional user might need should
be available at the time a purchase decision is made. Depending on
normal practice in the commercial sector, this may need to be provided
on the product itself or its packaging, and/or full technical
specifications of the product might be available through catalogues,
web sites or other reference sources (e.g. formularies or standards) that
are likely to be accessible to a professional user.
Specifications and/or promotional material should indicate whether
product-specific training is recommended by the producer, and the
availability of providers.

2) http://eur-lex.europa.eu/LexUriServ/
LexUriServ.do?uri=OJ:L:2002:011:0004:0017:en:pdf
3) http://eur-lex.europa.eu/LexUriServ/site/en/consleg/1985/L/01985L0374-
19990604-en.pdf

8 • © BSI 2007
PAS 130:2007

It is recommended that all PCMNPs sold for professional use should


indicate the presence of MNPs in any technical specification available to
potential purchasers and on any label listing ingredients, either in the
form of the most appropriate of the examples listed in 8.1, or in some
more precise description likely to be understood by the intended
professional user.

6.3 Information required for use (instructions for


use)
It should be expected that individual units of products or substances for
professional use might be handled and/or disposed of by
non-specialists, and that any additional information the latter need
when handling the unit or its packaging should be given in the labelling
of the smallest unit in which the product or substance is provided to a
professional user.
Products sold for professional use should be labelled so as to be
precisely identifiable visually (without reference to any source other
than the user’s professional knowledge) in any form, units or packaging
in which a professional user is likely to receive them (excluding outer
packaging intended purely for shipping of goods to an identified
recipient). For example, whilst a branded product name and model
number on a component or a generic chemical name on the container
of a substance might be sufficient for some professions, more detailed
information might be needed for other professions. A bar-code alone
would not enable the product to be identified correctly without access
to code-reading equipment.
Products intended for professional use should be clearly labelled with
unit-specific information. For substances this should include unit
quantity, concentration and expiry dates. For products this should
include a serial or batch number or production date.
Necessary additional instructions for use will vary with the profession,
product or practice. It may be appropriate to assume a minimum
professional competence when providing information on labels or
instructions for use. In some cases it might be that product-specific
training is required. In such cases, a warning of the need for specific
training should appear on the labelling of the smallest unit in which the
product or substance is provided to a professional user.
NOTE All instructions accompanying professional products should be
tested with potential users to ensure they are easily understood.

6.4 Information required for use after purchase


The traceability information described in 5.4 a) and b) should be
presented on a label permanently attached to the product itself or,
where that is impractical, on packaging or accompanying
documentation of the smallest unit in which the product is likely to be
stored by a professional user. If space is limited on the label
permanently attached to the product, priority should be given to
retaining the batch number or date of manufacture.

© BSI 2007 • 9
PAS 130:2007

7 Content of labels for PCMNPs or


MNPs for business-to-business use
7.1 General
Labelling of MNPs and PCMNPs supplied by one business to another
business under contract should be sufficient to ensure unambiguous
identification by the intended recipient. The purchaser should be
equipped and staffed to take responsibility for subsequent labelling for
identification and safety purposes, and maintenance of production
control systems from the point of receipt onwards.

7.2 Information required for purchase


It is recommended that for business-to-business supply of MNPs and
PCMNPs, a technical specification or list of ingredients (made available
to the purchaser before purchase) should be given, either in the form of
the most appropriate of the examples listed in 8.1, or in some more
precise description likely to be understood by the intended professional
user. Any contract or conditions of purchase (or a catalogue or
promotional material where this is relied on as a specification of the
goods) should either refer to this technical specification, or list of
ingredients, or itself include a similar statement.
If the supplier considers that specific training of the purchaser’s staff in
handling and use of its products will be required in order for the
purchaser to be able to take full responsibility for subsequent labelling
of the MNPs or PCMNPs it handles or produces, this should be stated in
the pre-sale documentation.
The contract, technical specification or other documentation should
state how the containers, units or packaging of products are to be
labelled so as to provide unambiguous identification by the intended
recipient. Where agreed, this may be no more than a bar code (plus any
labelling required for other legislative or health and safety purposes),
provided the systems employed by both parties ensure batch control.

7.3 Information required for use (instructions for


use)
Depending on normal practice in a sector or specific terms in a
particular contract, products might or might not need to be labelled
with information or instructions for use by staff in the recipient
business.

7.4 Information required after sale


Both supplier and recipient should take responsibility for co-ordinating
(and if appropriate, auditing) their systems for identification, labelling
and record keeping so as to ensure maintenance of traceability from
batches of the products output by the recipient back to batches of
materials or components produced by the supplier.

10 • © BSI 2007
PAS 130:2007

8 Label statements
8.1 Examples of label statements
• Having regard to whether the label is addressing consumers or
professional users, examples of general label statements relevant
to MNPs and PCMNPs might include the following:
• Contains manufactured nanoparticles;
• This product contains manufactured nanoparticles;
• Contains manufactured nanoparticles of X [chemical substance];
• This product contains manufactured nanoparticles of X;
• Contains 0.1g nanoparticles of X;
• Contains a dispersion of manufactured nanoparticles of X in Y.
• Titanium dioxide, size range X nm – Y nm, specific surface area
Z m2 gp1.

8.2 Other specific information


Consideration should be given, where relevant, to the inclusion of other
specific information about the MNPs such as:
• Whether free or not, i.e. whether bound in a solid matrix;
• Whether a mixture of MNPs (e.g. Contains nanoparticles of both
TiO2 and ZnO);
• Any special disposal requirements (e.g. “Return to…”, “Do not
burn…”, “Do not flush into public waste water system”);
• The specific source of the MNPs (e.g. derived from clay);
• Description of the function(s) of MNPs (e.g. use of the material in
nanoparticle form ensures more complete dissolution and hence
faster assimilation);
• Packaging information (e.g. for safe opening);
• Date information regarding the MNPs (e.g. normal practice);
• If unstable under specific conditions (e.g. UV, friction);

9 Characterization and hazards


This guidance is not intended to assist in the characterization of specific
MNPs (See PD 6699-1, Nanotechnologies – Part 1: Good practice
guide for specifying manufactured nanomaterials). However, when
labelling an item, it is relevant to consider hazards that might be
associated with its particular characteristics and use. It is recommended
that state-of-the-art life-cycle and risk-assessment methods, protocols
and data should be applied to evaluate potential nanoscale-related
hazards posed by the product in question.
Such life-cycle and risk-assessment should take into account the
relevant peer-reviewed (eco)toxicological and relevant hazard related
results, e.g. explosivity and inflammability.
For examples of MNP characteristics, see Annex D.

© BSI 2007 • 11
PAS 130:2007

10 Form of labels
10.1 Label text
In addition to fulfilling mandatory requirements, labels provide a wide
range of information, according to the product sector, including brand
name, other brand related material, proprietary and instructional
information.
Label statements about MNPs and PCMNPs should be easy to
understand, clearly legible, conspicuous and indelible.
Where an ingredients list is included, it is recommended that those in
MNP form are identified.

10.2 Negative labels


Where the use of negative labelling is considered (e.g. “this product
does not contain manufactured nanoparticles”), care should be taken
that it is accurate and verifiable and has regard to the Unfair
Commercial Practices Directive [7]. Where a product produces a
nano-enabled effect which does not result from the use of nanoparticles
the label might state this.

11 Uncertainty and change


In view of the rapid developments in nanoscale technologies regarding
the characterization and effects of MNPs, labels should not imply
knowledge or properties for which there is limited or no scientific data
available.
Users of this guidance will, as far as possible, need to keep abreast of
the research in the areas of public and occupational health, safety and
environment in respect of MNPs and PCMNPs when considering what is
relevant for the purposes of labelling.

12 Links
Links to other bodies of possible relevance to the context of this
guidance are given in Annex E.

12 • © BSI 2007
PAS 130:2007

Annex A (informative) Possible application areas for MNPs


MNPs are involved in an increasing number and range of applications,
and may roughly be divided into the following categories:
• Agricultural;
• Construction;
• Business to business materials;
• Bearings and lubricants;
• Catalysts;
• Cleaning products;
• Coatings and surfaces;
• Cosmetics;
• Electronic components;
• Energy generation and storage;
• Environmental remediation and filtration;
• Fibre optics and lasers;
• Flame retardants;
• Food and drink ingredients;
• Food contact materials;
• Food supplements;
• Fragrances;
• Garden-care products (including insecticides, herbicides and
fertilizers);
• General packaging materials;
• Home-care products (including cleaning, polishing and air
fresheners);
• Imaging;
• Insulation materials;
• Lightweight materials and components;
• Magnetic fluids;
• Medical and healthcare;
• Printing;
• Personal care (including sunscreen, moisturizers, toothpaste,
soaps)
• Recreational and sports;
• Security and defence;
• Sensors;
• Textiles and clothing;
• Tyres;
• Vehicle-care products;
• Veterinary products;
• Water purification and desalination.
NOTE Also see http://www.nanotechproject.org/44

© BSI 2007 • 13
PAS 130:2007

Annex B (informative) Examples of MNPs, chemical


substances and uses
This list of MNP chemical substances and uses is illustrative only and,
as such is far from exhaustive, and new manufactured nanoparticle
types can be introduced at any time.
• Metals, such as gold, titanium, iron, copper, aluminium, and silver,
which can be used, for example, in catalysts, medical devices, and
explosives;
• Metal oxides, such as titanium oxide, iron oxide, zinc oxide,
aluminium oxide, etc., which can be used, for example, in
polishing agents, coatings and cosmetics;
• Ceramics (nanocrystals, clays) such as talc, mica, vermiculite,
which can be used in plastic drinks bottles, juice cartons and
tennis balls;
• Forms of carbon such as fullerenes, nanotubes, and nano-fibres,
some used in anti-static coatings, field emitters, electronic devices
and tyres;
• Elemental or compound nanoparticles, for example silicon, and
cadmium selenide, used in sols, colloids, nanowires, and quantum
dots.

Annex C (informative) Possible activities for which labelling


might be relevant
• Business-to-business transactions;
• Clean-up (spills);
• Collection for recycling;
• Consumer use;
• Disposal processing;
• Distribution and storage;
• Inspection and monitoring;
• Manufacturing waste (particulates);
• Nanoparticle application manufacture;
• Nanoparticle manufacture – intermediate (for specific
applications);
• Nanoparticle manufacture – primary;
• Professional use;
• Raw material processing;
• Recycling;
• Research and development;
• Retail;
• Processing from re-use;
• Sample identification (e.g. laboratory).

14 • © BSI 2007
PAS 130:2007

Annex D (informative) Examples of MNP characteristics


• Agglomerate;
• Aggregate;
• Aspect ratio;
• Bio-reactive;
• Chemically bonded nanoparticles;
• Electrically charged;
• Explosive and inflammable;
• Free nanoparticles;
• Inorganic – metallic;
• Inorganic – non-metallic;
• Long-term persistent;
• Materials generating nanoparticles;
• Mobility in biological tissue;
• Mobility in environment;
• Mobility in fluids and gases;
• Multi-waandlled;
• Nanocrystals and quantum dots;
• Nanofibres;
• Nanofilms – by agglomeration;
• Nanofilms – not by agglomeration;
• Nanotube;
• Non-transient or stable;
• Optical properties;
• Organic;
• Organic-inorganic mix;
• Oxidative;
• Physically bonded nanoparticles;
• Polymeric;
• Self-assembling;
• Shape-specific properties;
• Single-walled;
• Size-specific properties;
• Specific quantum effects;
• Surface area: volume ratio;
• Toxic or non-toxic;
• Transient or unstable;
• Variable shape;
• Variable size.

© BSI 2007 • 15
PAS 130:2007

Annex E (informative) Other bodies relevant to labelling


Community Health & Consumer Protection Directorate (EC)
http://ec.europa.eu/dgs/health_consumer/index_en.htm
Environmental Protection Agency
http://www.epa.gov/
Food and Drug Administration (FDA)
http://www.nanotechia.co.uk/news/global/fda-nanotechnology-task-
force-sees-no-need-for-gen
For the original report see:
http://www.fda.gov/nanotechnology/taskforce/report2007.pdf
Health & Safety Executive
www.hse.gov.uk
International Council on Nanotechnology (ICON)
http://icon.rice.edu/
Institute of Occupational Medicine (UK)
http://www.iom-world.org
International Risk Governance Council
www.irgc.org
International Organization for Standardization
http://www.iso.org/iso/home.htm
Nanotechnology Industries Association
http://www.nanotechia.co.uk/
National Institute for Occupational Safety & Health (USA)
http://www.cdc.gov/niosh/topics/nanotech/strat_planINTRO.html
Trading Standards (UK)
http://www.tradingstandards.gov.uk/index.cfm

16 • © BSI 2007
PAS 130:2007

Bibliography
Standards publications
PAS 136, Terminology for nanomaterials
PD 6699-1, Nanotechnologies – Part 1: Good practice guide for
specifying manufactured nanomaterials
PD 6699-2, Nanotechnologies – Part 2: Guide to safe handling and
disposal of manufactured nanomaterials
BS EN 62079:2001, Preparation of instructions – Structuring,
content and presentation

Other publications
[1] Woodrow Wilson International Center for Scholars, Washington,
DC. A Nanotechnology Consumer Products Inventory, 2007.
See
http://www.nanotechproject.org/44]
[2] The Royal Society and the Royal Academy of Engineering (2004).
Nanoscience and nanotechnologies: opportunities and
uncertainties, p. 73.
See
http://www.nanotec.org.uk/finalReport.htm.
[3] European Commission, Communication on the Precautionary
Principle 2 February 2000 – COM (2000) 1 final.
[4] European Commission, DG Research and the Woodrow Wilson
International Center for Scholars (2007). Proceedings of the
Workshop on Nanotechnology and Life Cycle Assessment.
See
ftp://ftp.cordis.europa.eu/pub/nanotechnology/docs/
lca_nanotechnology_workshopoct2006_proceedings_en.pdf
[5] General Product Safety Directive (GPSD). Directive 2001/95/EC of
the European Parliament and of the Council of 3rd December 2001 on
General Product Safety: OJ L 11, 15.1.2002, p.4-17.
See
http://eur-lex.europa.eu/LexUriServ/
LexUriServ.do?uri=OJ:L:2002:011:0004:0017:en:pdf
[6] Product Liability Directive. Council Directive of 25th July 1985 on
the approximation of the laws, regulations and administrative
provisions of the Member States concerning liability for defective
products: OJ L 210, 7.8.1985, p.29.
See
http://eur-lex.europa.eu/LexUriServ/site/en/consleg/1985/L/
01985L0374-19990604-en.pdf
[7] Unfair Commercial Practices Directive. Directive 2005/29/EC of the
European Parliament and of the Council of 11 May 2005 concerning
unfair business-to-consumer commercial practices in the internal
market and amending Directive 84/450/EEC, Directives 97/7/EC,
98/27/EC and 2002/65/EC, and Regulation 2006/2004 of the European
Parliament and of the Council.
See
http://eur-lex.europa.eu/
LexUriServ.do?uri=OJ:L:2005:149:0022:0039:EN:PDF

© BSI 2007 • 17
PAS 130:2007

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