Pas 00130-2007
Pas 00130-2007
te
dKin
gdo
mo fGr
eat
Br
it
ai
nandNor
the
rnIr
el
and
≠ EDI
CTOFGOVERNMENT±
I
norde
rtop r
omotepub
li
ce d
ucat
ionandpub
li
csafe
ty,e
qualj
ust
ic
efor
a
ll
,abett
erinf
ormedci
ti
zenr
y,theru
leofla
w,wo r
ldtr
adeandwor
ld
p
eac
e,thi
sleg
aldocume
ntishere
bymadeavai
la
bleonanoncommer
cia
l
b
asi
s,a
sitisth
er i
ghto
fallhumanst
ok n
owa n
dspeakth
elawstha
t
g
ove
rnthem.
Null
iven
d e
mus
,nu
ll
ineg
abimusa
utdi
ff
ere
mu sRec
tumautJu
sti
ci
am.
Wewi
lls
el
ltonoman
,wewil
lnotde
nyord
efe
rtoa nymanei
th
erJus
ti
ceorRi
ght
.
MAGNACARTA( 1297)
PAS 130:2007
© BSI 2007
Publication history
First published December 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
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.
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).
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
0.3.1 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.
2 • © BSI 2007
PAS 130:2007
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
2.1 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.
4 • © BSI 2007
PAS 130:2007
© BSI 2007 • 5
PAS 130:2007
6 • © BSI 2007
PAS 130:2007
© BSI 2007 • 7
PAS 130:2007
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
© BSI 2007 • 9
PAS 130:2007
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.
© 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.
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
© BSI 2007 • 13
PAS 130:2007
14 • © BSI 2007
PAS 130:2007
© BSI 2007 • 15
PAS 130:2007
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
Revisions
British Standards are updated by amendment or revision. Users of British Standards
should make sure that they possess the latest amendments or editions.
It is the constant aim of BSI to improve the quality of our products and services.
We would be grateful if anyone finding an inaccuracy or ambiguity while using this
British Standard would inform the Secretary of the technical committee responsible,
the identity of which can be found on the inside front cover.
Tel: +44 (0)20 8996 9000. Fax: +44 (0)20 8996 7400.
BSI offers members an individual updating service called PLUS which ensures that
subscribers automatically receive the latest editions of standards.
Buying standards
Orders for all BSI, international and foreign standards publications should be
addressed to Customer Services. Tel: +44 (0)20 8996 9001.
Fax: +44 (0)20 8996 7001. Email: orders@bsi-global.com. Standards are also
available from the BSI website at http://www.bsi-global.com.
In response to orders for international standards, it is BSI policy to supply the BSI
implementation of those that have been published as British Standards, unless
otherwise requested.
Information on standards
BSI provides a wide range of information on national, European and international
standards through its Library and its Technical Help to Exporters Service. Various
BSI electronic information services are also available which give details on all its
products and services. Contact the Information Centre. Tel: +44 (0)20 8996 7111.
Fax: +44 (0)20 8996 7048. Email: info@bsi-global.com.
Subscribing members of BSI are kept up to date with standards developments and
receive substantial discounts on the purchase price of standards. For details of these
and other benefits contact Membership Administration. Tel: +44 (0)20 8996 7002.
Fax: +44 (0)20 8996 7001. Email: membership@bsi-global.com.
Information regarding online access to British Standards via British Standards
Online can be found at http://www.bsi-global.com/bsonline.
Further information about BSI is available on the BSI website at
http://www.bsi-global.com.
Copyright
Copyright subsists in all BSI publications. BSI also holds the copyright, in the UK, of
the publications of the international standardization bodies. Except as permitted
under the Copyright, Designs and Patents Act 1988 no extract may be reproduced,
stored in a retrieval system or transmitted in any form or by any means – electronic,
photocopying, recording or otherwise – without prior written permission from BSI.
This does not preclude the free use, in the course of implementing the standard, of
necessary details such as symbols, and size, type or grade designations. If these
details are to be used for any other purpose than implementation then the prior
written permission of BSI must be obtained.
389 Chiswick High Road Details and advice can be obtained from the Copyright & Licensing Manager.
London Tel: +44 (0)20 8996 7070. Fax: +44 (0)20 8996 7553.
W4 4AL Email: copyright@bsi-global.com.