1、PAS 130:2007Guidance on the labelling of manufactured nanoparticles and products containing manufactured nanoparticlesICS 71.100.99NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWPUBLICLY AVAILABLE SPECIFICATIONPublishing and copyright informationThe BSI copyright notice displa
2、yed in this document indicates when the document was last issued. BSI 2007ISBN 978 0 580 61315 9Publication historyFirst published December 2007Amendments issued since publicationAmd. no. Date Text affectedPAS 130:2007 BSI 2007 iPAS 130:2007ContentsForeword iii0 Introduction 11 Scope 32 Terms and de
3、finitions 43 Use of the term “nano” 54 What should be labelled? 55 Content of labels for PCMNPs for consumer use 66 Content of labels for PCMNPs or MNPs for professional use 87 Content of labels for PCMNPs or MNPs for business-to-business use 108 Label statements 119 Characterization and hazards 111
4、0 Form of labels 1211 Uncertainty and change 1212 Links 12AnnexesAnnex A (informative) Possible application areas for MNPs 13Annex B (informative) Examples of MNPs, chemical substances and uses 14Annex C (informative) Possible activities for which labelling might be relevant 14Annex D (informative)
5、Examples of MNP characteristics 15Annex E (informative) Other bodies relevant to labelling 16Bibliography 17Summary of pagesThis document comprises a front cover, an inside front cover, pages i to iv, pages 1 to 17 and a back cover.PAS 130:2007ii BSI 2007 This page deliberately left blank BSI 2007 i
6、iiPAS 130:2007ForewordPublishing informationThis 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
7、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; Nanotechnolo
8、gy Industries Association; Neville Craddock Associates;Oxonica; Quintiles Consulting Europe;Soil Asociation; 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.
9、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 Br
10、itish 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.Rela
11、tionship with other publicationsThis 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;
12、PAS 134, Terminology for carbon nanostructures;PAS 135, Terminology for nanofabrication;PAS 136, Terminology for nanomaterials.PAS 130:2007iv BSI 2007In 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
13、 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 nan
14、otubes 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 considerationsThis publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct applicatio
15、n.Compliance with a Publicly Available Specification cannot confer immunity from legal obligations. BSI 2007 1PAS 130:20070Introduction0.1 Background Nanotechnology is an enabling technology founded on harnessing the novel properties of materials with nanoscale dimensions or structures. At the end o
16、f 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 Rep
17、ort (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.” Nanoscien
18、ce 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 requ
19、irement 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
20、. 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 specificatio
21、ns 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. Appropriat
22、e 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 mis
23、interpretation 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
24、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.PAS 130:20072 BSI 20070.2 Purpose of
25、this guidanceThe 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 reg
26、ulatory 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 guidanc
27、e 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 framework0.3.1 ContextThis guidance is set within the context of general risk governance concepts such as transparency, upstream public engagement, the precautionary pr
28、inciple, life cycle approach and traceability, which are briefly considered in 0.3.2 to 0.3.6.0.3.2 TransparencyTransparency 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 choice
29、s.0.3.3 Upstream public engagementThe 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, commercia
30、l and regulatory developers to initiate such engagement as far as possible.0.3.4 Precautionary principleThe 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-discriminat
31、ory, 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. BSI 2007 3PAS 130:20070.3.5 Life-cycle approachThis approach encourages manufacture
32、rs, 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 TraceabilityTraceability is the system that enables products and t
33、heir 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 manufac
34、ture.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
35、 limit such action to just those products affected, by uniquely identifying products and batches.1 ScopeThis Publicly Available Specification (PAS) provides guidance on the format and content of voluntary labels for manufactured nanoparticles and products or substances containing manufactured nanopa
36、rticles. 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
37、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, unles
38、s 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 no
39、t 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 produce
40、d with the use of MNPs.PAS 130:20074 BSI 20072 Terms and definitionsFor the purpose of this PAS, the following terms and definitions apply.2.1 labelwritten, printed or graphic information provided on the product, its container or packaging2.2 labellinginformation about a product provided by its manu
41、facturer 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
42、 manufacturing processNOTE 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
43、 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-enab
44、led effecteffect which is enabled by the use of a nanomaterial or nanostructureNOTE 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
45、” 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 a
46、ssembles 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 F
47、or examples of application areas for MNPs, see Annex A. For examples of MNPs and their uses, see Annex B.2.6 processed nanoparticlesnaturally 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.
48、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 BSI 2007 5PAS 130:2007
49、2.8 products or substances for professional useproducts or substances supplied to a party with recognized competence to select and use them appropriately 2.9 products or substances for business to business usegoods supplied by one commercial entity to another commercial entity for further processing, incorporation into other products or for resale with or without repackaging3 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 c
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