1、BSI Standards PublicationPD CEN ISO/TS 13830:2013Nanotechnologies Guidanceon voluntary labelling forconsumer products containingmanufactured nano-objectsPD CEN ISO/TS 13830:2013 PUBLISHED DOCUMENTNational forewordThis Published Document is the UK implementation of CEN ISO/TS13830:2013.The UK partici
2、pation in its preparation was entrusted to TechnicalCommittee NTI/1, Nanotechnologies.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its
3、 correctapplication. The British Standards Institution 2013. Published by BSI StandardsLimited 2013ISBN 978 0 580 64497 9ICS 07.030Compliance with a British Standard cannot confer immunity fromlegal obligations.This Published Document was published under the authority of theStandards Policy and Stra
4、tegy Committee on 31 December 2013.Amendments issued since publicationDate Text affectedTECHNICAL SPECIFICATION SPCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN ISO/TS 13830 December 2013 ICS 07.030 English Version Nanotechnologies - Guidance on voluntary labelling for consumer products containin
5、g manufactured nano-objects (ISO/TS 13830:2013) Nanotechnologies - Lignes directrices pour ltiquetage volontaire des produits contenant des nano-objets manufacturs (ISO/TS 13830:2013) Nanotechnologien - Leitfaden zur freiwilligen Kennzeichnung fr industriell hergestellte Nanoobjekte enthaltende Kons
6、umartikel (ISO/TS 13830:2013) This Technical Specification (CEN/TS) was approved by CEN on 2 December 2011 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, particular
7、ly 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 na
8、tional 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 R
9、epublic 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 COMIT EUROPEN DE NO
10、RMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. CEN ISO/TS 13830:2013 EPD CEN ISO/TS 13830:2013CEN ISO/TS 13830:2013 (E)
11、3 Foreword This document (CEN ISO/TS 13830:2013) has been prepared by Technical Committee CEN/TC 352 “Nanotechnologies”, the secretariat of which is held by BSI, in collaboration with Technical Committee ISO/TC 229 “Nanotechnologies”. Attention is drawn to the possibility that some of the elements o
12、f this document may be the subject of patent rights. CEN and/or CENELEC 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
13、 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, Sl
14、ovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO/TS 13830:2013 has been approved by CEN as CEN ISO/TS 13830:2013 without any modification. PD CEN ISO/TS 13830:2013ISO/TS 13830:2013(E) ISO 2013 All rights reserved iiiContents PageForeword ivIntrodu
15、ction v1 Scope . 12 Normative references 13 Terms and definitions . 14 Content of label 24.1 General . 24.2 Content . 35 Obtaining information from other sources 36 Format of label 46.1 General . 46.2 Placing of information 4Annex A (informative) Examples 5Bibliography 6PD CEN ISO/TS 13830:2013ISO/T
16、S 13830:2013(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject
17、 for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC)
18、on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be note
19、d. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying a
20、ny or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents).Any trade name used in this document is information given for the convenience of u
21、sers and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplemen
22、tary informationThe committee responsible for this document is ISO/TC 229, Nanotechnologies.For the purposes of research, users are encouraged to share their views on this document and their priorities for changes to future editions. Click on the link below to take part in the online survey:https:/
23、ISO 2013 All rights reservedPD CEN ISO/TS 13830:2013ISO/TS 13830:2013(E)IntroductionIt is generally agreed that nanotechnology brings benefits and better performance to enabled consumer products along with possible concerns for adverse effects, which both raise issues about the public awareness on t
24、he benefits and concerns.As nanotechnology is implemented more broadly, the number of products using nanotechnology, in particular the consumer products containing manufactured nano-objects, will increase. Any approach to affixing a label to consumer products containing manufactured nano-objects (PC
25、MNOs) should ensure accurate communication about the product and its properties and avoid misleading labelling.It is important that sufficient openness and transparency accompany the responsible introduction of new technologies to the marketplace. Labelling can help consumers to make informed choice
26、s for purchase and use. The labelling specified by this Technical Specification does not attempt to prejudge either the positive or negative effects of consumer products containing manufactured nano-objects. The purpose of the guidance in this Technical Specification is to provide a framework to fac
27、ilitate a harmonized approach for the voluntary provision of labelling for PCMNOs that may or may not exhibit or impart nanoscale phenomena. This Technical Specification is designed as voluntary guidance on conveying specific product information that a manufacturer may choose to disclose on product
28、labels and is not intended to provide mandatory labelling requirements, which are established by relevant regulatory authorities.This Technical Specification is designed for use by businesses and other organizations involved in the manufacture and distribution of consumer PCMNOs. In order to conform
29、 to this Technical Specification, all the normative clauses of this Technical Specification apply. A decision about whether to use this Technical Specification is subject to voluntary consideration. Other parties such as authorities, healthcare professionals, consumers, consumer organizations, envir
30、onmental NGOs and trade unions may also find it useful.This Technical Specification provides guidance that does not supersede or substitute for any applicable legal requirements. Product manufacturers and distributors are advised to identify and understand applicable legal requirements and guidance
31、issued by regulatory authorities. Products intended for sale in a specific country or region should conform to, and the use of this document should not conflict with, legal requirements for product labels and labelling established for that country or region. ISO 2013 All rights reserved vPD CEN ISO/
32、TS 13830:2013PD CEN ISO/TS 13830:2013Nanotechnologies Guidance on voluntary labelling for consumer products containing manufactured nano-objects1 ScopeThis Technical Specification provides guidance on the content of voluntary labels for consumer products containing manufactured nano-objects (PCMNO).
33、This Technical Specification is not applicable to consumer products that contain naturally occurring nano-objects that were not subjected to manufacturing processes. Consumer products containing nano-objects that are incidentally present (i.e. unintentional by-products of a process) are also outside
34、 the scope of this Technical Specification.2 Normative referencesThe 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 th
35、e referenced document (including any amendments) applies.ISO/TS 80004-1, Nanotechnologies Vocabulary Part 1: Core terms3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO/TS 80004-1 and the following apply.3.1consumer productproduct that is intended to be
36、 acquired and used by an individual for personal rather than professional use, excluding its packagingSOURCE: ISO 20282-1:2006, 3.2 modified3.2labelwritten, printed, graphic matter affixed to a product, imprinted on a product, or its immediate container or packaging, which displays information relat
37、ed to the product3.3labellingprovided information about a product by means of the label affixed to a product, its immediate container or packaging by a manufacturer or supplier3.4manufactured nano-objectMNOnano-object intentionally produced for commercial purposes to have specific properties or comp
38、ositionSOURCE: ISO/TS 12805, 3.33.5nano-objectmaterial with one, two or three external dimensions in the nanoscaleNote 1 to entry: Generic term for all discrete nanoscale objects.TECHNICAL SPECIFICATION ISO/TS 13830:2013(E) ISO 2013 All rights reserved 1PD CEN ISO/TS 13830:2013ISO/TS 13830:2013(E)SO
39、URCE: ISO/TS 80004-1:2010, 2.53.6nanoscalesize range from approximately 1 nm to 100 nmNote 1 to entry: Properties that are not extrapolations from a larger size will typically, but not exclusively, be exhibited in this size range. For such properties the size limits should be considered approximate.
40、Note 2 to entry: The lower limit in this definition (approximately 1 nm) is introduced to avoid single and small groups of atoms from being designated as nano-objects or elements of nanostructures, which might be implied by the absence of a lower limit.SOURCE: ISO/TS 80004-1:2010, 2.13.7nanoscale ph
41、enomenoneffect attributable to nano-objects or nanoscale regionsSOURCE: ISO/TS 80004-1, 2.133.8nanotechnologyapplication of scientific knowledge to manipulate and control matter in the nanoscale in order to make use of size- and structure-dependent properties and phenomena, as distinct from those as
42、sociated with individual atoms or molecules or with bulk materialsNote 1 to entry: Manipulation and control includes material synthesis.SOURCE: ISO/TS 80004-1, 2.33.9products containing manufactured nano-objectsPCMNOproducts in which manufactured nano-objects are intentionally added, attached or emb
43、edded4 Content of label4.1 GeneralAny voluntary statement on a label (i.e. labelling) about manufactured nano-objects present in consumer products should be accurate, substantiated and not misleading. Such labelling should be consistent with other information about the PCMNO. Statements on a label a
44、bout the manufactured nano-object should neither suggest an improvement that does not exist nor overstate the contribution of the manufactured nano-objects to the product. Statements should not suggest that a PCMNO is endorsed or certified by any organization if it is not. Symbols such as asterisks
45、may be used to draw consumers attention to additional words or statements.The organization preparing the label should be able to substantiate the labelling (i.e. the content of the label) discussed in this Technical Specification with reliable information. This information should be maintained and m
46、ay be obtained from a variety of sources, such as a website, the published literature, or reproducible and validated scientific data.The labelling conforms to this Technical Specification only when it conforms to the specific recommendations given herein; however the manufacturer has flexibility in
47、interpreting how to implement those recommendations.2 ISO 2013 All rights reservedPD CEN ISO/TS 13830:2013ISO/TS 13830:2013(E)4.2 Content4.2.1 Identification and description of manufactured nano-objectsManufacturers may voluntarily disclose the presence of manufactured nano-objects in consumer produ
48、cts, provided that such disclosure on the label does not conflict with any applicable legal requirements. For such voluntary labelling, information that the consumer product contains manufactured nano-objects should be provided either: as part of an ingredient list on the label by placing the term “
49、nano” or “nanoscale” before or after the commonly used name of the manufactured nano-object, unless the name already contains it, e.g. carbon nanotubes; or, by placing the phrase “contains manufactured nano-objects” on the label.Where it is possible, the first option is preferable.If available, a concise description of the effect of the manufactured nano-object in the product may be provided, in relation to both beneficial and risk aspects, to inform consumers and to facilitate information exchange.
