1、BSI Standards PublicationPD CEN ISO/TS 13830:2013Nanotechnologies Guidanceon voluntary labelling forconsumer products containingmanufactured nano-objectsCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted withou
2、t license from IHS-,-,-PD CEN ISO/TS 13830:2013 PUBLISHED DOCUMENTNational forewordThis Published Document is the UK implementation of CEN ISO/TS13830:2013.The UK participation in its preparation was entrusted to TechnicalCommittee NTI/1, Nanotechnologies.A list of organizations represented on this
3、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 correctapplication. The British Standards Institution 2013. Published by BSI StandardsLimited 2013ISBN 978 0 580 64497 9ICS 07.03
4、0Compliance with a British Standard cannot confer immunity fromlegal obligations.This Published Document was published under the authority of theStandards Policy and Strategy Committee on 31 December 2013.Amendments issued since publicationDate Text affectedCopyright European Committee for Standardi
5、zation Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-TECHNICAL SPECIFICATION SPCIFICATION TECHNIQUE TECHNISCHE SPEZIFIKATION CEN ISO/TS 13830 December 2013 ICS 07.030 English Version Nanotechnologies - Guidance on voluntary l
6、abelling for consumer products containing 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 h
7、ergestellte Nanoobjekte enthaltende Konsumartikel (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 reques
8、ted 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.
9、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, Denm
10、ark, 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
11、 FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION 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 ECopyright
12、European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-PD CEN ISO/TS 13830:2013CEN ISO/TS 13830:2013 (E) 3 Foreword This document (CEN ISO/TS 13830:2013) has been prepared by Technical Committee
13、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 of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held
14、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, Esto
15、nia, 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. Endorsement notice The
16、text of ISO/TS 13830:2013 has been approved by CEN as CEN ISO/TS 13830:2013 without any modification. Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-PD CEN ISO/TS 13830:2013ISO/
17、TS 13830:2013(E) ISO 2013 All rights reserved iiiContents PageForeword ivIntroduction 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 informat
18、ion 4Annex A (informative) Examples 5Bibliography 6Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-PD CEN ISO/TS 13830:2013ISO/TS 13830:2013(E)ForewordISO (the International Orga
19、nization 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 for which a technical committee has been establis
20、hed 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) on all matters of electrotechnical standardization
21、.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 noted. This document was drafted in accordance with th
22、e 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 any or all such patent rights. Details of any paten
23、t 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 users and does not constitute an endorsement.For an
24、 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 - Supplementary informationThe committee responsible for this
25、 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:/ ISO 2013 All rights reservedCopyright European Com
26、mittee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-PD CEN ISO/TS 13830:2013ISO/TS 13830:2013(E)IntroductionIt is generally agreed that nanotechnology brings benefits and better performance to enabled con
27、sumer products along with possible concerns for adverse effects, which both raise issues about the public awareness on the benefits and concerns.As nanotechnology is implemented more broadly, the number of products using nanotechnology, in particular the consumer products containing manufactured nan
28、o-objects, will increase. Any approach to affixing a label to consumer products containing manufactured nano-objects (PCMNOs) should ensure accurate communication about the product and its properties and avoid misleading labelling.It is important that sufficient openness and transparency accompany t
29、he responsible introduction of new technologies to the marketplace. Labelling can help consumers to make informed choices 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
30、 manufactured nano-objects. The purpose of the guidance in this Technical Specification is to provide a framework to facilitate 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 designe
31、d as voluntary guidance on conveying specific product information that a manufacturer may choose to disclose on product 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
32、 businesses and other organizations involved in the manufacture and distribution of consumer PCMNOs. In order to conform 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 volunt
33、ary consideration. Other parties such as authorities, healthcare professionals, consumers, consumer organizations, environmental 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. P
34、roduct manufacturers and distributors are advised to identify and understand applicable legal requirements and guidance 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 require
35、ments for product labels and labelling established for that country or region. ISO 2013 All rights reserved vCopyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-PD CEN ISO/TS 13830:2
36、013Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-PD CEN ISO/TS 13830:2013Nanotechnologies Guidance on voluntary labelling for consumer products containing manufactured nano-obj
37、ects1 ScopeThis Technical Specification provides guidance on the content of voluntary labels for consumer products containing manufactured nano-objects (PCMNO).This Technical Specification is not applicable to consumer products that contain naturally occurring nano-objects that were not subjected to
38、 manufacturing processes. Consumer products containing nano-objects that are incidentally present (i.e. unintentional by-products of a process) are also outside the scope of this Technical Specification.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in
39、 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.ISO/TS 80004-1, Nanotechnologies Vocabulary Part 1: Core terms3 Terms and definitio
40、nsFor 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 acquired and used by an individual for personal rather than professional use, excluding its packagingSOURCE: ISO 20282-1:2006, 3.2 modified
41、3.2labelwritten, printed, graphic matter affixed to a product, imprinted on a product, or its immediate container or packaging, which displays information related to the product3.3labellingprovided information about a product by means of the label affixed to a product, its immediate container or pac
42、kaging by a manufacturer or supplier3.4manufactured nano-objectMNOnano-object intentionally produced for commercial purposes to have specific properties or compositionSOURCE: ISO/TS 12805, 3.33.5nano-objectmaterial with one, two or three external dimensions in the nanoscaleNote 1 to entry: Generic t
43、erm for all discrete nanoscale objects.TECHNICAL SPECIFICATION ISO/TS 13830:2013(E) ISO 2013 All rights reserved 1Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-PD CEN ISO/TS 13
44、830:2013ISO/TS 13830:2013(E)SOURCE: 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 sho
45、uld be considered approximate.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 80
46、004-1:2010, 2.13.7nanoscale phenomenoneffect 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 phenom
47、ena, as distinct from those associated 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 intent
48、ionally added, attached or embedded4 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 about 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 end
