ASTM_F_2725_-_11.pdf

Designation:F272511Standard Guide forEuropean Unions Registration,Evaluation,andAuthorization of Chemicals(REACH)Supply ChainInformation Exchange1This standard is issued under the fixed designation F2725;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide will assist companies that manufacture,buy,or sell,or both,substances,preparations,and articles to ensurethat supply chains comply with the European UnionsRegistration,Evaluation,and Authorization of Chemicals(REACH)regulation.This is accomplished by identifying thespecific information elements that must be specified,requestedand exchanged in communication between actors in the supplychain.1.2 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.3 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2F2576 Terminology Relating to Declarable Substances inMaterials2.2 European Union Directives and Regulations:367/548/EEC Directive on Dangerous Substances1999/45/EC Dangerous Preparations Directive2006/121/EC Amending Directive 67/548/EECRegulation(EC)No.1907/2006 OF THE EUROPEANPARLIAMENT AND OF THE COUNCIL of 18 Decem-ber 2006 concerning the Registration,Evaluation,Au-thorisation and Restriction of Chemicals(REACH)2.3 REACH Guidance Standards:3Annex 1:Automotive Industry GuidanceAnnex 2:Aerospace Industry GuidanceAnnex 3:European Engineering Industries(Orgalime)Guid-anceAnnex 4:Fragrance Industry GuidanceAnnex 5:Semiconductor Industry GuidanceAnnex 14:List of Substances Subject to AuthorisationREACH Title II Registration of SubstancesREACH Title IV Information in the Supply Chain2.4 REACH Implementation Project(RIP)Guidance Docu-ments:3Annex 6:RIP 3.4 Guidance on Data SharingAnnex 7:RIP 3.5 Guidance for Downstream UsersAnnex 8:RIP 3.8 Guidance on Requirements for ArticlesAnnex 9:EU Commission publication:REACH-in-BriefAnnex 17:List of Restricted Substances and Conditions ofRestriction3.Terminology3.1 Definitions:3.1.1 Terms and definitions related to declarable substancesin materials may be found in Terminology F2576.3.1.2 Terms and definitions in this guide not found inTerminology F2576 may be found in a common dictionary orother reference documents such as the ASTM Dictionary ofEngineering Science&Technology.43.2 Definitions of Terms Specific to This Standard:3.2.1 actors in the supply chain,nall manufacturers,importers,or downstream users in a supply chain.3.2.2 article,nobject that during production is given aspecial shape,surface,or design that determines its function toa greater degree than does its chemical composition.3.2.3 candidate list,nlist of substances that are subject toappear on Annex 14(authorization)list of substances and willsomeday require an authorization application for use.1This guide is under the jurisdiction of ASTM Committee F40 on DeclarableSubstances in Materials and is the direct responsibility of Subcommittee F40.02 onManagement Practices and Guides.Current edition approved Feb.1,2011.Published March 2011.Originallyapproved in 2008.Last previous edition approved in 2008 as F2725-08.DOI:10.1520/F2725-11.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from ec.europa.eu or www.echa.eu.4Available fromASTM International,100 Barr Harbor Dr.,P.O.Box C700,WestConshohocken,PA 19428-2959,ASTM Stock Number:DEF00.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.2.4 chemical safety report(CSR),nfindings of a chemi-cal safety assessment that shall consider the hazards and risksof a substances that is manufactured or imported in quantitiesgreater than 10 metric tonnes per year.3.2.5 community,n27-member states of the EuropeanUnion.3.2.6 downstream user,nany natural or legal personestablished within the European Community,other than themanufacturer or the importer,who uses a substance,either onits own or in a preparation,in the course of his or her industrialor professional activities.3.2.6.1 DiscussionA distributor or a consumer is not adownstream user.A re-importer exempted pursuant to REACHArticle 2(7)(c)in Directive 2006/121/EC shall be regarded asa downstream user.3.2.7 exposure scenario,nset of conditions,includingoperational conditions and risk management measures,thatdescribes how the substance i