1、Designation:F272508 Designation: F2725 11Standard 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 o
2、foriginal 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
3、 sell, or both, substances, preparations, and articles to ensure thatsupply chains comply with the European Unions Registration, Evaluation, and Authorization of Chemicals (REACH) regulation.This is accomplished by identifying the specific information elements that must be specified, requested and e
4、xchanged incommunication between actors in the supply chain.1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is t
5、he responsibilityof the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatorylimitations prior to use.2. Referenced Documents2.1 ASTM Standards:2F2576 Terminology Relating to Declarable Substances in Materials2.2 European Union Direc
6、tives 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 EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 December 2006concerning the Registration, Evaluation, Authorisation
7、 and Restriction of Chemicals (REACH)2.3 REACH Guidance Standards:3Annex 1: Automotive Industry GuidanceAnnex 2: Aerospace Industry GuidanceAnnex 3: European Engineering Industries (Orgalime) GuidanceAnnex 4: Fragrance Industry GuidanceAnnex 5: Semiconductor Industry GuidanceAnnex 14: List of Substa
8、nces Subject to AuthorisationREACH Title II Registration of SubstancesREACH Title IV Information in the Supply Chain2.4 REACH Implementation Project (RIP) Guidance Documents:3Annex 6: RIP 3.4 Guidance on Data SharingAnnex 7: RIP 3.5 Guidance for Downstream UsersAnnex 8: RIP 3.8 Guidance on Requireme
9、nts for ArticlesAnnex 9: EU Commission publication: REACH-in-BriefAnnex 17: List of Restricted Substances and Conditions of Restriction1This guide is under the jurisdiction of ASTM Committee F40 on Declarable Substances in Materials and is the direct responsibility of Subcommittee F40.02 onManagemen
10、t Practices and Guides.Current edition approved May 1, 2008. Published May 2008. DOI: 10.1520/F2725-08.Current edition approved Feb. 1, 2011. Published March 2011. Originally approved in 2008. Last previous edition approved in 2008 as F2725-08. DOI: 10.1520/F2725-11.2For referencedASTM standards, vi
11、sit theASTM website, www.astm.org, or contactASTM Customer Service at serviceastm.org. For Annual Book of ASTM Standardsvolume information, refer to the standards Document Summary page on the ASTM website.3Available from ec.europa.eu or www.echa.eu.1This document is not an ASTM standard and is inten
12、ded only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Becauseit may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the curren
13、t versionof the standard as published by ASTM is to be considered the official document.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.3. Terminology3.1 Definitions:3.1.1 Terms and definitions related to declarable substances in mate
14、rials may be found in Terminology F2576.3.1.2 Terms and definitions in this guide not found in Terminology F2576 may be found in a common dictionary or otherreference documents such as the ASTM Dictionary of Engineering Science quantities per year shall be calculated on the basis of the average prod
15、uction or import volumesfor the three preceding calendar years.3.2.16 phase-in substance, nsubstance that meets at least one of the following criteria: (1) it is listed in the EuropeanInventory of Existing Commercial Chemical Substances (EINECS) and (2) it is manufactured in the community, or in the
16、 countriesacceding to the European Union on January 1995 or 1 May 2004, but not placed on the market by the manufacturer or importerat least once in the 15 years before the entry into force of the REACH regulation, provided the manufacturer or importer hasdocumentary evidence of this.3.2.17 placing
17、on the market, vsupplying or making available, whether in return for payment or free of charge, to a third party.3.2.17.1 DiscussionImport shall be deemed to be placing on the market.3.2.18 preparation, nmixture or solution composed of two or more substances; preparations can contain several substan
18、ces;they are not the same as multiconstituent substances; the difference between preparation and multiconstituent substance is that apreparation is gained by blending of two or more substances without any chemical reaction occurring, whereas a multiconstituentsubstance is the result of a chemical re
19、action; examples of preparations include paints, varnishes, and inks.3.2.18.1 DiscussionREACH obligations apply individually to each of those substances depending on whether within thescope of REACH. Within the GHS, a preparation is known as a “mixture.”3.2.19 producer of an article, nany natural or
20、 legal person who makes or assembles an article in the community.3.2.20 restriction, nany condition for a prohibition of the manufacture, use, or placing on the market.3.2.21 safety data sheet, nhazard and risk information required by community law to be passed on from supplier to customerfor danger
21、ous substances and dangerous substances in mixtures above a certain concentration.3.2.22 substance, nchemical element and its compounds in the natural state or obtained by any manufacturing process,including any additive necessary to preserve its stability and any impurity deriving from the process
22、used, but excluding anysolvent that may be separated without affecting the stability of the substance or changing its composition.4Available from ASTM International, 100 Barr Harbor Dr., P.O. Box C700, West Conshohocken, PA 19428-2959, ASTM Stock Number: DEF00.F2725 1123.2.23 use, nany processing, f
23、ormulation, consumption, storage, keeping, treatment, filling into containers, transferring fromone container to another, mixing, production of an article, or any other utilization.3.3 Acronyms:3.3.1 CASChemical Abstracts Service3.3.2 ECHAEuropean Chemicals Agency3.3.3 EINECSEuropean Inventory of Ex
24、isting Commercial Chemical Substances3.3.4 ELINCSEuropean List of Notified Chemical Substances3.3.5 ELVEnd-of-Life Vehicles Directive3.3.6 EPAEnvironmental Protection Agency3.3.7 EUEuropean Union3.3.8 GHSGlobally Harmonized System of Classification and Labeling of Chemicals3.3.9 IMDSInternational Ma
25、terials Data System3.3.10 REACHRegistration, Evaluation, and Authorization of Chemicals3.3.11 RIPREACH Implementation Projecttechnical guidance documents published by EU RoHS Restriction of the Useof Certain Hazardous Substances in Electrical and Electronic Equipment3.3.12 SIEFSubstance Information
26、Exchange Forum3.3.13 SVHCsubstances of very high concern4. Summary of GuideNOTE 1This guide does not provide assistance on the legal requirements of REACH such as registration, evaluation, authorization, and restrictions.For a basic introduction to REACH and guidance for assessing your legal obligat
27、ions under the regulation, please consult the documentation in Annex9. For actual text of REACH, see: http:/reach.jrc.it/legislation_en.htm.4.1 What is REACH?4.1.1 Regulation (EC) No. 1907/2006 of the European Parliament and the Council of 18 December 2006 concerning theRegistration, Evaluation,Auth
28、orisation and Restriction of Chemicals (REACH). REACH replaces 40 existing legal acts and createsa single system for all chemical substances.4.1.1.1 RegistrationRegistration requires producers and importers to obtain and submit relevant information on chemicalsubstances produced in or imported to th
29、e EU market in quantities greater than 1 tonne per year.4.1.1.2 EvaluationEvaluation allows the regulatory authorities to decide on proposals for further testing and assess whetherdossier information provided by industry complies with the requirements.4.1.1.3 AuthorizationAuthorization may be requir
30、ed for SVHC (carcinogens; mutagens; reproductive toxins; substancestoxic, persistent, and bioaccumulative; substances very persistent and very bioaccumulative; and substances giving rise toequivalent concern).4.1.1.4 RestrictionThe safety net of the system; any substance on its own, in a preparation
31、 or in an article may be subject tocommunity-wide restrictions if its use poses unacceptable risks to human health or the environment.4.1.2 Who Are the Actors in the Supply Chain?4.1.2.1 Manufacturers and importers of substances and preparations are obliged to register substances they produce or imp
32、ortin quantities greater than 1 tonne per year. Importers and producers of articles are required to register substances imported orproduced in amounts greater than 1 tonne per year that are intentionally released from the articles. Failure to register means thatthe substance cannot be manufactured,
33、imported, or used in the EU market.4.1.2.2 Downstream users of chemicals shall apply the risk management measures for dangerous substances identified on thesupplier safety data sheets. They shall also ensure that any substances they use in quantities greater than 1 tonne per year, whichare manufactu
34、red or imported in quantities greater than 10 tonnes per year, are supported by a chemical safety report (CSR).4.1.2.3 Other actors in the supply chain include distributors, retailers, and storage providers, all of whom are not classified asdownstream users.4.1.2.4 Consumers are not considered actor
35、s in the supply chain, but have certain rights under REACH, including the right toreceive information about the presence of SVHCs in quantities 0.1 % in articles.4.2 Why Must REACH Information be Exchanged in Supply Chains?4.2.1 REACH Title IV, Information in the Supply Chain, specificallyArticles 3
36、1 through 34, legally requires manufacturers andtheir supply chains to exchange certain information. Information exchange both upstream and downstream in the supply chain isalso the only way to acquire the information necessary to meet many other requirements of the REACH regulation. Therefore,suppl
37、y chain communication is both a legal requirement and a necessary activity ancillary to complying with other aspects ofREACH.4.2.1.1 Because of the often complex nature of global supply chains, a legal requirement falling upon an EU-based importer,manufacturer, or downstream user will often have bot
38、h a downstream and upstream ripple effect that will extend beyond the EUand will require support from the entire supply chain. Therefore, companies based outside the EU, for example, in the UnitedStates, with no direct business in Europe, will be drawn into the supply chain information exchange proc
39、ess to support theircustomers requirements to provide information. All global companies may find it helpful to map out their location within supplychains to determine if any substances, preparations, or articles are imported into, exported out of, or manufactured in the EU and,F2725 113hence, at ris
40、k of being impacted by REACH.4.2.2 Fig. 1 illustrates how REACH has the potential to impact all but the most isolated supply chains. Your company need notsell product in, or buy products from, the EU to be impacted, either directly or indirectly.4.2.3 Fig. 2 depicts an example of “selling into a sup
41、ply chain that imports into the EU.” Note that there is no direct sale toan EU importer in this scenario, but that you sell to Customer A, who sells to the EU-based Customer D. Customer Ds need fordata will be cascaded down to you via the intermediary, Customer A. For example, Customer D may ask Cus
42、tomer A to identifythe substance content of a preparation or article. Customer A may turn to you as having knowledge of this composition. Note thatit is conceivable that you will need to turn to your own supplier(s) to obtain the chemical composition. Additionally, Customer Dmay need to describe the
43、ir application to Customer A, who then may desire to provide related handling or toxicity information orboth if available to help Customer Ds registration process.4.2.4 Similarly, Fig. 3 depicts an example of “purchasing out of a supply chain that exports from the EU.” In this scenario, youbuy from
44、U.S.-based Supplier D, who formulates a preparation or article from Substances A and B and Preparation C. Thesubstances in Preparation C are provided from an EU-based exporter.Any of a number of potential issues could result in an impact,including the following scenarios:4.2.4.1 Should any of the su
45、bstances in Preparation C be incorporated into the EUs candidate for authorization list, PreparationC (and hence Preparation/Article D) may no longer be available, or at least be subject to substantially increased costs.4.2.4.2 The cost of registration may exceed Supplier Cs desire to continue produ
46、cing Preparation C.4.2.4.3 Supplier C may choose to substitute substances/preparations used in Preparation C and may or may not tell Supplier D,who may or may not be able to pass this information along.4.2.5 To avert surprise supply changes or price increases or both, proactively mapping out the sup
47、ply chain and making adetermination about the reliability of Preparation/Article Ds supply is highly recommended. Note that this effort may becomplicated by the fact that you have no direct contractual relationship with Supplier C and may therefore need to coordinate theinvestigation via Supplier D
48、to address confidentiality and other concerns adequately.5. Significance and Use5.1 This guide recommends practices and solutions for global supply chain information exchange for substances, preparations,and articles as identified by REACH. The first five annexes of REACH guidance standards serve as
49、 a central repository for REACHindustry guidance that spans industry sectors and facilitates collaboration across complex global supply chains. Annexes 6-9provide key EU guidance on information exchange in the supply chain.5.2 Section 6 outlines the information that is to be exchanged in the supply chain both in the upstream and downstreamdirections. Fig. 4 provides a schematic depicting data flow in the upstream and downstream directions. A list of the elements toFIG. 1 Determining Your REACH ObligationsF2725 114be included in this exchange
