ASTM F2725-2008 Standard Guide for European Unions Registration Evaluation and Authorization of Chemicals (REACH) Supply Chain Information Exchange《欧洲联盟化学品注册、评估和许可(REACH)的供应链信息交换的标.pdf

《ASTM F2725-2008 Standard Guide for European Unions Registration Evaluation and Authorization of Chemicals (REACH) Supply Chain Information Exchange《欧洲联盟化学品注册、评估和许可(REACH)的供应链信息交换的标.pdf》由会员分享，可在线阅读，更多相关《ASTM F2725-2008 Standard Guide for European Unions Registration Evaluation and Authorization of Chemicals (REACH) Supply Chain Information Exchange《欧洲联盟化学品注册、评估和许可(REACH)的供应链信息交换的标.pdf（35页珍藏版）》请在麦多课文档分享上搜索。

1、Designation: F 2725 08Standard Guide forEuropean Unions Registration, Evaluation, andAuthorization of Chemicals (REACH) Supply ChainInformation Exchange1This standard is issued under the fixed designation F 2725; the number immediately following the designation indicates the year oforiginal adoption

2、 or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) 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, su

3、bstances, preparations, and articles to ensurethat supply chains comply with the European Unions Regis-tration, Evaluation, and Authorization of Chemicals (REACH)regulation. This is accomplished by identifying the specificinformation elements that must be specified, requested andexchanged in communi

4、cation 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 th

5、e 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:2F 2576 Terminology Relating to Declarable Substances inMaterials2.2 European Union Directives and Regulatio

6、ns: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, Autho-risation and Restriction

7、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 Substances Subject to Au

8、thorisationREACH 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 ArticlesA

9、nnex 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 F 2576.3.1.2 Terms and definitions in this guide not

10、 found inTerminology F 2576 may be found in a common dictionary orother reference documents such as the ASTM Dictionary ofEngineering Science quantitiesper year shall be calculated on the basis of the averageproduction or import volumes for the three preceding calendaryears.3.2.16 phase-in substance

11、, nsubstance that meets at leastone of the following criteria: (1) it is listed in the EuropeanInventory of Existing Commercial Chemical Substances (EI-NECS) and (2) it is manufactured in the community, or in thecountries acceding to the European Union on January 1995 or1 May 2004, but not placed on

12、 the market by the manufactureror importer at least once in the 15 years before the entry intoforce of the REACH regulation, provided the manufacturer orimporter has documentary evidence of this.3.2.17 placing on the market, vsupplying or makingavailable, whether in return for payment or free of cha

13、rge, to athird party.3.2.17.1 DiscussionImport shall be deemed to be placingon the market.3.2.18 preparation, nmixture or solution composed oftwo or more substances; preparations can contain severalsubstances; they are not the same as multiconstituent sub-stances; the difference between preparation

14、and multiconstitu-ent substance is that a preparation is gained by blending of twoor more substances without any chemical reaction occurring,whereas a multiconstituent substance is the result of a chemicalreaction; examples of preparations include paints, varnishes,and inks.3.2.18.1 DiscussionREACH

15、obligations apply individu-ally to each of those substances depending on whether withinthe scope of REACH. Within the GHS, a preparation is knownas a “mixture.”3.2.19 producer of an article, nany natural or legal personwho makes or assembles an article in the community.3.2.20 restriction, nany condi

16、tion for a prohibition of themanufacture, use, or placing on the market.3.2.21 safety data sheet, nhazard and risk informationrequired by community law to be passed on from supplier tocustomer for dangerous substances and dangerous substancesin mixtures above a certain concentration.3.2.22 substance

17、, nchemical element and its compoundsin the natural state or obtained by any manufacturing process,including any additive necessary to preserve its stability andany impurity deriving from the process used, but excluding anysolvent that may be separated without affecting the stability ofthe substance

18、 or changing its composition.3.2.23 use, nany processing, formulation, consumption,storage, keeping, treatment, filling into containers, transferringfrom one container to another, mixing, production of an article,or any other utilization.3.3 Acronyms:3.3.1 CASChemical Abstracts Service3.3.2 ECHAEuro

19、pean Chemicals Agency3.3.3 EINECSEuropean Inventory of Existing Commer-cial Chemical Substances3.3.4 ELINCSEuropean List of Notified Chemical Sub-stances3.3.5 ELVEnd-of-Life Vehicles Directive3.3.6 EPAEnvironmental Protection Agency3.3.7 EUEuropean Union3.3.8 GHSGlobally Harmonized System of Classif

20、icationand Labeling of Chemicals3.3.9 IMDSInternational Materials Data System3.3.10 REACHRegistration, Evaluation, and Authoriza-tion of Chemicals3.3.11 RIPREACH Implementation Projecttechnicalguidance documents published by EU RoHS Restriction of theUse of Certain Hazardous Substances in Electrical

21、 and Elec-tronic Equipment3.3.12 SIEFSubstance Information Exchange Forum3.3.13 SVHCsubstances of very high concern4. Summary of GuideNOTE 1This guide does not provide assistance on the legal require-ments of REACH such as registration, evaluation, authorization, andrestrictions. For a basic introdu

22、ction to REACH and guidance forassessing your legal obligations under the regulation, please consult thedocumentation in Annex 9. For actual text of REACH, see: http:/reach.jrc.it/legislation_en.htm.4.1 What is REACH?F27250824.1.1 Regulation (EC) No. 1907/2006 of the EuropeanParliament and the Counc

23、il of 18 December 2006 concerningthe Registration, Evaluation, Authorisation and Restriction ofChemicals (REACH). REACH replaces 40 existing legal actsand creates a single system for all chemical substances.4.1.1.1 RegistrationRegistration requires producers andimporters to obtain and submit relevan

24、t information on chemi-cal substances produced in or imported to the EU market inquantities greater than 1 tonne per year.4.1.1.2 EvaluationEvaluation allows the regulatory au-thorities to decide on proposals for further testing and assesswhether dossier information provided by industry complieswith

25、 the requirements.4.1.1.3 AuthorizationAuthorization may be required forSVHC (carcinogens; mutagens; reproductive toxins; sub-stances toxic, persistent, and bioaccumulative; substances verypersistent and very bioaccumulative; and substances giving riseto equivalent concern).4.1.1.4 RestrictionThe sa

26、fety net of the system; anysubstance on its own, in a preparation or in an article may besubject to community-wide restrictions if its use poses unac-ceptable 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 andpr

27、eparations are obliged to register substances they produce orimport in quantities greater than 1 tonne per year. Importersand producers of articles are required to register substancesimported or produced in amounts greater than 1 tonne per yearthat are intentionally released from the articles. Failu

28、re toregister means that the substance cannot be manufactured,imported, or used in the EU market.4.1.2.2 Downstream users of chemicals shall apply the riskmanagement measures for dangerous substances identified onthe supplier safety data sheets. They shall also ensure that anysubstances they use in

29、quantities greater than 1 tonne per year,which are manufactured or imported in quantities greater than10 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 classifiedas do

30、wnstream users.4.1.2.4 Consumers are not considered actors in the supplychain, but have certain rights under REACH, including theright to receive information about the presence of SVHCs inquantities 0.1 % in articles.4.2 Why Must REACH Information be Exchanged in SupplyChains?4.2.1 REACH Title IV, I

31、nformation in the Supply Chain,specifically Articles 31 through 34, legally requires manufac-turers and their supply chains to exchange certain information.Information exchange both upstream and downstream in thesupply chain is also the only way to acquire the informationnecessary to meet many other

32、 requirements of the REACHregulation. Therefore, supply chain communication is both alegal requirement and a necessary activity ancillary to comply-ing with other aspects of REACH.4.2.1.1 Because of the often complex nature of globalsupply chains, a legal requirement falling upon an EU-basedimporter

33、, manufacturer, or downstream user will often haveboth a downstream and upstream ripple effect that will extendbeyond the EU and will require support from the entire supplychain. Therefore, companies based outside the EU, for ex-ample, in the United States, with no direct business in Europe,will be

34、drawn into the supply chain information exchangeprocess to support their customers requirements to provideinformation. All global companies may find it helpful to mapout their location within supply chains to determine if anysubstances, preparations, or articles are imported into, exportedout of, or

35、 manufactured in the EU and, hence, at risk of beingimpacted by REACH.4.2.2 Fig. 1 illustrates how REACH has the potential toimpact all but the most isolated supply chains. Your companyneed not sell product in, or buy products from, the EU to beimpacted, either directly or indirectly.4.2.3 Fig. 2 de

36、picts an example of “selling into a supplychain that imports into the EU.” Note that there is no direct saleto an EU importer in this scenario, but that you sell toCustomerA, who sells to the EU-based Customer D. CustomerDs need for data will be cascaded down to you via theintermediary, Customer A.

37、For example, Customer D may askCustomer A to identify the substance content of a preparationor article. CustomerAmay turn to you as having knowledge ofthis composition. Note that it is conceivable that you will needto turn to your own supplier(s) to obtain the chemical compo-sition. Additionally, Cu

38、stomer D may need to describe theirapplication to Customer A, who then may desire to providerelated handling or toxicity information or both if available tohelp Customer Ds registration process.4.2.4 Similarly, Fig. 3 depicts an example of “purchasingout of a supply chain that exports from the EU.”

39、In thisscenario, you buy from U.S.-based Supplier D, who formulatesa preparation or article from Substances A and B and Prepa-ration C. The substances in Preparation C are provided from anEU-based exporter. Any of a number of potential issues couldresult in an impact, including the following scenari

40、os:4.2.4.1 Should any of the substances in Preparation C beincorporated into the EUs candidate for authorization list,Preparation C (and hence Preparation/Article D) may no longerbe available, or at least be subject to substantially increasedcosts.4.2.4.2 The cost of registration may exceed Supplier

41、 Csdesire to continue producing Preparation C.4.2.4.3 Supplier C may choose to substitute substances/preparations used in Preparation C and may or may not tellSupplier D, who may or may not be able to pass thisinformation along.4.2.5 To avert surprise supply changes or price increases orboth, proact

42、ively mapping out the supply chain and making adetermination about the reliability of Preparation/Article Dssupply is highly recommended. Note that this effort may becomplicated by the fact that you have no direct contractualrelationship with Supplier C and may therefore need tocoordinate the invest

43、igation via Supplier D to address confi-dentiality and other concerns adequately.F27250835. Significance and Use5.1 This guide recommends practices and solutions forglobal supply chain information exchange for substances,preparations, and articles as identified by REACH. The firstfive annexes of REA

44、CH guidance standards serve as a centralrepository for REACH industry guidance that spans industrysectors and facilitates collaboration across complex globalsupply chains. Annexes 6-9 provide key EU guidance oninformation exchange in the supply chain.5.2 Section 6 outlines the information that is to

45、 be ex-changed in the supply chain both in the upstream and down-stream directions. Fig. 4 provides a schematic depicting dataflow in the upstream and downstream directions. A list of theelements to be included in this exchange is represented inTables 1-5 that capture the necessary data fields for i

46、nformationexchange. Case studies 1-3 in Annex A1-Annex A3 providethree sample scenarios wherein a customer and supplierFIG. 1 Determining Your REACH ObligationsNOTECustomer D requirements will be cascaded down to you via tier one supplier (Customer A)FIG. 2 Example of Selling into a Supply Chain tha

47、t Imports into EUF2725084complete these five tables to exchange data to address theirREACH compliance issues.NOTEYou have a potentially vulnerable material, since Material C is supplied by an EU-based supplier. You will want to know about substances inMaterial C and whether they are on the Candidate

48、 List. You may have to work via Supplier D who has the direct contractual relationship with SupplierC.FIG. 3 Example of Purchasing out of Supply Chain that Exports from EUFIG. 4 Data Flow Pathway for F40 Supply Chain CommunicationsF2725085TABLE 1 UPSTREAM QUESTIONS: Information RequestUpstream Direc

49、tion,Supplier would populate for Customer0. Data Required or Optional? Expected Response/Comments1.CompanyInformation-Supplier1.1 Company Name Required Name of supplier/manufacturer.1.2 Company ID # Required Supplier/Vendor ID #1.3 Mailing Address Required Physical post-office mailing address of company.1.4 REACH ResponsibleIndividual NameRequired Name of person whom all REACH communications goto.1.5 Contact Phone # Required Phone number of this person.1.6 Contact Fax # Required Fax number of this person.1.7 Contact Email Required Email address o