ASTM F2725-08
(Guide)Standard Guide for European Union's Registration, Evaluation, and Authorization of Chemicals (REACH) Supply Chain Information Exchange
Standard Guide for European Union's Registration, Evaluation, and Authorization of Chemicals (REACH) Supply Chain Information Exchange
SIGNIFICANCE AND USE
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 a central repository for REACH industry guidance that spans industry sectors and facilitates collaboration across complex global supply chains. Annexes 6-9 provide key EU guidance on information exchange in the supply chain.
Section 6 outlines the information that is to be exchanged in the supply chain both in the upstream and downstream directions. Fig. 4 provides a schematic depicting data flow in the upstream and downstream directions. A list of the elements to be included in this exchange is represented in Tables 1-5 that capture the necessary data fields for information exchange. Case studies 1-3 in Annex A1-Annex A3 provide three sample scenarios wherein a customer and supplier complete these five tables to exchange data to address their REACH compliance issues.
SCOPE
1.1 This guide will assist companies that manufacture, buy, or sell, or both, substances, preparations, and articles to ensure that supply chains comply with the European Union’s Registration, Evaluation, and Authorization of Chemicals (REACH) regulation. This is accomplished by identifying the specific information elements that must be specified, requested and exchanged in communication 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 the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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Standards Content (Sample)
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Designation:F2725–08
Standard Guide for
European Union’s Registration, Evaluation, and
Authorization of Chemicals (REACH) Supply Chain
Information Exchange
This standard is issued under the fixed designation F2725; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope Annex 1: Automotive Industry Guidance
Annex 2: Aerospace Industry Guidance
1.1 This guide will assist companies that manufacture, buy,
Annex 3: European Engineering Industries (Orgalime)
or sell, or both, substances, preparations, and articles to ensure
Guidance
that supply chains comply with the European Union’s Regis-
Annex 4: Fragrance Industry Guidance
tration, Evaluation, andAuthorization of Chemicals (REACH)
Annex 5: Semiconductor Industry Guidance
regulation. This is accomplished by identifying the specific
Annex 14: List of Substances Subject to Authorisation
information elements that must be specified, requested and
REACH Title II Registration of Substances
exchanged in communication between actors in the supply
REACH Title IV Information in the Supply Chain
chain.
2.4 REACH Implementation Project (RIP) Guidance Docu-
1.2 The values stated in SI units are to be regarded as
ments:
standard. No other units of measurement are included in this
Annex 6: RIP 3.4 Guidance on Data Sharing
standard.
Annex 7: RIP 3.5 Guidance for Downstream Users
1.3 This standard does not purport to address all of the
Annex 8: RIP 3.8 Guidance on Requirements for Articles
safety concerns, if any, associated with its use. It is the
Annex 9: EU Commission publication: REACH-in-Brief
responsibility of the user of this standard to establish appro-
Annex 17: List of Restricted Substances and Conditions of
priate safety and health practices and determine the applica-
Restriction
bility of regulatory limitations prior to use.
3. Terminology
2. Referenced Documents
2 3.1 Definitions:
2.1 ASTM Standards:
3.1.1 Terms and definitions related to declarable substances
F2576 Terminology Relating to Declarable Substances in
in materials may be found in Terminology F2576.
Materials
3.1.2 Terms and definitions in this guide not found in
2.2 European Union Directives and Regulations:
Terminology F2576 may be found in a common dictionary or
67/548/EEC Directive on Dangerous Substances
other reference documents such as the ASTM Dictionary of
1999/45/EC Dangerous Preparations Directive
Engineering Science & Technology.
2006/121/EC Amending Directive 67/548/EEC
3.2 Definitions of Terms Specific to This Standard:
Regulation (EC) No. 1907/2006 OF THE EUROPEAN
3.2.1 actors in the supply chain, n—all manufacturers,
PARLIAMENT AND OF THE COUNCIL of 18 Decem-
importers, or downstream users in a supply chain.
ber 2006 concerning the Registration, Evaluation, Autho-
3.2.2 article, n—object that during production is given a
risation and Restriction of Chemicals (REACH)
special shape, surface, or design that determines its function to
2.3 REACH Guidance Standards:
a greater degree than does its chemical composition.
3.2.3 candidate list, n—list of substances that are subject to
This guide is under the jurisdiction of ASTM Committee F40 on Declarable
appear onAnnex 14 (authorization) list of substances and will
Substances in Materials and is the direct responsibility of Subcommittee F40.02 on
someday require an authorization application for use.
Management Practices and Guides.
3.2.4 chemical safety report (CSR), n—findings of a chemi-
Current edition approved May 1, 2008. Published May 2008. DOI: 10.1520/
F2725-08.
cal safety assessment that shall consider the hazards and risks
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. AvailablefromASTMInternational,100BarrHarborDr.,P.O.BoxC700,West
Available from ec.europa.eu or www.echa.eu. Conshohocken, PA 19428-2959, ASTM Stock Number: DEF00.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F2725–08
of a substances that is manufactured or imported in quantities 3.2.17.1 Discussion—Import shall be deemed to be placing
greater than 10 metric tonnes per year. on the market.
3.2.18 preparation, n—mixture or solution composed of
3.2.5 community, n—27-member states of the European
two or more substances; preparations can contain several
Union.
substances; they are not the same as multiconstituent sub-
3.2.6 downstream user, n—any natural or legal person
stances; the difference between preparation and multiconstitu-
established within the European Community, other than the
ent substance is that a preparation is gained by blending of two
manufacturer or the importer, who uses a substance, either on
or more substances without any chemical reaction occurring,
its own or in a preparation, in the course of his or her industrial
whereasamulticonstituentsubstanceistheresultofachemical
or professional activities.
reaction; examples of preparations include paints, varnishes,
3.2.6.1 Discussion—A distributor or a consumer is not a
and inks.
downstream user.Are-importer exempted pursuant to REACH
3.2.18.1 Discussion—REACH obligations apply individu-
Article 2 (7)(c) in Directive 2006/121/EC shall be regarded as
ally to each of those substances depending on whether within
a downstream user.
the scope of REACH. Within the GHS, a preparation is known
3.2.7 exposure scenario, n—set of conditions, including
as a “mixture.”
operational conditions and risk management measures, that
3.2.19 producer of an article, n—anynaturalorlegalperson
describes how the substance is manufactured or used during its
who makes or assembles an article in the community.
lifecycle and how the manufacturer or importer controls, or
3.2.20 restriction, n—any condition for a prohibition of the
recommendsdownstreamuserstocontrolexposuresofhumans
manufacture, use, or placing on the market.
and the environment.
3.2.21 safety data sheet, n—hazard and risk information
3.2.7.1 Discussion—These exposure scenarios may cover
required by community law to be passed on from supplier to
one specific process or use or several process or uses as
customer for dangerous substances and dangerous substances
appropriate.
in mixtures above a certain concentration.
3.2.8 import, v—physical introduction into the customs
3.2.22 substance, n—chemical element and its compounds
territory of the community.
in the natural state or obtained by any manufacturing process,
3.2.9 importer, n—any natural or legal person established
including any additive necessary to preserve its stability and
within the community who is responsible for the import.
anyimpurityderivingfromtheprocessused,butexcludingany
3.2.10 intermediate, n—substance that is manufactured for solvent that may be separated without affecting the stability of
and consumed in or used for chemical processing to be
the substance or changing its composition.
transformed into another substance. 3.2.23 use, n—any processing, formulation, consumption,
storage, keeping, treatment, filling into containers, transferring
3.2.11 manufacturer, n—any natural or legal person estab-
fromonecontainertoanother,mixing,productionofanarticle,
lished within the community who manufactures a substance
or any other utilization.
within the community.
3.3 Acronyms:
3.2.12 manufacturing, v—production or extraction of sub-
3.3.1 CAS—Chemical Abstracts Service
stances in the natural state.
3.3.2 ECHA—European Chemicals Agency
3.2.13 mixture, n—combination or solution of two or more
3.3.3 EINECS—European Inventory of Existing Commer-
substances that do not react.
cial Chemical Substances
3.2.14 only representative, n—third party who may serve as
3.3.4 ELINCS—European List of Notified Chemical Sub-
importer of record on behalf of natural or legal persons
stances
established outside of the community (see preparation).
3.3.5 ELV—End-of-Life Vehicles Directive
3.2.15 per year, n—per calendar year, unless stated other-
3.3.6 EPA—Environmental Protection Agency
wise, for phase-in substances that have been imported or
3.3.7 EU—European Union
manufactured for at least three consecutive years; quantities
3.3.8 GHS—Globally Harmonized System of Classification
per year shall be calculated on the basis of the average
and Labeling of Chemicals
production or import volumes for the three preceding calendar
3.3.9 IMDS—International Materials Data System
years.
3.3.10 REACH—Registration, Evaluation, and Authoriza-
3.2.16 phase-in substance, n—substance that meets at least
tion of Chemicals
one of the following criteria: (1) it is listed in the European
3.3.11 RIP—REACH Implementation Project—technical
Inventory of Existing Commercial Chemical Substances (EI-
guidance documents published by EU RoHS Restriction of the
NECS) and (2) it is manufactured in the community, or in the
Use of Certain Hazardous Substances in Electrical and Elec-
countries acceding to the European Union on January 1995 or
tronic Equipment
1 May 2004, but not placed on the market by the manufacturer
3.3.12 SIEF—Substance Information Exchange Forum
or importer at least once in the 15 years before the entry into
3.3.13 SVHC—substances of very high concern
force of the REACH regulation, provided the manufacturer or
importer has documentary evidence of this. 4. Summary of Guide
3.2.17 placing on the market, v—supplying or making
NOTE 1—This guide does not provide assistance on the legal require-
available, whether in return for payment or free of charge, to a
ments of REACH such as registration, evaluation, authorization, and
third party. restrictions. For a basic introduction to REACH and guidance for
F2725–08
assessing your legal obligations under the regulation, please consult the
legal requirement and a necessary activity ancillary to comply-
documentation in Annex 9. For actual text of REACH, see: http://
ing with other aspects of REACH.
reach.jrc.it/legislation_en.htm.
4.2.1.1 Because of the often complex nature of global
4.1 What is REACH?
supply chains, a legal requirement falling upon an EU-based
4.1.1 Regulation (EC) No. 1907/2006 of the European importer, manufacturer, or downstream user will often have
Parliament and the Council of 18 December 2006 concerning both a downstream and upstream ripple effect that will extend
the Registration, Evaluation, Authorisation and Restriction of beyond the EU and will require support from the entire supply
Chemicals (REACH). REACH replaces 40 existing legal acts chain. Therefore, companies based outside the EU, for ex-
and creates a single system for all chemical substances. ample, in the United States, with no direct business in Europe,
4.1.1.1 Registration—Registration requires producers and will be drawn into the supply chain information exchange
process to support their customers’ requirements to provide
importers to obtain and submit relevant information on chemi-
cal substances produced in or imported to the EU market in information. All global companies may find it helpful to map
out their location within supply chains to determine if any
quantities greater than 1 tonne per year.
substances,preparations,orarticlesareimportedinto,exported
4.1.1.2 Evaluation—Evaluation allows the regulatory au-
out of, or manufactured in the EU and, hence, at risk of being
thorities to decide on proposals for further testing and assess
impacted by REACH.
whether dossier information provided by industry complies
4.2.2 Fig. 1 illustrates how REACH has the potential to
with the requirements.
impact all but the most isolated supply chains. Your company
4.1.1.3 Authorization—Authorization may be required for
need not sell product in, or buy products from, the EU to be
SVHC (carcinogens; mutagens; reproductive toxins; sub-
impacted, either directly or indirectly.
stances toxic, persistent, and bioaccumulative; substances very
persistentandverybioaccumulative;andsubstancesgivingrise 4.2.3 Fig. 2 depicts an example of “selling into a supply
to equivalent concern). chainthatimportsintotheEU.”Notethatthereisnodirectsale
to an EU importer in this scenario, but that you sell to
4.1.1.4 Restriction—The safety net of the system; any
substance on its own, in a preparation or in an article may be CustomerA, who sells to the EU-based Customer D. Customer
D’s need for data will be cascaded down to you via the
subject to community-wide restrictions if its use poses unac-
ceptable risks to human health or the environment. intermediary, Customer A. For example, Customer D may ask
Customer A to identify the substance content of a preparation
4.1.2 Who Are the Actors in the Supply Chain?
or article. CustomerAmay turn to you as having knowledge of
4.1.2.1 Manufacturers and importers of substances and
this composition. Note that it is conceivable that you will need
preparations are obliged to register substances they produce or
to turn to your own supplier(s) to obtain the chemical compo-
import in quantities greater than 1 tonne per year. Importers
sition. Additionally, Customer D may need to describe their
and producers of articles are required to register substances
application to Customer A, who then may desire to provide
imported or produced in amounts greater than 1 tonne per year
related handling or toxicity information or both if available to
that are intentionally released from the articles. Failure to
help Customer D’s registration process.
register means that the substance cannot be manufactured,
4.2.4 Similarly, Fig. 3 depicts an example of “purchasing
imported, or used in the EU market.
out of a supply chain that exports from the EU.” In this
4.1.2.2 Downstream users of chemicals shall apply the risk
scenario,youbuyfromU.S.-basedSupplierD,whoformulates
management measures for dangerous substances identified on
a preparation or article from Substances A and B and Prepa-
the supplier safety data sheets. They shall also ensure that any
rationC.ThesubstancesinPreparationCareprovidedfroman
substances they use in quantities greater than 1 tonne per year,
EU-based exporter. Any of a number of potential issues could
which are manufactured or imported in quantities greater than
result in an impact, including the following scenarios:
10 tonnes per year, are supported by a chemical safety report
(CSR). 4.2.4.1 Should any of the substances in Preparation C be
incorporated into the EU’s candidate for authorization list,
4.1.2.3 Other actors in the s
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