ASTM F2577-06
(Guide)Standard Guide for Assessment of Materials and Products for Declarable Substances
Standard Guide for Assessment of Materials and Products for Declarable Substances
SCOPE
1.1 This guide uses case studies to illustrate the decision process to assess materials and products for declarable substances when evaluating conformance to relevant requirements. This may be accomplished by applying existing knowledge to determine the need for further action (for example, testing).
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.
General Information
Standards Content (Sample)
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Designation: F2577 − 06
StandardGuide for
Assessment of Materials and Products for Declarable
Substances
This standard is issued under the fixed designation F2577; 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 Electronic Equipment
European Union Directive 2002/96/EC on Waste Electrical
1.1 This guide uses case studies to illustrate the decision
and Electronic Equipment
process to assess materials and products for declarable sub-
stances when evaluating conformance to relevant require-
3. Terminology
ments. This may be accomplished by applying existing knowl-
3.1 Terms and definitions related to declarable substances in
edge to determine the need for further action (for example,
materials may be found in Terminology F2576.
testing).
3.2 Terms and definitions in the guide not found in Termi-
1.2 This standard does not purport to address all of the
nology F2576 may be found in a common dictionary or other
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro- reference documents such as the ASTM Dictionary of Engi-
neering Science & Technology.
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
4. Significance and Use
2. Referenced Documents
4.1 Due to requirements being placed on concentrations of
substances within (or on) materials, assessing conformance of
2.1 ASTM Standards:
products has become a complex, time-consuming and expen-
F2576 Terminology Relating to Declarable Substances in
sivetask.Thisguideisintendedtoassisttheuserindeveloping
Materials
a protocol for product assessment.
2.2 Other Documents:
4.2 A priori knowledge is based on logical deduction and
DTI ROHS Regulations Government Guidance Notes, No-
scientific principles, so actual testing of a material may not be
vember 2005, SI 2005 No. 2748
required in order to assess conformance to requirements. For
European Commission Decision 2005/618/EC Commission
example, it is possible to deduce that organic substances will
Decision of 18 August 2005 amending Directive 2002/
notsurvivethetemperaturesrequiredtoproducewroughtsteel,
95/EC of the European Parliament and of the Council for
so there is no need to test for organic substances in wrought
the purpose of establishing the maximum concentration
steel nor is it possible to develop test methods and reference
values for certain hazardous substances in electrical and
materials for determination of organic substances within
electronic equipment
wrought steel.
European Union Directive 2002/95/EC on the Restriction of
the Use of Certain Hazardous Substances in Electrical and
4.3 A posteriori knowledge is based on observation, expe-
rience and known facts. If a priori knowledge cannot rule out
the possibility that a substance is present within (or on) a
1 material, a test method may be required to verify or generate
This guide is under the jurisdiction of ASTM Committee F40 on Declarable
Substances in Materials and is the direct responsibility of Subcommittee F40.02 on information on the concentration of that substance within (or
Management Practices and Guides.
on) the material.
Current edition approved Dec. 1, 2006. Published December 2006. DOI:
10.1520/F2577-06. 4.4 Test methods can be used as a means to verify and
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
provide information related to substances within materials. At
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.
3 5
DTI RoHS Regulations, Government Guidance Notes, November 2005, SI Official Journal of the European Union, L 37/19, 13.2.2003.
2005 No. 2748,” p. 23. Reproduced by permission from the United Kingdom Official Journal of the European Union, L 37/24, 13.2.2003.
Department of Transportation and Industry (DTI). Sponsored by ASTM Committee E02 on Terminology; available from ASTM
Official Journal of the European Union, L 214/65, 19.8.2005; notified under International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA
document number C(2005) 3143. 19428-2959; ASTM Stock Number: DEF00.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2577 − 06
the same time, misinformation can be generated or inappropri- product falls under the scope and whether the product or
ate conclusions drawn when test methods are misapplied. This material is exempt from that scope.
guide is intended to provide recommendations on the applica-
5.3 Establish the basis of conformance to which limits for
tion of test methods.
substances given in the requirements apply. Requirements in
theformofsubstancerestrictionsordeclarationlimitstypically
4.5 Test methods may be applied by producers or by interim
or end users of materials. However, it is not necessary or cost list concentrations of substances above which the product or
material is considered non-conforming or the substances must
effective to test materials at each stage of production. The
decision to apply test methods and the frequency of testing be declared. It is important to determine the basis to which the
limits apply in order to properly assess conformance. For
shouldbebasedonriskperceivedbytheuserorcanbeamatter
of agreement. example, the limits may apply to an entire product or they may
apply to each material within the product
4.6 Assessment of plastics for presence of declarable sub-
NOTE 1—Limits of “zero” for substances or statements such as
stances is more complex than assessment of metals and alloys,
“products shall not contain” certain substances are indeterminate. Prod-
since the possible ingredients are comparatively much more
ucts or materials cannot be assessed to such limits without accounting for
and identifying every atom constituting the product or material being
numerous in plastic manufacture.
assessed.
4.7 Thisguideincludesageneralprocessandcasestudiesin
5.4 If appropriate, apply a priori knowledge of the material
ordertoprovideguidanceandtodistinguishwhereaprioriand
and its manufacture to assess the probability whether each
a posteriori knowledge should be applied. Flow charts as a
declarable substance may be present. Lists of declarable
guide for assessment of materials and products are provided in
substances in requirements may have been set with little or no
Appendix X1.
regard to material types to be assessed. Through application of
a priori knowledge of specific materials it may be possible to
5. General Process of Assessment of Materials and
eliminate the need to gather empirical data for certain sub-
Products for Conformance with Requirements
stances listed in the requirements.
5.1 The process of assessing materials and products for
NOTE2—Aprioriknowledgerequiresjustificationbaseduponscientific
principles and logical deduction. For example, the statement that it is not
conformance with requirements may be broken down into the
necessary to determine the hexavalent chromium concentration within
following steps:
wrought metals is based upon knowledge of metallurgy and atomic
5.1.1 Determine if the material or product is covered under
structure.
the scope of the requirements, taking into account any exemp-
5.5 As necessary, obtain a posteriori knowledge of sub-
tions from the scope.
stance concentrations based upon observations or empirical
5.1.2 Establish the basis of conformance to which limits for
data from the material. Data on substance concentrations
substances given in the requirements apply.
within or on materials may be obtained from suppliers in the
5.1.2.1 List each material to be assessed and assess each on
form of Certificates ofAnalysis or a laboratory report of a lot,
an individual basis.
batch or heat of material. While it is not necessary to confirm
5.1.3 If appropriate, apply a priori knowledge of the mate-
each and every certificate obtained from suppliers via repeti-
rial and its manufacture to assess the probability of whether
tion of testing, it is good practice to periodically confirm
each declarable substance may be present.
material data.
5.1.4 As necessary, obtain a posteriori knowledge of sub-
5.6 Assess the material or product for conformance to
stance concentrations based upon observations or empirical
requirements based upon a priori and a posteriori information.
data from the material.
Theconcentrationsofanydeclarablesubstancesinmaterialsor
5.1.5 Assess the material or product for conformance to
products are compared to the limits set by the requirements in
requirements based upon a priori and a posteriori information.
order to determine conformance or non-conformance. While a
5.1.5.1 If the basis of conformance to requirements is each
posteriori information in the form of empirical data may be
material within a product, assess each material separately for
directly compared to limit values, a priori information may
declarable substances content.
indicate that it is not appropriate to assess conformity of
5.1.5.2 If the basis of conformance to requirements is the
materials for certain substances.
entireproduct,assessthecumulativecontributionofdeclarable
NOTE 3—A priori knowledge that a substance cannot be present in a
substances in materials for the entire product
material precludes the possibility of generating empirical data for that
substance within that material. It is appropriate to state in such cases that
5.1.6 Document the assessment process for each material or
conformity assessment is not applicable.
product.
5.7 Document the assessment process for each material or
5.2 Determine if the material or product is covered under
product. Documentation in the form of data and illustration of
the scope of the requirements, taking into account any exemp-
the assessment process is necessary to back up statements of
tions from the scope. Requirements may be regulations or
compliance for materials and products
stipulations by clients, that is, they may be statutory or by
agreement. The first step in any assessment is to determine
6. Case Studies
what is covered by requirements, or the scope of the require-
ments. In some cases exemptions to the scope are allowed, so 6.1 A finished aluminum part is to be evaluated for confor-
it is important to establish whether a particular material or mance to the requirements of European Union Directive
F2577 − 06
2002/95/EContheRestrictionoftheUseofCertainHazardous knowledge, or knowledge that is based on measurement. At
Substances in Electrical and Electronic Equipment (RoHS). It some point in the life of the aluminum metal, testing would be
was established that the part would be incorporated into a required to quantify the concentrations of lead, cadmium,
finished electrical product to be sold on the European market mercury and hexavalent chromium associated with the alumi-
num. Information on the lead and cadmium content, as well as
after the effective date of the RoHS Directive and the finished
product fits the description of electrical products to be regu- totalchromium,maybeavailableintheformofaCertificateof
Analysis generated by the producer or by an independent
lated per the RoHS Directive and European Union Directive
2002/96/EC on Waste Electrical and Electronic Equipment laboratory. If such a document is not available or the available
information requires verification, testing of the part is required
(WEEE).
to evaluate conformance to requirements. Aluminum Associa-
6.1.1 The chemical requirements of the RoHS Directive are
tion specifications require that aluminum producers maintain a
given in European Commission Decision 2005/618/EC as
surveillance program for mercury so that production is moni-
follows: the Maximum Concentration Value (MCV) for lead,
tored on a periodic (quarterly within North America) basis to
mercury, hexavalent chromium, polybrominated biphenyls
ensure that mercury has not been introduced into any of the
(PBB) and polybrominated diphenyl ethers (PBDE) is 0.1% by
production processes. The test method(s) applied to the alumi-
weight per homogeneous material and the MCV for cadmium
num part should be designed specifically for analysis of the
is 0.01% by weight per homogeneous material. Per the Annex
substancesonorwithinaluminumoraluminumalloys;inother
of the RoHS Directive, aluminum is exempt from the restric-
words, both the substance sought and the material to be
tion on lead and is allowed to contain up to 0.4% by weight
analyzed should be included in the scope of the test method. If
lead. No other exemption was applicable to the aluminum part.
a standard method does not exist, it is incumbent upon the
6.1.2 A priori knowledge of aluminum and its method of
laboratory to demonstrate that the method employed is valid
manufacture were used to evaluate the part. Aluminum is not
for analysis of the substance in (or on) the specific material
flammable under normal conditions, so there is a low probabil-
tested.
ity that flame retardants such as PBB or PBDE were part of the
6.1.4 Validation of a method can be accomplished through
formulation. Furthermore, the temperature of a typical alumi-
analysisofareferencematerial,preferablyacertifiedreference
num smelter is maintained at 920°C – 980°C at which organic
material with traceability to SI units, using the same method of
substances such as PBB or PBDE are decomposed and become
analysis as is used on the unknown sample. The reference
volatile gases, so organic substances will not remain in the
material used for validation of the method shall be of the same
finished aluminum metal. While metal alloys may contain the
or similar composition of the unknown sample; for example,
element chromium, the chromium within the metal is in the
the reference material used to validate the analysis of alumi-
metallic state with an atomic valence of zero. With regard to
num or its alloys for a substance shall be covered by the scope
metals, hexavalent chromium is not found within the metal but
of the test method for aluminum and its alloys and shall also
maybefoundontheexteriorsurfacesintheformofachromate
contain a known concentration of the substance to be mea-
conversion coating. Hexavalent chromium may also be found
sured.
in coatings such as paint and plastic since hexavalent chro-
NOTE 4—Areference material to be used for validation of a test method
mium compounds have been employed as pigme
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