ASTM F2577-22
(Guide)Standard Guide for Compositional Evaluation of Declarable Substances and Substances of Concern for Materials in Products
Standard Guide for Compositional Evaluation of Declarable Substances and Substances of Concern for Materials in Products
SIGNIFICANCE AND USE
4.1 Regulations, standards, and market-defined requirements for chemical constituent (“substances of interest”) compliance and conformance have become increasing numerous and complex. Specific laws and standards may pertain to certain product and industry segments, for example, electrical/electronic instruments and components, pharmaceuticals, medical devices, consumer products, agrichemicals, and so forth. Others may be broader and relate specifically to assessment and management of specific chemical compounds or classes across multiple product sectors and sources, for example Ref (2). In addition, such requirements may be issued by national authorities, international standards setting groups, or, in the case of market-defined requirements, even by customer advocacy organizations or customers through supply contracts. The resulting global landscape of requirements and market access expectations is complex, and compliance/conformance presents numerous challenges for manufacturers.
Note 1: For example, IEC 62474:2012 provides some standardized definitions for reporting thresholds and declaration statements for electrotechnical industry. In another example, ISO 14021:2016 addresses self-declared environmental claims.
4.2 Declarable substances may be found on various lists and forms, including those listed in Refs (2-10) and on supply agreements and questionnaires. This guide is not intended to be exhaustive nor cover all declarable substances. Nor does this guide address specific declaration and labeling requirements within these regulation and standards nor address product safety and compliance requirements as dictated by law for specific products, industries, or market regions.
4.3 In addition to new laws and standards, more chemical substances are continually added to a variety of screening lists for review of potential hazards, identification and quantification of possible health or environmental hazards, or both, and consideration of control measures. To ...
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).
1.2 This guide assists in utilization and interpretation of various forms of information gathered to enable compliance or conformance or both to regulations, standards, supply agreements, or customer enquiries related to identified declarable substances, including the evidence required to issue declarations for the absence or presence of a declarable substance. Several examples are referenced. The target declarable substances will be specific to the product and product classification, the regulatory jurisdiction, customer/supplier requirements, and other relevant considerations. Consideration of which regulations and standards apply to a given product is beyond the scope of this guide.
1.3 The framework covered in this guide attempts to harmonize language used in the absence of objective data or specific regulatory requirements or both. This guide draws on a variety of existing documentation, which will be cited and referenced, as well as basic scientific principles for communication of chemical hazard and risk, and may be used as an approach for assessing composition of products and their components as part of product risk assessment.
1.4 This guide is applicable to a variety of materials, including polymeric and elastomeric materials, which are used in regulated industries and products.
1.5 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.6 This international st...
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F2577 − 22
Standard Guide for
Compositional Evaluation of Declarable Substances and
1
Substances of Concern for Materials in Products
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 1.6 This international standard was developed in accor-
dance with internationally recognized principles on standard-
1.1 This guide uses case studies to illustrate the decision
ization established in the Decision on Principles for the
process to assess materials and products for declarable sub-
Development of International Standards, Guides and Recom-
stances when evaluating conformance to relevant require-
mendations issued by the World Trade Organization Technical
ments. This may be accomplished by applying existing knowl-
Barriers to Trade (TBT) Committee.
edge to determine the need for further action (for example,
testing).
2. Referenced Documents
1.2 This guide assists in utilization and interpretation of
2
2.1 ASTM Standards:
various forms of information gathered to enable compliance or
D883 Terminology Relating to Plastics
conformance or both to regulations, standards, supply
F2576 Terminology Relating to Declarable Substances in
agreements, or customer enquiries related to identified declar-
Materials
able substances, including the evidence required to issue
F2931 Guide for Analytical Testing of Substances of Very
declarations for the absence or presence of a declarable
High Concern in Materials and Products
substance. Several examples are referenced. The target declar-
3
2.2 IEC Standards:
able substances will be specific to the product and product
IEC 62321-8:2017 Determination of certain substances in
classification, the regulatory jurisdiction, customer/supplier
electrotechnical products Part 8: Determination of specific
requirements, and other relevant considerations. Consideration
phthalates in polymer materials by mass spectrometry
of which regulations and standards apply to a given product is
IEC 62474:2012 Material declaration for products of and for
beyond the scope of this guide.
the electrotechnical industry
1.3 The framework covered in this guide attempts to har-
4
2.3 ISO Standards:
monize language used in the absence of objective data or
ISO 9001:2015 Quality management systems – Require-
specific regulatory requirements or both. This guide draws on
ments
a variety of existing documentation, which will be cited and
ISO 13485:2016 Medical devices – Quality management
referenced, as well as basic scientific principles for communi-
systems – Requirements for regulatory purposes
cation of chemical hazard and risk, and may be used as an
ISO 14021:2016 Environmental Labels and Declarations:
approach for assessing composition of products and their
Self-Declared Environmental Claims
components as part of product risk assessment.
ISO 14971:2019 Medical devices – Application of risk
1.4 This guide is applicable to a variety of materials,
management to medical devices
including polymeric and elastomeric materials, which are used
in regulated industries and products. 3. Terminology
1.5 This standard does not purport to address all of the
3.1 Definitions: Terms and definitions related to declarable
safety concerns, if any, associated with its use. It is the
substances in materials may be found in Terminology F2576.
responsibility of the user of this standard to establish appro-
priate safety, health, and environmental practices and deter-
2
mine the applicability of regulatory limitations prior to use. 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
1
This guide is under the jurisdiction of ASTM Committee F40 on Declarable the ASTM website.
3
Substances in Materials and is the direct responsibility of Subcommittee F40.02 on Available from the International Electrotechnical Commission, 3, rue de
Management Practices and Guides. Varembé, 1st floor, P.O. Box 131, CH - 1211 Geneva 20, Switzerland, www.iec.ch.
4
Current edition approved Oct. 1, 2022. Published November 2022. Originally Available from International Organization for Standardization (ISO), ISO
approved in 2006. Last previous edition approved in 2014 as F2577–14. DOI: Central Secretariat, Chemin de Blandonnet 8, CP 401, 1214 Vernier, Geneva,
10.1520/F2
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it 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 current version
of the standard as published by ASTM is to be considered the official document.
Designation: F2577 − 14 F2577 − 22
Standard Guide for
Assessment of Materials and Products for Declarable
SubstancesCompositional Evaluation of Declarable
Substances and Substances of Concern for Materials in
1
Products
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
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).
1.2 This guide assists in utilization and interpretation of various forms of information gathered to enable compliance or
conformance or both to regulations, standards, supply agreements, or customer enquiries related to identified declarable substances,
including the evidence required to issue declarations for the absence or presence of a declarable substance. Several examples are
referenced. The target declarable substances will be specific to the product and product classification, the regulatory jurisdiction,
customer/supplier requirements, and other relevant considerations. Consideration of which regulations and standards apply to a
given product is beyond the scope of this guide.
1.3 This guide is limited to the referenced European Union directives. Other regions, countries, states or local municipalities may
adopt these or similar regulations.The framework covered in this guide attempts to harmonize language used in the absence of
objective data or specific regulatory requirements or both. This guide draws on a variety of existing documentation, which will be
cited and referenced, as well as basic scientific principles for communication of chemical hazard and risk, and may be used as an
approach for assessing composition of products and their components as part of product risk assessment.
1.4 This guide is applicable to a variety of materials, including polymeric and elastomeric materials, which are used in regulated
industries and products.
1.5 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 safety, health, and healthenvironmental practices and determine the
applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
1
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
Management Practices and Guides.
Current edition approved March 1, 2014Oct. 1, 2022. Published April 2014November 2022. Originally approved in 2006. Last previous edition approved in 20062014
as F2577–06.–14. DOI: 10.1520/F2577-14.10.1520/F2577-22.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F2577 − 22
2. Referenced Documents
2
2.1 ASTM Standards:
D883 Terminology Relating to Plastics
F2576 Terminology Relating to Declarable Substances in Materials
F2931 Guide for Analytical Testing of Substances of Very High Concern in Materials and Products
2.2 Other Documents: IEC Standards:
33
DTI ROHS Regulations Government Guidance Notes, November 2005, SI 2005 No. 2748
European Commission Decision 2005/618/ECIEC 62321-8:2017 Commission Decision of 18 August 2005 amending Directive
2002/95/EC of the European Parliament and of the Council for the purpose of establishing the maximum concentration values
for certain hazardous substances in electrical and electronic equipmentDetermination of certain substances in electrotechnical
products Part 8: Determination of specific phthalates in polymer materials by mass spectrometry
European Union Directive 2011/65/EU (recast of 2002/95/EC) on the Restriction of the Use of Certain Hazardous Substances
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in Electrical and Ele
...
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