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...

  • Guide
    9 pages
    English language
  • Guide
    9 pages
    English language

SIGNIFICANCE AND USE
5.1 The REACH Candidate list classifies substances as SVHCs thus making them subject to possible authorization. Compliance to the REACH regulation requires that any identified SVHC be present at a concentration of less than 0.1 % (w/w) of the total article weight to avoid triggering a reporting obligation. This guide is intended to assist in the identification of available test methods for quantitative analysis of the substance(s) of interest.  
5.2 When possible, industry accepted standard test methods are cited. However, industry vetted test methods are not available for all of the substances contained in the REACH Candidate List. Thus, some caution and due diligence must be exercised when applying some of the methods listed in this guide.  
5.3 In some cases, test methods for the identification and quantification of a specific substance are not available. An example would include CoCl2. Methods currently in practice involve the individual determination of Co and Cl concentrations and use other sources of information or chemical judgment to assign the expected CoCl2 concentration. This approach obviously has its limitations and pitfalls and must be used judiciously.  
5.4 Under the REACH regulation, EU manufacturers, importers or distributors of articles containing more than 0.1 % (w/w) of a substance that the Agency has listed as being an SVHC shall provide their customers with the name of the substance and information allowing the safe use of the article. Producers and distributors of articles containing SVHC shall also supply the same information to consumers, upon request. In situations where this information is not readily available from the supply chain it is incumbent upon the supplier to collect this information through actual chemical analysis or other means. This guide is intended to assist in the selection of appropriate test methods in the event that chemical analysis is required.
SCOPE
1.1 This guide contains a list of potential test methods for the analysis of Substances of Very High Concern (SVHC) as designated by ECHA, the European Chemicals Agency. Information on the test methods cited is publicly available and is drawn from a variety of sources. The guide is intended to assist in the selection of test methods that are applicable for the SVHCs identified.  
1.2 The specific SVHCs covered within this guide are compiled from the ECHA Candidate List of Substances of Very High Concern. This list is also referred to as the REACH Candidate List.  
1.3 This guide specifically addresses methods for the analysis of SVHCs in products. It is not intended to cover the many and varied analysis challenges associated in the manufacturing environment.  
1.4 Limitations:  
1.4.1 This guide is intended to provide a compilation of available test methods for the SVHCs listed on the ECHA Candidate list and is not intended to be exhaustive. The test methods within this guide are not the only ones available for any specific substances and this guide does not recommend any specific test method.  
1.4.2 Test methods for specific substances at the detection limits required for REACH reporting are not always available. In some cases, it is necessary to deduce the quantity of substance present through the analysis and quantification of its elements. Although this approach is routinely used some degree of uncertainty exists in the final result due to the reduced specificity of the test method.  
1.4.3 Although this guide is intended to be updated on a periodic basis to capture new developments in the field, there is no assurance that the information provided is the most current.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 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...

  • Guide
    134 pages
    English language
  • Guide
    134 pages
    English language

SIGNIFICANCE AND USE
5.1 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 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.  
5.2 Section 6 outlines the information that is to be exchanged in the supply chain both in the upstream and downstream directions.
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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 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.

  • Guide
    46 pages
    English language
  • Guide
    46 pages
    English language

SIGNIFICANCE AND USE
5.1 The REACH Candidate list classifies substances as SVHCs thus making them subject to possible authorization. Compliance to the REACH regulation requires that any identified SVHC be present at a concentration of less than 0.1 % (w/w) of the total article weight to avoid triggering a reporting obligation. This guide is intended to assist in the identification of available test methods for quantitative analysis of the substance(s) of interest.  
5.2 When possible, industry accepted standard test methods are cited. However, industry vetted test methods are not available for all of the substances contained in the REACH Candidate List. Thus, some caution and due diligence must be exercised when applying some of the methods listed in this guide.  
5.3 In some cases, test methods for the identification and quantification of a specific substance are not available. An example would include CoCl2. Methods currently in practice involve the individual determination of Co and Cl concentrations and use other sources of information or chemical judgment to assign the expected CoCl2 concentration. This approach obviously has its limitations and pitfalls and must be used judiciously.  
5.4 Under the REACH regulation, EU manufacturers, importers or distributors of articles containing more than 0.1 % (w/w) of a substance that the Agency has listed as being an SVHC shall provide their customers with the name of the substance and information allowing the safe use of the article. Producers and distributors of articles containing SVHC shall also supply the same information to consumers, upon request. In situations where this information is not readily available from the supply chain it is incumbent upon the supplier to collect this information through actual chemical analysis or other means. This guide is intended to assist in the selection of appropriate test methods in the event that chemical analysis is required.
SCOPE
1.1 This guide contains a list of potential test methods for the analysis of Substances of Very High Concern (SVHC) as designated by ECHA, the European Chemicals Agency. Information on the test methods cited is publicly available and is drawn from a variety of sources. The guide is intended to assist in the selection of test methods that are applicable for the SVHCs identified.  
1.2 The specific SVHCs covered within this guide are compiled from the ECHA Candidate List of Substances of Very High Concern. This list is also referred to as the REACH Candidate List.  
1.3 This guide specifically addresses methods for the analysis of SVHCs in products. It is not intended to cover the many and varied analysis challenges associated in the manufacturing environment.  
1.4 Limitations:  
1.4.1 This guide is intended to provide a compilation of available test methods for the SVHCs listed on the ECHA Candidate list and is not intended to be exhaustive. The test methods within this guide are not the only ones available for any specific substances and this guide does not recommend any specific test method.  
1.4.2 Test methods for specific substances at the detection limits required for REACH reporting are not always available. In some cases, it is necessary to deduce the quantity of substance present through the analysis and quantification of its elements. Although this approach is routinely used some degree of uncertainty exists in the final result due to the reduced specificity of the test method.  
1.4.3 Although this guide is intended to be updated on a periodic basis to capture new developments in the field, there is no assurance that the information provided is the most current.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 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...

  • Guide
    122 pages
    English language
  • Guide
    122 pages
    English language

SIGNIFICANCE AND USE
5.1 The REACH Candidate list classifies substances as SVHCs thus making them subject to possible authorization. Compliance to the REACH regulation requires that any identified SVHC be present at a concentration of less than 0.1 % (w/w) of the total article weight to avoid triggering a reporting obligation. This guide is intended to assist in the identification of available test methods for quantitative analysis of the substance(s) of interest.  
5.2 When possible, industry accepted standard test methods are cited. However, industry vetted test methods are not available for all of the substances contained in the REACH Candidate List. Thus, some caution and due diligence must be exercised when applying some of the methods listed in this guide.  
5.3 In some cases, test methods for the identification and quantification of a specific substance are not available. An example would include CoCl2. Methods currently in practice involve the individual determination of Co and Cl concentrations and use other sources of information or chemical judgment to assign the expected CoCl2 concentration. This approach obviously has its limitations and pitfalls and must be used judiciously.  
5.4 Under the REACH regulation, EU manufacturers, importers or distributors of articles containing more than 0.1 % (w/w) of a substance that the Agency has listed as being an SVHC shall provide their customers with the name of the substance and information allowing the safe use of the article. Producers and distributors of articles containing SVHC shall also supply the same information to consumers, upon request. In situations where this information is not readily available from the supply chain it is incumbent upon the supplier to collect this information through actual chemical analysis or other means. This guide is intended to assist in the selection of appropriate test methods in the event that chemical analysis is required.
SCOPE
1.1 This guide contains a list of potential test methods for the analysis of Substances of Very High Concern (SVHC) as designated by ECHA, the European Chemicals Agency. Information on the test methods cited is publicly available and is drawn from a variety of sources. The guide is intended to assist in the selection of test methods that are applicable for the SVHCs identified.  
1.2 The specific SVHCs covered within this guide are compiled from the ECHA Candidate List of Substances of Very High Concern. This list is also referred to as the REACH Candidate List.  
1.3 This guide specifically addresses methods for the analysis of SVHCs in products. It is not intended to cover the many and varied analysis challenges associated in the manufacturing environment.  
1.4 Limitations:  
1.4.1 This guide is intended to provide a compilation of available test methods for the SVHCs listed on the ECHA Candidate list and is not intended to be exhaustive. The test methods within this guide are not the only ones available for any specific substances and this guide does not recommend any specific test method.  
1.4.2 Test methods for specific substances at the detection limits required for REACH reporting are not always available. In some cases, it is necessary to deduce the quantity of substance present through the analysis and quantification of its elements. Although this approach is routinely used some degree of uncertainty exists in the final result due to the reduced specificity of the test method.  
1.4.3 Although this guide is intended to be updated on a periodic basis to capture new developments in the field, there is no assurance that the information provided is the most current.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 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...

  • Guide
    112 pages
    English language
  • Guide
    112 pages
    English language

SIGNIFICANCE AND USE
5.1 The REACH Candidate list classifies substances as SVHCs thus making them subject to possible authorization. Compliance to the REACH regulation requires that any identified SVHC be present at a concentration of less than 0.1 % (w/w) of the total article weight to avoid triggering a reporting obligation. This guide is intended to assist in the identification of available test methods for quantitative analysis of the substance(s) of interest.  
5.2 When possible, industry accepted standard test methods are cited. However, industry vetted test methods are not available for all of the substances contained in the REACH Candidate List. Thus, some caution and due diligence must be exercised when applying some of the methods listed in this guide.  
5.3 In some cases, test methods for the identification and quantification of a specific substance are not available. An example would include CoCl2. Methods currently in practice involve the individual determination of Co and Cl concentrations and use other sources of information or chemical judgment to assign the expected CoCl2 concentration. This approach obviously has its limitations and pitfalls and must be used judiciously.  
5.4 Under the REACH regulation, EU manufacturers, importers or distributors of articles containing more than 0.1 % (w/w) of a substance that the Agency has listed as being an SVHC shall provide their customers with the name of the substance and information allowing the safe use of the article. Producers and distributors of articles containing SVHC shall also supply the same information to consumers, upon request. In situations where this information is not readily available from the supply chain it is incumbent upon the supplier to collect this information through actual chemical analysis or other means. This guide is intended to assist in the selection of appropriate test methods in the event that chemical analysis is required.
SCOPE
1.1 This guide contains a list of potential test methods for the analysis of Substances of Very High Concern (SVHC) as designated by ECHA, the European Chemicals Agency. Information on the test methods cited is publicly available and is drawn from a variety of sources. The guide is intended to assist in the selection of test methods that are applicable for the SVHCs identified.  
1.2 The specific SVHCs covered within this guide are compiled from the ECHA Candidate List of Substances of Very High Concern. This list is also referred to as the REACH Candidate List.  
1.3 This guide specifically addresses methods for the analysis of SVHCs in products. It is not intended to cover the many and varied analysis challenges associated in the manufacturing environment.  
1.4 Limitations:  
1.4.1 This guide is intended to provide a compilation of available test methods for the SVHCs listed on the ECHA Candidate list and is not intended to be exhaustive. The test methods within this guide are not the only ones available for any specific substances and this guide does not recommend any specific test method.  
1.4.2 Test methods for specific substances at the detection limits required for REACH reporting are not always available. In some cases, it is necessary to deduce the quantity of substance present through the analysis and quantification of its elements. Although this approach is routinely used some degree of uncertainty exists in the final result due to the reduced specificity of the test method.  
1.4.3 Although this guide is intended to be updated on a periodic basis to capture new developments in the field, there is no assurance that the information provided is the most current.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 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...

  • Guide
    105 pages
    English language
  • Guide
    105 pages
    English language

SIGNIFICANCE AND USE
5.1 The REACH Candidate list classifies substances as SVHCs thus making them subject to possible authorization. Compliance to the REACH regulation requires that any identified SVHC be present at a concentration of less than 0.1 % (w/w) of the total article weight to avoid triggering a reporting obligation. This guide is intended to assist in the identification of available test methods for quantitative analysis of the substance(s) of interest.  
5.2 When possible, industry accepted standard test methods are cited. However, industry vetted test methods are not available for all of the substances contained in the REACH Candidate List. Thus, some caution and due diligence must be exercised when applying some of the methods listed in this guide.  
5.3 In some cases, test methods for the identification and quantification of a specific substance are not available. An example would include CoCl2. Methods currently in practice involve the individual determination of Co and Cl concentrations and use other sources of information or chemical judgment to assign the expected CoCl2 concentration. This approach obviously has its limitations and pitfalls and must be used judiciously.  
5.4 Under the REACH regulation, EU manufacturers, importers or distributors of articles containing more than 0.1 % (w/w) of a substance that the Agency has listed as being an SVHC shall provide their customers with the name of the substance and information allowing the safe use of the article. Producers and distributors of articles containing SVHC shall also supply the same information to consumers, upon request. In situations where this information is not readily available from the supply chain it is incumbent upon the supplier to collect this information through actual chemical analysis or other means. This guide is intended to assist in the selection of appropriate test methods in the event that chemical analysis is required.
SCOPE
1.1 This guide contains a list of potential test methods for the analysis of Substances of Very High Concern (SVHC) as designated by ECHA, the European Chemicals Agency. Information on the test methods cited is publicly available and is drawn from a variety of sources. The guide is intended to assist in the selection of test methods that are applicable for the SVHCs identified.  
1.2 The specific SVHCs covered within this guide are compiled from the ECHA Candidate List of Substances of Very High Concern. This list is also referred to as the REACH Candidate List.  
1.3 This guide specifically addresses methods for the analysis of SVHCs in products. It is not intended to cover the many and varied analysis challenges associated in the manufacturing environment.  
1.4 Limitations:  
1.4.1 This guide is intended to provide a compilation of available test methods for the SVHCs listed on the ECHA Candidate list and is not intended to be exhaustive. The test methods within this guide are not the only ones available for any specific substances and this guide does not recommend any specific test method.  
1.4.2 Test methods for specific substances at the detection limits required for REACH reporting are not always available. In some cases, it is necessary to deduce the quantity of substance present through the analysis and quantification of its elements. Although this approach is routinely used some degree of uncertainty exists in the final result due to the reduced specificity of the test method.  
1.4.3 Although this guide is intended to be updated on a periodic basis to capture new developments in the field, there is no assurance that the information provided is the most current.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 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...

  • Guide
    105 pages
    English language
  • Guide
    105 pages
    English language

SIGNIFICANCE AND USE
5.1 The REACH Candidate list classifies substances as SVHCs thus making them subject to possible authorization. Compliance to the REACH regulation requires that any identified SVHC be present at a concentration of less than 0.1 % (w/w) of the total article weight to avoid triggering a reporting obligation. This guide is intended to assist in the identification of available test methods for quantitative analysis of the substance(s) of interest.  
5.2 When possible, industry accepted standard test methods are cited. However, industry vetted test methods are not available for all of the substances contained in the REACH Candidate List. Thus, some caution and due diligence must be exercised when applying some of the methods listed in this guide.  
5.3 In some cases, test methods for the identification and quantification of a specific substance are not available. An example would include CoCl2. Methods currently in practice involve the individual determination of Co and Cl concentrations and use other sources of information or chemical judgment to assign the expected CoCl2 concentration. This approach obviously has its limitations and pitfalls and must be used judiciously.  
5.4 Under the REACH regulation, EU manufacturers, importers or distributors of articles containing more than 0.1 % (w/w) of a substance that the Agency has listed as being an SVHC shall provide their customers with the name of the substance and information allowing the safe use of the article. Producers and distributors of articles containing SVHC shall also supply the same information to consumers, upon request. In situations where this information is not readily available from the supply chain it is incumbent upon the supplier to collect this information through actual chemical analysis or other means. This guide is intended to assist in the selection of appropriate test methods in the event that chemical analysis is required.
SCOPE
1.1 This guide contains a list of potential test methods for the analysis of Substances of Very High Concern (SVHC) as designated by ECHA, the European Chemicals Agency. Information on the test methods cited is publicly available and is drawn from a variety of sources. The guide is intended to assist in the selection of test methods that are applicable for the SVHCs identified.  
1.2 The specific SVHCs covered within this guide are compiled from the ECHA Candidate List of Substances of Very High Concern. This list is also referred to as the REACH Candidate List.  
1.3 This guide specifically addresses methods for the analysis of SVHCs in products. It is not intended to cover the many and varied analysis challenges associated in the manufacturing environment.  
1.4 Limitations:  
1.4.1 This guide is intended to provide a compilation of available test methods for the SVHCs listed on the ECHA Candidate list and is not intended to be exhaustive. The test methods within this guide are not the only ones available for any specific substances and this guide does not recommend any specific test method.  
1.4.2 Test methods for specific substances at the detection limits required for REACH reporting are not always available. In some cases, it is necessary to deduce the quantity of substance present through the analysis and quantification of its elements. Although this approach is routinely used some degree of uncertainty exists in the final result due to the reduced specificity of the test method.  
1.4.3 Although this guide is intended to be updated on a periodic basis to capture new developments in the field, there is no assurance that the information provided is the most current.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 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 ...

  • Guide
    100 pages
    English language
  • Guide
    100 pages
    English language

SIGNIFICANCE AND USE
5.1 The REACH Candidate list classifies substances as SVHCs thus making them subject to possible authorization. Compliance to the REACH regulation requires that any identified SVHC be present at a concentration of less than 0.1 % (w/w) of the total article weight to avoid triggering a reporting obligation. This guide is intended to assist in the identification of available test methods for quantitative analysis of the substance(s) of interest.  
5.2 When possible, industry accepted standard test methods are cited. However, industry vetted test methods are not available for all of the substances contained in the REACH Candidate List. Thus, some caution and due diligence must be exercised when applying some of the methods listed in this guide.  
5.3 In some cases, test methods for the identification and quantification of a specific substance are not available. An example would include CoCl2. Methods currently in practice involve the individual determination of Co and Cl concentrations and use other sources of information or chemical judgment to assign the expected CoCl2 concentration. This approach obviously has its limitations and pitfalls and must be used judiciously.  
5.4 Under the REACH regulation, EU manufacturers, importers or distributors of articles containing more than 0.1 % (w/w) of a substance that the Agency has listed as being an SVHC shall provide their customers with the name of the substance and information allowing the safe use of the article. Producers and distributors of articles containing SVHC shall also supply the same information to consumers, upon request. In situations where this information is not readily available from the supply chain it is incumbent upon the supplier to collect this information through actual chemical analysis or other means. This guide is intended to assist in the selection of appropriate test methods in the event that chemical analysis is required.
SCOPE
1.1 This guide contains a list of potential test methods for the analysis of Substances of Very High Concern (SVHC) as designated by ECHA, the European Chemicals Agency. Information on the test methods cited is publicly available and is drawn from a variety of sources. The guide is intended to assist in the selection of test methods that are applicable for the SVHCs identified.  
1.2 The specific SVHCs covered within this guide are compiled from the ECHA Candidate List of Substances of Very High Concern. This list is also referred to as the REACH Candidate List.  
1.3 This guide specifically addresses methods for the analysis of SVHCs in products. It is not intended to cover the many and varied analysis challenges associated in the manufacturing environment.  
1.4 Limitations:
1.4.1 This guide is intended to provide a compilation of available test methods for the SVHCs listed on the ECHA Candidate list and is not intended to be exhaustive. The test methods within this guide are not the only ones available for any specific substances and this guide does not recommend any specific test method.  
1.4.2 Test methods for specific substances at the detection limits required for REACH reporting are not always available. In some cases, it is necessary to deduce the quantity of substance present through the analysis and quantification of its elements. Although this approach is routinely used some degree of uncertainty exists in the final result due to the reduced specificity of the test method.  
1.4.3 Although this guide is intended to be updated on a periodic basis to capture new developments in the field, there is no assurance that the information provided is the most current.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 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 appropria...

  • Guide
    92 pages
    English language
  • Guide
    92 pages
    English language

SIGNIFICANCE AND USE
4.1 Due to requirements being placed on concentrations of substances within (or on) materials, assessing conformance of products has become a complex, time-consuming and expensive task. This guide is intended to assist the user in developing a protocol for product assessment.  
4.2 A priori knowledge is based on logical deduction and scientific principles, so actual testing of a material may not be required in order to assess conformance to requirements. For example, it is possible to deduce that organic substances will not survive the temperatures required to produce wrought steel, so there is no need to test for organic substances in wrought steel nor is it possible to develop test methods and reference materials for determination of organic substances within wrought steel.  
4.3 A posteriori knowledge is based on observation, experience and known facts. If a priori knowledge cannot rule out the possibility that a substance is present within (or on) a material, a test method may be required to verify or generate information on the concentration of that substance within (or on) the material.  
4.4 Test methods can be used as a means to verify and provide information related to substances within materials. At the same time, misinformation can be generated or inappropriate conclusions drawn when test methods are misapplied. This guide is intended to provide recommendations on the application of test methods.  
4.5 Test methods may be applied by producers or by interim or end users of materials. However, it is not necessary or cost effective to test materials at each stage of production. The decision to apply test methods and the frequency of testing should be based on risk perceived by the user or can be a matter of agreement.  
4.6 Assessment of plastics for presence of declarable substances is more complex than assessment of metals and alloys, since the possible ingredients are comparatively much more numerous in plastic manufacture.  
4.7 This guide incl...
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 is limited to the referenced European Union directives. Other regions, countries, states or local municipalities may adopt these or similar regulations.  
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.

  • Guide
    7 pages
    English language
  • Guide
    7 pages
    English language

SIGNIFICANCE AND USE
5.1 The REACH Candidate list classifies substances as SVHCs thus making them subject to possible authorization. Compliance to the REACH regulation requires that any identified SVHC be present at a concentration of less than 0.1 % (w/w) of the total article weight to avoid triggering a reporting obligation. This guide is intended to assist in the identification of available test methods for quantitative analysis of the substance(s) of interest.  
5.2 When possible, industry accepted standard test methods are cited. However, industry vetted test methods are not available for all of the substances contained in the REACH Candidate List. Thus, some caution and due diligence must be exercised when applying some of the methods listed in this guide.  
5.3 In some cases, test methods for the identification and quantification of a specific substance are not available. An example would include CoCl2. Methods currently in practice involve the individual determination of Co and Cl concentrations and use other sources of information or chemical judgment to assign the expected CoCl2 concentration. This approach obviously has its limitations and pitfalls and must be used judiciously.  
5.4 Under the REACH regulation, EU manufacturers, importers or distributors of articles containing more than 0.1 % (w/w) of a substance that the Agency has listed as being an SVHC shall provide their customers with the name of the substance and information allowing the safe use of the article. Producers and distributors of articles containing SVHC shall also supply the same information to consumers, upon request. In situations where this information is not readily available from the supply chain it is incumbent upon the supplier to collect this information through actual chemical analysis or other means. This guide is intended to assist in the selection of appropriate test methods in the event that chemical analysis is required.
SCOPE
1.1 This guide contains a list of potential test methods for the analysis of Substances of Very High Concern (SVHC) as designated by ECHA, the European Chemicals Agency. Information on the test methods cited is publicly available and is drawn from a variety of sources. The guide is intended to assist in the selection of test methods that are applicable for the SVHCs identified.  
1.2 The specific SVHCs covered within this guide are compiled from the ECHA Candidate List of Substances of Very High Concern. This list is also referred to as the REACH Candidate List.  
1.3 This guide specifically addresses methods for the analysis of SVHCs in products. It is not intended to cover the many and varied analysis challenges associated in the manufacturing environment.  
1.4 Limitations:
1.4.1 This guide is intended to provide a compilation of available test methods for the SVHCs listed on the ECHA Candidate list and is not intended to be exhaustive. The test methods within this guide are not the only ones available for any specific substances and this guide does not recommend any specific test method.  
1.4.2 Test methods for specific substances at the detection limits required for REACH reporting are not always available. In some cases, it is necessary to deduce the quantity of substance present through the analysis and quantification of its elements. Although this approach is routinely used some degree of uncertainty exists in the final result due to the reduced specificity of the test method.  
1.4.3 Although this guide is intended to be updated on a periodic basis to capture new developments in the field, there is no assurance that the information provided is the most current.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.6 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 appropria...

  • Guide
    56 pages
    English language
  • Guide
    56 pages
    English language

SIGNIFICANCE AND USE
The REACH Candidate list classifies substances as SVHCs thus making them subject to possible authorization. Compliance to the REACH regulation requires that any identified SVHC be present at a concentration of less than 0.1 % (w/w) of the total article weight to avoid triggering a reporting obligation. This guide is intended to assist in the identification of available test methods for quantitative analysis of the substance(s) of interest.
When possible, industry accepted standard test methods are cited. However, industry vetted test methods are not available for all of the substances contained in the REACH Candidate List. Thus, some caution and due diligence must be exercised when applying some of the methods listed in this guide.
In some cases, test methods for the identification and quantification of a specific substance are not available. An example would include CoCl2. Methods currently in practice involve the individual determination of Co and Cl concentrations and use other sources of information or chemical judgment to assign the expected CoCl2 concentration. This approach obviously has its limitations and pitfalls and must be used judiciously.
Under the REACH regulation, EU manufacturers, importers or distributors of articles containing more than 0.1 % (w/w) of a substance that the Agency has listed as being an SVHC shall provide their customers with the name of the substance and information allowing the safe use of the article. Producers and distributors of articles containing SVHC shall also supply the same information to consumers, upon request. In situations where this information is not readily available from the supply chain it is incumbent upon the supplier to collect this information through actual chemical analysis or other means. This guide is intended to assist in the selection of appropriate test methods in the event that chemical analysis is required.
SCOPE
1.1 This guide contains a list of potential test methods for the analysis of Substances of Very High Concern (SVHC) as designated by the European Chemical Agency (ECHA), in October 2008. Substances of Very High Concern are defined in Article 57 of the European Union Regulation #1907/2006. Information on the test methods cited is publicly available and is drawn from a variety of sources. This guide is intended to assist in the selection of test methods that are applicable for the SVHCs identified.
1.2 The specific SVHCs covered within this guide are compiled from the ECHA Candidate List of Substances of Very High Concern. This list is also referred to as the REACH Candidate List.
1.3 This guide specifically addresses methods for the analysis of SVHCs in products. It is not intended to cover the many and varied analysis challenges associated in the manufacturing environment.
1.4 Limitations:
1.4.1 This guide is intended to provide a compilation of available test methods for the SVHCs listed on the ECHA Candidate list and is not intended to be exhaustive. The test methods within this guide are not the only ones available for any specific substances and this guide does not recommend any specific test method.
1.4.2 Test methods for specific substances at the detection limits required for REACH reporting are not always available. In some cases, it is necessary to deduce the quantity of substance present through the analysis and quantification of its elements. Although this approach is routinely used some degree of uncertainty exists in the final result due to the reduced specificity of the test method.
1.4.3 Although this guide is intended to be updated on a periodic basis to capture new developments in the field, there is no assurance that the information provided is the most current.
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 This standard does not purport to address all of the safety concerns, if any, associa...

  • Guide
    15 pages
    English language

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.

  • Guide
    46 pages
    English language
  • Guide
    46 pages
    English language

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.

  • Guide
    35 pages
    English language

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.

  • Guide
    7 pages
    English language

Frequently Asked Questions

F40.02 is a Technical Committee within ASTM International. It is named "Management Practices and Guides". This committee has published 15 standards.

F40.02 develops ASTM standards in the area of Information technology. Currently, there are 15 published standards from this technical committee.

ASTM is a standardization organization that develops and publishes standards to support industry, commerce, and regulatory requirements.

A Technical Committee (TC) in ASTM is a group of experts responsible for developing international standards in a specific technical area. TCs are composed of national member body delegates and work through consensus to create standards that meet global industry needs. Each TC may have subcommittees (SCs) and working groups (WGs) for specialized topics.

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