ASTM F2577-22

1.1This 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).

1.2This 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.

1.3The 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.

1.4This guide is applicable to a variety of materials, including polymeric and elastomeric materials, which are used in regulated industries and products.

1.5This 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.

1.6This 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.