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This document is used in the implementation of Ïã¸ÛÁùºÏ²Ê¿ª½± 11238. This document defines substances based on their scientific identity (i.e. what they are) rather than on their use or method of production.

Ïã¸ÛÁùºÏ²Ê¿ª½± 11238 provides the conceptual framework for defining Substances and Specified Substances and for assigning unique identifiers in the context of the Ïã¸ÛÁùºÏ²Ê¿ª½± IDMP standards. Ïã¸ÛÁùºÏ²Ê¿ª½± 11238 describes general concepts for defining and distinguishing substances and a high-level model for the structuring of information for substances. This document provides detailed explanations of each type or grouping of substance information, an element-by-element description for implementation of Ïã¸ÛÁùºÏ²Ê¿ª½± 11238, and examples for a variety of Substances and Specified Substances.

This third edition of the document addresses Substances Groups 1 to 3 of the Specified Substances as defined in Ïã¸ÛÁùºÏ²Ê¿ª½± 11238 and Annexes A, B, C, D, E, F, G, H, I, J and K. It is anticipated that Specified Substances Group 4, as defined in Ïã¸ÛÁùºÏ²Ê¿ª½± 11238, will be addressed in a subsequent edition of this document. Some information that would typically fall under Specified Substances Group 4 is covered in the Annexes of this document. This information, although not defining of either a Substance or a Specified Substance Group 1, might be essential to distinguishing substances. This document addresses the following:

- data elements necessary for defining Substances and Specified Substances Groups 1 to 3;

- the logical use of data elements as defined in Ïã¸ÛÁùºÏ²Ê¿ª½± 11238;

- Substances and Specified Substances Groups 1 to 3 business rules for:

• - determining necessary data elements,
• - distinguishing and defining materials according to Ïã¸ÛÁùºÏ²Ê¿ª½± 11238,
• - triggering the assignment of identifiers.

This document does not address the following:

- business processes for data management;

- implementation of a specific data information system (e.g. a relational database schema);

- normative messaging standards for substances;

- the maintenance of controlled vocabularies;

- the specific global identifier system that should be used;

- nomenclature standards for substances.