Underlying Foundation of Science used in Regulation of Industrial Chemicals

Underlying Foundation of Science used in Regulation of Industrial Chemicals

This book reviews the relevant chemical nomenclature issues in the EU and in the US and their impact on regulatory compliance. In particular, during the pre-REACH period, chemical identities frequently were described differently by different manufacturers for the same chemicals. The importance of having consistent nomenclature rules under REACH is related to the establishment of Substance Information Exchange Forums (SIEF) by ECHA after the pre-registration process, and, ultimately, industry consortia to meet registration requirements. If consistency is not established, there is a substantial risk that multiple registrations for the same substance will occur in conflict with the "One Substance, One Registration" (OSOR) principle under REACH. This book will discuss the relationships between and among various nomenclature systems and how chemical identity issues are to be addressed under REACH, along with comparative examples of chemical issues under TSCA in the US.

Chemical identity issues are of central importance to the successful implementation of the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), both for the regulated community and for the European Chemical Agency (ECHA) responsible for REACH's implementation. A variety of nomenclature systems exists, some with similar naming convention but also with critically important differences. These systems include: International Union of Pure and Applied Chemistry (IUPAC) which is used in European Union (EU) countries and that provides the primary nomenclature system to be used in the implementation of REACH; Chemical Abstracts Services Registry Names and Numbers (CASRN), which is used in the United States and Canada, and will be used as an adjunct to IUPAC under REACH; common names and trade names; and the use of SMILES (Simplified Molecular Input Line Entry System) notation designed for computer use by chemists.

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