The world of chemical regulatory compliance is becoming increasingly complicated as product sourcing and formulations grow more complex and organizations expand into new markets on a global scale. New initiatives such as the Globally Harmonized System of Classification and Labeling of Chemicals and the Registration, Evaluation and Authorization of Chemicals add to the challenge of keeping on top of compliance issues, including the proper management of Material Safety Data Sheets.
GHS is the United Nations' system for harmonization of classification and labeling of chemicals. The system is already implemented and required in Japan and New Zealand. Korea has implemented GHS, and compliance is required through a phase-in period starting July 2010. Compliance is required in Taiwan by the end of 2008. The European Union and Australia also have drafted GHS regulations.
REACH is the new EU regulatory framework for managing chemical substances in Europe. REACH went into effect in June 2007. Requirements include the registration of chemicals, authorization of use of certain chemicals, and new and extended requirements to the information in MSDSs.
The implementation and requirement timelines for GHS and REACH are closely tied in Europe, and both regulations significantly impact MSDSs, as they require affected companies to update these documents to achieve compliance. Subsequently, the corporate strategy for managing MSDSs is impacted as well. Comprehensive inventory management, thorough regulatory reporting and consistent MSDS authoring are three critical components of a REACH- and GHS-compliant MSDS management program.
Accurate inventory management is the cornerstone of any comprehensive MSDS management program. Under REACH, obtaining and maintaining raw material MSDSs and the full composition of mixtures helps companies establish which category individual substances fall into: manufactured within the EU, imported into the EU or purchased from a supplier within the EU. Companies also must identify each substance's tonnage and current classification.
Comprehensive regulatory reporting is also crucial to achieving compliance. In addition to consistently tracking regulation, companies should track modifications made to ingredient, product, and quantities or inventories. This helps identify the monomers from which the polymers are made, and simplifies the tracking of annual volumes of manufactured or imported substances and preparations, including composition (the substances contained in each preparation).
Authoring accurate and compliant MSDSs is critical. For higher volume substances, the company must attach an exposure scenario to the MSDS. The exposure scenario describes how the chemical can be used in a safe manner, with no risk, for the intended use. The exposure scenario can either be for each of the substances in the chemical product or for the mixture as such. Companies should obtain the necessary overview of the REACH regulation as it stands today and dissect how it relates to their chemicals and their supply chain. Manufacturers, users and distributors should be aware of not only their own obligations but also their obligations to downstream customers and employees.
Both GHS and REACH will impact the MSDS for many products and chemicals. Companies must ensure their MSDS management system can accommodate these newly formatted MSDSs and must train employees on how to interpret these new MSDSs as they are introduced into the marketplace.
Creating, analyzing and managing globally compliant MSDSs, product label content, and hazardous materials transportation documents that reflect both REACH and GHS requirements can be extremely challenging. Many companies rely on an outsourced service provider to help facilitate their compliance with the vast scope of these new regulations.