The Globally Harmonized System of Classification and Labeling of Chemicals (GHS) has been developed to improve consistency in hazard labeling, facilitate international trade, and reduce the regulatory burden associated with conflicting global requirements for classification and labeling. All hazardous chemicals in supply, use and transport are within the scope of the GHS. Since the GHS will impact Schering-Plough in all business units and regions, a comprehensive compliance strategy has been developed to ensure that all company sites follow the GHS labeling guidance according to regional and local requirements. A core GHS implementation team with representation from Global Safety and Environmental Affairs (GSEA), Global Information Technology (GIT), and key operating sites has been developed to address implementation issues and provide guidance and training tools.

Implementation of the GHS in Schering-Plough will consist of three main components: (1) hazard classification of proprietary Schering-Plough substances and mixtures according to the GHS criteria; (2) hazard communication via labeling and Safety Data Sheets; and (3) training. Implementation of the GHS will have an impact on various hazard communication program elements including, but not limited to, documented standards and guidance, Safety Data Sheets (SDSs), labeling, and modification of computer programs/software for classification, labeling and SDSs. GSEA will provide oversight for the implementation of the GHS, including awareness training and coordination with sites regarding implementation options and compliance tools. GSEA’s Occupational & Environmental Toxicology unit will be responsible for assigning the GHS classifications and maintaining GHS-compliant SDSs for all Schering-Plough proprietary substances and mixtures according to regulatory timelines and for communicating these classifications for use on labels.

Consistent with the above strategy, each Schering-Plough site is responsible for understanding its local regulations, developing a GHS implementation plan, implementing a GHS labeling process at its facility and training site personnel according to local regulatory requirements.

In general, the timeline for the GHS implementation (classifications, SDS and labeling) will be according to the EU timelines of December 1, 2010, for substances and June 15, 2015, for mixtures or product formulations. However, other regional GHS implementations will be evaluated and addressed at a local level according to those local requirements.