In many countries around the world, an Environmental Risk Assessment must be conducted and submitted to regulatory authorities as part of the official marketing approval or the new substance notification processes.

Because Merck markets products globally, this means that new products have been assessed in a manner consistent with the most-conservative regulatory requirements.

To carry out these assessments, we put our medicines through a battery of environmental "fate and effects" tests that are appropriate for evaluating potential environmental impacts from pharmaceutical residues in the environment. All tests are performed in independent research laboratories officially accredited to perform regulatory testing. Tests are carried out following protocols issued by the Organization for Economic Cooperation and Development (OECD) and in full compliance with Good Laboratory Practice regulations. Environmental risk assessments carried out to date indicate that our products do not pose an unacceptable risk to human health or the environment.

The European Medicines Agency (EMEA) publishes detailed information on the drug products it assessed in a European Public Assessment Report (EPAR), which now includes the results of the Environmental Risk Assessments that are performed.

Merck scientists also collaborate with other pharmaceutical companies, governmental agencies and universities to increase awareness and use of the scientific methods used to assess the potential impacts of pharmaceuticals in the environment, and to increase the understanding of such impacts. For example:

• Merck joined with other pharmaceutical companies, Swedish stakeholders with environmental interests, and the Swedish Association of the Pharmaceutical Industry in establishing an environmental classification system for pharmaceuticals in Sweden. We voluntarily provide environmental risk data on our products to the Swedish system, which is publicly available online.
• Merck scientists are working with governmental agency and university scientists from Canada on the Canadian Environmental Impact initiative. This initiative is developing environmental assessment regulations aimed at addressing risks to the environment and to human health posed by products regulated under the Canadian Food and Drug Act.