Implications of REACH for the Pharma Industry

Actions needed by the pharmaceutical industry to meet the requirements of the European Union’s new Registration, Evaluation and Authorization of Chemicals (REACH) regulation are gradually becoming clearer now that the December 1, 2008 pre-registration deadline has passed. There has been considerable and ongoing confusion about the requirements of REACH amongst pharmaceutical firms: in some cases, substances used in drug manufacture are exempt from REACH, but this applies only in certain specific situations (See Know Your Exemptions below).

It is essential that pharmaceutical companies rapidly review their compliance with REACH requirements. Under the “No Data – No Market” message from REACH, companies have to register substances imported or manufactured in quantities of more than one tonne per year, providing toxicological data on the substance and risk assessment on their uses to the European Chemical Agency (ECHA). Users of substances have to make sure that their use is included in the registration and that they comply with authorization and restriction requirements under REACH.