Update on European Commission Regulatory Agency

The Directorate-General for Health and Consumers (DG SANCO) was renamed to the Directorate-General for Health and Food Safety (DG SANTE) as of 1st of January 2015.  This is due to the reform of the European Commission following the European elections of 2014.  Regarding DG SANCO’s work, this is an administrative change only and DG SANTE remains responsible for the implementation of European Union laws on food safety and health. 
 
With respect to the Confidentiality Commitment, DG SANTE confirms it remains bound by the existing arrangements the FDA had with DG SANCO. DG SANTE is committed to protecting FDA provided non-public information in the 2005 Confidentiality Commitment, and will continue to protect any non-public information provided previously or in the future.