Comparison of the European Union (EU) and the United States National Shellfish Sanitation Programme (NSSP) microbiological standards in relation to EU Regulation 2015/2285

Scope This report describes analyses undertaken to establish the effect of the introduction of Regulation (EU) 2015/2285 amending Regulation (EC) No 854/2004 on the official control of microbiological monitoring and classification of bivalve mollusc harvesting areas in the EU with respect to comparisons between EU ‘Class A’ and US ‘Approved’ classifications. This analysis was requested by the US FDA and EU Commission to inform the discussion on equivalence of standards in the context of trade negotiations. This report builds on previous work (Annex 1) undertaken at the EURL examining the equivalence of US and EU legislation for sanitary production of live bivalve molluscs for human consumption, and also a preliminary evaluation of any changes consequential on the introduction of (EU) 2015/2285.