Nuclear Load of pharmaceutical Products from Japan

Both ECA and Concept Heidelberg increasingly receive requests on whether a pharmaceutical manufacturer has to check substances and medicinal products from Japan for nuclear loads. A respective regulation has to come from the EU Commission who so far has only issued regulations with regard to food and animal feed from Japan, though. Industry organisations like the German Association of medicinal product manufacturers (BAH) now recommend to work with the respective regulation and with the confirmation mentioned in it.

Following the incident in the nuclear power plant in Fukushima, Japan, the EU released Commission Implementing Regulation No 297/2011 in March entitled "Import of Food and Animal Feed with Origin or Background in Japan". With regard to maximum values to be respected the document refers to the further so-called Euratom Regulations 3954/87, 944/89 and 770/90. These regulations were issued much earlier and the mentioned maximum values are partly higher than the current values in Japan. For that reason regulation (EU) No 297/2011 was modified on 11 April. The respective Commission Implementing Regulation No 351/2011 now states that it is "appropriate in order to provide consistency between the pre-export controls performed by the Japanese authorities and the controls on the level of radionuclides performed on feed and food originating in or consigned from Japan at the entry into the EU, to apply on a provisional basis the same maximum levels in the EU for radionuclides in feed and food from Japan as the action levels applicable in Japan as long as these are lower than the EU values."

The pharmaceutical industry should not just wait for clear input from the legislative bodies but take advantage of the best possibilities current GMP systems allow - namely the risk analysis. In this respect the supply chain should be precisely identified and evaluated, and respective decisions should also be made considering the mentioned regulations.

Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)