Two Commission Regulations are updated with acknowledgement of in silico methods as alternatives to in vivo testing 

Two Regulations were draft amended by DG SANTE to reflect new mentions of in silico methods as alternatives to in vivo testing. 

The Commission has published the following draft regulations:

1. COMMISSION REGULATION (EU) amending Regulation (EU) No 284/2013 as regards the information to be submitted for plant protection products and the specific data requirements for plant protection products containing micro-organisms

2. COMMISSION REGULATION (EU) amending Regulation (EU) No 283/2013 as regards the information to be submitted for active substances and the specific data requirements for micro-organisms-1 

Both regulations concern the information necessary to submit for approval of different potentially dangerous substances: plant protection products and active substances. For both of the regulations, annexes have been added to state that in-silico and in vitro methods should be used as much as possible to minimise the amount of testing on vertebrate animals. 

The mention of in silico – and the amending of an increasing number of documents and regulations to include in silico – is a testament to the increasing recognition and importance of in silico methods. That these amendments consider the impact of in silico on vertebrate testing demonstrates the breadth and scope of support for in silico methods, and the increasing appeal for many stakeholders of minimising in vivo testing for resource, capacity, ethics and safety reasons. 

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