Evaluation of trial descriptions of strains of Bacillus licheniformis and Aspergillus niger genetically modified with alpha-amylase gene(s)

Following a request from the Association of Manufacturers and Formulators of Enzyme Products (AMFEP), the European Food Safety Authority was asked to deliver a scientific assessment on trial descriptions of hypothetical strains of Bacillus licheniformis and Aspergillus niger modified with additional alpha-amylase gene(s). These two trial descriptions consider several scenarios with genetically modified B. licheniformis and A. niger strains. Recommendations are herein provided on how to assemble a data set necessary for the risk assessment of these strains and derived products.