On the safety of filamentous fungi with special emphasis on Trichoderma reesei and products made by recombinant means

Filamentous fungi are routinely used in industry to produce a variety of recombinant gene products, in particular enzymes. Because of the recombinant nature of the production, safety assessment requires information across the entire process including the safety of the intended production host, introduced DNA sequences, natural host (gene donor) and the recombinant product made. While the safety regulations, as a whole, follow the same principles, there are slight differences between different countries. The main regulatory bodies worldwide include Food and Drug Administration (FDA) in the US, and European Food Safety Authority (EFSA). The key in evaluating safety of a product is the assessment of the production strain. Here we will use the industrially-exploited enzyme producer Trichoderma reesei as an example in establishing the safety of filamentous fungi and their products. The questions and guidelines regarding the acceptance of T. reesei and its products for human use are similarly applicable to other fungi. Regulations and practices in the European Union (EU), United States of America (USA) and Australia are presented as examples typical of developed nations.