Division 2.2.1.2

The ability of micro-organisms to adapt to the environment must be evaluated. In particular, F1competent authorities must take account of the following principles:

1. (a)

   depending on the conditions (e.g. availability of substrates for growth and metabolism) micro-organisms can switch on or off the expression of given phenotypic traits;

2. (b)

   the microbial strains most adapted to the environment can survive and multiply better than the non-adapted strains. Adapted strains have a selective advantage and can form the majority within a population after a number of generations;

3. (c)

   the relatively rapid multiplication of micro-organisms leads to a higher frequency of mutations. If a mutation is promoting survival in the environment, the mutant strain can become dominant;

4. (d)

   the properties of viruses, in particular, can change rapidly, including their virulence.

Therefore, where appropriate, information on the genetic stability of the micro-organism under the environmental conditions of proposed use must be evaluated, as well as information on the micro-organism’s capacity to transfer genetic material to other organisms and information on the stability of encoded traits.