The original annex hereunder has been revised and must be replaced by the new text given in the Commission directive 94/51/EC.

A. Recipient or parental organism

• non-pathogenic;

• no adventious agents;

• proven and extended history of safe use or built-in biological barriers, which, without interfering with optimal growth in the reactor or fermentor, confer limited survivability and replicability, without adverse consequences in the environment.

B. Vector/Insert

• well characterized and free from known harmful sequences;

• limited in size as much as possible to the genetic sequences required to perform the intended function;

• should not increase the stability of the construct in the environment (unless that is a requirement of intended function);

• should be poorly mobilizable;

• should not transfer any resistance markers to micro-organisms not known to acquire them naturally (if such acquisition could compromise use of drug to control disease agents).

C. Genetically modified micro-organisms

• non-pathogenic;

• as safe in the reactor or fermentor as recipient or parental organism, but with limited survivability and/or replicability without adverse consequences in the environment.

D. Other genetically modified micro-organisms that could be included in Group I if they meet the conditions in C above

• those constructed entirely from a single prokaryotic recipient (including its indigenous plasmids and viruses) or from a single eukaryotic recipient (including its chloroplasts, mitochondria, plasmids, but excluding viruses);

• those that consist entirely of genetic sequences from different species that exchange these sequences by known physiological processes.