Techniques or methods of genetic modification yielding micro-organisms to be excluded from the Directive on the condition that they do not involve the use of recombinant-nucleic acid molecules or GMMs other than those produced by one or more of the techniques/methods listed below:

1. Mutagenesis.

2. Cell fusion (including protoplast fusion) of prokaryotic species that exchange genetic material by known physiological processes.

3. Cell fusion (including protoplast fusion) of cells of any eukaryotic species, including production of hybridomas and plant cell fusions.

4. Self-cloning consisting in the removal of nucleic acid sequences from a cell of an organism which may or may not be followed by reinsertion of all or part of that nucleic acid (or a synthetic equivalent) with or without prior enzymic or mechanical steps, into cells of the same species or into cells of phylogenetically closely related species which can exchange genetic material by natural physiological processes where the resulting micro-organism is unlikely to cause disease to humans, animals or plants.

Self-cloning may include the use of recombinant vectors with an extended history of safe use in the particular micro-organisms.

Criteria establishing the safety of GMMs to human health and the environment:

. . . (to be completed in accordance with the procedures in Article 20a)

Criteria have now been established by Council Decision 2001/204/EC of 8 March 2001.

Types of GMMs which meet the criteria listed in Part B:

. . . (to be completed in accordance with the procedure in Article 21)