This annex describes in general terms the criteria to be met when establishing the safety of types of GMMs to human health and the environment and their suitability for inclusion in Part C. It will be supplemented by guidance notes to be developed and, if necessary, amended by the Commission in accordance with the procedure referred to in Article 21(2).

1. Introduction

Types of genetically modified micro-organisms (GMMs) listed in Part C in accordance with the procedure referred to in Article 21(2) of the Directive are excluded from the scope. GMMs will only be added to the list on a case-by-case basis and the exclusion will only relate to the clearly identified GMM. This exclusion only applies when the GMM is used under conditions of contained use as defined in Article 2(c) and does not apply to the deliberate release of GMMs. For a GMM to be listed in Part C, it must be proven to meet the criteria given below.

2. General Criteria

2.1 Strain verification/authentication

Identity of the strain must be precisely established and the modification known and verified.

2.2 Documented and established evidence of safety

Documented evidence of the safety of the organism must be provided.

2.3 Genetic stability

Where any instability could adversely affect safety, evidence of stability is required.

3. Specific Criteria

3.1 Non-pathogenic

The GMM should not be capable of causing disease or harm to a healthy human, plant or animal. Pathogenicity includes both toxigenicity and allergenicity, accordingly the GMM should also be:

3.1.1 Non-toxigenic

The GMM should not produce increased toxigenicity as a result of the genetic modification nor be noted for its toxigenic properties.

3.1.2 Non-allergenic

The GMM should not produce increased allergenicity as a result of the genetic modification nor be a noted allergen, having for example allergenicity comparable with those micro-organisms identified in Directive 93/88/EEC [5].

3.2 No harmful adventitious agents

The GMM should not harbour known adventitious agents such as other micro-organisms, active or latent, existing alongside/inside the GMM that could cause harm to human health and the environment.

3.3 Transfer of genetic material

The modified genetic material must not give rise to harm if transferred nor should it be self transmissible or transferable at a frequency greater than other genes of the recipient or parental micro-organism.

3.4 Safety for the environment in the event of an escape from control

GMMs must not produce adverse effects on the environment, immediate or delayed, should any incident involving a significant and unintended release occur.

GMMs that do not meet the above criteria will not be suitable for inclusion into Part C.

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[5] OJ L 268, 29.10.1993, p. 71."