ANNEX II
PART BCriteria establishing the safety of GMMs for human health and the environment
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. Since pathogenicity includes both toxigenicity and allergenicity, the GMM should therefore 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 in particular with that of the micro-organisms identified in Directive 2000/54/EC.
3.2.No harmful adventitious agents
The GMM should not harbour known harmful adventitious agents such as other micro-organisms, active or latent, existing alongside or 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 a significant and unintended release
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 may not be included in Part C.