Environmental risk assessment
Because the microbial additive impact on the environment
can be considered negligible, the environmental risk
assessment is only required in exceptional cases. If the
additive contains or consists of a GMOs within the meaning
of article 2 (1) and 2 (2) of Council Directive 2001/18/
EC on the deliberate release of GMOs (OJ L 106, 17.4.2001)
must Wrst satisfy the requirements of the release Directive,
which includes an assessment of any risks for the environment
related to the GMOs. The conditions for the placing
on the market of the additive, including speciWc conditions
of use and handling and a proposal for labelling and packaging
should comprise at least the requirements laid down
in Annex IV of Directive 2001/18/EC (Anadón et al., 2004).