Paragraph 1 IntroductionF1

This schedule describes in general terms the objective to be achieved, the elements to be considered and the general principles and methodology to be followed to perform the environmental risk assessment.

In this schedule—

• “cumulative long-term effects” means the accumulated effects of consents on human health and the environment, including among other things flora and fauna, soil fertility, soil degradation of organic material, the feed/food chain, biological diversity, animal health and resistance problems in relation to antibiotics,

• “delayed effects” means the effects on human health or the environment which may not be observed during the period of the release of the genetically modified organism, but become apparent as a direct or indirect effect either at a later stage or after termination of the release,

• “direct effects” means the primary effects on human health or the environment which are a result of the genetically modified organism itself and which do not occur through a causal chain of events,

• “immediate effects” means the effects on human health or the environment which are observed during the period of the release of the genetically modified organism. Immediate effects may be direct or indirect, and

• “indirect effects” means the effects on human health or the environment occurring through a causal chain of events, through mechanisms such as interactions with other organisms, transfer of genetic material, or changes in use or management (observations of indirect effects are likely to be delayed).

A general principle for environmental risk assessment is that an analysis of the cumulative long-term effects relevant to the release and the placing on the market of genetically modified organisms is to be carried out.