Regulations 23(1), 25(1) and 31(3)

SCHEDULE 5INFORMATION TO BE INCLUDED IN AN ASSESSMENT REPORT

1.  An identification of the characteristics of the recipient organism which are relevant to the assessment of the relevant genetically modified organisms.

2.  An identification of any known risks to human health and the environment resulting from the release into the environment of the recipient non-modified organism.

3.  A description of the result of the genetic modification in the modified organism.

4.  An assessment of whether the genetic modification has been characterised sufficiently for the purpose of evaluating any risks to human health and the environment.

5.  An identification of any new risks to human health and the environment that may arise from the release of the relevant genetically modified organisms as compared to the release of the corresponding non-modified organism, based on the environmental risk assessment carried out in accordance with regulation 6.

6.  A conclusion which addresses the proposed use of the product, risk management and the proposed monitoring plan, and states whether the relevant genetically modified organisms should be placed on the market on its own or in a product and under which conditions, or not placed on the market for reasons which are specified, or whether the views of other competent authorities and the Commission are sought for on specified aspects of the environmental risk assessment carried out in accordance with regulation 6. Where it is concluded that the genetically modified organisms should not be placed on the market the Scottish Ministers shall give reasons for their conclusion.