ANNEX VI GUIDELINES FOR THE ASSESSMENT REPORTS

Identification of the characteristics of the recipient organism which are relevant to the assessment of the GMO(s) in question. Identification of any known risks to human health and the environment resulting from the release into the environment of the recipient non-modified organism.

Description of the result of the genetic modification in the modified organism.

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

Identification of any new risks to human health and the environment that may arise from the release of the GMO(s) in question as compared to the release of the corresponding non-modified organism(s), based on the environmental risk assessment carried out in accordance with Annex II.

A conclusion on whether the GMO(s) in question should be placed on the market or as (a) product(s) and under which conditions, whether the GMOs in question shall not be placed on the market or whether the views of other competent authorities and the Commission are sought for on specific issues of the e.r.a. These aspects should be specified. The conclusion should clearly address the use proposed, risk management and the monitoring plan proposed. In the case that it has been concluded that the GMOs should not be placed on the market, the competent authority shall give reasons for its conclusion.