Article 6 Additional information related to the risk assessment of genetically modified food or feed for applications submitted under Articles 5(3) and 17(3)

In addition to the information required in accordance with Article 5 and Annex II, the application shall include a systematic review of studies published in the scientific literature and studies performed by the applicant within the period of 10 years prior to the date of submission of the dossier on the potential effects on human and animal health of the genetically modified food and feed covered by the application.

During the authorisation procedure, the applicant shall submit, without delay, to the F1Food Safety Authority additional information which might influence the risk assessment of the genetically modified food or feed generated following the submission of the application. In particular, the applicant shall submit to the Food Safety Authority information regarding any prohibition or restriction imposed by a competent authority of any third country on the basis of a risk assessment of the genetically modified food and feed.