Requirements applicable for post-market monitoring of genetically modified food or feed for applications submitted under Articles 5(3) and 17(3)
Article 7
1. The applicant shall submit a proposal for post-market monitoring regarding the use of the food and feed as referred to in Articles 5(3)(k) and 17(3)(k) of Regulation (EC) No 1829/2003 when the information provided in accordance with Articles 4, 5 and 6 demonstrates that the genetically modified food and feed comply with Articles 4(1) and 16(1) of Regulation (EC) No 1829/2003 and when, in accordance with the outcome of the risk assessment, it is appropriate to confirm: (a) that specific recommendations of uses are followed by the consumer/animal owner; (b) the predicted consumption of the genetically modified food or feed; or (c) the relevance and intensity of effects and unintended effects detected during the pre-market risk assessment which can only be further characterised by post-market monitoring. 2. The applicant shall ensure that the post-market monitoring is: (a) developed to collect reliable information with respect to one or several of the aspects set out in paragraph 1. This information shall allow the detection of indications on whether any (adverse) effect on health may be related to genetically modified food or feed consumption; (b) based on strategies aiming at collecting relevant information from specific stakeholders including consumers and on a reliable and validated flow of information between the different stakeholders. More specific strategies shall be included when data on individual intakes of a specific food item or intakes of particular age groups have to be collected; (c) accompanied by adequate justification and a thorough description of the selected methodologies for the proposed post-market monitoring including aspects related to the analysis of the collected information.