Methodology to be applied in the risk assessment
Article 2
1. The risk assessment shall include the common elements, as specified in the Annex to this Regulation, and shall comply with the methodology set out in this Article. The risk assessment may be based on any protocol or method, provided that all requirements set out in this Regulation and in Regulation (EU) No 1143/2014 are fulfilled. 2. The risk assessment shall cover the territory of the Union, excluding the outermost regions (‘the risk assessment area’). 3. The risk assessment shall be based on the most reliable scientific information available, including the most recent results of international research, supported by references to peer reviewed scientific publications. In cases where there are no peer reviewed scientific publications or where the information provided by such publications is insufficient, or to supplement the information collected, the scientific evidence may also include other publications, expert opinions, information collected by Member States' authorities, official notifications and information from databases, including information collected through citizen science. All sources shall be acknowledged and referenced. 4. The method or protocol used shall allow for completion of the risk assessment to take place even where there is no information about a certain species or when the information about a species is insufficient. Where there is such a lack of information, the risk assessment shall state that fact explicitly so that no question in the risk assessment is left unanswered. 5. Each answer provided in the risk assessment shall include an assessment of the level of uncertainty or confidence attached to that answer, reflecting the possibility that information needed for the answer is not available or is insufficient or the fact that the available evidence is conflicting. The assessment of the level of uncertainty or confidence attached to an answer shall be based on a documented method or protocol. The risk assessment shall include a reference to that documented method or protocol. 6. The risk assessment shall include a summary of its different components, as well as an overall conclusion, in a clear and consistent form. 7. A quality control process shall be an integral part of the risk assessment and shall include at least a review of the risk assessment by two peer reviewers. The risk assessment shall include a description of the quality control process. 8. The author(s) of the risk assessment and the peer reviewers shall be independent and have relevant scientific expertise. 9. The author(s) of the risk assessment and the peer reviewers shall not be affiliated to the same institution.