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PROCEDURES AND MINIMUM ELEMENTS TO BE ADDRESSED IN AN ENVIRONMENTAL RISK ASSESSMENT AS FORESEEN UNDER ARTICLE 9 To evaluate risks associated with the introduction or translocation of aquatic organisms it is necessary to assess the probability that the organisms will become established and the consequences of that establishment. The process addresses the major environmental components. It provides a standardised approach for evaluating the risk of genetic and ecological impacts as well as the potential for introducing a non-target species that might impact the native species of the proposed receiving waters. During the review process, emphasis is not on the ratings but on the detailed biological and other relevant information statements that motivate them. In case of scientific uncertainty, the precautionary principle should be applied. For the purpose of this Annex, where an application refers to a proposed translocation the terms ‘introduction/introduced’ are to be replaced by ‘translocation/translocated’. PART 1 ECOLOGICAL AND GENETIC RISK ASSESSMENT PROCESS Step 1 Likelihood of establishment and spreading beyond the intended area of introduction Step 2

Consequences of establishment and spreading Step 3 Risk potential associated to the alien and locally absent species A single value is given based on the assessments done in Steps 1 and 2: The result of this assessment will be expressed in terms of the following risk levels: A high-risk movement:

(a) has a high risk of damaging biodiversity from spreading and other ecological consequences;

(b) operates under farming conditions which would increase the risk of such damage;

(c) involves an aquaculture facility which sells live aquatic animals for further farming or restocking;

(d) as a consequence, the movement is of major concern (major mitigation measures are required). It is advised that the proposal be rejected unless mitigation procedures can be developed to reduce the risk to low. A medium-risk movement:

(a) has a medium risk of damaging biodiversity from spreading and other ecological consequences;

(b) operates under farming conditions which would not necessarily increase the risk of such damage, taking account of the species and the containment conditions;

(c) involves an aquaculture facility which sells its products mainly for human consumption;

(d) as a consequence the movement is of moderate concern. It is advised that the proposal be rejected unless mitigation procedures can be developed to reduce the risk to low. A low-risk movement:

(a) has a low risk of damaging biodiversity from spreading and other ecological consequences.

(b) operates under farming conditions which would not increase the risk of such damage;

(c) involves an aquaculture facility which sells its products for human consumption only;

(d) as a consequence the movement is of negligible concern. It is advised that the proposal be approved. Mitigation is not needed. The proposal can only be approved as presented (no mitigating measures required) if the overall estimated risk potential is low and if the overall certainty for which the overall risk has been estimated is very certain or reasonably certain.

If, as a result of a first analysis, a high or medium category is attributed to the overall risk, then containment or mitigation proposals are to be incorporated in the application, which will be subject to subsequent risk analysis until the final rating for the overall risk becomes low with a very certain or reasonably certain assessment. Descriptions of these additional steps, together with detailed specifications of the containment or mitigation measures, will become an integral part of the risk assessment. PART 2 NON-TARGET SPECIES ASSESSMENT PROCESS Step 1 Likelihood of establishment and spreading of non-target species beyond the intended area of introduction Step 2 Consequences of non-target species establishment and spreading Step 3 Risk potential associated with non-target species A single value is given based on the assessments performed in Steps 1 and 2: The conditions applicable to the assessment of risk potential associated to the alien species (part 1) are to also apply, mutatis mutandis, to this risk potential associated with non-target species (part 2), including the obligation to introduce containment and mitigation measures. PART 3

OVERALL ENVIRONMENTAL RISK ASSESSMENT — SUMMARY REPORT — History, background and rationale for the request:

— risk assessment summary information — summary of the ecological and genetic risk assessment — summary of the non-target species risk assessment — Comments:

— Mitigation measures:

— Concluding statement on total organism potential risk:

— Advice to competent authority: