Annex E - Information Requirements for the Risk Profile

The purpose of the review is to evaluate whether the chemical is likely, as a result of its long-range environmental transport, to lead to significant adverse human health and/or environmental effects, such that global action is warranted. For this purpose, a risk profile shall be developed that further elaborates on, and evaluates, the information referred to in Annex D and includes, as far as possible, the following types of information:

1. Sources, including as appropriate:
   1. Production data, including quantity and location;
   2. Uses; and
   3. Releases, such as discharges, losses and emissions;
2. Hazard assessment for the endpoint or endpoints of concern, including a consideration of toxicological interactions involving multiple chemicals;
3. Environmental fate, including data and information on the chemical and physical properties of a chemical as well as its persistence and how they are linked to its environmental transport, transfer within and between environmental compartments, degradation and transformation to other chemicals. A determination of the bio-concentration factor or bio-accumulation factor, based on measured values, shall be available, except when monitoring data are judged to meet this need;
4. Monitoring data;
5. Exposure in local areas and, in particular, as a result of long-range environmental transport, and including information regarding bio-availability;
6. National and international risk evaluations, assessments or profiles and labelling information and hazard classifications, as available; and
7. Status of the chemical under international conventions.