The evaluation process begins once the dossier has passed the completeness check, and the fee for evaluation has been paid. Dossiers for new active substances are given priority (as these substances are not yet on the market) over existing active substances that are undergoing review.
Within HSE a project team (including experts on chemistry, efficacy, human toxicology, occupational hygiene and environment) will be assigned to each active substance dossier. A project team manager is assigned as the point of contact with the applicant and he/she maintains regular contact with the applicant and the project team so that if problems are encountered they can be discussed and resolved quickly.
During the evaluation process the project team members will assess the hazard and exposure data provided, and request additional data/explanations from the applicant as necessary via the project manager. The risk assessment submitted by the applicant is reviewed, and modified (if necessary) to ensure it is robust, complete and in line with EU guidance (eg TNsG on Human Exposure and TGD on Risk Assessment).
Once the preliminary evaluation is completed HSE makes it available to other UK Government Departments for comment. This preliminary evaluation is also sent to the applicant who is currently allowed 2-4 weeks to respond with their comments. Comments received are considered, and incorporated as appropriate, before the document (Rapporteur Member State evaluation) is sent to the EU Commission for placing on their Communication and Information Resource Centre Administrator website (CIRCA).
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