Division B Residue File

The dossier of residue tests shall include the following documents:

• an index of all studies included in the dossier;

• a statement confirming that all data known to the applicant/requestor at the time of submission, whether favourable or unfavourable, are included;

• a justification for the omission of any type of study;

• an explanation for the inclusion of an alternative type of study;

• in cases where a study pre-dates Directive 2004/10/EC or GLP status is unknown, a discussion of the contribution that any non-GLP study can make to the overall risk assessment.

Each study report shall include the following documents:

• a copy of the study plan (protocol, including amendments and deviations);

• a signed statement of compliance with GLP, where applicable;

• a description of the methods, apparatus and materials used;

• a description and justification of the test system;

• a description of the results obtained, in sufficient detail to allow the results to be critically evaluated independently of their interpretation by the author;

• a statistical analysis of the results where appropriate;

• a discussion of the results;

• a detailed description and a thorough discussion of the results of the study.