# Commission Implementing Regulation (EU) 2017/12 of 6 January 2017 regarding the form and content of the applications and requests for the establishment of maximum residue limits in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (Text with EEA relevance), Division B: Residue File

Extent: E+W+S+N.I.

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.

---
Source: https://www.legislation.gov.uk/eur/2017/12/annex/chapter/2/division/B (the official version)
Page: https://openlegislation.uk/eu-regulation-2017-12/annex/chapter-2/division-B
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.