# 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), Annex: APPLICATION/REQUEST FOR THE ESTABLISHMENT OF MAXIMUM RESIDUE LIMITS

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

1..The application or the request shall include all administrative information and scientific documentation necessary for demonstrating the safety of the residues of the substance in question and risk management considerations.
2..All volumes of the dossier shall be clearly numbered and paginated. Particular care shall be taken to ensure that there is adequate cross-referencing between volumes and between the detailed and critical summaries and the original data. Electronic submissions shall comply with guidance on veterinary e-Submissions published by the appropriate authority.
3..Where reference is made to published information, complete copies of the relevant articles should be inserted in the relevant section of the dossier.
4..The application or the request shall be submitted in accordance with the requirements specified below respecting the order of presentation indicated.
5..Pharmacological, toxicological and residue tests, results of which are accompanying an application or a request for the establishment of MRLs, shall be carried out in conformity with Directive 2004/10/EC of the European Parliament and of the Council and Directive 2010/63/EU of the European Parliament and of the Council.

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