# 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), Chapter 1: ADMINISTRATIVE INFORMATION

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

The administrative information shall comprise two parts, one providing the administrative data and the second providing a summary of the evaluation proposed by the applicant/requestor.
The following details shall be included:
Part 1 — Administrative data:
name of the substance for review, using international non-proprietary name (INN) where attributed;
name and address of the applicant/requestor;
name and address details of the applicant/requestor contact point for all correspondence related to the application;
Part 2 — Summary of the evaluation proposed by the applicant/requestor:
name of the substance for review, using INN where attributed;
clarification on whether the substance is used in the product as active ingredient, excipient, preservative, etc.;
summary of anticipated pattern of veterinary use (target species, major indications, dose-regimen);
information on any applications to other Union or international bodies, the dates of these applications and the outcome;
summary of the findings:
relevant no-observed (adverse) effect levels (NO(A)EL) or an accepted alternative for the safety evaluation,
reference to relevant study,
uncertainty factor proposed,
Acceptable Daily Intake (ADI) proposed, or an alternative in accordance with Article 6 of Regulation (EC) No 470/2009,
marker residue (where relevant),
MRLs proposed (where relevant),
method of analysis proposed (including limit of quantification and reference, where relevant).

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Source: https://www.legislation.gov.uk/eur/2017/12/annex/chapter/1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2017-12/annex/chapter-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.