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. )

1 An application or a request for the establishment of maximum residue limits (MRLs) shall be submitted to European Medicines Agency (EMA) electronically.

2 The particulars and documents accompanying an application or a request for the establishment of MRLs shall be presented in accordance with the requirements set out in the Annex.

1 The information and documentation submitted as part of an application or a request for the establishment of MRLs shall be accurate and conform to the current state of scientific knowledge and the scientific guidance issued by EMA relating to the safety of residues.

2 An application or a request for the establishment of MRLs shall include any information relevant to the evaluation of the safety of residues of the substance concerned, whether favourable or unfavourable to the substance. In particular, all relevant details shall be given of any incomplete or abandoned test or trial relating to the active substance.

3 An application or a request for the extension of existing MRLs to other animal species or other food commodities shall consist of an application or request form and a residue file. EMA may request safety data if the risk assessment performed with regard to the establishment of the existing MRL is not applicable to the extension proposed.

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.