EN Official Journal of the European Union L 4/1

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)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (1), and in particular Article 13(1) thereof,

Whereas:

(1) Pharmacologically active substances are classified on the basis of opinions on maximum residue limits (MRLs) issued by the European Medicines Agency (EMA).

(2) An application for an opinion to establish the MRL is submitted to EMA. It is necessary to provide a standard format for submitting such applications and to list the information requested to accompany such applications.

(3) Under certain circumstances, the Commission, a Member State, an interested party or organisation may submit a request to EMA for an opinion to establish the MRL. It is necessary to provide a standard format for such requests and to list the information that should accompany them.

(4) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,

HAS ADOPTED THIS REGULATION:

Article 1

Form and content of applications and requests

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.

Article 2

General requirements for applications and requests

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.

Article 3

Entry into force

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

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 6 January 2017. For the Commission The President Jean-Claude JUNCKER

(1) OJ L 152, 16.6.2009, p. 11.