Characteristics
A product can be authorised only if EU-MRLs (Maximum Residue Limits) that cover the requested use have been published in Annex II/III of Regulation (EC) 396/2005, or if no MRLs are required according to Annex IV of this Regulation.
Product authorisation and MRL-setting are two separate processes, following diverse timelines. Mostly and MRL process takes longer than a national application for authorisation. Therefore, we do advice to submit an application for MRL setting before the application for authorisation. It is more likely than, the MRL has been set when the authorisation process ends.
The legal basis
For active substances, maximum residue levels are set in accordance with Regulation (EC) No 396/2005.
Data requirements
The MRL application form must be accompanied by a complete dossier. This dossier should be prepared according to the requirements in Article 7 of Regulation 396/2005/EC.
Co-ordinating bodies
Clear roles of the Member States, EFSA and the Commission in the setting of MRLs. Standing Committee on Plants, Animals, Food and Feed (SCFCAH), Section “Phytopharmaceuticals-Pesticide residues”.