Procedure for setting / amending maximum residue levels

Maximum residue levels are set in the European Union according to Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin.

The regulation stipulates that an application has to be submitted to set, amend or delete maximum residue levels. The format for the application form is based on document SANCO 4044/2008. This document also provides for a review of the impact of a new residue definition on maximum residue levels.

It is recommended to submit the application in electronic form via the BVL applicant portal. Information on registering and the link to the portal can be found under 'Electronic applications'. If it is not possible to use the applicant portal for technical reasons, the application can be submitted on paper; the corresponding form can be retrieved at the bottom of this page under "Links and Documents".

Information on filling in the application form and the documents to be submitted with this can also be found at the bottom of this page.

The enclosures to support the application should be submitted in the form of a CADDY dossier on CD-ROM or DVD if possible (one copy). Information on compiling CADDY dossiers can be found on the right. Applicants who have no possibility of compiling CADDY dossiers can submit the documentation on paper.

Suitable residue analysis methods for monitoring purposes must also be submitted together with the MRL application, or a reference to methods which have already been submitted. Where food of plant origin is concerned, as a rule residue analysis methods are only necessary for standard matrices. The requirements for monitoring methods are explained in more detail in Guidance Document SANCO/825/00. Special provisions apply to matrices which are difficult to analyse.