One of the prerequisites to authorize a plant protection product (PPP) is that potential residues in food and feed resulting from the intended use of the PPP are covered by EU Maximum Residue Limits (EU MRLs).

The procedure for the application and setting of an EU MRL (incl. import tolerance) is clarified in Guidance Document SANTE/2015/10595 prepared by the European Commission.

The submission and evaluation of confirmatory data for an EU MRL following the MRL review follows more or less the same procedure as a standard application for setting/modification of an EU MRL (see above). Additional guidance is available in Working Document SANTE/E4/VW 10235/2016 prepared by the European Commission.

The MRL-application form to be used is available via the link further below.

Additional practical information and particular guidance regarding the implementation of this procedure in Belgium is included in a separate document (see pdf below).

This guidance document on the dose expression for vertical crops contains all the information necessary for applicants of authorisations for plant protection products to calculate the dose per hectare leaf wall area (LWA).

A detailed overview of the data requirements and the required risk evaluations for ecotoxicology.

An overview of guidance documents available for the assessment of the physico-chemical characteristics of plant protection products, incl. information about the possibility to extrapolation packaging materials, the FAO and WHO specifications and European guidance documents on the validation of analytical methods.

New European technical and procedural guidance documents are entering into force. This has repercussions on the applications for authorisation of plant protection products and on the dossiers for the approval of active substances at European level. The timing for these new guidance documents to be applied is given in the document below.

Unless indicated otherwise in the document here under, these guidelines are available on the website of DG Health and Food Safety.

The basic spreadsheet for PEC values. Other spreadsheets (multiple application PEC calculator; first-order multiple application accumulation PEC) are available on the website of the Chemicals Regulation Directorate (CRD) from the United Kingdom.

Guidelines for the selection and application of the precautionary statements (P statements) for plant protection products in Belgium (as applied by the Registration committee from 1/4/2016). Note that P statements can be assigned by the committee if it deems to be necessary based on the risk evaluation.

This guidance has the purpose to explain how the Belgian competent authority (the Service Plant Protection Products and Fertilisers, SPF) will undertake comparative assessment and substitution, a new requirement for plant protection products introduced by EU Regulation 1107/2009, and to announce new guidance for applicants. Furthermore, we propose applicants a form in annex 2, specific for Belgium, for submitting information to support the process of comparative assessment.