Step 2: Submission of application and supporting dossier
Submit dossiers electronically, preferably using CADDY (Computer Aided Dossier Design and supply). For information on other methods of submission email: [email protected].
Present the dossier in the format agreed by the Organisation for Economic Co-operation and Development (OECD).
OECD Guidance Documents for Pesticide Registration (OECD website).
Your dossier must consider the following data requirements under retained Regulation No (EC)1107/2009:
- active substance data requirements in retained Regulation (EC) No 283/2013
- product data requirements in retained Regulation (EC) No 284/2013
HSE guidance on fulfilling data requirements by specialist area
The dossier must include:
- full copies of all individual study reports
- risk assessment for the active substance and product (the summary dossier)
- information on at least one plant protection product containing the active substance with data to support the risk assessment required for approval of the active substance
Submit your application and dossier for a new active substance to HSE.
Submission email and postal address.
Maximum Residue Levels (MRLs) and import tolerances
You must apply to set MRLs as part of an active substance approval in GB if:
- the active substance does not currently appear in the GB MRL Statutory Register (including an application to include the active substance in Part 4 (substances exempt from MRLs)
- new MRLs need to be set to support the representative good agricultural practices (GAPs)
You must submit an CRDMRL application form. You do not need to submit an MRL evaluation report. The data and summaries can be included in the main dossier.
You may also apply for import tolerances or additional MRLs to support future GB PPP uses for HSE to assess alongside the active substance approval assessment. HSE may limit the number of additional MRLs or import tolerances to ensure the active substance approval assessment is not unduly delayed.
You should submit applications for additional MRLs or import tolerances separately to the active substance approval application and highlight the link to the approval of the active substance.
More on applying for new MRLs or import tolerances
Classification and Labelling
Substances and mixtures placed on the GB market must be classified and labelled in line with the GB CLP Regulation. The GB mandatory classification and labelling (MCL) system is managed and operated by HSE, as the GB CLP Agency.
HSE can propose new GB MCLs for pesticide active substances.
For assistance in preparing a GB MCL proposal, email: [email protected].