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).
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
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.
Maximum Residue Level (MRL)
You may have to apply for a new MRL as part of an active substance approval in GB. The MRL may be for:
- the representative good agricultural practice (GAP)
- additional GAPs required for product authorisation
You should discuss the number of additional crops being supported for MRL assessments at the pre-submission meeting.
For the approval of the active substance, data supporting the MRLs for the representative uses can be included in the main dossier. You should summarise the residue levels and toxicity information for metabolites in the plant and livestock metabolism spreadsheet.
You must submit an application for new MRLs.
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].