New summary table available for applications for authorisation
Companies applying for authorisation for their substances need to fill in also a summary table of their risk management measures and operational conditions.
Helsinki, 12 June 2015 - The table, which summarises the representative and relevant risk management measures (RMMs) and operational conditions (OCs) set out in the exposure scenario (ES) from the chemical safety report (CSR), will facilitate the enforcement process and will provide authorisation holders and downstream users with a simple format easily translatable into the local national language where the authorised use takes place.
The summary needs to be clear, unambiguous and presented in a tabulated manner, describing the RMMs/OCs for safe use of the substance. The applicant will compile the information required for the table from the full set of conditions which should be described in the exposure scenarios included in the CSR. There are no additional information requirements due to this new document.
The table is now a mandatory document to be filled in and submitted as a part of the application for authorisation dossier.