Since 3 December 2014, with the release of R4BP version 3.2, a new format for the summary of the product characteristics (SPC) has been mandatory for all companies wishing to apply for product authorisations.*
In order to support companies in preparing their applications for authorisation of biocidal products, either on a national or European level, an online application called SPC Editor has been prepared by ECHA. The tool is fully compatible with R4BP 3.
Applicants can use this tool to create SPC for single products, product families and members of the family. Applicants will be able to generate either new documents or amend existing ones. For example, applicants can create a new SPC for an additional member in a product family starting from an existing SPC prepared for another member of the same family.
Authorities will also use the tool to amend and finalise the SPC while granting an authorisation.
Additionally, an updated Report Generator plug-in for IUCLID is available at the IUCLID website. The plug-in is compatible with IUCLID version 5.6 and can be used to generate a draft SPC for single product authorisations. The relevant information available in the biocidal product file in IUCLID is automatically extracted into a format which is fully compatible with the SPC Editor.
The new structure of the SPC will make data dissemination easier and, in the long run, could support the comparative assessment of different products.
* with the exception of application for products' renewal.
SPC Editor manual
Dossier submission tools