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.
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.
Did you know?
In the future you must prepare SPC files in IUCLID instead of the SPC Editor.
The updated version of the SPC format will be compatible with IUCLID, a tool developed by ECHA in collaboration with the OECD, which promotes the harmonisation of chemicals data. You can find additional information about this tool on the IUCLID website.
You will have to
- use IUCLID to prepare SPCs in .i6z file format
- archive your SPC dossiers in IUCLID Cloud
- exchange your SPCs with authorities easily thanks to integration between IUCLID Cloud and R4BP
spc-editor IUCLID progress graph
How to adapt your internal databases to SPC IUCLID format
Adaptation of internal databases to SPC IUCLID format
In case you need to adapt your internal databases to SPC IUCLID format, the following support materials are available to help you implement the SPC IUCLID format outside of the ICULID tool:
- SPC IUCLID format [ZIP]
This format documentation package includes:
- List of relevant XML Schema Definitions (XSDs)
- SPC IUCLID data model
- List of IUCLID picklists
- Developers' Guide to the IUCLID i6z Format [EN][PDF]
In IUCLID, the exchange of chemical information is facilitated through a zip/archive file with the extension .i6z (IUCLID 6 zip). This file contains information concerning all (inter)related IUCLID 6 entities (documents and attachments), in a well-defined and structured format. This guide explains the structure of the IUCLID file to help developers build or consume dossiers from their own systems.