SPC integration in IUCLID
What is the SPC?
The Summary of Product Characterics (SPC) is an integral part of the application for a biocidal product or a biocidal product family authorisation as laid down in Article 22 of the Biocidal Products Regulation (BPR, Regulation (EU) 528/2012). It is one of the mandatory files for applications submitted to ECHA through the Register for Biocidal Products (R4BP 3) for national authorisations, mutual recognitions, union authorisations and simplified authorisations. The SPC contains important information about the biocidal product to be placed on the market, such as the product trade name(s), the authorised uses with the relevant directions for use and classification and labelling.
So far, the online application „SPC editor“ made available by ECHA has been used by applicants to generate the SPC in .xml format and by authorities to amend and finalise the SPC while granting an authorisation.
What is changing in 2023?
In order to promote the harmonisation between the information provided in the SPC and the IUCLID dossier for EU BPR authorisations, the SPC is currently being implemented into IUCLID as a selectable working context. Following the IUCLID October release in 2023, the SPC has to be prepared as a dossier (.i6z format) in IUCLID and submitted as .i6z file in R4BP 3. The SPC editor will be decommissioned in parallel at that time.
All SPCs previously prepared in the SPC editor as .xml file can be directly imported into IUCLID. Consequently, there are no delays for SPC work expected and there is currently no phase of transition planned for this change.
What does this mean for applicants?
- Following the October 2023 IUCLID release, a working IUCLID environment will be required to generate the SPC as .i6z file for submission.
o Do you have access to a working IUCLID environment?
o Are you knowledgeable in IUCLID?
o Are you able to prepare a SPC file in IUCLID which complies with EU BPR obligations?
o Are you aware of possible issues when working in IUCLID, e.g. overwriting issues during file import or when working with inbound/outbound references?
- ECHA’s IUCLID Cloud services can be used to prepare and archive the SPC files. However, other IUCLID installations such as IUCLID desktop and IUCLID servers can be used as well as they provide the same functionalities for the SPC creation.
- Professional translation services supporting with SPC translations into the languages required by different Member States will not have access to the SPC editor anymore once it is decommissioned. Companies working with translation services should plan ahead and adjust their procedures accordingly. This is especially important for time-sensitive SPC translation periods (14 days) as defined for union authorisations and mutual recognitions in parallel.
- For SPCs saved in internal company databases, ECHA has already provided support materials to facilitate the implementation of the SPC IUCLID format outside of IUCLID: https://iuclid6.echa.europa.eu/sv/web/guest/support/dossier-submission-tools/spc-editor
Are you sufficiently prepared for this change?
Do you want to deepen your IUCLID knowledge and learn how to create the SPC in IUCLID?
Check out the trainings offered by knoell in this context.
Do you need professional support in the future with the SPC preparation in IUCLID?
Learn more about our dedicated biocides services or contact us for IUCLID SPC services tailored to your individual needs.