THE DANISH GOVERNMENT ANNOUNCED THAT IUCLID MUST BE USED TO GENERATE PRODUCT SUMMARIES

The Danish government announced that IUCLID must be used to generate product summaries

The ‘European Chemicals Agency (ECHA)’ has released a new version of IUCLID i.e. v7.12.4, the International Uniform Chemical Information Database, bringing improvements to submissions for biocidal products and streamlining data management across various regulations.
‘Danish Environmental Protection Agency’ also mentions manufacturers of biocidal products in the European Union take note! Starting February 12, 2024, all applicant needs to create and submit their product summaries (Summaries of Product Characteristics, SPCs) exclusively through the IUCLID platform. This change streamlines the approval process and enhances data management across the biocidal products landscape. The old XML format will be phased out. Existing approved SPCs will be automatically converted to the new format between February 7th and 12th.

Benefits for Applicants and Authorities

• Efficient data management: Store and manage all product-related information in one place.
• Easier compliance: Ensure submissions meet regulatory requirements.
• Simplified collaboration: Share data seamlessly with authorities and other stakeholders.

All you need to know submission of an application!
Applicants should start preparing SPCs in IUCLID for new applications and update existing applications with SPCs in XML format.
Authorities shall adapt internal processes to receive and work with SPCs submitted in IUCLID.

What’s changing?

• As of February 12th, the previous XML format for SPCs is retired. All ‘new and existing SPCs must be created and submitted through IUCLID’, a user-friendly database for chemical information.
• IUCLID now includes ‘a dedicated category for SPCs’, aligning with the data package structure for biocidal product applications.
• Store and manage all product-related information, including SPCs, within a single platform for improved efficiency.
• Existing approved SPCs published by ECHA or under processing at R4BP (Register for Biocidal Products) will be automatically converted to the new IUCLID format between February 7th and 12th.

The adoption of IUCLID is a major step in expediting the approval of biocidal products and promoting smooth data management. Industry and authorities may benefit from increased efficiency and regulatory compliance by utilizing IUCLID’s capabilities, which will eventually help to create a safer and more transparent biocidal product landscape.

Reference:

https://iuclid6.echa.europa.eu/view-article/-/journal_content/title/iuclid-service-release-v7.12.4
https://mst.dk/nyheder/2024/februar/produktresume-for-biocidprodukter-skifter-format