EU SPCs will now be prepared at IUCLID

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EU SPCs will now be prepared at IUCLID

EU SPCs will now be prepared at IUCLID

20.02.2024

About SPC IUCLID

The SPC Editor, which is used in the authorization process of biocidal products at the European Union level, has been phased out. Henceforth, SPCs (Summary of Product Characteristics) for your biocidal product authorization applications will be prepared in SPC IUCLID.

IUCLID has been developed by ECHA to prepare and update Summaries of Product Characteristics under the Biocidal Products Regulation of the EU. These Summaries of Product Characteristics are necessary for biocidal product authorization applications.

The features of SPC IUCLID can be summarized as follows:

  • It contains the same content as SPC Editor.
  • There is a special IUCLID interface for individual products or product families.
  • Verification rules are available for reference while checking integrity and consistency.
  • Translations are available.
  • Instead of "Comments," there are "Annotations."
  • It includes extensions such as the Comparison Tool and Report Generator.

 

From now on, the Product Characteristics File must be prepared in IUCLID format (.i6z) for updates made or to be made in the biocide application tool named R4BP 3. While the SPC files in ongoing or approved applications that started in R4BP 3 before this new feature of IUCLID was introduced will be automatically converted to the new format, it is recommended that users check these for exceptional cases.

Previously used SPC Editor has been removed from the ECHA website and is no longer accessible. However, users can upload old SPC files in ".xml" format to IUCLID. In this case, these files will be automatically converted to IUCLID format.

According to ECHA, this change will reduce data duplication, improve document management, and enhance security. Thus, the preparation process for the authorization of biocidal products will be facilitated.

You can review ECHA's Biocides Submission Manuals for information on the changes made. Additionally, you can download IUCLID 6 from the official website or directly use it by creating an account on ECHA Cloud Services. You can also refer to ECHA's relevant webinar content for detailed information on IUCLID SPC.

This article was originated from ECHA. 

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