EUROPE – COM: Update of the guidance document on the evaluation of new active substance data post-approval

The European Commission has published an update to guidance document SANCO 10328/2004 on the evaluation of new active substance data submitted after (renewal of) approval. This 10th version incorporates the conclusions from the ZAPID (Zonal Authorisation Procedure Improvements and Developments) workshop held in December 2023. The main changes are outlined below.

This new version:

• updates the evaluation process for new active substance data submitted within a PPP dossier that require assessment prior to the renewal of the active substance. Where identical data are submitted in several zones, an izRMS is appointed to evaluate these data on behalf of all concerned zRMSs to avoid duplication of effort;

• reaffirms that any change to toxicological reference values (TRVs) or residue definitions must be evaluated at the EU level;

• specifies that the handling of “data gaps” identified by EFSA—if not required to finalise a product authorisation—is postponed until the next renewal of the active substance;

• adds detailed annexes on the management of data gaps from EFSA conclusions (Annex 1) and a flowchart of the zonal evaluation process (Annex 3); and

• enhances transparency with a centralised list of new active substance data currently under evaluation, downloadable from CIRCABC.

The document applies from 21 January 2026.

To download: 

Guidance document on the evaluation of new active substance data post (renewal of) approval (SANCO/10328/2004 – Rev 10)

See also our previous articles: 

EUROPE – COM : Update of guidance documents on new active substance data post approval, on rules for revision of assessment reports and on data matching

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