New guidance on processing of applications for regulated products

An administrative guidance published today sets out the principles that EFSA follows when processing applications for regulated products. This is part of EFSA’s continuous efforts to support applicants throughout the life-cycle of their applications.

The guidance enhances the transparency of the procedure and ensures that a coherent, sound, systematic and efficient process is carried out in compliance with each piece of sectorial legislation. The document describes:

• the general workflow of applications;
• the key steps of the scientific risk assessment process;
• the mechanism for suspending, restarting or extending an assessment, the conclusion of the scientific risk assessment process and the publication of the scientific output.  

The administrative guidance does not apply to pesticides processes nor to the re-evaluation of food additives. EFSA regularly updates administrative guidance to take account of amendments to legal acts, changes to guidance documents, and experience gained in the handling and assessment of applications. Applicants are therefore advised to consult the latest published version of the document available on the EFSA website.

EFSA receives around 500 mandates on applications for regulated products every year. These are governed by more than 34 EU directives and regulations and follow 39 workflows.