EFSA is continuously striving to enhance its support initiatives in the area of regulated products, enhancing a customer - oriented approach, supporting applicants during the whole life - cycle of the applications for regulated products. EFSA is registering around 500 mandates on applications for regulated products on a yearly basis governed by more than 34 different EU Directives and Regulations and following 39 workflows. In this context, EFSA developed this administrative guidance on the principles followed to process applications for regulated products in order to enhance transparency and understanding, and to ensure that a coherent, sound, systematic and efficient process is carried out, in compliance with each sectorial legislation. This administrative guidance for the processing of applications for regulated products describes in a harmonised way: the general workflow of applications, the key steps of the scientific risk assessment process, the mechanism of suspension / extension of the scientific assessment, its restart, the conclusion of the scientific risk assessment process and the publication of the scientific output. This administrative guidance does not apply to pesticides processes and to the re - evaluation of food additives which will be integrated in the document in a next version. EFSA will up date the administrative guidance for the processing of applications for regulated products, when needed, in line with amendments to the legal acts, to relevant changes to guidance documents and/or approaches, and according to the experience gained in handling and assessing applications. Applicants are advised to always consult the latest published version of this document available on the EFSA website.
First published in EFSA Supporting Publications:
15 January 2018
15 December 2017