Administrative guidance for the processing of applications for regulated products (update 2021)

Abstract

EFSA is continuously striving to enhance its support initiatives in the area of regulated products, enhancing a customer-oriented approach, supporting applicants during the applications for regulated products life-cycle. 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 sectoral legislation. This administrative guidance for the processing of applications for regulated products describes 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, the publication of the scientific output, as well as the new requirements introduced by the General Food Law in the pre-submission and submission application procedure: general pre-submission advice by EFSA, specific aspects for intended applications for renewal (notification of intended studies, including their design, public consultation on the intended studies, renewal pre-submission advice by EFSA), notification of commissioned or carried out studies, public disclosure of non-confidential version of all information submitted in support of the application and related confidentiality decision-making process, public consultation on submitted applications. These new requirements, as implemented by the Practical Arrangements laid down by EFSA, are applicable as of 27 March 2021. This administrative guidance applies to all areas of regulated products, with the exception of pesticides and the re-evaluation of food additives. The document includes an Annex listing the indicative timelines for submitting additional/supplementary information to EFSA during the risk assessment. 1 The annex applies to all areas of regulated products. For pesticides it includes only the timelines for requesting additional studies on endocrine properties.