EFSA implements new measures to improve transparency standards of communication with applicants

Posted 17 January, 2019

From 1 January 2019, EFSA has decided to adopt new measures to improve transparency between themselves and applicants during the risk assessment and evaluation of regulated products such as feed additives and novel foods.

The new update will entail publishing the cover letters of all applications which are currently experiencing a clock-stop (applications which require further information/studies before they can proceed with the evaluation), with EFSA then making these letters available to the public. All cover letters published will show others why an application has been delayed and will demonstrate the communication terms between EFSA & the applicant.

After an applicant has received a clock-stop, they will be asked to respond to EFSA promptly by submitting a Cover Letter along with an Annex (the main body of the reply). The Cover Letter should use the same format as the letter issued by EFSA.

All cover letters from this phase will be published in EFSA’s “Register of Questions”, but before the public are granted access, all confidential and sensitive information will be removed. The annexes submitted will remain confidential.

This change comes after a recommendation from the European Ombudsman and aims to better interaction with applicants as well as improving the public’s understanding of the general registration process and possible scenarios.

If you require assistance with a clock-stop, Pen & Tec would be happy to assist you so please do not hesitate to get in touch by emailing: [email protected].