For several weeks the EFSA has rejected several authorization application dossiers (Novel Food, Food and Feed additives, Food Enzymes, Recycling Processes, Substance to be used in plastic materials) within the framework of the administrative evaluation of the dossier, on the basis of unjustified absence or delays in the notification of the studies presented in these dossiers.
Since March 27, 2021, and the implementation of the new regulation on transparency and sustainability of EU risk assessment in the food chain (Regulation (EU) 2019/1381), all studies, defined as experiment or set of experiments in which a test item is examined under laboratory conditions or in the environment to obtain data with respect to the properties and/or the safety of that test item, submitted to the authority, as part of an assessment safety, and started after the 27 march 2021, must be properly notified.
The purpose of this notification is to ensure that all the data produced for the application are presented in the evaluation dossier. Article 32 ter of Regulation (EU) 2019/1381 states that economic operators, laboratories and other test facilities located in the Union shall notify the Authority without delay of the title and scope of any study that they commissioned or performed in support of a claim or notification, together with the laboratory or testing facility performing that study, and its start date and expected completion date. Based on the details provided by EFSA, the studies must be notified before the start of the studies.
In accordance with this transparency regulation, an application or a notification cannot be considered valid or admissible when it is supported by studies which have not been notified beforehand or have been notified with delay, unless the applicant or the notifier provides a valid justification for not reporting these studies or delaying reporting. In this context, requests presenting data from studies not notified or notified late, without admissible justification, risk rejection by EFSA. Regulation (EU) 2019/1381 stipulates that dossiers rejected for a lack of conformity in the notification of the studies can be the subject of a new request which will be assessed 6 months after notification of the studies.
The transparency regulation is therefore an additional complexity in the process of authorization of new ingredients and must be considered before any experiment designed for an EU approval for any ingredient.
Do not hesitate to contact us for any clarification on study notification or management of authorization process for your new products.
