Implementation Reg. EU No. 1381/2019 – Transparency Regulation
Starting from 27th of March 2021 Reg. EU No. 1381/2019 – Transparency Regulation influences all applications for Regulated Products authorization, including food and feed additives, novel foods, food enzymes, flavorings and GMOs.
Food businesses who want to apply for a Regulated Product should prepare for updates regarding:
Notification of Studies (NoS)
All studies commissioned or carried out after 27th March 2021 must be notified to EFSA’s NoS database before starting the study. EFSA recommends to submit the notification at least 5 months before the studies are started in order to allow for the appropriate consultation to take place. The definition of “study” is quite broad, so that this Regulation will impact on most analysis and studies, including analytical, stability and toxicology.
The Laboratory conducting the analysis will be required to co-notify the study.
Third parties, such as regulatory consultants, can also notify intended studies on behalf of the business operator who commits it.
Public Consultation
Public consultation will be available on the EFSA website for 3 weeks before the EFSA review starts. This means that a non-confidential version of the documents will need to be available for consultation. All notified studies will be included.
EFSA pre-submission
A new official system of advice by EFSA will be introduced. It will consider up to 2 requests. This feedback will be public, as part of the Public Consultation.
Electronic submission
All applications will now be submitted via website. It will be similar to the current novel food e-portal. This involves extensive administrative requirements whereby the application dossier needs to be split into the main sections for review.
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LabAnalysis can support its Customers throughout the new process.
Our Laboratory is already accredited on EFSA portal.
We can also offer, as third party regulatory consultants, consulting and notification services.
Need more information? Contact us at regulatory@chemservice.it