EU Transparency Regulation – what have we learned?

Posted 28 October, 2021

The new EU regulation on transparency entered into force in September 2019 and has applied since 27th March 2021. It has brought significant changes to the approval process for regulated products such as feed additives.

We interviewed Pen & Tec´s Transparency Regulation (TR) expert, Dr Eliana Henriquez and asked her to share her thoughts.

Q: What have been the main challenges of the TR?

I would say the notification of studies and the extensive procedure for requesting confidentiality. For study notification, applicants must ensure that the laboratory where the study will be performed has an account on the EFSA Connect Portal (if in the EU or EEA), check that the laboratory-notifies the study, establish a specific date for study start and end (DD/MM/YYYY) and notify the study before the start date, and to provide proper justifications if studies have to be withdrawn or the start and/or end date change. The new confidentiality procedure means that in addition to confidential and non-confidential versions of dossiers and annexes, applicants must also provide written justification for each piece of information they wish to keep confidential.

Q: How has the TR impacted timelines?

Applicants will need more time to build a feed additive dossier. For example, requesting an account on the EFSA Connect Portal (~3-4 weeks), notifying studies, requesting pre-submission advice for renewal dossiers, preparing confidential and non-confidential versions of the dossier and annexes, as well as drafting justifications for all confidential information. In relation to the risk assessment performed by EFSA, timelines could be increased by 6 months if applicants do not notify studies properly.

Q: What key lessons has Pen & Tec learned over the past six months?

It is important to closely monitor the platforms for pre-submission activities and dossier submission since they are still not working 100% and updates are still being implemented. It is also important to communicate with the authorities so they can clarify situations not clearly contemplated in either the TR or the Practical Arrangements, especially for dossiers where the TR will apply partially.

Access Pen & Tec´s webinar on the Transparency Regulation: