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AMGEN Regulatory Wrap-Up 2021

Updated: Jan 6

2021 was an exciting year for alternative proteins. In this article, I have summarised the major EU regulatory updates relating to alternative proteins during the last year.



What did we learn?


The new EU Transparency Regulation has made the novel food authorisation process more complex in terms of the obligation to notify studies and to submit a confidential and non-confidential version of your dossier.

We saw six EFSA opinions for alternative proteins, three were related to insect protein and the other three were related to plant proteins.

The average time from dossier validation to an EFSA opinion was 21 months and the average number of clock-stops issued by EFSA was three.

Four of the six applications received a positive EFSA opinion. Interestingly, the two applications that submitted the full suite of toxicological studies were the ones to receive a negative opinion, which highlights that even when the full suite of toxicological studies is performed, this does not guarantee a positive EFSA opinion.

We saw EFSA accept literature and history of safe use to waiver toxicological studies, which is great news!


We saw four novel food approvals for alternative proteins, all being insect proteins. One EU Member State delegation was not in favour of approving any of the insect proteins as they stated that as there is no protein deficiency in Europe that would make insect consumption necessary as food.


Interestingly, Wolffia arrhiza and/or Wolffia globosa was approved as a traditional food from a third country even though the novel food application for Wolffia globosa powder received a negative opinion from EFSA.

Data protection was granted for many different types of data not just for safety studies. Data such as manufacturing processes, analytical data, stability data, protein digestibility and intake assessments were accepted, which is good news for applicants.

The EC study on new genomic techniques was published although there were not any major breakthroughs that will affect the alternative protein industry just yet.

What does 2022 hold?


2022 looks to be another promising year for alternative proteins. There are five alternative protein applications due for an EFSA opinion during 2022 and another three pending to pass validation. Most of these applications are related to plant proteins.

I also predict that the first cell cultured meat/fat dossier will be submitted… so watch this space.

Whatever happens, 2022 will be another strong year for the alternative protein sector and I am sure we will see lots of new and exciting products hit the market (e.g., The long anticipated Just Egg… once the NF approval for mung bean protein is granted by the EC, which will hopefully be very soon!).

Happy New Year!


To read the full report click on the link below:


Amgen Consulting_Regulatory_Wrap_up_2021
.pdf
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