The status of alternative protein approvals in the EU, Singapore, UK & the USA

In this report, we have summarised the regulatory status of alternative proteins in the EU, UK, US and Singapore primarily looking at the number of applications in each country and the time to approval.

In terms of the number of approvals and the time it takes, the EU is lagging behind. In total, there are four alternative proteins approved and the average time from dossier submission to approval is 28 months. Whereas the USA is way ahead, with 18 approvals under the

Generally Recognised as Safe (GRAS) pathway and an average time from submission to a no questions letter of 10 months. The majority (50%) of approvals are for plant-derived

proteins.

Since the UK left the EU, there are two alternative protein novel food dossiers under

evaluation but neither have received approval. It will be interesting to see how the UK will redraw their novel food regulatory framework in the future, and whether they will achieve their ambition to build a framework which they say will be “the best in the world for innovators, investors and consumers”.

As we all know, Singapore was the first nation to approve a cell-cultured product and the timelines they outline in the latest guidance says approval time is in the region of 9 months to a year. Currently, Singapore does not publish a positive list of approved novel foods.

Many countries look to the EU regulatory framework for assessing the safety of regulated products in the food chain due to the stringent evaluation process and safety data

requirements. However, the results from this report indicate that the regulatory framework in the EU is a barrier to alternative proteins reaching the market. Moreover, the Singapore Food Agency (SFA) and the US FDA encourage applicants to engage with them to discuss the content of the dossier and the studies required to support safety in pre-submission

meetings. This approach allows applicants to better understand the requirements and ensure that their dossier meets the authorities’ expectations, which is likely to expedite the evaluation and approval process.

Download the complete report here: https://www.amgenconsulting.com/post/thestatusofalternativeproteinapprovalsintheeu-singapore-uk-theusa