What’s wrong with Europe’s novel food approval system?

The European Food Safety Authority launched the novel food regulation on 15 May, 1997. Demand was relatively quiet, with few applications for approval over the proceeding five or so years.

However, as activity ramped up, the regulation has been updated several times and the market is submitting an average of 40 new dossiers a year, versus just a handful in the early 2000s.

So is the system fit for purpose – even after new processes come into force​ – and if not, what are the pinch points?

The hoops of novel foods approvalThere are many hoops businesses must jump through when seeking novel food approval, explained professor Hans Verhagen, owner and consultant at Food Safety & Nutrition Consultancy.

This includes verifying a food or ingredient’s novel food status, submitting an application to register or verify a food and, depending on the outcome, compiling a dossier to gain approval. A process that can take months to complete, said Verhagen, who was speaking at Food Ingredients Europe this week.

“The goal is to establish it [the food or ingredient] is safe to consume, not misleading and that there are no nutritional disadvantages,” he said.

Elements in the new updated guidance include clarity on food from cell cultures, or tissue cultures derived from animals, plants, etc… It also covers foods containing or consisting of engineered nanomaterials.

But that’s positive and progressive. There are system challenges, like the EU’s 2021 transparency regulation. “It means the entire risk assessment procedure is in the open and comprises elements of public consultation,” said Verhagen.

Some businesses could push for confidential approval, however, most would have their products open for competitors to view.

Grey area of novel foods enforcementThere is also a grey area when it comes to enforcement, creating another potential competitive disadvantage and challenge, Verhagen pointed out. “If you [a company] don’t do the process, then maybe no authority would know. We’ve found several dozen novel foods on the market without evaluation,” he said, citing a study he led in 2009.

This means there are potentially risky products in markets that have not gained EFSA’s novel food approval.

The number of questions EFSA can ask a business about an application is also considered a process hindrance. The questions are vast, ranging from allergenicity to history and unclear descriptors – though questions are essential to ensuring consumer safety, it is difficult to prepare dossiers that answer everything to ensure a speedier process.

Finally, the system isn’t yet set up to deal with the high number of alternative proteins coming onto the market and dealing efficiently with the likes of toxicity and tasting, he added.