Companies keen on bringing innovative new ingredients and products onto the EU market need to meet stringent novel food criteria. At this year’s Fi Europe, a leading expert will be on hand to guide manufacturers through this rigorous process.
In EU and UK, a novel food is defined as food that has not been consumed to a significant degree by humans in the EU before 15 May 1997. What this means in effect is that any ingredient or product that meets this criterion must undergo a rigorous assessment to demonstrate that it is safe under the proposed conditions of use.
“The scientific requirements are clear,” says Prof Dr Hans Verhagen, an academic, former chair of the EFSA (European Food Safety Authority) Novel Foods working group, and now a private consultant. “Companies wishing to bring onto the market innovative foods and ingredients need to file a dossier.”
The original Novel Food Regulation (258/1997) was criticised because the procedure took too long. Another criticism was that traditional foods from third countries, enjoyed safely for years, faced hurdles to enter the EU market.
This led to a revision of the Novel Foods Regulation in 2015, which came into force on 1 January 2018 (Regulation 2283/2015). “Dossiers now go straight to EFSA, which provides for faster processing,” explains Verhagen. “A simplified notification procedure for traditional foods from third countries was also introduced. In general, these procedures work well. While the formal procedures for novel foods are very different in other countries like the UK, US, Singapore, and Australia and New Zealand, the scientific requirements are very similar.”
At Fi Europe in November, Dr Hans Verhagen will deliver a presentation entitled “Novel Foods in the EU and UK: Challenges and opportunities”.
One aspect of Europe’s novel food authorisation procedure that makes it stand out is its scientific rigour. “The requirements are very robust,” says Verhagen. “I’m proud to have worked on EFSA’s novel foods working group for […] three years and that I could even chair it for one round.”
While scientific rigour is a key strength of the EFSA evaluation procedure, it also means that approvals can still take a long time. “Companies need to generate a lot of safety data for their dossiers, and the process can take about three years in total,” says Verhagen. “This is not always attractive to businesses. Other countries, like the US for instance, can be much faster.”
Another challenge, says Verhagen, is simply the number of dossiers that EFSA must manage. “When I began working with EFSA in 2006, I’d say we had a handful of dossiers every year,” he says. “This was manageable. Now, I’d say the number of applications has increased ten-fold, creating an avalanche of work.”
Another issue for companies is the EU’s transparency requirements. The full dossiers will ultimately end up in the public domain, unless there is a justifiable reason for confidentiality, such as production methods.
Verhagen believes there are two key principles that food manufacturers should bear in mind when it comes to novel food submissions. The first is that the science should lead. Novel food evaluations are science-based, and science-based only, he says.
“Second, once you start thinking of making [a] dossier, do it in a prudent way,” he says. “Think before you start. Do what is required, but don’t overdo it. Just focus on the data that is relevant for safety and show that your product is safe under the proposed conditions of use and not nutritionally disadvantageous.”
One strategy could be to spend time studying previous cases, to source some of the scientific data needed. This can save time and resources. Verhagen points out that alternative protein ingredients tend to be very similar in terms of chemical makeup. What is important is to have a sufficiently large database of relevant information.
“I’m still working a lot on novel foods,” says Verhagen. “For example, I’m currently advising many companies preparing novel food dossiers, and I am a member of the UK Advisory Committee on Novel Foods and Processes (ACNFP) since 2021. I am also frequently lecturing on this topic. I like this work – it is good science, and it is challenging.”
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