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Navigating the novel food regulation: One expert’s advice for getting your dossier approved - Interview

Article-Navigating the novel food regulation: One expert’s advice for getting your dossier approved - Interview

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Ex-EFSA scientist and industry consultant Hans Verhagen shares his advice for companies wanting to improve their chances of getting their novel food dossier approved.

Hans is a board-certified toxicologist and nutritionist. For years, he was a member of the European Food Safety Authority’s (EFSA) scientific panel; today, he is the owner and founder of the Netherlands-headquartered Food Safety & Nutrition Consultancy, helping companies put together their novel food dossiers.

Hans will be presenting at this year’s Vitafoods Europe Virtual Expo, sharing his insights on “Challenges to novel foods in the EU and UK”. We caught up with him to find out more.

Click here to see the full conference programme.

What are some of the current challenges facing companies who wish to commercialise a novel food in the EU?

“The challenge is that novel foods in the EU, like in the UK and other places in the world, fall under a regulation which you need to conform with. You must make a dossier that supports the novel food being safe under the proposed conditions of use.

“And I think that's also a good development because the starting point is that our food is safe. It's required work, as you cannot bring [a food] directly on to the market without having adequate safety information.”

As a toxicology and nutrition consultant and ex-EFSA scientist, do you have any tips for companies to improve their chances of getting the dossier approved?

“Of course, on the one hand, the food needs to be inherently safe under the proposed conditions of use, otherwise you'll never make it. In addition to that, there are good guidance [documents] from EFSA on how to build a dossier for novel food or traditional food from third countries.

“When you are starting to prepare such a dossier, it is advisable to think what you must do and also about what is not required. So careful planning and, at an early stage, embarking on running the required tests. Note that some of the studies may take a long time – for example, stability studies or toxicology studies, etc – for which you will need to await the outcome.”

The novel food regulation is often criticised for being slow and holding back innovation in the EU. Do you think that is the case?

“It takes a while, indeed. You need to prepare a dossier, submit it to the Commission to get it evaluated by EFSA, and then the Commission and the member states need to take a decision on authorisation based on the EFSA scientific opinion. That takes quite a while – 1.5 to three years; it depends on the case.

“Preparing a dossier on a novel food or ingredient is not so different across geographies such as in the EU, the UK, the US, or Singapore. I note that in the US, the evaluation procedure is relatively quick, as per the GRAS (Generally Recognised As Safe) procedure.

“The UK has the EU novel food regulation as retained law. Hence, the UK follows the same regulation but has its own evaluation committee, of which I am a member for almost two years now. The UK is just developing the system and its pace may be different.

“I don't think [the regulation] is holding back innovation. Just realise that if you as a company want to market in the EU, you need to go through the EU procedure, and if you want to market in the UK, you go through the UK procedure; if you want to go you US, you need to follow the US procedure.”

Would you like to see the novel food regulation changed or reformed in any way, or do you believe it's currently fit for purpose?

“It has just changed, and it will not change again any time soon! I think the scientific requirements are very well spelled out. [...] The speed of the procedures are different, and you can have your own opinions about that. But obviously the EU doesn't accept US [procedures] and vice versa, and that's how life is. In addition, in the EU, under the Transparency Regulation, you need to notify the studies prior to their start.

“I'm also happy that the UK has the novel food regulation as retained law. Otherwise, companies would have to prepare a dossier twice, and that is not productive for a company.”

Are you aware of any exciting novel foods that are being developed by industry that strike you as being particularly innovative?

“I left EFSA almost two years ago now and, as a consultant, most of my activities are in the area of novel foods in the EU or UK, GRAS in the US, or Singapore. So, I see many interesting developments and that makes my day.

“I see a lot of developments in the area of, for instance, alternative proteins. Having a sufficient protein supply is a big challenge for mankind because we have many people on the planet and they need to be fed adequately. We cannot supply them all by animal sources, such as meat or eggs or dairy. We need to have alternatives in order to have a sufficient supply of protein [also regarding] amino acids.

“There are currently five interesting EU projects, one of which I am a member. Those projects are focusing on the world around new protein sources including their novel food aspects.”